#Shanghai #United States #Cancer Treatment #HER3 ADC #DualityBio

DualityBio's Breakthrough Development in Cancer Therapy

DualityBio, a pioneering biotherapeutics company, has recently announced a significant milestone in cancer treatment with the U.S. Food and Drug Administration (FDA) granting Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC), known as DB-1310. This designation is particularly focused on adult patients afflicted with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC), specifically those demonstrating an epidermal growth factor receptor (EGFR) exon 19 deletion or the L858R mutation, who have experienced disease progression after treatment with both a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

DB-1310 represents a significant advancement in the treatment of lung cancer, targeting the HER3 receptor—a protein known to facilitate tumor growth and progression. The development of this novel ADC has been made possible through the utilization of DualityBio's proprietary DITAC platform, which enhances the therapeutic potential of drug conjugates.

In a recent presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, Dr. Aaron E. Lisberg of UCLA shared promising results from the first-in-human Phase I/IIa clinical trial (NCT05785741) involving DB-1310. The trial highlighted not just the efficacy of the drug but also its manageability concerning safety, showcasing DB-1310’s potential to offer new hope for patients battling these advanced solid tumors after failing conventional therapies.

Dr. Hua Mu, the Global Chief Medical Officer at DualityBio, emphasized the promising clinical efficacy noted during the trials. He remarked, "DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with EGFRm nsqNSCLC and multiple solid tumors. Notably, preclinical studies in combination with EGFR TKIs and other anti-cancer agents indicated robust synergistic effects for tumor suppression." This insight hints at the broader clinical implications for DB-1310—and the dedication of DualityBio to escalate its clinical development, potentially providing a novel therapeutic alternative for a wide range of cancer patients.

DualityBiotherapeutics is focused on the discovery and development of next-generation ADCs, which are instrumental in addressing both cancer and autoimmune diseases. The company has successfully established advanced ADC technology platforms while securing global intellectual property rights, ensuring its innovations remain at the forefront of biotechnology.

In addition to this promising development, DualityBio is actively engaged in a series of global clinical trials spanning 17 different countries, with an impressive enrollment of over 2,000 patients across multiple ADC candidates. Such extensive research not only reflects the company’s commitment to advancing the field but also its strategic collaborations with major multinational corporations and biotech innovators, making it a significant player in the ADC landscape.

As DualityBio aims to solidify its presence as a global ADC powerhouse, the company is also exploring bispecific ADCs, novel payload ADCs, and ADCs tailored for autoimmune responses. For those interested in learning more about DualityBio's endeavors and their innovative therapies, further information can be obtained through their official website: www.dualitybiologics.com.

The FDA’s Fast Track Designation is an essential step towards expediting the development of promising therapies. For patients with limited options, DB-1310 could potentially represent the future of treatment possibilities against challenging forms of cancer like advanced lung cancer, emphasizing the importance of ongoing research and innovation in the biotech sphere.