Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More

Xconomy National — 

The novel coronavirus has driven the pharmaceutical industry to upend its research priorities. Big Pharma companies are focusing on vaccine development and a slew of biotechs are testing compounds, previously intended for a wide range of indications, as potential COVID-19 treatments.

This week saw another major development brought on by industry efforts to adjust to the new realities engendered by the pandemic, with the signing of an $18.5 billion merger in the digital health sector. How the tie-up, between telemedicine company Teladoc Health and remote monitoring firm Livongo Health, was finalized was another sign of the times: late-night Zoom sessions and a socially distanced whiteboard session in a Midwestern hotel.

In other news, a neuroscience drug maker placed a $1 billion bet on a potential Parkinson’s disease therapy, the FDA OK’d a new treatment for advanced multiple myeloma, and the biotech IPO wave continued. All that, and more, in this week’s roundup.

LET’S MAKE A DEAL

—Telemedicine company Teladoc Health (NYSE: TDOC) agreed to buy Livongo Health (NASDAQ: LVGO) in a cash and stock deal valued at $18.5 billion, a merger that comes as COVID-19 drives more people to find virtual healthcare services.

—Biogen (NASDAQ: BIIB) is committing $1 billion to a multi-drug partnership with Denali Therapeutics (NASDAQ: DNLI) that starts with a small molecule ready for a Phase 2/3 study in Parkinson’s disease.

—Cytovia Therapeutics acquired global rights to a chimeric antigen receptor from CytoImmune Therapeutics, which will be developed as part of a natural killer cell therapy for glioblastoma and other solid tumors. Financial terms weren’t disclosed.

—Merck (NYSE: MRK) is paying Hanmi Pharmaceuticals $10 million up front for rights to efinopegdutide, which the pharma giant plans to test in nonalcoholic steatohepatitis. The South Korean biotech had advanced the peptide drug to mid-stage testing in obesity and diabetes under a former partnership with Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceuticals.

DRUG DEVELOPMENTS

—A CymaBay (NASDAQ: CBAY) drug succeeded in a late-stage trial in patients with primary biliary cholangitis, setting it up for a registrational trial and, potentially, as a competitor to an existing Intercept Pharmaceuticals (NASDAQ: ICPT) treatment.

—AbbVie (NYSE: ABBV) this week terminated a neuroscience research alliance with Voyager Therapeutics (NASDAQ: VYGR) before any of the partnered programs reached human testing.

—The FDA accepted Biogen’s submission for Alzheimer’s drug candidate aducanumab, setting a target March 7, 2021, target date for a regulatory decision.

—Roche’s bid to make its cancer drug atezolizumab (Tecentriq) a first choice of treatment for metastatic triple negative breast cancer has fallen short. The pharma giant announced that the drug, in combination with chemotherapy, failed to achieve the main goal of a Phase 3 study.

—Without admitting wrongdoing, Bausch Health (NYSE: BHC) paid $45 million to settle an SEC inquiry about allegedly misleading financial disclosures made when the company was known as Valeant Pharmaceuticals. The Quebec-based company also paid about $69 million to resolve litigation in Canada regarding the same matter.

—Novartis (NYSE: NVS) moved closer to adding another indication for Kymriah after reporting interim data showing that the CAR-T treatment met the main goal of a pivotal study in follicular lymphoma. The cell therapy is approved for treating acute lymphoblastic leukemia and diffuse large B-cell lymphoma.

—Novartis also published data from a Phase 3 study showing that its experimental multiple sclerosis (MS) drug ofatumumab beat teriflunomide (Aubagio), a once-daily MS pill marketed by Sanofi (NYSE: SNY).

DRUG DECISIONS

—A skin patch developed by France’s DBV Technologies (NASDAQ: DBVT) to treat children with peanut allergies was rejected by the FDA, which directed the company to address its concerns about the sticker’s adhesion and its impact on the treatment’s efficacy.

—The FDA approved MorphoSys (NASDAQ: MOR) antibody drug tafasitamab (Monjuvi) as a treatment for diffuse large B-cell lymphoma. The German biotech will commercialize the drug in the US with partner Incyte (NASDAQ: INCY).

—GW Pharmaceuticals (NASDAQ: GWPH) drug cannabidiol (Epidiolex) was awarded an additional FDA approval for treating seizures in patients with tuberous sclerosis complex, a rare disorder. In 2018, the FDA approved the drug for addressing seizures in patients who have Dravet syndrome or Lennox-Gastaut syndrome, two rare forms of epilepsy.

—Johnson & Johnson drug esketamine (Spravato), a nasal spray, received FDA approval to expand its use, along with an oral antidepressant, to adults with major depressive disorder and suicidal thoughts or behavior. It was initially approved last year for treatment-resistant depression.

—The FDA approved GlaxoSmithKline (NYSE: GSK) drug belantamab mafodotin (Blenrep), which targets B-cell maturation antigen (BCMA), a protein found on the surface of cancerous plasma cells, for patients with advanced multiple myeloma.

STARTUP CASH

—Startup GentiBio raised $20 million in seed financing and unveiled its approach for engineering regulatory T cell therapies for treating autoimmune disorders.

—IgGenix nabbed $10 million in a round led by Khosla Ventures to move ahead its research on antibody treatments for people with allergies.

—Three early employees from G1 Therapeutics (NASDAQ: GTHX) launched Arc Therapeutics, a new oncology company in Research Triangle Park, NC, with a preclinical cancer program licensed from their former employer.

—Taysha Gene Therapies, a Dallas-based biotech that launched two months ago to develop gene therapies for central nervous system disorders, closed $95 million in a Series B financing that included crossover investors.

—Toronto-based Point Biopharma raised $20 million in Series A financing as it looks ahead to late-stage testing of its experimental radiotherapeutic for prostate cancer.

—Cancer drug developer PMV Pharmaceuticals closed $70 million in Series D financing as it moves toward the clinic with multiple drugs that target mutations of p53, a tumor suppressor protein.

—The Cystic Fibrosis Foundation committed $20 million to back Longwood Fund portfolio companies working on therapies for the condition.

—Versant Ventures spun out Matterhorn Biosciences, a biotech that aims to develop cell therapies that target MR1 molecules on cancerous tumors, and committed to investing $30 million in the startup.

—German biotech T-knife raised a €66 million (about $78 million) Series A financing to advance its pipeline of investigational T-cell receptor therapies as potential treatments for solid tumors.

THIS WEEK IN BIOTECH IPOS

Kymera Therapeutics set a preliminary $100 million goal for its IPO, which will fund clinical development of small molecule drugs that treat disease by harnessing a cellular mechanism called protein degradation.

—Israel-based Nano-X Imaging plans to raise $125 million from its IPO, which will finance manufacturing of its medical imaging system.

Cambridge, MA-based Checkmate Pharma went public at $15 per share, raising $75 million for its pipeline of investigational cancer immunotherapies. Checkmate shares are expected to begin trading on the Nasdaq Friday under the stock symbol “CMPI.”

—London-based Freeline Therapeutics, which is developing a gene therapy for hemophilia B, priced its IPO at $18 per American depository share—the top of its projected range. Those shares are expected to begin trading on the Nasdaq Friday under the stock symbol “FRLN.”

—Acutus Medical (NASDAQ: AFIB), developer of a cardiac mapping system intended to improve the outcome of a procedure used to treat irregular heartbeats, raised $158.8 million from its IPO.

COVID R&D

—Novavax released preliminary data for its COVID-19 vaccine candidate, NVX-CoV2373. The vaccine was well tolerated, produced neutralizing antibodies in all volunteers, and sparked T cell responses thought to be associated with a longer duration of immunity. The data, which hasn’t been peer reviewed, were published on a preprint server.

—Johnson & Johnson (NYSE: JNJ) reached an agreement to supply the US government with 100 million doses of its COVID-19 vaccine, if it receives approval or emergency use authorization from the FDA.

—Sanofi (NASDAQ: SNY) and GlaxoSmithKline announced “advanced discussions” with the European Commission to supply up to 300 million doses of the COVID-19 vaccine the companies are jointly developing.

PEOPLE ON THE MOVE

Legend Biotech (NASDAQ: LEGN) CEO Yuan Xu resigned and the company’s chairman, Frank Zhang, was named her successor… Dyne Therapeutics appointed Susanna High to serve as its chief operating officer… Paul Lizzul joined AnaptysBio (NASDAQ: ANAB) as chief medical officer…Black Diamond Therapeutics (NASDAQ: BDTX) made Fang Ni’s interim position as chief business officer permanent… Aspen Neuroscience co-founder Jeanne Loring stepped down from her role as chief scientific officer… Timothy Morris joined Humanigen as chief operating officer and chief financial officer… Valo Therapeutics appointed Paul Higham as its CEO… Oxurion named Grace Chang chief medical officer… Regulus Therapeutics Inc. (NASDAQ: RGLS) appointed Denis Drygin as its chief scientific officer… Selecta Biosciences (NASDAQ: SELB) added Peter Traber as chief medical officer… Mission Therapeutics promoted Paul Thompson to chief scientific officer and Nick Edmunds to chief technology officer… Excision BioTherapeutics tapped TJ Cradick as its chief scientific officer… Barclay “Buck” Phillips joined Ribometrix as chief operating officer and chief financial officer… Anika Therapeutics (NASDAQ: ANIK) appointed Michael Levitz as chief financial officer… MeiraGTx (NASDAQ: MGTX) tapped Robert Zeldin as its chief medical officer… Dicerna Pharmaceuticals (NASDAQ: DRNA) named Shreeram Aradhye as its chief medical officer… Alnylam Pharmaceuticals (NASDAQ: ALNY) announced Yvonne Greenstreet, its chief operating officer, would expand her role to include the position of president… and Valneva appointed Juan Carlos Jaramillo as chief medical officer.

Frank Vinluan contributed to this report. 

Image: iStock/Pornpak Khunatorn

 

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