CCR8

SHANGHAI, March 12, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that it will present results of three preclinical studies as poster presentation at the AACR Annual Meeting to be held in San Diego, USA, from April 5-10, 2024. The AACR Annual Meeting is one of the largest cancer research conferences in the world. The abstracts have been published on the AACR official website. Poster Presentation 01 Abstract title: Disrupting IL-11/IL-11R signaling by an efficacious anti-IL-11 antibody 9MW3811 enhances T cell tumor infiltration and synergizes with anti-PD-1 therapies in vivo Abstract Number: 2365 Location: Poster Section 38 Poster Board Number: 11 Session Date and Time: Apr 8, 2024 9:00 AM - 12:30 PM PDT 02 Abstract title: 2MW4991, a novel ADCC-enhanced integrin αvβ8 blocker, exhibits high anti-tumor potency and was well tolerated in cynomolgus monkeys Abstract Number: 6349 Location: Poster Section 41 Poster Board Number: 10 Session Date and Time: Apr 9, 2024 1:30 PM - 5:00 PM PDT 03 Abstract title: 2MW4691, a novel CCR8/CTLA-4 bispecific antibody, displays potent anti-tumor efficacy by specifically depleting tumor-infiltrating Tregs and blocking CTLA-4 signaling on CD8+ T cells Abstract Number: 6350 Location: Poster Section 41 Poster Board Number: 10 Session Date and Time: Apr 9, 2024 1:30 PM - 5:00 PM PDT About 9MW3811 9MW3811 is a high-affinity humanized neutralizing antibody against IL-11. It is currently undergoing Phase 1 clinical trials in Australia and China. IL-11 is an important inflammation factor that plays a crucial role in fibrosis and the development and progression of tumors. Studies have shown that high expression of IL-11 is associated with the prognosis of various tumors such as lung cancer, liver cancer, and colorectal cancer. It has significant effects on various cells in the tumor microenvironment, including tumor cells, macrophages, T cells, and tumor-associated fibroblasts. 9MW3811 inhibits the activation of the downstream signaling pathway of IL-11 by blocking the binding of IL-11 to IL-11R, demonstrating good anti-tumor therapeutic effects in multiple preclinical pharmacodynamic models. When used in combination with anti-PD-1 antibodies, 9MW3811 significantly promotes the infiltration of CD8+ T lymphocytes, improving the T cell exhaustion caused by anti-PD-1 antibodies, thereby showing better combined anti-tumor efficacy. About 2MW4991 2MW4991 is a high-specificity, high-affinity ADCC-enhanced antibody targeting integrin αvβ8. Integrin αvβ8 is an important activator of TGF-β, specifically regulating the activity of TGF-β in immune cells. Studies have found that integrin αvβ8 is highly expressed in certain tumors, and blocking αvβ8 can completely inhibit the release of TGF-β. 2MW4991 exhibits strong anti-tumor activity in immune-excluded tumor models, significantly promoting immune cell infiltration in immune-excluded tumors and greatly increasing the sensitivity of immune-excluded tumors to PD1 inhibitors. About 2MW4691 2MW4691 is an ADCC-enhanced bispecific antibody targeting CCR8/CTLA-4. CTLA-4 is expressed on both CD8+ T cells and Tregs, and targeting CTLA-4 has a strong anti-tumor effect, but its clinical application is limited due to strong side effects. CCR8 is a specific marker for tumor infiltrating Tregs, almost not expressed on other immune cells and peripheral Tregs. 2MW4691 retains high affinity for CCR8 and attenuated CTLA-4 targeting activity, specifically eliminating tumor-infiltrating Tregs and blocking the immunosuppression mediated by CTLA-4 signaling on peripheral CD8+ T cells. It demonstrates strong anti-tumor activity in preclinical transgenic animal models and shows good safety in primates. 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 . 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

The agreement combines Domain Therapeutics' candidate DT-7012 with Chime Biologics' internationally-recognized manufacturing expertise In June 2023, Domain nominated DT-7012, a Treg depleting anti-CCR8 monoclonal antibody (mAb) with best-in-class potential, which enters Phase I studies in 2025 The CCR8 GPCR target is a highly strategic approach in immuno-oncology to increase clinical success rates in non-responding patients STRASBOURG, France, BOSTON and SHANGHAI, March 12, 2024 /PRNewswire/ -- Domain Therapeutics ("Domain"), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), and Chime Biologics, a leading Contract Development and Manufacturing Organization (CDMO) that enables its partners' success in biologics, today announce the signing of a manufacturing service agreement for the production of Domain's best-in-class Treg depleting anti-CCR8 antibody candidate, DT-7012. This phase of manufacturing aims to deliver an effective therapeutic for cancer patients worldwide. Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries. Chime Biologics' first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records. DT-7012 is a novel anti-CCR8 mAb depleting tumor-infiltrating Tregs, major immunosuppressive cells. Treg depletion with anti-CCR8 mAb has demonstrated a unique anti-tumor potency as a monotherapy. DT-7012 has a proven best-in-class potential compared to other clinical-stage CCR8 antibodies, paving the way for effective GPCR-targeting immunotherapies, aiming to activate anti-tumor immunity for cancer patients unresponsive to other treatments. Phase I clinical studies of DT-7012 are expected to start in early 2025 for solid tumors and mid-2025 for cutaneous T-cell lymphoma (CTCL). Dr. Jimmy Wei, President of Chime Biologics, commented: "We look forward to progressing this strategic partnership, which combines Domain's leading anti-CCR8 antibody candidate with Chime Biologics' CLD to commercial manufacturing expertise, contributing to the development of DT-7012 for various cancers". Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "We're thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage. This new GPCR-targeting immunotherapy has immense potential to unlock the immune system's cancer fighting abilities and help patients globally. At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology".

Eight new antibody discovery agreements incorporate Vaccinex’s powerful ActivMAb® Drug Discovery Platform ActivMab® platform enables the discovery and development of high value antibodies against challenging multi-pass membrane targets ROCHESTER, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease and cancer through the inhibition of SEMA4D, announces that it has entered into eight new antibody discovery agreements integrating use of its proprietary ActivMAb platform to select antibodies against difficult-to-drug transmembrane protein targets. Within the last 3 months, Vaccinex has entered into new antibody discovery agreements for complex targets with 3 major pharma and biotech companies as well as 5 strategic relationships with other antibody service providers who have developed transgenic animal species for immunization or very large synthetic antibody libraries that complement our own technology. ActivMAb’s new “Antigen Virus” application is a powerful complement to drug discovery strategies targeting complex protein targets including ion channels and G-protein coupled receptors (GPCRs) such as chemokine receptors. Specific membrane targets are also key to development of antibody drug conjugates (ADC) for cancer, The ActivMAb system enables expression of functional, properly folded complex proteins on the relatively simple membrane of a mammalian virus. We believe that this is a much more highly purified presentation and efficient selection technology than the complex natural membrane fragments that have been termed virus-like particles. “We have recently publicized success in selecting high value antibodies against challenging multi-pass membrane targets. We are excited to be able to capitalize on what we believe is recognition of the unique capabilities of our drug discovery technology. We believe recent interest in this technology may reflect increased market optimism and renewed attention to pipelines that were neglected during the biotech downturn of the past two years. Ongoing partnerships can leverage the full suite of our ActivMAb Antibody Discovery solutions to accelerate development of novel, high-value therapeutics”, said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. Vaccinex’s ActivMAb catalog and custom services are available through Science Exchange. About ActivMAb® ActivMAb is a proprietary antibody discovery platform developed by Vaccinex with unique capabilities for multi-pass membrane targets such as G-protein-coupled receptors (GPCRs). The ActivMAb technology has multiple applications including: complex membrane antigen expression and presentation, antibody and antigen discovery, directed evolution and protein optimization. The first clinical candidate selected through use of this technology (CHS-114, a fully human monoclonal antibody targeting CCR8), is in clinical development for cancer immunotherapy by Coherus Biosciences, Inc. About Vaccinex Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, is designed to block SEMA4D, a potent biological effector that is believed to trigger damaging inflammation in chronic diseases of the brain and to inhibit immune infiltration and activation in tumors. Pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease that is expected to readout in Q3 2024, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma. Forward Looking StatementsTo the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about our plans, ability to capitalize on, expectations and objectives with respect to the “Antigen Virus” applications of the ActivMab® platform, and other statements identified by words such as “believe,” “being,” “can,” “may,” “expect,” “ongoing,” “potential,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later preclinical studies and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the possible delisting of our common stock from Nasdaq if we are unable to regain compliance with the Nasdaq listing standards, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC. Investor ContactElizabeth Evans, PhDChief Operating Officer, Vaccinex, Inc.(585) 271-2700eevans@vaccinex.com