Welcome to the latest edition of the  BioLines Weekender...
 
Over the last few weeks, BioNJ has hosted a number of webinars under our 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. 

For those who have not been able to attend our live webinars, we are happy to share recorded versions for your reference...

" Labor & Workforce Management in the Age of COVID-19 :
Legal and Tax Implications for Life Sciences Companies"
" IT/Cybersecurity Awareness in the Age of COVID-19 The Do's and Don'ts of Working from Home"
"Health Coverage in the Age of COVID-19 Members Health Plan NJ"
"Strategic Communications in the Age of COVID-19 Complex Messaging - Diverse Audiences"
 
We hope you join us for future BioNJ webinars, including "Tips and Tools on NCATS SBIR & STTR Funding: How to Successfully Apply" on May 20 at 1:30 p.m. and  "The Value of Medical Innovation in the Age of COVID-19: Ensuring Future Cures and Protecting Patient Access" on June 3 at 10:00 a.m. And, let us know if you have an idea for a webinar that you might like to sponsor!

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

Tips and Tools on NCATS SBIR & STTR Funding: How to Successfully Apply
May 20, 2020
The Value of Medical Innovation in the Age of COVID-19 Webinar
June 3, 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.



The medication that has turned my life around has, however, come under the suspicious eye of a watchdog group called the Institute for Clinical and Economic Review. ICER uses a discriminatory cost-effectiveness model called Quality-Adjusted Life Years to determine the value of different medications. QALY, which ICER calls the " gold standard " to determine cost-effectiveness, is a utility analysis that evaluates the price of a particular drug against its efficacy in improving a person's life, or according to the model, the utility value recovered by the drug. It is discriminatory because it does not value years of life equally for people who are terminally ill compared with people who are healthy.



For years, Patients Rising has given patients the information they need about health policy developments from Washington, all while giving them a voice in the nation's capital.  Now we are bringing the news to you in a format that's easy to take with you wherever you go. Every week, Patients Rising Podcast will dig deep into the week's health care policy issues that impact you.  Each episode features the latest news, in-depth discussions with policymakers and patient advocates, and updates from patient correspondents around the country.



As health care professionals across the country work tirelessly to treat the clinical consequences of COVID-19, many of us have transitioned to full-time remote work to limit the public health impact of infection spread. In this new reality, we, as a society, are quickly realizing the impact of our health on our ability to work and provide for our loved ones. Any loss in productivity due to ill health can come at a cost to the individual, employer and overall society. Conversely, any gains in productivity due to improved health can benefit not only the individual, but also the employer and society. 

NJ Pride



The  Biopharma Division of the New Jersey Innovation Institute (NJII), an NJIT corporation, introduced BioCentriq as the name of its cell and gene therapy production and manufacturing center. BioCentriq is the only process development and clinical manufacturing facility for cell and gene therapies located in Newark, N.J., and the first of its kind to be located on a university campus in the United States.



The coalition, led by the  New Jersey Business & Industry Association, is offering more than just broad-based ideas. It also has produced dozens of sector-specific documents -- covering everything from recreation to restaurants, child care to dental care, even major sectors, such as life sciences and pharma.  Michele Siekerka, the CEO of the NJBIA, said the proposals are meant to be a dynamic document that serves as a starting point for the State's leaders to use when the governor announces his next level of teams he will use to plan the State's economic reopening.

NJ Company News



BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week. Pfizer and BioNTech's development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. 



BioNJ Member Pfizer Inc., with offices in Peapack, announced detailed results of the first study to show the burden of both invasive and non-invasive Group B Streptococcus infections (GBS) among hospitalized adults in the United States. The study, published in The Journal of Infectious Diseasesestimated that 188,570 GBS-related hospitalizations (95% confidence interval [CI]: 175,290-202,710) and 5,660 deaths (95% CI: 5,260-6,080) occur each year among US adults ages 18 or older when including both invasive and non-invasive GBS infections. 



Cranbury-based BioNJ Member  Rafael Pharmaceuticals, Inc.  announced that it has entered into a research collaboration with  Roswell Park Comprehensive Cancer Center . Through this collaboration, researchers will evaluate the effects of CPI-613® (devimistat) with or without chemotherapy agents, including oxaliplatin/cisplatin/5-FU/carboplatin/taxol, on esophageal cancer cells. Rafael has several active clinical trials focusing on cancers in the gastrointestinal tract. Its Phase 3 clinical trial in metastatic pancreatic cancer (AVENGER 500) is enrolling significantly ahead of schedule, with more than 80% of the patients needed for the trial already enrolled.



Cranbury-based BioNJ Member  Rafael Pharmaceuticals, Inc.  announced that the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, granted approval for the opening of sites in India for the company's Phase 3 clinical trial in the treatment of acute myeloid leukemia (AML). The company has also received approval by Health Canada to open sites for the trial in Canada.



Princeton-based BioNJ Member Soligenix, Inc. announced that it has received approximately $840,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program. "Receipt of this non-dilutive funding is a welcomed addition to our non-dilutive government grant and contract funding," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is our ninth year receiving NOL funding, which now totals approximately $5.6 million. We are, again, very thankful for NJEDA's continued support of its biotechnology industry."



Princeton-based BioNJ Member Soligenix, Inc. announced that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in the open-label treatment cycle (referred to as Cycle 2) of its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients. 



Pennington-based BioNJ Member Oncosec Medical Incorporated announced published data in Clinical Cancer Research that demonstrated its lead product candidate, TAVO™ (interleukin-12 or "IL-12" plasmid), in combination with the anti-PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab), produced a 41% overall response rate (ORR), with 36% complete response in a Phase 2, single arm study evaluating patients with metastatic melanoma selected to be anti-PD-1 checkpoint resistant.



South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced positive results from part 2 of the pivotal FIREFISH study evaluating risdiplam in infants with type 1 spinal muscular atrophy (SMA). The global study met its primary endpoint of infants sitting without support for five seconds by month 12, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Type 1 SMA babies do not achieve this milestone without therapy. Substantial results were demonstrated across multiple secondary and exploratory endpoints, as infants in the study achieved milestones not seen in natural history.



South Plainfield-based BioNJ Member PTC Therapeutics Inc.  has acquired  Censa Pharmaceuticals Inc.  Under terms of the merger, PTC will pay $10 million in cash and up to 850,000 shares of common stock. In addition, future consideration includes $217.5 million in development and regulatory milestones.  Censa Pharmaceuticals is focused on the development of CNSA-001, an investigational therapy for orphan metabolic diseases. The deal is expected to close in the second quarter of 2020. 



Lawrenceville-based BioNJ Member Adare Pharmaceuticals, Inc. announced that it has acquired the pharmaceutical technology company, Orbis Biosciences, Inc. The acquisition of Orbis will enhance Adare's Pharmaceutical Technologies business, which develops and manufactures products for global pharmaceutical, animal health and over-the-counter (OTC) markets. "Orbis's customized technologies are an excellent complement to our contract development and manufacturing organization (CDMO) business which is currently focused on oral dosage forms for pharmaceutical and OTC medicines," said John Fraher, CEO of Adare Pharmaceuticals, Inc.



Ramsey-based BioNJ Member ADMA Biologics, Inc. announced several recent corporate achievements pertaining to its supply chain robustness objectives as established at the beginning of 2020. "We have been very active during these challenging times in executing upon what we believe to be high value-added improvements to our supply chain to enhance robustness, increase capacity and heighten control over the production of our products.  These achievements include the successful manufacturing of three BIVIGAM® conformance batches at an increased scale of plasma volume, purchase of a new aseptic filling machine and installation, along with our plasma collection center expansion initiatives, all of which are on schedule with our budgeted expectations.  



Morris Plains-based BioNJ Member Immunomedics, Inc. announced that Trodelvy (sacituzumab govitecan-hziy) is now available through major specialty distributors in the United States and that the first patient was treated with commercial product on April 29, 2020. Trodelvy is the first anti-Trop-2 ADC recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.



Morris Plains-based BioNJ Member Immunomedics, Inc. announced the closing of its previously announced underwritten public offering of common stock. The total number of shares of common stock sold was 16,947,389, composed of 14,736,860 shares of common stock initially offered and an additional 2,210,529 shares of common stock sold pursuant to the full exercise of the underwriters' option to purchase additional shares, in each case at a public offering price of $28.50 per share.



Basking Ridge-based BioNJ Member  Caladrius Biosciences recently said the U.S. Food and Drug Administration authorized its investigational drug 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. "CLBS119 offers the potential to repair the lung damage caused by COVID-19 and to address a serious unmet need for patients. In previous clinical trials and preclinical models, CD34+ cells consistently have shown evidence of vascular repair in multiple organs including models of severe lung inflammation," said Chief Medical Officer Dr. Douglas Losordo.



Warren-based BioNJ Member GlaxoSmithKline plc announced the U.S. Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. 



Princeton-based BioNJ Member Genmab A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the subcutaneous formulation of daratumumab for the treatment of adult patients with multiple myeloma in frontline and relapsed / refractory settings. "We are very pleased with this Positive Opinion from the CHMP as it potentially brings the convenient dosing of subcutaneous daratumumab closer to becoming available for multiple myeloma patients in Europe," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.



Cranbury-based BioNJ Member  Palatin Technologies, Inc. provided an update on business operations as a result of the global COVID-19 pandemic.  The company has taken steps to ensure the safety and well-being of its employees and clinical trial patients to comply with guidance from federal, state and local authorities, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve.



Birdgewater-based BioNJ Member Insmed Incorporated announced that it priced a registered underwritten public offering of 9,700,000 shares of its common stock at a price to the public of $23.25 per share. The gross proceeds to Insmed from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be approximately $225.5 million. In addition, Insmed has granted the underwriters a 30-day option to purchase up to an additional 1,455,000 shares of common stock.



Bridgewater-based BioNJ Member Sanofi announced topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron's PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy were announced. Libtayo demonstrated clinically meaningful and durable responses in this group of patients for whom there are no approved treatments. Sanofi and Regeneron plan regulatory submissions in 2020.



Bridgewater-based BioNJ Member Sanofi and Regeneron Pharmaceuticals, Inc. announced the primary endpoint of overall survival (OS) was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo® (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ≥50% of tumor cells. Based on a recommendation by the independent Data Monitoring Committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use.



Bridgewater-based BioNJ Member Sanofi and Regeneron Pharmaceuticals, Inc. announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with "severe" or "critical" respiratory illness caused by COVID-19. Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only "critical" patients continue to be enrolled to receive Kevzara 400 mg or placebo.  



Bridgewater-based BioNJ Member  Eli Lilly and Company and Junshi Biosciences announced they have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel Coronavirus.  At the beginning of the COVID-19 outbreak, Junshi Biosciences-a  China -based biopharmaceutical company specializing in discovery, development and commercialization of novel therapies-launched one of the industry's first R&D efforts aimed at discovering therapies to combat COVID-19.



East Hanover-based BioNJ Member  Novartis  announced that the U.S. Food and Drug Administration (FDA) approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).



East Hanover-based BioNJ Member  Novartis  announced the European Commission (EC) has approved Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA). "This approval of Cosentyx for non-radiographic axial spondyloarthritis means clinicians across Europe now have an effective new treatment option to help patients gain relief from the burden of this painful, debilitating disease and achieve a better quality of life both at home and at work," said Atul Deodhar, M.D., Professor of Medicine and Medical Director of Rheumatology Clinics at Oregon Health & Science University, USA, and an investigator in the PREVENT clinical trial.



East Hanover-based BioNJ Member  Novartis  U.S. Foundation announced that a grant provided to the New Jersey Primary Care Association (NJPCA) made it possible to launch five new telehealth programs for community health centers in the state. These telehealth programs provide virtual primary and specialty care, including mental health services, to New Jersey's most vulnerable citizens, the underserved and the uninsured, and has enabled the centers to continue providing these services during the COVID-19 pandemic. 



Princeton-based BioNJ Member  Bristol Myers Squibb  announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia (AML), who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation.



Princeton-based BioNJ Member  Bristol Myers Squibb  and Acceleron Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of:  Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.  Adult patients with transfusion-dependent anemia associated with beta thalassemia.



Parsippany-based BioNJ Member  Teva Pharmaceuticals USA, Inc.  announced that the autoinjector device for AJOVY ®  (fremanezumab-vfrm) injection is now available in the U.S. AJOVY is indicated for the preventive treatment of migraine in adults and is the only anti-CGRP (calcitonin gene-related peptide) preventive migraine treatment with quarterly (675 mg) and monthly (225 mg) subcutaneous dosing options. AJOVY is the only long-acting anti-CGRP injection with the option of dosing four times per year using either the autoinjector or prefilled syringe.



Kenilworth-based BioNJ Member  Merck & Co.  and its foundation arm announced an additional $10 million commitment to support COVID-19 relief efforts.  The Kenilworth-based drugmaker said with this commitment, it has contributed more than $30 million to help address health inequalities in underserved and vulnerable communities. "COVID-19 is an unprecedented challenge for the global community. At Merck, we are working to support patients, health care professionals and communities across the world in the fight against this disease," Dr. Julie L. Gerberding, Chief Patient Officer, Merck, said.



Kenilworth-based BioNJ Member  Merck & Co. announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase 3 clinical trial evaluating RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), the active comparator, in the primary and key secondary endpoints of the study, 28-day all-cause mortality and clinical response, respectively.



Kenilworth-based BioNJ Member  Merck & Co.  announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck's anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety. 



Kenilworth-based BioNJ Member  Merck & Co. announced a new research collaboration to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines. Merck has also entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the U.S. Department of Health and Human Services, for BARDA to provide funding support for this research effort under Contract No. HHSO100201600031C.



Kenilworth-based BioNJ Member  Merck & Co. announced the presentation of interim data from Cohort B of KEYNOTE-555, a Phase 1 trial evaluating a 400 mg every six-week (Q6W) dosing regimen for KEYTRUDA, Merck's anti-PD-1 therapy, in patients with metastatic melanoma. Results of the study -- which represent the first clinical outcomes evaluating Q6W dosing for KEYTRUDA -- demonstrated efficacy and safety comparable to findings from previous melanoma trials evaluating KEYTRUDA monotherapy.



Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. If approved for these indications, SIMPONI ARIA would be the first anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion available for the treatment of these juvenile arthritides.



Somerset-based Catalent Inc announced a collaboration with BioNJ Janssen Pharmaceutical Cos. of Johnson & Johnson.  Through its Biologics business unit, Catalent will accelerate the availability of manufacturing capacity, and prepare for large-scale commercial manufacturing, at its Bloomington, Ind. facility for Johnson & Johnson's lead vaccine candidate for COVID-19. The collaboration, according to Catalent, commits joint investment to accelerate rapid scale-up of segregated manufacturing capacity over the coming months to support the dedicated production of Johnson & Johnson's investigational vaccine candidate.



Somerset-based  Catalent Inc. and Arcturus Therapeutics Holdings Inc. announced a partnership to support the expected manufacture of Arcturus' COVID-19 mRNA vaccine candidate (LUNAR-COV19).  The partnership will see the LUNAR-COV19 vaccine manufactured at Catalent's drug substance biomanufacturing facility in Madison, Wis. Human clinical studies will also be conducted at that facility and, if successful, the vaccine will be commercialized. The COVID-19 vaccine program will take advantage of the facility's flex-suite, a cGMP manufacturing suite that can produce batches at multiple scales and support Arcturus' proprietary mRNA manufacturing process.


Florham Park-based Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. announces that the European Commission (EC) has granted a marketing authorisation for cefiderocol, a new antibiotic for the treatment of infections due to aerobic Gram-negative bacteria in adults (18 years or older) with limited treatment options. The EC approval of cefiderocol was based on the non-clinical data package, including the PK/PD data package.



Woodcliff Lake-based Eagle Pharmaceuticals, Inc. provided an update on its pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ("ER") inhibition and improve patient outcomes. "We have continued to refine our EA-114 program, collected additional pilot data and are pleased with our progress. With FDA's guidance, we hope to move ahead with our plans. We look forward to providing additional updates on the progress of this potential drug treatment for hormone-receptor ("HR")-positive advanced breast cancer," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.



Cranford-based Citius Pharmaceuticals, Inc. announced that it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) . The company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS. The company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. 



Lipocine Inc., with offices in Lawrence Township, announced that the U.S. Food & Drug Administration ("FDA")  has accepted the Company's Investigational New Drug application ("IND") to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for the treatment of liver cirrhosis in adult male cirrhotic patients. The planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled 52-week study in male cirrhotic patients that are on the liver transplant list. 



Princeton-based PDS Biotechnology Corporation announced an expansion of its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to include studies of PDS0103, a Versamune®-based product incorporating novel mucin-1 (MUC1) epitopes developed by the NCI. This expansion adds to the NCI's ongoing evaluation of PDS0101 in combination with two separate immune-modulating agents, NHS-IL12 and M7824, which will be evaluated in a Phase 2 clinical trial in advanced HPV-associated cancers (NCT04287868).



Moonachie-based Sterling Medical Devices announced a partnership with Cedars-Sinai and specialty pharmaceutical company Aytu BioScience Inc. for the development of the Healight Platform Technology as a potential treatment for critically ill patients infected with COVID-19 and other infections.  The Medically Associated Science and Technology (MAST) program at Cedars-Sinai has been working on the patent-pending Healight Platform since 2016.
Recently, MAST enlisted Sterling Medical Devices to help develop a novel endotracheal catheter to emit an ultraviolet UV-A light to critically ill patients on a ventilator.



People in the News



Glen Rock-based BioNJ Member RespireRx Pharmaceuticals Inc. announced that Mr. Timothy Jones has joined the company as its President and Chief Executive Officer. Mr. Jones has been a member of the company's Board of Directors since January 28, 2020. Mr. Jones is a highly experienced senior executive with a proven and outstanding track record in global commercial business development, specializing in developing and sustaining high value strategic and tactical partnerships. He is recognized for his expertise in the strategic development and growth of active pharmaceutical ingredient categories through partnerships with a broad cross section of brand and generic pharmaceutical and biopharmaceutical companies worldwide.



Paterson-based BrainsWay announced two new leadership appointments.  Hadar Levy has been promoted to senior vice president and general manager of North America, and Judith Huber to Senior Vce President and Chief Financial Officer, both effective May 11. Mr. Levy, who is currently the company's Chief Financial Officer and Chief Operating Officer, will be responsible for overseeing BrainsWay's North American business, including sales, operations, customer service, field engineering and customer training.



Monmouth Junction-based CytoSorbents Corporation and its Chief Executive Officer, Phillip Chan, M.D., Ph.D., announced the promotion of Chief Operating Officer Vincent J. Capponi to President and COO, effective immediately. Mr. Capponi stated, "At CytoSorbents, I have experienced what I believe is a once-in-a-lifetime opportunity: to work with a new product concept and be part of a fantastic team to transform that idea into a life-saving therapy worldwide. We are just beginning to see the true potential of CytoSorb and what it could mean for the future of critical care and cardiac surgery."



Monmouth Junction-based CytoSorbents Corporation announced the appointment of Dr. Efthymios Deliargyris as Chief Medical Officer.  According to  CytoSorbents , Dr. Deliargyris brings more than 19 years of experience in both academic medicine and industry to the position. From 2010 to 2016 Dr. Deliargyris held roles of increasing responsibility as Vice President and European Medical Director, based in Munich, Germany, and Global Medical Lead with Acute Cardiovascular Care at The Medicines Co., which was acquired by Novartis AG this year.



Parsippany-based Pacira Bioscience Inc. announced it has appointed Donald C. Manning to chief medical officer, effective immediately.  In his new role, Manning will report directly to David Stack, Chairman and CEO of Pacira. Dr. Manning, who has more than 20 years of experience in biopharmaceutical leadership, most recently served as the Chief Medical Officer at Adynxx Inc. 



Boonton-based Enteris Biopharma Inc. announced it has hired Rajiv Khosla as its new CEO, effective immediately. Mr. Khosla, who has more than 30 years of experience in the biopharmaceutical industry, will be responsible for leading the company as it looks for growth opportunities built around Peptelligence, its proprietary oral peptide and small molecule drug delivery platform. He will also expand on the company's internal and external programs as well as develop new licensing and partnership opportunities.


Institution and Education News



The presidents of 10 of New Jersey's public universities and colleges launched the New Jersey Scholar Corps Program, an initiative encouraging in-state students to come home to complete their higher education while helping to rebuild the state. The participating institutions include: Montclair State UniversityNew Jersey Institute of TechnologyRowan UniversityKean UniversityNew Jersey City UniversityRamapo CollegeStockton UniversityThe College of New JerseyThomas Edison State University and William Paterson University.



The Students 2 Science team presents a special edition of the newsletter Teach and Tech  with a collection of online STEM resources for teachers, parents and caregivers to support their efforts in providing remote learning to our students. S2S is making every effort to stay connected with partners and supporters as we get through this period of uncertainly during the COVID-19 pandemic. 



Read the latest news on research, treatment, prevention and education from the State's National Cancer Institute-designated Comprehensive Cancer Center in Cancer Connection Monthly.



Rutgers' RUCDR Infinite Biologics   received an amended emergency use authorization from the FDA for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.  The decision follows the FDA's recent emergency approval to RUCDR Infinite Biologics for the first saliva-based test, which involves health care workers collecting saliva from individuals at testing sites.



Rutgers is at the forefront of finding a way for colleges and universities to move forward as a member of the first Task Force for Emerging Infectious Diseases recently formed by the Big Ten Conference. With representatives from each conference institution, the task force will provide guidance and sound medical advice to ensure the health, safety and wellness of the Big Ten's students, coaches, administrators and fans.



Hackensack Meridian Health conducted an observational real-world study of more than 3,000 hospitalized COVID-19 patients and found that hypertension -- the most common co-existing condition -- does not have a major impact on survival from the infection when adjusted for age and other comorbid conditions.  The study also found that commonly prescribed medications to treat high blood pressure may potentially have a positive impact.  It was based on a ground-breaking database: the RE-COV-RY (Real world Evidence-COVid-RegistrY), one of the largest compilations of hospital-based COVID-19 data in the U.S. to date.



The  National Science Foundation announced it has selected  Stevens Institute of Technology to lead the first-ever industry-based cooperative research center, or IUCRC, devoted to financial technology and science.  The five-year award will establish a center focused on research partnerships relevant to the fintech industry with the goal of finding solutions to complex challenges. 



Heading into the first year of the new decade, the manufacturing industry finds itself in a unique position. On one hand, manufacturing is firing on all cylinders: output is bustling, capacity utilization is up, and many manufacturers are delivering solid performance results. On the other hand, trade tensions lurk in the background and supply chains are straining to keep up with demand, while skilled talent is in short supply and threatening to derail the current industry momentum.

Funding News


The New Jersey Economic Development Authority (NJEDA) is encouraging owners of small businesses impacted by the COVID-19 outbreak to explore the Authority's existing small business financing programs. These programs, which pre-date the outbreak, are important tools for business owners and can serve as valuable complements to federal and State programs launched specifically to respond to the pandemic.  "Under Governor Murphy's leadership, we have always been committed to providing small businesses with capital they need to grow," NJEDA Chief Executive Officer Tim Sullivan said. "While we created new resources to address the unique challenges COVID-19 poses, our established programs remain effective tools that businesses can use to face today's challenges and prepare for tomorrow."



The New Jersey Economic Development Authority (NJEDA) announced that it will receive an $800,000 United States Environmental Protection Agency (EPA) Revolving Loan Fund (RLF) Brownfields grant. The NJEDA can use this funding to capitalize a revolving loan fund or to provide subaward grants to communities, developers, and nonprofits carrying out cleanup and redevelopment activities at brownfield sites. EPA also awarded grants to the cities of Camden and Jersey City and the nonprofit Cooper's Ferry Partnership. In total, the Agency provided nearly $2.1 million to support brownfield remediation in New Jersey. 

Special Programs from Our Partners for BioNJ Members


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.