Eisai Deal A Milestone On HUYA’s Evolving Road
This article was originally published in PharmAsia News
Executive Summary
A recent exclusive license agreement with Eisai for a cancer compound discovered by a Chinese company builds on HUYA Bioscience’s position as a leader in accelerating the global development of novel biopharmaceutical products originating in China, and the firm says it will continue to pursue further deals based on its database of 14,000 China-sourced compounds across multiple therapeutic areas.
SHANGHAI – In a milestone for the company, HUYA Bioscience International LLC has out-licensed its first compound sourced from China, to Japan’s Eisai Co. Ltd. for development and marketing in several Asian countries.
The molecule, known as chidamide in China and coded HBI-8000 in the US, is a novel, benzamide class histone deacetylase (HDAC) inhibitor discovered wholly by China-based Shenzhen Chipscreen Biosciences Ltd. using a computer-aided rational design approach.
HUYA initially licensed chidamide from Chipscreen in 2007 and the drug was approved in China for use in the treatment of peripheral T-cell lymphoma (PTCL) in January 2015.
“HBI-8000 is a next generation HDAC inhibitor with proven efficacy and safety in lymphomas and, due to its superior properties and immunomodulatory effects, has potential for the treatment of a wide range of hematological and solid tumors,” Mireille Gillings, president, CEO and executive chairman of HUYA, told PharmAsia News.
“HBI-8000 is an oral drug, which has clear advantages over IV [intravenous] products. The drug appears to be well tolerated and side effects observed to date are manageable,” she added.
Under the exclusive licensing agreement, Eisai has the rights to develop and market HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia, the Philippines, Vietnam and Singapore, and will pay HUYA undisclosed upfront, development and commercial milestone payments, as well as royalties over the term of the license. [See Deal]
“HUYA will obviously benefit from potential upfront and milestone payments of up to $280 million from Eisai, greatly enhancing our value, and following through with our strategy,” said Gillings.
HBI-8000 Potential
US Phase I testing of HBI-8000 is complete and the product is moving into Phase II in combination with standard of care in multiple settings including solid tumors. In Japan, a Phase I study of HBI-8000 in non-Hodgkin’s lymphoma (NHL) is ongoing.
As part of the deal, HUYA will complete development of the agent for the NHL indication in Japan and Eisai will be responsible for commercialization and also has rights to develop future indications in its licensed territories. These potential indications include PTCL and adult T-cell leukemia/lymphoma (ATL), Gillings said.
PTCL represents an aggressive subset of NHLs that encompasses a broad range of diverse but rare mature lymphomas of T-cell or NK-cell origin. Regardless of subtype, cases of PTCL share aggressive clinical behavior, refractoriness to conventional chemotherapy, and poor overall prognoses, according to Gillings.
HBI-8000 was granted orphan drug designation in Japan for PTCL in December 2015. Unlike Japan, the US has three products approved for the treatment of second line PTCL. “Without the benefit of a comparative trial, the performance of HBI-8000 in China with PTCL already points to some rather distinct advantages over these three drugs,” said Gillings.
HBI-8000 has also demonstrated good efficacy as a single agent against NHL in China. “We believe the immunomodulatory properties of the drug’s selective class I HDAC effects is a critical component to the drugs activity in lymphoma that may translate into differentiating the product based on clinical benefit,” she added.
In Japan, the incidence of PTCL is approximately 25% of all malignant lymphomas. According to the most recent patient statistical survey conducted by Japan’s Ministry of Health, Labour and Welfare, the number of patients with malignant lymphoma is estimated at approximately 55,000, with an estimated PTCL number of about 14,000 patients.
Treatment advances in PTCL have been slow compared to other lymphomas and relapse occurs after treatment with most of the current therapies, with few effective options for salvage therapies, according to Gillings.
ATL is also a disease of high unmet medical need in Japan where it is responsible for 700 to 1,000 deaths per year. HTLV-1, the virus that causes ATL, has a high prevalence in Japan with more than one million people infected, Gillings said.
Tripartite Cooperation Treaty
In order to steer the direction of joint drug development, a Tripartite Agreement on health for sharing clinical trial data between China, Japan and Korea was created in 2007, and HUYA has taken advantage of this cooperation in its development of HBI-8000.
The three countries recognized the importance of regular meetings of their health ministers and pragmatic cooperation among the countries in clinical research, including clinical trials, especially in clarifying the influence of ethnic factors on clinical data in order to facilitate drug development.
“HUYA was the first to use the China-Japan-South Korea Tripartite Cooperation to support its development strategy for HBI-8000 in Japan, based on data from China,” explained Gillings.
Helped by this, Japan’s Pharmaceutical and Medical Devices Agency accepted HUYA’s accelerated development strategy for HBI-8000 for the treatment of ATL and PTCL in Japan. “Our goal is to continue to leverage the Tripartite Cooperation to support future development efforts across this region,” she noted. “Eisai's global strength in oncology will also help ensure the drug's path to regulatory approval."
Wider Business Strategy
“HUYA’s business model continues to evolve where HUYA first identifies and licenses the most promising early stage lead compounds in China,” said Gillings.
For the future, HUYA aims to continue setting itself apart from competitors by having a database of 14,000 China-sourced compounds in all therapeutic areas, including synthetic small molecules, purified natural products, therapeutic proteins, vaccines, nucleic acids and biomarkers. This is the industry’s largest such database, she noted.
HUYA also aims to sign more than 110 agreements with Chinese universities, research institutes and high-tech parks, while adopting diverse approaches to gaining access to new products, including in-licensing, alliances, co-development, research funding and creative financial partnerships, Gillings continued.
In December 2015, HUYA expanded its business model into South Korea by helping local companies initiate clinical trials and gain approval for new compounds. It also signed an agreement with the Korean Drug Development Fund (KDDF) to form partnerships with local companies and research institutions to accelerate the development and commercialization of Korean pharmaceutical discoveries for global markets.