Amid the bombast of Tuesday’s presidential debate, viewers caught some discussion about the response to the coronavirus pandemic and efforts to develop a COVID-19 vaccine. In the crosstalk, the president made an unsupported claim that we are weeks away from having vaccines.
It’s true that some pharmaceutical companies are already manufacturing their COVID-19 vaccine candidates for broader use. This production ensures that vaccine product is ready for distribution upon receiving a regulatory decision. But companies undertake this manufacturing “at-risk” because they don’t yet know how well their vaccines will work or if they’ll be approved. The industry is pushing back, even if privately, against suggestions that such regulatory decisions are imminent. The Associated Press obtained a memo that Pfizer CEO Albert Bourla wrote to employees, lamenting the politicization of the science.
“I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public,” he wrote. “But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms.”
Pfizer made other news this week, securing partial rights to a promising cancer drug. This week also saw some older biotechs restructure their organizations, and some newer biotechs land cash to build up their pipelines and move forward in clinical trials. Let’s get to those stories and more in this week’s news roundup.
DRUG DEVELOPMENTS
—A stem cell therapy that Mesoblast (NASDAQ: [[ticker:MESO]]) developed to treat acute graft-versus-host disease in children was rejected by the FDA. According to the company, the FDA recommended that the company conduct another clinical trial in adults and/or children to provide more evidence of the efficacy of remestemcel-L (Ryoncil).
—Genfit (NASDAQ: [[ticker:GNFT]]) is cutting 40 percent of its staff in a corporate restructuring that will split the company into two divisions. The changes follow the failure of the company’s lead drug in a pivotal study in nonalcoholic steatohepatitis.
—The FDA lifted a hold on a clinical trial testing a Solid Biosciences (NASDAQ: [[ticker:SLDB]]) gene therapy for Duchenne muscular dystrophy after the biotech made changes to reduce exposure of patients to high levels of the virus used to deliver the treatment to cells.
—The FDA rejected an Aquestive Therapeutics (NASDAQ: [[ticker:AQST]]) oral film formulation of diazepam (Libervant), which was developed as a treatment for seizure clusters. The Boston company says the FDA wants more pharmokinetic information and no new clinical trials are required.
—Ironwood Pharmaceuticals (NASDAQ: [[ticker:IRWD]]) drug candidate IW-3718 failed a Phase 3 study in gastroesophageal reflux disease, leading the Boston company to stop work on the compound and implement a corporate restructuring that will cut about 35 percent of its workforce.
—A little more than a month after the FDA rejected filgotinib, an experimental rheumatoid arthritis drug from Gilead Sciences (NASDAQ:[[ticker:GILD]]) and Galapagos (NASDAQ: [[ticker:GLPG]]), regulators in Europe and Japan approved the once-daily pill.
LET’S MAKE A DEAL
—Pfizer (NYSE: [[ticker:PFE]]) is making a $200 million equity investment in CStone Pharmaceuticals to secure commercialization rights in China to that company’s late-stage cancer immunotherapy, sugemalimab.
—Covis Group agreed to pay $13.75 per share to acquire AMAG Pharmaceuticals (NASDAQ: [[ticker:AMAG]]), a deal that values the company at about $498 million. Earlier this year, Waltham, MA-based AMAG implemented a corporate restructuring that cut staff and sold off products.
—Bial paid an unspecified amount to acquire clinical-stage Parkinson’s disease programs from Lysosomal Therapeutics. Concurrent with the deal, Portugal-based Bial is establishing a Parkinson’s-focused business unit in Cambridge, MA called Bial Biotech Investments.
—Orgensesis (NASDAQ: [[ticker:ORGS]]) is acquiring cell therapy developer Koligo in a stock deal that brings a commercialized treatment for acute pancreatitis and a Phase-2 ready compound for COVID-19-related respiratory distress.
BIOTECH CASH
—Galecto raised $64 million in financing to support mid-stage clinical testing of three drug candidates for three different forms of fibrosis.
—Eight months after launching with $40 million in financing, Sonoma Biotherapeutics topped off its Series A funding round with another $30 million. The preclinical-stage biotech is developing regulatory T cell therapies for autoimmune and degenerative diseases.
—Invetx, a startup applying the science of biologic therapies for humans to the development of biologic drugs for pets and farm animals, expanded its Series A funding round to $25.5 million as it prepares for pilot studies of its first drug candidate later this year.
—ARCH Venture Partners led a $77 million Series B financing for Dewpoint Therapeutics, a startup developing drugs that target biomolecular condensates. Cambridge-based Dewpoint has partnerships with Bayer and Merck (NYSE: [[ticker:MRK]]).
—Sophia Genetics, a company whose technology helps healthcare professionals gain insights from medical data, raised $110 million in Series F financing to expand those offerings in the US and Asia, and to work with biopharmaceutical companies developing new targeted therapies.
—Alzheimer’s disease drug developer AZTherapies closed its Series C round at $37.5 million and added another $33.6 million in a Series “C-1” financing. The Boston company’s lead drug candidate, ALZT-OP1, is currently in Phase 3 testing.
—Aegle Therapeutics, a biotech with sites in Boston and Miami, raised $6.5 million in Series A financing to support the development of extracellular vesicles as a treatment for the rare inherited skin disease epidermolysis bullosa.
—Imvaq Therapeutics of New York closed a $15 million Series B financing to support its research of viral-based immune system stimulating therapies for solid tumors.
—Carmot Therapeutics raised $47 million in Series C financing to support clinical development of therapies for metabolic disorders including type 2 diabetes, obesity, and fatty liver disease.
THIS WEEK IN BIOTECH IPOS
—Orphazyme (NASDAQ: [[ticker:ORPH]]) raised a combined $83 million by listing shares in the US and selling additional shares in Europe, but the Copenhagen-based company’s updated filings show that the FDA wants more data about a possible heart risk associated with arimoclomol, its drug currently under regulatory review for Neimann-Pick disease type C.
—C4 Therapeutics raised $182.4 million in its stock market debut. The developer of protein degradation drugs priced its offering of 9.6 million shares at $19 apiece, topping the Watertown, MA-based company’s projected $16 to $18 per share range. Those shares are set to begin trading on the Nasdaq Friday under the stock symbol “CCCC.”
—Oncorus, a developer of virus-based therapies for cancer, priced its IPO at the $15 per share midpoint of its targeted price range, raising about $87 million. Shares of the Cambridge company are expected to begin trading on the Nasdaq Friday under the stock symbol “ONCR.”
—Immunome priced its IPO at $12 per share, raising about $39 million. Shares of the Exton, PA-based antibody therapies developer are set to begin trading on the Nasdaq Friday under the stock symbol “IMNM.”
—The biotech IPO queue added Praxis Precision Medicines, Aligos Therapeutics, and Tarsus Pharmaceuticals.
COVID-19 R&D
—The FDA is widening its inquiry into the complications that led to a clinical hold being placed on a study testing an AstraZeneca (NYSE: [[ticker:AZN]]) COVID-19 vaccine candidate, according to a Reuters report. Additional requested data are coming, but the regulator will need time to analyze them, the unnamed sources told Reuters.
—CureVac (NASDAQ: [[ticker:CVAC]]) dosed the first patient in a Phase 2a study testing its messenger RNA COVID-19 vaccine candidate, CVnCoV. The study is expected to enroll 690 participants.
—Moderna (NASDAQ: [[ticker:MRNA]]) published in the New England Journal of Medicine interim results from a Phase 1 test of its vaccine candidate for COVID-19 in older adults, age 50-70. The data show that the mRNA vaccine elicited neutralizing antibodies and T cell responses.
—Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]) reported clinical data showing that its COVID-19 therapeutic candidate, consisting of a cocktail of antibodies, helped reduce medical visits.
—The FDA placed a clinical hold on a Phase 2/3 study evaluating an Innovio (NASDAQ: [[ticker:INO]]) COVID-19 vaccine candidate. The Plymouth Meeting, PA-based company said the agency has questions about the clinical trial plan, including the device that will deliver the therapy.
PEOPLE ON THE MOVE
Freeline therapeutics (NASDAQ: [[ticker:FRLN]]) promoted Romuald Corbau to chief scientific officer… Jose “Pepe” Carmona was named chief financial officer of Rubius Therapeutics (NASDAQ: [[ticker:RUBY]]) as chief financial officer… Nimbus Therapeutics appointed Abbas Kazimi its chief business officer… Thrive Earlier Detection named Sam Asgarian chief medical officer and Dina Ciarimboli chief legal officer… Invetx named Bill Brondyk chief scientific officer and Colin Giles chief development officer… Jack Bailey will succeed Mark Velleca as CEO of G1 Therapeutics (NASDAQ: [[ticker:GTHX]])… Kaleido Biosciences (NASDAQ: [[ticker:KLDO]]) appointed Daniel Menichella president and CEO… João Siffert, CEO, head of research and development, and chief medical officer of Abeona Therapeutics (NASDAQ: [[ticker:ABEO]]), resigned… TriSalus Life Sciences named Steven Katz its chief medical officer… MiNA Therapeutics appointed Peter Bains chief business officer… Ferdinand Massari joined Deep Genomics as chief medical officer… Prometheus Biosciences tapped Olivier Laurent as chief technology officer… Akouos appointed Sachiyo Minegishi its chief financial officer and promoted Jennifer Wellman to chief operating officer… AZTherapies appointed Marc de Garidel its CEO… Cara Therapeutics (NASDAQ: [[ticker:CARA]]) named Thomas Reilly its chief financial officer… Rupert Sandbrink is joining Vico Therapeutics as chief medical officer… Tarveda Therapeutics named Brian Roberts its CEO… Adrian Quartel was appointed chief medical officer of Adamas Pharmaceuticals (NASDAQ: [[ticker:ADMS]])… Intra-Cellular Therapies named Suresh Durgam its chief medical officer… Jennifer Jarrett rejoined Arcus Biosciences (NASDAQ: [[ticker:RCUS]]) as chief operating officer… and Roger Perlmutter is retiring as executive vice president and president of Merck Research Laboratories.
Image: iStock/Derek Brumby
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