ONC-841 is a potential first-in-class SIGLEC10 antibody with broad application in oncology
Designed to break tumor evasion of the immune system, ONC-841 can rejuvenate anti-tumor T cells, NK cells and macrophages within the tumor microenvironment
Initial Phase 1 safety, pharmacokinetics, and clinical activity data for ONC-841 monotherapy are expected in 2025
ROCKVILLE, MD, USA I September 04, 2024 I OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer and immunological diseases, today announced the first patient has been dosed in the first-in-human Phase 1 ONC-841-002 trial (NCT06352359) evaluating ONC-841, a potential first-in-class SIGLEC10 blocking antibody for the treatment of solid tumors.
“Dosing the first patient in this first-in-human trial for ONC-841 marks an important step for our SIGLEC program which holds promise to treat a range of malignancies,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “Targeting a novel SIGLEC10 immune checkpoint, ONC-841 is designed to block tumor evasion of the immune system by activating anti-tumor immunity within the tumor microenvironment. We are very excited at the broad therapeutic potential of ONC-841 and look forward to initial Phase 1 data in 2025.”
ONC-841-002 is a Phase 1 open label, dose-escalation trial evaluating the safety, efficacy and pharmacokinetics of ONC-841 as a single agent in patients with advanced and or metastatic solid tumors. The study will assess seven dose levels of intravenous ONC-841 once every 4 weeks at multiple clinical centers throughout the United States. The trial principal investigator is Dr. Tianhong Li of the University of California, Davis Comprehensive Cancer Center. OncoC4 enrolled its first patient under the care of site investigator Dr. John Hamm, of Norton Cancer Institute in Louisville, Kentucky. Initial data on the safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in 2025.
Dr. Hamm added, “It is very exciting to be part of this journey. As oncologists we know we need better answers and through clinical trials like this, especially in the past 5 years, we have seen rapid improvements in cancer care and treatment.”
Discovered in house, ONC-841 is a humanized antagonist anti-SIGLEC10 monoclonal antibody. To our knowledge, it is the first SIGLEC10 antagonist to enter clinical development. Siglec10 is an inhibitory receptor gene broadly expressed in tumor-infiltrating immune cells that plays an important role in tumor evasion of the immune system through its interaction with CD24 present on tumor cells. ONC-841 blocks this interaction, enabling anti-tumor activation of immune cells including NK cells, macrophages and T cells. SIGLEC10 has an authentic immunoreceptor tyrosine-based inhibitory motif, which is distinct from other siglecs such as SIGLEC15. In preclinical studies ONC-841 has been shown increased phagocytosis of cancer cells and improved function of tumor-infiltrating T cells and innate cells, as well as enhanced antibody-dependent CD16a signalling, a surrogate for antibody-dependent cell mediated cytotoxicity (ADCC).
About OncoC4
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 biologics for the treatment of cancer and immunological diseases. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 is targeting CD24-Siglec pathway, an innate immune checkpoint discovered by its cofounders. OncoC4 has two first-in-class clinical stage SIGLEC programs, including AI-071, a Phase 2 ready SIGLEC agonist designed for difficult to treat immune related adverse events, and ONC-841, a Phase 1 SIGLEC10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: www.oncoc4.com.
About Norton Cancer Institute
As the leading provider of cancer care in Louisville and Southern Indiana, Norton Cancer Institute’s mission is to blend comprehensive treatment and services with compassion, hope and healing for patients and their families. Through a multidisciplinary approach, its team offers patients the latest in treatments and technology focused on cancer prevention, diagnosis, care and survivorship. The institute’s specialists cover a broad range of oncology subspecialties, including behavioral, breast medical and radiation, gastrointestinal medical and radiation, genitourinary medical and radiation, gynecologic, head and neck medical and surgical, neurologic, orthopedic, sarcoma and connective tissue medical, and thoracic medical and radiation oncology, as well as cancer genetics, hematology and oncologic dermatology. Norton Cancer Institute offers state-of-the-art medical, surgical and radiation therapies, including minimally invasive robotic surgery, stereotactic radiosurgery (Novalis Tx and TrueBeam STx) and advanced brachytherapy. Patients have access to groundbreaking research through its participation in dozens of innovative National Cancer Institute and industry-sponsored clinical trials. Extensive educational, physical and emotional support services, including support groups, seminars, art and music therapy, massage therapy, yoga and nutritional counseling are available through five Norton Cancer Institute Resource Centers. Norton Cancer Institute is designated by the American College of Surgeons Commission on Cancer as the only accredited Integrated Network Cancer Program in Kentucky. More information is available at NortonCancerInstitute.com.
SOURCE: OncoC4
Post Views: 1,990
ONC-841 is a potential first-in-class SIGLEC10 antibody with broad application in oncology
Designed to break tumor evasion of the immune system, ONC-841 can rejuvenate anti-tumor T cells, NK cells and macrophages within the tumor microenvironment
Initial Phase 1 safety, pharmacokinetics, and clinical activity data for ONC-841 monotherapy are expected in 2025
ROCKVILLE, MD, USA I September 04, 2024 I OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer and immunological diseases, today announced the first patient has been dosed in the first-in-human Phase 1 ONC-841-002 trial (NCT06352359) evaluating ONC-841, a potential first-in-class SIGLEC10 blocking antibody for the treatment of solid tumors.
“Dosing the first patient in this first-in-human trial for ONC-841 marks an important step for our SIGLEC program which holds promise to treat a range of malignancies,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “Targeting a novel SIGLEC10 immune checkpoint, ONC-841 is designed to block tumor evasion of the immune system by activating anti-tumor immunity within the tumor microenvironment. We are very excited at the broad therapeutic potential of ONC-841 and look forward to initial Phase 1 data in 2025.”
ONC-841-002 is a Phase 1 open label, dose-escalation trial evaluating the safety, efficacy and pharmacokinetics of ONC-841 as a single agent in patients with advanced and or metastatic solid tumors. The study will assess seven dose levels of intravenous ONC-841 once every 4 weeks at multiple clinical centers throughout the United States. The trial principal investigator is Dr. Tianhong Li of the University of California, Davis Comprehensive Cancer Center. OncoC4 enrolled its first patient under the care of site investigator Dr. John Hamm, of Norton Cancer Institute in Louisville, Kentucky. Initial data on the safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in 2025.
Dr. Hamm added, “It is very exciting to be part of this journey. As oncologists we know we need better answers and through clinical trials like this, especially in the past 5 years, we have seen rapid improvements in cancer care and treatment.”
Discovered in house, ONC-841 is a humanized antagonist anti-SIGLEC10 monoclonal antibody. To our knowledge, it is the first SIGLEC10 antagonist to enter clinical development. Siglec10 is an inhibitory receptor gene broadly expressed in tumor-infiltrating immune cells that plays an important role in tumor evasion of the immune system through its interaction with CD24 present on tumor cells. ONC-841 blocks this interaction, enabling anti-tumor activation of immune cells including NK cells, macrophages and T cells. SIGLEC10 has an authentic immunoreceptor tyrosine-based inhibitory motif, which is distinct from other siglecs such as SIGLEC15. In preclinical studies ONC-841 has been shown increased phagocytosis of cancer cells and improved function of tumor-infiltrating T cells and innate cells, as well as enhanced antibody-dependent CD16a signalling, a surrogate for antibody-dependent cell mediated cytotoxicity (ADCC).
About OncoC4
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 biologics for the treatment of cancer and immunological diseases. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 is targeting CD24-Siglec pathway, an innate immune checkpoint discovered by its cofounders. OncoC4 has two first-in-class clinical stage SIGLEC programs, including AI-071, a Phase 2 ready SIGLEC agonist designed for difficult to treat immune related adverse events, and ONC-841, a Phase 1 SIGLEC10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: www.oncoc4.com.
About Norton Cancer Institute
As the leading provider of cancer care in Louisville and Southern Indiana, Norton Cancer Institute’s mission is to blend comprehensive treatment and services with compassion, hope and healing for patients and their families. Through a multidisciplinary approach, its team offers patients the latest in treatments and technology focused on cancer prevention, diagnosis, care and survivorship. The institute’s specialists cover a broad range of oncology subspecialties, including behavioral, breast medical and radiation, gastrointestinal medical and radiation, genitourinary medical and radiation, gynecologic, head and neck medical and surgical, neurologic, orthopedic, sarcoma and connective tissue medical, and thoracic medical and radiation oncology, as well as cancer genetics, hematology and oncologic dermatology. Norton Cancer Institute offers state-of-the-art medical, surgical and radiation therapies, including minimally invasive robotic surgery, stereotactic radiosurgery (Novalis Tx and TrueBeam STx) and advanced brachytherapy. Patients have access to groundbreaking research through its participation in dozens of innovative National Cancer Institute and industry-sponsored clinical trials. Extensive educational, physical and emotional support services, including support groups, seminars, art and music therapy, massage therapy, yoga and nutritional counseling are available through five Norton Cancer Institute Resource Centers. Norton Cancer Institute is designated by the American College of Surgeons Commission on Cancer as the only accredited Integrated Network Cancer Program in Kentucky. More information is available at NortonCancerInstitute.com.
SOURCE: OncoC4
Post Views: 1,990
