Tyligand Bioscience Receives U.S. FDA Fast Track Designation for puflirasib (TSN1611) as First-Line Treatment for KRAS G12D-Mutated Pancreatic Cancer

Tyligand Bioscience Ltd. ("Tyligand" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its self-developed KRAS G12D inhibitor, puflirasib (TSN1611), in combination with gemcitabine and nab-paclitaxel (the "GnP" regimen) for the first-line (1L) treatment of patients with KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Pancreatic ductal adenocarcinoma (PDAC) is the most common and aggressive form of pancreatic cancer, accounting for more than 90% of all pancreatic cancer cases and representing a high-mortality malignancy globally. KRAS G12D is the most prevalent KRAS mutation subtype in PDAC, with epidemiological and large-scale genomic studies indicating that it accounts for approximately 35% to 40% of all PDAC cases. Currently, no KRAS G12D-targeted inhibitor drugs have been approved for marketing globally, and first-line standard-of-care treatment for metastatic PDAC remains heavily reliant on traditional systemic chemotherapy represented by the GnP regimen, underscoring an urgent clinical need for precise and effective targeted treatment options.

Fast Track Designation is an expedited review mechanism established by the U.S. FDA to facilitate the development and review of innovative drugs intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. With this designation, Tyligand will benefit from more effective communications with the FDA during the subsequent clinical development of TSN1611, as well as potential eligibility for Accelerated Approval, Priority Review, and Rolling Review for a future New Drug Application (NDA) submission, if relevant criteria are met.

"Receiving FDA Fast Track Designation for puflirasib in combination with standard first-line chemotherapy for the treatment of metastatic pancreatic cancer is a significant milestone in Tyligand's global R&D and regulatory progress, and once again validates the clinical application potential of our Core Product," said Dr. Tony Zhang, Co-Founder, Chairman, and Chief Executive Officer of Tyligand Bioscience. "In clinical studies conducted to date, puflirasib has not only demonstrated encouraging anti-tumor activity across multiple KRAS G12D-mutated solid tumors - including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC) - but also exhibited a favorable safety and tolerability profile, with a low incidence of Grade 3 or higher treatment-related adverse events (TRAEs). These differentiated advantages strongly validate puflirasib's substantial potential to serve as a cornerstone agent in combination with standard first-line chemotherapy. We look forward to working closely with regulatory authorities and global investigators to advance the clinical development of this regimen at full speed and strive to benefit the broad population of pancreatic cancer patients in urgent need of new therapies as soon as possible."