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Allogene (ALLO) Begins Phase II Study on Allogeneic CAR T Therapy
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Allogene Therapeutics, Inc. (ALLO - Free Report) recently announced that it has initiated the pivotal phase II ALPHA2 study evaluating its allogeneic CAR T (AlloCAR T) therapy, ALLO-501A for treating patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL).
The study is designed to support the ease and convenience of a single dose of ALLO-501A in a given patient population.
Per the company, the above-mentioned study is the industry’s first potentially pivotal phase II study on an AlloCAR T product.
The primary endpoint of the ALPHA2 study is to check the objective response rate. The study will enroll around 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. s
The FDA granted Regenerative Medicine Advanced Therapy designation to ALLO-501A for treating patients with r/r LBCL in June 2022.
Shares of Allogene have declined 26.6% so far this year compared with the industry’s decrease of 25.3%.
Image Source: Zacks Investment Research
Along with the press release, ALLO announced that it is also looking to initiate a separate potentially registrational study, EXPAND, which will evaluate its anti-CD52 monoclonal antibody, ALLO-647.
The EXPAND study intends to demonstrate the safety of ALLO-647 and its contribution to the standard fludarabine/cyclophosphamide lymphodepletion regimen.
The company expects data from the ALPHA2 and the EXPAND studies to support regulatory approval of both ALLO-501A and ALLO-647, respectively.
Allogene’s other CAR T cell product candidates are ALLO-501, ALLO-605, ALLO-316 and ALLO-715. All of these are in the early stage of development, targeting various types of cancer indications.
Allogene currently has no approved products in its portfolio. Hence, in the absence of a marketed drug, pipeline development remains in key focus for the company.
Achilles Therapeutics’ loss per share estimates narrowed 7.4% for 2022 and 9.5% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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Allogene (ALLO) Begins Phase II Study on Allogeneic CAR T Therapy
Allogene Therapeutics, Inc. (ALLO - Free Report) recently announced that it has initiated the pivotal phase II ALPHA2 study evaluating its allogeneic CAR T (AlloCAR T) therapy, ALLO-501A for treating patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL).
The study is designed to support the ease and convenience of a single dose of ALLO-501A in a given patient population.
Per the company, the above-mentioned study is the industry’s first potentially pivotal phase II study on an AlloCAR T product.
The primary endpoint of the ALPHA2 study is to check the objective response rate. The study will enroll around 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. s
The FDA granted Regenerative Medicine Advanced Therapy designation to ALLO-501A for treating patients with r/r LBCL in June 2022.
Shares of Allogene have declined 26.6% so far this year compared with the industry’s decrease of 25.3%.
Image Source: Zacks Investment Research
Along with the press release, ALLO announced that it is also looking to initiate a separate potentially registrational study, EXPAND, which will evaluate its anti-CD52 monoclonal antibody, ALLO-647.
The EXPAND study intends to demonstrate the safety of ALLO-647 and its contribution to the standard fludarabine/cyclophosphamide lymphodepletion regimen.
The company expects data from the ALPHA2 and the EXPAND studies to support regulatory approval of both ALLO-501A and ALLO-647, respectively.
Allogene’s other CAR T cell product candidates are ALLO-501, ALLO-605, ALLO-316 and ALLO-715. All of these are in the early stage of development, targeting various types of cancer indications.
Allogene currently has no approved products in its portfolio. Hence, in the absence of a marketed drug, pipeline development remains in key focus for the company.
Zacks Rank & Stocks to Consider
Allogene currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Achilles Therapeutics plc (ACHL - Free Report) , Atara Biotherapeutics, Inc. (ATRA - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 7.4% for 2022 and 9.5% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.