gotistobart (BNT316) / OncoC4, BioNTech - LARVOL DELTA

A randomized, phase II, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in combination with standard dose pembrolizumab in platinum-resistant recurrent ovarian cancer: Safety, efficacy and dose optimization (PRESERVE-004/GOG-3081) (ESMO 2024) - P2 | "Early results show encouraging safety and clinical activity in PROC patients receiving gotistobart + pembrolizumab."

Clinical • Combination therapy • Late-breaking abstract • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer

Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1/2 | "With known limitations in sample size during dose escalation, gotistobart in combination with Lu 177 demonstrated a manageable safety profile and promising preliminary PSA50 rates in patients with mCRPC during the dose escalation phase. Overall findings support combination regimens with gotistobart doses less than 10 mg/kg in the ongoing Phase 2 randomized dose optimization study."

Clinical • Combination therapy • Metastases • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immunology • Oncology • Prostate Cancer • Solid Tumor

Safety and clinical activity of target-preserving anti-CTLA-4 antibody ONC-392 as monotherapy in NSCLC patients who progressed on PD(L)1-targeted immunotherapy. (ASCO 2023) - P1a/1b, P3 | "Overall, ONC-392 monotherapy with 10 mg/kg is safe and tolerable. Onc-392 monotherapy has showed encouraging anti-tumor activity in IO-resistant NSCLC when compared with historical data. Based on these encouraging data, we have initiated a Phase 3 study testing ONC-392 monotherapy among NSCLC who progressed on PD(L)1-targeting immunotherapy (NCT05671510)."

Clinical • Monotherapy • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • Squamous Cell Carcinoma

BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients (BioNTech Press Release) - "At the data cut-off on July 17, 2026, with a median follow-up of 25.4 months, 87 patients with metastatic squamous NSCLC had been randomized to receive either gotistobart monotherapy 6 mg/kg with two 10 mg/kg loading doses (N=45) or docetaxel 75 mg/m2 (N=42) in the second-line or later treatment setting. The median OS was 18.5 months for patients treated with gotistobart compared to 10.0 months for patients treated with docetaxel (HR: 0.56; nominal p-value=0.0295). The safety profile of gotistobart was consistent with previously reported data and remained manageable....The pivotal stage 2 portion of PRESERVE-003 is currently ongoing at more than 160 sites globally."

P3 data • Trial status • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer

Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab. (ASCO 2026) - P2 | "The chemotherapy-free combination of gotistobart and pembrolizumab demonstrated clinically meaningful ORR, OS and a manageable safety profile in pts with PROC, where the majority were heavily pretreated with no further standard-of-care treatment options."

Clinical • Combination therapy • Platinum resistant • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Immunology • Nephrology • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Disease • Solid Tumor

Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. (PubMed, Nat Med) - P3 | "Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC. ClinicalTrials.gov identifier: NCT05671510 ."

Journal • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4 • PD-L1

PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - P1/2 | N=733 | Active, not recruiting | Sponsor: OncoC4, Inc. | Trial primary completion date: Jun 2026 ➔ Dec 2026

First-in-human • Monotherapy • Trial primary completion date • Adenoid Cystic Carcinoma • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Salivary Gland Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(l)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003 (IASLC-WCLC 2026) - "Population PK model-predicted exposure metrics indicated that gotistobart achieved approximately 2-fold higher C max and 3-fold higher C through and AUC than ipilimumab at the same dosing regimen. These results support ongoing evaluation of gotistobart in the pivotal part of the PRESERVE-003 trial. $$graphic_1BA59175-034E-4920-8346-FF8472A061B8$$"

Clinical • Metastases • Gastroenterology • Gastrointestinal Disorder • Hepatology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Solid Tumor

MO07. Novel Immunotherapeutic Strategies in mNSCLC (IASLC-WCLC 2026) - "The first part features three studies on immune checkpoint inhibitor-based strategies, including the Lonestar trial of nivolumab/ipilimumab with local consolidation, gotistobart in the post-PD-(L)1 setting, and 8-year follow-up data from KEYNOTE-189/407, followed by an expert discussion. The second part highlights three novel immunotherapeutic platforms: an EGFR CAR T-cell therapy for HER2-mutant NSCLC, an anti-PD-1-proIL-2 fusion protein, and a PD-L1/4-1BB bispecific antibody combined with chemotherapy. Together, these presentations capture the evolving NSCLC immunotherapy landscape, from refining checkpoint inhibitor combinations to advancing next-generation engineered therapies."

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • HER-2

PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: OncoC4, Inc. | Active, not recruiting ➔ Completed

Trial completion • Anal Carcinoma • Biliary Cancer • Bladder Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • High Grade Serous Ovarian Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Anti-tumor activity of gotistobart compared to docetaxel in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) progressing on PD-(L)1 inhibitors: Stage 1 PRESERVE-003 phase III trial (ELCC 2026) - P3 | "and is conducted in collaboration with BioNTech SE. Funding OncoC4, Inc."

Clinical • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Gotistobart Plus Pembrolizumab Demonstrates Durable Antitumor Activity in Advanced Melanoma Refractory or Resistant to Both Prior Anti–CTLA-4 and Anti–PD-(L)1 Therapies (ESMO 2026) - No abstract available

Metastases • Melanoma • Oncology • Solid Tumor

Population pharmacokinetics for the CTLA-4 modulator gotistobart in patients with advanced solid tumors. (PubMed, J Clin Pharmacol) - "Compared with 6 mg/kg every 3 weeks, administration of two 10 mg/kg loading doses followed by 6 mg/kg every 3 weeks accelerated the attainment of steady state. The validated population pharmacokinetic model provides a quantitative foundation for subsequent exposure-response analyses and regimen selection."

Journal • PK/PD data • Oncology • Solid Tumor • CTLA4

Dose escalation of next generation Anti-CTLA-4 antibody ONC-392 in combination with fixed dose of pembrolizumab in patients with advanced solid tumors (SITC 2022) - P1a/1b | "Eleven patients had prior anti-PD-1/PD-L1 and 5 melanoma patients had prior ipilimumab. The rate of irAE is low relative to drugs of the same class. These results support the feasibility to significantly increase drug exposure for full immunotherapeutic potential of anti-CTLA-4 and anti-PD-1 combination therapy."

Clinical • Combination therapy • Cervical Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Gotistobart Long Term Extension (LTE) Study (clinicaltrials.gov) - P3 | N=20 | Enrolling by invitation | Sponsor: OncoC4, Inc. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Oncology • Solid Tumor

BioNTech SE…will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026. (The Manila Times) - "The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate ("ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311)..."

Clinical data • P1/2 data • P3 data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov) - P3 | N=630 | Active, not recruiting | Sponsor: OncoC4, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4 • LAG3 • TIGIT

A global Phase 3 clinical trial (PRESERVE-003; NCT05671510) is ongoing to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic squamous NSCLC that progressed on previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment. (BioNTech Press Release) - "Updated data from the Stage 1 of this trial are expected to be presented at the International Association for the Study of Lung Cancer ('IASLC') 2026 World Conference on Lung Cancer ('WCLC'); Based on current event accrual projections, the first interim analysis from Stage 2 of the two-stage Phase 3 clinical trial is expected in 2026."

P3 data • Lung Non-Small Cell Squamous Cancer

PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - P1a/1b; N=413; Recruiting; Sponsor: OncoC4, Inc.; N=300 ➔ 413; Trial completion date: Dec 2023 ➔ Dec 2024; Trial primary completion date: Dec 2022 ➔ Dec 2023

Clinical • Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • BRAF • EGFR

PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - P1/2 | N=733 | Recruiting | Sponsor: OncoC4, Inc. | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Adenoid Cystic Carcinoma • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Salivary Gland Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - P1/2 | N=914 | Recruiting | Sponsor: OncoC4, Inc. | Phase classification: P1a/1b ➔ P1/2 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Combination therapy • Metastases • Monotherapy • Phase classification • Trial primary completion date • Adenoid Cystic Carcinoma • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Salivary Gland Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - P1a/1b | N=914 | Recruiting | Sponsor: OncoC4, Inc. | N=468 ➔ 914

Combination therapy • Enrollment change • Metastases • Monotherapy • Adenoid Cystic Carcinoma • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Salivary Gland Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Gotistobart Long Term Extension (LTE) Study (clinicaltrials.gov) - P3 | N=20 | Not yet recruiting | Sponsor: OncoC4, Inc.

New P3 trial • Oncology • Solid Tumor

PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov) - P1/2 | N=148 | Active, not recruiting | Sponsor: OncoC4, Inc. | Trial completion date: Jun 2027 ➔ Nov 2027 | Trial primary completion date: Jun 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

BioNTech to Showcase Progress Across Late-Stage Oncology Pipeline at the 2026 ASCO Annual Meeting (GlobeNewswire) - "1L NSCLC: Data from the interim analysis of the Phase 2 dose-optimization part of the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) showed encouraging anti-tumor activity in first-line ('1L') non-small cell lung cancer ('NSCLC')....Updated data from a later cut-off date will be presented in a rapid oral presentation....PROC: Data from the Phase 2 PRESERVE-004 clinical trial (NCT05446298) evaluating gotistobart plus pembrolizumab in heavily pre-treated patients with platinum-resistant ovarian cancer ('PROC') showed durable anti-tumor activity and clinically meaningful overall survival outcomes."

P2 data • Platinum resistant • Non Small Cell Lung Cancer • Ovarian Cancer