Carboplatin, Etoposide, Obrixtamig, Pumitamig, Bnt327
Extensive-Stage Small Cell Lung Carcinoma, Advanced Small Cell Lung Cancer
Phase I/II
Not Yet Recruiting
A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)
Sep 22, 2026
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Atezolizumab, Bevacizumab, Ipilimumab, Pumitamig
Hepatocellular Carcinoma (Hcc)
Phase I/II
Recruiting
A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
Dec 17, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BioNTech SE (BNTXN) have in its pipeline
BNTXN is currently developing the following drugs: Carboplatin, Etoposide, Obrixtamig, Pumitamig, Bnt327, Bnt162b2 Vaccine, Tdap Vaccine, Bnt168. These drug candidates are in various stages of clinical development as the company works toward FDA approval.