Chinese WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, a Contract Research, Development and Manufacturing Organization focusing on end-to-end bioconjugates services, and South Korean biotechnology AbTis, which is dedicated to the development of antibody-drug conjugates (ADC), have signed a Memorandum of Understanding (MOU) to form a strategic partnership in AbTis’ portfolio of ADC products.

AbTis specializes in the development of ADC. Using the company’s proprietary technology platform Abclick has resulted in the development of a pipelines of novel, site-specific ADCs for the treatment of various forms of cancer. As part of their R&D program, the company has also developed stable, hydrophilic and cleavable linkers can to be used in conjunction with various payloads.

Under the terms of the agreement with WuXi XDC, AbTis will have access to WuXi XDC’s integrated services for linker and payload manufacturing, ADC conjugation process development, ADC formulation and drug product manufacturing process development, as well as drug substance and drug product manufacturing. This full range of development and manufacturing services will be provided by WuXi XDC at facilities that are all located within a two-hour drive of each other.

“We are glad to be collaborating with WuXi XDC,” noted Sang Jeon Chung, Chief Executive Officer of AbTis.

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“This partnership will allow us to leverage WuXi XDC’s world-class expertise in both innovative conjugation technologies and comprehensive capabilities for ADC development and manufacturing,” Chung added.

Jincai (Jimmy) Li, Ph.D., is the Chief Executive Officer of WuXi XDC where he manages the company’s overall ADC business and the Shanghai cGMP facility. Prior this role Li built and led the Cell Culture Process Development & Pilot Plant Production group, and managed Wuxi’s cGMP facility. Li has close to 20 years of experience in biologics process development, scale-up, and cGMP manufacturing. Before joining WuXi XDC, Li was Group Leader at Genentech, where he led the cell culture process development group.

“With our integrated services and know-how, we are pleased to be enabling AbTis to develop and manufacture its portfolio of ADC products,” said Jimmy Li, Ph.D., Chief Executive Officer of WuXi XDC.

“This strategic partnership demonstrates the trust and confidence our clients have in our end-to-end services, maintained even during the COVID-19 lockdown period, when WuXi XDC teams showcased the strong execution and reflected our commitment to a culture of ‘Putting the Customer First.’ We will continue to accelerate and transform the discovery, development and manufacturing of bioconjugates, enabling our global partners and benefiting patients worldwide,” Li concluded

Funding and more Agreements
Earlier 2021, AbTis successfully closed Series B round with leading Korean investors, including Stonebridge Ventures, K2 Investment Partners, Aju IB Investment, CKD Venture Capital, KDB Capital, Kingo Investment Partners, Prodigy Investment, and Timefolio Asset Management.

In August 2021, AbTis also signed a memorandum of understanding with Abclon to co-develop novel ADCs, using Abclon’s ability to discover antibodies and Abtis’s ADC platform technology.

Abclon has developed a propriatary technology platform called Novel Epitope Screening Technology (NEST), which is designed to speed up the discovery of antibodies and epitope. The technology is designed to find antibodies that connect to specific epitopes of an antigen. Among such examples are AC101, the antibody treatment for gastric and breast cancer licensed out to Shanghai Henlius Biotech, and AT101 CAR-T cell therapy that the company has applied for an Investigational New Drug (IND).

Through the co-development project with Abtis, Abclon also plans to select antibodies developed by the NEST platform to develop novel ADCs using Abtis’ proprietary Abclick platform.

Unlike the current site-specific ADC linker technologies, Abclick combines drugs to two specific amino acids without producing any variants of natural antibodies. As a result, its drug antibody ratio (DAR) is easily adjustable,  enjoying an advantage in establishing CMC (chemistry, manufacturing, and control) and economic efficiency.

“By combining Abtis’ Abclick platform and Abclon’s NEST antibody platform technologies, we will be able to develop novel ADC treatments to help meet the needs of patients with unmet medical needs,” noted Chung Sang-jeon/

“Our goals is to take the lead in the development of novel ADCs with synergies through a technological and strategic partnership that combines each company’s specialized expertise efficiently,” added Lee Jong-seo Abclon Chief Executive Office.-

ADC Targeting Claudin 18.2
In December 2021, AbTis and GenScript ProBio grated AbTis an exclusive, worldwide, license of an anti-Claudin 18.2 monoclonal antibody to develop and commercialize as an ADC. In this partnership, AbTis and GenScript ProBio will collaboration in the preclinical CMC development as well as clinical and commercial production of the antibodies for ADCs designed to target Claudin 18.2 (CLDN18.2).[1]

Brian Hosung Min, Ph.D., is the Chief Executive Officer of GenScript ProBio. With a deep understanding in biopharmaceutical discovery, manufacturing, strategic planning and business development, Min has 30+ years of experience in biologics development and manufacturing, including 10+ years’ experience of antibody discovery at Amgen. Min led the development and manufacturing of all biosimilars at Samsung Bioepis and was a core team member of a team that led to the formation for Samsung Bio companies through joint venture formations In 2019 Min was appointed as the Chief Executive Officer at of GenScript Probio.

Claudin-18 is an important member of Claudin family of proteins, acting to maintain the tight junction that controls the interchange of molecules between the cells.

Claudin18.2 is prevalently expressed in gastric epithelial cells and highly expressed in primary malignant tumors, such as gastric, pancreatic, breast, colon and liver cancers.[1]

The subtype Claudin 18.2, which is a stomach specific-isoform, has emerged as an ideal target, since it is a highly selective molecule that is widely expresses only in cancer cells. This understanding paved the way for the development of specific, anti-claudin18.2 ADCs.[1]

Claudin 18.2 is typically buried in gastric mucosa, largely inaccessible to monoclonal antibodies in normal tissues. It’s malignant carcinogenesis that leads to disruptions in tight junctions, exposing claudin 18.2 epitopes on the surface of tumor cells to be specifically targeted. As a result, claudin 18.2 provides targeting therapy with specificity. With the identification of Claudin 18.2 in pancreatic cancer (50%), esophagus cancer and lung cancers, the potential of finding a targeted approach for the treatment of these diseases is only growing.[1]

Antibody discovery
GenScript ProBio’s team has completed antibody discovery, functional validation and cell line development for this licensed antibody while AbTis will continue to develop and commercialize ADC products based on it.

“We are pleased to partner with GenScript ProBio and are looking forward to working with there team of experts to help us accelerate the development of the next generation of promising ADCs,” said AbThis’ Sang Jeon Chung

“We’re honored to support this promising antibody drug conjugate project,” added Brian Hosung Min, Ph.D., Chief Executive Officer of GenScript ProBio.

“I believe the cooperation will further show the technology and platform advantages of both parties. We will look forward to using our rich CMC development experience to get the project to IND and commercialization to benefit patients soon,” Min concluded.

Reference
[1] Zhang J, Dong R, Shen L. Evaluation and reflection on claudin 18.2 targeting therapy in advanced gastric cancer. Chin J Cancer Res. 2020 Apr;32(2):263-270. doi: 10.21147/j.issn.1000-9604.2020.02.13. PMID: 32410803; PMCID: PMC7219097

Featured Image: Funding Contract. Courtesy: © 2010 – 2022 Fotolia/Adobe. Used with permission.

 

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