Allogene (ALLO) Focuses on Pipeline Amid Lack of Marketed Drugs
Allogene Therapeutics, Inc. ALLO has no marketed drug in its portfolio. The company is primarily focused on the development and commercialization of genetically engineered allogeneic CAR T (AlloCAR T) therapies for the treatment of cancer.
The company has six pipeline candidates in the early stage of development, including five CAR T cell product candidates — ALLO-501, ALLO-501A, ALLO-605, ALLO-316 and ALLO-715 — and a monoclonal antibody (mAB), ALLO-647.
In January 2022, Allogene announced that the FDA removed the clinical hold on all five AlloCAR T therapies after the agency concluded from its investigations that the chromosomal abnormality discovered in one of the company’s study participants was not related to Allogene’s manufacturing process or the TALEN gene-editing technology and had no clinical significance. The FDA placed the hold last October based on a report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II ALPHA2 study evaluating its next-generation AlloCAR T candidate, ALLO-501A.
Allogene’s most advanced product candidates are ALLO-501 and ALLO-501A, which have been designed to target CD19 protein that is expressed on the cell surface of B-cells. ALLO-501 is being evaluated in a phase I APLHA study for r/r non-Hodgkin lymphoma (NHL) subtypes. A second-generation version of ALLO-501, ALLO-501A, is also being developed for NHL in a phase I/II ALPHA2 study.
In December 2021, Allogene shared interim data from the ALPHA study and phase I portion of the ALPHA2 study at the Annual American Society of Hematology meeting, which showed that there were no relapses in CAR T naïve patients with large B cell lymphoma (LBCL) for six months following treatment with either of the candidates. Based on these results, ALLO is planning to start a pivotal phase II portion of the ALPHA2 study in mid-2022, which will evaluate ALLO-501A in patients with r/r LBCL. Allogene is currently finalizing the clinical design of the study with the FDA.
Apart from NHL, the company is also developing engineered AlloCAR T therapy candidates for multiple myeloma (MM), clear cell renal cell carcinoma (ccRCC) and other cancer indications.
Allogene is evaluating ALLO-715 in the phase I UNIVERSAL study targeting B-cell maturation antigen in adult patients with r/r MM. The candidate is also being evaluated in combination with SpringWorks Therapeutics’ SWTX investigational gamma secretase inhibitor (GSI), nirogacestat, in the UNIVERSAL study. Similar to ALLO-501, ALLO-605 is a second-generation version of ALLO-715 that is also being evaluated in r/r MM in the IGNITE study. Allogene intends to provide an update on both ALLO-715 and ALLO-605 by 2022-end.
Please note that nirogacestat is SpringWorks’ most advanced product candidate. SWTX is currently evaluating this GSI inhibitor as a monotherapy in the phase III DeFi study in patients with desmoid tumors. SpringWorks anticipates reporting top-line data from the DeFi study in first-half 2022.
Allogene’s first CAR-T candidate for solid tumors, ALLO-316, is being evaluated in a phase I TRAVERSE study for ccRCC. The mAB candidate, ALLO-647, is part of the lymphodepletion regimen, which is likely to increase the potency of AlloCAR T therapies.
Although there are a few CAR T therapies approved by the FDA, the market for CAR T therapies has not evolved like other immunotherapies (like PD-1/PD-L1 inhibitors). In fact, there are no approved allogenic CAR T therapies in the United States yet. Also, allogenic CAR T therapies likely hold an edge over autologous CAR T therapies, given the latter’s manufacturing limitations.
To make up for the lack of marketed products in its portfolio, the company has entered into many agreements with different companies like Pfizer PFE and Cellectis CLLS to accelerate the growth and development of its pipeline. While these collaborations have boosted Allogene’s pipeline growth, we note that they also result in a significant cash burn for the company. ALLO continues to undergo such cash burns in anticipation of a potential regulatory approval and successful commercialization of its pipeline candidates.
Allogene acquired certain assets from Pfizer in 2018 related to the development and administration of allogeneic CAR T cells to treat cancer. In return, Pfizer is eligible to receive aggregate potential regulatory and development milestones totaling up to $840 million from the company.
ALLO has an exclusive worldwide license from Cellectis for its TALEN gene-editing technology to develop AlloCART product candidates directed against 15 different cancer antigens. In return, Cellectis is eligible to receive potential development and sales milestone payments of up to $2.8 billion from Allogene.
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