ABL Bio, Inc.

Lonza’s Synaffix has secured two separate licensing deals with Boehringer Ingelheim and Japanese drugmaker Mitsubishi Tanabe Pharma for its antibody-drug conjugate tech. The two “long-term” deals were announced Thursday. While details are sparse, including information on drug targets, Synaffix’s licensing deals tend to focus on cytotoxic ADCs for oncology despite some new interest in non-oncology targets, CEO Peter van de Sande told Endpoints News in an interview . Synaffix will give Mitsubishi access to its ADC tech for a single target. Synaffix could receive up to $1.3 billion from Boehringer in milestone payments and is eligible to gain royalty payments from both companies depending on sales from future products. No upfront payments were disclosed. Since Lonza’s $107 million (€100 million) acquisition of Synaffix in June 2023, it has boosted its headcount from around 30 employees to 60 and has “doubled down” on R&D, van de Sande said. Before joining Lonza, Synaffix spun out its own pharma subsidiary called Kivu Bioscience, which launched in October with three ADC assets and $92 million in hand. For 2025, Synaffix is continuing to look for more partners and is open to both small and large collaborations, van de Sande said. The company is eager to secure more collaborations within the APAC region, as illustrated by the deal with Mitsubishi, he added. Van de Sande predicts there will still be a strong interest in using topoisomerase I inhibitors as payloads for ADCs. With two new deals, Synaffix has a total of 17 publicly announced partnerships, which helps to raise its profile as a key ADC development partner. It secured at least five licensing deals in 2023. Boehringer and Mitsubishi join the likes of Sotio Biotech , ABL Bio and Amgen , who have all struck licensing deals with Synaffix. As for Boehringer, the German pharma has recently honed in on boosting its cancer portfolio with its $1.3 billion buy of immuno-oncology Nerio Therapeutics in July last year, and by securing another ADC licensing deal with the Agency for Science, Technology and Research a month prior. Mitsubishi has two oncology assets in its portfolio, which both use ADCs licensed from ADC Therapeutics from a partnership announced in 2022. Editors Note: This article was updated to clarify timelines.

Givastomig: a Claudin 18.2 ("CLDN18.2") x 4-1BB bispecific antibody, will be the lead clinical program following the Company's portfolio prioritization The Company has completed enrollment of a dose escalation study of givastomig in combination with nivolumab plus chemotherapy, and data is expected in the early second half of 2025; a 40-patient dose expansion study is now underway with data expected in early 2026 Cash balance of $184.4 million (as of September 30, 2024), expected to support operations into 2027, complemented by a strengthened U.S.-based leadership team and streamlined operating model ROCKVILLE, MD, Jan. 6, 2025 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today highlighted its strategic outlook for 2025 and a re-prioritization of resources, with a focus on advancing its lead program, givastomig, a CLDN18.2 x 4-1BB bispecific antibody, targeting first-line metastatic gastric cancers, with further potential in other solid tumors. "I-Mab made excellent progress executing its corporate strategy in 2024, including the establishment of a new operating model as a U.S.-based global biotech company, completion of the divestiture of operations in China, including extinguishment of all remaining redemption obligations, appointment of U.S.-based auditors, enhanced transparency through quarterly financial reporting, and buildout of a U.S.-based leadership team," said Sean Fu, PhD, MBA, CEO and Board Member of I-Mab. "Building on this positive momentum, the Company has implemented a portfolio prioritization to support the accelerated development of givastomig." Portfolio Prioritization Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting CLDN18.2-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain a strong tumor-binding property and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. The Company will focus its resources on advancing givastomig as its lead asset. Topline Phase 1 monotherapy dose escalation and dose expansion data presented at the annual meeting of the European Society for Medical Oncology ("ESMO 2024") showed: An overall response rate ("ORR") of 16.3% (7/43), including seven partial responses ("PR") at doses between 5 mg/kg and 18 mg/kg, with five of the seven responders (71%) having received prior checkpoint inhibitor ("CPI") therapy. A favorable safety profile, with mainly grade 1 or 2 treatment-related adverse events ("TRAEs"). No dose-limiting toxicities ("DLTs") were observed, and a maximum tolerated dose ("MTD") was not identified. A Phase 1b dose escalation study of givastomig in combination with nivolumab plus chemotherapy has been fully enrolled (n = 17) with no MTD reached and no DLTs to date; the Company expects to present these data in the early second half of 2025 . Based on encouraging early data from the dose escalation study, the Company is expanding the previously planned dose expansion cohort (n = 6-8) to include two dose cohorts, each evaluating 20 patients, for a total of 40 patients. Patients are being enrolled with tumors that express CLDN18.2 as low as 1+ intensity in ≥1% of cells, regardless of PD-L1 expression The Company expects to share these data in early 2026. This program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding China and South Korea, equally with ABL Bio. According to Phillip Dennis, MD, PhD, CMO of I-Mab, "Data arising from this study will not only help establish the breadth of patients who might respond to this novel regimen (such as those with low levels of CLDN18.2 expression that would not qualify for approved CLDN18.2 therapies), but also help establish the recommended dose of givastomig for subsequent studies." Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. I-Mab owns worldwide rights to uliledlimab outside of Greater China. The development of uliledlimab is being paused to allow the Company to focus resources toward advancing its lead clinical program, givastomig, and to allow data to mature from an ongoing China-only randomized study conducted by its partner TJ Biopharma evaluating uliledlimab in combination with a CPI (toripalimab) in CD73-high NSCLC patients. As a result, further clinical investment in uliledlimab will be put on hold. The Company will continue to monitor data as it becomes available. I-Mab is positioned to potentially resume clinical development, pending positive data. Ragistomig (TJ-L14B / ABL503) is a bispecific, Fc-silent antibody designed to provide anti-PD-L1 activity and conditional 4-1BB-driven T-cell activation in one molecule. Ragistomig is being developed for solid tumors that are refractory or have relapsed after exposure to CPIs. The program is being jointly developed through a global partnership with ABL Bio, in which ABL Bio is the lead party and shares worldwide rights, excluding China and South Korea, equally with I-Mab. Data reported by ABL Bio at the annual meeting of the American Society of Clinical Oncology ("ASCO 2024") showed promising objective responses in patients with various solid tumors whose tumors progressed or recurred after prior standard treatments, including patients with prior exposure to PD-(L)1 inhibitors. ABL Bio is continuing the Phase 1b study to increase the therapeutic index by altering the dosing level and/or frequency, and to identify the appropriate tumor types for further development. Financial Outlook The Company's current cash position is expected to fund the givastomig Phase 1b study through dose expansion data readouts and further development initiatives into 2027. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. I-Mab has established operations in the U.S. in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit us at: and follow us on LinkedIn and X. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will", "expects", "believes", "designed to", "anticipates", "future", "intends", "plans", "potential", "estimates", "confident", and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and capital strategy; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the Company's expectations regarding its cash runway; timing and progress of studies and trials; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts SOURCE I-Mab Biopharma 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, MA, USA I December 12, 2024 I 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 www.ElevationOncology.com . 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. SOURCE: Elevation Oncology