NewYorkBIO News for September 2016

Read the latest news from NewYorkBIO

NewYorkBIO News

September 2016

NewYorkBIO Today * New York Legislative Updates * Events * Member News

Notes from Nathan

Looking through the Member News this month,with its updates on approvals, patents, discoveries, and new administrations, I feel as though I can hear engines rev ving, such is the power and pace of innovation, growth, and change in New York's life science community.

We here at NewYorkBIO are experiencing some changes too, as we welcome Judith Dunn, PhD, as our Chairman of the Board of Directors. Judy is global head of clinical development at Roche's Pharma Research and Early Development unit and leads the Translational Research Center in New York City. Judy is the first representative of a global pharmaceutical company to serve as NewYorkBIO chair. In creating the TCRC, Judy built on New York's academic excellence and its early stage development opportunities, and she has a unique perspective for how to support bio science development throughout New York.

Of course, all of us at NewYorkBIO recognize that our organization owes its current strength to the leadership of our Immediate Past Chairman, Robert Easton. For us, Bob employed his healthcare business consulting experience of over 25 years and applied his market development and strategic advisory skills to help NewYorkBIO reach new industry sectors and develop relationships and programs with New York's academic institutes. Fortunately, Bob will continue on our Board of Directors.

There are similar signs of growth and development in legislative work as well. Even though NewYorkBIO saw notable success with several items of legislation over the last few months, we are revving up our advocacy activities. We defeated two pricing and labeling bills that threatened our members and business development in New York, and we won some impressive victories to pass helpful legislation, most recently with GMOs. Even as we look forward to the exciting changes this fall, we continue to focus on advocacy for our members' concerns.

I look forward to seeing you at BioCruise!

Nathan Tinker

Executive Director

NewYorkBIO Today

Inaugural Buffalo BioCruise Ready to Set Sail

The summer networking staple in New York life sciences, BioCruise, is launching a September outing in Buffalo. Upstate life scientists will enjoy the opportunity to don some resort wear and reconnect with life science friends in a dinner cruise on Lake Erie.

Sponsored by Johnson & Johnson Innovation and Pfizer, the Buffalo Biocruise features cocktails, dinner, and spectacular views of the city and lake on a tour Buffalo Harbor, Lake Erie, and even the Erie Canal. Passengers will gather for cocktails at 5:30, with a 6:00 PM embarkation.

Executive Director of NewYorkBIO, Nathan Tinker, explains, " Our annual voyage through New York and New Jersey waterways is always the networking event of the summer, bringing together the life science community in a fun and productive way, and we are proud and thrilled to offer this Lake cruise to the Buffalo area. " Along with networking, the cruise features fine dining and live music, including Toast, Buffalo's best bar band.

Jason Park of Flagship Ventures Breakfasts with CEOs

Jason Park, Flagship Ventures principal, headlined NewYorkBIO's CEO Breakfast Club, one of the most popular NewYorkBio events. The Breakfast offers life science executives an opportunity to share ideas with about 25 of their peers in an intimate setting in the Stanford White Room at New York City's renowned Lamb's Club. The event attracts life science leaders entrepreneurship and investment who appreciate the opportunity to share ideas and experiences with an insider's perspective.

Jason Park is a principal at Flagship Ventures and leads the Flagship team administering the $150 Million City of New York Life Science Fund. The co-investment partnership exceeded its initial funding goal by $50 million to launch with a total of $150 million, which includes $10 million in anchor funding from NYCEDC and leveraged with capital from industry partners and managed by leading venture capital partners. The Funding Initiative will identify and invest in the most promising research generated by the city's academic medical institutions and leading entrepreneurs, creating and growing companies working on the leading edge of life sciences advances.

The Early Stage Life Sciences Funding Initiative was initially announced in 2013 with the aim of deploying $100 million in public and private capital. The project leverages NYCEDC funding with capital from industry partners Celgene Corporation, GE Ventures and Eli Lilly and Company (Lilly). Two top tier venture capital firms, Flagship Ventures and ARCH Venture Partners, will manage separate investment activities within the Funding Initiative and will each establish a presence in New York City.

NewYorkBIO Rooftop Soiree Draws Overflow Crowds

On a hazy, hot, and humid kind of summer evening that only happens in Manhattan, over 120 NewYorkBIO members and future members met for cocktails and networking in Midtown. The Summer Soiree under the stars took place on August 16th on the roof at the Overlook Bar.

This always popular event, sponsored by White & Case, BioMed Realty, and VWR, seems to attract every New York life scientist not on August vacation, and 2016 was no exception. "Sweltering" is how one attendee described it: "sweltering, but so much fun to meet up outside of the labs, and conference rooms, and screens where we usually see each other." So many members turned up on the roof that some of the party moved downstairs, and, as the moon rose over the roof, many life scientists were spotted at the 80's karaoke contest inside.

New York Legislative Update

After a very successful summer for advocacy, NewYorkBIO is working on legislation with the idea of protecting the interests of the New York life sciences community. Despite this being an election year, there is still important bioscience activity in Washington DC.

Lawmakers returned to Washington on September 6th and will have less than a month to address a host of outstanding issues before departing for campaigning and Election Day.

Government funding is t he only item that must by law be addressed in September. FY16 will end on September 30th, requiring Congress to pass additional bills to fund the government into the beginning of FY17. Funding is likely to be in the form of Continuing Resolutions to take funding past the elections. Funding from National Institutes of Health (NIH) and other federal granting institutions would fall under these CRs, potentially affecting our members.

Still, it is possible that action could be taken on other relevant legislation in September, including 21st Century Cures, Zika funding, and energy legislation.
NewYorkBIO, along with The Biotechnology Innovation Organization (BIO) welcomed Congressional passage of a federal, uniform approach to GMO disclosure. "The Congress' strong, bipartisan support for a national GMO labeling and disclosure solution is a win for consumers, farmers, businesses, and agricultural innovation," said Jim Greenwood, BIO's President and CEO. President Obama signed the bill into law in August.
We also worked closely with The Biotechnology Innovation Organization (BIO) on a letter to the SEC supporting its proposed expansion of the definition of "small" business and asking the commission to include those businesses as exempt from Sarbanes-Oxley (SOX), Section 404(b). In the letter, we underscored the need that "the SEC should take revenue into account when categorizing SRCs and non-accelerated filers given that many growing biotechs are highly valued (i.e., over the $250 million public float ceiling) but do not yet have product revenue to pay for expensive compliance burdens like SOX 404(b)." We support the efforts of BIO to reform the SRC and non-accelerated flier definitions.

Sponsored by BioMed Realty

NewYorkBIO Member News

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MV Lamothe, Editor, [email protected]

AbbVie Inc.

AbbVie announced that the U.S. Food and Drug Administration (FDA ) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG), known to be highly aggressive and difficult to treat brain tumors found at the base of the brain.

Advaxis, Inc.

Advaxis announced that it has entered into a definitive securities purchase agreement with healthcare institutional specialist investors to sell approximately 2.2 million shares of its common stock at a price of $13.50 per share in a registered direct offering for gross proceeds of approximately $30 million.

Albert Einstein College of Medicine

Albert Einstein College of Medicine and Montefiore, in collaboration with the City University of New York (CUNY), have received a $9.4 million grant from the National Institutes of Health (NIH) to lead research in Central Africa to improve clinical care and health outcomes for patients with HIV.

Applied DNA Sciences

Applied DNA Sciences has entered into a two-year agreement with R&R Partnership Enterprises Incorporated.

Astellas

Astellas announced that John Demaree has been promoted to vice president, Oncology Marketing, Astellas Americas.

Biotherapeutics Inc.

Biotherapeutics Inc. announced that the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) has awarded the company a small business innovation grant to develop abscisic acid (ABA) as a medical food ingredient for glycemic control.

Bristol Myers Squibb

AbbVie and Bristol-Myers Squibb Company announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie's investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).

Celgene Corporation

Celgene announced that the European Commission (EC) has approved REVLIMID ® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma

Chembio Diagnostic Systems Inc.

Chembio Diagnostic Systems Inc. announced that it has been awarded a contract for up to $13.2 million in total funding from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) for the development and commercialization of the Company's rapid POC Zika test and Zika-related products.

Cold Spring Harbor Laboratory

Cold Spring Harbor Laboratory (CSHL) announced that its free, not-for-profit preprint service bioRxiv has received generous additional financial support.

Columbia University

Columbia University Medical Center scientists have captured images of one of the smallest proteins in our cells to be "seen" with a microscope.

Cornell University

US Patent Issued for Cornell Bacterial ClyA-Display System for Vaccine and Drug Delivery.

Eli Lilly and Company

Eli Lilly and Company announced that John C. Lechleiter, Ph.D., chairman, president and chief executive officer, will retire as president and CEO and from the company effective December 31, 2016.
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Enumeral Biomedical Corp.

Enumeral Biomedical Corp. announced that it has received a $750,000 license maintenance fee from and entered into a Definitive License and Transfer Agreement with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH to continue Pieris' license to Enumeral's 388D4 anti-PD-1 antibody.

Helen and Robert Appel Alzheimer's Disease Research Institute

The Fourth Annual Appel Alzheimer's Disease Research Institute Symposium to be held on Wednesday, October 5, 2016 from 8:30 a.m. - 12:15 p.m. at the Belfer Research Building on 413 East 69th Street, New York, NY.

HHMI/The Rockefeller University

Using novel computational and biochemical approaches, HHMI scientists have designed and built from scratch 10 large protein icosahedra that are similar to viral capsids that carry viral DNA.

iCell Gene Therapeutics

iCell Gene Therapeutics announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for its chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma.

Immix Biopharma

Immix Biopharma, Inc. announced the successful completion of six-month stability testing for its lead and foundational candidate, Imx-110.

Immune Pharmaceuticals

Immune Pharmaceuticals Corp. announced that it has entered into an amended agreement with NPT, a syndicate of experienced healthcare investors.

International AIDS Vaccine Initiative

The International AIDS Vaccine Initiative has been awarded a new contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) to expedite the development of promising AIDS vaccine candidates.

Lupus and Allied Diseases Association, Inc.

Kathleen Arntsen, President and CEO of Lupus and Allied Diseases Association, participated in a video project through the Patients for Biologics Safety and Access (PBSA) to promote advocacy.

Merck & Co Inc.

Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company's anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

New York Blood Center, Inc

Innovative Blood Resources (IBR) and New York Blood Center (NYBC) announced today that they are combining their operations to create one of the nation's leading blood centers, serving patients and hospitals in the Northeast, Midwest and nationally.

New York Genome Center

The New York Genome Center (NYGC) announced that Princeton University has joined the Center as its newest Associate Member.

New York Medical College

New York Medical College (NYMC) recently welcomed Sapience Therapeutics Inc. to BioInc@NYMC.

New York Stem Cell Foundation

The National Stem Cell Foundation (NSCF) and the New York Stem Cell Foundation (NYSCF) Research Institute announced today that a grant from NSCF will be used to fund NYSCF research being conducted by Dr. Valentina Fossati, a NYSCF Senior Investigator, and her team.

Novomer

Novomer's Converge Polyols in Ford Automotive applications are featured in July's Journal of Applied Polymer Science

Ophthotech Corporation

Opthotech announced the election of Ian F. Smith, Executive Vice President and Chief Financial Officer of Vertex Pharmaceuticals, to its Board of Directors, effective immediately.

Optologix, LLC

Optologix LLC, a developer of non-invasive, light-controlled gene ('optogenetic') tools, is pleased to announce a new sales agreement with Funakoshi Co. Ltd.

Pfizer

Pfizer announced that it has entered into an agreement with AstraZeneca to acquire the development and commercialization rights to its late-stage small molecule anti-infectives business

Provista Diagnostics, Inc.

Provost Diagnostics announced the signing of 13 agreements with Third Party Administrator (TPA) Networks for coverage of Videssa® Breast.

Purdue Pharma L.P.

The University of Nebraska and Purdue Pharma have entered into a partnership to advance graduate education and scientific research that could lead to new drug therapies for patients.

Regeneron

Regeneron Pharmaceuticals, Inc. and Adicet Bio, Inc. announced today a collaboration and licensing agreement to develop next-generation engineered immune cell therapeutics

Relburn-Metabolomics, Inc.

Relburn-Metabolomics, Inc. announced that the Company has filed a fourth patent application for its anti-gout drug portfolio.

RespireRx Pharmaceuticals Inc.

RespireRx Pharmaceuticals Inc. announced that the Company is effecting the one-for-three-hundred-twenty-five reverse stock split of the Company's issued and outstanding common stock (the "Reverse Split") that was approved by the Company's stockholders at the Special Meeting of Stockholders held on August 16, 2016.

Rheonix

Rheonix Inc., a developer of fully automated molecular testing solutions, announced its expansion in food and beverage testing with the introduction of the Encompass Optimum™ workstation.

Rockefeller University

Physician-scientist Richard P. Lifton took office on September 1, 2016, as Rockefeller University's 11 th president.

Roche

Roche announced the launch of the Accu-Chek® Guide, the next-generation blood glucose monitoring system.

RxC International

RxC International announced that James Hoyes has joined the firm as an executive partner.

SIGA Technologies, Inc.

SIGA Technologies, Inc. announced completion of enrollment and dosing in the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX™ (tecovirimat), for the treatment of orthopoxvirus infections.

Symbiomix Therapeutics, LLC

Symbiomix Therapeutics announced it is accelerating plans for the commercial launch of Solosec™ (secnidazole) oral granules following the presentation of clinical results from the second pivotal trial for the treatment of bacterial vaginosis (BV) with the hiring of Taunia Markvicka, PharmD, MBA, as Chief Commercial Officer.

Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticals, Inc., announced that it has entered into an exclusive worldwide license agreement with UCB for UCB6352, an IND-ready anti-CSF- 1R monoclonal antibody

Synthetic Genomics

Researchers from Synthetic Genomics, Inc. (SGI) announced the development and extensive engineering of Vibrio natriegens into a next-generation biotechnology host organism Vmax™.

Tetragenetics, Inc.

Tetragenetics announced a new partnership with one of the world's "top ten" pharmaceutical companies.

The Center for Technology Licensing

Cornell startup, Pacific Biosciences of California, Inc. announced it has released a set of key updates for the Sequel™ System, the company's latest product based on its Single Molecule, Real-Time (SMRT ® ) Sequencing technology

The Research Foundation of SUNY

Research Foundation of SUNY announced that their Scientists have captured atomic level snapshots showing how one key enzyme modifies a protein involved in turning genes on or off inside cells.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals announced successful end-of-phase 2 meeting with FDA for TNX-102 SL in Post-Traumatic Stress Disorder.

University of Rochester Medical Center

The Blood and Marrow Transplant (BMT) Program at UR Medicine's Wilmot Cancer Institute recently performed its 3,000th transplant. The program, which opened in 1989, treats both adults and children for life-threatening conditions including blood cancers and sickle-cell anemia.

Vertex Pharmaceuticals Inc.

Vertex Pharmaceuticals Inc and Moderna Therapeutics announced that the two companies have entered into an exclusive research collaboration and licensing agreement aimed at the discovery and development of messenger Ribonucleic Acid (mRNA) Therapeutics™ for the treatment of cystic fibrosis (CF).

Virtual SurgerySIM

Virtual SurgerySIM took the top prize at this year's Buffalo Student Sandbox contest.

VWR International, LLC

VWR announced that it has acquired PAW BioScience Products, Inc., a manufacturer and distributor of sanitary fluid handling products used in the biotechnology, biopharmaceutical and diagnostic industries.

Weill Cornell Graduate School of Medical Sciences

A powerful next-generation genome-sequencing test developed at Weill Cornell Medicine can detect mutations that guide precision cancer treatment with over 95 percent accuracy, according to new research. The scientists say their findings , published July 20 in NPJ Genomic Medicine, validate the test, called Weill Cornell Medicine EXaCT-1 , and demonstrate its feasibility in a clinical setting.

MV Lamothe, Editor | NewYorkBIO | 212.433.2623 | [email protected] | NewYorkBIO.org

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