Weekly Cover: Acepodia’s NK Cell Therapy Drug Candidate ACE1702 Receives FDA Clearance of IND

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Acepodia’s NK Cell Therapy Drug Candidate ACE1702 Receives FDA Clearance of IND to HER2-Expressing Solid Tumors

Acepodia, a U,S.-Taiwan immunotherapy company, announced on January 9 that the company has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA), to initiate a Phase 1 clinical study of its natural killer (NK) cell therapy and lead drug candidate ACE1702 in patients with HER2-expressing solid tumors.
ACE1702 is the Company’s lead clinical product candidate, developed from its proprietary ACC™ (Antibody Cell-Conjugation) technology platform. ACC™ links tumor targeting antibodies to certain human NK cell lines. GLP toxicology studies show ACE1702 has demonstrated enhanced tumor cell killing activities both in vitro and in vivo, while maintaining a favorable safety profile. In preclinical studies, ACE1702 has shown enhanced tumor-killing activities against HER2 cancer cells.

About Acepodia
Acepodia is a privately held US-Taiwan biotechnology company committed to developing safe, effective, and affordable immunotherapeutic medicines targeting diseases with significant unmet medical needs, with a primary focus on oncology.


Anticancer Agent Halaven® Launched in China

Halaven®, a natural product isolated from the marine sponge halichondria okadai, inhibits the growth phase of microtubule dynamics and leads to the prevention of cell division. Other functions include the increase in vascular perfusion and permeability in tumor cores in the tumor microenvironment, promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate, and etc.

Halaven® was first approved in the United States, as a treatment for patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens, since November 2010, and is currently used worldwide.

Eisai Co., Ltd. announced on January 10, 2020 that it has launched the Company’s in-house developed anticancer agent Halaven® (eribulin mesylate), a microtubule dynamics inhibitor with a distinct binding profile in China.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. The company positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer.


Chugai and Verastem Signs Licensing Deal

On January 9, 2020, Chugai Pharmaceutical Co., Ltd. announced that the Company entered into a global licensing agreement with Verastem Oncology, to develop its investigational anticancer agent CKI27 for solid tumors.

Under the agreement, Chugai will grant Verastem an exclusive worldwide license to manufacture, develop and commercialize CKI27. Chugai will in return receive an upfront fee of USD three million. Furthermore, in the future, if the compound is successfully launched, Chugai will receive royalty payments from Verastem.

CKI27 is treated as monotherapy or combination therapy with other anticancer agents in solid tumors including non-small cell lung cancer, ovarian cancer and colorectal cancer. Phase I studies initiated to investigate CKI27 are ongoing.

About Chugai
Chugai is one of Japan’s leading research-based pharmaceutical companies actively involved in the R&D of oncological drugs,and is a member of the Roche Group.


About Verastem Oncology

Verastem Inc. is a commercial biopharmaceutical company that markets Copiktra® (duvelisib), a drug indicated for relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma and R/R follicular lymphoma.


Meiji Seika Pharma to Commercialize HUYABIO’s HBI-8000 in Asia

Lymphoma, the type of cancer that affects lymphocytes, can affect organs throughout the body. Many subtypes of lymphoma exist, two of which are: Hodgkin’s lymphoma and Non-Hodgkin’s lymphoma.

Lymphoma treatment may involve radiation therapy, chemotherapy, immunotherapy, bone marrow transplant or combination therapies composed of the above mentioned.

On January 8, the CEO & Executive Chair of HUYA Bioscience International LLC announced the appointment of Meiji Seika Pharma 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.

About HUYA Bioscience International

HUYA Bioscience International LLC (HUYABIO) is a pharmaceutical research and marketing company that develops novel biopharmaceutical products originating from China.

The Company promotes early stage compounds from its product portfolio, and positions them for development in markets worldwide.


About Meiji Seika Pharma Co., Ltd.

Meiji Seika Pharma is a generic pharmaceuticals company that manufactures pharmaceuticals and chemicals in three main fields, infectious disease and central nervous system disorders, as well as generic drugs.


Samsung Bioepis to Enter Taiwan and Hong Kong Markets and Join Force with Mundipharma

Mundipharma, one of the world’s top 50 multinational pharmaceutical companies, has established a partnership with Samsung Bioepis and will commercialize the Companys’ biosimilar drug candidates in Taiwan and Hong Kong.

According to the agreement, Mundipharma will become the exclusive commercialization partner of Samsung Bioepis’ biosimilar drug candidates, in the fields of immunology and oncology, which covers SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), and SB8 (bevacizumab). Samsung Bioepis will be responsible for clinical development, regulatory registration and the production of the list of biosimilars.

This partnership is expected to help meet the needs of patients in immunology and oncology in two important regions of Asia.

About Samsung Bioepis Biopharmaceutical company

Samsung Bioepis was established in 2012 under a joint venture between Samsung BioLogics and Biogen. The Company has a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology and ophthalmology.


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