Core Insights - Allogene Therapeutics is advancing its allogeneic CAR T therapy, cema-cel, showing promising results in treating relapsed/refractory large B-cell lymphoma (LBCL) and aiming to surpass autologous CAR T therapies in accessibility and patient reach [2][6][7] Program Updates - The pivotal Phase 2 ALPHA3 trial for cema-cel in LBCL has 40 sites activated and is designed to improve event-free survival (EFS) in patients with minimal residual disease after standard treatment [3][4] - The ALPHA3 trial will enroll approximately 240 patients, with efficacy analyses expected in 2026 and a potential biologics license application (BLA) submission targeted for 2027 [5][6] - The company has received FDA clearance for the ALLO-329 trial in autoimmune diseases, with trial initiation expected in mid-2025 and proof-of-concept data anticipated by year-end 2025 [9][10] - ALLO-316 has shown significant anti-tumor activity in advanced renal cell carcinoma (RCC), with data from the Phase 1b cohort expected in mid-2025 [11][12] Financial Results - As of December 31, 2024, the company reported a net loss of $257.6 million for the year, with a cash position of $373.1 million, projected to fund operations into the second half of 2026 [15][16][22] - Research and development expenses for Q4 2024 were $45.0 million, while general and administrative expenses were $15.5 million [16][22] - The company expects a decrease in cash reserves of approximately $170 million in 2025, with total operating expenses projected at $250 million [15][22]

Conference Call and Webcast Scheduled for March 13, 2025 at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., March 03, 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 report the fourth quarter and full year 2024 financial results and provide a business update on March 13, 2025, after the close of the market. The ...

Allogene Therapeutics, Inc. (NASDAQ: ALLO ) is pioneering the development of allogeneic chimeric antigen receptor T-cells (CAR-Ts) for the treatment of cancer and autoimmune diseases. In other words, Allogene is genetically modifying immune cells (T-cells), obtained from healthy donors, inOriginally a Biologist, M.Sc in Biomedicine, PhD in Bioengineering, with +20 years experience in the research and development of novel Cell & Gene Therapies (CGT) tackling several clinical needs. As an investor, I have bee ...

SOUTH SAN FRANCISCO, Calif., Feb. 26, 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 March. TD Cowen 45th Annual Health Care ConferenceWednesday, March 5, 20258:20AM PT/11:50AM ET Any available webcasts will be posted to the Company's website at www.allogene.com unde ...

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- ...