Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Alx, Eloxx, Epimab, Moderna, Nextcure, NGM, Nrx, Opiant, Stratatech, Tetherex, Trevena, Xenon.
A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.
Getting cell therapies to work against solid tumors is proving difficult – but two biopharma firms have begun early-stage studies with technologies that aim to crack this tough nut. Gadeta B.V. and Apeiron Biologics AG are using two different approaches to cell therapy that they hope will be effective against tough-to-treat solid tumors.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Athira, Boehringer Ingelheim, Clover, Eiger, Eli Lilly, Hutchmed, Innate, Longeveron, Marker, Trillium, Ysopia.
In a new chapter for the ongoing story of sodium glucose transporter-2 inhibitor (SGLT2) inhibitors, Boehringer Ingelheim International GmbH and Eli Lilly and Co.'s Jardiance (empagliflozin) has become the first therapy of the class to significantly reduce the risk of cardiovascular death or hospitalization vs. placebo for heart failure patients with preserved ejection fraction (HFpEF). The finding comes from the phase III Emperor-Preserved study, which tested once-daily Jardiance 10 mg vs. placebo in nearly 6,000 adults living with HFpEF, with and without diabetes.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arrowhead, Gan and Lee, J&J, Krystal, Nicox, Philogen, Rallybio, Roche, Sab, Transcenta, Zydus.
Arrowhead Pharmaceuticals Inc. said it voluntarily paused a phase I/II study of its RNAi candidate for treating cystic fibrosis (CF) out of an “abundance of caution” while considering its next steps. “This may delay our pulmonary program a bit, but it’s just part of drug development,” said Christopher Anzalone, Arrowhead’s CEO. The halt was prompted by signals of local lung inflammation found in an ongoing chronic toxicology study in rats.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
As confirmed cases and deaths from COVID-19 continue their downward slide, biopharma research efforts remain front and center, providing a new therapeutic for emergency use in the U.S. and high-efficacy phase III data for what could become the country’s fourth vaccine and its first protein subunit option.
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