The Phase 2 multicenter, open-label combination trial builds upon the promising results of monotherapeutic activity of ONC-392 seen in previous clinical trial
ROCKVILLE, MD, USA I December 30, 2022 I OncoC4, Inc., a clinical-stage biopharma company developing novel immunotherapies for cancer, today announced that the first patient has been dosed in the Phase 2 combination study of ONC-392, a nextgen target-preserving anti-CTLA-4 antibody and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with platinum-resistant ovarian cancer (PROC) (PRESERVE-004, NCT05446298).
The patient was dosed at the Women’s Cancer Care Associates, LLC, located in Albany New York. Dr. Joyce Barlin is the site Principal Investigator (PI). The study is sponsored by OncoC4, Inc., in collaboration with Merck (known as MSD outside the US and Canada) and the GOG Foundation Inc.
“It is an exciting time for immunotherapy clinical trial research. I am incredibly grateful for the opportunity to serve as the Co-PI on this Phase 2 trial with Dr. Bradley Monk. We are thrilled to dose the first patient at our institution with this innovative immunotherapy combination, which hopes to address the unmet need in platinum-resistant ovarian cancer,” said Dr. Joyce Barlin.
“We are pleased to be making progress on our ONC-392 clinical program with the dosing of our first patient in the PRESERVE-004 trial in the combination arm with KEYTRUDA. We are hopeful these results will build on the promising responses we’ve seen with ONC-392 as monotherapy,” said Pan Zheng, M.D., Ph.D. Chief Medical Officer and co-founder of OncoC4. Dr. Zhang further added, “We are grateful to our partners, Merck and the GOG Foundation for their support of the PRESERVE-004 trial. We look forward to providing additional data as they become available.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About ONC-392
ONC-392 is OncoC4’s lead product candidate currently in late-stage clinical development. ONC-392 has received fast-track-designation from the FDA as a monotherapy for immunotherapy-resistant non-small cell lung cancer (NSCLC). ONC-392 is the first known acid pH-sensitive anti-CTLA-4 mAb that interacts strongly with CTLA-4 at a pH typical of normal tissues/organs and the tumor microenvironment. When the pH drops below 6.0, ONC-392 rapidly disassociates from its target, thus allowing CTLA-4 to preserve its normal life cycle and avoid antibody-induced lysosomal degradation. By avoiding antibody-induced degradation of CTLA-4, ONC-392 preserves immune tolerance function of Treg in normal tissues while preserving the target molecule on tumor infiltrating Treg for efficient depletion induced by ONC-392. This unique feature not only reduces toxicity, but also increases therapeutic efficacy, resulting in a better therapeutic index that allows sufficient dosing to untap the immunotherapeutic potential of anti-CTLA-4 antibodies.
About PRESERVE-004 Trial (NCT05446298)
This trial is a Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC). Patients who meet the eligibility criteria will enroll in one of the two experimental arms to receive either 3 mg/kg or 6 mg/kg of ONC-392, in combination with a fixed dose of 200 mg of pembrolizumab, for up to 24 months at the prespecified interval of once every 3 weeks. The primary endpoints are the efficacy measured by objective response rate per RECIST1.1, and the safety measured by treatment related adverse events (TRAEs) and immune related adverse events (irAEs). This PRESERVE-004 study is also known as Merck study MK3475-E24 or GOG study GOG-3081 and is conducted by OncoC4 as the sponsor under the FDA IND 160987.
About OncoC4, Inc. (www.oncoc4.com)
Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Our lead clinical candidate is ONC-392, a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has a pipeline of first-in-class preclinical products focusing on the CD24-Siglecs cancer immune evasion pathway.
SOURCE: OncoC4
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The Phase 2 multicenter, open-label combination trial builds upon the promising results of monotherapeutic activity of ONC-392 seen in previous clinical trial
ROCKVILLE, MD, USA I December 30, 2022 I OncoC4, Inc., a clinical-stage biopharma company developing novel immunotherapies for cancer, today announced that the first patient has been dosed in the Phase 2 combination study of ONC-392, a nextgen target-preserving anti-CTLA-4 antibody and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with platinum-resistant ovarian cancer (PROC) (PRESERVE-004, NCT05446298).
The patient was dosed at the Women’s Cancer Care Associates, LLC, located in Albany New York. Dr. Joyce Barlin is the site Principal Investigator (PI). The study is sponsored by OncoC4, Inc., in collaboration with Merck (known as MSD outside the US and Canada) and the GOG Foundation Inc.
“It is an exciting time for immunotherapy clinical trial research. I am incredibly grateful for the opportunity to serve as the Co-PI on this Phase 2 trial with Dr. Bradley Monk. We are thrilled to dose the first patient at our institution with this innovative immunotherapy combination, which hopes to address the unmet need in platinum-resistant ovarian cancer,” said Dr. Joyce Barlin.
“We are pleased to be making progress on our ONC-392 clinical program with the dosing of our first patient in the PRESERVE-004 trial in the combination arm with KEYTRUDA. We are hopeful these results will build on the promising responses we’ve seen with ONC-392 as monotherapy,” said Pan Zheng, M.D., Ph.D. Chief Medical Officer and co-founder of OncoC4. Dr. Zhang further added, “We are grateful to our partners, Merck and the GOG Foundation for their support of the PRESERVE-004 trial. We look forward to providing additional data as they become available.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About ONC-392
ONC-392 is OncoC4’s lead product candidate currently in late-stage clinical development. ONC-392 has received fast-track-designation from the FDA as a monotherapy for immunotherapy-resistant non-small cell lung cancer (NSCLC). ONC-392 is the first known acid pH-sensitive anti-CTLA-4 mAb that interacts strongly with CTLA-4 at a pH typical of normal tissues/organs and the tumor microenvironment. When the pH drops below 6.0, ONC-392 rapidly disassociates from its target, thus allowing CTLA-4 to preserve its normal life cycle and avoid antibody-induced lysosomal degradation. By avoiding antibody-induced degradation of CTLA-4, ONC-392 preserves immune tolerance function of Treg in normal tissues while preserving the target molecule on tumor infiltrating Treg for efficient depletion induced by ONC-392. This unique feature not only reduces toxicity, but also increases therapeutic efficacy, resulting in a better therapeutic index that allows sufficient dosing to untap the immunotherapeutic potential of anti-CTLA-4 antibodies.
About PRESERVE-004 Trial (NCT05446298)
This trial is a Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC). Patients who meet the eligibility criteria will enroll in one of the two experimental arms to receive either 3 mg/kg or 6 mg/kg of ONC-392, in combination with a fixed dose of 200 mg of pembrolizumab, for up to 24 months at the prespecified interval of once every 3 weeks. The primary endpoints are the efficacy measured by objective response rate per RECIST1.1, and the safety measured by treatment related adverse events (TRAEs) and immune related adverse events (irAEs). This PRESERVE-004 study is also known as Merck study MK3475-E24 or GOG study GOG-3081 and is conducted by OncoC4 as the sponsor under the FDA IND 160987.
About OncoC4, Inc. (www.oncoc4.com)
Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Our lead clinical candidate is ONC-392, a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has a pipeline of first-in-class preclinical products focusing on the CD24-Siglecs cancer immune evasion pathway.
SOURCE: OncoC4
Post Views: 289
