SOUTH SAN FRANCISCO, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced an expanded strategic collaboration with Foresight Diagnostics, Inc. to include the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) for treatment wit ...

Core Insights - Allogene Therapeutics has published data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel) for relapsed/refractory large B-cell lymphoma, marking a significant advancement in allogeneic CAR T therapy [1][2] Study Overview - The ALPHA/ALPHA2 studies were single-arm, multicenter, open-label, Phase 1 trials involving 87 heavily pretreated patients with relapsed/refractory non-Hodgkin lymphoma treated between May 2019 and September 2022 [3] - The focus was on 33 CD19 CAR T-naive patients who received cema-cel manufactured for pivotal studies [3] Efficacy Results - The overall response rate (ORR) was 58% and the complete response (CR) rate was 42% across the study, with the pivotal study regimen achieving ORR and CR rates of 67% and 58% respectively [4][5] - Among patients achieving CR, the median duration of response (DOR) was 23.1 months, with median overall survival (OS) not reached [4][5] Safety Profile - The safety profile was manageable and consistent with approved autologous CD19 CAR T therapies, with no cases of graft-versus-host disease (GvHD), immune effector cell-associated neurotoxicity syndrome (ICANS), or high-grade cytokine release syndrome (CRS) reported [4][5] - Common treatment-emergent adverse events included neutropenia (85%), anemia (67%), and infusion-related reactions (58%) [6] Treatment Timing - The median time to treatment initiation was two days from enrollment, significantly shorter than the typical wait times for autologous CAR T therapies [6] Low Disease Burden Potential - In patients with low disease burden, the CR rate was 100% for those with baseline tumor burden <1000 mm² and 82% for those with normal lactate dehydrogenase levels, indicating cema-cel's promise in treating minimal residual disease (MRD) [7] Foundation for Future Trials - The ongoing ALPHA3 trial is evaluating cema-cel as a consolidation therapy for LBCL patients in remission but positive for MRD, aiming to predict and intervene before relapse [8][9] - The ALPHA3 trial is designed to establish cema-cel as a potential standard "7th cycle" of frontline treatment for patients with MRD following initial therapy [11] Product Information - Cemacabtagene ansegedleucel (cema-cel) is an investigational anti-CD19 AlloCAR T™ product, which received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for relapsed/refractory LBCL [10]

Efficacy Comparable to Approved Autologous CD19 CAR Ts: Achieved Overall Response (ORR) and Complete Response (CR) Rates of 58% and 42% Across the Study and 67% and 58% with Pivotal Study Regimen, RespectivelyDurability of Response: Among Patients Who Achieved CR, Median Duration of Response (DOR) of 23.1 Months and Median Overall Survival (OS) Not ReachedManageable Safety Profile Consistent with Approved Autologous CD19 CAR T: No Graft-versus-Host Disease (GvHD), Immune Effector Cell-Associated Neurotoxici ...

SOUTH SAN FRANCISCO, Calif., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that it will participate in one upcoming investor conference in February. Oppenheimer 35th Annual Healthcare Life Sciences ConferenceWednesday, February 1212:20PM PT/3:20PM ET Any available webcasts will be posted to the Company's website at www.a ...

SOUTH SAN FRANCISCO, Calif., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that Benjamin M. Beneski has been promoted to Senior Vice President and Chief Technical Officer (CTO). Mr. Beneski succeeds Tim Moore, who will be stepping down at the end of February after two years with the Company. Mr. Moore’s impactful career ...

Dual-Targeted CD19/CD70 Allogeneic CAR T: Best-in-Class Design to Enhance Therapeutic Benefit and Expand Treatment Potential Across a Range of Autoimmune Disease IndicationsInnovative Dagger® Technology: Empowers ALLO-329 to Overcome Rejection, Potentially Reducing or Eliminating Reliance on Traditional LymphodepletionPhase 1 RESOLUTION Rheumatology Basket Trial: Initiation Planned for Mid-2025, Targeting Proof-of-Concept to Demonstrate Allogeneic Potential and the Dagger® Effect on Lymphodepletion by Year- ...

Industry Overview - The biotech sector experienced a volatile performance in 2024, starting positively but facing declines in the second half due to disappointing third-quarter results, guidance cuts, pipeline setbacks, and the appointment of Robert F. Kennedy Jr. as head of Health and Human Services [1] Company Summaries Immunocore Holdings (IMCR) - IMCR is focused on developing TCR bispecific immunotherapies, with Kimmtrak being the first FDA-approved immunotherapy for metastatic uveal melanoma, generating $226 million in sales in the first nine months of 2024, a 32% year-over-year increase [3] - Despite strong sales growth, IMCR's stock has dropped 58% year to date due to perceived risks in pipeline development, particularly concerning brenetafusp's efficacy beyond cutaneous melanoma [12] - Analysts expect a significant upside for IMCR in early 2025 with anticipated positive updates on an investigational HIV therapy and ongoing late-stage studies for Kimmtrak [13] Allogene Therapeutics (ALLO) - ALLO is developing allogeneic CAR T therapies for cancer treatment, with a strategic pivot that has delayed the initial market introduction of its lead drug cema-cel to 2027 [6] - The stock has declined 35% year to date, but loss per share estimates for 2025 have improved from $1.45 to $1.34 [7][15] - ALLO is also exploring CAR-T therapies for multiple myeloma and renal cell carcinoma, with plans to initiate a study for lupus by early 2025 [16] Day One Biopharmaceuticals (DAWN) - DAWN focuses on therapies for pediatric cancer, with its drug Ojemda being the only systemic therapy for pLGG in the U.S., generating over $28 million in revenue in the first nine months of 2024 [8][17] - The company is conducting a pivotal late-stage study for Ojemda and has two other investigational candidates in its pipeline [9] - DAWN's stock has decreased over 13% year to date, but loss per share estimates for 2025 have improved from $2.03 to $0.99 [10]

Investors might want to bet on Allogene Therapeutics (ALLO) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a cha ...

The year 2024 has been a mixed ride for the biotech industry. It started on a positive note, attracting investors’ attention in areas with great commercial potential, like obesity, immunology and gene therapy.However, their interest started to wane in the second half of the year amid lower-than-expected third-quarter results, guidance cuts and pipeline setbacks. While Wall Street viewed Trump’s victory as an accelerant for M&A activity in the sector, the President-elect’s decision to nominate vaccine skepti ...

SOUTH SAN FRANCISCO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene, will present at the 43rd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco. 43rd Annual J.P. Morgan Healthcare Conferen ...