Bio Roundup: Biotech Billions, COVID-19 R&D, Zolgensma’s Path & More

Xconomy National — 

The coronavirus pandemic has shaken the global economy, but three life sciences venture capital firms this week announced new funds totaling nearly $3 billion.

ARCH Venture Partners led the pack, adding two funds totaling $1.46 billion to its war chest. Flagship Pioneering bagged $1.1 billion, and venBio Partners reeled in $394 million. Flagship CEO Noubar Afeyan told Xconomy that the pandemic unexpectedly highlights the need for investment in one of its new thematic areas of interest: “health security” tools and technologies to prevent, detect, and delay disease. And Corey Goodman, managing partner at venBio, said the firm doesn’t expect the coronavirus-related instability will diminish the appetite of pharmaceutical companies and biotechs for promising new medicines in the years ahead.

In the meantime, of course, the pandemic continues to dominate the news as the industry works feverishly to develop COVID-19 tests and treatments. Catch up on those stories and more in this week’s roundup.

CORONAVIRUS NEWS

—New Jersey biotech Celularity, which is developing experimental cancer treatments derived from human placentas, is starting human testing of its lead immunotherapy for cases of COVID-19 disease.

—Johnson & Johnson (NYSE: JNJ) announced that it has selected a lead COVID-19 vaccine candidate that it expects to start testing in humans by September.

—Medical device giant Medtronic (NYSE: MDT) made design specifications of one of its ventilators publicly available in hopes of sparking others to develop ventilator technologies for treating COVID-19.

—The FDA authorized a COVID-19 test designed by Abbott (NYSE: ABT) that can provide positive results in as little as five minutes and negative results in about 13 minutes. The portable test is designed to offer rapid results in healthcare settings.

—Amgen (NASDAQ: AMGN) and Adaptive Biotechnologies (NASDAQ: ADPT) are partnering to discover and develop antibodies that target SARS-CoV-2 to potentially prevent or treat COVID-19.

—Vir Biotechnology (NASDAQ: VIR) CEO George Scangos spoke with Xconomy sister publication Scrip to discuss his company’s work and his role leading the Biotechnology Innovation Organization’s coronavirus response.

—Generation Bio and Vir announced a collaborative research agreement to bring together Generation’s non-viral gene therapy platform and Vir’s monoclonal antibodies to develop potential treatments for COVID-19.

—Vir is also expanding an existing collaboration with Alnylam Pharmaceuticals (NASDAQ: ALNY) to develop RNA interference drugs for infectious diseases, including the novel coronavirus.

DOLLARS & DEALS

—Belgium-based Iteos Therapeutics raised $125 million, a Series B2 financing round, to advance cancer immunotherapies designed to target mechanisms it believes aid in the suppression of an anti-tumor immune response in the tumor microenvironment.

Pandion Therapeutics closed an $80 million Series B financing to continue Phase 1 testing of its lead drug for ulcerative colitis and advance another autoimmune disease drug to the clinic.

—In other autoimmune disease drug news, Eli Lilly (NYSE: LLY) agreed to pay $50 million in cash and make a $10 million equity investment in Sitryx to start a partnership studying four preclinical targets identified by the startup that could lead to new medicines.

—Zentalis Pharmaceuticals pushed through the debris of the economic crash with a $165.2 million IPO to support clinical development of its small molecule cancer drugs.

—Fate Therapeutics (NASDAQ: FATE) began an alliance with Johnson & Johnson unit Janssen Biotech focused on developing new cancer cell therapies. Under the deal, San Diego-based Fate receives $50 million up front and a $50 million equity investment from its new partner.

—Less than a year after emerging with $150 million in financing along with plans to launch and support a portfolio of gene and cell therapy developers, Elevate Bio closed a $170 million Series B round of funding.

—Daiichi Sankyo is paying Ultragenyx Pharmaceutical (NASDAQ: RARE) $200 million up front for non-exclusive access to the Novato, CA-based company’s technology for manufacturing gene therapies.

—Perceptive Xontogeny Venture Fund led a $21 million Series A round for Toronto-based Zucara Therapeutics, which is preparing to advance its experimental type 1 diabetes drug into Phase 1 testing.

—Waltham, MA-based Affinia Therapeutics raised $60 million in Series A financing to advance its work developing gene therapies for muscular and central nervous system disorders.

—Cambridge, MA-based biotech Rgenta Therapeutics landed a $20 million seed round to move into preclinical studies with its research into small molecules targeting the RNA regulation and splicing of disease-causing genes in oncology and neurological disorders.

—ARCH Venture Partners raised $1.46 billion for two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, to pump into early-stage biotech startups.

DRUG DEVELOPMENTS

—Novartis (NYSE: NVS) says the clinical data it has for Zolgensma, its spinal muscular atrophy treatment, is sufficient to begin discussions with the FDA about the approval pathway for the gene therapy in patients older than 2. Meanwhile, the company is ramping up its manufacturing capacity for that gene therapy and others in its pipeline.

—Axsome Therapeutics (NASDAQ: AXSM) reported that its drug, AXS-05, failed to achieve the main goal of a late-stage test in treatment-resistant depression. But the company plans to conduct another Phase 3 clinical trial based on the drug’s performance according to secondary endpoints of the study.

—The FDA requested manufacturers withdraw prescription and over-the-counter ranitidine (Zantac) as the latest step in an investigation of a carcinogen in some of the products.

—Regeneron Pharmaceuticals (NASDAQ: REGN) presented detailed results from its Phase 3 test of evinacumab, which was evaluated in patients who have a severe, inherited form of high cholesterol. Based on the data, the Tarrytown, NY, company plans to seek FDA approval in mid-2020.

—With positive data in hand for pralsetinib, a drug for medullary thyroid cancer patients whose tumors have a particular genetic mutation, Blueprint Medicines (NASDAQ: BPMC) says it plans to submit its pill for FDA review in the second quarter of this year.

—Immunovant (NASDAQ: IMVT) announced positive preliminary Phase 2a data for IMVT-1401, the company’s experimental treatment for thyroid eye disease.

—Partners Bristol Myers Squibb (NYSE: BMY) and Bluebird Bio (NASDAQ: BLUE) submitted an application for idecabtagene vicleucel, a CAR T cell therapy for multiple myeloma.

—Reata Pharmaceuticals (NASDAQ: RETA) ended a Phase 3 study of bardoxolone methyl, an activator of the a transcription factor Nrf2, in patients with pulmonary arterial hypertension associated with connective tissue disease. In addition to the COVID-19 exposure risks from continuing the clinical trial, the company said an initial review of data suggested the study was unlikely to reach its main goal.

PEOPLE ON THE MOVE

Bioventus CEO Tony Bihl is retiring and will be succeeded by Ken Reali… Assembly Biosciences (NASDAQ: ASMB tapped Jason Okazaki as its chief legal and business officer… Lisa Rojkjaer was named chief medical officer of Viracta Therapeutics… Rhythm Pharmaceuticals (NASDAQ: RYTM) appointed Hunter Smith interim CEO… Locana added Micah Mackison as its chief business officerDavid Setboun was named executive vice president and chief operating officer of Brainstorm Cell Therapeutics (NASDAQ: BCLI)… and BioCryst Pharmaceuticals (NASDAQ: BCRX) tapped Anthony Doyle as its new chief financial officer.

Frank Vinluan contributed to this report. 

Image: iStock/Sensay