#USA #Rockville #Cancer Immunotherapy #OncoC4 #ONC-783

OncoC4 Advances Cancer Treatment with ONC-783

OncoC4 Inc., a biopharmaceutical company based in Rockville, Maryland, is making strides in the field of oncology with the announcement of the first patient receiving a dose in their Phase 1 clinical trial of ONC-783. This investigational drug is designed to treat advanced solid tumors and has shown potential to offer new hope for patients facing limited treatment options.

The dosing follows the clearance of the Investigational New Drug (IND) application for the clinical trial, registered under NCT07408258. Dr. Yang Liu, the CEO and Chief Scientific Officer of OncoC4, expressed excitement over this clinical milestone, emphasizing the innovative nature of ONC-783. This drug is notable for being the first and only T-cell engager currently at the clinical stage, which specifically targets the neoCD24 glycoform – an epitope prevalent in nearly 70% of human cancers.

The approach taken by ONC-783 aims to exploit the cancer-specific features of the neoCD24 epitope, which is typically absent from normal tissues. This selective targeting is expected to result in a favorable safety profile by minimizing potential on-target/off-tumor toxicity that often complicates therapies in this area. Hence, ONC-783 may potentially surpass limitations seen with existing immunotherapies by enhancing the body's immune response against tumors while reducing adverse reactions.

Preclinical assessments have already hinted at the broad anti-tumor activity of ONC-783 across various malignancies, including pancreatic, lung, breast, and colorectal cancers, among others. This promising data supports the drug's potential as a multi-therapeutic option for various solid tumors.

The formulation of ONC-783 was developed to be administered subcutaneously, which allows for gradual systemic exposure. This could mitigate risks of Cytokine Release Syndrome (CRS), a complication often associated with intravenous T-cell engagers. The clinical trial currently seeks to establish the drug's safety, pharmacokinetics, and efficacy as a standalone treatment for patients classified with advanced or metastatic solid tumors, with a focus on colorectal, ovarian, pancreatic, and breast cancer.

The first patient was successfully dosed at the Columbia University Irving Medical Center, and preliminary observations reported the treatment was well tolerated without severe adverse events noted, including cases of CRS or immune effector cell-associated neurotoxicity syndrome.

Dr. Aiwu Ruth He, a Professor of Medicine at Columbia University, echoed OncoC4’s enthusiasm, highlighting the need for innovative solutions in treating advanced solid tumors, particularly in patients who have limited options after standard therapies.

OncoC4 stands firm on its commitment to advancing cancer immunotherapy, focusing on building first-in-class therapeutics that address the unmet needs in cancer care. ONC-783 is only a part of their larger agenda to establish transformative treatment pathways for cancer patients through a diverse pipeline featuring both novel and validated targets across oncology and immunological diseases.

Interested parties can find more information about the clinical trial at www.oncoc4.com, where OncoC4 continues to push the boundaries of what's possible in cancer therapeutics. The commitment to developing groundbreaking medications demonstrates OncoC4's role as a leader in the frontier of cancer treatment.

Summary

As OncoC4 continues its journey with ONC-783, the cancer community watches with anticipation, hoping that innovations like these will pave the way for more effective, safer therapies that can ultimately lead to enhanced survival and quality of life for patients battling aggressive forms of cancer.