On June 22, 2020 ImmunSYS, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer immunotherapy products, reported results from a proof of concept (PoC) study evaluating its proprietary technology platform, YourVaccx for the treatment of patients with metastatic cancers (Press release, ImmunSYS, JUN 22, 2020, View Source;utm_medium=rss&utm_campaign=50-complete-response-rate-observed-in-yourvaccxtm-study-for-patients-with-metastatic-prostate-cancer-was-presented-at-the-aacr-virtual-annual-meeting-ii [SID1234561319]).
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The retrospective, IRB approved case series was independently monitored by a contract research organization. A total of 27 patients were enrolled, including 21 with metastatic prostate cancer (mPCa), and 6 with metastatic cancers of varying types: 2 bladder, 1 pancreatic, 1 melanoma, 1 colon cancer and 1 unknown. A single treatment cycle consisted of in situ cryosurgical lysis of tumor tissue followed by a direct injection of a combination of anti CTLA-4 antibody, anti PD-1 antibody and GM-CSF into the target treatment zone, followed by 30 days of daily subcutaneous GM-CSF. The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment. All responses to therapy were assessed by RECIST v. 1.1 and metastatic prostate cancer patients were also assessed by serum PSA levels. 3 patients could not be evaluated due to a lack of follow-up imaging. For all evaluable patients, the PoC study data showed a 38% (9/24) complete response rate (CR) and a 4% (1/24) partial response rate (PR), for an objective response rate (ORR) of 42% (10/24). The combination therapy was
generally well tolerated.
Key findings in mPCa patients:
Among the 18 evaluable mPCa patients, there was a 50% (9/18) CR
50% (9/18) ORR
62% (13/21) of patients had post-therapy PSA reductions of ≥ 50%
The majority of responses have been durable, with 5 of 9 CRs persisting from 12 months to over 51 months to date
6 Grade 3-4 adverse events occurred in 14.3% (3/21), with no treatment-related deaths
"We are pleased to present these encouraging findings at the AACR (Free AACR Whitepaper) virtual annual meeting II," said Eamonn Hobbs, Chairman and Chief Executive Officer of ImmunSYS. "These results demonstrate longterm, durable responses, ranging from 1 to 4.5 years, and a favorable tolerability profile in tough-to-treat patient populations. There is an unmet need for effective treatment options for patients with metastatic cancers and these data demonstrate the potential that YourVaccx has to significantly improve the lives of patients."
Our poster #6540 entitled, "Regression of metastatic cancer and abscopal effects following in situ vaccination by cryosurgical tumor cell lysis and intratumoral immunotherapy: A case series" and accompanying audio clip narrated by Gary Onik, M.D. is now available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II.