CLINICAL AND REGULATORY
CARsgen leverages investigator-led study to advance solid tumor CAR-T
CARsgen reported interim results of investigator-initiated trial of CT041 were reported in the Nature Medicine. The Phase 1 results of CLDN18.2-specific CAR-T in gastrointestinal cancers are from a multi-center, open-label trial conducted in China to explore the safety, efficacy and cellular pharmacokinetics of CT041 in patients with CLDN18.2-positive advanced gastrointestinal cancers. The study results showed that among 37 patients with advanced gastrointestinal cancers, CT041 was well tolerated with a manageable safety. ORR and DCR in patients with gastrointestinal cancers were 48.6% and 73%, respectively, and ORR and DCR in patients with gastric cancer reached 57.1% and 75%, respectively.
Caribou announced positive initial data for CB-010 anti-CD19 allogeneic CAR-T
Caribou Biosciences announced initial results demonstrating a 100% overall response rate (ORR) and 80% complete response rate (CR) in cohort 1 (n=5 evaluable) from its ANTLER Phase 1 trial for CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). These initial data are scheduled to be shared at EHA congress. Caribou reported that a low dose of CB-010 led to an ORR of 100% in the first five relapsed or refractory NHL patients. Four of the patients (80%) achieved a complete response in the Phase 1 ANTLER study. The patients received a median of three prior lines of treatment.
CRISPR Therpauetics announced presentation of new clinical data of CTX130
CRISPR announced that an abstract providing safety and efficacy data from the ongoing CTX130 clinical trial for patients with T-cell lymphoma has been accepted for oral presentation at EHA 2022. In an abstract released ahead of the meeting, CRISPR reported that CTX130 led to ORR of 71% and a CR rate of 29% among seven patients with peripheral or transformed cutaneous T-cell lymphoma in the Phase 1 COBALT-LYM study. Across the four dose levels tested, which included 15 patients treated with a median of three prior lines, ORR was 47%, CR was 20%, and 73% of patients achieved disease control.
Adicet Bio shows early efficacy for γδ CAR-T therapy
Adicet reported updated data from Phase 1 of ADI-001 showing a 67% ORR and complete response complete in six non NHL patients. The allogeneic anti-CD20 γδ CAR T cell therapy was well tolerated.
DEALS AND FINANCING
Bayer returning rights to Atara’s mesothelin CAR-T program
Atara announced that it received notification of Bayer’s intention to end the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies. The collaboration included the funding and development of ATA3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer. Upon termination of the agreement in September 2022, the rights and licenses granted by Atara to Bayer under the collaboration will be returned to Atara, and Atara will have full rights to continue the clinical development and future commercialization of its programs worldwide. Atara will continue to support the ongoing ATA2271 Phase 1 study, which is being conducted by Memorial Sloan Kettering Cancer Center who has voluntarily paused enrollment of new patients in the study on a temporary basis. Atara and MSK expect to provide a Phase 1 data update for ATA2271 in H2 2022. Atara will also continue to lead IND-enabling studies and process development for ATA3271.
Inceptor Bio announced $37 million Series A financing
Inceptor Bio, a biotech advancing cell therapies for difficult-to-treat cancers, announced the closing of a $37 million Series A financing led by Kineticos Ventures. Proceeds from the Series A financing will be used to advance Inceptor Bio’s CAR-T lead program to Phase 1 trial and continue development of its CAR-M and CAR-NK platforms. Inceptor’s CAR-T, CAR-M, and CAR-NK platforms are at the center of a diversified portfolio of cell therapies focused on novel mechanisms that enhance cell performance in the tumor microenvironment.
Engimmune raised $17 million in seed financing to develop novel T-cell receptor therapeutics
Engimmune Therapeutics, a Swiss biotech developing novel T-cell receptor-based therapeutics, announced the completion of a CHF 15.5 million ($16.7 m) seed financing, co-led by Pureos Bioventures and Novo Holdings. Engimmune addresses major efficacy and safety challenges that currently limit the full potential of TCR-T cell and soluble TCR therapies. Engimmune’s lead products are focused on oncology, with potential to expand to autoimmune diseases in the future.