DualityBio Announces DB-1303 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA)
DualityBio Announces DB-1303 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the Treatment of Advanced, Recurrent or Metastatic Endometrial Carcinoma with HER2 Overexpression
Duality Biologics ("DualityBio"), a clinical-stage biotech company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment. DB-1303 is a novel antibody-drug conjugate comprised of anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003. It is designed to have potent anti-tumor activity and bystander killing effect, high plasma stability, low free payload in circulation and wide therapeutic index.
Dr. John Zhu, CEO of DualityBio, said: "The FDA's decision to grant FTD underscores the potential for DB-1303 to address the unmet medical need and potentially serve as a new therapeutic option for patients with advanced, recurrent or metastatic endometrial carcinoma." "We are committed to advance this investigational drug to help those patients who are suffering from cancers. We will work closely with clinical investigators and health authorities to unlock the full potential of DB-1303 in patients with malignant tumors."
DualityBio is currently evaluating DB-1303 in an ongoing Phase I/IIa clinical trial for preliminary safety and efficacy in advanced/metastatic solid tumors with Her2 expression, including both HER2 positive and HER2 low patients.
About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
About Endometrial Carcinoma
Endometrial carcinoma (EC) is the most common cancer of the female genital tract in USA. On January 1, 2019, there were an estimated 822,388 people living with uterine corpus cancer in the U.S. (https://seer.cancer.gov), and it is estimated that 66200 new uterine corpus cancer cases will occur with 13030 deaths resulting from the disease in 2022. Around 1 in 4 women with endometrial cancer may experience a recurrence or be diagnosed with advanced disease In endometrial cancer, approximately 60%–70% of high-grade carcinomas appear to overexpress HER2 (reference attached) There is no accepted standard of care and limited therapeutic options for the patients with recurrent or metastatic EC who have failed previous platinum-based systemic therapy with or without immunotherapy. DualityBio is working to develop treatments for the disease to fill this significant unmet medical need.
DB-1303, a 3rd generation HER2 ADC molecule built from Duality Biologics' Proprietary DITAC platform, exhibited potent antitumor activity in both HER2 positive and HER2 low tumor models with superior efficacy, safety and expanded therapeutic window. Both preclinical data and preliminary clinical data from DB1303 suggest the potential of DB-1303 to address unmet medical needs in various HER2 expressing cancers.
About Duality Biologics
Duality Biologics ("DualityBio") is a clinical-stage biotech company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers and autoimmune diseases. Leveraging its DITAC (Duality Immune Toxin Antibody Conjugates) and DIMAC (Duality Immune Modulating Antibody Conjugates), Duality is developing more than 10 ADCs at clinical and preclinical stage.
The company has an international team located in China and the United States, with proven track record in the field of novel drug research, clinical development and global business development. The global clinical development team has led clinical trials for more than 50 oncology and immunology drugs, and facilitated the approval of five innovative drugs in China and the United States. The global business development team has led and executed more than 20 strategic global in-licensing, out-licensing and M&A collaboration deals, with a total valuation of more than $5 billion. DualityBio will continue to expand and deepen the existing pipeline and R&D platform, both through internal R&D effort and strategic external collaborations.