BioNTech's HER2-targeted Drug Shows Positive Results in Advanced Endometrial Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 12 2026
0mins
Should l Buy BNTX?
BioNTech announced positive results from the primary analysis of a Phase 2 cohort evaluating trastuzumab pamirtecan, BNT323 or DB-1303, in patients with HER2-expressing, advanced endometrial cancer whose disease progressed on or after first-line chemotherapy with or without prior checkpoint inhibitor treatment. This cohort is part of a global Phase 1/2a clinical trial investigating the HER2-targeted antibody-drug conjugate, ADC, candidate trastuzumab pamirtecan in multiple solid tumors. The data demonstrated clinically meaningful efficacy and a manageable safety profile for trastuzumab pamirtecan monotherapy across all HER2 immunohistochemistry expression levels. Outcomes were consistent among patients regardless of prior checkpoint inhibitor treatment. The data will be presented today in an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women's Cancers in San Juan, Puerto Rico. The analysis of the Phase 2 cohort included 145 patients with advanced or metastatic HER2-expressing endometrial cancer whose disease had progressed following first- or later lines of therapy. This cohort met its primary efficacy endpoint of objective response rate evaluated in 73 patients previously treated with checkpoint inhibitor therapy and confirmed HER2 status by central testing, showing a confirmed ORR of 49.3%. In all centrally tested patients the confirmed ORR was 47.9% with a median progression-free survival of 8.1 months.
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Analyst Views on BNTX
Wall Street analysts forecast BNTX stock price to rise
13 Analyst Rating
12 Buy
1 Hold
0 Sell
Strong Buy
Current: 102.920
Low
113.00
Averages
143.17
High
181.00
Current: 102.920
Low
113.00
Averages
143.17
High
181.00
About BNTX
BioNTech SE is a Germany-based clinical-stage biotechnology company. The Company focuses on patient-specific immunotherapies for the treatment of cancer and other serious diseases. The Company is providing technologies including mRNA-based therapies, cell therapies, small molecules and antibodies, which can be utilized for specific purposes or can be even combined with each other in a synergistic manner. It also develops a broad product pipeline using different scientific approaches and technology platforms, including individualized mRNA-based product candidates, chimeric antigen receptor T-cells, checkpoint immunomodulators, targeted cancer antibodies and small molecules. In addition, the Company offers diagnostic products and drug discovery services for other therapeutic areas, including infectious diseases, allergies and autoimmune disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Analysis of Investment Prospects in Healthcare Stocks
- Animal Health Leader: Zoetis has faced challenges over the past two years, including increased competition and scrutiny over drug side effects; however, its strong market position and the potential market for untreated dogs make it attractive for long-term investors, with expectations to continue launching new products to meet rising pet spending.
- New Drug Development Potential: BioNTech has underperformed in the coronavirus vaccine market, but its impressive pipeline with over 25 clinical trials in oncology, particularly the promising BNT327 developed with Bristol Myers Squibb, could set new standards of care across multiple indications, with significant clinical and regulatory progress expected over the next five years.
- Gene Editing Risks: Intellia Therapeutics' lonvo-z and nex-z are undergoing phase 3 studies but face uncertainty; despite the FDA lifting the hold on clinical trials, the high costs and complexities of gene editing treatments make steady revenue generation unlikely in the coming years, presenting substantial investment risks.
- Dividend Appeal: Zoetis has increased its dividends by 458% over the past decade, making it a top choice for income-seeking investors, reflecting its long-term investment value in the animal health market despite facing short-term challenges.
See More
BioNTech Reports Phase 2 Results for HER2 Cancer Drug
- Trial Results: BioNTech's Trastuzumab Pamirtecan demonstrated a 47.9% objective response rate in 145 patients with HER2-positive advanced endometrial cancer, indicating its efficacy even after first-line chemotherapy, potentially offering new treatment options for patients.
- Safety Profile: Among the 145 patients, 46.9% reported grade 3 or higher treatment-related adverse events; however, most of these events were manageable with appropriate medical interventions, highlighting the drug's controllable safety profile.
- Future Plans: BioNTech and DualityBio plan to file a biologics license application in 2026, subject to FDA feedback, reflecting the company's confidence in the market potential of this drug.
- Market Performance: BNTX shares traded between $79.52 and $124.00 over the past year, closing at $59.50 with a 3.83% increase, indicating a positive market reaction to its clinical advancements.
See More
Trastuzumab Pamirtecan Shows Promising Results in Endometrial Cancer Clinical Trial
- Clinical Trial Results: Trastuzumab pamirtecan demonstrated a 47.9% objective response rate in 145 heavily pre-treated patients, with a notable 49.3% response rate in those previously treated with immune checkpoint inhibitors, indicating significant potential in treating HER2-expressing recurrent endometrial cancer.
- Survival Data: The drug achieved a median progression-free survival of 8.1 months, showcasing robust efficacy across all evaluable patients, particularly providing new treatment options for those with lower HER2 expression levels, thus addressing a critical clinical need.
- Safety Profile: Among the 145 patients, 46.9% reported grade 3 or higher treatment-related adverse events, primarily low-grade nausea and anemia, indicating a manageable safety profile that supports broader clinical application.
- Future Development Plans: BioNTech plans to file a biologics license application in 2026 and continues to advance the clinical development of Trastuzumab pamirtecan, aiming to address significant unmet medical needs in patients with HER2-driven tumors.
See More
BioNTech's Trastuzumab Pamirtecan Shows Promising Results in Endometrial Cancer Trial
- Clinical Trial Results: BioNTech's trastuzumab pamirtecan demonstrated a 47.9% objective response rate in 145 heavily pre-treated patients, with a notable 49.3% response rate in those previously treated with immune checkpoint inhibitors, indicating significant potential in treating HER2-expressing recurrent endometrial cancer.
- Survival Data: The drug achieved a median progression-free survival of 8.1 months, highlighting its effectiveness in a clinical context where current standard chemotherapy offers only a 15% response rate, thus marking a substantial advancement in treatment options.
- Safety Profile: Among the 145 patients, 46.9% reported grade 3 or higher treatment-related adverse events, primarily low-grade nausea and anemia, suggesting a manageable safety profile that supports broader clinical application.
- Future Development Plans: BioNTech plans to file a biologics license application in 2026 and continue advancing trastuzumab pamirtecan in clinical trials, aiming to address significant unmet medical needs for patients with HER2-driven tumors.
See More
BOEHRINGER INGELHEIM: BIONTECH AND CO MAINTAIN COMPLETE OWNERSHIP OF THEIR ASSETS, WITH A NON-EXCLUSIVE MUTUAL AGREEMENT
- Core Rights: BioTech companies retain full rights to their respective assets.
- Mutual Agreement: The agreement between parties is mutually non-exclusive.
See More
Boehringer Ingelheim: BioNTech to Provide Pumitamig, While Co. Acts as Regulatory Sponsor for Phase IB/II Trial
BioNTech's Role: BioNTech will supply Pumitamig, a new therapeutic agent, as part of its ongoing research and development efforts in biotechnology.
Regulatory Sponsorship: The company will also act as the regulatory sponsor for the Phase I/II study of Pumitamig, indicating its commitment to advancing clinical trials.
See More
Analysis of Investment Prospects in Healthcare Stocks
- Animal Health Leader: Zoetis has faced challenges over the past two years, including increased competition and scrutiny over drug side effects; however, its strong market position and the potential market for untreated dogs make it attractive for long-term investors, with expectations to continue launching new products to meet rising pet spending.
- New Drug Development Potential: BioNTech has underperformed in the coronavirus vaccine market, but its impressive pipeline with over 25 clinical trials in oncology, particularly the promising BNT327 developed with Bristol Myers Squibb, could set new standards of care across multiple indications, with significant clinical and regulatory progress expected over the next five years.
- Gene Editing Risks: Intellia Therapeutics' lonvo-z and nex-z are undergoing phase 3 studies but face uncertainty; despite the FDA lifting the hold on clinical trials, the high costs and complexities of gene editing treatments make steady revenue generation unlikely in the coming years, presenting substantial investment risks.
- Dividend Appeal: Zoetis has increased its dividends by 458% over the past decade, making it a top choice for income-seeking investors, reflecting its long-term investment value in the animal health market despite facing short-term challenges.
See More
BioNTech Reports Phase 2 Results for HER2 Cancer Drug
- Trial Results: BioNTech's Trastuzumab Pamirtecan demonstrated a 47.9% objective response rate in 145 patients with HER2-positive advanced endometrial cancer, indicating its efficacy even after first-line chemotherapy, potentially offering new treatment options for patients.
- Safety Profile: Among the 145 patients, 46.9% reported grade 3 or higher treatment-related adverse events; however, most of these events were manageable with appropriate medical interventions, highlighting the drug's controllable safety profile.
- Future Plans: BioNTech and DualityBio plan to file a biologics license application in 2026, subject to FDA feedback, reflecting the company's confidence in the market potential of this drug.
- Market Performance: BNTX shares traded between $79.52 and $124.00 over the past year, closing at $59.50 with a 3.83% increase, indicating a positive market reaction to its clinical advancements.
See More
Trastuzumab Pamirtecan Shows Promising Results in Endometrial Cancer Clinical Trial
- Clinical Trial Results: Trastuzumab pamirtecan demonstrated a 47.9% objective response rate in 145 heavily pre-treated patients, with a notable 49.3% response rate in those previously treated with immune checkpoint inhibitors, indicating significant potential in treating HER2-expressing recurrent endometrial cancer.
- Survival Data: The drug achieved a median progression-free survival of 8.1 months, showcasing robust efficacy across all evaluable patients, particularly providing new treatment options for those with lower HER2 expression levels, thus addressing a critical clinical need.
- Safety Profile: Among the 145 patients, 46.9% reported grade 3 or higher treatment-related adverse events, primarily low-grade nausea and anemia, indicating a manageable safety profile that supports broader clinical application.
- Future Development Plans: BioNTech plans to file a biologics license application in 2026 and continues to advance the clinical development of Trastuzumab pamirtecan, aiming to address significant unmet medical needs in patients with HER2-driven tumors.
See More
BioNTech's Trastuzumab Pamirtecan Shows Promising Results in Endometrial Cancer Trial
- Clinical Trial Results: BioNTech's trastuzumab pamirtecan demonstrated a 47.9% objective response rate in 145 heavily pre-treated patients, with a notable 49.3% response rate in those previously treated with immune checkpoint inhibitors, indicating significant potential in treating HER2-expressing recurrent endometrial cancer.
- Survival Data: The drug achieved a median progression-free survival of 8.1 months, highlighting its effectiveness in a clinical context where current standard chemotherapy offers only a 15% response rate, thus marking a substantial advancement in treatment options.
- Safety Profile: Among the 145 patients, 46.9% reported grade 3 or higher treatment-related adverse events, primarily low-grade nausea and anemia, suggesting a manageable safety profile that supports broader clinical application.
- Future Development Plans: BioNTech plans to file a biologics license application in 2026 and continue advancing trastuzumab pamirtecan in clinical trials, aiming to address significant unmet medical needs for patients with HER2-driven tumors.
See More
BOEHRINGER INGELHEIM: BIONTECH AND CO MAINTAIN COMPLETE OWNERSHIP OF THEIR ASSETS, WITH A NON-EXCLUSIVE MUTUAL AGREEMENT
- Core Rights: BioTech companies retain full rights to their respective assets.
- Mutual Agreement: The agreement between parties is mutually non-exclusive.
See More
Boehringer Ingelheim: BioNTech to Provide Pumitamig, While Co. Acts as Regulatory Sponsor for Phase IB/II Trial
BioNTech's Role: BioNTech will supply Pumitamig, a new therapeutic agent, as part of its ongoing research and development efforts in biotechnology.
Regulatory Sponsorship: The company will also act as the regulatory sponsor for the Phase I/II study of Pumitamig, indicating its commitment to advancing clinical trials.
See More
