Mabwell Presented IDDCtm Platform Technology and ADC Drug Development Achievements at the 14th World ADC London

SHANGHAI, March 21, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, published "Mtoxintm Payload Applied in IDDCtm ADC Platform Significant Increases Therapeutic Index and Overcome MultiDrug Resistance in Various Tumor" as poster presentation from March 12 to 15, 2024 at the 14^th World ADC London. The development of several ADC drugs under the capabilities of IDDCtm, a next generation ADC technology platform, was demonstrated.

Overview of Poster Presentation

Evolutions of conjugation technologies, new release structures, and multiple mechanism payloads have prompted the development of ADC field. However, further improving drug delivery and overcoming drug resistance are urgent problems for the next generation of ADC drugs. Mabwell has independently developed IDDCtm technology and novel payload Mtoxintm. The study results show:

1. DARfinitytm produces site-specific conjugated drugs with DAR 4 as the main component (DAR 4 ? 95%).

2. IDconnecttm enhances plasma stability and payload transfer efficiency of ADC drugs (40% increase from control group).

3. LysOnlytm technology enhances tumor-specific release capacity of ADC drugs and reduces off-target effects.

4. Mtoxintm has good tumor penetration, bystander killing effect and anti-multidrug resistance.

5. ADC drugs developed based on IDDCtm and Mtoxintm have good pharmacodynamic and safety characteristics, especially in the DXd-resistant multidrug resistance model.

Summary

IDDCtm is a clinically validated site-specific conjugation technology with good homogeneity, efficacy, and safety advantages. In addition, the novel payload Mtoxintm (MF6) has good pharmacodynamics, bystander killing efficacy, and anti-multidrug resistance.

Novel ADC Drugs Developed Based on IDDCtm Platform

The IDDCtm platform has been validated in multiple drugs under study.

9MW2821 - novel Nectin-4-targeting ADC:
For the indication of urothelial carcinoma, 9MW2821 is the first Nectin-4 ADC developed by a Chinese company to enter phase III clinical studies, making it the second globally in terms of progress. 9MW2821 is also the first therapeutic drug with the same target in the world to disclose clinical efficacy data for indications of cervical cancer and esophageal carcinoma. It has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA)  for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

7MW3711 - novel B7-H3-targeting ADC:
Clinical trials have been conducted for 7MW3711 for the indication of advanced solid tumors in China, and it has received FDA approval to conduct clinical trials for patients with advanced malignant solid tumors.

9MW2921 - novel Trop-2-targeting ADC:
Clinical trials have been conducted for 9MW2921 for the indication of advanced solid tumors in China.

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 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 products have been filed for MA 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 located in Shanghai is 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. 

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