Momentum is building at Jnana Therapeutics Inc. The firm has raised $107 million in a series C round and banked another $50 million up front from a new drug discovery and development pact with Roche Holding AG, which could potentially deliver significant near-term milestones and more than $2 billion in future milestone payments. It also commenced recruitment onto a first-in-human study of its lead drug candidate, JNT-517, an inhibitor of the phenylalanine transporter SLC6A19, which is in development for phenylketonuria.

CG Oncology nabs a $120M series E to develop oncolytic bladder cancer treatments

CG Oncology Inc. has closed an oversubscribed $120 million series E financing to continue developing bladder cancer treatments. The company just reported data from a phase II study testing CG-0070, an intravesically delivered oncolytic immunotherapy, combined with Keytruda (pembrolizumab, Merck & Co. Inc.) showing 88% of patients had a complete response at three months of treatment. CG said it plans to widen its pipeline to address other urologic cancer treatments, including a first-line setting in Bacillus Calmette-Guérin-naïve, intermediate-risk, non-muscle invasive bladder cancer. CG, renamed in 2020, is the former Cold Genesys Inc. The round was co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corp., Ally Bridge Group and Sirona Capital.

Akeso’s Ivonescimab scores third breakthrough therapy designation for NSCLC from China’s NMPA

China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy. The move marks the third breakthrough therapy designation for AK-112 for NSCLC, and it is the only drug candidate granted that status for PD-(L)1-resistant lung cancer treatment in China.

Bio/nonprofit deals slow, grants pick up, in 2022’s second half

The number of biopharma deals with nonprofit or government entities has dwindled in recent months, while industry grants are climbing. Combined, however, a total of 936 bio/nonprofit deals and grants worth $11.17 billion is down by 37% in comparison with last year’s $17.8 billion and by 58.7% in comparison with 2020’s $27 billion. The volume also is down significantly by 16.8% from 2021 and by 33.4% from 2020. The drop is a wider gap than was seen last month, but it is mostly attributable to 26.6% fewer bio/nonprofit deals, as grants are up 5% over last year.

Neuroscience 2022: ‘Strawberries’, ‘cabbages,’ fats in neuronal mitochondria

Neurons are specialized cells with a high metabolic demand to fulfill their function, survive or keep a healthy half-life. In this sense, the anabolism and catabolism of proteins and lipids could be associated to different neurodegenerative diseases. At the 2022 annual meeting of the Society for Neuroscience, scientists reported the latest discoveries on neuron metabolic needs at a session on “Powering Thoughts: The Regulation of Neuronal Energy Metabolism and Mitochondria.”

Ambiguity a sticking point for industry in FDA’s computer software assurance draft 

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe, which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful.

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