Innovent Secures Fast Track Status from the FDA for IBI343

Innovent Secures Fast Track Status from the FDA for IBI343

By, Admin 14 June 2024

Innovent Secures Fast Track Status from the FDA for IBI343, a Monotherapy for Advanced Pancreatic Cancer

Overview

Innovent Biologics, Inc. (HKEX: 01801), a global leader in biopharmaceuticals, focuses on the development, manufacturing, and commercialization of high-quality medicines for various major diseases, including oncology, cardiovascular and metabolic disorders, autoimmune conditions, and ophthalmology. The company recently announced that its TOPO1 inhibitor anti-CLDN18.2 antibody-drug conjugate (ADC), known as IBI343, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed or is resistant to a prior therapy. This follows FDA approval of IBI343’s Investigational New Drug (IND) application for PDAC.

Points from ASCO 2024 Annual Meeting

  • At the ASCO 2024 Annual Meeting, Innovent shared initial results from Phase 1 trials of IBI343, focusing on PDAC patients who had received at least one prior treatment. 
  • In the 6 mg/kg dose cohort, a 40% overall response rate was observed among 10 evaluable patients with high CLDN18.2 expression levels.

From Innovent

  • Innovent, noted, ""Pancreatic cancer is notably aggressive and often hard to detect early. Current treatments for advanced pancreatic cancer predominantly involve systemic chemotherapy, with limited second-line options showing only a 6%-16% response rate and a median survival of about 3-6 months. This underscores the critical need for improved treatment options.” 
  • “IBI343, the first CLDN18.2 ADC to receive Fast Track Designation for this challenging cancer, shows promising efficacy and acceptable safety in advanced-stage treatment. We are committed to further validating its effectiveness and safety in upcoming clinical trials, and exploring its use in combination therapies and other solid tumors, such as gastric cancer."

Fast Track Designation

Fast Track Designation is intended to expedite the development and review of treatments for serious conditions with unmet medical needs, offering increased opportunities for interactions with the FDA to potentially speed up the approval process.
Pancreatic cancer

  • Pancreatic cancer is among the most aggressive cancers within the digestive system, with a 5-year survival rate of around 10%. 
  • The disease’s incidence has been rising, but early detection remains a challenge, significantly affecting health outcomes. 
  • Current treatment options for advanced pancreatic cancer mainly involve systemic chemotherapy, primarily using regimens based on fluorouracil (5-FU) or gemcitabine. 
  • Second-line treatments are limited and generally provide a median survival of about 3 to 4 months. 
  • Claudin, a component of epithelial cell tight junctions, is typically obscured in the gastric lining but becomes exposed in cancerous conditions, making CLDN18.2 a key target in approximately 50% to 70% of pancreatic cancer cases.

About IBI343

  • IBI343 is a recombinant human anti-Claudin 18.2 monoclonal antibody-drug conjugate developed by Innovent Biologics. 
  • It targets tumor cells expressing Claudin 18.2, prompting internalization of the ADC, processing in lysosomes, and release of the active drug (TOP1i), which results in DNA damage and subsequent apoptosis of the cancer cells. 
  • The free drug can also affect nearby cells, leading to a ""bystander killing effect."" I
  • BI343 has demonstrated manageable safety and promising efficacy in Phase 1 clinical studies, and its therapeutic potential is being further explored in treatments for gastric and pancreatic cancers.

NMPA Breakthrough Therapy Designation to IBI343

  • In May 2024, the National Medical Products Administration (NMPA) of China granted breakthrough therapy designation to IBI343 for use as a single agent in patients with Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma who have progressed after two prior systemic treatments. 
  • Preparations are underway for a multi-center Phase 3 trial for this indication.