Innovent Biologics and Synaffix Expand ADC Collaboration Following Positive Preliminary Clinical Signal from Ongoing Phase 1 Study

• New deal builds on encouraging preliminary clinical data from the Phase 1 study of the first antibody-drug conjugate (ADC) developed under the agreement signed in June 2021
• The expanded collaboration to provide Innovent with access to additional targets and further proprietary Synaffix linker-payloads for the development of additional innovative ADCs
• Synaffix will be eligible to receive an upfront fee plus potential milestone payments and royalties on commercial sales for each licensed target

AMSTERDAM, Dec. 6, 2023 /PRNewswire/ -- Synaffix B.V., a Lonza company (SIX: LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, today announces the expansion of its licensing agreement with Innovent Biologics (Innovent), Inc. (HKEX:01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases.

Building on the core value proposition of Synaffix ADC technology – to enable best-in-class efficacy and tolerability for ADCs – the expanded deal with Innovent focuses on at least one new ADC candidate. This builds on a previous agreement signed in June 2021, which granted Innovent rights to deploy Synaffix's ADC technologies on a target-specific, non-exclusive basis, including GlycoConnect®, HydraSpace® and one of its toxSYN® linker-payloads, for a therapeutic molecule (Innovent R&D code: IBI343, a CLDN18.2 ADC) which has advanced to Phase 1 clinical development.

Under the terms of the expanded agreement, Innovent will be responsible for the research, development, manufacturing and commercialization of new ADC candidates. Synaffix is eligible to receive an upfront payment plus potential milestone payments and royalties on commercial sales for each licensed target.  

Peter van de Sande, Head of Synaffix, said: "With its focus on innovative medicines and R&D expertise, Innovent has proven to be an ideal partner for us. Our partnership with Innovent has rapidly built momentum around IBI343 and we look forward to expanding our collaboration using our technology platform, including enabling off-the-shelf conversion of antibodies into ADCs, and Innovent's world-leading clinical development capabilities with its strong proven track record to swiftly advance product candidates to the clinic."

Dr. Kaijie He, Vice President of Cancer Biology and ADC Research at Innovent, said: "Innovent has progressed one ADC candidate under the initial phase of our collaboration with Synaffix to the clinical development stage. This expanded deal adds additional novel ADC to our research projects, allowing us to further build on our understanding of ADC research and ADC pipeline development."

Notes to Editors

About Synaffix

Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect®, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix.

The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Granted patents covering Synaffix' technology provide end-to-end protection of the manufacturing technology as well as the resulting products through at least 2039. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen (acquired by Lepu Biopharma), Innovent Biologics, ProfoundBio, Kyowa Kirin, Genmab, Macrogenics, Emergence Therapeutics (acquired by Eli Lilly), Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio and SOTIO Biotech.

Synaffix was fully acquired by Lonza in June 2023.

About The Synaffix ADC Platform Technology

Synaffix' proprietary ADC technology platform consists of GlycoConnect®, HydraSpace® and toxSYN® technologies.These technologies are aimed at enabling best-in-class ADCs from any antibody, with significantly enhanced efficacy and tolerability. 

GlycoConnect® clinical-stage conjugation technology exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. HydraSpace®  clinical-stage compact and highly polar spacer technology  is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN® linker-payload platform spans key, validated MOAs for ADC product development. This includes potent topoisomerase 1 inhibitor (SYNtecan E™), DNA damaging agents (SYNeamicin D™ and SYNeamicin G™), ⍺-Microtubule (SYNtansine™) and β-Microtubule (SYNstatin E™ and SYNstatin F™) inhibitors as well as several unlaunched proprietary linker-payloads that were generated through the ongoing innovative efforts of the Synaffix R&D team.

The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases.

Innovent has 10 products in the market. These include: TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). In addition, one asset is under NMPA NDA review, seven assets are in Phase III or pivotal clinical trials, and 17 more molecules are in clinical studies.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

About IBI343

IBI343 is a recombinant human anti-Claudin 18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the Claudin 18.2-expressing tumor cells, the Claudin 18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in a "bystander killing effect".  Currently, Phase I study of IBI343 has been conducted in Australia and China (NCT05458219) to assess the safety, tolerability, and preliminary efficacy of IBI343 in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).