In line with this decision, the company will reduce its workforce to extend cash runway and prioritize the advancement of CRG-023 to Phase 1 proof-of-concept data as well as its novel allogeneic platform. Based on an ad hoc analysis of FIRCE-1 prompted by recent safety events, the company believes the results do not support a competitive benefit-risk profile of firi-cel for the intended patient population. While data from 51 patients with at least one post baseline scan demonstrated an overall response rate of 77% and complete response rate (CR) of 43%, the durability of CR at three months was 18%. Safety data indicated 18% of patients developed immune effector cell-associated hemophagocytic lymphohistiocytosis like syndrome (IEC-HS) that were grade 3 or higher, including grade 4 and grade 5 serious adverse events. IEC-HS is a toxicity that is associated with CAR T-cell therapy and firi-cel in other clinical studies. The company is implementing a workforce reduction of approximately 50% to preserve cash. Further, CARGO will continue to advance CRG-023, its tri-specific CAR T, into a Phase 1 dose escalation study and its allogeneic platform to lead vector candidate selection while evaluating its strategic options. With preliminary cash, cash equivalents and marketable securities of $368.1 million as of December 31, 2024, the company expects its cash runway to be extended into mid-2028.
DEALS AND FINANCING
Leveragen announced strategic collaboration with Moonlight Bio to Advance T Cell Therapies
Leveragen, a biotech company specializing in next-generation genetic models for antibody discovery, announced a strategic collaboration with Moonlight Bio, a biotech pioneering advanced T cell therapies. This partnership aims to develop cutting-edge T cell therapies to address some of the most challenging and difficult-to-treat cancers. The collaboration integrates Leveragen’s proprietary Singularity Sapiens Mouse platform, a groundbreaking tool for generating fully human single-domain antibodies, with Moonlight Bio’s expertise in T cell engineering. Together, the two companies seek to create T cell therapies with enhanced functionality, persistence, and efficacy, overcoming significant barriers in the treatment of solid tumors. Leveragen will spearhead the discovery of fully human single-domain antibodies against therapeutic targets and Moonlight Bio will oversee the preclinical development of T cell therapies. This collaboration highlights Leveragen’s leadership in single-domain antibody discovery and its commitment to advancing immunotherapy through innovative science and transformative applications.
CARsgen introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-Ts in China
CARsgen Therapeutics announced reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise to jointly invest in UCARsgen Biotech, a China-based new drug discovery biotechnology company focused on allogeneic CAR-T cell therapies for the treatment of hematologic malignancies. UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies. An investment fund managed by Zhuhai SB Xinchuang (currently undergoing registration and filing procedures) subscribed to the newly increased registered capital of UCARsgen for a consideration of RMB 80 million ($11 million), thus retaining an 8% equity stake in the registered capital of UCARsgen upon completion of the transaction, equity stake of CARsgen Therapeutics in UCARsgen will be diluted from 100% to 92%.
