Sosei Heptares announced Wednesday morning that Pfizer dosed its first patient in a Phase II trial as part of their partnership on a GLP-1 agonist known as PF-07081532.
Sosei will get $10 million as a result of the drug progressing into a Phase II trial. The drug was discovered by Pfizer scientists but used Sosei’s discovery platform.
The Phase II trial will aim to test Pfizer’s drug in 780 participants with either Type 2 diabetes or obesity. For the Type 2 diabetes portion of the trial, aside from Pfizer’s drug and placebo, some patients will also be randomized to Novo Nordisk’s Rybelsus, a GLP-1 pill approved for Type 2 diabetes in 2019.
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The Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region. 
Demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having in Asia Pacific, according to the latest analysis from GlobalData in a new report titled State of the Global Biotech Landscape: Where the Opportunities Lie.
One of the pioneers of first-gen CAR T has now swooped in to buy a second-gen cell therapy player with some stellar scientific ties, impressive early responses and a clinical record that includes a high-profile blowup in the clinic that killed several patients.
Gilead sub Kite is putting out word today that it’s nailed down the buyout of Tmunity, a cell therapy spinout out of Penn that was derailed by lethal toxicity.
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Zymeworks is capping a rocky year with a committed partner.
After announcing it would dole out $50 million to become the second partner on Zymeworks’ HER2 bispecific, Jazz Pharmaceuticals was met with some questions from analysts around the financing engineering of the deal, particularly curious as to why the duo linked up before a crucial readout of the drug, known as zanidatamab.
But with a 41.3% objective response rate in a pivotal trial in biliary tract cancer earlier this week, the pair will march forward. Jazz is forking over $325 million to exclusively develop and commercialize zanidatamab in the US, Europe and Japan. If the collaborators make it to the end of the album, the payout could be $1.76 billion for Zymeworks, as well as tiered royalties between 10% and 20% on Jazz’s net sales. BeiGene holds the China, South Korea, Australia and New Zealand rights to the drug.
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Roche let the air out of the TIGIT party balloon with a pair of crushing Phase III failures. Now Gilead $GILD and Arcus $RCUS are back with details of their closely-watched Phase II data in Stage IV non-small cell lung cancer, hoping to spark some renewed enthusiasm for their contender and the rest of the field.
But despite some positive results in frontline therapy for patients with high PD-L1 levels, plus a claim on a potential “new standard of care,” the mid-stage readout from the ARC-7 study won’t end the running debate that has blighted expectations for the target.
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Madrigal Pharmaceuticals says its NASH drug, resmetirom, has met its early endpoints in a Phase III trial, marking a major success in a field littered with failures in recent years. Now, the company plans to submit for accelerated approval in the first half of next year, CEO Paul Friedman said in a statement.
The biotech’s stock $MDGL was up over 200% in pre-market trading, eclipsing the $200 mark. It had closed at just under $64 on Friday.
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Moderna has plucked a new commercial executive from the ranks at Merck as CEO Stéphane Bancel promises the company is in a “much better place” for 2023 Covid-19 vaccine deliveries.
Chantal Friebertshäuser is joining Moderna on Jan. 1 as senior vice president of commercial, where she’ll be responsible for efforts in Europe, the Middle East and Canada. Chief commercial officer Arpa Garay — who also spent years at Merck — touted a slate of vaccine contracts lined up for 2023 on Moderna’s recent Q3 call, including in Switzerland, Kuwait and Canada, with more to come.
On Jan. 26, the FDA’s vaccines adcomm will meet to discuss the future of Covid-19 booster shots and variant strain selection moving forward, and CBER Director Peter Marks yesterday previewed some of what will be discussed in that meeting.
As the bivalent booster uptake has stalled, particularly among children, Marks is now pointing to ways to simplify the process.
The VRBPAC adcomm won’t only look at what the composition of these Covid-19 vaccines should be, and what’s the timing for selecting new strains, but also how often strain selection should take place, he said, noting that the FDA is “trying to get to some sense of normalcy for how we treat vaccinations.”
Magenta Therapeutics has informed the FDA of two dose-limiting toxicities in the highest-dose group of its Phase I/II study. No more patients will be dosed in that cohort, the biotech said Tuesday.
The toxicities were found in two of three patients in that group, the company said. It has not identified any dose-limiting toxicities in the first three cohorts of the trial, which include 15 patients.
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The end has come for Otonomy, a California-based biotech that developed treatments for neurological conditions of the ear, after a series of failed trials.
The company announced on Monday it had fired all remaining employees on Dec. 15 and approved a liquidation and dissolution plan as the company winds down operations. The announcement comes just just two months after it said it would “explore strategic options,” a fancy way of saying it’s struggling and looking for a way out.
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