Shanghai Miracogen, Inc.

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). SOURCE Synaffix

Synaffix to provide access to proprietary Antibody-Drug Conjugate (ADC) technologies SOTIO to develop up to three next generation bioconjugates Total potential deal value of up to $740 million, plus royalties on commercial sales for three ADC programs AMSTERDAM, Oct. 16, 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, enters licensing agreement with SOTIO Biotech (SOTIO), a clinical stage immuno-oncology company owned by PPF Group. SOTIO will gain access to Synaffix's ADC technologies, GlycoConnect™, HydraSpace™ and toxSYN™ linker-payloads, in an initial ADC program with the option to expand research and commercial licenses into two additional programs at a later date. Under the terms of the agreement, Synaffix will be eligible to receive up to $740 million in payments spanning signature, target nomination and milestone payments plus additional royalties on commercial sales. SOTIO will be responsible for the research, development, and commercialization of the ADCs. Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary technologies. Peter van de Sande, Head of Synaffix, said: "The selection of our ADC technologies by a seasoned ADC player like SOTIO is a strong recognition of the potential of these technologies to maximize the therapeutic index of ADCs. We look forward to partnering with SOTIO, and believe that with their singular focus on cancer immunotherapies and robust clinical pipeline, this partnership can deliver innovative medicines for patients in areas of high unmet medical need." Radek Spisek, Chief Executive Officer of SOTIO, said: "At SOTIO, we are building a broad pipeline of next-generation ADCs to address the challenges of solid tumors – and access to Synaffix's ADC platform technologies will ensure we remain at the leading edge of this space. This collaboration combining SOTIO's deep expertise in solid tumor drug development with Synaffix's clinical-stage platform technology will drive important new innovations for the benefit of patients." Synaffix was fully acquired by Lonza in June 2023 and represents a newly formed 'Center of Excellence' for bioconjugation. As a Lonza company, Synaffix will continue to operate under the Synaffix name and further expand its operations in Oss (NL) to cater for further innovation and growth. 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™, 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 and ABL Bio. 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™ is a clinical-stage conjugation technology that exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. HydraSpace™ is a clinical-stage compact and highly polar spacer technology that is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN™ is a linker-payload platform that 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 Lonza Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene and Capsules & Health Ingredients. Our unparalleled breadth of offerings across divisions enables our customers to commercialize their discoveries and innovations in the healthcare industry. Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 17,500 full-time employees, we comprise high-performing teams and individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 3.1 billion with a CORE EBITDA of CHF 922 million in Half-Year 2023. Find out more at Follow @Lonza on LinkedIn Follow @LonzaGroup on Twitter About SOTIO SOTIO Biotech (SOTIO) is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The SOTIO pipeline includes SOT102, a next-generation Claudin-18.2-targeted antibody-drug conjugate which entered the clinic in 2022; BOXR1030, a metabolically-enhanced CAR-T cell therapy targeting GPC3-expressing tumors as well as other molecules approaching clinical stage such as SOT201, our next-generation PD-1-inhibiting cytokine. SOTIO is a member of the PPF Group. For more information, please visit the company's website at . SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries. SOURCE Synaffix

SOTIO will leverage Synaffix’s antibody-drug conjugate platform for the design of up to three novel ADCs to address indications with high unmet medical need Collaboration bolsters SOTIO’s wider portfolio of differentiated immuno-oncology therapies tailored to address the specific challenges of solid tumors Synaffix will receive an upfront payment and potential development milestone payments totaling $740 million PRAGUE--(BUSINESS WIRE)-- SOTIO, a clinical-stage immuno-oncology company owned by PPF Group, today announced a license and option agreement with Synaffix B.V., a Lonza company, to develop next-generation antibody-drug conjugates (ADCs) for the treatment of solid tumors. SOTIO will leverage Synaffix’s ADC technology platform to develop up to three novel ADCs targeting distinct tumor-associated antigens. “At SOTIO, we are building a broad pipeline of next-generation ADCs to address the challenges of solid tumors – and access to Synaffix’s ADC platform technologies will ensure we remain at the leading edge of this space,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “This collaboration combining SOTIO’s deep expertise in solid tumor drug development with Synaffix’s clinical-stage platform technology will drive important new innovations for the benefit of patients.” The deal enables SOTIO to combine its proprietary antibodies with Synaffix’s ADC technology platform in order to deliver innovative new ADCs that can overcome the challenges of treating solid tumors. In addition to GlycoConnect™ and HydraSpace™, the deal also includes Synaffix’s potent linker-payload platform including multiple different payloads. “Synaffix’s ADC technology perfectly complements the technologies already in SOTIO’s ADC platform, including the iADC technology licensed from NBE-Therapeutics and the ConjuALL technology licensed from LegoChem,” said Martin Steegmaier, chief scientific officer of SOTIO. “The addition of Synaffix’s capabilities will greatly expand our ability to select and tailor the most suitable ADC technology and payload for the needs of a particular target and particular solid tumor indication.” Under the terms of the agreement, Synaffix is eligible to receive upfront and potential milestone payments worth up to $740 million, plus single-digit royalties on net sales. SOTIO will be responsible for research, development, manufacturing and commercialization of the ADC products, while Synaffix will closely support SOTIO’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect™, HydraSpace™, and linker-payload technologies. Peter van de Sande, head of Synaffix, added, “The selection of our ADC technologies by a seasoned ADC player like SOTIO is a strong recognition of the potential of these technologies to maximize the therapeutic index of ADCs. We look forward to partnering with SOTIO, and believe that with their singular focus on cancer immunotherapies and robust clinical pipeline, this partnership can deliver innovative medicines for patients in areas of high unmet medical need.” SOTIO is advancing a pipeline of novel ADCs tailored to address the treatment needs of specific solid tumor types. SOT102, the company’s most advanced ADC program, is a CLDN18.2-targeting ADC in Phase 1/2 development for the treatment of gastric, pancreatic and other cancers that have very few targeted treatment options available. The company is progressing dose-finding studies in the trial’s monotherapy arm, with SOT102 as a later-stage treatment, and recently announced the initiation of the trial’s combination therapy arm in first-line treatment of gastric and pancreatic cancer patients. SOTIO additionally has two other ADC programs in preclinical development. 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™, 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 and ABL Bio. Synaffix was fully acquired by Lonza in June 2023. For more information, please visit the website at . About SOTIO SOTIO Biotech (SOTIO) is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The SOTIO pipeline includes SOT102, a next-generation Claudin-18.2-targeted antibody-drug conjugate which entered the clinic in 2022; BOXR1030, a metabolically-enhanced CAR-T cell therapy targeting GPC3-expressing tumors as well as other molecules approaching clinical stage such as SOT201, our next-generation PD-1-inhibiting cytokine. SOTIO is a member of the PPF Group. For more information, please visit the company’s website at . SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries. View source version on businesswire.com: Contacts Company contact: Richard Kapsa Head of Communication T: (+420) 224 174 448 M: (+420) 603 280 971 kapsa@sotio.com Media contact: Lisa Raffensperger Ten Bridge Communications M: +1 (617) 903-8783 lisa@tenbridgecommunications.com Source: SOTIO Biotech View this news release online at: