Bio Roundup: Clinical Trials Paused, New MS Drug, Kallyope’s Cash & More

Xconomy National — 

Finding and enrolling patients for clinical trials is always challenging. The coronavirus pandemic has made it nearly impossible.

Fallout from the spread of COVID-19 infections led several companies to declare this week that they would stop enrolling patients in clinical trials or postpone studies that have not yet started. Eli Lilly (NYSE: LLY) said that many healthcare systems are devoting their resources to treating COVID-19 patients, which makes it difficult for these sites to also start new clinical trials. Pfizer (NYSE: PFE) is delaying new patient recruitment for three weeks. Bluebird Bio (NASDAQ: BLUE) said the pandemic could shift its enrollment and clinical trial completion timelines by three months. That company and others noted that their ongoing studies are continuing.

In other news this week the FDA approved a new multiple sclerosis drug, two biotechs raised $100 million financing rounds to reach the clinic, and a big pharmaceutical company struck a deal in the burgeoning field of RNA interference therapies. Let’s get to those stories and more in this week’s roundup.

DOLLARS AND DEALS

—Astellas Pharma is paying CytomX Therapeutics (NASDAQ: CTMX) $80 million up front to start a cancer immunotherapy research partnership based on the South San Francisco-based biotech’s antibody technology.

—AstraZeneca (NYSE: AZN) jumped into the mix of companies developing RNA interference therapies by striking up an alliance with London-based Silence Therapeutics (LON: SLN). The pharma giant is paying Silence $60 million up front and purchasing $20 million worth of its partner’s stock.

“Gut brain axis” drug developer Kallyope landed a $112 million Series C financing round and revealed its lead program is an investigational treatment for patients with obesity.

—Industry veterans said the pandemic could lead to a financing slowdown for biotechs and, later, a reduction in M&A deals give the reduction in drug discovery and development activity.

Keros Therapeutics laid out plans for an initial public offering, money it is looking to raise to advance the new drugs it is developing, which inhibit a family of proteins called TGF-beta to treat patients with blood and musculoskeletal disorders, through clinical trials.

—Exton, PA-based Castle Creek Biosciences closed $75 million in financing to continue clinical development of its experimental gene therapy for epidermolysis bullosa, a rare genetic skin disease.

—SutroVax raised a $110 million Series D financing round to move into clinical testing for SVX-24, the Foster City, CA, company’s vaccine candidate for pneumococcal disease.

—Gene therapy developer Redpin Therapeutics raised a $15.5 million Series A financing round to further develop its chemogenetics platform to address diseases of the nervous system, including epilepsy, neuropathic pain and Parkinson’s disease.

—With $80 million in fresh capital ReCode Therapeutics plans to move its two lead programs, investigational RNA therapies for rare genetic lung diseases, into the clinic next year.

FDA YEAS AND NAYS

—Bristol Myers Squibb (NYSE: BMY) was awarded FDA approval for ozanimod, a multiple sclerosis drug that came to the company via its acquisition of Celgene. But Bristol says the coronavirus pandemic will delay the drug’s launch.

—The FDA rejected an application by Boehringer Ingelheim and Eli Lilly for empagliflozin (Jardience) as a treatment for patients with type 1 diabetes. The drug is already approved for treating type 2 diabetes.

—Pfizer (NYSE: PFE) atopic dermatitis drug crisaborole (Eucrisa) won supplemental FDA approval extending use of the drug to patients as young as 3 months old. The initial approval for the drug had set the lower age limit at 24 months.

—Somryst, a prescription digital therapeutic developed by Pear Therapeutics, was granted FDA marketing clearance as a treatment for chronic insomnia. The product was also evaluated under the regulator’s new software precertification pilot program, an initiative to streamline regulatory oversight of software-based medical devices.

DRUG DEVELOPMENTS

—Aimmune Therapeutics (NASDAQ: AIMT) CEO Jayson Dallas spoke with Xconomy sister publication the Pink Sheet about his company’s plans for commercializing and manufacturing peanut allergy immunotherapy Palforzia.

—Three weeks after announcing that venetoclax (Venclexta), in combination with the chemotherapy cytarabine, failed a late-stage study in patients with acute myeloid leukemia, AbbVie (NYSE: ABBV) announced preliminary data showing success in a separate Phase 3 clinical trial testing it with azacytidine, a different chemotherapy.

—Forge Therapeutics entered a partnership with Roche to support development of its novel antibiotic for drug-resistant bacterial infections in the lungs. The deal gives the Swiss pharma giant an option to license the program.

—The FDA lifted a clinical hold on IMS001, an experimental ImStem Biotechnology treatment for multiple sclerosis. The Farmington, CT, company says it plans to start a Phase 1 study testing the allogeneic stem cell therapy later this year.

—Bristol Myers Squibb declined to exercise its option to develop AG-270, an Agios Pharmaceuticals (NASDAQ: AGIO) drug in early-stage testing in lung cancer and pancreatic cancer. The drug is part of a collaboration that began under Celgene, which was acquired by Bristol last year.

—Oncology industry veterans discussed how cancer care might improve over the next decade during a webcast recorded for Bio-Europe Spring, a partnering conference that took place virtually this week instead of in Paris as previously planned.

THIS WEEK IN COVID-19

—The UC San Diego Health system teamed up with a handful of private companies that are making COVID-19 diagnostics in a bid to scale up its testing efforts.

—Roche launched a Phase 3 study in collaboration with the Biomedical Advanced Research and Development Authority of tocilizumab (Actemra) in adults hospitalized with severe COVID-19 pneumonia. The rheumatoid arthritis drug, which was the first antibody engineered to block the receptor for an inflammatory protein called IL-6 approved by the FDA, will be compared to a placebo on top of the standard of care.

—Soon after Gilead Sciences (NASDAQ: GILD) was granted orphan drug designation for remdesivir, an experimental therapy in clinical testing for COVID-19 infection, the Foster City, CA, company asked the FDA to take it back. The designation sparked condemnation from those who said Gilead should not get the tax breaks and marketing exclusivity incentives that come with the designation. Gilead responded that it can develop the drug quickly without the designation.

—France-based diagnostics company bioMerieux received emergency FDA authorization for its COVID-19 test. The test, which was developed with funding from the US Department of Defense, can detect the novel coronavirus in about 45 minutes, according to the company.

PEOPLE ON THE MOVE

Emulate named Jim Corbett its new CEO…. Paul Wren joined Escape Bio as chief scientific officer… Carlos Campoy joined CytomX Therapeutics as chief financial officer… David Happel succeeded Brent Vaughan as CEO of Chrono Therapeutics… Genprex (NASDAQ: GNPX) appointed Catherine Vaczy its chief strategy officer and Michael Redman its chief operating officerJeffery Kutok was appointed chief scientific officer of Epizyme (NASDAQ: EPZM)… Fusion Pharmaceuticals tapped James O’Leary as its chief medical officer… and Akcea Therapeutics’s interim CEO Damien McDevitt was made the company’s permanent chief executive.

Sarah de Crescenzo contributed to this report.

Image: iStock/redrhino78