CLDN1

SHANGHAI, April 30, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, presented 6 study results of innovative drugs and platforms in poster format at the American Association for Cancer Research (AACR) annual meeting, held from April 25 to 30, 2025. Poster Presentation 1. A B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiate the antitumor activity in B7-H3-positive cancers Published Abstract Number: 830 Both PARP inhibitors and B7-H3-targeting ADC are feasible therapies to chemotherapy resistant solid tumors. Mabwell combines its self-developed 7MW3711 with PARP inhibitors to explore the synergistic antitumor activity of the ADC+PARPi combination strategy in preclinical solid tumor models. In this study, the synergistic antitumor activity shown by 7MW3711 in combination with PARPi suggests that it is a promising strategy to combine DNA damage repair inhibitor and B7-H3-targeting ADC for the treatment of B7-H3-positive solid tumors. The data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical application. 2. Design and synthesis of the novel camptothecin analog MF6 for application into site-specific antibody-drug conjugate Published Abstract Number: 5733 This study preliminarily validated the antitumor activity and safety of MF6, a novel payload based on the Mtoxin™ platform, in multiple in vivo and in vitro models. The experimental results demonstrated that MF6 possessed favorable tumor-killing activity and maintains significant efficacy in multidrug-resistant models resistant to DXd. ADCs constructed using the clinically validated site-specific conjugation technology IDDC™ and our novel payload MF6 demonstrated good uniformity and stability, and exhibited significant antitumor efficacy in multiple CDX models. Additionally, these ADCs show a potent bystander killing effect enabling the killing of nearby tumor cells and thereby further enhancing the antitumor efficacy. ADCs synthesized with MF6 have excellent serum and plasma stability and pharmacokinetic properties, providing strong support for future clinical application. 3. MW-C01/C02, novel CLDN1-targeting antibody-drug conjugates, demonstrate compelling anti-tumor efficacy and favorable safety profiles in preclinical studies Published Abstract Number: 1573 MW-C01/C02 are novel CLDN1-targeting ADCs, developed based on our own ADC site-specific conjugation technology platform IDDC™. Claudins localize to tight junctions in healthy tissues, while their overexpression in solid tumors leads to aberrant exposure outside of these junctions, making them attractive targets for ADC therapies. Studies have shown that high expression of CLDN1 is associated with tumor proliferation, invasion, metastasis, and poor prognosis. MW-C01/C02 exhibit robust binding, rapid internalization, and potent cytotoxicity in CLDN1-positive cancer cell lines. MW-C01/C02 demonstrate potent anti-tumor activity in both preclinical CDX and PDX models and show good PK and safety profiles in primates. 4. 2MW7061, a novel LILRB4xCD3 bispecific T-cell engager targeting monocytic acute myeloid leukemia Published Abstract Number: 2116 2MW7061 (LILRB4xCD3) is a bispecific T-cell engager (TCE) targeting LILRB4 developed based on Mabwell's TCE platform. With its unique structural design and mechanism of action, 2MW7061 exhibits minimal binding to T cells while demonstrating potent cytotoxicity against tumor cells, thereby significantly improving its safety margin without compromising efficacy. In preclinical models of AML (acute myeloid leukemia), 2MW7061 showed strong anti-tumor activity. Non-primate toxicology studies indicate a favorable safety profile, highlighting its therapeutic potential for treating AML patients. 5. An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors Published Abstract Number: 2866 As a promising cancer therapeutic strategy, T‑cell engagers (TCEs) simultaneously bind to CD3 on T cells and tumor-associated antigens (TAAs) on cancer cells, facilitating the formation of an immunological synapse that activates T cells and directs their cytotoxic activity toward tumor cells. Clinical data have robustly demonstrated the efficacy of TCEs in hematologic malignancies; however, their clinical benefits in solid tumors remain to be fully validated. As agonists, TCEs present significant developmental challenges that require a delicate balance between efficacy and safety. In response, Mabwell has established an innovative TCE platform that meticulously optimizes various parameters—including CD3 affinity, TAA selection, and bispecific antibody format—to effectively widen the therapeutic window and maximize clinical outcomes. 6. 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers Published Abstract Number: 5466 7MW4911 is a novel ADC developed by Mabwell targeting CDH17, a membrane protein highly expressed in gastrointestinal cancers with limited normal tissue distribution, offering a promising therapeutic strategy for gastrointestinal malignancies. 7MW4911 is composed of a proprietary anti-CDH17 monoclonal antibody, a cleavable linker, and innovative cytotoxic payload Mtoxin™, with full intellectual property ownership. In preclinical CDX and PDX models, 7MW4911 demonstrated robust antitumor activity and superior efficacy over MMAE-based ADCs in multidrug resistance models. Pharmacokinetic and safety studies in non-human primates support a favorable profile and a high non-severely toxic dose (HNSTD), enabling clinical advancement. 7MW4911 represents a differentiated and promising ADC candidate for GI cancers, with an IND submission to the NMPA and FDA planned for H2 2025. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Robust Dose-Dependent Target Engagement Demonstrated by Lixudebart in Both Studies Preliminary Evidence of Improvement in Organ Function: eGFR and Proteinuria in ANCA-RPGN, and ALT/AST in Liver Fibrosis Lixudebart Exhibited a Favorable Safety Profile and was Well-Tolerated BASEL, Switzerland I January 09, 2025 I Alentis Therapeutics (“Alentis”), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced positive topline results from two clinical trials of lixudebart (ALE.F02), a monoclonal antibody targeting Claudin-1 (CLDN1), developed to reverse organ fibrosis. Lixudebart was investigated in two double-blind, placebo-controlled, randomized studies. RENAL-F02 is an ongoing Phase 2 study in Anti-Neutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis (AAV) with Rapidly Progressive Glomerulonephritis (RPGN) ( NCT06047171 ), where 26 patients have been dosed for up to 24 weeks. FEGATO-01 is a Phase 1b clinical trial where 41 patients with mainly advanced F3/F4 liver fibrosis and/or mild cirrhosis were dosed for up to 4 weeks ( NCT05939947 ). “ The results from the two studies are very encouraging, particularly given the dose-dependent target engagement and favorable safety profile, ” said Luigi Manenti, Chief Medical Officer. “ We also observed an initial decrease in ALT/AST in liver fibrosis patients treated with lixudebart.” “Interim results from the RENAL-F02 study in ANCA-RPGN indicate beneficial effects of lixudebart on Glomerular Filtration Rate (GFR) recovery and proteinuria reduction,” said David Jayne, Professor of Clinical Autoimmunity at Cambridge University . “ These observations were further supported by reductions of CD163, a validated urinary biomarker, also indicating an impact on immune cell homing and trafficking to the kidney.” In both clinical trials, lixudebart demonstrated a favorable safety profile, both as a monotherapy and in combination with standard of care (n=51 active patients across the two trials). These findings are consistent with the safety results from the Phase 1 clinical trial of lixudebart in healthy volunteers (n=48 active patients). About Lixudebart (ALE.F02) Lixudebart is a first-in-class monoclonal antibody developed for liver, lung and kidney fibrosis. The investigational antibody is designed to reverse organ fibrosis by specifically targeting a unique CLDN1 epitope exposed in fibrotic tissue. In Phase 1 single- and multiple-ascending dose studies in healthy volunteers, lixudebart was well tolerated, with no serious safety concerns. Lixudebart has been granted Orphan Drug designation by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF). About Alentis Therapeutics Alentis Therapeutics is a clinical-stage biotechnology company pioneering first-in-class antibody-drug conjugates (ADCs) and antibodies targeting Claudin-1 (CLDN1) for oncology and multi-organ fibrosis. CLDN1 is a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis is the leading company pioneering CLDN1 ADCs and antibodies to modify and reverse the course of select diseases. The FDA granted Fast Track designation to the lead ADC program, ALE.P02, for the treatment of advanced or metastatic CLDN1+ squamous cancers, irrespective of the organ of origin. Alentis was founded based on ground-breaking research in the laboratory of Prof. Thomas Baumert, MD at the University of Strasbourg and the French National Institute of Health and Medical Research (Inserm). Alentis is headquartered at the pharma-biotech hub in Basel, Switzerland, with an R&D subsidiary in Strasbourg, France, and clinical operations in the US. Visit www.alentis.ch SOURCE: Alentis Therapeutics

BASEL, Switzerland--( BUSINESS WIRE )--Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALE.P02 for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin. ALE.P02 is an investigational antibody-drug conjugate (ADC) targeting CLDN1, developed for CLDN1+ squamous cancers including but not limited to lung, head and neck, cervical and esophageal cancers. " We are encouraged by the FDA’s recognition of ALE.P02’s potential as a treatment for CLDN1+ squamous cancers, " said Roberto Iacone, Chief Executive Officer of Alentis Therapeutics . " It reflects the importance of advancing ALE.P02 through clinical development, and it brings us one step closer to providing a new treatment option for patients. " Fast Track designation is designed to expedite the development and review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. " We have set out to develop ALE.P02 in the most rational way, following CLDN1 science and the clinical understanding of squamous cancers. The FDA’s support in this endeavor is certainly motivating, " added Luigi Manenti, Chief Medical Officer of Alentis . " We are optimistic about the potential of ALE.P02 and look forward to the start of our first-in-human clinical trial in Q1 2025. " " Squamous cancers of various origin have been shown to overexpress CLDN1, making ALE.P02 a promising ADC to address the unmet medical needs of these patients, " said Tony Mok Professor of Clinical Oncology at the Chinese University of Hong Kong. " CLDN1 is an exciting new target for ADCs and Alentis has been the frontrunner in developing anti-CLDN1 therapeutics. " About ALE.P02 ALE.P02 is a first-in-class ADC designed by linking a tubulin inhibitor, a potent cancer drug, to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination could be a powerful new tool to fight the many squamous cancers that overexpress CLDN1 with less toxicity than traditional cancer drugs. The IND application for ALE.P02 to commence a Phase 1/2 clinical trial in advanced or metastatic CLDN1+ squamous solid tumors was recently cleared by the FDA. About Alentis Therapeutics Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors and organ fibrosis. CLDN1 is a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis is the leading company pioneering anti-CLDN1 antibodies and ADCs to modify and reverse the course of disease. Alentis was founded based on ground-breaking research in the laboratory of Prof. Thomas Baumert, MD at the University of Strasbourg and the French National Institute of Health and Medical Research (Inserm). Alentis is headquartered at the pharma-biotech hub in Basel, Switzerland with an R&D subsidiary in Strasbourg, France and clinical operations in the US. Visit www.alentis.ch