SYSA-1801

Licensing agreement gives Elevation Oncology access to Synaffix's ADC technology for one program in combination with SYNstatin E™ Elevation Oncology nominates a novel HER3 ADC candidate EO-1022 leveraging its antibody as well as Synaffix's proprietary ADC development technologies AMSTERDAM, Dec. 12, 2024 /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 that it has entered into a licensing agreement with Elevation Oncology, Inc., an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. Synaffix gives Elevation Oncology global access to its clinical stage, site-specific ADC technology platform, including GlycoConnect® antibody conjugation technology, HydraSpace® polar spacer technology, as well as the toxSYN® linker-payload, SYNstatin E™, which enables the transformation of Elevation Oncology's antibody into a differentiated ADC with best-in-class potential. Under the terms of the agreement, Synaffix is eligible to receive up to USD 368 million in upfront and clinical, regulatory, and commercial milestone payments, plus tiered royalties on net sales. Synaffix is responsible for manufacturing the components related to its proprietary technologies, and Elevation Oncology is responsible for the research, development, manufacturing, and commercialization of the ADC. Peter van de Sande, Head of Synaffix, said: "As a dedicated partner in the ADC space, Synaffix is excited to collaborate with Elevation Oncology to push the boundary of ADC innovation. With our state-of-the-art ADC technology platform and established supply chain, Elevation is well-positioned to accelerate the development of its differentiated HER3 ADC." David Dornan, Chief Scientific Officer at Elevation Oncology, commented: "Our partnership with Synaffix enables us to build a HER3 ADC candidate with best-in-class potential, which leverages Synaffix's state-of-the-art site-specific conjugation and differentiated linker-payload for a potentially improved safety and efficacy profile. We look forward to advancing our pipeline as we work toward transforming the care and treatment of patients living with solid tumors that express HER3." 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. Synaffix holds granted patents to its technology. 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, Kyowa Kirin, Genmab, Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio, SOTIO Biotech, Kivu Bioscience, BigHat Biosciences, Illuminaand Elevation Oncology. Synaffix was fully acquired by Lonza in June 2023. About The Synaffix ADC Platform Technology Synaffix's proprietary ADC technology platform consists of GlycoConnect®, GlycoConnect™ High DAR Technology, HydraSpace®, and toxSYN®. 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. The extension of GlycoConnect® with High DAR Technology enables ADCs with high drug loading (6, 8 and above), while retaining high drug substance homogeneity and therapeutic index. 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 newest proprietary linker-payload, "SYN-PNU™" is part of the established and expanding toxSYN® linker-payload portfolio. SYN-PNU™ represents (based on pre-clinical models) a significantly potency-attenuated and better tolerated version of PNU-159,682, to enable enhanced administered dose levels and competitive therapeutic properties versus ADCs prepared using the original molecule. The reference compound (PNU-159,682) is a metabolite of the anthracycline Nemorubicin and represents a highly potent DNA topoisomerase II inhibitor. 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 one of the world's largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments. Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of CHF 3.1 billion with a CORE EBITDA of CHF 893 million during the first 6 months 2024. Find out more at  Follow @Lonza on LinkedIn Follow @LonzaGroup on X About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. We are also advancing EO-1022, a HER3-targeting ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit . SOURCE Synaffix B.V. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

-- EO-1022 is comprised of seribantumab, an anti-HER3 monoclonal antibody, and an MMAE payload – -- Following recently signed global license agreement with Synaffix, EO-1022 leverages the company's GlycoConnect® and HydraSpace® ADC technologies for glycan site-specific conjugation and SYNstatin E™ linker-payload -- – Elevation Oncology expects to present EO-1022 preclinical data in 1H 2025 and to file an IND application in 2026 – BOSTON, Dec. 12, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced the nomination of EO-1022 as its HER3 ADC development candidate. EO-1022 is currently progressing through preclinical development, and Elevation Oncology expects to file an investigational new drug (IND) application in 2026. HER3 is a protein expressed across several types of solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer, and often associated with poor clinical outcomes. EO-1022 is a differentiated ADC containing seribantumab, an anti-HER3 monoclonal antibody (mAb), and a monomethyl auristatin E (MMAE) payload, with site-specific conjugation to the glycan. EO-1022 is being developed for the treatment of patients living with solid tumors that express HER3. "The nomination of our HER3-ADC development candidate marks a key milestone for Elevation Oncology in bolstering our ADC pipeline. EO-1022 combines the seribantumab antibody and state-of the-art ADC site-specific technology. We believe seribantumab is ideally-suited to be used in an ADC due to its selectivity in delivering cytotoxic payload to HER3-expressing cancer cells and its well-tolerated safety profile demonstrated in over 900 patients in multiple studies," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This program is another step forward in leveraging our ADC and oncology drug development expertise to develop innovative, selective cancer therapies that address significant unmet needs. We look forward to sharing preclinical data for EO-1022 in the first half of 2025, as we continue to advance this asset toward the clinic." Also today, Elevation Oncology announced that it has entered into a licensing agreement with Synaffix B.V. (Synaffix). This licensing agreement gives Elevation Oncology global access to Synaffix's clinical stage, site-specific ADC technology platform, including GlycoConnect® antibody conjugation technology, HydraSpace® polar spacer technology, as well as the toxSYN® linker-payload, SYNstatin E™. The license granted to GlycoConnect® and HydraSpace® technologies is exclusive to HER3 as a single target in combination with SYNstatin E® linker-payload. "HER3 is broadly expressed in various cancer types, making it a compelling target for innovative therapeutic strategies. We believe an ADC approach is uniquely positioned to fully unlock the clinical potential of HER3," said David Dornan, Ph.D., Chief Scientific Officer of Elevation Oncology. "We are excited to nominate EO-1022, which leverages Synaffix's state-of-the art site-specific conjugation and differentiated linker-payload for a potentially best-in-class profile. We look forward to advancing our pipeline, as we work towards transforming the care and treatment of patients living with solid tumors that overexpress HER3." "As a dedicated partner in the ADC space, Synaffix is excited to collaborate with Elevation Oncology to push the boundary of ADC innovation," said Peter van de Sande, Head of Synaffix. "With our state-of-the-art ADC technology platform and established supply chain, Elevation is well-positioned to accelerate the development of its differentiated HER3 ADC." About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our ADC expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class, Claudin 18.2 ADC and is currently being evaluated in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. We are also advancing EO-1022, a HER3-targeting ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit . 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. Synaffix holds granted patents to its technology. 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, Kyowa Kirin, Genmab, Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio, SOTIO Biotech, Kivu Bioscience, BigHat Biosciences, Illumina and Elevation Oncology. Synaffix was fully acquired by Lonza (SIX:LONN) in June 2023. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical development activities, expected timing of announcements of preclinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Gracie Tong Senior Director, Investor Relations and Corporate Communications [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED