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Allogene (ALLO) Falls on FDA Clinical Hold on CAR-T Studies

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Allogene Therapeutics, Inc. (ALLO - Free Report) announced that the FDA has placed its clinical studies evaluating AlloCAR T-based cancer therapies on clinical hold. The decision was taken by the regulatory authority, following a report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II study — ALPHA2 — evaluating its next-generation, AlloCAR T candidate, ALLO-501A.

The FDA is currently reviewing the end of phase I materials submitted by the company to support the start of a pivotal phase II study on ALLO-501A. Meanwhile, the company is investigating the abnormality for further evidence of clinical relevance, evidence of clonal expansion, or potential relationship to gene editing. The company expects to provide additional updates from the study, especially on this abnormality, in the upcoming weeks, following consultation with the FDA.

Allogene is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. It has a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors. The FDA’s clinical hold should temporarily halt all its ongoing clinical studies, hurting the company’s prospects.

The clinical hold hurt investors’ sentiments that led to a decline of 32.7% in Allogene’s share price during after-hours trading on Oct 7. The company’s shares have declined 3.4% so far this year compared with the industry’s decrease of 12%.

Zacks Investment ResearchImage Source: Zacks Investment Research

The clinical hold was based on a single case in the ALPHA2 study in a patient with stage IV transformed follicular lymphoma whose disease was refractory to two prior lines of immune-chemotherapy and additional radiation therapy. Moreover, the patient was not able to receive an autologous CD19 CAR T cell therapy due to some manufacturing failure.

The company reported that the patient experienced complications following the administration of ALLO-501A, which required a course of high-dose steroid therapy. The patient developed progressive pancytopenia or low blood count subsequently. The company did a bone marrow biopsy and found the patient suffering from aplastic anemia and also detected the presence of ALLO-501A CAR T cells with the chromosomal abnormality. However, the company stated that the patient has achieved a partial response to the AlloCAR T therapy.

Apart from ALLO-501A, the company has three other AlloCAR T- based therapy candidates in its internal pipeline evaluating them in hematologic cancers. The company is sponsoring a phase I study (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The company continues to advance the phase I study (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). A phase I study, UNIVERSAL, is underway. The study is evaluating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ (SWTX - Free Report) investigational gamma secretase inhibitor.

While the CAR T space holds promise competition is stiff.  Earlier in the year, the FDA approved bluebird bio (BLUE - Free Report) /Bristol Myers Squibb’s (BMY - Free Report) CAR T cell immunotherapy, Abecma. Other approved CAR T cell therapies in the United States included Gilead’s Yescarta and Novartis’ Kymriah.

Zacks Rank

Allogene currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.