MedPath

Allogene Therapeutics Halts Enrollment in Leukemia Trial Cema-Cel Due to Slow Recruitment

• Allogene Therapeutics stopped enrolling patients in its Phase 1 trial of cemacabtagene ansegedleucel (cema-cel) for relapsed or refractory chronic lymphocytic leukemia (CLL). • The decision was driven by slower-than-expected recruitment, influenced by the emergence of new treatment options for CLL patients. • Allogene is reallocating resources to other ongoing programs, focusing on advancing its broader pipeline of innovative therapies. • Despite halting enrollment, Allogene maintains a strong cash balance and is progressing with other trials, including the ALPHA3 trial for large B cell lymphoma.

Allogene Therapeutics, Inc. (NASDAQ: ALLO) has ceased patient enrollment in the Phase 1 clinical trial cohort evaluating cemacabtagene ansegedleucel (cema-cel) for treating relapsed or refractory chronic lymphocytic leukemia (CLL), effective Monday. The decision comes as recruitment rates lagged expectations, influenced by the increasing availability of alternative treatments for this patient population.

Strategic Shift

According to the company's recent 8-K filing with the Securities and Exchange Commission, this strategic shift allows Allogene to optimize resource allocation towards other ongoing programs. While investigators showed strong interest and recognized the need for additional treatment options for CLL patients who have undergone BTKi and BCL2i therapies, the company is prioritizing its broader pipeline.

Ongoing Programs and Financial Stability

Allogene remains focused on developing innovative therapies and advancing its pipeline. H.C. Wainwright recently maintained a Buy rating on Allogene, with a steady price target of $9.00, following encouraging data from the TRAVERSE trial, which explores ALLO-316 in treating adult patients with CD70+ advanced renal cell carcinoma, showing promising results with a 38% objective response rate. The company's ALPHA3 trial for cema-cel, which targets large B cell lymphoma, is progressing with over half of the sites activated.
In the Third Quarter 2024 Earnings Call, Allogene disclosed a net loss of $66.3 million but maintains a robust cash balance of $403.4 million, expected to extend into the second half of 2026. ALLO-316 has also demonstrated a 50% best overall response rate in renal cell carcinoma patients, and the company is preparing for an IND filing for ALLO-329, targeting autoimmune diseases, expected in Q1 2025.

Financial Insights

Allogene's market capitalization stands at $570.31 million. InvestingPro Tips highlight that Allogene is "quickly burning through cash" and "not profitable over the last twelve months," which may have influenced the decision to reallocate resources. However, Allogene "holds more cash than debt on its balance sheet," and "liquid assets exceed short term obligations," suggesting financial stability to support strategic pivots. The company's operating income margin is -1,222,168.18% for the last twelve months as of Q3 2024.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Apollomics' Uproleselan Fails Phase 3 Trial in Relapsed/Refractory AML

Apollomics' Phase 3 trial of uproleselan in China did not meet its primary endpoint, showing no significant benefit in overall survival for patients with relapsed or refractory AML.
The median overall survival in the uproleselan arm was 9.3 months, compared to 14.3 months in the chemotherapy-only arm, indicating a potential detriment with the addition of uproleselan.

Relmada Therapeutics Halts REL-1017 Depression Trials, Explores Strategic Alternatives

Relmada Therapeutics discontinues Phase 3 trials (RELIANCE II and RELIGHT) of REL-1017 for depression after unfavorable data monitoring committee evaluation.
The company will continue Phase 1 study of REL-P11, a psilocybin derivative, for treating metabolic diseases, shifting focus from CNS to metabolic disorders.

Halozyme Abandons Evotec Acquisition, Neurogene Trial Faces Setback, Argenx Advances Myositis Program, and Kyowa Kirin Licenses Kura Oncology's Leukemia Drug

Halozyme withdrew its $2.1 billion offer to acquire Evotec after the latter declined to engage in acquisition talks, despite Halozyme's repeated attempts to initiate discussions.
A patient in Neurogene's Rett syndrome gene therapy trial died due to complications from a hyperinflammatory syndrome, a known risk associated with AAV-delivered gene therapies.

Allogene Pauses Cema-Cel Trial Enrollment, Prioritizes Other Programs

Allogene Therapeutics halts new patient enrollment in the Phase 1 ALPHA2 study of cema-cel for relapsed/refractory Chronic Lymphocytic Leukemia (r/r CLL) due to slow enrollment.
Piper Sandler reduces Allogene's price target to $9, excluding cema-cel revenue in CLL from its valuation model, while maintaining an Overweight rating.

Allogene Therapeutics Advances AlloCAR T Pipeline in Oncology and Autoimmune Diseases

Allogene's ALPHA3 trial for cema-cel in large B-cell lymphoma is actively enrolling, potentially integrating CAR T into first-line treatment.
ALLO-316 demonstrated a 50% overall response rate in heavily pretreated renal cell carcinoma patients, earning FDA's RMAT designation.

2Seventy Bio Halts Abecma Trial Amid Evolving Multiple Myeloma Treatment Landscape

2Seventy Bio has stopped enrolling patients in the Phase 3 KarMMa-9 study evaluating Abecma in newly diagnosed multiple myeloma patients with suboptimal responses to stem cell transplants.
The decision aims to save $80 million and help 2Seventy Bio achieve financial breakeven next year, following a $27 million operating loss in the second quarter.

Ultimovacs Discontinues Patient Recruitment in Phase II Lungvac Trial for NSCLC

Ultimovacs ASA halts patient recruitment for the LUNGVAC trial due to slow enrollment attributed to evolving NSCLC treatment options.
The Phase II trial investigated UV1 cancer vaccine combined with checkpoint inhibitors (cemiplimab or pembrolizumab) as first-line NSCLC treatment.

Acelyrin Shifts Focus to Thyroid Eye Disease Drug, Halts Further Investment in Izokibep

Acelyrin will discontinue development of izokibep for hidradenitis suppurativa and psoriatic arthritis despite positive trial data, due to strategic prioritization.
The company will now focus on lonigutamab, an experimental antibody treatment for thyroid eye disease, advancing directly to Phase 3 trials.

Relyvrio Fails Phase 3 Trial, Amylyx Considers Market Withdrawal

Amylyx Pharmaceuticals' Relyvrio failed to demonstrate significant benefit in the Phase 3 PHOENIX trial for ALS, raising concerns about its efficacy.
The trial did not meet its primary endpoint of improving ALS functional scale or secondary endpoints like quality of life and overall survival.

Reference News

[1]
Allogene halts enrollment in leukemia trial By Investing.com
investing.com · Nov 15, 2024

Allogene Therapeutics halts cema-cel trial enrollment due to slow recruitment and new treatment alternatives, shifting f...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy