The U.S. FDA advised Agenus Inc. to conduct a phase III trial for its immunotherapy combination, botensilimab (bot) and balstilimab (bal), instead of seeking accelerated approval based on phase II data, sending company shares plunging by 58.8% July 18.
As the “most concrete achievement” since its entry into the radiopharmaceutical therapy space last year, SK Biopharmaceuticals Co. Ltd. picked up rights to Full-Life Technologies Ltd.’s RPT asset, FL-091, in a deal fetching up to $571.5 million.
Sotio Biotech AS and Biocytogen Pharmaceuticals Co. Ltd. are partnering to discover antibody-drug conjugates (ADCs) via an option and license agreement worth up to $325.5 million plus sales royalties. The deal grants Sotio of Prague, Czech Republic, the option to license multiple fully human bispecific antibodies generated with Biocytogen’s Renlite platform, which Sotio will use to develop next-generation ADCs targeting solid tumors.
Catalym GmbH has closed a $150 million series D to take its first in class immune potentiator visugromab into phase IIb development in a number of solid tumors. The round follows on the heels of data from a phase I/IIa trial which showed visugromab in combination with the PD-1 inhibitor antibody Opdivo (nivolumab, Bristol Myers Squibb) increased T-cell infiltration and generated durable antitumor responses in patients who had exhausted all other treatment options.
Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
India’s first indigenous CAR T therapy is selling at around $50,000 per shot, nearly one-tenth of the price of top-selling CAR Ts in the U.S., and Immunoact founder and CEO Rahul Purwar told BioWorld he anticipates bringing the price down to as low as $20,000 per shot.
Orum Therapeutics Inc. struck a potential $945 million (₩1.3 trillion) deal with Vertex Pharmaceuticals Inc. to discover novel degrader antibody conjugates (DAC) as targeted conditioning agents for use with gene editing, including Vertex’s gene therapy, Casgevy (exagamglogene autotemcel).
Two weeks after reporting positive top-line results in first-line head and neck cancer with its lead candidate, eftilagimod alfa, in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab), Immutep Ltd. presented updated data indicating the treatment could offer a non-chemotherapy option for patients with negative PD-L1 expression. Data from cohort B of the Tacti-003 (Keynote-PNC-34) phase IIb trial, which included 31 evaluable patients with PD-L1 expression of less than 1, as measured by Combined Proportion Score, showed a 35.5% objective response rate per RECIST 1.1 assessment.
New company Pan Cancer T BV is preparing for a clinical trial of a next-generation T-cell receptor-engineered T cell it has designed to remove the current barriers and make T-cell therapies effective in treating solid tumors. Its products have two distinguishing features: They are targeted at antigens the company has shown are exclusively and robustly expressed by multiple solid cancers, and have a minor genetic modification that enhances the durability of autologous TCR-Ts in the tumor microenvironment after they are administered back into a patient.
The lively antibody-drug conjugate (ADC) space chalked another collaboration as Taipei, Taiwan-based Foreseen Biotechnology Co. Ltd. scored a global licensing agreement worth as much as $1.03 billion with Ipsen SA, of Paris, for antibody-drug conjugate FS-001, which is said to bear first-in-class potential. The drug takes aim at a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis, the companies said.
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