BioNTech & DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate

BioNTech SE and Duality Biologics recently announced the US FDA granted Fast Track designation for BNT325/DB-1305 for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. BNT325/DB-1305 is a next-generation antibody-drug conjugate (ADC) candidate targeting the trophoblast cell-surface antigen 2 (“TROP2”), a protein which is overexpressed on a range of tumor types. The candidate is currently being evaluated 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 globally each year. Over 90% of ovarian tumors arise from epithelial cells including the epithelial tissue of the ovary, the lining of a fallopian tube or the peritoneum. Ovarian epithelial cancer is often diagnosed at advanced disease stages, leading to a poor prognosis for patients. This makes it one of the most frequent causes of cancer death in women. The 5-year survival rate ranges from 26% to 42%, depending on the initial disease stage.

“The FDA’s decision is an important recognition of the potential of our TROP2-targeting ADC candidate. Platinum-based chemotherapy is the backbone of treatment for ovarian epithelial cancer and related subtypes that form in the epithelial tissue. Patients with platinum resistance who relapse within under six months have a poor prognosis, and effective and well-tolerated treatment options remain a substantial unmet medical need,” said Prof. Özlem Türeci, MD, Chief Medical Officer and Co-Founder at BioNTech. “Recent studies have indicated the role of TROP2 in aggressive tumor growth and progression in patients with chemotherapy-resistant ovarian tumors. We are committed to further advancing BNT325/DB-1305 and believe that a TROP2-targeted treatment approach has the potential to overcome current limitations in the treatment of advanced ovarian cancers.”

“BNT325/DB-1305 is the second investigational asset in our strategic collaboration which has received FDA Fast Track designation highlighting the potential of the candidate to fill an unmet medical need,” added Vivian Gu, MD, Chief Medical Officer at DualityBio. “Data from the Phase 1/2 clinical trial with BNT325/DB-1305 have demonstrated encouraging anti-tumor signals in heavily pretreated patients with TROP2-expressing solid tumors who had failed standard therapy with an objective response rate of 30.4% and a disease control rate of 87.0%.⁵ We look forward to progressing the further development of BNT325/DB-1305 within the fast track framework, and hope to be one step closer to potentially improving outcomes for a range of patients.”

Fast Track is a process designed to facilitate the development and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need. The designation is based on preliminary data from an ongoing Phase 1/2 study with BNT325/DB-1305 in patients  with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer patients. With the Fast Track designation, the development of BNT325/DB-1305 can benefit from more frequent engagement with the FDA, to support the development and expedite the review of BNT325/DB-1305.

BNT325/DB-1305 is a third-generation topoisomerase-1 inhibitor-based ADC targeting TROP2, which was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform. TROP2 is a cell surface protein which is expressed in many normal tissues but is overexpressed in a variety of tumors. TROP2 plays an important role in tumor cell proliferation, apoptosis, and invasion, thereby impacting the prognosis and treatment of cancer patients. BNT325/DB-1305 has exhibited antitumor activity in tumor models as well as in several advanced solid tumor indications, including non-small cell lung cancer (NSCLC) and ovarian epithelial cancer. Preclinical data and preliminary clinical data for BNT325/DB-1305 indicate its potential to target TROP2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window.

Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron and Pfizer. For more information, visit www.BioNTech.com.

DualityBio is a clinical-stage company focusing on the discovery and development of the next generation ADC therapeutics for patients with cancer and autoimmune diseases. DualityBio has successfully established a number of next generation Antibody-Drug Conjugate (ADC) technology platforms with global intellectual property rights. Building upon deep understanding of disease biology and translational capability, DualityBio has advanced 4 assets into global clinical studies, and developed more than 10 innovative product candidates which are currently in preclinical stage. Additionally, DualityBio is continuing evolving its novel protein engineering and ADC technology platforms for the next wave of “super ADC” molecules including diverse payload classes, bispecific ADCs and dual payload ADCs. For more information, visit www.dualitybiologics.com.