Johnson & Johnson announced positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating Carvykti (cilta-cel) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.
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Carvykti achieved statistically significant improvement in OS in CARTITUDE-4
CLINICAL AND REGULATORY
Carvykti achieved statistically significant improvement in overall survival in CARTITUDE-4
The interim analysis showed a statistically significant and clinically meaningful improvement in OS for patients treated with Carvykti versus standard therapies. Safety data were consistent with the approved label. Updated results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
Lyell revealed strong response rates, but reported death in early-stage CAR-T trial
Lyell Immunopharma announced initial clinical and translational data from its Phase 1 trial of LYL797, its first-generation reprogrammed ROR1 CAR T-cell product candidate enhanced with proprietary anti-exhaustion technology. The initial dataset consists primarily of patients with triple-negative breast cancer (TNBC) and demonstrated dose-dependent antitumor clinical activity and the ability of LYL797 CAR T cells to proliferate, infiltrate tumors and kill cancer cells in patients with relapsed or refractory disease. Patients with TNBC treated with LYL797 had an ORR of 40 % and clinical benefit rate (CBR) of 60% at the 150 x 106 CAR T cell dose level, with a CBR of 38% across all dose levels evaluable to date. Common treatment-related adverse events in patients without lung metastases included Grade 1 and 2 cytokine release syndrome (CRS) and headache, and the expected cytopenia from lymphodepletion. There were no reports of immune effector cell-associated neurotoxicity syndrome (ICANS) attributed to LYL797. Pneumonitis occurred in patients with lung metastases and dose escalation is continuing separately and more gradually in those patients. No dose-limiting toxicities have been reported in patients without lung involvement. All patients are now receiving prophylactic steroids prior to LYL797 treatment. One patient died of respiratory failure in the study, however the company said it has not definitively linked the fatality to the treatment.
DEALS AND FINANCING
Nona Biosciences enters into collaboration with Alaya.bio to advance CAR-T cell therapy
Nona Biosciences has entered into a collaboration agreement with Alaya.bio to precisely target and reprogram cells in situ and thus to significantly simplify the way CAR-T cell therapies in particular are being developed, manufactured and administered. This collaboration aims to leverage Nona's proprietary HCAb Harbour Mice platform and its newly introduced site-specific conjugation technology, alongside Alaya.bio's polymeric in situ delivery platform, to develop CAR-T product candidates for potential clinical applications. Nona's fully human HCAbs are revolutionizing antibody discovery with their compact size, simplified structure, and precisely calibrated binding properties, making them ideal for next-generation biotherapeutics. Nona's novel site-specific conjugation technology preserves the antibody's binding and function, thereby enhancing the specificity of Alaya.bio's novel polymeric delivery systems while reinforcing the versatility of the platform. Nona will provide Alaya.bio with access to antibodies against multiple targets as potential targeting moieties for Alaya.bio's in vivo CAR program. In the second phase of the collaboration, Alaya.bio will nominate one or more binders that will be conjugated onto their polymeric nanoparticles in a site-specific manner using Nona's site-specific conjugation technology to advance Alaya.bio's CAR product candidate towards clinics.
Innovent and IASO Bio enahnce strategic collaboration in cell therapy
Innovent Biologics and IASO Biotechnology jointly announced the agreement on a series of cooperation, including IASO Bio's purchase from Innovent regarding its relevant right of Fucaso (equecabtagene autoleucel) and obtaining license from Innovent regarding the intellectual property related to Fucaso, as well as Innovent's equity investment in IASO Bio. According to the agreement, IASO Bio will purchase Innovent's relevant rights of Fucaso under the original "BCMA CAR-T Cell Therapy Cooperation Agreement" at the agreed price and Innovent will use the proceeds to acquire an 18% stake in IASO Bio. Under the new strategic cooperation framework, the parties will achieve high-level integration in the field of cellular immunotherapy. IASO Bio obtains global commercial rights and the IP license for Fucaso and will be fully responsible for development, manufacturing and commercialization of the product, while Innovent becomes a strategic shareholder of IASO Bio.