HUYA Bioscience International Presents Positive Data on HBI-8000 at Society for Immunotherapy of Cancer Meeting

Study confirms tolerability and significant anti-tumor activity of HBI-8000 in combination with nivolumab in checkpoint naive melanoma patients

San Diego, CA, USA – 9 November 2020 – HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the presentation of results from an ongoing Phase II study evaluating the efficacy and safety of HBI-8000 in combination with nivolumab in patients with advanced metastatic melanoma. The results were presented at the Society for Immunotherapy of Cancer’s virtual 35th Anniversary Annual Meeting (SITC 2020; Abstract # 797).

“Data from this combination study are very encouraging,” said lead investigator, Nikhil I. Khushalani, MD, Vice Chair and Senior Member of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, Florida. “As standard of care, patients with metastatic melanoma are routinely treated with a PD-1 inhibitor such as nivolumab or pembrolizumab.

When nivolumab was combined with HBI-8000, it appears the efficacy was enhanced while safety profile remains quite acceptable. The patients on the study are being followed for long- term outcomes. A Phase III study to further investigate the efficacy and safety of this combination of therapy is now planned.”

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, “These data further demonstrate the promise of HBI-8000 in cancer therapy. This builds on the momentum from our October 2020 regulatory submission to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL).”

In a Phase Ib/II trial in patients with melanoma, renal and non-small cell lung cancer, the recommended Phase II dose of HBI-8000 was 30 mg orally twice weekly combined with nivolumab administered at the approved dosing schedule. The SITC 2020 presentation described the safety profile of this combination in melanoma patients and showed signs of clinical benefit relative to historic controls who were receiving nivolumab for the first time.

Forty-nine patients (32 anti-PD1 naïve, 17 with prior anti-PD1 therapy) were treated with HBI- 8000 in combination with nivolumab. The median age was 63 years (range 28-84). The most common all grade treatment related adverse events (AEs) were fatigue (n=25), diarrhea (n=24), abdominal pain (n=14), and lymphopenia (n=13). Although HBI-8000 related thrombocytopenia (n=25) and neutropenia (n=15) were common, clinically significant bleeding or febrile neutropenia were not seen. Twelve patients discontinued treatment due to AEs. Among 31 anti- PD1 naïve patients evaluable for response, there were 23 objective responses (74%), five with stable disease (disease control rate 90%), and three with progressive disease. Median time to response was 1.9 months. At a median follow-up for this cohort of 8.9 months (range, 0.9-35.5 months), the median duration of response and median progression-free survival had not yet been reached.

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also is immunomodulatory, increasing the efficacy of checkpoint inhibitors in preclinical animal models through its role in sustaining acetylation and nuclear transport of PD-L1.

About HUYA Bioscience International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally. For more information please visit www.huyabio.com.

Contact details:
Bob Goodenow, PhD
President
+1.858 354.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

www.huyabio.com

Copyright © 2020 HUYA Bioscience International, LLC. All rights reserved. HUYABIO™ and HUYA Bioscience International® are either registered trademarks or trademarks of HUYA Bioscience International, LLC or its affiliates in the United States and/or other countries.

HUYA Bioscience International Submits HBI-8000 Monotherapy for Adult T-cell Leukemia/Lymphoma for Regulatory Approval in Japan

San Diego, CA, USA – October 6, 2020  HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL). 

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said,The submission of the regulatory application in Japan for R/R ATL is a significant milestone for HUYABIO. The durability and strong immuno-oncology properties of HBI-8000 sets the stage for improved cancer treatment of both solid and liquid tumors. We look forward to drug approval and a positive impact on the quality of life of these patients.”

The new drug application is based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients all had advanced disease either refractory or relapsed after receiving mogamulizumab and had few effective treatment options. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile. 

“Aggressive ATL is primarily a disease of the elderly with a poor three-year survival rate of 25%. There are few effective treatment options. It remains to be an important unmet medical need in Japan and a challenging public health issue. Clinical data from HBI-8000 has shown the promise to fulfill such a need. Orphan Drug Designation has been granted to HBI-8000 for R/R ATL, and peripheral T-cell lymphoma”, said Dr. Bob Goodenow, President of HUYABIO.

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.

About HUYA Bioscience International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information please visit www.huyabio.com

Contact details:
Bob Goodenow, PhD
President
+1.858 354.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

www.huyabio.com

Copyright © 2019 HUYA Bioscience International, LLC. All rights reserved. HUYABIO™, HUYA Bioscience International® are either registered trademarks or trademarks of HUYA Bioscience International, LLC or its affiliates in the United States and/or other countries.

HUYA Bioscience International Announces Orphan Drug Designation for HBI-8000 Monotherapy Adult T-cell Leukemia-Lymphoma ATL in Japan

San Diego, CA, USA – September 28, 2020 HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation (ODD) in Japan as monotherapy for relapsed or refractory Adult T-cell Leukemia-Lymphoma or (ATL). HBI-8000 already has ODD in Japan for peripheral T-cell lymphoma (PTCL).

ATL is caused by latent infection of the human t-cell leukemia virus type 1 or HTLV-1 and is endemic in Japan with up to one million carriers and a disease incidence estimated at 0.05-0.10%. There are approximately 2,000 patients and as many as 700 – 1,000 deaths reported each year. It is primarily a disease of the elderly with poor prognosis, three-year survival rate in aggressive ATL after chemotherapy is 25% and few effective treatment options other than allogenic bone marrow transplantation and high dose chemotherapy in a subset of eligible patients.

“Effective treatment options for relapsed or refractory (R/R) aggressive ATL are very limited and the designation of ODD status recognizes the need for new treatment for this difficult-to-manage disease, I hope that development of HBI-8000 could be accelerated with the ODD” said Dr. Kunihiro Tsukasaki, MD PhD, Principal Investigator of HBI-8000 clinical study & Professor, Department of Hematopoietic Tumor, Saitama Medical University, International Medical Center.

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting viral antigens. This is a novel mechanism of action and does not overlap with currently available drugs. Recent clinical studies conducted by HUYABIO in Japan suggest clinical efficacy of HBI-8000 in this rare disease setting of R/R aggressive ATL.

The orphan drug designation of HBI-8000 recognizes the potential of this agent to meet an important unmet medical need and ATL is a critical public health issue in Japan.” said Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO. “The designation is appropriate for this rare malignancy, which afflicts an elderly population with such devastating effects. We are now preparing an application to the PMDA for approval of HBI-8000 as monotherapy for the treatment for R/R ATL.”

About HUYA Bioscience International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information please visit www.huyabio.com.

Contact details:
Bob Goodenow, PhD
President
+1.858 354.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

www.huyabio.com

Copyright © 2019 HUYA Bioscience International, LLC. All rights reserved. HUYABIO™, HUYA Bioscience International® are either registered trademarks or trademarks of HUYA Bioscience International, LLC or its affiliates in the United States and/or other countries.

HUYA Bioscience International Licenses the Novel SHP2 Inhibitor HBI-2376 for Development in Oncology

SAN DIEGO, CA, USA – August 4, 2020 HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, announced today it has exclusively licensed worldwide rights, outside of China, to the SHP2 inhibitor, HBI-2376, from Suzhou GenHouse.

SHP2 is an important component of RAS signaling pathway leading to activation of ERK/MAPK pathways in a variety of cancer cells. Additionally, SHP2 interaction with PD-L1 (an immune checkpoint molecule) results in the inhibition of T cell activity in the tumor microenvironment. The possibility of SHP2 inhibition to enhance T-cell immunity is of enormous potential relative to the success of PD-L1 checkpoint inhibitors in oncology. As a result, SHP2 multi-functions in tumor progression, cancer cell growth and suppression of anti-tumor immunity, further demonstrating development of SHP2 inhibitors for unmet clinical need.

“SHP2 is an exciting target and inhibitors of this enzyme have excellent potential to combine broadly with checkpoint inhibitors as well as other targeted anti-tumor agents, especially those targeting the RAS pathway,” said Dr. Dan Von Hoff, a leader in oncology drug development and long-time advisor to HUYABIO who serves as Director of Translational Research at the Translational Genomics Research Institute as well as Professor of Medicine at the University of Arizona and the Mayo Clinic.

Dr. Mireille Gillings, CEO and Executive Chair of HUYABIO said, “There is a large unmet medical need for safer and more effective cancer treatments. We believe that HBI-2376 is a promising novel compound that has the potential to treat cancer patients across many tumor types. Our lead program HBI-8000 continues to exceed expectations as regards efficacy and breadth of immune oncology effects across a wide variety of solid and liquid tumors. The addition of HBI-2376 expands our pipeline and our current momentum in developing new standards of care in oncology.”

About HBI-2376
HBI-2376 is an oral small molecule inhibitor of SHP2 for multiple tumor types whose cellular growth is dependent on the activity of receptor tyrosine kinases in the mitogen-activated protein kinase or MAPK pathway. Extensive biochemical characterization has shown that HBI-2376 is a highly potent and selective inhibitor of SHP2 phosphatase. Furthermore, preclinical investigations showed significant efficacy for HBI-2376 as a single agent or in combination with other small molecule inhibitors or checkpoint inhibitors in multiple tumor models. HUYABIO is planning to conduct the necessary studies to advance HBI-2376 to IND filing in the USA in the near future.

About HUYA Bioscience International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information please visit www.huyabio.com.

Contact details:
Bob Goodenow, PhD
President
+1.858 354.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

www.huyabio.com

Copyright © 2019 HUYA Bioscience International, LLC. All rights reserved. HUYABIO™, HUYA Bioscience International® are either registered trademarks or trademarks of HUYA Bioscience International, LLC or its affiliates in the United States and/or other countries.

HUYA Bioscience International Announces the Successful Completion of Phase 1 Trial of HBI-3000

Phase 2 trial will test the unique multi-channel ion blocker in acute atrial fibrillation

San Diego, CA, USA – February 28, 2020 HUYA Bioscience International, the leader in accelerating global development of China’s pharmaceutical innovations, has presented the results of a Phase I study of HBI-3000, a novel drug for cardioversion of atrial fibrillation (AF).

The study, conducted in the UK, was a single ascending dose trial of intravenous HBI-3000 in healthy subjects. The objective was to establish the safety, tolerability and pharmacokinetics with electrocardiogram (ECG) monitoring. The data were presented during a poster session at the American Heart Association 2019 annual meeting. A copy is available via the HUYA Bioscience website (www.huyabio.com).

HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on INa-Peak, INa-Late, ICa,L and IKr being developed for the cardioversion of recent onset AF. AF is 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, requires fasting and sedation and can be anxiety provoking for patients.

Dr Jay Mason, University of Utah, commented “HBI-3000 was well tolerated with no dose limiting adverse events or arrhythmias observed. These data demonstrate that HBI-3000 is a potent inhibitor of multiple cardiac ion channels that play a role in onset and maintenance of AF, exhibiting linear pharmacokinetic (PK)-pharmacodynamic (PD) relationships. It should now be further investigated for its ability to pharmacologically convert patients with recent onset AF back into a normal rhythm”.

“The successful completion of our Phase 1 study is a very significant milestone in our journey to identify a new and improved treatment for patients with AF.” said Dr Mireille Gillings, CEO and Executive Chair of HUYA Bioscience. “Based on the supportive PK/PD and safety results in this study in healthy subjects, HBI-3000 is now entering Phase 2 clinical development in patients with recent onset AF”.

About HBI-3000
HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on INa-Peak, INa-Late, ICa,L and IKr being developed by HUYA Bioscience International for the conversion of recent onset atrial fibrillation (AF). The drug’s preclinical and clinical pharmacology supports the potential of HBI-3000 to restore sinus rhythm in AF. The drug has demonstrated a low risk for proarrhythmia in preclinical testing.

About HUYA Bioscience International
HUYABIO is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. The Company has emerged as the partner-of-choice for maximizing the value of innovation in China. With the largest team of scientists working with Chinese innovators, HUYABIO identifies and advances promising drug candidates globally and has offices in the US, Japan, South Korea and China.

Contact details:
Yiota Merianos,
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com
www.huyabio.com

HUYA Bioscience International Appoints Meiji Seika Pharma as Exclusive Distributor For HBI-8000 in Japan and Other Asian Countries

Meiji Seika Pharma to Commercialize HUYABIO’s Product in Lymphoma

San Diego, CA, USA – January 8, 2020 – HUYA Bioscience International CEO & Executive Chair, Dr. Mireille Gillings announced the appointment of Meiji Seika Pharma (Meiji) as an exclusive distributor for its lymphoma product, HBI-8000, in Japan. Meiji also acquired exclusive rights for HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore. The drug, an epigenetic immunomodulator, is the first approved oral class I-selective histone deacetylase inhibitor which is now in various stages of development globally for Peripheral T-Cell Lymphoma (PTCL) and Adult T-Cell Leukemia (ATL) in Japan and solid tumors in the United States. Increased excitement has been generated by studies that show that HBI-8000 produces cumulative effects over time that increase the receptivity of cancer cells to immunologic therapy.

The product has orphan drug designation for PTCL granted by Japan’s Ministry of Health, Labor and Welfare. HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights. Meiji will pay HUYABIO an upfront and milestones plus royalties on net sales. HUYABIO will manufacture and supply the product to Meiji for initial commercialization.

“This collaboration aligns with Meiji’s R&D commitment to oncology to develop new drugs to fulfil unmet needs of patients worldwide. By continually improving our R&D process with innovation, Meiji brings high-value and high-quality drugs to market quickly. Meiji and HUYABIO will cooperate to commercialize HBI-8000, for the benefit of cancer patients” said Daikichiro Kobayashi, President and Representative Director of Meiji Seika Pharma Co, Ltd.

“We are delighted to enter into this partnership with Meiji to bring HBI-8000 to patients with PTCL or ATL. We also look forward to advancing the development of our drug based on its immunomodulatory properties” said Dr. Mireille Gillings. “The agreement reinforces our vision to leverage assets licensed from China for global development and commercialization. Meiji Seika Pharma’s strong position in hematologic malignancy will help ensure the drug’s success in the Japanese market.”

About HBI-8000
The novel epigenetic drug, HBI-8000, is a member of the benzamide class of histone deacetylase inhibitors, which regulate gene expression through histone modification, which enables the efficacy of increasing other cancer agents such as checkpoint inhibitors.

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 allowed accelerated development of this drug in lymphoma.

About HUYA Bioscience International
HUYABIO is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. The Company has emerged as the partner-of-choice for maximizing the value of innovation in China. With the largest team of scientists working with Chinese innovators, HUYABIO identifies and advances promising drug candidates globally and has offices in the US, Japan, South Korea and China.

About Meiji Seika Pharma Co., Ltd.
In order to protect and improve people’s health and lives, Meiji Seika Pharma, as a “Speciality and Generic Pharmaceuticals Company,” runs its pharmaceutical business in the two main fields, infectious disease and central nervous system disorders, as well as generic drugs. Meiji Seika Pharma strives to respond to diversified medical needs and contributes to the well-being of people worldwide.

Contact details:
Bob Goodenow, Ph.D.
President
HUYA Bioscience International
+1.858.342.2430
bgoodenow@huyabio.com
www.huyabio.com