Cancer Vaccines presents encouraging preliminary data from ongoing Phase 1/2 study of ACIT-1 cellular immunotherapy for cancer
- The first two dose level cohorts have been completed and the third has begun although recruitment has been paused because of the coronavirus pandemic.
- ACIT-1 has been found to be safe and well tolerated for these two cohorts.
- There have been some notable successes in terms of survival for patients treated so far.
Coventry, UK. 15 January, 2021
Cancer Vaccines, a biotechnology company developing novel cellular immunotherapies for cancer is pleased to provide an update on the clinical trial of its lead product ACIT-1. The results are from the initial dose escalation cohorts of an ongoing Phase 1/2 clinical trial evaluating ACIT-1 as a therapy in a range of different cancers.
The 13 evaluable patients recruited to the trial for the first two dose levels were patients with pancreatic or other late-stage cancers. Treatment related adverse events were primarily mild injection site reactions, mild fatigue and mild flu-like symptoms. 4 of the 6 patients treated at dose level 1 and 2 of the 7 patients treated at dose level 2 survived longer than 12 months.
For pancreatic cancer CRUK median survival statistics for Stage 3 (locally advanced inoperable) and Stage 4 (metastatic) disease are 6-11 months for Stage 3 and 2-6 months for Stage 4. The following findings are therefore noteworthy in patients with pancreatic cancer:
- A Stage 3 patient treated with ACIT-1 alongside their standard chemotherapy was still alive 26 months later
- A Stage 4 patient treated alongside their standard chemotherapy was still alive 13 months after their first vaccination with ACIT-1 and had no disease progression whilst on the trial.
- A Stage 4 patient who during the trial received no treatment other than ACIT-1 reported an increase in quality of life and decreased symptoms 8 weeks after the first vaccination and was still alive at 21 months.
These three patients are still being followed up. Furthermore, a Stage 4 pancreatic cancer patient treated alongside their standard chemotherapy survived for 15 months but during the trial reported increased quality of life and decreased symptoms 8 weeks after the first vaccination and a decrease in tumour size was observed by CT scan at 5 months.
“This is the first in human trial of ACIT-1 so although expected the excellent safety profile of ACIT-1 is foundational and a significant finding,” said Dr John Maudsley, CEO of Cancer Vaccines. “The patients receiving ACIT-1 treatment either had no other treatment options available or, for pancreatic cancer, short life expectancy even with treatment so the clinical findings are excellent news, and require further follow up.”
“There remains a considerable unmet need in the treatment of pancreatic cancer, and these preliminary data are encouraging,” said Prof Daniel Palmer, Chief Investigator for the trial.
About the trial
The Phase 1/2 clinical trial is an open-label dose escalation and dose expansion trial evaluating four different dose levels of ACIT-1 treatment. The trial is designed to compare outcomes in patients who receive ACIT-1 alongside their standard of care chemotherapy with patients who receive ACIT-1 with no other treatment. Patients receive two vaccinations a month apart and follow up data collected is at 2 and 5 months after the first vaccination. The primary endpoint is safety and the secondary endpoint is survival time from Day 0 of treatment. Exploratory endpoints include indicators of anti-tumour activity as defined by immunological assays and by analysis of CT scans.
The immune system has an important role in helping prevent cancer by destroying early cancer cells. When cancer does develop antigen-specific immune (T) cells are still present in the blood but are either not responding or are not effective. Vaccines stimulate these T cells to respond and kill cancer cells. ACIT-1 is designed to stimulate tumour antigen-specific T cells to respond and kill cancer cells.
About Cancer Vaccines
Cancer Vaccines is a biotechnology company established in 1999 and based in Coventry, UK. The company’s aim is to develop safe, effective and affordable immunotherapies for the treatment of cancer. ACIT-1 is its first product.