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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.
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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Allogene (ALLO) CAR T Therapy for Myeloma Gets FDA RMAT Tag
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.
Allogene Therapeutics, Inc. Price
Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote
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.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 3 crypto-related stocks now >>