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EMA’s CHMP recommended marketing authorization for CAR-T Carvykti cilta-cel

Sotio Biotech

15/5/2022 | 3 minutes to read

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Janssen and Legend’s Carvykti headed for approval in Europe after nod from regulators

Legend Biotech announced that the CHMP of the EMA recommended Janssen’s marketing authorization of Carvykti (cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Data from the ongoing pivotal CARTITUDE-1 study supported the positive CHMP opinion. Two-year follow-up results were presented at ASH 2021.

First clinical data for Lava’s γδ and iNKT-engaging bispecific at ESMO

Lava Therapeutics said its lead bispecific antibody LAVA-051 induced dose-dependent receptor occupancy and activation of the Vγ9Vδ2 subset of γδ T cells without dose-limiting toxicities or cytokine release syndrome in the first three European cohorts of the company’s Phase I/IIa study. The data were presented at the 2022 ESMO Targeted Anticancer Therapies Congress. The Dutch company is developing LAVA-051, which targets CD1D and engages both Vγ9Vδ2 T cells and iNKT cells, for CD1d-expressing hematological cancers; in October, FDA granted the compound orphan drug designation for treatment of CLL. At least six other companies have launched first-in-human studies of γδ T cell-based cancer therapies in the past three years, and recent clinical readouts have been adding to the space’s momentum.


NEC OncoImmunity acquired Vaximm’s neoantigen vaccine development assets

NEC OncoImmunity and Vaximm announced that the companies have signed an agreement under which NOI will acquire all of Vaximm’s neoantigen program assets. NOI will acquire Vaximm’s neoantigen vaccine-related patents, license the requisite manufacturing patents, and will take over several existing contracts with key collaborators and partners. Financial terms of the agreement have not been disclosed. In 2019, the companies entered into a strategic clinical trial collaboration agreement and an equity investment agreement to develop   novel   personalized   neoantigen  cancer vaccines. VAXIMM retains rights to its first-in-class oral T-cell activation platform technology and all other product candidates, including VXM01, which is being developed for the treatment of glioblastoma.

Triumvira completed series A financing bringing $100 million

Triumvira Immunologics completed a series A extension that brings the round’s total funding to about $100 million and will advance clinical and preclinical development of its T cell therapy platform for solid tumors. The platform involves a T cell Antigen Coupler technology; the therapies have a similar antigen binding domain as a CAR, but signal through the endogenous TCR complex to preserve natural activation and inhibition pathways. New investors B Capital Group, ATEAM Capital and the Myeloma Investment Fund joined existing investors Leaps by Bayer and Northpond Ventures in the extension round. With the funding, Widya Mulyasasmita of B Capital joined the board.

2seventy bio has secures $170 million in PIPE financing

Cell therapy company 2seventy bio raised $170 million through the sale of 13.9 million shares at 12.20. Investors participating in this private placement include 683 Capital, Armistice Capital, Bain Capital Life Sciences, Boxer Capital, CaaS Capital, Casdin Capital, Cowen Healthcare Investments, EcoR1 Capital, Heights Capital, Janus Henderson Investors, Madison Avenue Partners, Newtyn Management, Nick Leschly & family, RTW Investments, LP, and existing investors.

Affini-T Therapeutics completed oversubscribed financing raising $175 million

Affini-T Therapeutics announced the completion of an oversubscribed $175 million financing co-led by Vida Ventures and Leaps by Bayer, the impact investment unit of Bayer. Additional investors participating in the round include Humboldt Fund, The Parker Institute for Cancer Immunotherapy, Catalio Capital Management, Agent Capital, Alexandria Venture Investments, Erasca Ventures, Fred Hutchinson Cancer Research Center and other leading blue chip life science investors. With proceeds from this financing, the company will operationalize its platform discovery engine and seek to drive multiple oncogene driver programs into the clinic while pursuing complementary technology licenses to bolster its cell therapy platform.

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