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

Thank you to everyone who joined us for yesterday's BioNJ Board and Member Connection. We were excited to bring our Membership together for this interactive program. During yesterday's event, BioNJ announced the election of its 2021 Officers and Board Members. 
 
Newly elected Officers include Chair Will Lewis, JD, MBA, Chair and CEO, Insmed, Inc.; Vice Chair Monika A. Vnuk, M.D., Vice President, R&D Business Development, Pfizer, Inc.; Treasurer Greg Oakes, MBA, President, North America, Vifor Pharma and re-elected as Secretary Michele Korfin, R.Ph., MBA, Chief Operating Officer & Chief Commercial Officer, Gamida Cell. Mr. Lewis succeeds Christopher J. Schaber, Ph.D., President and CEO, Soligenix, Inc., who concluded a two-year term moving into the Immediate Past Chair's role. 
 
"It is an honor to serve as the Chair of BioNJ and to follow in the path of the strong leaders before me, particularly during these extraordinary times. I look forward to working with the Board, our Members and the Team to support our industry's unique ability to address the ongoing COVID-19 pandemic and to educate and raise awareness of the positive impact that the New Jersey biopharmaceutical community can have on society. Just as importantly, we will continue to foster good corporate citizenship and champion diversity, equity and inclusion in the biopharma industry, as well as in the communities in which we live and work," said Mr. Lewis.
 
Newly elected Board Members include Amadou Diarra, Ph.D., Senior Vice-President, Global Policy & Government Affairs, Bristol Myers Squibb; Emer Leahy, Ph.D., President and CEO, PsychoGenics, Inc.; Susan L. Levinson, Ph.D., Chief Executive Officer, BioAegis Therapeutics, Inc. and Scott Megaffin, President and CEO, Adastra Pharmaceuticals, Inc.  

"Because Patients Can't Wait®, we are grateful for our talented and dedicated Board whose guidance is instrumental in enabling our Mission," stated Debbie Hart, BioNJ's President and CEO. (Click here for BioNJ's 2021 Board of Trustees.)

Not yet a Member? Not a problem! Contact Kim Minton at KMinton@BioNJ.org to discuss how your organization can benefit from BioNJ Membership. 

Because Patients Can't Wait®,
The BioNJ Team
IMPORTANT MESSAGE TO BioNJ MEMBERS
We'd like to take this time to thank our Members for your continued support and assure you that we value our relationship. In doing so, please know that we do not share any Member contact information. Should you receive a solicitation to purchase BioNJ's Membership Contact List, please disregard it and know that it is spam and that we keep all contact information confidential. Should you have any questions or concerns, please reach out to us at BioNJ@BioNJ.org. Thank you, again.
One of our favorite Patient advocates, the 2019 Heart of BioNJ Honoree and renowned industry artist, 12-year old "Magic" Max Schill, drew this beautiful picture after the attack on the Capitol, January 6. 

Max walked the halls of the Capitol on numerous occasions delivering hand-drawn pictures to Senators while advocating for the passage of the 21st Century Cures which he played a key role in getting passed in 2019. Keep up the great work and advocacy, Max!
BioNJ Calendar

BioNJ BioPartnering Virtual Conference 
May 18 & 19, 2021
Diversity, Equity and Inclusion
Save the Date!
March 24-25, 2021
Putting Patients First: The Value of Medical Innovation

Twenty-four years ago, my family's world changed as we welcomed a new son. And along with this boundless new love, we were introduced to a wider community that is characterized as rare. Our stories, nevertheless, are common -- and they must be heard. My son was born with congenital hyperinsulinism. In response, I, along with others in New Jersey and around the world, founded Congenital Hyperinsulinism International. We work to foster research for better treatments and a potential cure, as well as raise awareness of the condition, advocate for policies that will assist patients, and support families every step of the way.

For many patients with complex and chronic conditions, high out-of-pocket costs for medicines pose a significant challenge. Recent research revealed a broken insurance system that fails to help those who need care most. New resources further demonstrate how patients with asthma, diabetes, HIV and cancer can face high out-of-pocket costs due to insurance design. In 2019, compared to patients with fixed copays, patients with deductibles and coinsurance taking brand medicines to treat their condition paid on average: 25x more out of pocket for cancer medicines,  10x more out of pocket for HIV medicines and 3x more out of pocket for asthma and diabetes medicines.

A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year. These figures are in addition to innovative medicines that are approved through FDA's Center for Biologics Evaluation and Research-which include for example, cell therapies, gene therapies, vaccines and other biologic medicines. Beyond the novel drugs that became available to patients for the first time in 2020, the report also highlights the tremendous innovation provided by new and expanded uses of existing medicines for use in new diseases or treatment populations, as well as new formulations and dosage forms.

NJ Pride

Choose New Jersey, a privately funded 501(c)(3) economic development organization with a mission to stimulate job creation and attract capital investment to New Jersey, celebrated its 10th anniversary. CEO Jose Lozano said he expects 2021 to be even better. "As Choose New Jersey celebrates its 10-year anniversary, we are determined in our commitment to help New Jersey rebuild and recover from this unprecedented health and economic crisis," he said. "We are already seeing positive signs of relocation and expansion activity, and global interest in New Jersey has picked up during the pandemic as companies learn more about everything New Jersey has to offer."

NJ Company News

North Brunswick-based BioNJ Member BioAegis Therapeutics said that its Phase 2 trials for a potential new COVID-19 therapeutic continue to show promising results after determining a key link between severe cases and low levels of a certain protein in the body called gelsolin. While the eyes of the world have honed in on vaccines to build large-scale immunity to the virus and loosen the myriad of business restrictions, many drugmakers have focused on developing therapeutics that could keep patients out of the hospital and lower the fatality rate.

Princeton-based BioNJ Member Soligenix, Inc. announced that the Hong Kong Registrar of Patents has granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B. The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL), similar to those granted in Europe in 2020. Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of CTCL were recently announced. 

Basking Ridge-based BioNJ Member Matinas BioPharma Holdings, Inc. announced topline results from the ENHANCE-IT study (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia), the second head-to-head comparative study of LYPDISO™ vs. Vascepa®. In ENHANCE-IT, the key parameters evaluated included triglycerides (TGs), other lipoprotein and inflammatory markers, and blood levels of omega-3 fatty acids. The primary endpoint was the percent change from baseline to end-of-treatment in TG and superiority vs. Vascepa®.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced that it has dosed several subjects in its Phase 1 clinical trial of CORVax12, the only vaccine candidate to include an immunostimulatory cytokine to address COVID-19. This trial, entitled, CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)(NCT04627675), will address safety and anti-viral immunological responses with the combination of a DNA-encodable stabilized SARS-CoV-2 spike glycoprotein and OnocSec's cancer immunotherapy candidate, TAVO™ (tavokinogene telseplasmid), a potent and well-characterized plasmid-based IL-12 cytokine.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced the closing of a previously announced underwritten public offering of 7,711,284 shares of its common stock at a price of $5.45 per share. The gross proceeds to OncoSec from the offering, before deducting underwriting discounts, commissions and other offering expenses payable by OncoSec, were approximately $42 million. OncoSec intends to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of its product candidates; (ii) clinical development of the company's product candidates; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.
Bridgewater-based BioNJ Member Nevakar Inc. and Laboratoires Théa announced that they recently entered into an exclusive licensing agreement for the commercialization of NVK-002 in Europe. NVK-002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for slowing the progression of myopia in children ages three to 17. It is currently under clinical evaluation in the CHAMP (Childhood Atropine for Myopia Progression) study, a Phase III clinical trial being carried out in the U.S. and Europe.
Bridgewater-based BioNJ Member Amarin Corporation plc announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include "icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population."

Plainsboro-based BioNJ Member Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of once-weekly Sogroya® (somapacitan), recommending marketing authorisation for the treatment of adults with growth hormone deficiency (AGHD). The CHMP recommends once-weekly Sogroya® (somapacitan) to be indicated for the replacement of endogenous growth hormone in adults with AGHD. 

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent, product-specific J-code for ASCENIV™. Under the Healthcare Common Procedure Coding System (HCPCS), the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes. The company will retain transitional pass-through status granted for ASCENIV from CMS.

Princeton-based BioNJ Member Photocure ASA announced that it has entered into a partnership agreement with Asieris MediTech Co., Ltd. (Asieris), a division of Jiangsu Yahong Meditech Co., Ltd., whereby Asieris has obtained exclusive rights to register and commercialize Hexvix® in Mainland China and Taiwan. Based on the Agreement, Photocure will receive an upfront payment of USD 750,000 from Asieris for the rights to Hexvix in the designated territories, as well as payments of up to USD 1.4 million for the achievement of certain regulatory milestones including market approvals in Mainland China and Taiwan. 

Morris Plains-based BioNJ Member Gilead Sciences, Inc. and the Human Rights Campaign (HRC), the nation's largest lesbian, gay, bisexual, transgender and queer (LGBTQ+) civil rights organization, today announced that Gilead will provide a $3.2 million grant over two years to support communities disproportionately impacted by the HIV epidemic in the United States, particularly communities of color. Gilead will directly fund the efforts of the HRC Foundation -- HRC's educational arm -- aimed at ending the HIV epidemic, as well as fund the organization's Transgender Justice Initiative.

Morris Plains-based BioNJ Member Gilead Sciences, Inc. and Gritstone Oncology, Inc. announced that the companies have entered into a collaboration, option and license agreement to research and develop a vaccine-based immunotherapy as part of Gilead's efforts to find a curative treatment for human immunodeficiency virus (HIV) infection. Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone's proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead.

New Brunswick-based BioNJ Member Johnson & Johnson announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company's EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The company expects to have product available to ship immediately following authorization. 

New Brunswick-based BioNJ Member Johnson & Johnson announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. 

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced results from an analysis determining the validity of the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2 risk calculator, an abridged version of the REVEAL 2.0 risk calculator, in patients with pulmonary arterial hypertension (PAH), a rapidly progressive disease with no known cure. The analysis showed that REVEAL Lite 2 offers a simplified method of risk assessment using six non-invasive and modifiable variables that may be implemented routinely in daily clinical practice and can be used in conjunction with REVEAL 2.0, and differentiates patients among low, intermediate and high risk of one-year mortality.

Bridgewater-based BioNJ Member Eli Lilly and Company announced Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths (collectively, "events") in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of the Phase 3 BLAZE-1 trial. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 percent) in patients taking placebo, representing a 70 percent risk reduction (p= 0.0004). There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together.

Bridgewater-based BioNJ Member Eli Lilly and Company and Asahi Kasei Pharma Corporation announced a license agreement whereby Lilly will acquire the exclusive rights for AK1780 from Asahi Kasei Pharma. AK1780 is an orally bioavailable P2X7 receptor antagonist that recently completed Phase 1 single and multiple ascending dose and clinical pharmacology studies. P2X7 receptors have been consistently implicated in neuroinflammation, a driving force in chronic pain conditions. Under the terms of the agreement, Lilly will be responsible for future global development and regulatory activities for AK1780.

Bridgewater-based BioNJ Member Eli Lilly and Company and Life for a Child (LFAC) are significantly expanding their long-term partnership and shared mission to provide free immediate care as well as build sustainable diabetes care models for vulnerable populations. Additionally, Life for a Child announced a new strategic partnership with Beyond Type 1, a global diabetes nonprofit focused on changing what it means to live with chronic illness. Starting this month, the partners will expand access to care for youth with diabetes from approximately 23,000 in 2020 to approximately 150,000 in 65 countries over the next 10 years.

Bridgewater-based BioNJ Member Eli Lilly and Company announced that Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The Phase 3 BLAZE-2 COVID-19 prevention trial -- conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) -- enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S.

Bridgewater-based BioNJ Member Eli Lilly and Company, Vir Biotechnology, Inc. and GlaxoSmithKline plc announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

Warren-based BioNJ Member GlaxoSmithKline plc and CureVac N.V. announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK will also support the manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine candidate CVnCoV in 2021. Through this new exclusive co-development agreement, GSK and CureVac will contribute resources and expertise to research, develop and manufacture a number of novel mRNA vaccine candidates, including multi-valent and monovalent approaches.

ViiV Healthcare, the global specialist HIV company majority owned by Warren-based BioNJ Member GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the U.S. Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines - ViiV Healthcare's cabotegravir and Janssen's rilpivirine - dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
BioNJ Member Pfizer, with offices in Peapack, and Myovant Sciences announced that the Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. 
BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021. COVAX is a global initiative coordinated by the Global Alliance for Vaccines and Immunization (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to ensure equitable access to COVID-19 vaccines for all countries, regardless of income levels. COVAX includes an Advanced Market Commitment (AMC) financial mechanism that aims to ensure that 92 low- and lower-middle-income countries will be able to secure access to COVID-19 vaccines at the same time as higher-income countries.

Bridgewater-based BioNJ Member Sanofi and BioNTech have entered into an agreement under which Sanofi will support manufacturing and supply of BioNTech's COVID-19 vaccine which is being co-developed with Pfizer. Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi's production facilities in Frankfurt from summer of 2021.

East Hanover-based BioNJ Member Novartis announced that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland. Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world.
Princeton-based BioNJ Member Bristol Myers Squibb and The Rockefeller University today announced that they have entered into a definitive agreement under which Bristol Myers Squibb has been granted a global exclusive license to develop, manufacture and commercialize Rockefeller's novel monoclonal antibody ("mAb") duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. This novel treatment is a combination of two mAbs directed at blocking the SARS-CoV-2 spike protein and neutralizing the virus. 
Berkeley Heights-based BioNJ Member Amgen announced that its investigational KRASG12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the first BTD submission for Amgen in China, as well as the first under Amgen's strategic collaboration with BeiGene.

Princeton-based BioNJ Member Evotec announced that the company has entered into a multi-year partnership with the Medical Center Hamburg-Eppendorf ("UKE") for the development of a highly innovative first-in-class cell therapy approach for the treatment of heart failure. Under the terms of the partnership, Evotec and UKE will leverage their complementary strengths for the development of a new cell therapy approach using Engineered Heart Tissue for the treatment of heart failure. 
Kenilworth-based BioNJ Member Merck & Co. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of an expanded label for KEYTRUDA, Merck's anti-PD-1 therapy. The opinion is recommending KEYTRUDA as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission has approved KEYTRUDA, Merck's anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This approval is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80]; p=0.0002) compared with chemotherapy (investigator's choice: mFOLFOX6 [oxaliplatin, leucovorin and fluorouracil (FU)] with or without bevacizumab or cetuximab; or FOLFIRI [irinotecan, leucovorin and FU] with or without bevacizumab or cetuximab). 
Kenilworth-based BioNJ Member Merck & Co. announced first-time data from the Phase 3 KEYNOTE-598 study evaluating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with ipilimumab (Yervoy®) compared with KEYTRUDA monotherapy as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%). Results of the study showed that the addition of ipilimumab to KEYTRUDA did not improve overall survival (OS) or progression-free survival (PFS) but added toxicity compared with KEYTRUDA monotherapy in these patients.
Kenilworth-based BioNJ Member Merck & Co. announced new interim data from the Phase 2a trial (NCT04003103) in adults evaluating the safety, tolerability and pharmacokinetics (PK) of the once-monthly oral islatravir tablet -- the company's investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) -- for pre-exposure prophylaxis (PrEP). Interim findings demonstrate that once-monthly oral islatravir achieved the pre-specified efficacy PK threshold for PrEP at both of the two doses studied (60 mg and 120 mg). In the interim analysis using blinded data, both monthly doses of islatravir were found to have an acceptable tolerability profile.

Red Bank-based Provention Bio, Inc. reported results from a pre-clinical proof-of-concept study for PRV-3279, a DART® (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B, conducted in a murine model of gene therapy for Pompe disease. A PRV-3279 mouse surrogate was tested in mice transgenic for human CD32B, which received gene therapy with an adeno-associated virus (AAV) vector AAV9 encoding for the enzyme acid-alpha-glucosidase (GAA) gene. Errors in the GAA gene cause the serious human glycogen storage disease type II (Pompe disease).

Ridgefield Park-based BeiGene, Ltd. and EUSA Pharma (UK) Limited and announced that the Biologics License Application (BLA) for SYLVANT® (siltuximab for injection) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Siltuximab is a monoclonal antibody approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). iMCD is a rare, life-threatening and debilitating condition of the lymph nodes and related tissues.

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced that researchers in Dr.  David Ho's Columbia University lab and Regeneron scientists have independently confirmed that REGEN-COVTM (casirivimab and imdevimab antibody cocktail) successfully neutralizes the circulating SARS-CoV-2 variants first identified in the UK (B.1.1.7) and South Africa (B.1.351). Columbia's findings were included in a paper posted to bioRxiv and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to antibody neutralization. Both teams of researchers assessed in vitro neutralization potency of numerous COVID-19 antibodies (including those that have received emergency authorization and those still in development) against various mutated strains of the virus.

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced positive initial results from an ongoing Phase 3 clinical trial evaluating REGEN-COV™ (casirivimab and imdevimab antibody cocktail) used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient). The trial is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). An exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo.

Basking Ridge-based Daiichi Sankyo Company, Limited announced that the first patient has been dosed in HERTHENA-Lung01, a phase 2 study evaluating patritumab deruxtecan, a HER3 directed DXd antibody drug conjugate (ADC), in patients with epidermal growth factor receptor (EGFR)-mutated metastatic or locally advanced non-small cell lung cancer (NSCLC) previously treated with a tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

Basking Ridge-based Daiichi Sankyo Company, Limited announced the Japan Ministry of Health, Labour and Welfare (MHLW) has approved YESCARTA® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas. YESCARTA has been approved in Japan for treatment of patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B cell lymphoma. The use of YESCARTA is limited to patients not previously treated with a CD-19 CAR-positive T-cell infusion; patients previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant; and, patients not eligible for an autologous stem cell transplant.

Basking Ridge-based Daiichi Sankyo Company, Limited announced exploratory biomarker analyses from an ongoing Phase 1 study of patritumab deruxtecan, a HER3 directed DXd antibody drug conjugate (ADC), in patients with previously treated EGFR-mutated metastatic/unresectable non-small cell lung cancer (NSCLC). The exploratory analyses assessed genomic alterations in 56 evaluable patients with EGFR inhibitor resistant NSCLC receiving patritumab deruxtecan in the dose escalation (n=12) and cohort 1 of the dose expansion (n=45) part of the Phase 1 study. HER3 expression was evaluated by H score, which is a method of assessing the percentage of tumor cells with cell membrane staining.

Florham Park-based PDS Biotechnology Corporation announced that the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response. The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β "trap"/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine, will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor (CPI) naïve patients.   

Woodcliff Lake-based PaxMedica, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PAX-101 (IV suramin) for the treatment of Human African Trypanosomiasis (HAT), a rare infectious disease. "Receiving this designation from the FDA is an important milestone for PaxMedica and the treatment of HAT," said Howard Weisman, CEO of PaxMedica. Human African Trypanosomiasis (HAT) is a neglected tropical disease commonly known as African sleeping sickness. It is endemic to regions of sub-Saharan Africa and is a serious disease that is fatal if not treated quickly with the appropriate medication.

Englewood Cliffs-based Enzychem Lifesciences announced that NASA's Human Research Program has awarded $150K in grant funding to conduct research on its lead compound EC-18, and how it impacts astronaut health and performance during future long-duration missions beyond low-Earth orbit. In this study, EC-18 will be investigated whether it can provide protection against both radiation and pathogen-induced tissue damage and inflammation.

Woodcliff Lake-based Eisai Inc. and Biogen announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer's disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021. As part of the ongoing review, Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time for review. 

Woodcliff Lake-based Eisai Inc. announced that it has been listed in the 2021 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. This marks Eisai's fifth inclusion on the list. Ranked 16th, Eisai was the highest ranking company among global pharmaceutical companies. Also, Eisai became the highest ranking Japanese company among the five Japanese companies listed in the Global 100.

Basking Ridge-based EyePoint Pharmaceuticals announced it intends to raise more than $100 million through an underwritten public offering of 9.1 million shares of its common stock at a price of $11 per share. EyePoint is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. EyePoint intends to use the net proceeds from the offering for the advancement of EYP-1901 for wet AMD, for pipeline and commercial programs, and for general corporate purposes.

People in the News

Pennington-based BioNJ Member OncoSec Medical Incorporated announced the addition of two new executives to the company's management team. Industry veteran Brian Leuthner has been appointed as OncoSec's Chief Operating Officer and Joe Smith has joined as Vice President of Business Development. Mr. Leuthner joins OncoSec having held a variety of leadership positions over his 32 year biotech and pharmaceutical career. For a decade, Mr. Leuthner was President, CEO and co-founder of Edge Therapeutics, Inc. Mr. Smith was most recently an independent transaction advisor and acting Head of Business Development to a number of biotechnology and specialty pharmaceutical companies. 

Dr. Andrew Pecora, CEO of Outcomes Matter Innovations LLC, has added the role of Executive Chairman to his duties. Dr. Pecora, who became CEO of Jersey City-based OMI in May 2019, has led the company through a period of rapid growth tied to its value-based care line of business, as well as overseeing the overall development of its point-of-care technology. "Dr. Pecora continues to be a transformative force in health care," Dr. Andrew Jennis, a Board Member, said. Dr. Pecora, who had been president, physician enterprise, and chief innovation officer at Hackensack Meridian Health prior to joining OMI, is an expert in blood and marrow stem-cell transplantation, cellular medicine and immunology research.

BioNJ Member Vifor Pharma, with offices in Basking Ridge, announced that the Board of Directors will propose Dr. Alexandre LeBeaut for election to the Board at the next Annual General Meeting on 6 May 2021. Jacques Theurillat, Chairman of Vifor Pharma, commented: "We are very pleased to nominate Alexandre LeBeaut for election to the Vifor Pharma Group Board of Directors. Dr LeBeaut has broad experience in R&D, clinical development and research/medical affairs. He will optimally complement the Board to assess Vifor Pharma's pipeline development and clinical programs aiming to become the global leader in iron deficiency, nephrology and cardio-renal therapies."
Kenilworth-based BioNJ Member Merck & Co. announced that Kenneth C. Frazier, Chairman and Chief Executive Officer, will retire as CEO, effective June 30, 2021. Mr. Frazier will continue to serve on Merck's Board of Directors as Executive Chairman, for a transition period to be determined by the board. The Merck Board of Directors has unanimously elected Robert M. Davis, Merck's current Executive Vice President, Global Services and Chief Financial Officer, as Chief Executive Officer, as well as a member of the Board, effective July 1, 2021. Mr. Davis will become President of Merck, effective April 1, 2021, at which time the company's operating divisions-Human Health, Animal Health, Manufacturing, and Merck Research Laboratories-will begin reporting to him.

Kenilworth-based BioNJ Member Merck & Co. announced that Dr. Stephen "Steve" L. Mayo, Professor, California Institute of Technology, will join the company's Board of Directors effective March 15, 2021. Dr. Mayo will stand for election with the company's other directors at Merck's Annual Meeting of Shareholders on May 25, 2021. With the addition of Dr. Mayo, the Merck board will consist of 14 members. "We are pleased to welcome Dr. Mayo to the Merck Board. He brings extensive scientific expertise, and we look forward to his contributions and insights," said Kenneth C. Frazier, Chairman and CEO, Merck.

Princeton-based BioNJ Member Evotec announced that Dr. Cord Dohrmann has been appointed to the German Council of Science and Humanities for a term of three years. He is appointed by the Federal President Frank-Walter Steinmeier on the joint recommendation of the German Federal Government and the governments of the German states. Dr. Dohrmann joins the German Council of Science and Humanities as one of eight public figures and with more than 25 years of experience in biomedical research at leading academic institutions and in the biotech industry. 

Institution and Education News

Andrew Brooks, 51, a research professor who led the creation of the first coronavirus saliva-based test, which received FDA emergency approval last spring and has played a significant role in the fight against the COVID-19 pandemic, died unexpectedly. More than four million rapid response tests, which were the first approved for home use, have been performed since March, earning Brooks and his lab's pioneering work recognition in The New York Times, CNN and other national media outlets. Gov. Phil Murphy recognized Brooks and his contribution to help stem the spread of COVID-19 in New Jersey and around the country, calling him "one of our State's unsung heroes."

When Alexander Ploss' team discovered a compound that blocks the cancer-causing hepatitis B virus in lab experiments, the Princeton Associate Professor of molecular biology immediately grasped the potential benefit for society. He also knew that laboratory findings typically require additional research before they are ready for testing in patients. For assistance, Dr. Ploss turned to the Science Center, a Philadelphia-based organization that aims to help translate promising discoveries into valuable products and services while developing the regional workforce and catalyzing economic growth.

Spurred by the demands of the COVID-19 pandemic, researchers at Princeton and Google are applying mechanical engineering and artificial intelligence in an effort to increase the availability and effectiveness of ventilation treatments worldwide. Ventilators and their support equipment are lifesaving technologies, but they are also expensive and complex devices that require expert attention from doctors and other highly trained medical workers. The devices must be carefully calibrated and monitored to ensure they are meeting a range of parameters -- pressure, volume, breath rate -- tuned to each individual patient. 

Princeton University spinout NeuTigers has launched a rapid screening app that uses wearable sensor data to triage patients who may be suffering from Covid-19. CovidDeep is 90%+ accurate in predicting whether a person has the virus, and is twice as effective as current triage tools like temperature checks and questionnaires. The technology is designed to measure galvanic skin response (GSR), skin temperature, heart inter-beat interval (IBI), blood pressure and blood oxygen saturation levels (SpO2). All of these biomarkers can be impacted by COVID-19, meaning CovidDeep can help indicate that a patient may need a test for the disease before they even feel unwell.

Within days of shutting down their laboratories in response to the COVID-19 pandemic in March 2020, Princeton researchers were asking how they could help. "Many members of the Princeton faculty reached out with requests for opportunities to use their knowledge, ideas and skills to assist in combating the COVID-19 pandemic," said Dean for Research Pablo Debenedetti. In response, the University created a fund of over half a million dollars to support research on COVID-19. The projects, which are still ongoing, range from vaccines and treatments to policy, social and economic topics.

Researchers and clinical experts at Hackensack Meridian Health were awarded Department of Defense funds to continue their work into convalescent plasma for treatment of COVID-19 patients. The approximately $5.5 million will allow the researchers at Hackensack Meridian John Theurer Cancer Center at Hackensack University Medical Center, and their colleagues at the Hackensack Meridian Center for Discovery and Innovation (CDI) to continue phase 2 testing of the clinical treatments. The goal of this outpatient work is to treat infected patients in the first 96 hours of symptoms with the antibodies found in plasma collected from COVID-19 survivors -- with the aim to prevent hospitalization.

Brian Strom, the Chancellor of Rutgers Biomedical and Health Sciences, said the university's relationship with RWJBarnabas Health always has had a higher purpose.
"Our shared goal has always been to be a transformational leader in health care -- and it is exciting to continue to see our vision come to fruition," he said. That vision was on full display when Rutgers University and RWJBarnabas Health took a big step toward integrating the clinical services provided within the university's Robert Wood Johnson Medical School in the New Brunswick region and RWJBarnabas Health medical group practices through the execution of an integrated practice agreement.

Funding News

The New Jersey Economic Development Authority (NJEDA) announced it will open pre-registration for Phase 2 of its Small Business Emergency Assistance Loan Program at 9:00 a.m. EST on Wednesday, February 10, 2021. The $10 million program expansion will support New Jersey small businesses and nonprofits impacted by the COVID-19 pandemic and will be capitalized by a United States Economic Development Administration (USEDA) Coronavirus Aid, Relief, and Economic Security (CARES) Act appropriation. Any business or entity that intends to apply for a loan must first pre-register during this pre-registration period, which will run from 9:00 a.m. EST on February 10, 2021 to 5:00 p.m. EST on February 22, 2021.

Thought Leadership from BioNJ Members
A resource by By J.P. Morgan

Fast-growing companies and start-ups often need capital to fuel their ascent. When attracting investors and negotiating rights, you should understand how your company is valued and what that means for fundraising. Click here for 10 considerations to keep in mind when valuing your company and determining the capital you may need.
A whitepaper by MSQ Ventures

In 2020, the global biopharma industry was growing strong, especially the China biopharma industry which has made a breakthrough year with strong capital investment in the private and public market, and global transactions of license in/out driven by local innovation-focused policies. We expect that the China biopharma industry in 2021 will keep the steady growth and will play a more integrated role for global new drug development.

Special Programs from Our Partners for BioNJ Members
February 16-19, 2021

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics. The course is intended for scientists and engineers from the biopharma industry interested in learning about upstream and downstream processing of viral vectors. Click here for more information.
February 25, 2021

We invite you to get to know these entrepreneur-scientists, help them succeed and get an inside look at the newest cell and gene therapy breakthroughs coming out of university research. Investors, accelerators, fellow entrepreneurs, students and members of the community are all welcome to attend. After pitching, an interactive virtual expo will be available for guests to speak with founders and sponsors. The format is flexible so feel free to drop in whenever your schedule permits!
March 15-17, 2021

Take advantage of this unique opportunity for professionals to make connections, start collaborations and forge partnerships in North America's life sciences and health technology hub. The agenda co-created by the organizing committee is aimed at entrepreneurs, scientists, researchers, students, investors and life sciences and health technology professionals in Canada and abroad. 
March 16-18, 2021

Join over 150 leading VCs, Corp VCs, Angel Investors and over 100 Top Innovators at #VSVC Venture Summit Virtual Connect West. Dedicated Life sciences / Health care Track, One-on-One (zoom) investor meetings, two days of content, including timely panel discussions, workshops and an inspiring keynotes. Early Bird Rates expire February 11. Contact RBromberg@BioNJ.org for 20% discount code for BioNJ Members.



BioNJ Member Services Provider Directory

BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:
The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7.

Please contact BioNJ at BioNJ@BioNJ.org 
or call 609-890-3185 with any questions.