Allogene Therapeutics

Advances in immunotherapy, including CAR T-cell therapy and bispecific antibodies, have significantly improved treatment for follicular lymphoma (FL), especially for relapsed patients. Axicabtagene ciloleucel (Yescarta) has shown durable remissions. DelveInsight's 'Follicular Lymphoma Pipeline Insight 2024' report highlights 50+ companies and 55+ therapies in development. Key companies include Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, and Johnson & Johnson Innovative Medicine. Promising therapies like Parsaclisib and TQ-B3525 are in various clinical phases. Recent developments include tafasitamab's Phase III success and collaborations for CAR-T therapies.

FDA issues Complete Response Letter for Applied Therapeutics' govorestat NDA for classic galactosemia, citing deficiencies in clinical study results. APLT plans to request a meeting with the FDA to discuss next steps. Shares dropped 77.3% post-announcement.

Replimune submitted a BLA to the FDA for RP1, in combination with Bristol Myers' Opdivo, for advanced melanoma. The filing is under the FDA's Accelerated Approval pathway, supported by positive IGNYTE study results. The FDA also granted Breakthrough Therapy designation to RP1 for advanced melanoma, contributing to a 19.4% stock rise.

At the 2022 ASH meeting, Stanford physicians and Foresight Diagnostics introduced a new MRD test for LBCL, detecting cancer cells undetectable by conventional methods. This led to the ALPHA3 trial, combining Allogene's CAR-T therapy with Foresight's MRD test to prevent LBCL relapse. The trial aims to use ultrasensitive MRD detection to identify high-risk patients for CAR-T treatment, potentially transforming cancer care by making advanced treatments more accessible in community settings.

DelveInsight's 2024 report on CAR T-Cell Therapy for Non-Hodgkin's lymphoma highlights 5+ companies developing 5+ therapies, including JCAR017, CB010, and BREYANZI. The report covers clinical trials, mechanisms of action, route of administration, and market dynamics, emphasizing Novartis's Rapcabtagene autoleucel and its reduced turnaround time.

ALLO-316, an allogeneic CD70-directed CAR-T therapy, showed responses in advanced RCC patients in the TRAVERSE trial, with 3 on-study deaths reported. The best ORR was 27% across 26 evaluable patients, and 76% with high CD70 TPS showed tumor burden decrease. Common AEs included CRS, fatigue, and neutropenia, with no cases of graft versus host disease. ALLO-316's potential marks a major advancement in RCC treatment, according to Allogene's CMO.

Allogene Therapeutics halts cema-cel trial enrollment due to slow recruitment and new treatment alternatives, shifting focus to other programs. The company maintains a robust cash balance and positive investor response, with significant progress in ALLO-316 and ALPHA3 trials.

Piper Sandler lowers Allogene Therapeutics' price target to $9 from $11, maintaining Overweight rating. Allogene halts ALPHA2 study enrollment due to slow recruitment, shifting focus to ALPHA3 trial and autoimmune programs. Despite net loss, Allogene's cash balance supports pipeline advancements, with ALLO-316 showing 50% response rate in renal cell carcinoma patients. InvestingPro data highlights Allogene's resilience and strategic financial decisions.

Artiva Biotherapeutics expands Board of Directors with Dr. Alison Moore, focusing on AlloNK® in autoimmune diseases. Initial data expected H1 2025. Cash reserves of $199.6 million fund operations through 2026.

ALLO-316 showed 50% overall response and 33% confirmed response in CD70-positive RCC patients with TPS >50% in the TRAVERSE trial. 76% of patients with TPS ≥50% had tumor burden reduction, and 33% of high TPS patients showed durable responses. ALLO-316 demonstrated a manageable safety profile with no graft-vs-host disease.