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Allogene's (ALLO) AlloCAR T Therapy ALLO-715 IND Gets FDA Nod

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Allogene Therapeutics, Inc. (ALLO - Free Report) announced that the FDA has cleared an investigational new drug (IND) application for its BCMA AlloCAR T therapy candidate, ALLO-715. The IND application sought clearance for initiation of a study to evaluate ALLO-715 in combination with SpringWorks Therapeutics’ (SWTX - Free Report) late-stage gamma secretase inhibitor candidate, nirogacestat, in patients with relapsed or refractory (r/r) multiple myeloma (MM).

Allogene will start evaluation of the combination regimen by adding a new cohort in the ongoing phase I study — UNIVERSAL. Based on the pre-clinical data on nirogacestat, Allogene believes that addition of nirogacestat to ALLO-715 may enable deeper and more durable responses in MM patients.

Please note that Allogene entered into a clinical collaboration with SpringWorks in January this year to develop this combination regimen as novel treatment option for MM patients.

The UNIVERSAL study is evaluating ALLO-715 in combination with ALLO-647 in patients with r/rMM. Allogene utilizes ALLO-647, its monoclonal antibody candidate, as part of its differentiated lymphodepletion regimen in clinical studies. Initial data from the study on this combination regimen is expected by year-end.

Allogene’s shares have gained 7.3% so far this year compared with the industry’s increase of 9.9%.

Apart from ALLO-715, Allogene has three other CAR T cell product candidates in early-stage of development — UCART19, ALLO-501, ALLO-501A.

The company is evaluating ALLO-501 in a phase I study — ALPHA — in patients with r/r non-Hodgkin lymphoma. Initial data from the study demonstrated an overall response rate of 75% and a complete response rate of 44% in CAR T naïve patients. The company initiated a phase I/II study on next-generation, AlloCAR T candidate, ALLO-501A, during the second quarter of 2020.

The company has an exclusive collaboration with Servier to develop and commercialize UCART19. Two phase I clinical studies sponsored by Servier are evaluating the candidate in pediatric and adult patients with r/r B-cell precursor acute lymphoblastic leukemia.

Please note that Allogene acquired certain assets from Pfizer (PFE - Free Report) including strategic license and collaboration agreements and other intellectual property related to the development and administration of allogeneic CAR T cells for the treatment of cancer in 2018.

Zacks Rank & Stock to Consider

Allogene currently has a Zacks Rank #3 (Hold).

Repligen Corporation (RGEN - Free Report) is a better-ranked stock from the biotech sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Religen’s earnings per share estimates have increased from $1.42 to $1.66 for 2022 in the past 60 days. The company delivered an earnings surprise of 37.36%, on average, in the last four quarters. The stock has surged 112.9% so far this year.

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