BioNTech and DualityBio Receive FDA Fast Track Designation for Innovative Antibody-Drug Conjugate Candidate BNT325/DB-1305
Thursday, February 01, 2024
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced that the US Food and Drug Administration ( “FDA”) has granted Fast Track Designation to BNT325/DB-1305. The status applies to the treatment of patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have previously received one to three systemic therapies. BNT325/DB-1305 is a next-generation antibody-drug conjugate ( “ ADC”) candidate that targets trophoblast cell surface antigen 2 (“TROP2”), which has been identified in a series is over-expressed by tumor types. The candidate is currently being investigated in an ongoing phase 1/2 study ( NCT05438329 ) in patients with TROP2-expressing advanced solid tumors.
Ovarian cancer is the fourth most common gynecological tumor type with over 300,000 cases diagnosed worldwide each year. 3 Over 90% of these tumors arise from epithelial cells of the ovary or surrounding tissues such as those of the fallopian tube or peritoneum. 4 Epithelial ovarian cancer is often only diagnosed in advanced stages of the disease, resulting in a poor prognosis for patients. This type of cancer is therefore one of the most common causes of cancer-related deaths in women. 3 The 5-year survival rate is 26% to 42%, depending on the initial stage of the disease. 3
“The FDA’s decision is an important recognition of the potential of our TROP2-targeting ADC candidate. Platinum-based chemotherapy is the basis of treatment for epithelial ovarian cancer and related subtypes that form in epithelial tissue. Patients who develop resistance to platinum-based chemotherapy and relapse within less than six months have a poor prognosis. Effective and well-tolerated treatment options are still rare,” said Prof. Dr. Özlem Türeci, Chief Medical Officer and co-founder of BioNTech . “Recent studies have shown that TROP2 can contribute to aggressive tumor growth and influence tumor spread in patients with chemotherapy-resistant ovarian tumors. We are committed to further advancing the development of BNT325/DB-1305 because we believe that a TROP2-targeted therapeutic approach has the potential to overcome current limitations in the treatment of advanced ovarian cancers."
“BNT325/DB-1305 is the second investigational drug from our strategic collaboration to receive FDA Fast Track designation. “This highlights the candidate’s potential to address unmet medical needs,” said Dr. Vivian Gu, Chief Medical Officer at DualityBio . “Data from the Phase 1/2 clinical trial of BNT325/DB-1305 have shown encouraging antitumor signals with an objective response rate of 30 in heavily pretreated patients with TROP2-expressing solid tumors that have not responded to standard therapy. 4% and a disease control rate of 87.0%. 5 We look forward to advancing the development of BNT325/DB-1305 and taking another step toward potentially improving therapeutic outcomes in a broad range of patients.”
Fast Track is a process to facilitate the development and accelerate testing of new medicines and vaccines intended to treat or prevent serious diseases and have the potential to address unmet medical needs. The FDA's decision is based on preliminary data from an ongoing Phase 1/2 trial of BNT325/DB-1305 in patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal epithelial cancer. 1 With Fast Track status, the development of BNT325/DB-1305 may benefit from closer collaboration with the FDA. This will support the collection of the appropriate data needed to accelerate the development of BNT325/DB-1305.
About BNT325/DB-1305
BNT325/DB-1305 is a third-generation topoisomerase-1 inhibitor-based antibody-drug conjugate targeting TROP2 based on DualityBio's proprietary Immune Toxin Antibody Conjugates (“DITAC”) platform based. TROP2 is a cell surface protein that is expressed in many healthy tissues but is overexpressed in a variety of tumors. TROP2 plays an important role in the proliferation, apoptosis and invasion of tumor cells and thus influences the prognosis and treatment of patients with cancer. 6 , 7 BNT325/DB-1305 has demonstrated antitumor activity in both tumor models and various advanced solid tumors, including non-small cell lung cancer (“NSCLC”) and epithelial ovarian cancer. 8 Preclinical data and preliminary clinical data for BNT325/DB-1305 suggest the potential to target TROP2 receptors on solid tumors regardless of expression level with a manageable safety profile and a potentially expanded therapeutic window. 5
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering therapies for cancer and other serious diseases. The company combines a variety of advanced therapeutic platforms and bioinformatics tools to rapidly advance the development of novel biopharmaceuticals. The diversified portfolio of oncology product candidates includes individualized therapies as well as off-the-shelf mRNA-based medicines, innovative chimeric antigen receptor (CAR) T cells, various protein-based therapeutics including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody drugs. Conjugates and low-molecular active ingredients. Based on its extensive expertise in the development of mRNA vaccines and in-house manufacturing capabilities, in addition to its diverse oncology pipeline, BioNTech is developing various mRNA vaccine candidates for a range of infectious diseases together with collaboration partners. BioNTech works side by side with globally renowned collaboration partners from the pharmaceutical industry, including DualityBio, Fosun Pharma, Genentech (a Roche Group company), Genevant, Genmab, OncoC4, Regeneron and Pfizer.
Further information can be found at: www.BioNTech.de .
About DualityBio
DualityBio is a clinical-stage product candidate company focused on identifying and developing next-generation antibody-drug conjugates (“ADCs”) for the treatment of cancer and autoimmune diseases . DualityBio has successfully developed a series of next-generation ADC technology platforms with global intellectual property rights. Building on a deep understanding of disease biology and translational capabilities, DualityBio has advanced four product candidates into global clinical trials and developed more than ten innovative product candidates that are currently in preclinical stages. In addition, DualityBio continues to develop its novel protein engineering and ADC technology platforms for the next wave of innovation of "super ADC" molecules, including various payload classes, bispecific ADCs and dual payload ADCs.
For more information, visit www.dualitybiologics.com .
BioNTech Forward-Looking Statements
This press release contains certain forward-looking statements under the amended Private Securities Litigation Reform Act of 1995, including, but not limited to, statements, express or implied, regarding: BioNTech and DualityBio's collaboration to jointly develop antibody Active ingredient conjugates ( antibody-drug conjugates, “ADCs”), including BNT325/DB-1305; the regulatory potential of any studies that may be initiated for BNT325/DB-1305; the form, characterization and timing of publication of clinical data from BioNTech's development platforms, which are subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech's development programs, including, but not limited to, statements regarding the timing of the initiation or enrollment of clinical trials, the application for and receipt of product approvals with respect to BioNTech's product candidates; the ability of BioNTech's mRNA technology to demonstrate clinical efficacy outside of BioNTech's infectious disease platform; the potential safety and effectiveness of BioNTech's other product candidates; BioNTech's expected market opportunity and size for its product candidates. All forward-looking statements in this press release are based on BioNTech's current expectations and beliefs regarding future events and are subject to numerous risks and uncertainties that could cause actual results to differ materially and adversely from those contained in or contained in these forward-looking statements be implied. These risks and uncertainties include, but are not limited to, discussions with regulatory authorities regarding the timing and requirements for additional clinical trials; and the ability to achieve comparable clinical results in future clinical trials. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "should," "expects," "intends," "plans," "targets," "anticipates," "estimates," believes," "predicts," "potential," "continues" or the negative form of these terms or other comparable terminology, although not all forward-looking statements need to contain these words. The forward-looking statements in this press release are neither promises nor guarantees and should not be relied upon as such because they are subject to a number of known and unknown risks, uncertainties and other factors, many of which are beyond BioNTech's control and which could result in actual results may differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties associated with research and development, including the ability to achieve the expected clinical endpoints, the dates for commencement and/or completion of clinical trials, the dates for submission to the authorities,regulatory approval and/or commercial launch dates, as well as the risks associated with preclinical and clinical data, including the data disclosed in this press release and including the possibility of adverse new preclinical, clinical or safety data emerging, and others Analyzes of existing preclinical, clinical or safety data; the nature of clinical data subject to ongoing peer review, regulatory review and market interpretation; the timing and ability of BioNTech to obtain and maintain regulatory approvals for BioNTech's product candidates; the ability of BioNTech and its contractors to manage and procure necessary energy resources; BioNTech's ability to identify research opportunities and identify and develop investigational medicinal products; the ability and willingness of BioNTech's collaborators to continue research and development activities related to BioNTech's product candidates and investigational products; unforeseen safety issues and potential claims alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; the ability of BioNTech and BioNTech's collaborators to commercialize product candidates and, if approved, commercialize them; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale manufacturing capabilities and produce BioNTech's products and BioNTech's product candidates; risks related to the global financial system and markets; and other factors not currently known to BioNTech.continue research and development activities related to BioNTech's product candidates and investigational products; unforeseen safety issues and potential claims alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; the ability of BioNTech and BioNTech's collaborators to commercialize product candidates and, if approved, commercialize them; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale manufacturing capabilities and produce BioNTech's products and BioNTech's product candidates; risks related to the global financial system and markets; and other factors not currently known to BioNTech.continue research and development activities related to BioNTech's product candidates and investigational products; unforeseen safety issues and potential claims alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; the ability of BioNTech and BioNTech's collaborators to commercialize product candidates and, if approved, commercialize them; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale manufacturing capabilities and produce BioNTech's products and BioNTech's product candidates; risks related to the global financial system and markets; and other factors not currently known to BioNTech.
Risks and uncertainties can be found under the section “Risk Factors” in BioNTech's Report (Form 6-K) for the quarter ended September 30, 2023 and in its subsequent filings with the SEC. These are available on the SEC's website at www.sec.gov . BioNTech undertakes no obligation, other than as required by law, to update such forward-looking statements after the issuance of this statement to reflect new information, future developments or otherwise. These forward-looking statements are based on BioNTech's current expectations and speak only as of the date hereof.
CONTACT
BioNTech
Investoranfragen
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
Medienanfragen
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
DualityBio
Business Development
bd@dualitybiologics.com
Source: globenewswire.com
