7MW-3711

SHANGHAI, May 23, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced multiple clinical research results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including phase Ib/II clinical study data of 9MW2821 (Bulumtatug Fuvedotin, BFv), a novel Nectin-4 targeting ADC, in combination with Toripalimab in locally advanced or metastatic uroepithelial carcinoma to be presented as oral presentation, and clinical study data of 7MW3711 and 9MW2921, a novel B7-H3 targeting ADC and a novel Trop-2 targeting ADC respectively, to be presented as poster presentations. The study of 9MW2821 was the only selected Chinese oral presentation in the field of urothelial carcinoma at this meeting. Nectin-4 ADC (9MW2821): In the phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUc), a total of 40 patients with previously untreated for la/mUC were enrolled in the study and were treated with 9MW2821 (1.25 mg/kg) and Toripalimab (240 mg). As of December 19, 2024, the objective response rate (ORR) was 87.5% and the confirmed ORR was 80%. The disease control rate (DCR) was 92.5%. Median progression-free survival (PFS) and duration of response (DoR) have not been achieved. No new safety signals of 9MW2821 or Toripalimab were observed in this study. 9MW2821 stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it's the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. Currently, 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for urothelial carcinoma have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA). B7-H3 ADC (7MW3711): 7MW3711 has enrolled 43 patients as of January 2, 2025 in a phase I/II clinical study in patients with advanced solid tumors. During the dose-escalation phase, dose-limiting toxicity (DLT) was not observed and the maximum tolerated dose (MTD) has not been reached. In patients evaluated at doses of 4.5 mg/kg or higher, the ORR for esophageal cancer, ovarian cancer, and prostate cancer was 33.3%, 60.0%, and 50.0%, respectively, and the DCR was 100%. In the phase I/II clinical study in lung cancer patients, 37 lung cancer patients were enrolled as of January 8, 2025, including 16 small cell lung cancer (SCLC) patients and 21 non-small cell lung cancer (NSCLC) patients. Common grade ≥3 adverse reactions were neutrophil count decreased, white blood cell count decreased, anemia, lymphocyte count decreased, and platelet count decreased. Among the 25 patients who received 7MW3711 at a dose of 4.5 mg/kg or greater and completed at least one tumor evaluation, the ORR was 36.0% and the DCR was 96.0%; of these, the ORR and DCR were 62.5% and 100.0%, respectively, for patients with small-cell lung cancer at a dose of 4.5 mg/kg. Among squamous lung cancer (Sq-NSCLC) patients with a B7-H3 H-score >5, the ORR and DCR were 37.5% and 87.5%, respectively. The study results suggest that 7MW3711 has a tolerable safety profile and good anti-tumor activity in patients with advanced tumors such as lung, esophageal, prostate and ovarian cancers. 7MW3711 was developed with Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform. It consists of an innovative antibody molecule, a novel linker, and a novel payload: Mtoxin™, which is a topoisomerase I inhibitor. It has been granted ODD by the FDA for the treatment of SCLC. Trop-2 ADC (9MW2921): In the first-in-human clinical study in patients with advanced solid tumors, a total of 39 patients were enrolled as of November 12, 2024. The most common ≥3 grade adverse were stomatitis, anemia, white blood cell count decreased, neutropenia, lymphocyte count decreased, etc. The ORR of 3.0 mg/kg dose group was 42.1% and the DCR was 84.2%. Under this dose level, the ORR and DCR was 75% and 100% for endometrial cancer, 50% and 75% for HR+/HER2- breast cancer, 50% and 100% for gastric cancer, 25% and 100% for non-squamous non-small cell lung cancer. The study result suggests that 9MW2921 has a tolerable safety profile and good anti-tumor activity in patients with advanced tumors. 9MW2921 was developed with Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform. It consists of an innovative antibody molecule, a novel linker, and a novel payload: Mtoxin™, which is a topoisomerase I inhibitor. 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

SHANGHAI, China I April 30, 2025 I 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 www.mabwell.com/en . SOURCE: Mabwell