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September 23, 2022

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Welcome to the latest edition of the BioLines Weekender...

New Jersey’s innovative life sciences industry develops groundbreaking treatments and cures upon which Patients everywhere depend. Medical innovation also supports a healthy New Jersey economy. But a threat is looming. Patients and innovation itself may be endangered.

Bad actors across the healthcare system ─ including pharmacy benefit managers (PBMs) ─ have significant influence over the treatments Patients can access. PBMs manage prescription drug benefits on behalf of health insurers, Medicare Part D drug plans, large employers, and other payers. While Patients with chronic conditions like cancer typically require long-term, continuous treatment to slow or prevent the progression of a disease, medicines to treat those conditions are most frequently excluded from PBM formularies. 

In a new BioNJ guest blog, Patricia Goldsmith, Chief Executive Officer of CancerCare, speaks to how the recent progress made in developing new oncology therapies has brought new hope to millions of Americans who have received a cancer diagnosis, and why we must all work together to protect the frameworks that bring new therapies forward. 

Click here to read Patricia's blog post, entitled "Innovation in Cancer Therapies: Protecting Patient Access and Future Cures"

Meanwhile, BioNJ President and CEO Debbie Hart, authored an op-ed, entitled "A Missed Opportunity for Patients and for Medical Innovation," which speaks to the negative impact of the Inflation Reduction Act of 2022, recently signed into law by President Biden. Click here for a copy of the op-ed published earlier this week in New Jersey Business Magazine.

Please join BioNJ in our efforts to advocate for policies and solutions that help Patients access the medicines they need and promote a thriving life sciences industry in New Jersey and beyond. Click here to learn more.

Because Patients Can't Wait®,

The BioNJ Team

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Upcoming BioNJ Events


BioNJ's Member Café

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October 12, 2022

BioNJ's C-Suite Summit

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October 18, 2022

BioNJ's IT/Cybersecurity Breakfast Briefing

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October 27, 2022

BioNJ's Inspiring Women in STEM Conference

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December 2, 2022

BioNJ's Patient Advocacy Summit

Attendance is exclusive to Patient Advocacy Groups and R&D company Patient advocacy and government affairs professionals.

Register Today!

December 13, 2022

Putting Patients First:

The Value of Medical Innovation


Peer Review Study Finds The Total Amount Of NIH Funding Is Not Statistically Significant For The Likelihood Of A Drug’s FDA Approval

The economic consultancy Vital Transformation (VT) has published a peer reviewed study comparing the levels of National Institutes of Health (NIH) and private funding of therapies to the likelihood they received FDA approval. The study found a positive and significant relationship between private sector funding and the likelihood of FDA approval, but the relationship between public funding and FDA approval was negative and not statistically significant. NIH funding and private sector funding for 18 FDA-approved therapies was calculated from a starting point of NIH grants awarded in the year 2000. NIH funding totaled $0.670 billion, but in contrast, private sector funding for those same 18 therapies totaled $44.3 billion, 66 times the total amount of NIH funding.

BioNJ in the News


BioNJ President and CEO Debbie Hart Appointed as New Commission on Science, Innovation and Technology Chair

Governor Phil Murphy has appointed BioNJ President and Chief Executive Officer (CEO) Debbie Hart as the next Chair of the Commission on Science, Innovation and Technology (CSIT). CSIT is tasked with leading the way in promoting the State as a home for academic and technological research, development and commercialization. The Governor signed legislation in 2018 re-establishing the former New Jersey Commission on Science and Technology as the CSIT and appointed Hart as the Commission’s Vice-Chair at that time. CSIT is comprised of representatives from the public and private sectors, as well as academia. To date, CSIT has provided nearly 150 startups with a total of over $6 million in funding.

A Missed Opportunity for Patients and for Medical Innovation

Op-ed by BioNJ President and CEO, Debbie Hart

President Biden recently accomplished a signature goal of his presidential agenda by signing the Inflation Reduction Act of 2022 (IRA) into law. While some will argue that this revised version of the Build Back Better Act will improve healthcare affordability for Americans, policymakers in Washington missed a prime opportunity to enact meaningful change for Patients by ignoring the profound negative impact that such policy will have on future medical innovation and discovery. We can’t course correct what the president codified by signing this legislation into law, but we can recognize future opportunities to ensure Patient access to current and future medicines.

BioNJ Holds In-Person Manufacturing Brief at NJIT

BioNJ’s Manufacturing Brief returned to an in-person format at the New Jersey Institute of Technology’s Newark campus. “This is our first in-person biomanufacturing conference in two years,” said Debbie Hart, President and CEO, BioNJ. “At BioNJ, we want to make sure that we’re supporting New Jersey’s life sciences ecosystem and make sure that it is a place where innovation is happening unencumbered and then patients can access that innovation.” The pandemic played a central role in the topics and issues covered during the event, with many panels focused on navigating the new normal that COVID-19 has created in the world and within the biomanufacturing industry. “Biomanufacturing has been evolving over many years recently, and not ever more so than during COVID-19,” said Hart. “And this discussion today, I think it’s really timely and important. We have an impressive roster of thought leaders with us.”

BioNJ Details Agenda, Speakers for C-Suite Summit 

BioNJ, the statewide life sciences advocacy organization, has announced the agenda and speakers for its 10th annual C-Suite Summit. The event will take place Oct. 18 at the Bridgewater Marriott. BioNJ said that the Summit will bring together life sciences executives from companies ranging from early to late-stage, public and private, and more to discuss topics affecting C-suite decision-making. “We have entered a new era in how leaders are shaping the next generation of innovation and the way in which patients are impacting the life sciences industry,” CEO and President Debbie Hart said. “From new modalities, AI-driven drug discovery and digital therapeutics to a reshuffling of the ecosystem, we are witnessing an unparalleled opportunity to revolutionize patient care globally.”

NJ Company News


Gilead, Impressed by Talent Pool and State’s Commitment to Shared Values, is all in on N.J.

When BioNJ Member Gilead Sciences Inc. acquired Morris Plains-based cancer treatment specialist Immunomedics, it did so under the idea that it was getting far more than just access to Immunomedics’ potentially game-changing drugs for the treatment of certain cancers. Gilead was getting access to New Jersey, too. Gilead recently signed an 11-year lease to take nearly 100,000 square feet of space in Latitude, the ultramodern office complex in Parsippany — a space it currently is building out to ensure it reflects the culture of the company. Gilead also has upped its desired employee count at the office to 550 – 100 more than it had previously stated. It is doing all this for one reason: In the limited time the company has been in the state, Gilead officials have found New Jersey to be even better than they hoped.

WHO Expands Recommendation for Veklury® (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline

BioNJ Member Gilead Sciences Inc., with a site in Morris Plains, announced updates to the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline, which now conditionally recommends Veklury® (remdesivir) for the treatment of patients with severe COVID-19 and continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization. The WHO conditional recommendation for Veklury’s use in the treatment of patients with severe COVID-19 is mainly driven by the final results of the WHO-sponsored SOLIDARITY study, which showed a statistically significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline, compared to standard of care (RR: 0.83; 95% CI: 0.75–0.93). 

CHMP Adopts Positive Opinion to Extend Indication of Veklury® (Remdesivir) for the Treatment of Pediatric Patients With COVID-19

BioNJ Member Gilead Sciences Inc., with a site in Morris Plains, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury® (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen. 

BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults With Marginal Zone Lymphoma

BioNJ Member BeiGene, with a site in Hopewell, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of BRUKINSA ® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. “There are currently no BTK inhibitors approved for MZL in Europe and with this positive opinion, we are one step closer to bringing forward a chemotherapy-free treatment option for this rare blood cancer. We look forward to a decision from the European Commission in the coming months,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.  

NICE Recommends BeiGene’s BRUKINSA® (zanubrutinib) for Patients With Waldenström’s Macroglobulinemia Who Have Had at Least One Treatment

BioNJ Member BeiGene, with a site in Hopewell, announced that England’s health technology assessment institute, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal document (FAD) recommending BRUKINSA (zanubrutinib) for the treatment of Waldenström’s Macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable. This decision from NICE marks BRUKINSA as the first and only treatment for WM to be recommended for routine use in England and Wales. The NICE Committee acknowledged the high unmet need for an effective and well tolerated treatment for WM “where current chemoimmunotherapy options can cause severe adverse reactions and the need for frequent hospital visits”.

Celsion Completes Enrollment of the Phase I/II OVATION 2 Study With GEN-1 in Advanced Ovarian Cancer

Lawrenceville-based BioNJ Member Celsion Corporation announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. GEN-1 is the company’s IL-12 gene-mediated immunotherapy. Topline results are expected in the second half of 2023. The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. The study is designed with an 80% confidence interval to show an approximate 33% improvement in progression-free survival when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only).

Celsion Corporation Announces Company Name Change to Imunon, Inc.

Lawrenceville-based BioNJ Member Celsion Corporation announced a company name change to Imunon, Inc., reflecting the evolution of the company’s business focus and its commitment to developing cutting-edge immunotherapies and next-generation vaccines to treat cancer and infectious diseases. The company has filed an amendment to its Articles of Incorporation to effect the new corporate name and is introducing a new logo and a new corporate website, Imunon is establishing a leadership position in immunology by developing DNA-mediated therapies with a lead asset targeting advanced ovarian cancer. The new name better reflects the company’s progress in immunology and emphasizes its commitment to harnessing the building blocks of life to work in harmony with the body’s immune system.

Lactiga Therapeutics Raises $1.6M USD in Oversubscribed Pre-Seed Round, Secures $350K in Research Grants

North Brunswick-based BioNJ Member Lactiga Therapeutics, an early stage biotechnology company focused on improving the quality of life of patients with primary immunodeficiency diseases, announced that it has oversubscribed its pre-seed financing, raising $1.6 million in new capital including over $350,000 in research grants. In addition to the capital raised, the company has secured over $350,000 in nondilutive grants and awards over the last four months, including funds from the New Jersey Commission on Science, Innovation and Technology (CSIT) and Innovation Factory’s Southern Ontario Pharmaceutical and Health Innovation Ecosystem (SOPHIE) program. These funded projects further the company’s preclinical studies and strengthen its intellectual property portfolio.

Palatin Announces Initiation of Patient Recruitment for Phase 2 Clinical Study Evaluating Oral PL8177 for Treatment of Ulcerative Colitis

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced the initiation of a Phase 2 clinical study of PL8177, a potent melanocortin-1 receptor agonist, in ulcerative colitis (UC). The study will evaluate the safety, tolerability, efficacy, pharmacokinetics and biomarkers of orally administered PL8177 in adult patients with active UC. Clinical sites participating in the study have been activated, with screening and recruitment of potential patients underway. The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177, with once daily (QD) oral dosing in adult UC subjects. The study is designed to enroll up to 28 adult subjects with active UC from approximately 22 sites. All subjects who meet the eligibility criteria will be randomized to receive either placebo or oral PL8177.

Caladrius Biosciences and Cend Therapeutics Announce Closing of Merger and the Emergence of Lisata Therapeutics

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. and Cend Therapeutics, Inc. announced that the proposed merger of the two companies has closed following the approval of Caladrius’ stockholders. The merged company will operate as Lisata Therapeutics, Inc. and will focus primarily on advancing its CendR Platform™ technology product candidates in a range of oncology indications, in addition to Caladrius’ existing development programs. “The completion of the merger of Caladrius and Cend is an extraordinary milestone for our companies, our employees, our stockholders and, it is our fervent hope, for patients,” stated David J. Mazzo, Ph.D., Chief Executive Officer of Lisata. 

Celularity Enters Into $150 Million Pre-Paid Advance Agreement With Yorkville

Florham Park-based BioNJ Member Celularity Inc. announced that it entered into a Pre-Paid Advance Agreement with YA II PN, LTD, an affiliate of Yorkville Advisors Global, LP. Under the Agreement, Celularity may request individual pre-paid advances from Yorkville in an amount up to $40 million each subject to certain conditions, up to $150 million over the next eighteen (18) months from time to time and as mutually agreed by the parties. Celularity intends to use the proceeds for working capital and other general corporate purposes. General corporate purposes may include research and development and clinical development costs to support the development of its cellular therapy candidates and the expansion of research and development programs, as well as costs associated with its commercial biomaterials businesses; working capital; capital expenditures and other general corporate purposes.

CHMP Recommends Approval of Enjaymo™ (sutimlimab), First and Only Approved Treatment for Hemolytic Anemia in Adult Patients With Cold Agglutinin Disease

Bridgewater-based BioNJ Member Sanofi announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Enjaymo™ (sutimlimab), recommending that the C1 protein (C1s) inhibitor be approved in the European Union (EU) for treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD). CAD is a rare, serious, and chronic autoimmune hemolytic anemia. The positive CHMP opinion is based on data from two Phase 3 clinical trials: CADENZA, a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months), and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. 

CHMP Recommends Approval of Beyfortus® (nirsevimab) for Prevention of RSV Disease in Infants

Bridgewater-based BioNJ Member Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Beyfortus® (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. If approved, Beyfortus would be the first and only single-dose passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca. Jean-François Toussaint, Global Head of Research and Development Vaccines, at Sanofi said “Today’s positive CHMP opinion is one of the most significant public health achievements in RSV in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems.”

Positive Dupixent® (dupilumab) Phase 3 Data in Children Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis Published in The Lancet

Bridgewater-based BioNJ Member Sanofi announced that The Lancet has published positive results from a Phase 3 Dupixent® (dupilumab) trial in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. These data were the basis for the U.S. Food and Drug Administration (FDA) approval of Dupixent and for a regulatory submission currently under review by the European Medicines Agency. Data from this trial showed that adding Dupixent to low-potency topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch compared to TCS alone (placebo) at 16 weeks. Additionally, Dupixent patients experienced significant improvement in measures of sleep quality and skin pain, as well as patient- or caregiver-reported outcomes and health-related quality of life. 

New Late-Breaking Results from Phase 3 Trials of SKYRIZI® (risankizumab) Evaluating Long-term Effect on Skin and Joint Symptoms in Patients With Psoriatic Arthritis at Week 100

BioNJ Member AbbVie, with a site in Madison, announced new, long-term data analyses of KEEPsAKE 1 and 2, Phase 3 trials evaluating SKYRIZI® (risankizumab, 150 mg) in adult patients with active psoriatic arthritis. Results showed that at week 100 of the open-label extension period, patients receiving SKYRIZI reported improvement in skin and joint symptoms, with more than half of patients in KEEPsAKE 1 and 2 achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response. Additionally, the data demonstrated no new observed safety signals through 100 weeks.

AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults With Moderate to Severe Crohn's Disease

BioNJ Member AbbVie, with a site in Madison, announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CMHP) adopted a positive opinion recommending the approval of risankizumab (SKYRIZI®, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study). Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.

U.S. Food and Drug Administration Approves Sotyktu™ (deucravacitinib), Oral Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Sotyktu™ (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu is not recommended for use in combination with other potent immunosuppressants. The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla® (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks.

Bristol Myers Squibb Announces New Sotyktu™ (deucravacitinib) Long-Term Data Showing Clinical Efficacy Maintained for Up to Two Years With Continuous Treatment in Moderate-to-Severe Plaque Psoriasis

Princeton-based BioNJ Member Bristol Myers Squibb announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial. At 112 weeks of Sotyktu treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90 and 66.5% for static Physician's Global Assessment (sPGA) 0/1. 

Bristol Myers Squibb Announces Adjuvant Treatment With Opdivo (nivolumab) Demonstrated Statistically Significant and Clinically Meaningful Improvement in Recurrence-Free Survival (RFS) in Patients With Stage IIB/C Melanoma in the CheckMate -76K Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Phase 3 CheckMate -76K trial evaluating Opdivo (nivolumab) as a single agent in the adjuvant setting in patients with completely resected stage IIB/C melanoma met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo at a pre-specified interim analysis. No new safety signals were observed at the time of the analysis. CheckMate -76K is part of BMS’ development program studying Opdivo and Opdivo-based combinations in earlier stages of cancer, which currently spans seven tumor types. The company will complete a full evaluation of the CheckMate -76K data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities.

Bristol Myers Squibb Receives European Commission Approval for LAG-3-Blocking Antibody Combination, Opdualag (nivolumab and relatlimab), for the Treatment of Unresectable or Metastatic Melanoma With Tumor Cell PD-L1 Expression < 1%

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved the fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. The EC’s decision is based upon an exploratory analysis of results from the Phase 2/3 RELATIVITY-047 trial in patients with tumor cell expression < 1%, which demonstrated that treatment with the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy – an established standard of care. No new safety events were identified with the combination when compared to nivolumab monotherapy. 

Novartis Kisqali® Adds One More Year of Survival Benefit for Broadest Set of Patients, Including Those With Aggressive HR+/HER2- Advanced Breast Cancer

East Hanover-based BioNJ Member Novartis announced results from a new pooled exploratory analysis across the entire MONALEESA Phase III program, confirming nearly one year of additional overall survival (OS) benefit in a subgroup of patients with aggressive forms of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer (aBC). This subgroup analysis found that patients with visceral metastases – including liver metastases and multiple metastatic sites, which are typically associated with a poor prognosis – who were treated with Kisqali® (ribociclib) plus endocrine therapy in the first-line setting, achieved a median OS of 62.7 months compared to 52.1 months for those treated with endocrine therapy alone (HR=0.79; 95% CI: 0.65-0.97). 

Novartis Cosentyx® Shows Clinically Meaningful Symptom Improvements in Patients With Hidradenitis Suppurativa in Pivotal Phase III Trials

East Hanover-based BioNJ Member Novartis announced the results from two pivotal, Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx® (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa (HS) with a favorable safety profile. These Phase III data have been submitted to regulatory authorities in Europe and will be submitted to regulatory authorities in the United States this year, with the goal of bringing Cosentyx as a new treatment option to patients living with HS as soon as possible. Novartis also plans to share the long-term results from the trials in 2023. Available data support the sustained efficacy over continuous treatment up to 52 weeks in patients with HS.

Novartis Announces Tislelizumab Demonstrated Efficacy and Tolerability in First-Line Advanced Liver Cancer in Phase III Trial

East Hanover-based BioNJ Member Novartis announced new data from the Phase III RATIONALE 301 trial that show tislelizumab demonstrated non-inferior overall survival (OS) compared to sorafenib (median OS: 15.9 months vs. 14.1 months; stratified HR=0.85 [95.003% CI: 0.712, 1.019]) in patients with previously untreated, unresectable hepatocellular carcinoma (HCC). The trial met its primary objective of non-inferiority for OS; superiority was subsequently tested, which was not met. "People living with advanced liver cancer face poor survival outcomes and frequently suffer from cirrhosis, which further complicates their treatment,” said Richard S. Finn, MD, Professor of Medicine, Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine and Jonsson Comprehensive Cancer Center at UCLA and the lead US investigator on the trial. “These positive results show that tislelizumab has the potential to deliver a meaningful clinical benefit for patients with HCC who need more safe and effective therapeutic options.” 

Sandoz Announces Further Progress on its Biosimilar Pipeline, With Release of Positive Results for Denosumab Integrated Phase I/III Clinical Trial

Sandoz, a division of East Hanover-based BioNJ Member Novartis, announced further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab. Denosumab is indicated for treating a variety of conditions, including osteoporosis in postmenopausal women, in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, and giant cell tumor of the bone. The results from the integrated Phase I/III study confirm the biosimilar matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in the respective indications; and contributes to demonstration of similarity, which is the basis for use in all indications.

Novo Nordisk Launches Unbranded Biologic of Tresiba® Analog Insulin to Expand Affordability Options for Patients

Plainsboro-based BioNJ Member Novo Nordisk announced the upcoming availability of an unbranded biologic of Tresiba® (insulin degludec) injection, a once-daily long-acting basal insulin indicated to control high blood sugar in patients 1 year of age and older with diabetes. The unbranded biologic, insulin degludec, was approved by the U.S. Food and Drug Administration (FDA) and will be available for prescription-holding patients to order from pharmacies nationwide later this Fall as part of an ongoing effort to expand affordability options for patients in need. "Unbranded biologics are a part of our ongoing efforts to expand our options for patients who struggle to afford their prescribed insulin, support that is especially crucial for the uninsured and underinsured," said Doug Langa, Executive Vice President, North America Operations and President of Novo Nordisk, Inc.

Lebrikizumab Dosed Every Four Weeks Maintained Durable Skin Clearance in Lilly's Phase 3 Monotherapy Atopic Dermatitis Trials

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced new detailed results from its Phase 3 monotherapy studies in atopic dermatitis (AD) that showed investigational lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response at Week 16 through one year of treatment. Lebrikizumab, a high-affinity and potent IL-13 inhibitor, delivered similar results when dosed once every four weeks or once every two weeks after Week 16. Efficacy with every four week dosing, after a 16-week induction period with lebrikizumab every two weeks, was similar to that of every two week dosing.

FDA Approves Lilly's Retevmo® (selpercatinib), the First and Only RET Inhibitor for Adults With Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced the U.S. Food and Drug Administration (FDA) has granted approval to Retevmo® (selpercatinib, 40 mg & 80 mg capsules) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on ORR and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

TREMFYA®▼ (guselkumab) Demonstrates Higher Rates of Complete Skin Clearance With Earlier Treatment in Adults With Moderate to Severe Plaque Psoriasis in Phase 3b GUIDE Study

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data for TREMFYA®▼(guselkumab) from the ongoing Phase 3b GUIDE study, which is designed to understand the impact of early intervention and potential dosing interval flexibility on the long-term disease course in adult patients with moderate to severe plaque psoriasis (Pso). These new data demonstrated that “super responders” to guselkumab who received every-16-week dosing maintained disease control (absolute Psoriasis Area and Severity Index [PASI] score <3) at a rate that was non-inferior to the approved every-eight-week dosing interval (92.6 percent vs 91.9 percent, P=0.001), meeting the study’s week 68 primary endpoint. Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.

Five-Year Data for Merck's KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Sustained Survival Benefit Versus Chemotherapy Alone in Two Studies for Metastatic Non-Small Cell Lung Cancer (NSCLC)

Kenilworth-based BioNJ Member Merck & Co. announced KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy continued to demonstrate a survival benefit and durable responses in two five-year exploratory analyses of pivotal Phase 3 studies as first-line treatment for metastatic non-small cell lung cancer (NSCLC). KEYTRUDA is the first immunotherapy to demonstrate a sustained five-year survival benefit both in combination with chemotherapy and as monotherapy for the first-line treatment of NSCLC. In addition to NSCLC, five-year survival data for KEYTRUDA have been presented in three other types of cancer, including bladder cancer (KEYNOTE-045), head and neck cancer (KEYNOTE-048) and melanoma (KEYNOTE-054). 

LYNPARZA® (olaparib) in Combination With Bevacizumab, and as Monotherapy, Demonstrates Clinically Meaningful Long-Term Survival in Certain Patients With First-Line Advanced Ovarian Cancer in Exploratory Analyses of Two Phase 3 Trials

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced long-term follow-up results from the Phase 3 PAOLA-1 and SOLO-1 trials in first-line advanced ovarian cancer, which represent the longest-term data for any PARP inhibitor in this setting. These results and the SOLO-1 results were published in the Journal of Clinical Oncology. Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories, said, “These latest data from the PAOLA-1 and SOLO-1 trials further highlight the importance of HRD testing, including for BRCA1/2 mutations, for all newly diagnosed advanced ovarian cancer patients at the point of diagnosis. Maintenance therapy with LYNPARZA may provide certain patients with HRD-positive or BRCA-mutated advanced ovarian cancer the opportunity to live longer.”

Merck and Eisai Present Results from Phase 3 LEAP-002 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

Kenilworth-based BioNJ Member Merck & Co. and Eisai announced the first presentation of results from the final analysis of the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, versus LENVIMA monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). “The LEAP-002 trial reflects our research strategy to build on evolving standards of care to further improve outcomes for more people with unresectable hepatocellular carcinoma,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “The median overall survival of 21.2 months seen with KEYTRUDA plus LENVIMA provides critical insights for further research into the potential role of this combination.” 

Seagen, Astellas and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) With KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer

Kenilworth-based BioNJ Member Merck & Co., Seagen Inc. and Astellas Pharma Inc. announced results from the Phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Cohort K investigating PADCEV® (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and PADCEV alone as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cisplatin-based chemotherapy. “We’re pleased that this combination provided a meaningful benefit to this group of advanced bladder cancer patients in this study, and we will continue to investigate enfortumab vedotin plus pembrolizumab through our collaboration,” said Eliav Barr, M.D., Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories.

Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Infants and Children

Kenilworth-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. VAXNEUVANCE is currently authorized for use in the European Union (EU) for individuals 18 years of age and older. The CHMP opinion will now be considered by the European Commission (EC) for amending the marketing authorization in the EU, and a final decision is expected by the end of the year. 

LYNPARZA® (olaparib) Approved in China as First-Line Maintenance Treatment With Bevacizumab for Homologous Recombination Deficient (HRD)-Positive Advanced Ovarian Cancer

BioNJ Members Kenilworth-based Merck & Co. and AstraZeneca announced that LYNPARZA has been approved in China as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. The approval by China’s National Medical Products Administration was based on an HRD-positive subgroup exploratory analysis of the Phase 3 PAOLA-1 trial, which showed LYNPARZA plus bevacizumab following response to platinum-based chemotherapy demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. 

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon. The Omicron BA.4/BA.5-adapted bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Apart from the addition of the mRNA sequence of the BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.

FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older With Alopecia Areata

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is expected to make a decision in the second-quarter 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the same patient population with a decision anticipated in the fourth-quarter 2023. Ritlecitinib is an investigational oral once daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3).

Pfizer Initiates Phase 3 Study of mRNA-Based Influenza Vaccine

BioNJ Member Pfizer, with a site in Peapack, announced that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of the company’s quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults. The quadrivalent modRNA vaccine candidate will encode World Health Organization recommended strains for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines. This Phase 3 study is informed by previously shared data from the ongoing Phase 2 trial which demonstrates a safety and immunogenicity profile supportive of program advancement and is part of Pfizer’s broader influenza vaccine program, focused on leveraging mRNA technology in a vaccine to help protect against the flu. 

Pfizer Announces Positive Top-Line Results from Phase 3 Trial of Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents

BioNJ Member Pfizer, with a site in Peapack, announced positive top-line results from the pivotal Phase 3 trial (NCT04440163) assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y. Currently, MenACWY and MenB vaccines are licensed separately, and no single vaccine is available to help protect against the five serogroups. Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application to the U.S. Food and Drug Administration in the fourth quarter of this year. 

Pfizer Announces Positive Top-Line Results from Phase 3 Study in 20-Valent Pneumococcal Conjugate Vaccine in Infants in the European Union

BioNJ Member Pfizer, with a site in Peapack, announced positive top-line results from its pivotal E.U. Phase 3 study in infants (NCT04546425) evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population. “Today marks another important milestone in the 20vPnC pediatric program, with these data demonstrating 20vPnC’s potential to provide the most comprehensive pneumococcal serotype coverage of any available pneumococcal conjugate vaccine,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Based on the totality of immunogenicity and safety data, we feel confident that 20vPnC is likely to be protective against all vaccine serotypes in a three-dose series.”

CytoReason Announces Expanded Collaboration Deal With Pfizer to Deliver AI for Drug Discovery and Development

CytoReason announced an extension of its multi-year partnership with BioNJ Member Pfizer, with a site in Peapack, to use CytoReason’s artificial intelligence technology for Pfizer’s drug development programs. Under the terms of the agreement, Pfizer will make a $20M equity investment, have options to license CytoReason’s platform and disease models, and fund supplementary project support, in a deal potentially worth up to $110M over the next five years. Since launching the collaboration, Pfizer has used CytoReason's biological models in its research to enhance the understanding of the immune system, as it develops innovative drugs for immune-mediated and immuno-oncology diseases. CytoReason's platform has provided Pfizer with multiple insights in research and development programs across over 20 diseases.

Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for Injection for the Treatment of Hepatorenal Syndrome (HRS)

Mallinckrodt, with a site in Bedminster, announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization. Siggi Olafsson, President and Chief Executive Officer, said, "The FDA approval of Terlivaz is a significant milestone for Mallinckrodt as it brings an important treatment option to these critically ill patients requiring hospitalization and to U.S. physicians who historically have had limited treatment interventions. We're excited to bring Terlivaz to U.S. patients and physicians and plan to launch the product in the coming weeks.” 

LEO Pharma Presents New Adtralza® Safety Data in Moderate-to-Severe Atopic Dermatitis at the 31st EADV Congress

LEO Pharma, with a site in Madison, announced new safety data for Adtralza® (tralokinumab) for adult patients with moderate-to-severe atopic dermatitis (AD). An interim analysis of the ongoing open-label ECZTEND trial evaluated the long-term safety of Adtralza, including adverse events of special interest (AESI), in adult patients with moderate-to-severe AD. The AESI were predefined based on areas of safety interest for monoclonal antibodies in AD, including conjunctivitis, skin infections requiring systemic treatment, eczema herpeticum and malignancies diagnosed after dosing. Long-term treatment with Adtralza 300 mg every two weeks (Q2W) with optional topical corticosteroids (TCS) demonstrated a consistent safety from the parent trials for up to 3.5 years. Exposure-adjusted incidence rates of AESI were generally lower than the rates reported during the placebo-controlled period up to Week 16 and declined over time. 

LEO Pharma Receives Positive CHMP Opinion of Adtralza ® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis

LEO Pharma, with a site in Madison, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending extending the approval of Adtralza® (tralokinumab) in the European Union (EU) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The recommended dose for adolescent patients is an initial dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients. Adtralza, a high-affinity human monoclonal antibody, is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates and Switzerland. It also is approved for adults in the United States under the tradename Adbry™. 

New Long-Term Data in Adult Patients With Hypoparathyroidism Treated With Ascendis Pharma’s TransCon™ PTH through Week 110 in the PaTH Forward Trial Presented at ASBMR 2022

Ascendis Pharma, with a site in Princeton, announced new Week 110 data from the Phase 2 PaTH Forward Trial showing that long-term therapy with TransCon PTH, an investigational prodrug designed to provide sustained release of active parathyroid hormone (PTH) at stable levels in the physiological range for 24 hours/day, provided a durable response in adults with hypoparathyroidism, as seen in continued normalization of mean serum calcium levels and 93% of patients achieving independence from conventional therapy with active vitamin D and therapeutic levels of calcium. The data also showed continued restoration of skeletal bone mineral density (BMD) toward sex- and age-expected norms for study participants treated with TransCon PTH, which augments turnover of stagnant bone. 

ENHERTU ® Continues to Demonstrate Clinically Meaningful Tumor Response in Patients With HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo announced detailed positive results from an interim analysis of the DESTINY-Lung02 Phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful tumor responses in previously treated patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC). “DESTINY-Lung02 reinforces HER2 as an actionable mutation in patients with metastatic non-small cell lung cancer and further demonstrates that ENHERTU provides a clinically meaningful tumor response for these patients who have historically had limited treatment options,” said Koichi Goto, M.D., Medical Oncologist and Investigator at National Cancer Center Hospital East, Kashiwa, Japan. “The response seen in this trial along with the disease control observed support ENHERTU as a potential treatment option in this type of non-small cell lung cancer.”

DS-7300 Continues to Show Promising Durable Response in Patients With Several Types of Advanced Cancer

Basking Ridge-based Daiichi Sankyo and Sarah Cannon Research Institute (SCRI) announced that extended follow-up data from a Phase 1/2 trial of DS-7300, a specifically designed potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC), continues to show promising durable tumor response in patients with several types of heavily pretreated cancers including lung, prostate or esophageal cancer. B7-H3 is overexpressed in a wide range of cancer types, including lung, prostate and esophageal, and its overexpression has been shown to correlate with poor prognosis in some cancers, making B7-H3 a promising therapeutic target. 

BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn® Phase 2 Progressive MS Trial in Multiple Sclerosis Journal

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced the peer reviewed publication of data from the Phase 2 trial of NurOwn in progressive multiple sclerosis (MS) in Multiple Sclerosis Journal. Results from the Phase 2, single-arm, open-label study demonstrated NurOwn's safety and provided preliminary evidence of its efficacy in people with progressive MS. Additionally, biomarker analyses confirmed NurOwn's proposed mechanism of action by showing consistent treatment effects in neuroinflammation and neuroprotection pathways. Treatment with NurOwn resulted in large, clinically meaningful improvements in some patients, as defined by response criteria, across all endpoints measured. These observed improvements diverged from what was seen in matched patients with progressive MS from the CLIMB registry.

New Study Demonstrates that Tumor Removal in the Outpatient Setting is as Good as TURBT Under General Anesthesia

Photocure, The Bladder Cancer Company, with a site in Princeton, announced the publication of first results from the Laser III clinical study in the medical journal, European Urology. The study is part of a systematic program aimed at verifying the safe treatment of bladder tumors in the outpatient setting. Laser III results demonstrate the non-inferiority of outpatient laser-mediated destruction of bladder tumors in conjunction with blue light cystoscopy (BLC®) and Hexvix® versus inpatient BLC TURBT under general anesthesia. “The study outcomes clearly demonstrate that for patients with small low grade stage Ta bladder tumors the procedure can be safely moved from the OR to the office, thereby reducing the burden for patients stemming from general anesthesia and cost related to hospital stays,” said Dr. Gregers G Hermann, the Lead Investigator of this study and Consultant Urologist, Dept. of Urology, Herlev/Gentofte hospital, Denmark. 

Fianlimab (LAG-3 Inhibitor) Combined With Libtayo® (cemiplimab) Demonstrates Greater than 60% Response Rates in Two Independent Cohorts of Patients With Advanced Melanoma Naïve to PD-1 or PD-L1 Inhibitors

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the presentation of positive data from multiple expansion cohorts of an initial Phase 1 trial for an investigational combination of LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo® (cemiplimab) in advanced melanoma. "After regulatory approvals of our PD-1 inhibitor Libtayo in two advanced non-melanoma skin cancers, we are expanding our efforts in dermato-oncology to address advanced melanoma," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "Combining LAG-3 and PD-1 inhibition has shown promise in advanced melanoma but achieving response rates above 50% has been challenging. In two independent dose expansion cohorts from a Phase 1 clinical trial of patients naïve to PD-1 or PD-L1 inhibitors, our LAG-3 inhibitor fianlimab combined with Libtayo demonstrated greater than 60% response rates.”

Positive Neoadjuvant Libtayo® (cemiplimab) Monotherapy Data in Resectable Cutaneous Squamous Cell Carcinoma Presented at ESMO and Published in NEJM

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced positive clinical data for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The data, from the primary analysis of a confirmatory Phase 2 trial, were published in the New England Journal of Medicine. Patient follow-up in the trial is ongoing to assess disease-free survival. A separate global Phase 3 trial investigating Libtayo in the adjuvant CSCC setting for patients at heightened risk (i.e., due to involvement of multiple lymph nodes, extension of cancer through the lymph node capsule, perineural invasion) for recurrence is enrolling patients.

Intellia and Regeneron Announce Initial Data from the Cardiomyopathy Arm of Ongoing Phase 1 Study of NTLA-2001, an Investigational CRISPR Therapy for the Treatment of Transthyretin (ATTR) Amyloidosis

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, and Intellia Therapeutics, Inc. announced positive interim results from an ongoing Phase 1 clinical trial of NTLA-2001, an investigational in vivo CRISPR/Cas9 genome editing therapy in development as a single-dose treatment for transthyretin (ATTR) amyloidosis. The interim data include 12 adult patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM) with New York Heart Association (NYHA) Class I – III heart failure. Single doses of 0.7 mg/kg and 1.0 mg/kg of NTLA-2001 were administered via intravenous infusion, and the change from baseline in serum transthyretin (TTR) protein concentration was measured for each patient. Administration of NTLA-2001 led to rapid and deep reductions in serum TTR by day 28.

CytoSorbents Receives $2M Grant for ‘Universal Plasma’ Technology

The U.S. Army Medical Research Acquisition Activity awarded Princeton-based CytoSorbents Corp. a two-year, $1.98 million grant to further develop its HemoDefend-BGA adsorber, which can be used to create a “universal plasma.” This proprietary adsorption technology can remove more than 99% of anti-A and anti-B antibodies from plasma to create a “universal plasma” that could be administered to anyone, regardless of blood type. According to CytoSorbents, this technology would eliminate the need for blood typing, thereby speeding up emergency treatment in both civilian and military settings. Because of the new U.S. Army funding, CytoSorbents researchers can take “what we believe is a transformative technology into large animal testing, where we will evaluate the safety and efficacy of universal plasma generated by HemoDefend-BGA.”

Rocket Pharmaceuticals to Acquire Renovacor

Cranbury-based Rocket Pharmaceuticals, Inc., and Renovacor, Inc. have announced a definitive agreement under which Rocket will acquire Renovacor in an all-stock transaction valued at $53 million. The boards of directors of both companies have unanimously approved the transaction, which is currently expected to close by the first quarter of 2023. Renovacor’s most advanced program, REN-001, is an AAV-based gene therapy targeting BAG3-associated dilated cardiomyopathy (DCM), a severe form of heart failure. BAG3-DCM represents a significant unmet medical need in a patient population with rapidly progressive cardiac dysfunction in whom no treatments targeting the underlying mechanism of disease exist. Renovacor has deep technical expertise in the development of precision therapies that address genetically driven cardiac diseases.

Lexicon Pharmaceuticals Highlights Scientific and Medical Presentations Relating to Its Successful Phase 2 Proof-Of-Concept Study of LX9211 in Painful Diabetic Neuropathy

Lexicon Pharmaceuticals, Inc. with a site in Basking Ridge, announced a series of scientific and medical presentations describing the progression of its investigational drug LX9211 from discovery to translation in a clinical proof-of-concept study. “We believe the successful translation of a novel mechanism for the potential treatment of neuropathic pain could be transformational for patients,” said Dr. Craig Granowitz, Lexicon’s Senior Vice President and Chief Medical Officer. “We are excited to present these findings to the medical and scientific community and expect to communicate additional LX9211 clinical and preclinical data as they become available. Based on these results, we will expeditiously advance the clinical development of LX9211 for the treatment of neuropathic pain, an area of significant unmet clinical need.”

SJP Properties: Lexicon Pharmaceuticals to Relocate N.J. Office from Basking Ridge to Bridgewater Campus

Lexicon Pharmaceuticals, located in Basking Ridge, will relocate its New Jersey office from Basking Ridge to Somerset Corporate Center. SJP Project Solutions, SJP’s project and construction management division, will execute a custom interior buildout to accommodate the unique needs of Lexicon’s operations. The company is scheduled to occupy the space no later than Q1 of 2023. “Somerset Corporate Center is perfectly situated to attract top talent from the surrounding area given its unparalleled highway access,” Alexander Erdos, Senior Vice President, Leasing & Marketing, SJP Properties, stated. Lexicon will occupy 20,000 square feet of office space at Somerset Corporate Center 1 in Bridgewater.

Syros Closes $60M Merger With Bedminster’s TYME

Stockholders of both Syros Pharmaceuticals Inc. and Bedminster’s TYME Technologies approved plans for a merger valued at approximately $60 million. As previously announced, TYME – an emerging biotech company developing cancer metabolism-based therapies – will become a wholly owned subsidiary of Syros. The total cash balance of the combined company has been valued at approximately $240 million. Syros’ stockholders also approved issuing shares of Syros’ common stock to TYME’s common stockholders in connection with the merger and to certain Syros’ investors in connection with a $130 million private investment in public equity (PIPE) financing. 

People in the News


Provention Bio Announces Senior Leadership Addition

Red Bank-based Provention Bio announced the appointment of Sarah O’Brien as Chief People Officer. Ms. O’Brien brings more than 20 years of experience building strong employee culture and leading human resources within the biotech sector and will report to CEO Ashleigh Palmer. Ms. O’Brien’s leadership will support plans for continued growth and enhancement of Provention’s unique mission-driven culture, as well as providing leadership around the company’s organizational design, talent acquisition, employee engagement, diversity & inclusion, training and development, employee experience and benefits administration and design. She most recently served as Chief People Officer at Ardelyx and has also served in prior senior leadership roles at Ohana Bioscience, Relay Therapeutics, Novartis and Sobi.

Cumulus Neuroscience Appoints Digital Health and Pharmaceutical Exec Bhatti as CEO

Cumulus Neuroscience, a global digital health company developing multidomain digital biomarkers for the brain, with U.S. offices in Bridgewater, said it appointed Dr. Aman Bhatti as its CEO. Dr. Bhatti, a noted digital health executive with experience launching and scaling world-renowned consumer health care brands, joins Cumulus as it shifts toward health care and expands biopharma partnerships in its next growth phase. Before joining Cumulus, Dr. Bhatti was senior vice president of AliveCor BioPharma, where he led a team focused on establishing partnerships with contract research organizations and biopharma companies, drawing upon more than 15 years of experience in prior executive roles at Sanofi, GSK, Novartis and Reckitt.

Catalent Appoints Former Bristol Myers Squibb Leader as Chief Accounting Officer

Catalent announced the appointment of Karen Santiago as Vice President and Chief Accounting Officer. Ms. Santiago will become a member of the Somerset-based company’s executive leadership team and serve as its principal accounting officer. Prior to joining Catalent, Ms. Santiago spent 19 years with Bristol Myers Squibb in various roles of increasing responsibility, including Senior Vice President and Corporate Controller, Principal Accounting Officer from 2018 to 2022, and lead enabling functions and finance transformation from 2016 to 2018.



Kean University Creates College of Health Professions and Human Services for Health Care-Related Programs

Kean University announced that, as a means to move along its trajectory as a research university, it is reorganizing and created the new College of Health Professions and Human Services for all its health care-related programs. Under the reorganization, all Kean colleges will offer both undergraduate and graduate programs, according to their discipline. The new college replaces Kean’s Nathan Weiss Graduate College. The board of trustees approved the sweeping reorganization plan, and all changes take effect immediately. Kean Associate Provost for Science and Technology Keith Bostian was named acting Dean of the College of Health Professions and Human Services. 

Researchers at Rutgers and Tel Aviv Universities Set to Receive $200,000 in Seed Grants to Further Collaborative Projects

Twelve researchers at Rutgers, The State University of New Jersey and Tel Aviv University (TAU) in Israel are poised to receive a combined $200,000 in seed grants to further joint projects across a broad spectrum of academic areas. The grants, which were awarded to six partnerships through the TAU – Rutgers University Research Collaboration Fund (the Fund), will support projects in such areas as genomics, agriculture, neurology, quantum computing and computer science. The Fund was established last year to foster international collaborative partnerships between faculty at TAU and Rutgers.

10 NJ Schools Ranked Among Best Colleges; Princeton Again Tops U.S. News List

For the 12th consecutive year, Princeton University came in at No. 1 in the U.S. News & World Report ranking of the nation’s best colleges with nine other New Jersey schools also making the list. In all, four Garden State institutions ranked among the top 100 national universities. In addition to Princeton, Rutgers University – New Brunswick came in at No. 55, up from 63rd last year; Stevens Institute of Technology ranked 83rd, the same position as last year; and the New Jersey Institute of Technology ranked 97th, breaking into the top 100 after placing 103rd last year. In assembling the rankings, U.S. News evaluates more than 1,500 colleges and universities on 17 measures of academic quality. 

NJIT’s New Jersey Innovation Institute Finds Leader for Strategic Partnerships

The New Jersey Institute of Technology’s New Jersey Innovation Institute announced it hired Kathy Naasz as Vice President of Strategic Partnerships to craft strategy and forge new partnerships between the university and industry. This new position will focus on analyzing current and future market opportunities, developing an effective partnership strategy and cultivating strategic relationships that deliver on NJII’s mission of being a conduit between industry and NJIT’s expertise. Most recently, Ms. Naasz served as Dean of the largest academic school at County College of Morris, overseeing programs that brought together engineering, management and technology students for real-world problem solving. Prior to that, she was a professor, Dean and Vice President of Innovation at Centenary University.

Rowan Innovation Fund Swells to $25M

As part of its continued effort to spur economic development in South Jersey, Rowan University Foundation announced its venture capital fund expanded to $25 million. The Rowan Innovation Venture Fund (RIVF) launched in 2014 with $5 million to seed startup ideas. It has since received an additional $20 million to support evolving businesses from within and outside the Rowan University community. Since 2015, the RIVF has seeded 14 South Jersey-based and regional startups, many of which were started by students and faculty. The University says the Fund’s broader mission supports its key goal for economic development beyond the campus. The RIVF has typically invested up to $500,000 in scalable companies. The increased funding makes it poised to increase the number of companies it supports, including smaller start-ups that need less capital to get off the ground.

Rutgers Cancer Institute of New Jersey Receives $2M Grant from Merck Foundation to Advance Equitable Cancer Care

RWJBarnabas Health, in partnership with Rutgers Cancer Institute of New Jersey has been awarded a $2 million grant over five years through the Alliance for Equity in Cancer Care, an initiative funded by the Merck Foundation. In total, the $20 million, Merck’s five-year initiative will help make cancer care more equitable in the U.S. by assisting patients living in underserved communities receive timely access to high-quality, culturally responsive care. Patients will see an improvement in the timeliness of care; better coordination between providers; ongoing support; increased use of telehealth for convenience; and more visibility for care in their communities via community advisory board engagement and increased community outreach and education.

RWJUH and Rutgers RWJMS Launch Center for Innovation, Signaling Future of Medical Research

The grand opening of a new model for medical research and innovation from Robert Wood Johnson University Hospital and Rutgers Robert Wood Johnson Medical School took place recently with the unveiling of the Center for Innovation, located on the main campus of the hospital in New Brunswick. The center is a partnership between the two to bring together clinicians, researchers and private industry to invent and develop new technologies that address both complex and common health care issues. It was made possible via donor funding from the RWJ University Hospital Foundation. The ultimate goal is to develop innovative clinical trials that yield medical breakthroughs to improve preventive care and health outcomes for patients.

Cooper Health Embarking on $2B Expansion in Camden

Cooper University Health Care and MD Anderson Cancer Center at Cooper announced a new, $2 billion expansion in the City of Camden. The investment is the largest in the county’s history and will dramatically expand the system’s Camden campus to meet current and future demand. The expansion will include three new clinical towers with more than 100 private rooms. The facilities, which will be environmentally sustaining, will include emerging technologies and innovations to provide support for the academic health system. “By supporting public safety, educational opportunities, and job creation in addition to providing quality medical care, Cooper has taken a holistic and meaningful approach to strengthening the health of the community it serves,” said Governor Murphy. “I applaud this new expansion and Cooper’s ongoing work to improve the lives of Camden residents.”



Propelify Innovation Festival

October 6, 2022

For Those Who Propel Ideas Into Action! If you’re in the innovation community in the northeast you belong here. Learn from amazing speakers, connect with start-ups and investors, hire and be hired. Plus virtual reality, drones, music and a start-up competition. And lots more. BioNJ Members can attend for free. Register using code BioNJPropels.

Made in New Jersey Manufacturing Day

October 7, 2022

NJMEP celebrates New Jersey manufacturers who develop and manufacture products and unlock new technologies that grow our economy. They create career opportunities for tens of thousands of residents, and their competitiveness and successes revitalize the national economy. National Manufacturing Day aims to empower manufacturers, change public perception about the industry, highlight its economic impact and introduce more people to available career opportunities.

ISG TechXchange: Healthcare & Life Sciences

October 13, 2022

The ISG TechXchange: Healthcare & Life Sciences will explore the evolving healthcare and life science ecosystems. Register today and embrace the digital transformation approaches organizations are taking to succeed in pushing the boundaries of innovation. Put interoperability at the heart of your organization. Utilize emerging innovations to rapidly respond to shifts in patient and payer expectations. Leverage the effects of pandemic-forced advancements to focus on innovation and diversification. Learn more and register here.

Celebrate Princeton Innovation 2022

October 13, 2022

Celebrate Princeton Innovation honors faculty researchers, postdoctoral researchers, graduate students and undergraduates who are making a difference through their discoveries and entrepreneurial spirit. This annual event features faculty innovators and discoveries that have the potential to become everyday innovations that improve life, benefit the planet and grow the economy.

Life Science Funding & Incentives in New Jersey

October 20, 2022

Join Princeton Innovation Center BioLabs on Thursday, October 20, from 5–6:30 p.m., to learn about New Jersey’s funding and incentive programs and hear from New Jersey’s life sciences industry leaders who have benefited from these important incentive funding programs. Free and open to the public, but registration is a must and guests must comply with Princeton Innovation Center’s COVID policy for visitors.

Genesis 2022

December 7, 2022

The annual Genesis conference has been a pillar of the life science sector for over two decades. Bringing together key opinion leaders, investors and innovators from across the sector to share insight, debate key trends and generate deals. Under a headline theme of “Maximizing Returns from Life Science Innovation”, we expect 2022 to be no different! 

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Please contact BioNJ with any questions.  | 609-890-3185 |

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