German multinational biotechnology company headquartered in Mainz, developing immunotherapies and vaccines for cancer and infectious diseases using mRNA-based platforms; gained prominence through its COVID-19 vaccine partnership with Pfizer.
Clinical Trials
139
48 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Active, not recruiting
45
32.4%
Completed
37
26.6%
Not yet recruiting
3
2.2%
Recruiting
45
32.4%
Terminated
6
4.3%
Withdrawn
3
2.2%
No approval data available
- The FDA has granted Fast Track Designation to OncoC4's PD-1/VEGF bispecific antibody cesalatamig for NSCLC that progressed after PD-(L)1 immunotherapy and platinum-based chemotherapy. - Cesalatamig, also known as AI-081, is being evaluated in global Phase 1/2 BiPAVE-001 trials in the United States and China across more than 50 clinical sites. - OncoC4 says the designation reflects clinical safety and efficacy signals from the trials and supports rapid advancement to registrational Phase 3 development in PD-(L)1-refractory or resistant NSCLC. - The antibody is engineered for high PD-1 affinity and more than 40-fold higher VEGF affinity than bevacizumab-based PD-(L)1/VEGF inhibitors, with Fc-silencing to spare PD-1 positive effector T cells.
- BioNTech and OncoC4 reported median overall survival of 18.5 months with gotistobart versus 10.0 months with docetaxel in stage 1 of the Phase 3 PRESERVE-003 trial. - The CTLA-4-targeting immunotherapy produced a hazard ratio of 0.56 with a nominal p-value of 0.0295 in 87 patients with metastatic squamous NSCLC. - Grade 3 or higher treatment-related adverse events occurred in 44.4% of gotistobart patients versus 48.8% of docetaxel patients, consistent with prior safety data. - The pivotal stage 2 portion of PRESERVE-003 is ongoing at more than 160 sites globally, with overall survival as the primary endpoint.
- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer. - In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up. - Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.
- Oncology still accounts for 38.6% of newly identified drug candidates, but the number of cancer drugs in development fell 4.6% for a second consecutive year. - The anti-obesity category grew 30.7% to 588 drugs, and obesity entered the top 10 indications for the first time with 576 candidates. - Rare disease drugs slipped 1.3% to 7,618 candidates yet rose to 33.2% of the overall pipeline, with Novartis leading at 116 candidates. - Lilly's retatrutide delivered 28.3% average weight loss at 80 weeks, while Novo Nordisk's CagriSema missed noninferiority to tirzepatide.
- BioNTech and Genentech terminated the Phase II BNT122-01 trial of autogene cevumeran in resected colorectal cancer after a DSMB found an overall survival imbalance favoring the control arm. - The DSMB had previously flagged futility in October 2025 but allowed the trial to continue, concluding the data were too immature for reliable efficacy conclusions. - No new safety signals were identified, and the pancreatic cancer program IMcode003 testing autogene cevumeran with atezolizumab and mFOLFIRINOX continues as planned. - The result reinforces questions about personalized mRNA vaccines in immunologically cold, microsatellite stable tumors without checkpoint inhibitor support.
- BioNTech announced it will terminate the mid-stage trial of its experimental mRNA-based cancer vaccine, autogene cevumeran, in colorectal cancer patients, sending its U.S.-listed shares down nearly 9%. - An independent data safety monitoring board recommended discontinuing treatment and terminating the study after identifying a numerical imbalance in overall survival between treatment arms. - The immunotherapy, co-developed with Roche's Genentech, was being evaluated as an adjuvant monotherapy in high-risk stage II/III colorectal cancer patients who remained ctDNA-positive after surgery. - The board noted that further trial continuation was unlikely to change the efficacy outcome in this specific patient population.
- BioNTech and Genentech have decided to terminate the Phase 2 BNT122-01 trial (NCT04486378) of autogene cevumeran as adjuvant monotherapy in ctDNA-positive, resected Stage II/III colorectal cancer. - The decision follows a Data Safety Monitoring Board recommendation citing a numerical imbalance in overall survival and low likelihood that further continuation would change the efficacy outcome. - No new safety signals were identified for autogene cevumeran, and the parallel Phase 2 IMcode003 trial in adjuvant pancreatic ductal adenocarcinoma continues as planned. - BioNTech will conduct a thorough analysis of trial data to inform patient selection and the future development of investigational mRNA cancer immunotherapies.
- Intismeran Autogene, an individualized neoantigen therapy paired with Merck's Keytruda, hit its primary endpoint in the Phase 3 INTerpath-001 study for skin cancer. - The breakthrough sent Moderna shares soaring more than 100% and Merck up over 12%, lifting rival vaccine makers BioNTech and Novavax. - The SPDR S&P Biotech ETF (XBI) surged more than 5% to its highest level since February 2021, reflecting renewed investor appetite across mRNA and vaccine therapeutics. - Novavax rode the sector-wide optimism despite not being directly involved in the trial, adding momentum to its recent earnings beat and raised 2026 revenue guidance.
- GSK's infringement claims over mRNA delivery patent EP 2 590 626 will be heard at The Hague Local Division of the Unified Patent Court on 1 and 3 September, targeting Moderna, BioNTech and Pfizer. - The dispute stems from GSK's decision to enforce its mRNA patent portfolio against the manufacturers of the successful Covid-19 vaccines, with parallel litigation also underway in the US, Ireland and the UK. - The Hague has emerged as the leading UPC venue for pharmaceutical patent litigation, handling roughly a quarter of all such cases despite accounting for only about 12% of overall filings. - A prior CureVac–BioNTech–Pfizer settlement, involving a $370 million payment and 1% royalty to GSK, expressly reserved GSK's own patent enforcement rights against Pfizer and BioNTech.
- OncoC4 announced first-patient dosing in the Phase 1 trial (NCT07408258) of ONC-783, the first-and-only clinical-stage T-cell engager targeting the cancer-specific glycoform of CD24 (neoCD24). - ONC-783 uses a subcutaneous formulation designed to provide gradual systemic exposure, potentially mitigating cytokine release syndrome (CRS) risk compared with intravenous T-cell engagers. - The first patient was dosed at Columbia University Irving Medical Center, with treatment well tolerated and no severe adverse events, CRS, or ICANS observed to date. - The open-label, dose-escalation study evaluates safety, pharmacokinetics, and efficacy in advanced/metastatic solid tumors, focusing on colorectal, ovarian, pancreatic, and breast cancers.
