After a Decade of Development, BinHui Bio's Oncolytic Virus Candidate BS001 (OH2) Receives FDA Clearance for Multi-Solid Tumor Clinical Trials

Following the initiation in early August of a clinical trial at Beijing Tiantan Hospital to evaluate the investigational oncolytic virus drug BS001 (0H2) injection (hereinafter referred to as “BS001 Injection”) for the treatment of recurrent glioblastoma,Binhui Biopharmaceutical Co., Ltd. (hereinafter referred to as “BINHUI BIOPHARM”), an oncolytic virus drug developer, has once again announced good news.

August 20, 2021 (North American time),BINHUI BIOPHARM Announces FDA Clearance to Conduct Clinical Trials for Multiple Solid Tumors in the United States.

Recognition from international high standards not only affirms the quality and safety of BINHUI BIOPHARM’s oncolytic virus product development, but also marks a new milestone in the innovative drug R&D for BS001 injection, representing a new breakthrough for China’s oncolytic virus immunotherapy to go global. It is reported thatBS001 injection received IND approval from China’s NMPA in 2018 and has since been evaluated in clinical trials for multiple solid tumors at more than 20 hospitals.Safety and efficacy have been fully validated.

Amid frequent good news in clinical drug research, BINHUI BIOPHARM has also attracted the favor of many well-known venture capital and industrial funds. To date, BINHUI BIOPHARM has raised nearly 800 million yuan, with investors including Fortune Venture Capital, Longpan Investment, Lepu Medical, Fenxiang Investment, CICC Capital, Vertex Ventures, and Qianhai Fund of Funds.

BINHUI BIOPHARM, established in 2010 and headquartered in Wuhan, is a high-tech enterprise specializing in the research, development, and production of viral vectors. Currently, the companyWithII. Herpes Simplex Virus Type 2 as a Vector, has developed multiple candidate drugs, including oHSV2-hGM-CSF (BS001 Injection), oHSV2-BiTEs, and multivalent oHSV2 (oHSV2 Cocktail), targeting indications such asColorectal Cancer, Esophageal Cancer, and other cancer types with high incidence in the Chinese population, as well asPancreatic Cancer, Melanoma, Glioma...refractory tumors for which there is an urgent need to seek new treatment options in international clinical practice.

Among the numerous product pipelines, in addition to the two notable recent developments regarding BINHUI BIOPHARM’s BS001 injection mentioned at the beginning of this article, the clinical trial of BS001 injection as monotherapy for melanoma was officially launched at Peking University Cancer Hospital in 2018, with the latest clinical trial data disclosed in April 2021.

Clinical data show that,BS001 achieved an objective response rate (ORR) of 30%, a disease control rate (DCR) of 50%, and a one-year overall survival (OS) rate of 93% in Phase Ib/II clinical trials as monotherapy for melanoma.Currently, the clinical trial evaluating this candidate drug in combination with immune checkpoint inhibitors for the treatment of melanoma was initiated in December 2020. Among the four cases currently evaluable, one patient has demonstrated a response, and efficacy is under ongoing observation.

The latest clinical data on BINHUI BIOPHARM's BS001 injection for the treatment of colorectal cancer show that,The objective response rate (ORR) of BS001 injection as monotherapy in patients with colorectal cancer has exceeded 10%; the ORR of BS001 injection in combination with PD-1 monoclonal antibody therapy reached 18.2%.According to relevant data from 2018, there are approximately 430,000 new cases of colorectal cancer and 280,000 deaths annually in China, characterized by a high incidence rate and a scarcity of effective drugs. The currently clinically recommended drugs for metastatic colorectal cancer (mCRC) in China include regorafenib, fruquintinib, capecitabine, and irinotecan; among these, the most efficacious drug has an objective response rate of less than 5%. Internationally, except for a very small subset of mCRC patients with MSI-H/dMMR, trials of PD-(L)1 monoclonal antibodies in the treatment of advanced colorectal cancer have all failed. BINHUI BIOPHARM’s BS001 injection is expected to bring new hope to patients with advanced colorectal cancer.Currently, it is planned to enter pivotal clinical trials.

Oncolytic Virus (OV), also known as conditionally replicative viruses or selectively replicative viruses, refers to a class of natural or genetically engineered viruses that can selectively target and destroy tumor cells while causing minimal damage to normal cells.

After entering tumor cells, this virus willExtensive replication within tumor cells causes their lysis,Directly kills tumor cells,while simultaneously releasing a large amount of tumor-associated antigens,Improve the tumor microenvironment, increase the infiltration and proliferation of immune cells, and stimulate the body to produce an anti-tumor immune response to continuously exert anti-cancer effects.

Professor Liu Binlei, Chairman and Founder of BINHUI BIOPHARM, stated that compared with traditional therapies, oncolytic virus therapy offers the advantages of high safety, strong targeting capability, and sustained anti-tumor effects by activating the body’s own immune function.As a novel cancer therapy, oncolytic viruses can be used as monotherapy or in combination with chemotherapy, molecular targeted agents, immune checkpoint inhibitors, and CAR-T cell therapy, further expanding their clinical and commercial applications.

Currently, clinical trials combining oncolytic viruses with PD-1/PD-L1 inhibitors have been conducted abroad. Multiple studies have concluded that this combination therapy achieves a synergistic effect (“1+1>2”), significantly enhancing patient benefits. Therefore, oncolytic virus products hold promising application prospects in the field of combination cancer therapy.

It is understood that Professor Liu Binlei, the founder, was a member of the original research and development team for T-VEC, an oncolytic type I herpes simplex virus drug approved for marketing by the U.S. FDA and the European EMA.

For many years, Professor Liu Binlei has been dedicated to research in tumor immunotherapy and oncolytic viruses. He has published nearly 50 scientific papers in domestic and international journals. Notably, his original paper as the first author on the construction of T-VEC (Gene Therapy, 2003) has been cited more than 500 times, and the development of oncolytic virus candidate drugs has reached an internationally advanced level. Professor Liu led the team at BINHUI BIOPHARM to establish an oncolytic virus immunotherapy platform based on oncolytic herpes simplex virus type 2 (HSV-2), which demonstrates greater therapeutic potential. The projects have received funding from major national initiatives, including the National Major Project for New Drug Innovation, the 973 Program, the 863 Program, the 12th Five-Year Plan Support Program, and the National Natural Science Foundation. These efforts have culminated in BINHUI BIOPHARM’s current impressive portfolio of high-quality product candidates.

When asked about his decision to return to China to start a business, Professor Liu Binlei stated, “Developing innovative anticancer biologics has long been my dream. I hope to realize this dream by leveraging my years of experience in molecular virology and oncolytic viruses, supported by favorable national policies.”

It is understood that BINHUI BIOPHARM’sBS001 Injection is the world’s first oncolytic virus candidate drug that selects herpes simplex virus type 2 (HSV-2) as its vector and has entered clinical trials,It is also China’s first novel oncolytic virus strain with fully independent intellectual property rights, marking its debut on the global stage of oncolytic virus immunotherapy.

After a decade of dedicated research, BINHUI BIOPHARM has screened out a novel viral vector. Compared with traditional genetically modified oncolytic virus strains, the company has systematically enhanced oncolytic activity by more than an order of magnitude. To ensure drug safety, BINHUI BIOPHARM adopted the engineering strategies used in the approved oncolytic type 1 herpes simplex virus drugs T-VEC and G47Δ. By knocking out the neurovirulence gene ICP34.5 and the immunosuppressive gene ICP47, and inserting the human granulocyte-macrophage colony-stimulating factor (hGM-CSF), the company has ensured viral oncolytic activity and immune activation while improving druggability.

Furthermore, BINHUI BIOPHARM has overcome the complex manufacturing processes associated with the HSV-2 strain. By leveraging its proprietary GMP-compliant production platform, the company has significantly reduced product manufacturing costs, thereby laying a solid research foundation and providing flexible application potential for future cocktail therapies based on this oncolytic virus immunotherapy platform.

The impressive performance of BS001 Injection marks a milestone achievement in BINHUI BIOPHARM’s decade-long dedication to research and development. Moving forward, BINHUI BIOPHARM will build on this momentum, leveraging its robust CMC capabilities to accelerate the market launch of innovative products, thereby providing global oncology patients with more advanced, diverse, and safer therapeutic options.