In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. (BMS) in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. BMS is paying $55 million up front and making a $55 million equity investment in Prime. The biggest chunk of the money comes from more than $3.5 billion in milestones. Prime’s stock (NASDAQ:PRIME) had risen sharply at midday, with shares up 16% to $4.02 each. Other top deals this year are those worth $7.2 billion between Flaghsip Pioneering and GSK plc, $6 billion between Jiangsu Hengrui Medicine Co. Ltd. and Hercules CM Newco Inc., and $4.16 billion between Shanghai Argo Biopharmaceutical Co. Ltd. and Novartis Pharma AG.

Cereno’s HDAC inhibitor wins in hypertension phase IIa

Cereno Scientific AB disclosed positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension (PAH). The data show CS1 is safe, well-tolerated, and has a positive impact on parameters such as risk, functional class and hemodynamics, the Gothenburg, Sweden-based firm said. CS1 deploys a reformulation of valproic acid and acts as an epigenetic modulator with anti-thrombotic, anti-inflammatory, anti-fibrotic, and pressure-relieving properties in PAH. Shares (STO:CRNO-B) were trading at SEK8.40 (US83 cents), up SEK1.40, or 20%.

Alphamab and JMT-Bio ink $439M antibody-drug conjugate China deal

Jiangsu Alphamab Biopharmaceuticals Co. Ltd. is out-licensing its anti-HER2 bispecific antibody-drug conjugate (ADC), JSKN-003, to JMT-Bio Technology Co. for China rights in a deal worth up to ¥3.08 billion (US$439 million) plus sales royalties. Under the license, JMT-Bio gains exclusive rights to develop and commercialize JSKN-003 for the treatment of tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). JMT-Bio will bear all clinical development costs and becomes the sole marketing authorization holder for JSKN-003 in mainland China. Alphamab retains the right to supply the ADC for any purpose within or outside mainland China.

Kezar halts lupus trial of zetomipzomib on four fatalities

South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of its immunoproteasome inhibitor zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events (SAEs) of patients enrolled in the Philippines and Argentina. The company’s phase IIa Portola trial in autoimmune hepatitis remains active with no grade 4 or 5 SAEs observed to date. Zetomipzomib, also known as KZR-616, is the company’s lead drug and lupus nephritis is the lead program. Nevertheless, the company’s shares (NASDAQ:KZR) moved upward Sept. 30, rising by 37%, or 20 cents, to 75 cents in midday trading.

Apimeds prices $11.5M IPO for bee venom-based therapy

Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange (NYSE) with its S-1 filing showing a targeted offering of $11.5 million. Apimeds’ lead asset is Apitox, approved as Apitoxin in South Korea. Apitox is a purified, pharmaceutical grade, intradermally administered bee venom of the Apis mellifera, or western honeybee, which is classified by the U.S. FDA as an active pharmaceutical ingredient. “We believe that naturalized bee venom can provide an additive treatment, [currently] pending clinical demonstration of success and U.S. FDA approval, and provide value to osteoarthritis patients in need … and potentially multiple sclerosis,” Seoul-based Apimeds Korea said in a statement.

BioWorld Insider podcast: Capricor’s CEO pursues a BLA and talks rare disease

Capricor Therapeutics Inc. just wrapped up a visit with the U.S. FDA and is prepping to file a BLA in October for its Duchenne muscular dystrophy treatment. Linda Marbán, Capricor’s CEO, is the guest on the newest BioWorld Insider podcast and she talks about deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating the rare disease and how the FDA has made strong efforts in helping lay the groundwork for deramiocel. Marbán has been working on the Duchenne treatment for many years and she has strong insights into how to tackle a rare disease development program and how the FDA has changed its ways over time to help out. She has been in the biopharma space for more than 20 years and also is a co-founder of Capricor.

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