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

We hope this letter finds you safe and well. During these most difficult times, there are numerous examples of brilliance and rays of hope being provided by New Jersey's robust life sciences ecosystem. As always, we are happy to celebrate them and all of you who make it possible here in the BioLines Weekender!

First congratulations to founding BioNJ Member Immunomedics for its accelerated FDA approval this week for Trodelvy™ (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease. Trodelvy is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC. We are so proud of and happy for the Team at Immunomedics and their Patients! Congratulations! 
Huge congratulations are also in order for BioNJ Member Insmed Incorporated for the announcement this week that they will provide funding and clinical drug supply for the STOP-COVID19 (Superiority Trial of Protease inhibition in COVID-19) trial, an investigator-initiated study of brensocatib in up to 300 hospitalized patients with COVID-19, sponsored by the University of Dundee. The study, which has been prioritized and designated an Urgent Public Health trial by the UK's National Institute for Health Research, is expected to begin enrollment in May 2020. 

And, also super exciting, is Rutgers University's new saliva COCID-19 test that could more than double the amount of daily testing in New Jersey, with results in less than 48 hours, providing hope for a rapid expansion of testing as part of a larger strategy to reopen the State!  Go Scarlet Knights!

Thank you to all of our Members and New Jersey's life sciences community for your unwavering work... making a difference for Patients everywhere. Governor Murphy featured his Jersey Pride in his recent tweet, "Our State is the historic home of innovations in the life sciences, and now we have a huge breakthrough coming from our very own flagship university." So true, Governor!
Lastly, during this time of social distancing and perhaps the feeling of isolation, we invite our Members to connect in BioNJ's Members-Only LinkedIn Group, as well as join us for BioNJ's new "Business UnUsual Webinar Series: In the Age of COVID-19," featuring timely topics specifically focused on how they relate to the life sciences community. Our next webinar, "Strategic Communications in the Age of COVID-19: Complex Messaging - Diverse Audiences," is taking place Thursday, May 7, at 10:00 a.m. Please click here to register.
Wishing everyone the very best of health. Please reach out if we can assist you in any way.  It is such an honor to serve this noble community at this extraordinary time. Thank you for the privilege of doing so.

Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

NEW! BioNJ's Business UnUsual Webinar Series:

Strategic Communication in the Age of COVID-19
May 7, 2020

BioNJ's 10th Annual BioPartnering Conference
Somerset, NJ
October 6, 2020
BioNJ's C-Suite Summit
Bridgewater, NJ
October 30, 2020
BioNJ's Manufacturing Briefing
New Jersey Innovation Institute
Save the date!
November 12, 2020
Putting Patients First: The Value of Medical Innovation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of health care. Share with our community how your medical innovation is improving lives and impacting health care costs. Send us your Patient and related stories to BioNJ@BioNJ.org. Plus, click here for valuable tools and resources on the Value of Medical Innovation.

Vaccines represent some of the most impactful advances in public health, helping to prevent the spread of many infectious diseases and, in many parts of the world, eliminating some of the most devastating conditions.  In the U.S. today,  16 diseases  are now preventable as a result of childhood vaccines, and routine immunization of U.S. children born between 1994-2018 has prevented more than  419 million illnesses Today, biopharmaceutical companies are working with stakeholders across the research and development (R&D) ecosystem to develop new ways of preventing and treating illnesses with innovative vaccines. According to a  new report , there are currently 258 vaccines in development for the treatment or prevention of disease.

This new eight-episode educational video series will examine the latest efforts to respond to the COVID-19 pandemic and break down the complex process of developing a vaccine.  Each week our host Lisa Ling, Executive Producer and Host of This Is Life on CNN, will talk to leading scientists and researchers, healthcare workers on the front lines and public health experts around the world working collaboratively to bring an end to the deadly pandemic.

NJ Company News

Bridgewater-based BioNJ Member Insmed Incorporated announced that it will provide funding and clinical drug supply for the STOP-COVID19 (Superiority Trial oProtease inhibition in COVID-19) trial, an investigator-initiated study of brensocatib (formerly known as INS1007) in up to 300 hospitalized patients with COVID-19 sponsored by the University of Dundee. The study, which has been prioritized and designated an Urgent Public Health trial by the UK's National Institute for Health Research, is expected to begin enrollment in May 2020.

Morris Plains-based BioNJ Member Immunomedics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy™ (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease. Trodelvy is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC.

Princeton-based BioNJ Member Soligenix, Inc. announced that it has executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific Corporation, for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic fluCoVaccine HT is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. 

Cranbury-based BioNJ Member  Outlook Therapeutics, Inc.  provided a clinical update on the impact of the COVID-19 pandemic on the status of NORSE 1 and NORSE 2, its ongoing registration clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab. All clinical and chemistry, manufacturing and control (CMC) activities are currently active for both NORSE 1 and NORSE 2, registration clinical trials evaluating ONS-5010 for treatment of wet age-related macular degeneration (wet AMD). 

Pennington-based BioNJ Member OncoSec Medical Incorporated announced pre-clinical data from a feasibility study of its visceral lesion applicator (VLA) electroporation device and APOLLO generator. The feasibility study demonstrated the capability of a rigid, trocar-like VLA applicator to safely deliver and electroporate DNA-based immunotherapy directly into target organs in a large animal model using a CT-guided approach and OncoSec's new, lower voltage APOLLO generator.

Iselin-based BioNJ Member Helsinn Therapeutics announces a change to the financial assistance program for VALCHLOR® (mechlorethamine) gel 0.016% to ensure that commercially insured patients have access to treatment during the COVID-19 crisis. Starting today, eligible patients' prescription copays will be waived in full until at least June 30, 2020. Helsinn will continue to monitor the crisis and reassess the June 30th end date if necessary .

Madison-based BioNJ Member LEO Pharma A/S announced that is has signed a worldwide exclusive licensing agreement with Oneness Biotech and Microbio Shanghai covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825. FB825 is a first-in-class drug candidate with a unique mechanism of action (MoA) targeting the CεmX domain of the membrane bound IgE (mIgE) causing a depletion of mIgE positive B-cells. 

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced positive top-line results for its Phase 3 VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp, a novel broad-spectrum antifungal, as a treatment for women with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. With these results, ibrexafungerp has now achieved superiority over placebo with a high degree of statistical significance on key study endpoints required for regulatory approval of the VVC indication in both VANISH pivotal trials, clearing the way for the NDA submission for the treatment of VVC in the second half of 2020.

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced that it has entered into a Common Stock Purchase Agreement of up to $20 million with Aspire Capital Fund, LLC.  Under the terms of the agreement, SCYNEXIS has the right to sell to Aspire Capital, from time to time and in its sole discretion, up to $20 million in shares of SCYNEXIS's common stock over the next 30 months, subject to certain limits.

Princeton -based BioNJ Member Kyowa Kirin and MEI Pharma jointly announced that the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI's ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for the treatment of B-cell malignancies. MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S., with MEI booking all revenue from U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S. 

A growing number of drug developers are embracing artificial intelligence as a tool for finding new medicines. BioNJ Member  Lantern Pharma, with offices in Kearny, is betting the technology can also resurrect failed cancer drugs and it is now preparing an initial public stock offering to support their development.  Lantern filed its  IPO paperwork.  Lantern's research aims to turn failed or abandoned drugs into new therapeutic candidates. The company says in its IPO filing that AI technology helps it find compounds best suited for such "drug rescue."

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. 

Princeton-based BioNJ Member Genmab A/S announced that worldwide net trade sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 937 million in the first quarter of 2020. Net trade sales were USD 463 million in the U.S. and USD 474 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

Berkeley Heights-based BioNJ Member  Cyclacel Pharmaceuticals, Inc.  announced that it entered into an agreement with the University of Edinburgh to study fadraciclib (CYC065) and seliciclib (CYC202 or R-roscovitine), its clinical stage CDK2/9 inhibitors, as potential early treatments for the inflammatory response observed in patients with COVID-19 disease. The parties will assess Cyclacel's medicines above for their suitability for use in safety and experimental medicine studies in COVID-19 patients.

Berkeley Heights-based BioNJ Member  Cyclacel Pharmaceuticals, Inc.  announced the pricing of a public offering with expected total gross proceeds of approximately $20 million, before deducting placement agent fees and other offering expenses payable by the company. Roth Capital Partners is acting as the lead placement agent for the offering.  Ladenburg Thalmann  and  Brookline Capital Markets , a division of  Arcadia Securities, LLC  are acting as co-placement agents for the offering.

Berkeley Heights-based BioNJ Member Amgen  and Adaptive Biotechnologies are hard at work on a potential medicine, and the top scientists from both companies recently provided their perspectives on their new R&D collaboration.  "We are focused on making progress as quickly as possible," said David Reese, Amgen's Executive Vice President for Research and Development. "We are trying to strike the right balance between getting the highest quality antibody or antibodies as therapeutic candidates with the shortest timeline that we can manage." 

Plainsboro-based BioNJ Member Novo Nordisk is offering a free 90-day supply of insulin to patients who were financially affected by the COVID-19 pandemic.  Patients in the U.S. who can prove they lost their healthcare benefits because of a job termination notice or job status change are eligible. In addition, the offer will be extended past 90 days for anyone who is denied Medicaid benefits. "The pandemic is taking a serious toll on the nation's health and economy. Millions of people are losing jobs and health coverage, and that's especially tragic if you have a chronic disease like diabetes," said Doug Langa, Executive Vice President of Novo Nordisk's North America Operations and President of Novo Nordisk.

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that the U.S. Food and Drug Administration ("FDA") has authorized its investigational new drug ("IND") application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage. The study will target patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure.

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that it has finalized an agreement to sell $10.9 million in New Jersey net operating losses ("NJ NOLs") to a qualifying and approved buyer pursuant to the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Program. "The ability to convert our NJ NOLs into non-dilutive capital is an exciting development for Caladrius, especially in these challenging financial times, and we appreciate the NJEDA's commitment to supporting research and development for small New Jersey-based companies," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. 

Bridgewater-based BioNJ Member Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older. MenQuadfi was designed to elicit and demonstrated a high immune response across all four serogroups for multiple ages and was well tolerated.

Bridgewater-based BioNJ Member Sanofi's investigational BTK (Bruton's tyrosine kinase) inhibitor, an oral, brain-penetrant, selective small molecule achieved both the primary and secondary endpoints in a Phase 2b trial evaluating efficacy and safety in participants with relapsing forms of multiple sclerosis. The BTK inhibitor (SAR442168) significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging (MRI). The Phase 2 study was designed to assess the dose-response relationship after 12 weeks of treatment with SAR442168, by measuring the number of new brain lesions on MRI.

Bridgewater-based BioNJ Member Sanofi and Warren-based BioNJ Member GSK announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi's licensed recombinant influenza product in the U.S. GSK will contribute its proven pandemic adjuvant technology.

Bridgewater-based BioNJ Member Sanofi said it is donating 100 million doses of hydroxychloroquine, a treatment for rheumatoid arthritis and lupus, to 50 countries worldwide and has begun to progressively deliver the medicine to authorities that have requested it. Sanofi said it has already doubled its incremental production capacity - on top of the usual production for current indications - across its eight hydroxychloroquine manufacturing sites worldwide and is on track to quadruple it by the summer. The company said it will continue to donate the medicine to governments and hospital institutions if ongoing clinical studies demonstrate its efficacy and safety in COVID-19 patients.

East Hanover-based BioNJ Member  Novartis  announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah® (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL). Kymriah, which is designed to be a one-time treatment, is the first-ever FDA-approved CAR-T cell therapy. The potential approval in r/r FL will be the third indication for Kymriah, which also has indications in r/r pediatric and young adult acute lymphoblastic leukemia (ALL) and r/r adult diffuse large B-cell lymphoma (DLBCL).

East Hanover-based BioNJ Member  Novartis  has acquired Amblyotech Inc., a clinical stage digital therapeutics company.  Once the deal has closed, Novartis intends to develop Amblyotech's novel digital technology for the treatment of amblyopia (lazy eye). The approach utilizes active gaming and passive video technology with 3D glasses to train patients' eyes to work together. "We believe Novartis is best positioned to maximize the opportunity for our amblyopia treatment to reach and help patients who suffer from this condition. The Amblyotech technology has the potential to be a first-in-class product for patients with this debilitating condition," Joseph Koziak, CEO of Amblyotech, said.

East Hanover-based BioNJ Member  Novartis  has reached an agreement with the U.S. Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis. The large trial sponsored by Novartis will be conducted at more than a dozen sites in the United States. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible.

East Hanover-based BioNJ Member  Novartis  announced new Mayzent® (siponimod) data in the April supplemental issue of Neurology®. The data build on existing clinical evidence that Mayzent has proven to slow physical disability progression and provide cognitive benefits in people living with secondary progressive multiple sclerosis (SPMS)1. Although every patient's multiple sclerosis (MS) journey is unique, 1 in 4 relapsing-remitting MS (RRMS) patients on treatment transition to SPMS within 10 years of RRMS onset.

East Hanover-based BioNJ Member  Novartis  announced that clinical data for Aimovig® (erenumab) was reported in Neurology. The data strengthens the role Aimovig as a preventive migraine treatment and confirms its real-world and long-term safety and efficacy benefit in patients with episodic and chronic migraine. "These newly shared data reinforce Novartis commitment to reimagine migraine care and add to the growing body of real world and long-term evidence demonstrating the efficacy of Aimovig for migraine prevention across the migraine spectrum," said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals.

Princeton-based BioNJ Member Bristol Myers Squibb announced that CheckMate -743, a pivotal Phase 3 trial evaluating Opdivo ® (nivolumab) in combination with Yervoy® (ipilimumab) in previously untreated malignant pleural mesothelioma (MPM) met its primary endpoint of overall survival (OS). Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in OS compared to chemotherapy (pemetrexed and cisplatin or carboplatin).

Princeton-based BioNJ Member Bristol Myers Squibb and Exelixis, Inc. announced that CheckMate -9ER, a pivotal Phase 3 trial evaluating Opdivo ® (nivolumab) in combination with CABOMETYX® (cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced it has entered into an agreement with the  National Institute of Allergy and Infectious Diseases  (NIAID), part of the  National Institutes of Health  (NIH), to study baricitinib as an arm in NIAID's Adaptive COVID-19 Treatment Trial. The study will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19, beginning this month in the  U.S.  with a planned expansion to additional sites including  Europe  and  Asia . Results are expected within the next two months.

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced non-branded versions of Humalog® Mix75/25 KwikPen® (insulin lispro protamine and insulin lispro injectable suspension, 100 units/mL) and Humalog® Junior KwikPen® (insulin lispro injection, 100 units/mL) are now available for order by  U.S.  pharmacies. These non-branded insulin options are identical to the branded versions, with different packaging and a 50 percent lower list price of  $265.20  for a package of five KwikPens.

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE have announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech's BNT162 vaccine program to prevent COVID-19 infection. BioNTech and Pfizer are jointly developing BNT162. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly.

BioNJ Member Pfizer Inc., with offices in Peapack, and EMD Serono announced completion of the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BAVENCIO® (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). The FDA granted Breakthrough Therapy Designation to BAVENCIO for this indication, and the sBLA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.

Kenilworth-based BioNJ Member  Merck & Co. announced the resubmission of its supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) to update the dosing frequency for KEYTRUDA, Merck's anti-PD-1 therapy, to include a 400 mg dose infused over 30 minutes every six weeks (Q6W), in addition to the currently approved dose of 200 mg every three weeks (Q3W). sBLAs were filed across all adult indications for KEYTRUDA, including monotherapy and combination therapy. Merck has filed the resubmissions to address the Complete Response Letter issued in February 2020.

Kenilworth-based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved the kinase inhibitor KOSELUGO (selumetinib) for the treatment of pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA approval is based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored Phase 2 SPRINT Stratum 1 trial coordinated by the NCI's Center for Cancer Research, Pediatric Oncology Branch. 

Kenilworth-based BioNJ Member  Merck & Co. announced the U.S. launch of ONTRUZANT (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. ONTRUZANT is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. ONTRUZANT will be introduced in the U.S. at a list price (wholesaler acquisition cost) of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of Herceptin. 

Monmouth Junction-based CytoSorbents Corporation announced the United States Food and Drug Administration has granted Emergency Use Authorization of CytoSorb® for use in patients with COVID-19 infection. Under the EUA, CytoSorbents can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit with confirmed or imminent respiratory failure who have early acute lung injury or acute respiratory distress syndrome (ARDS), severe disease or life-threatening illness resulting in respiratory failure, septic shock and/or multiple organ dysfunction or failure, as described in FDA's authorization and as detailed below. 

Branchburg-based  ZEUS Scientific announced the submission for an Emergency Use Authorization to the  U.S. Food and Drug Administration for its rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibodies to COVID-19 virus.  ZEUS's lateral flow test uses patient serum, plasma or whole blood and provides results in 15 minutes. Assay performance has been confirmed by testing sample cohorts from healthy donors, confirmed positive COVID-19 patients and cross-reactive samples acquired from heavily afflicted regions in both China and the United States.

Paramus-based  Octapharma USA is supporting a new investigator-initiated clinical trial led by Dr. George Sakoulas of Sharp Memorial Hospital in San Diego, Calif., focused on treating the most critical patients at the heart of the COVID-19 pandemic -- those experiencing respiratory failure who become ventilator dependent.  The trial is entitled Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection.

Princeton-based UroGen Pharma Ltd. announced the U.S. Food and Drug Administration (FDA) granted expedited approval for Jelmyto™   (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). This landmark approval is based on positive results from the Phase 3 OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer. Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using UroGen's proprietary sustained release RTGel™ technology. 

Ridgefield Park-based  BeiGene, Ltd.  announced that the  Center for Drug Evaluation  (CDE) of the  China National Medical Products Administration  (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene's anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). This sNDA is supported by clinical results from a Phase 3 trial of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin compared to paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland  China  (NCT03594747).

Princeton-based PDS Biotechnology Corporation announced an expanded infectious disease pandemic development program, including novel vaccines for COVID-19 and universal influenza, in addition to its previously announced tuberculosis development collaboration with Farmacore Biotechnology. The company also announced that initiation of its multi-center Phase 2 VERSATILE-002 trial for PDS0101 in advanced/metastatic head and neck cancer has been delayed due to the severe adverse impact on clinical trial operations from the COVID-19 pandemic.

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced that its product RYANODEX® (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. Eagle submitted its Investigational New Drug application to the U.S. Food and Drug Administration for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA's Coronavirus Treatment Acceleration Program to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Oldwick-based Provention Bio, Inc. announced the initiation of the rolling submission of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031), an anti-CD3 monoclonal antibody for the delay or prevention of clinical Type 1 Diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies. Provention submitted the non-clinical module and expects to submit the clinical module in Q3 and the chemistry, manufacturing and controls (CMC) module in Q4 of 2020.

Bridgewater-based Amneal Pharmaceuticals, Inc. announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Butrans® (buprenorphine) Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr and 20 mcg/hr. In addition, Amneal was granted the Competitive Generic Therapy (CGT) designation and 180 days of exclusivity for the 7.5 mcg/hr dose. Amneal immediately initiated commercialization activities across all dosages for its Buprenorphine Transdermal System. 

Bedminster-based  Mallinckrodt plc  announced that the  U.S. Food and Drug Administration  (FDA) has accepted for review the company's New Drug Application (NDA) for terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1 (HRS-1). On  March 17, 2020  the company announced the completion of its rolling submission of the NDA for terlipressin. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of  September 12, 2020 .

Bedminster-based  Mallinckrodt plc  announced the publication of findings from its randomized, placebo-controlled, double-blind Phase 4 study to assess the safety and efficacy of Acthar® Gel (repository corticotropin injection, or RCI) in patients with persistently active rheumatoid arthritis (RA) despite treatment with stable background disease-modifying antirheumatic drugs (DMARDs) and low-dose glucocorticoids. Results of the study were recently published in Rheumatology and Therapy.

Basking Ridge-based  Daiichi Sankyo Company, Limited has renewed a joint research agreement with the Drugs for Neglected Diseases initiative with regard to a new research program, the Lead Optimization Project, with the aim of developing innovative drug treatments for Chagas disease, one of the neglected tropical diseases. This collaborative project is funded through the Global Health Innovative Technology Fund Product Development Platform and will receive approximately 430 million yen over a period of two years.

Basking Ridge-based  Daiichi Sankyo Company, Limited  announced that, through the Japan Center for International Exchange, it will make a donation of $1 million to the COVID-19 Solidarity Response Fund in support of relief efforts for countermeasures against COVID-19.  Daiichi Sankyo decided to provide this donation as part of our global contribution to society in light of the need for global support of measures against COVID-19 and concerns about the rapid spread of infection in the future in areas where access to health care is inadequate.

Basking Ridge-based  Daiichi Sankyo Company, Limited, Mitsubishi UFJ Capital Co., Ltd. and Nagoya Institute of Technology announced that they have commenced open innovation research concerning a gene therapy for restoring vision. In a project under TaNeDS, Daiichi Sankyo's open competition grant program for joint drug discovery research, the laboratory led by Professor Hideki Kandori of Life Science and Applied Chemistry, Graduate School of Engineering, Nagoya Institute of Technology discovered that a highly active, novel photo-responsive protein could be applied to the restoration of vision. 

Englewood-based  Enzychem Lifesciences announced that it has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) covering treating COVID-19 infections and symptoms using EC-18, the company's lead compound. EC-18 can significantly reduce the development of cytokine storm and prevents the progression of ARDS. Consistent with our current new drug development pipeline, Enzychem is currently seeking appropriate partners to develop and commercialize EC-18 worldwide as a potential treatment for COVID-19.

Chatham-based  Acquist Therapeutics, Inc . announced that the company received a fourth patent from the U.S. Patent Office that covers the Acquist investigational drug library. The patent covers compounds that are intended to help patients with gout, NASH (nonalcoholic steatohepatitis) and other illnesses. Compositions, uses and claims of this patent -- 2019/0117654 A1 -- have also been filed worldwide. Collectively, the four U.S. patents cover more than 100 novel compounds, which the company believes will provide composition exclusivity to 2039.

Morristown-based  Melinta Therapeutics and health care investment firm Deerfield Management Company, L.P. announced that Melinta has successfully completed its financial restructuring and has emerged from Chapter 11.  In accordance with the pre-negotiated Chapter 11 plan of reorganization, Melinta is now privately owned by affiliates of Deerfield and has eliminated its debt obligations, resulting in a well-financed and strongly positioned anti-infectives company with plans for future growth.

Berkeley Heights-based  CorMedix Inc. announced that  it has completed the previously announced sale of $5.5 million of the total $6.0 million of its  available tax benefits to an unrelated, profitable New Jersey corporation through the New Jersey  Economic Development Authority's New Jersey Technology Business Tax Certificate Transfer
program for State Fiscal Year 2019. As a result, the company has received approximately $5.2  million in cash from the sale of these NOL tax benefits.

People in the News

Princeton-based BioNJ Member  Agile Therapeutics, Inc.  announced that the company has nominated Sharon Barbari  for election as a Class III Director to replace Abhijeet Lele , a member of the company's board of directors and the board's Lead Independent Director, who will not stand for re-election and cease to be a director on  June 9, 2020 , the date of the company's Annual Meeting of Stockholders. In addition, William McKee  has informed the company that he will retire from the company's board of directors effective  June 9, 2020 . The company plans to appoint  Sandra Carson , M.D., FACOG as a Class II Director to replace Mr. McKee  when he retires.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced the appointment of Herbert Kim Lyerly, M.D., George Barth Geller Professor, Professor of Immunology, Surgery and Pathology at Duke University School of Medicine, to its Board of Directors. In addition, OncoSec's co-founder, Avtar Dhillon, M.D., has stepped down as chair of the company's Board and current board member, Margaret R. Dalesandro, Ph.D., has assumed the role of chair.

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced the appointments of Matthew Klein, M.D., to Chief Development Officer and Eric Pauwels to Chief Business Officer. Dr. Klein will be responsible for the development of our clinical stage programs. As the Chief Business Officer, Mr. Pauwels will be responsible for our customer facing activities with health care providers, patients and payers ensuring that our therapies are available and accessible to rare disease patients and their families worldwide.

Princeton-based PDS Biotechnology Corporation announced that it has appointed Ilian Iliev, Ph.D. to its Board of Directors. "We are very pleased to welcome Dr. Iliev to the Board of Directors. He brings a wealth of experience to PDS Biotech as a recognized entrepreneur and venture capitalist across multiple industries, including health care," commented Steve Glover, Chairman of the Board of PDS Biotech. 

Institution and Education News

As the urgency of finding a treatment and vaccine for the Coronavirus accelerates, dozens of American biomedical companies, start-ups and universities are rushing to develop COVID-19 therapeutics. There's a good chance the Bayh-Dole Act will play a critical behind-the-scenes role in facilitating these efforts. Congress passed the bipartisan Bayh-Dole Act in 1980 to give universities and nonprofit research institutions such as Battelle Memorial Institute, Sloan Kettering and Mass General Hospital rights to the intellectual property they generate from federally funded research. 

A new saliva test for the Coronavirus developed by Rutgers University could more than double the amount of daily testing in New Jersey, with results in less than 48 hours, providing hope for a rapid expansion of testing as part of a larger strategy to reopen the State. The test, which uses saliva instead of a swab that is inserted deep into the nose or throat, will be administered to 10,000 people a day as soon as next week, said Brian Strom, chancellor Rutgers Biomedical and Health Sciences. Currently, between 7,000 to 9,000 people in New Jersey are tested each day.

While health care professionals worldwide are facing shortages of personal protection equipment (PPE), students and staff from across  Rutgers are coming together to produce face shields and intubation boxes themselves with off-the-shelf materials to help relieve the PPE shortage at area hospitals.  In the largest university-wide initiative to protect frontline hospital workers, the RU 3D PPE project is bringing together more than 70 people from the  School of Engineering School of Arts and Sciences School of Environmental and Biological Sciences Rutgers Robert Wood Johnson Medical School  and  Rutgers New Jersey Medical School .

Rutgers University announced that it has launched the nation's largest prospective study of health care workers exposed to COVID-19. The study includes a series of clinical trials that will explore new drug treatments, antibody testing and long-term health tracking in the hope of providing insight into how to treat the disease and prevent its spread.  The study is being coordinated by  Rutgers Biomedical and Health Sciences  (RBHS), the university's academic health center. Initial results suggest a gender disparity in risk: women have been infected at a rate of 13 times their male counterparts. Some of this may be attributed to the existing disparity in the nursing workforce, which currently includes more women than men.

Rutgers University physicians and  University Hospital are making an appeal for blood donations from those who have survived COVID-19, saying their blood plasma contains antibodies that may help critically ill patients fight, and perhaps conquer, the virus.  The physicians, who received FDA approval Friday to use blood plasma from patients who recovered from COVID-19 to treat new patients, have thus far treated 17 patients with convalescent plasma. FDA approval is pending for the use of this treatment for additional patients.

The fight against the Coronavirus is underway in a Rutgers University-Camden research laboratory, where chemistry professor  Jinglin Fu  is working to develop a mechanism to rapidly detect viral RNA for potential diagnosis of COVID-19. "The main problem that we want to address is an urgent need of a rapid and reliable assay that is simple and affordable for mass screening to prevent the spread of infectious diseases, such as the current COVID-19 pandemic," explains Dr. Fu.

The newly adopted principles aim to reduce barriers to developing COVID-19 research and innovations into products and services for the global health response. Princeton is one of the first signatories to the new guidelines, which were developed by the  Association of University Technology Managers (AUTM)  and are being adopted by universities across the country. Under the guidelines, most Princeton COVID-19-related innovations will be made accessible during the pandemic without charge to companies or other entities in exchange for their commitment to make and broadly distribute any resulting products and services for the benefit of the public.

Answering the growing need for additional testing, and in direct response to shortages encountered in testing kit supply pipelines, the Coriell Institute for Medical Research is now offering services to create viral testing collection tubes containing different media and/or buffer formulations, for use in COVID-19 testing kits. Coriell is also exploring the feasibility of saliva as a means for testing for the new Coronavirus.  These new media and buffer products in Coriell's lineup have been proven effective through validation testing conducted by Cooper University Health Care. 

New Jersey Institute of Technology had four undergraduate students named Goldwater Scholars, one of the top academic honors for undergraduate research.  The total was the highest of any school in the State -- and tied for second-highest in the nation. NJIT had more honorees than Columbia University (3), Harvard University (3), Massachusetts Institute of Technology (2) and Princeton University (2).

New Jersey Innovation Institute , an  NJIT  Corp., announced hat Jennifer D'Angelo has been named Vice President and General Manager, responsible for leading the company's health care division, effective May 4. Ms. D'Angelo is the current senior vice president and chief information officer at the Paramus-based Bergen New Bridge Medical Center. There, she heads cybersecurity, HIPAA security and privacy, information services, clinical informatics, and telecommunications. Earlier in her career, she held a similar role at Christian Health Care Center in Wyckoff.

The New Jersey Innovation Institute (NJII) has appointed Dr.  Deirdre Letson-Christofalo as Vice President of its Human Capital Division and  Dan Kaminski as Vice President and General Manager of Data & Technology. Both units were created earlier this year. Dr. Christofalo joins us from Felician University, where she was dean of the School of Business and the Center for Innovation & Professional Studies. Before joining NJII last month, Mr. Kaminski was Co-founder & Chairman of Global Finance Links.

Researchers and clinical experts at Hackensack Meridian Health announced that they are looking into the blood of COVID-19 survivors as a potential treatment for current COVID-19 patients.  The work will scrutinize the antibodies within the serum of the surviving patients, in an attempt to discover more about the disease, and perhaps develop new ways to fight it. Convalescent plasma treatments have previously been used to fight other viral outbreaks, including those of severe acute respiratory syndrome (SARS), which sickened thousands in 2002-2003, caused by a virus that's a cousin to the one responsible for COVID-19.

A COVID-19 patient who was on a ventilator at St. Luke's Warren Campus is on the road to recovery after successful extubation that followed an experimental blood plasma treatment.
According to St. Luke's, the patient's treatment was part of a nationwide expanded access treatment protocol overseen by the Mayo Clinic. Convalescent plasma (the liquid part of blood) from a person who recovered from COVID-19 contains antibodies that may provide a powerful boost to someone else fighting the viral infection.

Some of the best high schools hail from New Jersey, according to  U.S. News & World Report, which released its 2020 rankings of the  Best High SchoolsThe publication considered data on more than 24,000 public high schools in 50 states and the District of Columbia, ranking nearly 18,000 schools on six factors, based on their performance on state assessments and how well they prepare students for the future.

Funding News

The New Jersey Economic Development Authority (NJEDA) today launched its New Jersey Entrepreneur Support Program to help Garden State entrepreneurs with limited funding navigate COVID-19-related cashflow constraints by giving them access to capital from investors that are already investing in their companies. A link to the program application is posted on the State's COVID-19 Business Information Hub. This guarantee program is part of a package of initiatives, including grants and loans, announced late last month to support businesses and workers facing economic hardship due to the outbreak of the novel coronavirus COVID-19.

In response to the COVID-19 outbreak in New Jersey, the New Jersey Economic Development Authority (NJEDA) Board modified reporting requirements for businesses receiving tax credits through the Grow New Jersey (Grow NJ) and Urban Transit Hub (HUB) programs. Companies that have been approved for tax credits through these programs must submit annual reports that include the average of the number of workers they employed each month during the previous year. The rule change modifies these reporting requirements to exclude months during which Governor Phil Murphy's Executive Order 107 (EO 107) is in effect if the business can demonstrate COVID-19 prevented employees from working at the qualified business facility and there are no viable work-from-home options.

Donations from individuals and companies of at least $100,000 are now being accepted by the New Jersey Economic Development Authority to support its Small Business Emergency Assistance Grant Program, which provides awards to New Jersey small businesses impacted by the COVID-19 outbreak.  Those interested in doing so should contact donation@njeda.com. The gifts must be unrestricted and without conditions. To avoid conflicts of interest, donors must have no existing contracts with the NJEDA and may not enter into a contract with the organization for at least six months following the donation. This includes tax incentive agreements, financial assistance, bond contracts, leases and other contracts.

Special Programs from Our Partners for BioNJ Members

April 29-30, 2020 | Virtual

RESI  is planning its first ever, dedicated, digital partnering event on April 29-30th  with over 200 investors participating!  We're offering a special opportunity to our tech hubs to help your companies continue their business development in these difficult times . To receive a a special 50% discount code , good until April 17th, use special discount code RESITH50 . That means the registration for 2 full days of partnering will cost less than $300!

June 8-12, 2020 | Virtual

For 2020, the BIO International Convention will transition to a new, virtual event format, BIO Digital. This virtual gathering of the global biotech industry will provide access to key partners via BIO One-on-One Partnering, educational resources to help drive your business, and the insights you need to continue critical research and development.  Join us, June 8-12, from wherever you are in the world, for BIO Digital 2020.

June 16, 2020 | Morristown

Students 2 Science is delighted to invite you to S2S: The Salon, a community gathering in celebration of S2S' 10-year anniversary. It will be a wonderful event with key influencers in the State of New Jersey representing both public and private sectors, including corporate leaders, educators, administrators and policy officials.  A panel discussion, led by BioNJ President and CEO Debbie Hart will engage participants in a dialogue on the urgent and important topics of equity and diversity in STEM education: "How Do We Encourage a Ready and Diversified Workforce in STEM?" For more information on tickets and sponsorship contact S2S@students2science.org. 

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.