Biotech Roundup: GSK’s Ante, Shakeup at Sage, Telehealth’s Rise & More

Xconomy National — 

The COVID-19 pandemic has stopped enrollment in many clinical trials and postponed the start of others but there is still life in the life sciences sector. The coronavirus research is expected. It’s the other activity that might come as a surprise.

Two biotech companies have gone public in the past week; each upsized its offering and saw a healthy IPO pop. Startups are raising money, and there is more financing on the way as investment firms close new funds. Time will tell if this activity will continue. Arrakis Therapeutics and Roche announced a drug discovery partnership this week, but Arrakis CEO Michael Gilman says that was based on negotiations that mostly happened before the pandemic shut down the economy. The current inability for business leaders to meet face to face could clamp down on dealflow in months to come, he says.

In other news this week, a telehealth company is seizing the moment, a biotech merger falls apart, and a commercial-stage company’s reorganization is slashing more than half of its staff. Let’s get to those stories and more in this week’s roundup.

DOLLARS & DEALS

Roche is paying Arrakis Therapeutics $190 million up front to start an alliance developing drugs based on the Waltham, MA-based biotech’s technology for discovering and developing small molecules that bind to RNA.

Tango Therapeutics closed a $60 million Series B round to advance its research of drugs based on a concept called synthetic lethality.

—Deerfield Management Company closed an $840 million fund that will invest in companies developing new medicines and medical technologies.

Dynacure raised a $55 million Series C financing round to advance its lead drug candidate, a treatment for a group of rare genetic muscle disorders, and expand the program to pediatric patients.

—Keros Therapeutics (NASDAQ: KROS) made its market debut, raising $96 million in its IPO advance its pipeline of drugs targeting a family of proteins called TGF-beta.

—Organovo (NASDAQ: ONVO) shareholders rejected a merger proposal that would have combined the company with privately held Tarveda Therapeutics, a cancer drug developer. Organovo last year ended its efforts to “bioprint” 3D patches of liver tissue for therapeutic use.

Tyto Care raised $50 million to accelerate commercialization of its telehealth app and modular device, which allows consumers to record sound, video, and image to share with their doctors.

—Gilead Sciences (NASDAQ: GILD) is paying South San Francisco-based microbiome drug developer Second Genome $38 million up front in a partnership intended to bolster its pipeline of treatments for inflammatory diseases.

—Scottish biotech Amphista Therapeutics raised a $7.5 million Series A financing round to advance small molecules that use a process called protein degradation to treat cancer and other conditions.

COVID-19 R&D

—GlaxoSmithKline (NYSE: GSK) is investing $250 million in Vir Biotechnology (NASDAQ: VIR) as part of a new partnership developing antibody drugs, vaccines, and genomic-based products addressing the novel coronavirus.

—Pfizer (NYSE: PFE) and partner BioNTech (NASDAQ: BNTX) are preparing to advance multiple mRNA vaccines for COVID-19 into clinical trials expected to start by the end of April.

—Inovio Pharmaceuticals (NASDAQ: INO) this week began a Phase 1 trial of its DNA vaccine candidate for COVID-19 that could produce early data by late summer.

—LabCorp (NYSE: LH) is teaming up with Ciox Health to build a registry of COVID-19 patient data that will be used for clinical research and analyses related to the disease.

DRUG DEVELOPMENTS

—Sage Therapeutics (NASDAQ: SAGE) is laying off 53 percent of its staff, mostly workers involved in selling post-partum depression drug brexanolone (Zulresso). The corporate restructuring will save an estimated $170 million annually and allow the company to focus on pivotal tests of depression drug zuranolone.

—An FDA decision for risdiplam, an experimental spinal muscular atrophy treatment developed by Roche subsidiary Genentech, has been pushed back three months to Aug. 24. Genentech said the change gives the regulator more time to review additional clinical data that had been submitted by the company.

—The GW Pharmaceuticals (NASDAQ: GWPH) epilepsy drug cannabidiol (Epidiolex), the only CBD-based drug approved by the FDA, is no longer considered a controlled substance by the US federal government. Descheduling the medicine, OK’d to treat certain severe forms of epilepsy, will make it easier for patients to obtain by prescription.

DATA & DECISIONS

—A potential treatment for rare genetic condition Prader-Willi syndrome developed by Ann Arbor, MI-based Millendo Therapeutics (NASDAQ: MIND) failed to beat a placebo in a pivotal trial.

—Serlopitant, a Menlo Therapeutics (NASDAQ: MNLO) drug, failed two Phase 3 tests evaluating the pill as a treatment for the itching associated with prurigo nodularis, a skin disorder.

—Axsome Therapeutics (NASDAQ: AXSM) reported positive Phase 3 data for AXS-07, an experimental treatment for acute migraine. The New York company plans to seek FDA approval in the fourth quarter of this year.

—Luspatercept (Rebloyzl), a drug from Acceleron Pharma (NASDAQ: XLRN) and Bristol Myers Squibb (NYSE: BMY) won an additional FDA approval as a treatment for anemia in patients who have myelodysplastic syndromes. The drug was approved last year as a treatment for anemia in patients with another blood disorder, beta thalassemia.

—The European Commission approved Nustendi, a cholesterol-lowering pill that combines bempedoic acid and ezetimibe. The FDA approved the Esperion Therapeutics (NASDAQ: ESPR) drug in February.

—Novo Nordisk (NYSE: NVO) won European Commission approval for Rybelsus, a pill version of its injectable type 2 diabetes drug semaglutide. The FDA approved the pill last September.

—France’s LFB received FDA approval for its new hemophilia drug, a recombinant form of a blood-clotting protein Factor VII it is marketing as Sevenfact. The drug is intended to treat and control bleeding in hemophilia A and B patients 12 years and older who have developed antibodies to other clotting treatments.

—The European Commission approved Takeda Pharmaceutical (NYSE: TAK) drug brigatinib (Alunbrig) as a primary treatment for adults with advanced non-small cell lung cancer (NSCLC) whose tumors overexpress the anaplastic lymphoma kinase (ALK) gene. The decision expands the scope of patients that can be treated with the drug.

PEOPLE ON THE MOVE

—Seres Therapeutics (NASDAQ: MCRB) named Lisa von Moltke executive vice president and chief medical officer… Harout Semerjian is leaving Ipsen to become president and CEO of Immunomedics (NASDAQ: IMMU)… Don Haut joined Asklepios BioPharmaceutical as chief business officer… Morphic Therapeutic (NASDAQ: MORF) appointed Marc Shegerin its chief financial officer and chief operating officer… Debra Barker was named chief medical officer of Polyneuron PharmaceuticalsBolt Biotherapeutics appointed Edith Perez its chief medical officer…. and Aravive (NASDAQ: ARAV) promoted Gail McIntyre to CEO, succeeding Rekha Hemrajani, who resigned.

Sarah de Crescenzo contributed to this report.

Image: iStock/artisteer