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Allogene (ALLO) CAR T Therapy for Myeloma Gets FDA RMAT Tag

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Allogene Therapeutics, Inc.’s (ALLO - Free Report) CAR T cell product candidate — ALLO-715 — has been given Regenerative Medicine Advanced Therapy (“RMAT”) designation by the FDA for treating relapsed/refractory multiple myeloma (r/rMM).

The RMAT designation was created under the 21st Century Cures Act. It is granted to speed up the development and review of regenerative therapies that target serious or life-threatening conditions. The designation was bestowed on ALLO-715 due to its potential to address the growing unmet need in heavily pre-treated r/rMM patients.

Allogene’s shares have gained 39.2% this year so far against the industry’s decrease of 3.7%.

Please note that the company is currently evaluating ALLO-715 in a phase I study — UNIVERSAL — as a potential treatment for r/rMM. Initial data from the study presented in December demonstrated treatment with ALLO-715, an allogeneic CAR T therapy directed at BCMA achieved clinical response and also eliminated the need for bridging therapy and delays associated with autologous CAR T manufacturing. Data from the study also showed that higher the dose, higher was the response rate.

Allogene is also evaluating ALLO-715 in combination with SpringWorks Therapeutics’ (SWTX - Free Report) late-stage candidate, nirogacestat, as a potential treatment for r/rMM as part of the UNIVERSAL study.

Apart from ALLO-715, the company has three other pipeline candidates in early-stage of clinical development, including three CAR T cell product candidates — ALLO-501 and ALLO-501A— and a monoclonal antibody (mAB), ALLO-647. Please note that the company utilizes ALLO-647 as part of its differentiated lymphodepletion regimen in clinical studies evaluating ALLO-501 or ALLO-715.

The company plans to announce updated and initial data from two phase I studies — ALPHA and ALPHA2 — evaluating ALLO-501 and ALLO-501A, respectively, in the second quarter. It intends to start a pivotal, phase II study on ALLO-501A, subject to positive data and regulatory approvals. Please note that ALLO-501A is the second-generation version of ALLO-501, which is designed to potentially target more patients compared to ALLO-501.

The company is likley to have initiated a phase I study on its first CAR T candidate for solid tumors, ALLO-316, in the first quarter. Meanwhile, the FDA cleared an investigational new drug (“IND”) application for initiation of a clinical study to evaluate first anti-BCMA TurboCAR T cell therapy, ALLO-605, in r/rMM earlier this month.

Although the company’s pipeline candidates are in early- to mid-stage studies, the candidates hold potential as they primarily target oncology indications with high unmet need.

Zacks Rank

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

A couple of better-ranked stocks from the biotech sector include Avid Bioservices, Inc. (CDMO - Free Report) and Immunome, Inc. (IMNM - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Avid’s earnings per share estimates have moved north from 5 cents to 9 cents for 2021 in the past 30 days. The company delivered an earnings surprise of 100.42%, on average, in the last four quarters. The stock has risen 73.6% so far this year.

Immunome’s loss per share estimates have narrowed from $1.53 to $1.46 for 2021 in the past 30 days. The stock has surged 181.5% so far this year.

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