
AstraZeneca hands off epilepsy programs to Ovid; Amylyx scores priority review for ALS drug
Still recovering from a setback in its lead program, Ovid Therapeutics has turned to AstraZeneca for a suite of experimental epilepsy drugs.
Ovid is paying the Big Pharma partner $5 million in cash and $7.5 million in stock to access a library of early-stage small molecules targeting the KCC2 transporter, including lead candidate OV350. AstraZeneca stands to receive milestones adding up to more than $200 million and retains an option for a strategic collaboration.
The epilepsy franchise did relatively well in a year full of bad news for Ovid, as Takeda bought back rights to soticlestat, a cholesterol 24-hydroxylase inhibitor in Phase III trials for Dravet and Lennox Gastaut syndromes.
Other than OV350, Ovid also got its hands on OV329, a new version of pregabalin for tuberous sclerosis and infantile spasms, which is expected to enter the clinic in 2022.
“The KCC2 transporter is an exciting and novel target that we believe holds great promise in treating epilepsies,” CEO Jeremy Levin said in a statement. “The compounds are a natural fit for our franchise dedicated to small molecule epilepsy medicines, and they follow our track record of successful partnering with large pharmaceutical companies.”
AstraZeneca had worked with Stephen Moss and Jamie Maguire at the Tufts Laboratory for Basic and Translational Neuroscience Research to develop these compounds. Ovid said it will continue collaborating with them. — Amber Tong
Amylyx scores priority review for ALS drug
After years of futile efforts, the FDA is ready to make a decision on a potential new amyotrophic lateral sclerosis drug in six months — but not before convening an advisory committee.
Amylyx announced over the holiday that its only drug, AMX0035, has been granted priority review and assigned a PDUFA date of June 29, 2022. But the FDA noted it’s planning to hold an adcomm to discuss the NDA.
Experts will likely be dissecting data from the Phase II CENTAUR trial, where ALS patients demonstrated statistically significant reduction in clinical decline.
While regulators had asked last year for a Phase III study to confirm those benefits, they later reversed course, flashing the green light for Amylyx to file directly for approval amid an uproar in the ALS community over what they saw as double standards in the wake of the controversial Aduhelm approval. — Amber Tong
Eli Casdin-backed DNA sequencing player tacks $35M more onto Series C
DNA Script has tacked on another bundle of cash, officially closing its Series C.
The South San Francisco-based company completed the round’s second tranche of $35 million, it announced Tuesday, adding to the $165 million raised in the Series C last October. New funds come from T. Rowe Price Associates, Baillie Gifford, Healthcor Management, eureKARE and Irving Investors.
Also backed by Eli Casdin, DNA Script is looking to make a mark on the DNA sequencing field by cutting down on expensive and messy byproducts associated with earlier versions of sequencing technology. The company, founded in 2014, is gearing up for its first product launch this year, a benchtop DNA printer using a platform known as SYNTAX.
The company hopes to eventually deliver therapeutics for personalized and precision medicine.
“SYNTAX is the first step toward creating a new paradigm for DNA and RNA synthesis,” CEO Thomas Ybert said in a statement. “With the support of our investors, we look forward to continuing to advance this new paradigm to solve some of our largest challenges and advance human health.” — Max Gelman
After almost a year, the FDA lifts clinical trial hold on Spero’s lung disease candidate
Spero Therapeutics got a breath of fresh air from the FDA — the agency lifted its hold on Spero’s planned Phase II trial for SPR720, a drug candidate for nontuberculous mycobacterial disease, a bacterial infection in the lungs.
The Phase IIa trial was officially put on hold back in February last year after Spero notified regulators of its decision to pause dosing.
Scientists had uncovered “mortalities with inconclusive causality” in a toxicology study involving non-human primates, and a Safety Review Board recommended that Spero hit the brakes on the drug, which it had acquired from Vertex. Spero’s stock $SPRO went down more than 20% to $4.04 after the news broke.
Spero said earlier today that it plans to meet with the FDA by the end of the quarter to discuss restarting the trial, and hope to have it running by next quarter.
CEO Ankit Mahadevia expressed optimism, saying in a prepared statement “We are very pleased with the FDA’s decision and eager to bring SPR720 back into the clinic.” — Paul Schloesser
Boasting ‘comprehensive coverage of breast cancer,’ China’s Xuanzhu nabs $96M
As the tune of the innovative drug business gets louder in China’s pharma industry, a biotech spun out of a 20-year-old player has bagged $96 million in Series B cash.
Xuanzhu Biopharm plans to deploy the cash on developing its sprawling pipeline, which has more than 25 programs, including two in the NDA stage: anaprazole sodium for duodenal ulcer, and an SGLT-2 inhibitor for diabetes.
Retaining close ties to its parent company Sihuan Pharmaceutical Holdings Group, Xuanzhu says it’s focusing on the R&D of “new frontier drugs” in areas like oncology, diabetes, NASH, anti-infection and digestion disorders.
Specifically, Xuanzhu said its 400 staffers mainly target breast cancer, lung cancer and other solid tumors — making it “one of the companies with the most comprehensive coverage of breast cancer domestically.”
Other oncology drugs in development include a next-generation CDK4/6 inhibitor and an ALK/ROS1 dual-target inhibitor.
“(W)e will gradually expand the comprehensive strength encompassing overseas collaboration, industrialization and commercialization, and create a novel, innovative pipeline and portfolio that is differentiated and sustainable,” CEO Yanjun Xu said in a statement. — Amber Tong
Novartis keeps generic challenger out of Gilenya’s way
Thanks to a new court ruling, Novartis can now guarantee that it can continue selling its multiple sclerosis drug Gilenya without any generic competition in the US at least for the next two years.
The Swiss pharma giant announced that the US Court of Appeals has upheld a patent covering a dosing regimen of Gilenya, meaning a permanent injunction against the generic maker HEC Pharma will remain in place until that patent expires in December 2027.
Having reached settlement agreements with a number of abbreviated new drug application filers, precluding them from launching copycat versions of Gilenya, Novartis said HEC Pharma was the only remaining ANDA filer challenging the patent.
The potential generic entry date and other terms, it added, are confidential. — Amber Tong