San Francisco-based Allogene Therapeutics (NASDAQ:ALLO) reported favorable results from its dose escalation phase 1 alpha study of ALLO-501, a potential treatment for patients with non-Hodgkin lymphoma (NHL).
Of the 19 patients that were evaluated for efficacy, seven complete responses (CR) and five partial responses (PR) were observed for an overall response rate (ORR) of 12 out of 19, or 63% of patients. The responses were observed across all cell doses and tumor types including diffuse large B-cell lymphoma and follicular lymphoma.
ALLO-501 is Allogene’s anti-CD19 therapy candidate and is based on technologies developed by French biopharmaceutical company Cellectis. The company, which is working on the study with global biotech company Servier Pharmaceuticals, presented the results during the American Society of Clinical Oncology Meeting on May 29th.
Allogene develops allogeneic CAR T-cell (AlloCAR T) therapies for the treatment of cancer. It has a pipeline of CAR T-cell product candidates that are designed to deliver on-demand cell therapy at a greater scale.
Three-fourths of patients remain in response
All patients reached at least 1-month of assessment for the efficacy portion of the analysis. Nine of the 12 patients remained in response as of the May 2020 data cutoff and the median follow-up period was 3.8 months. A higher ORR of 75% was observed in 16 chimeric antigen receptor (CAR) T-cell naïve patients.
ALLO-501 was used in combination with ALLO-647, the company’s monoclonal antibody (mAb) targeting CD52 antigen. The lymphodepletion regimen was well tolerated by the study’s participants as there was an absence of dose-limiting toxicities, graft-versus-host disease (GVHD), or immune effector cell-associated neurotoxicity syndrome (ICANS). Another promising aspect of the study was that higher CR rates were observed in patients that received a higher dose of ALLO-647.
President and CEO Dr. David Change commented, “We are very pleased with these initial phase 1 results which indicated that ALLO-501 and ALLO-647 were well tolerated and produced complete responses in patients with advanced NHL. Based on these results, we believe we are on the right trajectory to make AlloCAR T therapy a reality for patients.”
Although additional analysis of the data will be necessary, the patient response to the therapy and safety profile of the phase 1A study are encouraging. Allogene has initiated a phase 1 trial for its ALLO-501A drug candidate and hopes to move forward to phase 2 development later this year or early next year.
If the therapy continues to progress it has the potential to address a much broader patient population. The American Cancer Society has estimated that more than 77,000 Americans will be diagnosed with Non-Hodgkin lymphoma this year.
Shares of Allogene moved nearly 10% higher on the day of the announcement. The mid cap stock is already up around 74% in 2020. The company is scheduled to report second quarter performance on August 5th.