Welcome to the latest edition of the BioLines Weekender. 

The BioNJ Team has been enjoying its summer -- cruising with our Members, planning future events and working with the administration on initiatives to create new growth opportunities for our industry in the great state of New Jersey. Here's a quick look at what we've been up to...
  • Spoke at Governor Murphy's press conference announcing the Incubator and Collaborative Workspace Rent Initiative and a modernized Research and Development (R&D) Tax Credit 
  • Visited New Jersey federal delegation members in support of increased Patient access to lifesaving treatments 
  • Attended PhRMA briefing for New Jersey partner organizations
  • Participated in RWJF roundtable discussion of business leaders on improving the culture of health in New Jersey
  • Attended We Work for Health's summit with Patient advocates and others from around the country
  • Hosted this year's BioCruise with NewYorkBIO delivering a great night of networking on the Hudson
  • Participated in ResearchWithNJ's Board Advisory Meeting
  • Opened registration for BioNJ's Manufacturing Briefing, entitled "Manufacturing in Transition: Trends, Insights and Implications," with insights from McKinsey and Company 
  • Met with Steering Committees for BioNJ's C-Suite Summit and Inspiring Women in STEM Conference
  • Starting planning BioNJ's 2019 BioPartnering Conference with J.P. Morgan
Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

BioNJ's Manufacturing Briefing
Rutgers University, Piscataway, NJ

September 21, 2018
Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop
Amicus Therapeutics, Cranbury, NJ

October 11, 2018
Save the date!
BioNJ's C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ

October 25, 2018
BioNJ's Patient Advocacy Summit
Celgene Corporation, 179 Passaic Ave, Summit, NJ

December 13, 2018

Putting Patients First: The Value of Medical Innovation
Brought to You by Celgene Corporation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of healthcare. Share with our community how your medical innovation is improving lives and impacting healthcare 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.

Hackensack Meridian Health's  Hackensack University Medical Center has teamed with  UnitedHealthcare to offer a bundled payment option to patients for knee, hip and spine procedures.  Under UHC's Spine and Joint Solution bundled payment program, patients covered by UHC undergoing these types of procedures can make an upfront payment -- covered by UnitedHealthcare -- and get coverage for the procedure as well as pre- and post-surgical care.

Doctors across the U.S. say the health care industry has made little progress toward creating fee-for-value medicine, or value-based care.  That's according to a new survey by Secaucus-based  Quest Diagnostics Of 451 physicians, 67 percent said the U.S. generally has made little progress moving towards a value-based system. And 57 percent said they don't have the tools to implement a fee-for-value system, such as efficient billing systems and value-based payment models from insurance companies. Click here for the full study.

Governor Phil Murphy announced two important tools- - the Incubator and Collaborative Workspace Rent Initiative (ICWRI) and a modernized Research and Development (R&D) tax credit -- to support new and established high-tech companies in growing the Garden State's Innovation Economy. "Both of these initiatives will allow us to take full advantage of all New Jersey has to offer entrepreneurs and start-ups as well as our established innovation-driven companies," said Governor Phil Murphy. "We've led this sector before, and through these additional tools, New Jersey will reclaim our national and international prominence for innovation and discovery."

BioNJ in the News

Entitled "Recent Advances in Laboratory and Innovation Space in New Jersey", the paper includes profiles of major biopharma incubators and innovation spaces in New Jersey and perspectives from leaders of successful industrial and academic incubators as well as the recognized biopharma industry organization, BioNJ, all who support prioritizing investment in infrastructure for biopharma start-ups.

When the budget deal was finally completed, many legislative and business leaders complained that changing the corporate business tax is so complicated it needed more than just a last-minute push to get it done.  What many don't know is that the fight is more than a decade old.  BioNJ President and CEO Debbie Hart told ROI-NJ,  "We are still parsing our way through the budget and determining where the challenges and opportunities lie for the industry for our members both large and small. Certainly one of the greatest opportunities for our economy is the biotechnology and life sciences industry and we look forward to working with the governor and his administration and the legislature to make the New Jersey life sciences industry as well as New Jersey's economy the strongest it can be." 

New Jersey has a lot going for it, from an enviable location to a well developed workforce to a transportation network that connects it with many key centers of commerce. But high taxes, regulatory burdens and other issues are hurting the State's ability to attract and retain businesses.  BioNJ's President and CEO  Debbie Hart commented  "New Jersey has an excellent educational  system and has established itself  as a biotechnology industry hub, which  makes it easier to attract these companies,  since they can find talent and collaborate  with other companies. New  Jersey also enjoys an excellent geographic  location, with access to transportation  that promotes participation  in the global economy. At the same  time, we're concerned about the tax  structure and affordability of doing  business here."

BioNJ is pleased to shine the spotlight on one of our Innovation Members each month featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem. This month's Emerging Company in the Spotlight is Evotec. So many of our Members are making a dramatic impact on our State's innovation ecosystem. We celebrate you! Evotec is one such company.

Interested in Receiving BioNJ's Biweekly Jobs Beat Featuring the Latest Job Opportunities? Click here!

Whatever your services needs may be,  BioNJ's Member Service Provider Directory   can guide you to the right source. This Member-only categorical listing by service sector is your "one-stop-shop" solution to support and drive your business.  Click on the RESOURCES tab at www.BioNJ.org to view the full BioNJ Member Service Provider Directory categories. Here's a sample for supplies -- laboratory / environmental / research instrumentation and other:   

NJ Company News

Ever proud of our ecosystem, we are pleased to share our New Jersey Company News. Be sure to click on the article titles below to read the full release.

Edison-based BioNJ Member  ContraVir Pharmaceuticals, Inc.  announced that it has completed dosing of the first cohort in Part 1 of the Phase 1/2A trial of CRV431. Preliminary data from the first completed cohort suggest that CRV431 is safe and well-tolerated. The pharmacokinetic (PK) profile following oral dosing indicates that systemic exposures of CRV431 are in-line with anticipated exposures from completed pre-clinical studies.

Morris Plains-based Immunomedics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. 

Morris Plains-based Immunomedics, Inc. announced a clinical collaboration with AstraZeneca and its global biologics research and development arm, MedImmune, to evaluate the safety and efficacy of the combination of Imfinzi® (durvalumab), a human monoclonal antibody directed against PD-L1, and Immunomedics' lead antibody-drug conjugate (ADC) product candidate, sacituzumab govitecan, as a frontline treatment of patients with triple-negative breast cancer (TNBC) and urothelial cancer (UC).

Princeton-based BioNJ Member Photocure ASA announced that the Patient Reported Outcomes (PRO) with Blue Light Cystoscopy (BLC™) with Cysview® Study was published online, in the prestigious British Journal of Urology. The publication shows that patient anxiety levels decreased following flexible blue light cystoscopy with Cysview, and the vast majority of patients (94%) undergoing this procedure found it worthwhile and would do it again and recommend it to others (91%). 

Bedminster-based BioNJ Member  Advaxis, Inc.  announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's Investigational New Drug (IND) application for its Phase 1/2 study of axalimogene filolisbac (AXAL) in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.

Princeton-based BioNJ Member Oyster Point Pharma announced results from the PEARL study, a Phase 2b clinical trial evaluating the company's novel therapy for the treatment of Dry Eye Disease (DED). The study met both sign and symptom primary endpoints by showing a statistically significant improvement in each compared to a vehicle control. The study evaluated OC-02, a nicotinic acetylcholine receptor (nAChR) agonist the company is developing to treat the signs and symptoms of DED. 

The Food and Drug Administration (FDA) has approved  Parsippany-based BioNJ Member Ferring Pharmaceuticals'   Zomacton  (somatropin;  Ferring ) for the treatment of pediatric patients with idiopathic short stature (ISS), short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by 2-4 years, and short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency. 

Berkeley Heights-based BioNJ Member CorMedix Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB  recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. 

Ramsey-based BioNJ Member ADMA Biologics, Inc.announces that the Company has received formal notice from the U.S. Food and Drug Administration of the successful close-out for the April 2018 compliance inspection of the Boca Raton, FL production facility. This is the first EIR issued to the site since 2012. The EIR received by the company contains detailed information about the April 2018 FDA inspection, discussions had with the investigators, requests for clarification and information, as well as a summary of potential next steps for the review of the Prior Approval Supplement ("PAS") for BIVIGAM®. 

The U.S. label for  Bridgewater-based BioNJ Member Eli Lilly  and Company's  once-weekly Trulicity® (dulaglutide) is updated to show the medicine's safety and efficacy in people with type 2 diabetes who have moderate to severe chronic kidney disease (CKD). The label now includes data from the AWARD-7 clinical trial, which showed that people treated with Trulicity 1.5 mg or 0.75 mg in combination with mealtime insulin lispro achieved similar glycemic control with weight loss, compared to those treated with traditional basal-bolus insulin.

Bridgewater-based BioNJ Member  Eli Lilly and Company  partnered with Bernardsville-based Anima Biotech Inc. to discover and develop translation inhibitors against undisclosed targets chosen by Lilly using Anima's Translation Control Therapeutics platform. Anima will receive $30 million up front and $14 million in research funding. Anima will also be eligible for $1.1 billion in milestones, plus low to mid single-digit tiered royalties. The pharma will be responsible for clinical development and commercialization.

Princeton-based BioNJ Member Genmab A/S announced that it has entered into a research collaboration and exclusive license agreement with privately owned Immatics Biotechnologies GmbH (Immatics), to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. The deal strengthens Genmab's position in immuno-oncology by combining Genmab's proprietary technologies and antibody know-how with Immatics' XPRESIDENT® targets and T-cell receptor (TCR) capabilities.

BioNJ Member Evotec AG, with offices in Princeton, announced that its multi-target alliance with Bayer, with offices in Whippany, in the field of endometriosis has advanced a promising small molecule into Phase II clinical development for the treatment of chronic cough, resulting in a payment of € 4 m to Evotec. This new trial has been initiated following positive results from a Phase I study which is part of the ongoing Bayer-Evotec endometriosis alliance.

Rutherford-based BioNJ Member Cancer Genetics, Inc. announced the closing of a $2.625 million convertible note financing with a single institutional investor. John A. Roberts, Chief Executive Officer of Cancer Genetics, commented, "This capital raise helps the company continue to execute on our strategy of consolidating operations and expanding our biopharma business. We plan to utilize this capital to assist with funding our 2018 transformation and strategic plan to streamline our business and execute against a path to profitability with an emphasis on becoming a leader in oncology-focused testing, genomic services and biomarker insight capabilities."

BioNJ Member  Ovid Therapeutics Inc. and Takeda P harmaceutical Company Limited provided an overview o f their TAK-935/OV935 broad clinical development program. The companies plan to initiate three clinical trials: in pediatric patients with Dravet syndrome and Lennox-Gastaut syndrome, in pediatric patients with CDKL5 deficiency disorder (CDD) and Duplication 15q (Dup15q) syndrome, and an extension trial for patients with developmental and epileptic encephalopathies (DEEs) who participated in a previous TAK-935/OV935 clinical study.

Now that genomic analytics company  Health Interactive, Inc . has expanded into New Jersey, it is strategically positioned within the State's vast pharmaceutical and biotechnology research ecosystem. Health Interactive's research and development (R&D) focuses on developing capabilities in bioinformatic analysis and reporting of genetic sequencing data. Health Interactive was founded in Massachusetts in 2016 but quickly expanded its footprint into New Jersey in 2017, setting down roots at the New Jersey Economic Development Authority's (EDA's) Commercialization Center for Innovative Technologies (CCIT).

Woodcliff Lake-based Eisai Co., Ltd.  announced and Biogen Inc. announced detailed results from the Phase II study (Study 201) with BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, in 856 patients with early Alzheimer's disease. Study 201 is a placebo-controlled, double-blind, parallel-group, randomized Phase II clinical study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid pathology in the brain.

Woodcliff Lake-based Eisai Co., Ltd.  announced that it has obtained the topline results of the ongoing Cardiovascular Outcomes Trial ("CAMELLIA-TIMI61") of lorcaserin hydrochloride (generic name, product name in the U.S.: BELVIQ®, "BELVIQ") in 12,000 patients as a post-marketing clinical trial evaluating safety as the primary objective. BELVIQ was approved in the United States in June 2012 by the U.S. Food and Drugs Administration (FDA) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients, and was launched in June 2013.

Maywah-based Glenmark Pharmaceuticals announced results from a Phase 1 study that suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark's GBR 310 proposed biosimilar and reference product omalizumab, marketed in the U.S. under the brand name Xolair®. GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. 

Parsippany-based GlaxoSmithKline pc and Adaptimmune Therapeutics plc announced the transition of the development programme for GSK3377794 (GSK '794), an NY-ESO SPEAR T-cell therapy, to GSK.  GSK '794 is an engineered T-cell therapy, for which a patient's own cells have been genetically modified to express a T-cell receptor (TCR) recognising with high affinity the tumour-specific antigen, NY-ESO. 

Lawrenceville-based Asana BioSciences announced initiation of a Phase 2b study of ASN002, an oral JAK/SYK inhibitor, in patients with moderate-to-severe atopic dermatitis (AD). In the recently concluded Phase 1b study in patients with moderate-to-severe atopic dermatitis, ASN002, dosed at 40 and 80 mg once daily, was well tolerated and showed clear evidence of clinical efficacy per EASI score and rapid symptom improvement, with significant reduction in patient-reported itch as early as day 2. 

Freehold-based  Avalon GloboCare Corp. announced that the company has formed a new wholly owned U.S. subsidiary, Avactis Biosciences, Inc., which will be focused on accelerating commercial activities related to its proprietary Chimeric Antigen Receptor (CAR)-T technologies. The new subsidiary is designed to integrate and optimize the company's global scientific and clinical resources. 

Hackensack-based BrainStorm Cell Therapeutics Inc.  announced that the European Patent Office ("EPO") has granted an European-wide patent entitled 'Mesenchymal Stem Cells for the Treatment of CNS Diseases' for the treatment of Amyotrophic Lateral Sclerosis (ALS) with NurOwn®. This patent provides protection for NurOwn® in  Europe  until 2029. The allowed claims cover methods of treating amyotrophic lateral sclerosis (ALS) using mesenchymal stem cells that secrete neurotrophic factors, including Brain derived neurotrophic factor (BDNF).

Bedminster-based Aerie Pharmaceuticals, Inc. reported that it has received the "Day 74" notification from the U.S. Food and Drug Administration (FDA) earlier than scheduled, the FDA has completed its initial 60-day review of the NDA (new drug application) for Roclatan™ and the FDA has determined that the application is sufficiently complete to permit a substantive review.

Bedminster-based Aerie Pharmaceuticals, Inc. announced that the  $125 million  of senior secured convertible notes held by affiliates (the "holders") of  Deerfield Management Company L.P.  ("Deerfield") since  September 2014  have been fully converted into 5,040,323 shares of Aerie common stock in accordance with their terms, plus the issuance of 329,124 additional shares mutually agreed to with the holders in order to complete the conversion at this time, for a total of 5,369,447 shares.

East Rutherford-based  Cambrex Corporation announced it has entered into a definitive agreement to acquire Halo Pharma (Halo), a leading dosage form Contract Development and Manufacturing Organization (CDMO), majority owned by funds managed by the private investment firm SK Capital Partners, for approximately $425 million. With the acquisition of Halo, Cambrex will enter the large and growing finished dosage form CDMO market. 

Glen Rock-based RespireRx Pharmaceuticals Inc. announced that an article describing the company's translational research on the ability of its proprietary ampakines to stimulate neurotrophin expression has been published in Biomedical Pharmacotherapy. The paper demonstrates that low-impact ampakines, when administered to animals at therapeutically relevant doses for two weeks, enhance expression of the neurotrophic factors, brain derived neurotrophic factor (BDNF) and nerve growth factor (NGF). 

Warren-based Aquestive Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, announced the pricing of its initial public offering of 4,500,000 shares of common stock at a public offering price of $15.00 per share for aggregate gross proceeds of $67,500,000 . All of the shares in the offering are being offered by Aquestive Therapeutics .

Teva Pharmaceuticals USA Inc. which announced earlier this month  that it was moving its U.S. headquarters to Parsippany, has signed a lease at the MCCBLUE office complex in the township The life sciences company signed a 12-year lease for 345,000 square feet at the site, a 541,000-square-foot Class A complex at 400 Interpace Parkway. The deal is the largest lease in New Jersey so far this year.

Two animal health compounding pharmacies, Swedesboro-based  Wedgewood Pharmacy and Scottsdale, Arizona-based  Diamondback Drugs, have merged.  The merger will increase medication availability and delivery, and enhance the service and quality available to the market, they said. Compounding pharmacies make customized medications for animals when commercial drugs cannot meet their needs.

People in the News

Pennington-based BioNJ Member OncoSec Medical Incorporated  announced the appointment of Sara Bonstein as Chief Financial Officer and Chief Operating Officer.  In her new roles, Ms. Bonstein will lead financial and capital market activity and oversee G&A and technical operations for the biotechnology company which moved its executive offices from San Diego, California to Pennington  in May

Hamilton-based Genesis Drug Discovery & Development, the contract research organization of  Genesis Biotechnology Group , announced it has appointed Dr. Olesia Buiakova its new Chief Scientific Officer. Dr. Buiakova will be responsible for managing the company's entire portfolio of drug discovery services. She will also head development and management of new preclinical drug discovery platforms in oncology, immunology, metabolic and ocular diseases.

Princeton-based  Slayback Pharma LLC, a pharmaceutical research and development company, announced it has appointed Dr. Girish Jain as Senior Vice President and Head of Global R&D.  Prior to Slayback, Dr. Jain was President and Head of R&D at Alkem. Before that, he was at Wockhardt as Senior Vice President and Head of R&D.

Institution and Education News

With the success of the  VOICE Summit - nearly 3,000 attendees in one day versus an anticipated 1,500 -- in Newark, and the recent buzz around Propelify in Hoboken, the state appears ripe to push an innovation agenda. It's why New Jersey Innovation Institute President Donald Sebastian is bullish on New Jersey's ability to grow an innovation economy.

Rutgers University's  TechAdvance Fund received $100,000 from Celgene Corp.  The fund was created through the university's Office of Research and Economic Development to advance early stage Rutgers technologies toward commercialization. "Celgene's donation to the Rutgers TechAdvance fund is consistent with Celgene's entrepreneurial vision to enable bold pursuits in science and to support the start-up ecosystem in N.J.," said Rupert Vessey, President of Research and Early Development, Celgene.

After 10 years of research, a Rutgers-led team of scientists has identified two molecules that protect nerve cells after a traumatic brain injury and could lead to new drug treatments.
The molecules promote full recovery after traumatic brain injury (TBI) in mice, according to the study published online in Neurobiology of Disease. Traumatic brain injury is the leading cause of death for people under 45 years old in the United States and is associated with disability, early-onset dementia, cognitive disorders, mental illness and epilepsy.

The New Jersey Department of Health and Rutgers Cancer Institute have been chosen to participate in a $26.5 million, statewide cancer surveillance and population-based epidemiological cancer research study of prostate cancer among African-American men. The goal of the study is to determine social and biological factors that contribute to prostate cancer in African-American men in the state. According to Rutgers Cancer Institute, the incidence of prostate cancer among African-American men in New Jersey is 50 percent higher than Caucasian men. 

Students in New Jersey looking to get a pharmacy degree just got another option.
Ramapo College in Mahwah has entered into an agreement with Touro College of Pharmacy in Harlem, creating a pre-pharmacy program that will allow qualified students to earn both bachelor's and Doctor of Pharmacy (PharmD) degrees in seven years, rather than the eight usually needed to complete both.  Interested students can apply to the program through Ramapo beginning Sept. 1.

Funding News

Nokia officially launched the Nokia Open Innovation Challenge (NOIC), an annual global competition that seeks innovative technologies, products and solutions that can change the world. The focus of this year's competition is industrial automation and the industrial Internet of Things (IoT) domain, with prize money totaling $175,000 available to winning companies. The winners will also be given access to Nokia Bell Labs research & development resources, as well as opportunities to grow their businesses through joint partnerships with Nokia.

Special Programs from Our Partners for BioNJ Members

August 2, 2018 | Woodbridge

Always a leader in innovation, New Jersey wants to attract more technology start-ups and grow the businesses already headquartered here.  CIANJ assembled a panel of industry leaders, investors and financial experts to discuss the Garden State's goals, the opportunities for technology firms and the challenges they face.  Click here to register.

August 20, 2018 | 100 David Hollowell Dr., Newark, DE

SBIR is America's Largest Seed Fund for researchers and technology businesses. With access to over $2.5 billion , the SBIR's Road Tour stop in Delaware will give you the opportunity to schedule one-on-one meetings with Federal Funders from over a dozen agencies so you can better understand how this fund can support your research and your business.

September 24-26, 2018 | Philadelphia

The MedTech Conference is the leading North American gathering of global medtech executives. More than 2,700 attendees will network, gain access to capital and share insights in Philadelphia, PA. from September 24-26. The conference features world-class plenary speakers, networking and business development. BioNJ Members receive a 10% discount. Contact RBromberg@BioNJ.org for BioNJ's special discount code. Visit www.themedtechconference.com to learn more about the conference.