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BioNTech's BNT323 shows promise in slowing breast cancer progression, boosting shares and paving the way for new treatment options.
This marks the first success in a cancer trial for BioNTech with potential to lead to market approval.
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BioNTech and partner Duality Biologics announced that BNT323 has achieved its main goal of slowing down disease progression for breast cancer in a late-stage trial. Following the announcement BioNTech saw its shares jump nearly 10% prompting excitement for the treatment.
“With over 350,000 new cases annually, breast cancer has a high incidence rate in China, making it the second most common malignant tumor among Chinese women,” said global medical officer of DualityBio, Dr. Hua Mu. “The positive Phase 3 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. Together with our partner BioNTech, we plan the development of trastuzumab pamirtecan in further tumor types towards Biologics License Application in other regions including the United States and the European Union to maximize its potential for patients around the world.”3
Participants in the trial were diagnosed with Her2-positive breast cancer that is unable to be surgically removed and have undergone previous established drug treatment. According to an independent data monitoring committee, patients administered with the experimental treatment lived for longer periods of time before symptoms worsened when compared to those given an alternative antibody drug conjugate (ADC).
Van Lanschot Kempen analyst, Sushila Hernandez, discussed the trial results with Reuters, saying, “It is exciting that this is BioNTech’s first late-stage oncology program that meets the primary endpoint of a pivotal Phase III trial."1
BNT323 (DB-1303/Trastuzumab pamirtecan) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2, contrasted from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (“DITAC”) platform.3 HER2 is a surface-expressed protein on solid tumors, linked to aggressive growth and spread of cancer cells, identifying it as a potential target for cancer therapeutics. BNT323 exhibits antitumor activity in HER2-positive, along with HER2-low tumor models, while also being present in several solid tumor indications, including patients with breast and endometrial cancers, and advanced solid tumors.3 Preclinical data indicates BNT323’s potential in targeting HER2 receptors on solid tumors disregarding expression level with a stable safety profile and the potential to expand its therapeutic window.
Following the successful Phase III trial results, both BioNTech and Duality are internally discussing submission for approval in China, where the clinical trial was located. BioNTech will then hold discussions with The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for submissions of its Biologics License Application. According to BioNTech’s chief medical officer, Ozlem Tureci, BNT323’s success marks the first from the company’s late-stage oncology programs to meet its goal within a pivotal study.
Tureci went on to write about the potential of the treatment, saying, "We believe that trastuzumab pamirtecan is an ADC candidate with enormous potential which makes it an important asset in our global oncology strategy including combinational approaches."1
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