HUYABIO Development Compounds

HUYA Bioscience International identifies a select subset of promising early stage compounds from its product portfolio and positions them for development in markets worldwide. HUYABIO seeks opportunities in therapeutic areas with significant market potential and unmet medical need, where the compound has a competitive advantage, strong patent position worldwide, and a clear clinical development path.

HUYABIO performs preliminary diligence on many drug candidates to find the most promising opportunities that would benefit from added value. The company is currently working with a number of compounds including the next generation oncology drug HBI-8000, the novel anti-arrhythmic HBI-3000, and the small molecule with regenerative properties for myocardial infarction HBI-3802.

About HBI-8000

The novel epigenetic drug, HBI-8000, is a member of the benzamide class of histone deacetylase inhibitors (HDACIs), working by controlling how tightly DNA is wound around histone proteins, which regulate gene expression. This alters the expression of several proteins involved in processes that arrest the growth of cancer cells, increase tumor immunity and change the tumor microenvironment. Evidence suggests that this mechanism increases the efficacy of other cancer agents such as checkpoint inhibitors.

HUYA Bioscience International is developing HBI-8000, the first approved, oral class I selective HDACI. The company was the first to leverage the Tripartite Agreement between China, Japan and South Korea, which allowed Chinese clinical data to be leveraged in the other two countries. Based on clinical results, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) allowed accelerated development of this drug in lymphoma. Currently, HUYABIO has two ongoing registration clinical studies in Japan, investigating the use of HBI-8000 in peripheral T-cell lymphoma (PTCL), for which the PMDA granted orphan drug status, and adult T-cell lymphoma (ATL).

Due to its immunomodulatory properties, HUYABIO is conducting a Phase II trial of HBI-8000 in the US, investigating efficacy and safety in combination with nivolumab for the treatment of solid tumors. HUYABIO will pursue pivotal trials for HBI-8000 in combination with checkpoint inhibitors and other anti-cancer therapeutics with the aim of meeting unmet medical needs in oncology.

About HBI-3000

HBI-3000 is a multi-ion channel blocker in development for the treatment of cardiac arrhythmias. Anti-arrhythmic drugs are used to treat patients with atrial fibrillation (AF), a serious condition that affects more than 3.5 million patients in the US and 30 million patients worldwide. There is a significant need for safer and more effective pharmacological interventions to treat AF, as current treatments have poor safety and efficacy profiles and the alternative, electrical cardioversion, has poor patient acceptance and requires patient sedation.
HBI-3000 has a unique ion channel profile (Ito, fast and slow Na, IKr and L-Ca) and does not pose a pro-arrhythmic risk in preclinical models. The drug’s preclinical pharmacology also supports the potential of HBI-3000 to restore sinus rhythm in AF. This profile makes HBI-3000 a promising antiarrhythmic candidate for clinical development.

A Phase I study of HBI-3000 is underway in the UK. The first subjects were dosed in a randomized, double-blind, placebo-controlled, serial cohort, dose escalation study. A Phase II dose escalation study of this compound in acute AF is planned.

About HBI-3802

HBI-3802 is a small molecule with unique preclinical activity in regenerating cardiac muscle cells, or cardiomyocytes, damaged by ischemia. Coronary artery disease is the leading cause of death in the US and many other countries. Treatment of patients after a myocardial infarction, or heart attack, currently involves drugs to improve blood flow. However, no therapy in current development appears to offer improved heart function to a clinically significant extent.

In animal models of myocardial infarction, HBI-3802 stimulates stem cell differentiation into functional cardiomyocytes, replacing and remodeling dead myocardium with new functional tissue. This potentially revolutionary agent has several promising uses, including treatment of the consequences of myocardial infarction, improving global heart function and preventing chronic heart failure.