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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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.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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