OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1/2 Trial of BioNTech-partnered BNT316/ONC-392 Program

• The Phase 1/2 trial will assess the efficacy and safety of BNT316/ONC-392 in combination with the radioligand therapy lutetium (¹⁷⁷Lu) vipivotide tetraxetan (Pluvicto^®) in patients with metastatic castration resistant prostate cancer (“mCRPC”) who have progressed on an androgen receptor (“AR”) pathway inhibitor.
• The trial is expected to enroll 144 patients at clinical trial sites in the United States
• The study is in furtherance of the strategic collaboration between BioNTech and OncoC4 which includes joint development BNT316/ONC-392 in a range of solid tumor indications

ROCKVILLE, Md., Feb. 22, 2024 (GLOBE NEWSWIRE) — OncoC4, Inc. (“OncoC4”) today announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (¹⁷⁷Lu) vipivotide tetraxetan (Pluvicto^®). BNT316/ONC-392 is being jointly developed by BioNTech and OncoC4.

Prostate cancer is the most common diagnosed cancer and among the leading causes of cancer death in men globally.¹ Approximately 10-20% of prostate cancer patients develop castration-resistant prostate cancer.² These patients often have a poor prognosis, with a median survival of about two years for patients at metastatic disease stage.³ The medical need remains high for new treatment options that increase survival for patients with mCRPC.

“Advances in the treatment of mCRPC have demonstrated improved outcomes, but a high unmet need remains for additional well-tolerated targeted therapies that can further extend survival in these patients. We look forward to evaluating BNT316/ONC-392 in combination with radioligand therapy with the aim to further improve outcomes for patients with this advanced stage of disease,” said David R. Wise, M.D., Ph.D., Director of the Perlmutter Cancer Center at NYU Langone Health, and Principal Investigator of the Phase 1/2 trial.

The open label, randomized Phase 1/2 trial, PRESERVE-006 (NCT05682443), will assess the safety and efficacy of BNT316/ONC-392 in combination with lutetium (¹⁷⁷Lu) vipivotide tetraxetan in patients with mCRPC who have progressed on an androgen receptor (“AR”) pathway inhibitor. The OncoC4-sponsored trial is expected to enroll 144 patients across 20 sites within the United States. The trial will initially evaluate the safety of BNT316/ONC-392 in combination with lutetium (¹⁷⁷Lu) vipivotide tetraxetan and help inform the preferred dosage. The Phase 2 part of the trial will evaluate safety and efficacy in patients with metastatic castration resistant prostate cancer with prostate-specific membrane antigen (“PSMA”)-positive scans who have progressed on prior AR targeted agents and are lutetium (¹⁷⁷Lu) vipivotide tetraxetan-naïve. The trial will assess whether the combination increases progression free survival over the current standard of care as the primary endpoint.

In March 2023, BioNTech and OncoC4 announced entry into a strategic collaboration, which includes joint development of BNT316/ONC-392 in a range of solid tumor indications, with the parties equally sharing development costs for such joint development studies. BioNTech holds the exclusive worldwide commercialization rights for this product candidate. BNT316/ONC-392 is currently being evaluated in multiple ongoing clinical trials in patients with advanced solid tumors, including one ongoing registrational Phase 3 trial, PRESERVE-003 (NCT05671510), which is evaluating BNT316/ONC-392 as monotherapy in patients with metastatic, immunotherapy-resistant non-small cell lung cancer (“NSCLC”).

About gotistobart (BNT316/ONC-392)
BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development as monotherapy or combination therapy in various cancer indications. The immune checkpoint receptor CTLA-4 inhibits T cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells.⁴ This mechanism is also exploited by cancer cells to prevent them from being eliminated by T cells.⁵ Blocking CTLA-4 may help to preserve T cell activity and enhance anti-tumor activity. BNT316/ONC-392 was designed with the aim to address this mechanism while preserving CTLA-4 recycling and thus the immunosuppressive T cell (regulatory T cells, or “Tregs”) function in the peripheral tissues. The aim with this approach, which is currently under clinical evaluation, is to give rise to fewer immune-related adverse effects.

About Prostate Cancer
Prostate cancer is the most common diagnosed cancer and leading cause of cancer death in men globally, with an incidence of 1.4 million in 2020.¹ Often driven by male sex hormones, called androgens, metastatic castration-resistant prostate cancer (“mCRPC”) is a type of prostate cancer associated with a significant mortality rate that has spread to different parts of the body and no longer responds to androgen blocking therapy.⁶ The prostate-specific membrane antigen (“PSMA”) is a biomarker expressed on prostate cancer cells that can be targeted with radioligand therapy.⁷ Up to 30% of men with prostate cancer will develop castration-resistant prostate cancer (“CRPC”) within five years, with approximately 84% at metastatic disease stage at the time of CRPC diagnosis.^{2, 8}

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 potential treatment of cancer. Its lead clinical candidate is BNT316/ONC-392, a 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 has a pipeline of potentially first-in-class preclinical product candidates focusing on the CD24-Siglecs cancer immune evasion pathway.

More information: www.oncoc4.com.

CONTACTS

OncoC4
Investor Contact:
Alexandra Folias
LifeSci Advisors
afolias@lifesciadvisors.com

Media Contact:
Mari Purpura
LifeSci Advisors
mpurpura@lifesciadvisors.com

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¹ International Agency for Research on Cancer. GLOBOCAN 2020. Online at: https://gco.iarc.fr/today
² A J, Zhang B, Zhang Z, et al. Cancers (Basel). 2021 Feb 22;13(4):917. doi: 10.3390/cancers13040917.
³ Freedland SJ, Davis Metthew, Epstein AJ, et al. Prostate Cancer Prostatic Dis. 2023 Oct 2. doi: 10.1038/s41391-023-00725-8. Online ahead of print.
⁴ Seidel JA, Otsuka A, Kabashima K. Front Oncol. 2018 Mar 28:8:86. doi: 10.3389/fonc.2018.00086. eCollection 2018.
⁵ Front. Immunol., 2021 Aug. 31; Vol. 12 – 2021; https://doi.org/10.3389/fimmu.2021.651634
⁶ American Society of Clinical Oncology (ASCO). Prostate Cancer: Types of Treatment. Available under: https://www.cancer.net/cancer-types/prostate-cancer/types-treatment (last access: 03.01.2024)
⁷ Hyväkkä A, Virtanen V, et al. Cancers (Basel). 2021 May 7;13(9):2244. doi: 10.3390/cancers13092244.
⁸ Kirby M, Hirst c, Crawford ED. Int J Clin Pract. 2011 Nov;65(11):1180-92. doi: 10.1111/j.1742-1241.2011.02799.x.