Positive phase Ib/II data sent shares of Tempest Therapeutics Inc. (NASDAQ:TPST) skyward to trade midday at $4.18, up $3.94, or 1,641%. The Brisbane, Calif.-based firm unveiled results from the planned data analysis of an ongoing global randomized study in which TPST-1120, Tempest’s oral selective peroxisome-proliferator activated receptor-alpha antagonist, showed clinical superiority on multiple study endpoints. The experiment combined TPST-1120 with Tecentriq (atezolizumab, Roche Holding AG) and Avastin (bevacizumab, Roche Holding AG) in a randomized comparison to the two approved drugs in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.

Novo’s CKD trial testing semaglutide stopped early for efficacy

Novo Nordisk A/S has halted its phase IIIb kidney outcomes trial testing GLP-1 drug semaglutide after the independent data monitoring committee concluded results from an interim analysis met efficacy criteria for stopping the trial early. The trial, called Flow, was designed as a randomized, double-blind, superiority study testing the 1-mg dose of injectable semaglutide vs. placebo as an adjunct to standard of care to see if the drug could delay progression of chronic kidney disease and lower the risk of kidney and cardiovascular mortality.

BioJapan 2023: Fear of failure at heart of Japan’s failure to deliver innovation

Insanity has often been defined as doing the same thing and expecting different results, and Japan seems to be trapped in that rut largely because it can’t seem to do innovation differently, said speakers at the BioJapan 2023 meeting held Oct. 11 in Yokohama, Japan. Japan has been steadily declining economically for the last three decades, said keynote speaker Tomoko Namba, founder and executive chairman of Dena Co. Ltd., one of Japan’s leading information technology companies. She attended Harvard University business school about 30 years ago, and at the time, 32 of the top 100 global companies were Japanese, and today one company made the list.

Biomap, Sanofi strike potential $1B+ deal to co-map AI drug discovery modules

Sanofi SA will pay $10 million up front and potentially $1 billion down the road to build artificial intelligence (AI) drug discovery modules with Biomap – the Silicon Valley-based biotech led by Chinese billionaire, software engineer and serial entrepreneur Robin Li known for founding China’s largest internet search engine and AI platform, Baidu, in 2000. Along with the French pharma giant’s up-front $10 million payout, the Menlo Park, Calif.-based Biomap stands to gain over $1 billion for hitting prespecified but undisclosed preclinical, clinical, regulatory and commercial milestones. Specific target indications were also not disclosed. Biomap and Paris-headquartered Sanofi aim to create advanced AI modules and large language models for protein drug discovery.

Confirmatory trials job one with US accelerated approval

As it continues its crackdown on accelerated approval grants, the FDA is making it clear that successfully completing confirmatory trials should be the top priority for sponsors of drugs that entered the U.S. market under accelerated approval. Toward that end, the agency scheduled a Nov. 16 meeting of its Oncologic Drugs Advisory Committee to consider next steps for two Acrotech Biopharma Inc. drugs, Folotyn and Beleodaq, which were both given accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma. The conversation will focus on delayed confirmatory trials and ways to decrease the time involved in verifying whether a drug with accelerated approval has clinical benefit.

Most-edited-ever donor genomes lead to 2-year survival in porcine-to-primate kidney transplants

Scientists at Egenesis Inc. have transplanted kidneys from genome-edited pigs into cynomolgus monkeys that remained functional for long periods after transplantation. The monkeys, whose own kidneys were removed during the surgery, survived for a median of 176 days after receiving one pig kidney. Maximal survival was just over 2 years. The data were published today in Nature. Egenesis CEO Mike Curtis told reporters that the study has achieved the longest survival to date “using clinically translatable immunosuppression … longer survival has been achieved using really aggressive immunosuppression that really isn’t clinically translatable.” He also noted that transplantation in a nonhuman primate (NHP) is “actually more challenging than doing the transplants in people.”

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