50% Complete Response Rate Observed in YourVaccx Study for Patients with Metastatic Prostate Cancer was Presented at the AACR Virtual Annual Meeting II – ImmunSYS, Inc.

50% Complete Response Rate Observed in YourVaccx™ Study for Patients with Metastatic Prostate Cancer was Presented at the AACR Virtual Annual Meeting II

                                – In 18 evaluable patients with metastatic prostate cancer, 50% had a 

                          Complete Response (CR) and 62% had post-therapy PSA reductions of ≥ 50%–

 

FORT LAUDERDALE, Florida, June 22, 2020 — (BUSINESS WIRE) — 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.

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 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) 2020 Virtual Annual Meeting II.

For more information, a copy of the poster may be found on www.immunsys.com

About ImmunSYS

ImmunSYS, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative cancer immunotherapy products to improve the lives of patients with metastatic prostate cancer and other metastatic solid tumors. ImmunSYS is committed to bringing life-changing treatments to patients with metastatic cancer. The Company’s platform technology, YourVaccx, empowers the immune system to generate a strong anticancer effect, potentially creating abscopal effects through the combination of cryosurgical cellular lysis and the intratumoral delivery of a proprietary triple-component immunotherapeutic drug that is in development.

The YourVaccx therapy has the potential to offer patients with metastatic solid tumors benefits over the existing standard of care. The company’s lead development program is the treatment of metastatic prostate cancer, followed by a pipeline of development programs for other metastatic solid tumors. For more information about the company and its programs, visit www.immunsys.com. Follow and connect with us on Twitter, Facebook, YouTube and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This news release contains forward-looking statements. Forward-looking statements can be identified by words such as “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and other words and terms of similar meaning. The forward-looking statements contained in this news release include, but are not limited to, statements relating to future clinical results and the effectiveness of the Company’s therapies. These forward-looking statements are subject to risks, uncertainties and other factors. Accordingly, actual results may differ significantly from those projected in the forward-looking statements contained herein. Readers should not place undue reliance on these forward-looking statements. The forward-looking statements included in this news release are made only as of the date hereof, and the Company does not undertake any obligation to update any forward-looking statements to reflect subsequent events or circumstances, except as required by applicable law.

Contacts

ImmunSYS, Inc.
Joseph Gerardi, +1-518-796-6110
Executive Vice President, Chief Financial Officer
jgerardi@immunsys.com