NJ’s Biopharma Sector in a Price Controlled World

In this Vital Health Podcast, we speak with Debbie Hart, President & CEO of BioNJ about the direct impacts of the Inflation Reduction Act upon BioNJ's Members. According to the trade journal BioSpace, “New Jersey is one of the most important states in the U.S. pharmaceutical industry. The state is home to 14 of the 20 largest pharmaceutical companies in the U.S., and the New Jersey pharmaceutical industry generates over $120.9 billion in revenue each year, with 63,415 jobs directly linked to the industry.” 

Welcome New Member

• Mercadien
• NeuroTechR3, Inc.
• Outcomes Matter Innovations, LLC
• TriRadial Solutions LLC

Learn more at www.BioNJ.org/Membership.

Nick Shipley - IRA’s Impact on the Biopharma Ecosystem

An overview of the IRA’s chilling effect on R&D in orphan oncology, and how mandated negotiations at year nine for small molecules will create an exodus of research funding in neurological disorders, a therapeutic area of high unmet medical need.

IRA's Impact on Orphan Therapies Featuring David Meeker, Chairman, President & CEO of Rhythm Pharmaceuticals

Vital insights on the risks posed by the Inflation Reduction Act on the development of orphan therapies, as well as the many uncertainties it creates for biopharmaceuticals investors.

Life Sciences Redevelopment Underway at Trenton’s Historic Roebling Center

Another life sciences space is under development in New Jersey, as the sector continues to proliferate throughout the State. Hx2 Development and JLL recently announced the start to work for the next phase of the Roebling Center in Trenton. At 100,000 square feet, Building 114 is tailored toward the life sciences and pharmaceutical manufacturing sectors. In a report released at the recent BIO International Convention, the Garden State was recognized as a national leader for its number of bioscience enterprises (upward of 4,300) and employees of the industry (nearly 105,000 people).“New Jersey’s biosciences sector has been a strong contributor to the State and national economies for generations,” BioNJ President and CEO Debbie Hart commented upon its release. “Our State offers companies a highly educated workforce, incubators and lab space, collaboration opportunities with world-class research universities and biopharmaceutical companies and an environment that supports them at every stage of their growth.”

A Rutgers Biomedical Research Powerhouse Turns 10

This month marks 10 years since the creation of Rutgers Biomedical and Health Sciences (RBHS), born from legislation introduced by then-Senate President Steve Sweeney and Senators Donald Norcross and Joseph F. Vitale and championed by Gov. Christie. Designed to strengthen collaboration opportunities and draw more research funding to the State, the education bill transferred to Rutgers most of the assets of the University of Medicine and Dentistry of New Jersey (UMDNJ) – including the medical schools in Newark and New Brunswick. It was the largest higher education merger in United States history. “This was, in many ways, the answer to a very specific need in the State’s life sciences ecosystem – the need for increased medical innovation and the benefits that come with it for students, patients, and the economy,” said Debbie Hart, president and chief executive of BioNJ. “The integration of UMDNJ and Rutgers has delivered, and continues to deliver, significant and meaningful economic results for New Jersey and beyond.”

More Biotech Facilities Coming to Lincoln Equities Group’s Princeton West Innovation Campus

On the heels of news that Enzene Biosciences will open a new 55,000-square-foot facility and bring 300 jobs to Princeton area, Lincoln Equities Group and H.I.G. Realty have announced plans for three new planned specialty manufacturing buildings at the Princeton West Innovation Campus in Hopewell, totaling 380,000 square feet, to accommodate advanced manufacturing uses, including biotech, pharmaceutical, nutritional and medical device and other high-tech needs. Lance Bergstein, Managing Director of LEG, added: “The collective team thanks Choose New Jersey, BioNJ and the NJEDA for their support and guidance in attracting Enzene Biosciences to New Jersey. We anticipate continued demand from companies who can utilize the property’s existing infrastructure and embrace its prime location along New Jersey’s life sciences corridor.”

PTC Therapeutics Announces Results from MIT-E Clinical Trial of Vatiquinone for the Treatment of Mitochondrial Disease Associated Seizures

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that the MIT-E trial of vatiquinone for the treatment of mitochondrial disease associated seizures (MDAS) failed to achieve its primary endpoint of reduction in observable motor seizures. The study showed evidence of treatment effect in reducing seizure frequency in the overall study population and in the largest subgroup of children with Leigh syndrome, in whom benefit was also observed in the key secondary endpoints of occurrence of status epilepticus and disease-related hospitalizations. The MIT-E study is a double-blind, placebo-controlled study of vatiquinone in pediatric patients with genetically confirmed mitochondrial disease and associated refractory seizures. The study enrolled 68 children at study sites worldwide. The study included a 24-week placebo-controlled phase followed by a 48-week open-label phase. 

Amicus Therapeutics Announces Approval and Launch of New Pompe Disease Therapy in the European Union

BioNJ Member Amicus Therapeutics, with a site in Cranbury, announced that the European Commission (EC) has granted approval for pfolda® (miglustat) 65mg capsules, an enzyme stabilizer of cipaglucosidase alfa, a long-term enzyme replacement therapy for adults with late-onset Pompe disease. Pombiliti® (cipaglucosidase alfa) was previously approved by the EC in March 2023. Pompe disease is an inherited lysosomal disorder caused by deficiency of the enzyme acid α-glucosidase (GAA). Amicus plans to immediately launch Pombiliti + Opfolda in Germany and is commencing reimbursement processes with healthcare authorities in other European countries. Pombiliti + Opfolda is a unique two-component therapy. Pombiliti (cipaglucosidase alfa), is a bis-M6P-enriched rhGAA enzyme, designed for increased uptake into muscle cells. Once in the cell, Pombiliti can be processed into its most active and mature form to break down glycogen.

Nevakar Injectables Announces FDA Approval of Cyclophosphamide RTD Solution

Bridgewater-based BioNJ Member Nevakar announced that the U.S. Food and Drug Administration (“FDA”) has approved its new drug application (“NDA”) for Cyclophosphamide Injection, 200mg/mL vials for use in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma and various types of leukemia. “We are delighted to receive FDA approval and believe that cyclophosphamide ready-to-dilute multi dose injection serves a very important need in oncology therapy. The product is available in two configurations, 500 mg / 2.5 mL and 1 gram / 5 mL vials to provide the health care providers with flexibility to use based on patient needs. Our simple and elegant formulation contains no unnecessary additives and benefits both providers and patients, as it minimizes waste, is easy to prepare, and reduces the risk of dosing error and product exposure,” stated Sriram Ramanathan, MS, MBA, Chief Executive Officer of Nevakar Injectables.

Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Eosinophilic Esophagitis

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that the first patient has been dosed in the company’s Phase 2 subcutaneous study of barzolvolimab in eosinophilic esophagitis (EoE). EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus. Several studies have suggested that mast cells may be an important driver in this disease. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of subcutaneous barzolvolimab in patients with active EoE.

Hillstream BioPharma Licenses Technology to Develop Proprietary HER2 and HER3 Antibody Drug Conjugates against Drug-Resistant Breast, Lung, Gastric and Ovarian Cancers

Bridgewater-based BioNJ Member Hillstream BioPharma, Inc. announced the signing of an exclusive agreement with Applied Biomedical Science Institute (ABSI) to license technology for human antibodies targeting novel HER2 and HER3 Conformational Epitopes. The goal is to develop proprietary multi-format biologics, including bi-specific antibodies, and antibody drug conjugates (ADCs). The HER2/HER3 binding ADC is targeted to have a high drug-to-antibody ratio which should increase the anti-tumoral efficacy with an enhanced bystander killing effect. Hillstream intends to combat drug resistant cancers such as HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer. The ErbB family of cell surface proteins, including ErbB2 or HER2 (human epidermal growth factor receptor) and Erb3 or HER3, are some of the most well-known and validated oncology drug targets.

AbbVie and Genmab Announce Positive Topline Results from Phase 1/2 EPCORE™ NHL-1 Trial Evaluating Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

Princeton-based BioNJ Member Genmab and BioNJ Member AbbVie, with a site in Madison, announced topline results from the follicular lymphoma (FL) cohort of the Phase 1/2 EPCORE™ NHL-1 clinical trial evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously. The study cohort includes 128 adult patients with relapsed or refractory (R/R) FL who received at least two or more lines of systemic therapy. 70.3 percent of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. EPCORE™ NHL-1 is an open-label trial evaluating the safety and preliminary efficacy of epcoritamab and consists of three parts: a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a Phase 2a optimization part. 

Tevogen Bio to Become Publicly Listed on NYSE via Business Combination With Semper Paratus Acquisition Corporation

Warren-based BioNJ Member Tevogen Bio Inc. and Semper Paratus Acquisition Corporation announced the execution of a merger agreement. Upon closing of the merger, the combined company will be named Tevogen Bio Holdings Inc. Tevogen Holdings common stock and warrants are expected to be listed on the NYSE under the new ticker symbol “TVGN”. Tevogen Bio is currently focused on developing its pipeline using its precision T cell platform, ExacTcell. ExacTcell is a product development toolkit that utilizes CD8+ Cytotoxic T Lymphocytes (“CTLs”), also known as Killer T Cells, one of nature’s most powerful weapons against cancer and infection.

First Wave BioPharma Announces Final Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

BioNJ Member First Wave BioPharma, Inc. announced that the final patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The Phase 2 multi-center clinical trial (NCT05719311) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Topline results from the study are anticipated by mid-2023.

Evotec Receives Milestone Payment for First Patient Dosed in Phase I Study of Bayer Kidney Disease Program

Princeton-based BioNJ Member Evotec SE announced that it is to receive a € 2 m milestone payment from Bayer AG, which is triggered by the first patient dosed in the clinical Phase I study of a kidney disease program stemming from the Evotec-Bayer multi-target research collaboration in kidney diseases. The drug candidate, a monoclonal antibody (“mAb”) targeting the protein Semaphorin-3A (“Sema3A”) is being developed as a potential first-to-market treatment for Alport syndrome, a rare genetic kidney disease. The Phase I clinical evaluation of the Sema3A mAb was initiated in June 2023, including dosing of the first healthy study participant. Under the terms of the agreement, Evotec is eligible to receive further significant clinical and sales milestones as well as tiered royalties of net sales depending on the future progress during clinical development and potential commercialization of a drug in the future.

Sandoz to Launch Hyrimoz® (adalimumab-adaz) High-Concentration Formulation, Marking Sandoz Entrance into U.S. Immunology Space

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection is now available in the United States. Hyrimoz HCF (100 mg/mL) is approved to treat all indications no longer covered by the regulatory exclusivity for the reference medicine, Humira®* (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Hyrimoz HCF offers a 50% reduction in injection volume compared to the 50 mg/mL concentration and can decrease the number of injections required for people who need at least 80 mg/0.8 mL dosing. The HCF formulation is citrate free and uses the same auto-injector as Hyrimoz 50 mg/mL, the Sensoready® pen, which is designed with patients in mind. 

Bausch + Lomb Will Acquire XIIDRA from Novartis

Bausch + Lomb Corporation has entered into a definitive agreement with BioNJ Member Novartis to acquire XIIDRA® (lifitegrast ophthalmic solution) 5%, a non-steroid eye drop approved to treat the signs and symptoms of dry eye disease (DED) focusing on inflammation associated with dry eye. Along with the purchase of Novartis’s libvatrep and AcuStream™ technology, the deal will be worth $2.5 billion. The acquisition of XIIDRA will complement Bausch + Lomb’s existing dry eye portfolio that includes eye and contact lens drops from the company’s consumer brand franchises and its pharmaceutical business that features MIEBO™ (perfluorohexyloctane ophthalmic solution), which was recently approved by the U.S Food and Drug Administration as the first and only approved eye drop for DED that directly targets tear evaporation. 

Organon & Samsung Bioepis Announce U.S. Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent With Originator

Jersey City-based BioNJ Member Organon & Co. & Samsung Bioepis Co., Ltd. announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States. Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care. HADLIMA is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. 

Janssen Announces Positive Topline Results for JNJ-2113 - a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced positive topline results from its Phase 2b FRONTIER 1 clinical trial evaluating the novel, first and only oral interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis (PsO).1 The trial achieved all primary and secondary efficacy endpoints. A greater proportion of patients who received JNJ-2113 achieved PASI 75 (primary endpoint) as well as PASI 90 and PASI 100 (75, 90 and 100 percent improvement in skin lesions as measured by the Psoriasis Area and Severity Index, respectively)a compared to placebo, at week 16.1 Trial results for JNJ-2113 demonstrated a profile1 that supports its advancement into Phase 3 clinical development for moderate-to-severe plaque PsO in adult patients.

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN). A statistically significant (54 percent [n=7/13]) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs) compared to the historic reference point of 10 percent, which was derived from published and unpublished data. Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.

Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients With Pulmonary Arterial Hypertension (PAH)

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II-III. The application is based on data from the Phase 3 A DUE study, which demonstrated that the M/T STCT significantly improved pulmonary haemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in patients with PAH.

Pfizer Provides Update on GLP-1-RA Clinical Development Program for Adults With Obesity and Type 2 Diabetes Mellitus

BioNJ Member Pfizer, with a site in Peapack, announced its decision to continue to progress one oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate toward further clinical development for the potential treatment of adults with obesity and Type 2 diabetes mellitus (T2DM). Moving forward, the company will continue advancing the clinical program for danuglipron (PF-06882961), subject to results from the ongoing Phase 2 trial, and discontinue the clinical development of lotiglipron (PF-07081532). The company expects to finalize plans for the danuglipron late-stage program by the end of 2023 and also is developing a once-daily modified release version. Results previously published in the Journal of the American Medical Association Network Open from the Phase 2 study (NCT03985293) of danuglipron in T2DM showed dose-dependent placebo-adjusted reductions (doses ranging from 2.5 mg through 120 mg for 16 weeks) in HbA1c of up to -1.16%; fasting plasma glucose of -33.24 mg/dL; and body weight of -4.17 kg over 16 weeks. 

FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA). Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity variant of human coagulation Factor IX (FIX) gene. For people living with hemophilia B, the goal of this gene therapy is to enable them to produce FIX themselves via this one-time treatment rather than needing regular intravenous infusions of FIX, as is the current standard of care.

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

BioNJ Member Pfizer, with a site in Peapack, and OPKO Health Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. NGENLA is expected to become available for U.S. prescribing in August 2023. Growth hormone deficiency (GHD) is a rare disease characterized by the inadequate secretion of the growth hormone somatropin from the pituitary gland, affecting one in approximately 4,000 to 10,000 children. Without treatment, children will have persistent growth attenuation, a very short height in adulthood, and puberty may be delayed. Children living with GHD may also experience challenges in relation to their physical health and mental well-being.

FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata. LITFULO is a kinase inhibitor which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases. The FDA approval was based on results of clinical trials in alopecia areata. The ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), evaluated the efficacy and safety of LITFULO at 118 sites in 18 countries. 

Novo Nordisk A/S: New Data Show Once-Weekly Insulin Icodec Met Additional Endpoints in Adults With Type 2 Diabetes In Phase 3a Trials

Plainsboro-based BioNJ Member Novo Nordisk announced data from the Phase 3a ONWARDS 1 and 3 trials evaluating investigative once-weekly basal insulin icodec. The data showed the studies met their primary endpoints, while reducing injections from seven to one per week, compared with once-daily basal insulin. Additionally, data from the ONWARDS 1 and 3 studies demonstrated that more insulin-naïve adults with type 2 diabetes treated with once-weekly basal insulin icodec achieved an HbA1c target of <7.0% without experiencing clinically significant or severe hypoglycaemia compared with once-daily basal insulin comparators at 52 and 26 weeks, respectively. In ONWARDS 1, as a confirmatory secondary endpoint, superior Time in Range (blood glucose 70–180 mg/dL) was achieved with once-weekly basal insulin icodec vs once-daily basal insulin glargine U100 (71.9% vs 66.9%, respectively) from week 48–52.

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) With Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients With Tumor Cell PD-L1 Expression ≥1%

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%. With this EC decision, Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved for patients in the European Union (EU) in this setting. The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery. 

Bristol Myers Squibb Receives European Commission Approval of CAMZYOS® (mavacamten), for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved CAMZYOS® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. CAMZYOS is the first and only allosteric and reversible inhibitor selective for cardiac myosin approved in all European Union (EU) member states and is the first cardiac myosin inhibitor that targets the underlying pathophysiology of HCM. The EC approval of CAMZYOS is based upon positive efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM. 

ALTUVIIIO Late-Breaking Data at ISTH Demonstrates Highly Effective Bleed Protection in Children With Severe Hemophilia A With Once-Weekly Dosing

Pivotal data from the Phase 3 XTEND-Kids study evaluating ALTUVIIIOTM [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis, a first-in-class, high-sustained factor VIII replacement therapy, in previously treated patients younger than 12 years of age with severe hemophilia A were presented by Bridgewater-based BioNJ Member Sanofi. The results from the XTEND-Kids study and confirmed that ALTUVIIIO met the primary endpoint with no inhibitor development to factor VIII detected, and key secondary endpoints including annualized bleeding rate (ABR) and maintenance of factor VIII activity above pre-specified levels.

Positive Topline Phase 2b Data in Atopic Dermatitis Support Amlitelimab As A Potential First And Best-In-Class Novel Investigational Anti-OX40-Ligand Monoclonal Antibody

The primary endpoint was met in a Phase 2b study (STREAM-AD) of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. In this dose-ranging study by Bridgewater-based BioNJ Member Sanofi, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied. There were also improvements in key secondary outcome measures and continued improvements were observed through week 24 in primary and key secondary outcomes. Biomarker results support an effect on both type 2 and non-type 2 pathways.

GSK Receives U.S. FDA Fast Track Designation for Investigational Vaccine Against Gonorrhoea

Warren-based BioNJ Member GSK announced the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG). The vaccine candidate is currently in an ongoing Phase II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age, considered at risk of gonorrhoea. Antimicrobial resistance (AMR) to gonorrhoea has increased over the past 80 years, rendering many classes of antibiotics used to treat the disease ineffective. Vaccines can play a critical role in the fight against AMR by helping prevent bacterial, viral and other infections. At this time, there are no gonorrhoea vaccines approved anywhere in the world. 

GSK Completes Acquisition of BELLUS Health

Warren-based BioNJ Member GSK and BELLUS Health Inc. announced GSK has completed the acquisition of BELLUS, a biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC), by way of a plan of arrangement in accordance with Section 192 of the Canada Business Corporations Act. As previously announced, the acquisition of BELLUS includes camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC. Luke Miels, Chief Commercial Officer, GSK said, “The acquisition of BELLUS is highly synergistic with GSK’s expertise in respiratory medicines and is further supported by GSK’s leading R&D, manufacturing and commercialization capabilities. We are now focused on progressing camlipixant through Phase III trials to offer a therapeutic option for RCC patients as soon as possible.”

Spesolimab Prevents Generalized Pustular Psoriasis Flares in EFFISAYIL™ 2 Trial

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, presented new late-breaking data from the EFFISAYIL™ 2 trial showing that spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. Furthermore, the trial with 123 patients demonstrated no flares after Week 4 of spesolimab treatment in the high dose group.

“EFFISAYIL™ 2 is the first and largest multinational randomized clinical trial to evaluate a treatment for the prevention of GPP flares,” said Bruce Strober, M.D., Ph.D., Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology. “These results provide further compelling clinical evidence for the role IL-36 signaling plays in the pathogenesis of GPP. Moving forward, our hope is that dermatologists not only have a specific treatment for GPP flares, but that we can effectively prevent them in the future.”

Jardiance® Recommended for the Treatment of Adults With Chronic Kidney Disease in The EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), BioNJ Members Boehringer Ingelheim, North Brunswick-based, and Eli Lilly and Company, with a site in Branchburg, announced. Empagliflozin is currently indicated for the treatment of heart failure and type 2 diabetes in adults. When approved, empagliflozin’s indications in the EU will include adults living with CKD, paving the way for an approach to managing the amplified risks of interconnected cardio-renal-metabolic conditions.

New England Journal of Medicine Publishes BRUIN Phase 1/2 Trial Data for Pirtobrutinib in BTK Inhibitor Pre-Treated Adult Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Loxo@Lilly, the oncology unit of BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that The New England Journal of Medicine published detailed results from the BRUIN Phase 1/2 trial evaluating the efficacy and safety of an investigational use of pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were previously treated with a BTK inhibitor. The NEJM publication provides additional clinical details from the data set that was presented at the 2022 American Society of Hematology (ASH) Annual Meeting. The data set includes 247 BTK inhibitor pre-treated CLL/SLL patients enrolled across both the Phase 1 and Phase 2 portions of the BRUIN study.

Lilly's SURMOUNT-2 Results Published in The Lancet Show Tirzepatide Achieved a Mean Weight Reduction Of 15.7% at the Highest Dose (15 Mg) in Adults With Obesity or Overweight and Type 2 Diabetes

Detailed results from SURMOUNT-2, a Phase 3 clinical trial evaluating the efficacy and safety of BioNJ Member Eli Lilly and Company, with a site in Branchburg, tirzepatide (10 mg and 15 mg) for chronic weight management in participants with obesity or overweight and type 2 diabetes, showed that tirzepatide led to superior weight reduction versus placebo for both doses. Tirzepatide met both co-primary endpoints and all key secondary endpoints compared to placebo for both estimands, with those taking tirzepatide achieving a mean weight reduction of 13.4% (29.8 lb. or 13.5 kg) on 10 mg and 15.7% (34.4 lb. or 15.6 kg) on 15 mg compared to 3.3% (7.0 lb. or 3.2 kg) on placebo for the efficacy estimand, which evaluates the treatment effect if all participants adhered to treatment.

Lilly to Acquire Sigilon Therapeutics

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Sigilon Therapeutics, Inc. announced a definitive agreement for Lilly to acquire Sigilon, a biopharmaceutical company that seeks to develop functional cures for patients with a broad range of acute and chronic diseases. Since 2018, Lilly and Sigilon have worked together to develop encapsulated cell therapies, including SIG-002, for the treatment of type 1 diabetes. The goal of these therapies is to free patients from constant disease management by sensing blood glucose levels, restoring insulin production and releasing it over the long term. "By combining Sigilon's talent and expertise in cell therapy with the knowledge and skills of Lilly's research and development teams, we will enhance opportunities to create innovative islet cell therapy solutions to improve the care of people living with diabetes." said Ruth Gimeno, Ph.D., Group Vice President, diabetes, Obesity and Cardiometabolic Research, Lilly.

Lilly's Phase 2 Results Published in The New England Journal of Medicine Show Orforglipron, A Once-Daily Oral Nonpeptide GLP-1 Receptor Agonist, Achieved Up To 14.7% Mean Weight Reduction at 36 Weeks in Adults With Obesity Or Overweight

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced new Phase 2 data for orforglipron, its first nonpeptide oral glucagon-like peptide-1 (GLP-1) receptor agonist being studied for chronic weight management in participants with obesity or overweight. The results were published in The New England Journal of Medicine. Orforglipron met both primary and secondary endpoints for the efficacy estimand and demonstrated clinically significant weight reductions in adults with obesity or overweight, with at least one weight-related comorbidity (not including type 2 diabetes). At the 26-week primary endpoint, orforglipron (12 mg, 24 mg, 36 mg or 45 mg) showed statistically significant dose-dependent body weight reductions for all doses ranging from 8.6% (19.8 lb. or 9.0 kg) to 12.6% (29.3 lb. or 13.3 kg) compared to 2.0% (4.6 lb. or 2.1 kg) for placebo. 

Lilly's Phase 2 Retatrutide Results Published in The New England Journal of Medicine Show the Investigational Molecule Achieved Up to 17.5% Mean Weight Reduction at 24 Weeks in Adults With Obesity and Overweight

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced new Phase 2 data from retatrutide, Lilly's investigational molecule being studied for the treatment of obesity. At 24 weeks, retatrutide (1 mg, 4 mg, 8 mg or 12 mg) met the primary endpoint for the efficacy estimand in participants living with obesity or overweight without diabetes, demonstrating a mean weight reduction up to 17.5% (41.2 lb. or 18.7 kg). In a secondary endpoint, retatrutide demonstrated a mean weight reduction up to 24.2% (57.8 lb. or 26.2 kg) at the end of the 48-week treatment duration. The results were published in The New England Journal of Medicine.

Teva’s 3rd Interim Analysis of PEARL Real-World Study on AJOVY® (fremanezumab) Reveals Sustained Long-Term Effectiveness in Reducing Frequency, Duration and Severity of Attacks in Patients With Chronic and Episodic Migraine

Parsippany-based BioNJ Member Teva Pharmaceuticals Ltd. announces further positive data from the pan-European PEARL study investigating the impact of AJOVY® (fremanezumab) on the prevention of migraine in a real-world setting, due to be completed in 2024. The data from the 3rd interim analysis reveals that almost 60% of patients achieved a ≥50% reduction in monthly migraine days from baseline for migraine prevention, with sustained improvement in disability scores and acute medication use observed over 12 months. Treatment persistence rates were high, with 82.3% of patients remaining on treatment by month 12. Not only was fremanezumab effective in preventing migraine attacks in patients with chronic and episodic migraine, but it has also shown to be effective in reducing the severity and duration of remaining migraine attacks.

Hepcludex® (Bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced Week 96 results from the pivotal MYR301 Phase 3 clinical trial evaluating the first-in-class entry inhibitor Hepcludex® (bulevirtide) for the treatment of adults with chronic hepatitis delta (HDV) infection. These new data reinforce the role of bulevirtide as an efficacious and well-tolerated treatment for the management of chronic HDV. Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S. The new findings (OS-068) reinforce the efficacy and safety of bulevirtide and demonstrate that additional improvements in combined response are observed at Week 96 compared with Week 48, with no signs of treatment resistance. 

Gilead Receives CHMP Positive Opinion for Trodelvy® in Pre-Treated HR+/HER2- Metastatic Breast Cancer

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 for Trodelvy® (sacituzumab govitecan) as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. The final European Commission decision on the additional indication for Trodelvy is anticipated later in 2023. The CHMP positive opinion is supported by results from the Phase 3 TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02).

FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease  

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD or mild AD.

Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression Free Survival in Patients With Advanced Non Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial  

Basking Ridge-based Daiichi Sankyo announced topline results from the TROPION-Lung01 Phase 3 trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. For the dual primary endpoint of overall survival (OS), the data were not mature and an early trend was observed in favor of datopotamab deruxtecan versus docetaxel that did not meet the pre-specified threshold for statistical significance at this interim analysis.

LEO Pharma Receives Positive CHMP Opinion for New Adtralza® (tralokinumab) Injection Device

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 that recommends the approval of Adtralza® (tralokinumab) solution for injection in a new single dose (300 mg) 2 ml pre-filled pen. Adtralza, a high-affinity fully human monoclonal antibody, has previously been available in a 1 ml pre-filled syringe. The 2 ml pre-filled pen will be an additional option for Adtralza patients and prescribers who prefer a simplified method of administration that halves the number of injections required, with a single 300 mg dose given every other week rather than two 150 mg doses with the pre-filled syringe. For patients who prefer the pre-filled syringe, this administration option will continue to be available in markets where Adtralza is already launched.

Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Shionogi & Co., Ltd., with a site in Florham Park, announced the first participant has been enrolled in Japan in its global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP). The study will evaluate the safety and efficacy of the novel COVID-19 oral antiviral ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection in study participants exposed to household contacts who are symptomatic and tested positive for SARS-CoV-2, when compared to placebo. The first participant is expected to be enrolled in the U.S. this month. In addition, Shionogi also announced that it has filed for full approval of ensitrelvir in Japan.

Lexicon Announces Planned Advancement of LX9211 Into Late-Stage Development

Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced plans to advance its investigational drug LX9211 into late-stage development in a clinical program directed towards an application for regulatory approval in diabetic peripheral neuropathic pain, or DPNP. The first late-stage study will be a Phase 2b dose optimization study, with start-up scheduled in the third quarter of 2023 and the initiation of dosing expected in the fourth quarter. The Phase 2b study includes an extension to run in parallel with planned next-stage Phase 3 studies. “We are energized by our interactions with the FDA and value the feedback we have received, which has helped to inform the design of our clinical program for LX9211,” said Craig Granowitz, M.D., Ph.D., Lexicon’s Senior Vice President and Chief Medical Officer. 

BrainStorm Cell Therapeutics Data Show Treatment With NurOwn Significantly Reduces NfL, a Key Biomarker of Neurodegeneration

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced presented new biomarker data from the Phase 3 trial of its late-stage investigational ALS treatment, NurOwn at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference. These data show that treatment with NurOwn significantly elevated markers of neuroprotection and lowered markers of neuroinflammation and neurodegeneration, including neurofilament light (NfL) over time compared to placebo in all trial participants. New data analysis presented this week was motivated by the regulatory precedent set by a recent FDA drug approval in ALS, and the knowledge gained through the regulatory process, suggesting that the blood-based biomarker neurofilament light (NfL) is associated with disease prognosis and progression in patients with ALS and potentially other neurodegenerative diseases.

Tonix Pharmaceuticals to Acquire "Gold Standard" of Migraine Meds

Chatham-based Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiary Tonix Medicines Inc. announced that they entered into an agreement to acquire two fast-acting migraine treatments from Upsher-Smith Laboratories LLC. The products, Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray), are both indicated for the treatment of acute migraine with or without aura in adults. Tonix said “each may provide onset of migraine pain relief in as few as 10 minutes for some patients.” Upsher-Smith also agreed to provide certain commercial operations, regulatory and other transition services to Tonix Medicines for up to nine months after closing, in exchange for agreed upon service fees. 

CBRE Analysis: New Jersey Remains Among Top Markets for Life Sciences Research Talent

The greater New Jersey market ranked fourth in the nation for life sciences research talent, according to a recent analysis conducted by CBRE. Nationally, the growth of U.S. life sciences researchers remains resilient in the face of economic concerns, with the number of life sciences researchers in the U.S. increasing by 87% over the past 20 years, compared with 14% for all U.S. occupations. CBRE evaluated each of the largest 74 U.S. life sciences labor markets against multiple criteria, including the number and concentration of life sciences researchers, number of new graduates with life sciences degrees and specifically with doctorate degrees in life sciences, concentration of all doctorate degree holders and concentration of jobs in the broader professional, scientific and technical services professions.

AbbVie and Heart of America to Develop Makerspace at New Brunswick School

More than 60 employees from AbbVie are giving back to the local New Brunswick community and more than 600 students at Roosevelt Elementary School by creating an immersive and modern makerspace as part of AbbVie’s eighth annual Week of Possibilities employee volunteer program. AbbVie is partnering with Heart of America to bring the makerspace to life, which aims to enhance science, technology, engineering and mathematics (STEM) education for students attending the school. Heart of America is a longstanding partner for AbbVie’s Week of Possibilities that focuses on creating quality educational environments that positively impact children’s development across the country. By providing access to educational resources and programs, Heart of America strives to bridge the opportunity gap that exists in under-resourced areas.

First New Jersey Patient Treated With Genetically Modified T-Cells Developed at State’s Only National Cancer Institute-designated Comprehensive Cancer Center

Rutgers Cancer Institute of New Jersey, the State’s only National Cancer Institute-designated Comprehensive Cancer Center together with RWJBarnabas Health, has treated its first patient using genetically modified T-cells that were manufactured in its own state-of-the-art Good Manufacturing Practices (GMP) facility, a fully commissioned clean space for manufacturing of viral vectors and cell products for human administration. Harnessing the immune system to target cancer is the goal of a groundbreaking area of oncology research called cell therapy. This includes harvesting T-cells from a patient and genetically engineering those cells to produce receptors that allow the T-cells to specifically target antigens on the surface of the cancer cells of the patient in order to kill those cancer cells.

Highlighting Women Scientists: Rutgers Cancer Institute Researcher Awarded V Foundation for Cancer Research Grant 

Christina Glytsou, Ph.D., member of the Cancer Metabolism and Immunology Cancer Pharmacology Program at Rutgers Cancer Institute of New Jersey, the state’s leading cancer program and only National Cancer Institute-designated Comprehensive Cancer Center together with RWJBarnabas Health, has received $600,000 over a three-year period from The V Foundation for Cancer Research, a premier cancer research charity, to support her research on mitochondrial dynamics adaptations in drug-resistant acute myeloid leukemia. This landmark initiative called A Grant of Her Own: The Women Scientists Innovation Award for Cancer Research, is helping to counteract longstanding gender disparities in research by investing $8 million in the groundbreaking work of 11 women scientists leading the charge in cancer research.

In First Decade, Dean for Research Innovation Funds Spur Discoveries, Collaborations and Research Investments

A decade ago, Princeton established a pioneering program to catalyze bold new directions in research and scholarship. A set of funding opportunities, supported by the University, would enable exploratory projects with the potential to expand frontiers and benefit humanity. A new report on the first 10 years of the Dean for Research Innovation Funds demonstrates that these funds are highly effective engines of exploration. The program has sparked over 80 projects involving faculty from across the disciplines in areas ranging from the natural sciences to engineering, humanities, social sciences and the arts.

Peter Schiffer Named Princeton’s Next Dean for Research

Peter Schiffer, a professor of applied physics and physics at Yale University and the Director for Strategic Projects at Yale’s Faculty of Arts and Sciences, has been named Princeton’s next Dean for Research. His appointment will take effect Aug. 28. “I am honored and excited,” said Dr. Schiffer, who will also join the Department of Physics as a professor. Princeton is a spectacular institution with extraordinarily strong faculty and leadership. My personal research background is in a multidisciplinary area of physics, and I’ve interacted substantially with scholars across the academic spectrum through my administrative roles. I’m looking forward to engaging with new colleagues across the humanities, social sciences, sciences and engineering.”

Biocentriq, Cytiva Receive Funding to Accelerate Gene Therapy Development

Newark-based BioCentriq as well as Cytiva were awarded funding to accelerate bringing gene therapies to market as part of a grant round from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public-private partnership with a mission of ramping up biopharmaceutical innovation. While viral clearance is a key regulatory requirement for all biopharmaceutical processes, it is a relatively new topic in cell and gene therapy. This project, which is being granted funding as part of NIIMBL’s $15.8 million initiative to drive biotech innovation through technology and workforce development, will involve the creation of a viral and exotoxin clearance platform in an adeno-associated virus (AAV) manufacturing process.

Overlook Becomes Trial Site for Brain Tumor Treatment

The Gerald J. Glasser Brain Tumor Center at Overlook Medical Center in Summit, part of Atlantic Health System, has become the first site in the nation to dose a patient in the Phase IIb RESTORE Trial for newly diagnosed glioblastoma tumors. The new treatment is developed by NuvOx Pharma, a clinical stage biotechnology company developing a first-in-class therapeutic to treat life-threatening diseases where hypoxia – low levels of oxygen in body tissue – plays a role. This phase of the trial’s primary objective is to determine progression free survival (PFS) in newly-diagnosed glioblastoma patients after treatment with NanO2 TM – the company’s lead drug – in combination with radiation and chemotherapy.

Theurer Cancer Center is No. 1 in NJ Says ‘Newsweek’

The Hackensack Meridian John Theurer Cancer Center at Hackensack University Medical Center has been recognized as one of America’s Best Cancer Hospitals 2023 by Newsweek. The facility is ranked #1 in New Jersey and recognized as a top 75 cancer hospital in the country. The cancer center is part of the NCI-designated Lombardi Comprehensive Cancer Center at Georgetown University. The America’s Best Cancer Hospitals ranking is a resource for informed healthcare decision-making. The list is based on the results of a national online survey of healthcare professionals and hospital managers, patient surveys and hospital quality metrics and also includes which hospitals or medical centers have state-of-the-art facilities and the most knowledgeable, accomplished physicians. 

Click here to view report.

Organon Publishes FY2022 ESG Report Showcasing Progress Toward Global Sustainability Goals

Organon's 2022-2023 Environmental, Social and Governance (ESG) Report highlights the company’s progress on its comprehensive ESG platform, Her Promise, and its related goals, which are in line with the United Nations Sustainable Development Goals (SDGs). Organon has continued to make focused investments and form strategic partnerships to introduce and expand access to health solutions and advance gender equity.

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming and networking, with global deal making opportunities.