JW Therapeutics announced that the NMPA of China has approved the NDA for its anti-CD19 autologous CAR-T cell immunotherapy product relmacabtagene autoleucel injection for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and has released the drug registration certificate. Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally. The product was independently developed based on a CAR-T cell process platform of Juno Therapeutics to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted Priority Review and Breakthrough Therapy designations (in follicular lymphoma).
NMPA approved China’s first independently developed CAR-T therapy Relma-cel
CLINICAL
Poseida gains proof of concept for its solid tumor CAR-T
One year after a patient death was reported in its Phase I prostate cancer study, Poseida is providing some of the strongest evidence to date — from the same trial — that CAR T cells may work in solid tumors. At the CAR-TCR Summit virtual meeting, Poseida Therapeutics Inc. presented preliminary Phase 1 data for P-PSMA-101 in metastatic castration-resistant prostate cancer showing that the PSMA-targeting CAR T cell therapy led to complete tumor elimination in one of the nine treated patients and measurable declines in PSA levels in four others. Three of the heavily pretreated patients, who received a median of six prior therapies, achieved more than a 50% reduction in PSA levels with concordant improvements on PSMA-PET imaging. Investors were hoping for more. Though over half of the patients in the study achieved some level of PSA decline, the preliminary data don’t put the solid tumor CAR-T on a trajectory to deliver the near 100% response rates achieved by some CAR-T therapies in hematological malignancies.
TCR2 Therapeutics’ stock falls on its gavo-cel safety concerns
The latest data for mesothelin-targeted gavo-cel from TCR2 Therapeutics has investors concerned that the next-generation TCR cell therapy may not improve on the safety of other T cell therapies as hoped. All three mesothelioma patients treated at the highest dose experienced severe cytokine release syndrome and one had grade 5 bronchoalveolar hemorrhage, leading to its assignment as the maximum tolerated dose. A patient in the lowest dose cohort also experienced Grade 3 pneumonitis. Despite safety concerns, four of 16 patients with mesothelin-expressing solid tumors achieved a partial response for an ORR of 25% and a disease control rate of 81%. TCR’s TRuC T platform fuses a TCR’s tumor antigen recognition domain rather than the full TCR to a T cell’s surface to avoid HLA restriction. TCR2 stock was off 36% after the announcement.
DEALS AND FINANCING
Bluebird secures $75 million ahead of separation into two companies
Preparing for its spin out of oncology company 2seventy, bluebird bio raised $75 million in a private placement through the sale of 2.3 million shares at $16.50 and warrants to purchase 2.3 million shares at $16.49 to support the pipelines of both companies. Bluebird and 2seventy are expected to be independent in October, at which time they expect to have $900 million of cash on hand in addition to the $75 million just raised. The investor was reported to be a healthcare investment fund selected as part of a competitive process. Last month, bluebird announced it was winding down European operations due to reimbursement challenges with its β thalassemia therapy. The company’s stock has fallen 67% over the past year. The stock ended the week at $17.88, leaving the company with a market cap of $1.2 billion.
Aganus’ NK T cell therapies subsidiary MiNK is seeking NASDAQ listing
MiNK Therapeutics, the subsidiary of Agenus, set up to develop allogeneic invariant natural killer T cell therapies, has filed for an IPO on NASDAQ. Formerly known as AgenTus, the company expects data next quarter from a Phase 1 study of lead program AGENT-797 to treat multiple myeloma, as well as a trial to treat acute respiratory distress syndrome secondary to COVID-19. MiNK is planning additional studies in solid tumors and graft-versus-host disease, with a potential path to accelerated approval in the former indication. Agenus holds 80.6% of MiNK’s equity. Garo Armen, who is MiNK’s chairman and Agenus’ chairman and CEO, has 10.5%.
