OncoC4 to Present Global Pivotal Phase 3 Trial Design for Next-Generation CTLA-4 Antibody Gotistobart Monotherapy Being Co-Developed with BioNTech in NSCLC at the IASLC 2025 World Conference on Lung Cancer
PRESERVE-003 is evaluating gotistobart vs. docetaxel in patients with squamous non-small cell lung cancer (sqNSCLC) who have progressed on chemotherapy and immune checkpoint therapies
Pivotal Stage II design was based on data from the Stage I part of the Phase 3 trial that supported selecting the high dose for 1: 1 randomization between gotistobart and docetaxel in patients with sqNSCLC
Stage II recruitment continues to be on pace with nearly 160 sites activated/enrolling patients worldwide
ROCKVILLE, Md., Sept. 08, 2025 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer today announced that it will have a poster presentation at the upcoming World Conference on Lung Cancer (WCLC) 2025 hosted by the International Association for the Study of Lung Cancer (IASLC), taking place September 6-9, 2025 in Barcelona, Spain. The presentation will feature the pivotal trial Stage II design for PRESERVE-003 (NCT05671510), a two-stage, randomized, open-label, active-controlled Phase 3 Study evaluating gotistobart monotherapy compared to docetaxel in squamous non-small cell lung cancer (sqNSCLC) after progression on a PD-(L)1 inhibitor.
Squamous NSCLC is among the deadliest cancers with very limited treatment options following traditional chemotherapy and immunotherapy (IO) with immune checkpoint inhibitors1. OncoC4 and its strategic partner BioNTech have embarked on this indication based on encouraging Phase 1/2 results and the match between the vulnerability of the sqNSCLC and the mechanism of action of gotistobart (ONC-392/BNT316). The Stage I of the 2-stage PRESERVE-003 study was designed for dose confirmation based on safety, efficacy and exposure-response analyses. The data supported selecting the high dose for Stage II, which consists of 1:1 randomization between gotistobart and docetaxel in patients with squamous NSCLC. Enrollment of Stage II (potentially registrational) continues to progress well with nearly 160 active sites worldwide.
Gotistobart is a next generation, acid pH-sensitive anti-CTLA-4 monoclonal antibody candidate that avoids antibody-induced lysosomal target degradation for better therapeutic index. Together with modifications in Fc, gotistobart induces more potent and selective depletion of regulatory T cells in the tumor microenvironment.
“The mechanism of action of gotistobart has the potential for clinical development of the drug beyond lung cancers for other indications with unmet medical needs, either as monotherapy or in combination with other therapeutic modalities,” said Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO), and Chief Scientific Officer (CSO) of OncoC4.
WCLC Poster Presentation Details
Title: PRESERVE-003: A Phase 3 Study of Gotistobart Versus Docetaxel in Metastatic NSCLC
After Progression on PD-(L)1 Inhibitors (NCT05671510)
Abstract Number: 1363
Session: P3.18 - Ongoing Clinical Trials
Date: Tuesday, September 9, 2025
Time: 10:00 AM CEST
Presenter: Dr. Tianhong Li, Professor, Department of Internal Medicine, Division of Hematology and Oncology at UC Davis Comprehensive Cancer Center, CA
About PRESERVE-003
PRESERVE-003 is a randomized, open label, active controlled, multi-center Phase 3 trial (ClinicalTrials.gov NCT 05671510) sponsored by OncoC4 and consists of two stages. Stage 1, the dose-confirmation stage, assessed the efficacy and safety of two gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg Q3W) in comparison to docetaxel 75 mg/m2 Q3W in patients with squamous and non-squamous non-small cell lung cancer (NSCLC). Stage 2 assesses the safety and efficacy of gotistobart at 6 mg/kg Q3W with 2 loading doses of 10 mg/kg versus docetaxel (75 mg/m2 Q3W) on squamous cell NSCLC. The primary endpoint is Overall Survival.
About gotistobart (BNT316/ONC392)
Gotistobart is licensed to BioNTech for commercialization and jointly developed clinically by OncoC4 and BioNTech for oncology indications. There are several ongoing clinical trials in different tumor types, investigating gotistobart either as monotherapy or in combination with other therapeutic agents.
About squamous non-small cell lung cancer (NSCLC)
Squamous cell non-small cell lung cancer makes up 25 – 30% of all lung cancers, and is the most common lung cancer found in smokers2. In the US, first-line treatment for metastatic squamous NSCLC commonly involves a combination of chemotherapy and immunotherapy. However, treatment choices diminish when patients progress on prior IO options.
About OncoC4
Based in Rockville, Maryland, OncoC4 is a privately held, late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for the treatment of cancer and immunological diseases. OncoC4’s pipeline features assets with first-in-class and best-in-class potential targeting both novel and well validated targets across oncology and immunological diseases. Among them, AI-081 is a fully owned and potentially best-in-class bispecific antibody candidate targeting PD-1 and VEGF. AI-081 is currently enrolling patients in a Phase1/2 trial that could enable two or more pivotal studies. In addition, OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a next-generation anti-CTLA-4 antibody candidate, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.
For more information, please visit www.oncoc4.com.
CONTACTS
OncoC4
Investor Contact:
Shiniu Wei
Chief Financial Officer
swei@oncoc4.com
Media Contact:
Jason Braco, Ph.D.
LifeSci Communications
jbraco@lifescicomms.com
Citations:
- Lau SCM, Pan Y, Velcheti V and Wong K, Cancer Cell, 40:1279-1293, 2022.
- Houston KA, Henley SJ, Li J, White MC and Richards TB, Lung Cancer, 86:22-28, 2014.
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