BioNTech reports a medical breakthrough in the treatment of uterine cancer and is planning to apply for approval in 2026 following promising study data.
• Promising study data for drug against uterine cancer
• Rising death rate from uterine cancer creates high medical needs
• FDA grants fast track and breakthrough therapy status to active ingredient
Breakthrough in cancer therapy – Strong data on uterine cancer
The Mainz-based biotechnology company BioNTech presented impressive phase 2 data for its drug candidate Trastuzumab Pamirtecan (BNT323/DB-1303) at the SGO annual meeting in Puerto Rico on Saturday. The antibody-drug conjugate (ADC) candidate was studied in patients with advanced uterine cancer who had already undergone previous treatments, according to the corresponding press release.
What is particularly noteworthy is the high effectiveness: in patients with previous immunotherapy, the confirmed objective response rate was 49.3 percent. The median progression-free survival was around 8 months. A key advantage of the new agent is that it was effective regardless of HER2 status – even at low expression levels. Prof. Dr. Özlem Türeci, co-founder of BioNTech, emphasizes the importance: “These positive results in patients with uterine cancer, including those with low HER2 expression levels, underline the potential of trastuzumab pamirtecan.”
Approval in sight
In view of increasing death rates from uterine cancer and inadequate standard chemotherapy treatments (response rate only around 15 percent), there is an urgent medical need, as the company explains. The BioNTech candidate demonstrated a manageable safety profile that meets expectations for this class of drugs. The most common side effects were nausea and anemia.
The regulatory course has also already been set: the US authority FDA has already granted the active ingredient Fast Track and Breakthrough Therapy status. A pivotal phase 3 study is currently underway. BioNTech plans to submit the official approval application (BLA) in 2026. Dr. Bhavana Pothuri from NYU Langone Perlmutter Cancer Center puts the results into clinical perspective: “The results for trastuzumab pamirtecan are encouraging, as the candidate demonstrated clinically meaningful treatment results across all HER2 levels. Of particular note, these results were observed in a broad patient population that reflects clinical practice.”
Evelyn Schmal, editorial team at finanzen.net
By the way: BioNTech (ADRs) and other US stocks can even be traded on finanzen.net ZERO until 11 p.m. (without order fees, plus spreads). Open a depot now for free and secure a new customer bonus!
Selected leverage products on BioNTech (ADRs)
With knock-outs, speculative investors can participate disproportionately in price movements. Simply select the desired leverage and we will show you suitable open-end products on BioNTech (ADRs)
The leverage must be between 2 and 20
Advertising
Image sources: Pavlo Gonchar/SOPA Images/LightRocket via Getty Images, Thomas Lohnes/Getty Images
