Atara Biotherapeutics(US:ATRA)2022-05-06 03:59Tab-cel® Program - Atara submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for tab-cel® in November 2021, with potential European Commission (EC) approval anticipated in Q4 2022[10, 34] - Phase 3 ALLELE study data presented at ASH 2021 demonstrated a 50% Objective Response Rate (ORR) across Hematopoietic Cell Transplant (HCT) and Solid Organ Transplant (SOT) cohorts[38] - In responders from the Phase 3 ALLELE study, the Overall Survival (OS) at 1 year was 100% for HCT and 82.5% for SOT[38] - Atara received an upfront payment of $45 million and is eligible to receive up to ~$320 million in milestones, plus tiered royalties from Pierre Fabre for commercializing Tab-cel® in Europe, Middle East, Africa, and other select emerging markets[52] ATA188 Program - Up to ~1.2 million Multiple Sclerosis (MS) patients worldwide have a progressive form of the disease (PMS)[23, 64] - A longitudinal analysis identified Epstein-Barr Virus (EBV) as the required trigger for multiple sclerosis, with the risk of MS increasing 32-fold after EBV infection[75] - Atara is planning for two Phase 3 randomized pivotal studies focused on non-active progressive MS, with the primary endpoint of confirmed EDSS (Expanded Disability Status Scale) improvement at 12 months[74, 107, 109] CAR T Portfolio - Atara received $60 million in cash upon signing and is eligible to receive up to $610 million in development, regulatory, and commercial milestone payments, plus tiered royalties up to low double-digit percentage of net sales from Bayer for the mesothelin CAR T program (ATA3271) and autologous program (ATA2271)[137] - In an Investigator Sponsored Trial (MSKCC), 83% (5/6) of R/R B-ALL, NHL and CLL patients had durable Complete Response (CR) with median follow up of 26.9 months after receiving partially HLA matched EBV CD19 CAR T cells manufactured from third-party donors[145] - ATA3271 IND Submission is expected in Q4 2022[22, 138, 142]