A series of severe cases of cytokine release syndrome forced Austin, TX-based Mirna Therapeutics to shut down a Phase I study of its lead microRNA drug, MRX34. Mirna also opted not to start another study until it can analyze the situation. Their shares $MIRN cratered in the news, dropping 23%. “We made the difficult decision to close the study after a fifth, immune-related serious adverse event was recently reported by one of our clinical sites,” noted CEO Paul Lammers. “This patient experienced severe (Grade 4) cytokine release syndrome and is undergoing treatment. We have notified the U.S. FDA and the Korean FDA of our decision and are in the process of closing the trial.”
Cambridge, UK-based Artios Pharma is launching with a $33.2 million venture round led by SV Life Sciences. The biotech is run by Niall Martin, an experienced PARP player, who is focused on advancing drugs that derail the natural DNA repair mechanisms in place that can allow cancer to spread. The company in-licensed two DDR programs from Cancer Research Technology and plans to advance the first into the clinic with the A round.
Kite Pharmaceuticals, one of the leaders of the CAR-T development race, has forged a licensing deal with the NIH covering TCR drugs for KRAS mutated antigens. The deal paves the way to clinical studies, which Kite says will get underway this year. “Kite has taken an important step toward building the first therapeutic franchise of its kind for cancers driven by KRAS mutations and has further expanded its efforts in building a TCR portfolio across key classes of antigens, including cancer testis and viral antigens,” said Kite CEO Arie Belldegrun.
Zafgen’s shares were buoyed after the Boston-based biotech said it had begun dosing patients in a Phase I study of ZGN-1061. The biotech’s lead weight drug imploded in a late stage study recently, forcing the company to start over with a preclinical next-gen therapy.
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