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Allogene Therapeutics, Inc. (Nasdaq: ALLO) is a clinical-stage biotechnology company focused on the development and commercialization of allogeneic chimeric antigen receptor T-cell (AlloCAR T™) therapies for cancer and autoimmune diseases. Leveraging the expertise of former Kite Pharma executives, Allogene aims to revolutionize cancer treatment with innovative off-the-shelf CAR T solutions. These therapies, derived from healthy donor cells, provide a scalable and readily available option, eliminating the lengthy and complex process of personalized cell therapy.
The company's portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy in phase 1 development for acute lymphoblastic leukemia (ALL). Notable core programs target various malignancies such as lymphoma, leukemia, solid tumors, and autoimmune diseases. Among its leading investigational products is cemacabtagene ansegedleucel (cema-cel), currently undergoing pivotal phase 2 ALPHA3 trials for large B-cell lymphoma (LBCL) and phase 1 trials for relapsed/refractory chronic lymphocytic leukemia (CLL). ALLO-316, aimed at renal cell carcinoma (RCC), and ALLO-329, targeting autoimmune diseases with Dagger® technology, further strengthen Allogene's robust pipeline.
Allogene collaborates with leading biotech firms like Foresight Diagnostics and Arbor Biotechnologies to enhance its clinical development capabilities. Recent achievements include strategic partnerships and a $15 million grant from the California Institute for Regenerative Medicine (CIRM) supporting the development of ALLO-316. Financially, Allogene reported a strong cash runway extending into 2026, with latest funding rounds ensuring continued support for its R&D initiatives.
Stay informed on Allogene's progress as it drives the future of allogeneic CAR T therapy, providing broader patient access and more efficient cancer treatment options.
Allogene Therapeutics reported Q3 2024 financial results and provided updates on key programs. The company ended Q3 with $403.4 million in cash and investments, projecting runway into 2H 2026. Key highlights include: Phase 2 ALPHA3 trial of cema-cel in LBCL continuing with enrollment completion expected in 1H 2026; ALLO-316 showing 50% overall response rate in RCC patients with CD70 TPS ≥50%; and plans for ALLO-329 IND filing in Q1 2025 for autoimmune diseases. Q3 net loss was $66.3 million, with R&D expenses at $44.7 million and G&A expenses at $16.3 million.
Allogene Therapeutics presented positive Phase 1 TRAVERSE trial data for ALLO-316 in treating advanced renal cell carcinoma (RCC). The trial showed a 50% overall response rate and 33% confirmed response rate in patients with CD70 Tumor Proportion Score ≥50%. Among 39 enrolled patients, 26 were CD70 positive and evaluable for efficacy. The treatment demonstrated a manageable safety profile, with cytokine release syndrome being the most common adverse event. The FDA granted RMAT designation to ALLO-316 for advanced or metastatic RCC treatment. Additional data from the Phase 1b expansion cohort is expected in mid-2025.
Allogene Therapeutics will present new data from its Phase 1 TRAVERSE trial for ALLO-316, an off-the-shelf AlloCAR T™ therapy targeting CD70-positive renal cell carcinoma (RCC), at the International Kidney Cancer Symposium and SITC Annual Meeting. The presentations will showcase data from 26 heavily pretreated patients and include details on managing treatment-associated hyperinflammatory responses.
The FDA granted RMAT designation to ALLO-316 in October 2024, recognizing its potential to address unmet needs in adult patients with advanced RCC who have failed standard therapies. The ongoing TRAVERSE trial demonstrates ALLO-316's ability to elicit responses from a single infusion, suggesting a breakthrough in allogeneic CAR T therapy for solid tumors.
Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotech company focused on developing allogeneic CAR T products for cancer and autoimmune disease, has announced its participation in two major investor conferences in November. The company will present at the Stifel 2024 Healthcare Conference on November 18 at 5:35AM PT and the Jefferies London Healthcare Conference on November 20 at 10:00AM GMT. Webcasts will be available on the company's website for approximately 30 days after the events.
Allogene Therapeutics (ALLO), a clinical-stage biotech company focused on allogeneic CAR T products, will release its Q3 2024 financial results on November 7, 2024, after market close. The company will host a conference call and webcast at 2:00 p.m. PT/5:00 p.m. ET on the same day. Interested parties can access the webcast through the company's website, with a replay available for approximately 30 days. Those wishing to ask questions during the call must register to receive a personal PIN for access.
Allogene Therapeutics announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for treating adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC). The designation was based on clinical data from the TRAVERSE trial, showing potential in treating patients who failed multiple standard RCC therapies. ALLO-316 utilizes the Dagger® technology as a next-generation allogeneic platform for single-infusion 'off-the-shelf' CAR T therapy. The company will present updated Phase 1 data at the upcoming SITC annual meeting. ALLO-316 previously received Fast Track Designation in March 2022.
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, has announced its participation in the Goldman Sachs Cell Therapy Day Conference. The event is scheduled for October 1, 2024 in New York.
Allogene will be part of a panel discussion centered on innovations in the allogeneic cell therapy landscape. The panel is set to take place at 10:00 AM PT/1:00 PM ET. A webcast of the discussion will be available on the company's website at www.allogene.com under the Investors tab in the News and Events section. The replay will remain accessible for approximately 30 days after the live webcast.
Allogene Therapeutics (Nasdaq: ALLO) will present pre-clinical data for ALLO-329, its next-generation investigational AlloCAR T candidate for autoimmune indications, at the ACR Convergence 2024. ALLO-329 is a CD19/CD70 dual AlloCAR T product designed to target both B-cells and T-cells implicated in autoimmune diseases. It utilizes CRISPR-based site-specific integration and incorporates the Dagger® technology to potentially reduce or eliminate the need for lymphodepletion.
The company aims to address challenges in CAR T therapy for autoimmune diseases by making it available off-the-shelf and potentially reducing chemotherapy conditioning. Allogene plans to file an IND application in Q1 2025 and expects proof-of-concept by year-end 2025.
Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, has announced its participation in two upcoming investor conferences:
1. Canaccord Genuity 44th Annual Growth Conference on Tuesday, August 13, 2024, at 7:00 AM PT/10:00 AM ET
2. Baird 2024 Global Healthcare Conference on Wednesday, September 11, 2024, at 7:15 AM PT/10:15 AM ET
Webcasts, if available, will be accessible on the company's website at www.allogene.com under the Investors tab in the News and Events section. Replays will be available for approximately 30 days after the live webcasts.
Allogene Therapeutics reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Initiation of pivotal Phase 2 ALPHA3 trial for cema-cel in 1L LBCL consolidation, with enrollment completion expected in 1H 2026 and potential BLA submission in 2027.
2. ALLO-329 IND application for autoimmune diseases on track for Q1 2025, with proof-of-concept data expected by YE 2025.
3. ALLO-316 Phase 1 TRAVERSE data update in RCC planned for YE 2024.
4. Q2 2024 ended with $444.6M in cash, cash equivalents, and investments, with runway projected into 2H 2026.
5. Q2 2024 net loss of $66.4M, or $0.35 per share.
6. 2024 guidance unchanged, expecting a decrease in cash of ~$200M and GAAP Operating Expenses of ~$300M.
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