CLINICAL AND REGULATORY
Abecma from BMS shows survival benefit in earlier multiple myeloma
KarMMa-3 is the first randomized clinical trial to evaluate a CAR T cell therapy in multiple myeloma. Results of a pre-specified interim analysis conducted through an independent review committee showed that KarMMa-3 met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. Follow-up for overall survival, a key secondary endpoint, remains ongoing. Safety results in the trial were consistent with the well-established and predictable safety profile of Abecma previously demonstrated in the pivotal KarMMa trial. No new safety signals were reported in this study.
Beam announced FDA clinical hold on BEAM-201 IND application
Beam Therapeutics announced that the company was informed via e-mail communication from the FDA that the BEAM-201 IND application for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia and T cell lymphoblastic lymphoma has been placed on clinical hold. BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic CAR-T development candidate. The BEAM-201 IND was submitted at the end of June. The FDA indicated they will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA.
DEALS AND FINANCING
Zelluna Therapeutics announced investment from Takeda Ventures
Zelluna Immunotherapy announced an investment from Takeda Ventures, the strategic investing arm of Takeda. TVI investment joins Zelluna’s latest financing round. The funds will enable the advancement of a lead TCR-NK product through manufacturing to Clinical Trial Application and IND application readiness and, continue the advancement of Zelluna’s platform with additional programs reaching the preclinical stage. TCR-NK products are a novel and proprietary class of allogeneic cell therapies that combine the inherent, pan-cancer killing mechanism, efficiency, and the allogeneic nature of NK cells with the targeting capabilities of TCRs. Arming NK cells with TCRs may unlock the potential to treat a wide range of currently untreatable cancers.
Bennu raised $20 million in angel round to advace T cell therapy platform
China-based Bennu Biotherapeutics (Shanghai) raised a $20 million “angel+” round to advance its T cell therapy platform and pipeline. The financing was led by INCE Capital, with participation from Beijing Life Science Park Innovation Investment Fund and Witruth Capital. Bennu was founded in 2021 by Chen Dong of Tsinghua University and is backed by Hillhouse Venture Capital, CD Capital and other institutions.
3T Bio raised $40 million in Series A to develop its T cell receptor platform
3T Biosciences raised $40 million in a series A funding round to take forward a platform for identifying novel T-cell receptors and their targets, which is based on the work of scientific co-founder K. Christopher Garcia of Stanford University. Westlake Village Biopartners led the round. Lightspeed Partners also participated. The company is marrying deep knowledge of the biology of T-cell recognition and activation with expertise in robotics and machine learning, which enables it to probe the whole area at scale.
Elevate nad Boston Children’s Hospital launch cell therapy play
A newly launched company from ElevateBio, George Daley and Boston Children’s Hospital will develop allogeneic immune cell therapies based on a platform developed in Daley’s lab that generates functionally mature immune cells from induced pluripotent stem cells. The announcement of the as-yet-unnamed company coincides with a paper in Cell Stem Cell unveiling the platform. The company is the first to emerge from a deal between Boston Children’s and ElevateBio.