Bio Roundup: Pandemic Declared, Rubius Restarts, Kymera’s Cash & More

Xconomy National — 

The financial markets are tumbling, event cancellations are mounting, and sports leagues are suspending their seasons. March Madness is in full swing but not in any way that people wanted or expected.

The World Health Organization this week declared that the COVID-19 outbreak was serious enough to classify as pandemic. The toll on public health is continuing, and the economic fallout is following as stock market indexes slid into bear market territory. If there is a bright spot, it might be in remarks from Tedros Adhanom, the WHO’s director general. He noted that China and South Korea are now showing significant declines in COVID-19 cases—examples of how a comprehensive strategy can change the course of the virus’s spread.

There was much more in life science news this week besides coronavirus. Wipe your touchscreen clean and use your Purell-sanitized finger to scroll through these headlines.

CASH GRABS & NEW STARTS

Kymera Therapeutics closed a $102 million Series C financing to bring up to three targeted protein degradation drugs into human testing next year.

—Another protein degradation startup, Nurix Therapeutics, raised $120 million—from some of the same investors as Kymera—to advance its drug pipeline into clinical trials.

—Harbour BioMed, which has built a portfolio of antibody therapies, raised $75 million in a Series “B plus” round to advance its therapeutics, including a Phase 1 cancer immunotherapy designed to block the immune-system protein CTLA-4.

—Imara (NASDAQ: IMRA) braved the turbulent financial markets and raised $75.2 million from its IPO to support clinical development of its drugs for rare blood disorders.

—Zentalis Pharmaceuticals, Lyra Therapeutics, and Ayala Pharmaceuticals secured spots in the biotech IPO queue.

—Healthcare investment firm LSP raised a $620 million fund to invest in European firms developing new drugs or medical technologies.

—The latest Flagship Pioneering startup is a combination of two of the venture capital firm’s portfolio companies. Repertoire Immune Medicines, an amalgamation of Cogen Immune Medicines and Torque Therapeutics, is developing immunotherapies for cancer, autoimmune conditions, and infectious diseases.

DRUG DEVELOPMENTS

—Rubius Therapeutics (NASDAQ: RUBY) is ending its rare disease programs—including a clinical trial of its lead drug candidate for phenylketonuria—and focusing instead on advancing its red blood cell therapies for oncology and autoimmune indications.

—The FDA approved osilodrostat (Isturia), a drug from Novartis (NYSE: NVS) developed to treat Cushing’s disease. Novartis sold that drug and another Cushing’s disease therapy to Italy-based Recordati last year.

—An experimental Acceleron Pharma (NASDAQ: XLRN) drug for Charcot-Marie-Tooth disease posted mixed results in a mid-stage study, leading the biotech to discontinue the program.

—Takeda Pharmaceutical (NYSE: TAK) multiple myeloma drug ixazomib (Ninlaro) failed a Phase 3 test in newly diagnosed patients who are ineligible for a stem cell transplant. Though the results showed improvement in overall survival, they were not enough to be statistically significant.

—Bristol Myers Squibb (NYSE: BMY) also reported a failed Phase 3 failure in multiple myeloma. Treatment with its drug elotuzumab (Empliciti) did not improve how long patients lived without the cancer worsening, the study’s main goal.

—Kala Pharmaceuticals (NASDAQ: KALA) plans to resubmit to the FDA for review the eye drops it developed to temporarily relieve dry eye disease. The FDA rejected the drug last year but additional data from a new study show the treatment improved patients’ eye pain.

—The FDA gave the green light to Boehringer Ingelheim Pharmaceuticals drug nintedanib (Ofev), an oral drug to treat patients with a group of interstitial lung diseases that cause progressive lung scarring, or fibrosing. It’s the first treatment approved by the agency for the subset of people with fibrosing lung diseases that worsen over time.

—The FDA placed a partial clinical hold on a Phase 1 study of Unum Therapeutics (NASDAQ: UMRX) drug ACTR707 for CD20 positive B cell non-Hodgkin lymphoma after one patient experienced a serious adverse event possibly related to the study drug.

—Japan’s Santen Pharmaceutical and Tracon Pharmaceuticals, a San Diego biotech, ended development of an experimental treatment for wet age-related macular degeneration after Phase 2a clinical data showed the drug did not improve vision.

—The FDA issued a safety alert that warns of potentially serious or life-threatening infections from fecal microbiota transplantation product supplied by an unnamed US stool bank company. The agency says it has been notified of six patients who received that company’s product who later developed infections.

EMD Serono and Pfizer (NYSE: PFE) are terminating a study testing avelumab plus chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck. An interim analysis by an independent committee concluded that the study was unlikely to meet the main goal of progression-free survival.

LET’S MAKE A DEAL

—ViiV Healthcare, the HIV-therapies focused company majority owned by GlaxoSmithKline (NYSE: GSK), renewed a five-year, $20 million partnership with the University of North Carolina at Chapel Hill focused on discovering a cure for HIV.

—Menlo Therapeutics (NASDAQ: MNLO) and Foamix Pharmaceuticals completed a merger resulting in a combined company operating under the Menlo name and led by Foamix management.

—AI drug discovery firm Atomwise reached a deal with South Korea-based Bridge Biotherapeutics to find up to 13 small molecule programs for inflammation and other unspecified disease areas. Specific financials weren’t disclosed but if all of the programs succeed, the San Francisco startup estimates it could earn up to $1 billion in payments.

—Israel’s largest life sciences investor, Arkin Holdings, partnered with an investor group that includes Migdal and Phoenix Group to start a new $140 million fund. The investors plan to pump cash into as many as a dozen private companies working on novel therapeutics.

PEOPLE ON THE MOVE

NGM Biopharmaceuticals (NASDAQ: NGM) Chief Operating Officer Aetna Wun Trombley is leaving to become CEO of an unnamed company… Anthony Mancini was appointed executive vice president and chief operating officer of Genmab (NASDAQ: GMAB)… Soma Gupta was appointed chief commercial officer of G1 Therapeutics (NASDAQ: GTHX)… CureVac founder Ingmar Hoerr succeeded Dan Menichella as CEO… Karyopharm Therapeutics (NASDAQ: KPTI) named John Demaree its chief commercial officer… John Cox was appointed CEO of Repertoire Immune Medicines.

Sarah de Crescenzo contributed to this report.

Image: iStock/Eugene_Onischenko