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Drug Farm and Amoytop Partner on First-in-Class ALPK1 Agonist DF-006 for Hepatitis B and Liver Cancer Treatment

2 months ago3 min read

Key Insights

  • Drug Farm and Xiamen Amoytop Biotech have entered into an option agreement for clinical collaboration on DF-006, a first-in-class ALPK1 agonist targeting hepatitis B and hepatocellular cancer in Greater China.

  • DF-006 is an orally administered immunomodulator that stimulates innate immunity in the liver and has completed dose evaluation studies in healthy volunteers and chronic hepatitis B patients with encouraging anti-HBV activity.

  • The collaboration will assess the clinical combination of DF-006 with Amoytop's approved drug PEGBING® as a potential therapeutic regimen to improve functional cure rates in hepatitis B patients.

Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies, has announced an option agreement with Xiamen Amoytop Biotech Co., Ltd. for clinical collaboration on DF-006, a first-in-class ALPK1 agonist immunomodulator targeting hepatitis B and hepatocellular cancer in the Greater China region, including Mainland China, Taiwan, Hong Kong, and Macau.

Novel Mechanism Targets Liver Immunity

DF-006 represents a breakthrough approach as an orally administered ALPK1 agonist that potently stimulates local, innate immunity in the liver. The drug has successfully completed single and multiple ascending dose (MAD) evaluation in healthy volunteers, as well as MAD evaluation in virologically suppressed HBeAg negative chronic hepatitis B (CHB) patients, where encouraging anti-HBV activity was observed.
Dr. Tony Xu, COO of Drug Farm, emphasized the drug's unique therapeutic potential: "DF-006 has a novel mechanism of action that is uniquely able to stimulate innate immunity in the liver to fight hepatitis B infection and hepatocellular cancer. In preclinical studies, DF-006 has shown enhanced efficacy against hepatitis B when combined with interferon-alpha."

Strategic Combination Therapy Approach

The collaboration will focus on assessing the clinical combination of DF-006 with Amoytop's approved drug PEGBING® as a potential new therapeutic regimen aimed at improving functional cure rates in hepatitis B patients. This combination approach builds on PEGBING®'s demonstrated ability to enhance functional cure rates across diverse HBV-infected populations.
Mr. Sun Li, Chairman and Chief Executive Officer of Amoytop, outlined the company's strategic vision: "Amoytop is dedicated to becoming the leading company developing a functional cure for CHB. PEGBING®-based therapy has already demonstrated significant enhancement of functional cure rates across diverse HBV-infected populations. Through investigational research of a novel, innovative drug DF-006, we offer the potential for sustained functional cure with significant reduction of risk for hepatocellular cancer."

Advanced Drug Discovery Platform

Drug Farm's development of DF-006 stems from its proprietary IDInVivo platform, which combines breakthrough technologies in genetics and AI to discover new treatments. This platform allows direct assessment of gene targets in living animals with intact immune systems, enabling the identification of novel innate immunity pathways and targets for rapid advancement of first-in-class drug candidates into clinical development.
The company's pipeline extends beyond hepatitis B to include treatments for heart and kidney diseases, as well as ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome, all targeting innate immunity pathways.

Partnership Significance

Amoytop, an innovative biopharmaceutical company listed on China's Science and Technology Innovation Board (SSE STAR Market), specializes in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. The company focuses on immune-related cytokine medicines and is committed to becoming a leader in solving cytokine medicine-based systemic immune problems for major diseases including viral hepatitis and malignant tumors.
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