SQZ Biotechnologies Company, focused on unlocking the full potential of cell therapies, announced that, according to RECIST 1.1 criteria, a confirmed complete response was observed in the first patient in the lowest-dose cohort of the Phase 1 SQZ-AAC-HPV-101 clinical trial. The company has decided to continue to enroll patients in the SQZ-AAC-HPV-101 clinical trial. The second and third patients have also been enrolled in the trial. The company has completed the dose-limiting toxicity period for the lowest-dose cohort. The Study Safety Committee has completed their review and recommends that the company enroll patients in the highest-dose cohort. The company anticipates initial clinical data from the highest-dose cohort by the fourth quarter of 2023.
“Although early in this trial, we have observed good tolerability among the patients. The confirmed complete response observed in this patient demonstrates the potential of the investigational therapy’s intended immunotherapy mechanism,” said Richard T. Maziarz, M.D., Professor of Medicine and Investigator, Oregon Health & Science University.
“We are motivated by the clinical response in our first patient in the AAC trial,” said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. “We find it encouraging that the confirmed complete response occurred in our lowest-dose cohort. It is still early days, but we are optimistic as we look to enroll additional patients and anticipate initial data from the highest-dose cohort in the fourth quarter of this year.”
Patient Characteristics & Treatment Journey
The patient is a 61-year-old male with a history of metastatic HPV16+ rectal squamous cell carcinoma. The patient had two prior lines of treatment but had not been treated with immune checkpoint inhibitors. The patient remains on study and the treatment has been well tolerated to date.
In December 2022, after two cycles of SQZ-AAC-HPV, a CT scan showed reduction of the target lesion to meet RECIST 1.1 criteria for a partial response. In February 2023, after four cycles of SQZ-AAC-HPV, a CT scan showed further reduction of the target lesion which was consistent with a confirmed partial response by RECIST 1.1 criteria. In March 2023, after seven cycles of SQZ-AAC-HPV, a CT scan confirmed the complete response by RECIST 1.1 criteria.
SOURCE: Businesswire