SynAffix BV

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

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. National Resilience is replacing its CEO effective immediately with COO William Marth, who will take over from Rahul Singhvi. Marth previously served as CEO of Curia Global, known then as AMRI, as well as CEO of Teva Pharmaceutical’s US division. Moderna has opened its new mRNA manufacturing facility in Australia within the campus of Monash University. The new site will be able to make 100 million vaccine doses a year, and the first dose is anticipated to be produced next year. Around 140 new “direct” jobs will be created at the site. Reckitt Benckiser is pouring £155 million ($200 million) into a new facility in Wilson, NC, to make its over-the-counter flu and cold drug products, the company said Tuesday. This will be Reckitt’s largest OTC manufacturing site in the US and will create 300 new jobs. CDMO Cambrex is partnering with Eli Lilly’s biotech innovative arm, dubbed Lilly Catalyze360-ExploR&D, to offer its services to Lilly’s biotech partners, according to a Thursday release. Agenus has revealed its planning to make layoffs as a part of its wider plan to reduce costs, the company said Thursday. The company said Monday it is restructuring its manufacturing sites to become a biologics CDMO. Nature’s Toolbox has secured $15 million from JP Morgan to fund the development of its manufacturing platforms to make biomaterials, the company said Wednesday. Altasciences is the manufacturer for several of Metsera’s weight loss candidates, the company said on Nov. 28. The CDMO has produced the biotech’s Phase 1/2 GLP-1 asset, dubbed MET-097i. It is also making two other candidates for Metsera: a long-acting amylin analog (MET-233i) and an oral GLP-1 drug (MET-002). Rallybio is moving its C5 inhibitor into a confirmatory study next year following manufacturing improvements, the company said Monday. After data analysis and changes to the production of the drug, named RLYB116, the study will be completed in the second quarter of 2025. GE Healthcare is gaining full ownership of the radiopharma manufacturer Nihon Medi-Physics by buying Sumitomo Chemical’s 50% stake in the company, according to a Sunday release. The transaction is expected to close early next year. Telix IsoTherapeutics has renewed its supply agreement with clinical-stage radiopharma Plus Therapeutics, according to a Tuesday release. Telix will continue to supply rhenium-186 isotopes for Plus’ lead candidate, obisbemeda, which is being studied for CNS tumours. Eckert & Ziegler is supplying the radiopharma company Ariceum Therapeutics with actinium-225 and lutetium-177 for its lead asset, satoreotide, under study for hard-to-treat cancers. KBI Biopharma will manufacture Alanis Therapeutics’ preclinical antibody that is being investigated for myelodysplastic syndromes and acute myeloid leukemia, according to a Tuesday release. CELLforCURE by SEQENS is partnering with clinical-stage biotech Smart Immune, according to a Tuesday release. The CDMO will make the biotech’s Phase 1/2 asset, SMART101, for acute leukemia or primary immunodeficiencies. NorthX Biologics will make Amarna Therapeutics’ clinical-stage gene therapy called Nimvec AM510, which is being investigated for type 1 diabetes, according to a Tuesday announcement. API manufacturer Antheia will receive $12 million from the US Department of Health and Human Services over two years to manufacture an unnamed pharma ingredient domestically, according to a Tuesday release. Lonza’s ADC company Synaffix has entered a licensing agreement with DNA sequencer Illumina, the companies said Wednesday. Synaffix’s so-called “metal-free clock chemistry” tech will be used by Illumina for its DNA sequencing products. Chemical manufacturer LG Chem is collaborating with microbiology biotech Acies Bio on sustainable commercial production of chemicals in high demand, the companies said Thursday. The UK Health Security Agency has signed a contract with CSL Seqirus to manufacture five million doses of human H5 influenza vaccines for the UK, the agency said Tuesday. The Brazilian research organization Oswaldo Cruz Foundation signed a memorandum of understanding with Belgian companies Quantoom Biosciences and Univercells to boost production of RNA therapeutics in Belgium, according to a Friday release. Gavi, the Vaccine Alliance, is investing $23.4 million to help vaccinate children in Sudan, in partnership with Save the Children and UNICEF, according to a Monday release. The funding will in part be used to improve vaccine storage and cold supply chains. With additional reporting by Katherine Lewin