BioNTech (NASDAQ: BNTX) and its partner, Duality Biologics, have announced a major milestone in their oncology program. Their experimental drug, BNT323, has successfully achieved its primary goal of slowing disease progression in HER2-positive breast cancer during a pivotal Phase III clinical trial. This marks BioNTech's first success in a late-stage cancer trial, sparking optimism for its potential approval and future applications.

The announcement led to a nearly 10% surge in BioNTech's stock, reflecting the excitement surrounding the treatment's promise. BNT323, also known as DB-1303 or trastuzumab pamirtecan, is a third-generation topoisomerase-1 inhibitor-based antibody-drug conjugate (ADC) targeting HER2, a protein associated with aggressive tumor growth. The drug has shown potential not only in HER2-positive breast cancer but also in other solid tumors, including HER2-low cancers.

Promising Results in Breast Cancer Treatment

The Phase III trial focused on patients with HER2-positive breast cancer that could not be surgically removed and had progressed despite prior treatments. According to an independent data monitoring committee, patients treated with BNT323 experienced longer periods without disease progression compared to those receiving an alternative ADC. This positive outcome highlights the drug's potential to become a new standard of care for breast cancer patients.

Dr. Hua Mu, Global Medical Officer of Duality Biologics, emphasized the significance of the results, particularly in regions like China, where breast cancer has a high incidence rate. "With over 350,000 new cases annually, breast cancer is the second most common malignant tumor among Chinese women," Dr. Mu stated. "The positive Phase III data and trastuzumab pamirtecan meeting the primary endpoint at the interim analysis indicate the potential of the BNT323/DB-1303 program to become a new treatment option for breast cancer patients."

Expanding Horizons for BNT323

Beyond breast cancer, BNT323 has demonstrated antitumor activity in various solid tumor models, including endometrial cancers and advanced solid tumors. Preclinical data suggests that the drug can target HER2 receptors regardless of expression levels, offering a stable safety profile and a broader therapeutic window. This positions BNT323 as a versatile candidate in oncology, with potential applications across multiple tumor types.

Van Lanschot Kempen analyst Sushila Hernandez described the trial results as a pivotal moment for BioNTech. "It is exciting that this is BioNTech's first late-stage oncology program that meets the primary endpoint of a pivotal Phase III trial," Hernandez told Reuters.

Next Steps for Approval

Following the successful trial, BioNTech and Duality Biologics are preparing to submit a Biologics License Application (BLA) in China, where the trial was conducted. Discussions with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) are expected to follow. BioNTech's Chief Medical Officer, Dr. Ã?zlem Tureci, expressed optimism about the drug's future, stating, "We believe that trastuzumab pamirtecan is an ADC candidate with enormous potential, making it an important asset in our global oncology strategy, including combinational approaches."

A Milestone in Oncology

The success of BNT323 represents a significant step forward for BioNTech, a company best known for its COVID-19 vaccine. This achievement underscores its commitment to advancing oncology treatments and expanding its portfolio beyond infectious diseases. With the potential to address unmet needs in cancer care, BNT323 could pave the way for new treatment options and improve outcomes for patients worldwide.

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