Biohealth Innovation - 411th Edition

BioHealth Innovation

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June 23, 2020

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Charles Andres and Christian Barrow join BioTalk to discuss investing, growth and the BioHealth Capital Region during COVID-19

Charles Andres, Ph.D., RAC, Associate at Wilson Sonsini Goodrich & Rosati, and Christian Barrow, Executive Director, Life Sciences Banking at JP Morgan, join Rich Bendis for a Virtual BioTalk

Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati. He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.

The BioHealth Capital Region Featured at Digital RESI LSN Global Conference

The Life Science Network's Digital Redefining Early State Investments (RESI) took place online June 8-10, 2020, and featured some of the most knowledgeable voices from the BioHealth Capital Region. The region was well represented across four panels titled:

AstraZeneca taps Catalent for COVID-19 vaccine finishing, packaging at Italian plant | FiercePharma

British drugmaker AstraZeneca is shooting for the moon with its plan to produce 2 billion doses per year of a potential COVID-19 vaccine. To reach that lofty goal, AstraZeneca has reached a deal with New Jersey-based Catalent to help with the final stages of the shot's manufacturing.

Catalent will be tasked with finishing and packaging duties for AstraZeneca and the University of Oxford's COVID-19 vaccine candidate, AZD1222, at its 305,000-square-foot manufacturing facility in Anagni, Italy, the CDMO said Monday.

Image: Catalent will be tasked with helping finish and package AstraZeneca's COVID-19 vaccine candidate. (Catalent)

Emergent Bio to invest $75M in Canton site (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) will invest $75M in its Canton, Massachusetts facility, focused on the development and manufacturing of drug substance for live viral vaccines and plans to expand into viral vector and gene therapy.

The investment will include a state-of-the-art, multi-suite operation up to 1000L scale.

Rexahn and Ocuphire Enter into Definitive Merger Agreement :: Rexahn Pharmaceuticals, Inc. (REXN)

ROCKVILLE, Md. and FARMINGTON HILLS, Mich., June 17, 2020 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN) and Ocuphire Pharma, Inc., a privately-held clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of eye disorders, today announced the companies have entered into a definitive merger agreement under which Ocuphire will merge with a wholly-owned subsidiary of Rexahn in an all-stock transaction. Following closing, which is expected to occur in the second half of 2020, the combined company will change its name to Ocuphire Pharma, Inc. and is expected to trade on the Nasdaq Capital Market under the ticker symbol “OCUP.” The combined company will focus on the advancement of its pipeline of ophthalmic drug candidates.

Emmes Chosen as a Top Area Workplace

ROCKVILLE, Md., June 17, 2020 /PRNewswire/ -- Emmes today announced that it was selected as one of the best places to work in the greater Washington area. The Washington Post's 2020 Top Workplaces list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees.

The Washington Post partnered with employee research and consulting firm Energage, LLC, to conduct the survey, and the highest ranked workplaces were chosen based on employee responses about their own company. There were 3,500 area companies invited to participate, and 406 were surveyed. This is the seventh year the survey has been conducted.

Sirnaomics and Precision NanoSystems Have Formed a Partnership | BioSpace

Developing and Manufacturing Novel RNAi drug Candidates Using Precision NanoSystems' NxGen™ Platform

GAITHERSBURG, MD and VANCOUVER, BC, June 17, 2020 /PRNewswire/ - Sirnaomics Inc. (Sirnaomics) and Precision NanoSystems Inc. (PNI) jointly announced a partnership on the development and manufacture of Sirnaomics polypeptide nanoparticle-based RNAi therapeutic product. This strategic joint effort includes the execution of a NanoAssemblr® platform license and supply agreement, plus successful production of multiple batches of Sirnaomics drug product candidates, STP705 and STP707, for ongoing IND enabling safety and toxicity studies, as well as several clinical studies.

ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001 – Immunomic Therapeutics

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems (“Ichor”), a privately held biotech company based in San Diego, CA, announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001.

ITI will leverage Ichor’s TriGrid® Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

Children's National Hospital ranked a top 10 children's hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

WASHINGTON, June 16, 2020 /PRNewswire/ -- Children's National Hospital in Washington, D.C., was ranked No. 7 nationally in the U.S. News & World Report 2020-21 Best Children's Hospitals annual rankings. This marks the fourth straight year Children's National has made the list, which ranks the top 10 children's hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children's hospitals for the fourth year in a row.

The Children's National Hospital neonatology program, which provides newborn intensive care, ranked No.1 in the nation by U.S. News for the fourth year in a row.

Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B | BioSpace

GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.

Preclinical Data for PRGN-3005 UltraCAR-T® Demonstrate Superior Expansion and Persistence of UltraCAR-T Compared to Traditional CAR-T | BioSpace

GERMANTOWN, Md., June 22, 2020 /PRNewswire/ -- Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced preclinical data for its innovative investigational PRGN-3005 UltraCAR-T® in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer has been published as an e-poster and accompanying audio presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. The e-poster presentation titled PRGN-3005 UltraCAR-T: Multigenic CAR-T Cells Generated Using Non-viral Gene Delivery and Rapid Manufacturing Process for the Treatment of Ovarian Cancer (Abstract 6593) is part of the Immunology/Adoptive Cell Therapy session and is accessible on the AACR e-poster website.

Emergent to add gene therapy capacity - Bioprocess InsiderBioProcess International

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector.

The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts.

At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000.

CrazyCap helps Martine Rothblatt Cheer On Her Team Through Crisis! - PharmiWeb.com

MIAMI, June 22, 2020 /PRNewswire/ -- Esteemed lawyer, author, and entrepreneur, Martine Rothblatt, Ph.D., found a thoughtful and practical way to thank her employees at United Therapeutics, who have been going above and beyond during this time of the coronavirus crisis. The team at United Therapeutics, a biopharmaceutical company, has always been dedicated to working hard on life-saving biotech innovations. During the global coronavirus pandemic, United Therapeutics has recognized the dire need to develop treatments for COVID-19 patients and has responded quickly by initiating three projects intended to help with COVID-19, including an artificial lung technology that could help avoid the need for the use of ventilators.

Image: https://en.wikipedia.org/wiki/Martine_Rothblatt

GMU selects three finalists for $250M Institute for Digital InnovAtion | Virginia Business

George Mason University on Monday announced three development and property management firms as finalists to build and operate its proposed $250 million Institute for Digital InnovAtion (IDIA), set to open in September 2025 on its Arlington campus. The university released a request for proposals in February, to which 105 developers responded.

Image: Concept rendering of George Mason University's Institute for Digital InnovAtion (IDIA) in Arlington - https://www.virginiabusiness.com

AstraZeneca agrees to make Covid-19 vaccine for Europe | BreakingNews.ie

Pharmaceutical giant AstraZeneca has struck a deal with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of an experimental Covid-19 vaccine, as efforts to boost manufacturing capacity continue at pace.

The alliance, which was forged by Germany, France, Italy and the Netherlands to speed up production of a vaccine, is set to take delivery of the material being tested by the University of Oxford by the end of 2020.

University of Maryland Medical System awarded $18.7 million federal grant to fight coronavirus - Baltimore Sun

The University of Maryland Medical System will receive more than $18.7 million in funding from the Federal Emergency Management Agency (FEMA) in the ongoing effort to combat the coronavirus, the arm of the U.S. Department of Homeland Security announced Monday.

GSK gets FDA approval for HIV drug for children - MarketWatch

Shares of GlaxoSmithKline GSK, +0.36% were down 0.05% in premarket trading on Monday after the Food and Drug Administration late on Friday approved its HIV drug Tivicay as a treatment for infants and children. Tivicay is the company's second-best selling drug in its HIV portfolio. About 2,200 children in the U.S. had been diagnosed with HIV in 2016, according to statistics provided by the Centers for Disease Control and Prevention. GSK's stock has gained 14.9% since the start of the year. The S&P 500 SPX, -0.56% is down 5.8% year-to-date. The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.

Novavax Appoints Biotechnology Veteran David Mott to Board of Directors | Novavax Inc. - IR Site

GAITHERSBURG, Md., June 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has appointed David Mott as an independent director to its Board of Directors. Mr. Mott brings more than three decades of global management, board and investment experience across numerous private and public biopharmaceutical companies. Prior to February 2020, he was the global head of healthcare investing at New Enterprise Associates (NEA).

Advisory Board | Johns Hopkins Technology Ventures

The IDEA Board champions innovation and entrepreneurship across the Johns Hopkins University, providing the vision and strategy by which Johns Hopkins will bring the next generation of discoveries to market. This group of stakeholders from industry, academia, startups, and the broader ecosystem is also helping to catalyze new economic activity and partnerships that will build a better Baltimore.

GSK Expands Synthetic Lethality Scope With $120M Ideaya Bio Alliance - Xconomy

GlaxoSmithKline got its first taste of synthetically lethal cancer therapies via an acquisition. Now it’s trying for a bigger bite of this emerging drug class through a research alliance with Ideaya Biosciences that spans three of the biotech’s programs, all slated to reach clinical trials in the next three years.

Emergent BioSolutions Adding Approximately 300 Jobs After New COVID-19 Vaccine Contracts

Business is booming for Emergent BioSolutions as it has assisted in the country’s push to create COVID-19 treatments and vaccines. Emergent is developing two plasma-based treatments for COVID-19 and has partnered with four companies on vaccine candidates. It is additionally partnering with the Federal Government to develop and manufacture COVID-19 vaccines. As a result of this wave of new business, the company is hiring approximately 300 new employees in Baltimore and Rockville.

Emergent BioSolutions Enters Viral Vector And Gene Therapy Arena - Contract Pharma

Emergent BioSolutions has unveiled plans to strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. The company will invest $75 million in its Canton, MA facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.

Lockheed's ventures arm backs quantum computing and training tech firms -- Washington Technology

Lockheed Martin Ventures -- the defense company’s technology startup investment arm -- has backed two companies through separate avenues announced this week.

In a release Tuesday, quantum computing company IonQ said it grew its total fundraising amount to $84 million through a new Series B round that represents its second significant round of investments since the 2015 founding with $2 million in seed money.

Image: https://washingtontechnology.com

Royalty Pharma, drug firm that doesn’t develop drugs, shatters IPO record

Royalty Pharma, a business built on investing in other people’s medicines, raised $2.2 billion in a record IPO on Tuesday, and the early hours of trading boosted its valuation to more than $25 billion.

The company, founded in 1996, priced about 78 million shares at $28 each. Royalty Pharma opened trading at $44, an instant 57% increase, suggesting the company’s bankers left a fair amount of money on the table.

BIA | EPIDAREX CAPITAL CLOSES NEW £102 MILLION UK VENTURE FUND TO BUILD SUCCESSFUL LIFE SCIENCE COMPANIES

Edinburgh, UK, 22 June 2020 - Epidarex Capital (“Epidarex”), a transatlantic life science venture firm, announces that it has closed Epidarex Capital III UK LP (the “Fund”) at £102.1 million. The Fund will build new life science companies based on world-class research and innovation from emerging hubs across the UK, including spinouts from highly regarded universities. Typical initial investments will range from £2 million to £5 million.