Eye Abnormalities

SHANGHAI, March 19, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative-driven biopharmaceutical company with entire industry chain, presented the clinical study data of the 9MW2821 for patients with cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on March 16, 2024. The data showed good efficacy and safety of 9MW2821 in patients with cervical cancer, which is expected to bring new breakthroughs for the treatment of recurrent or metastatic cervical cancer, meeting a large number of unmet clinical needs. 9MW2821 is the first drug to report clinical data for the indication of cervical cancer among the drugs with the same target in the world. Report on Study Data of Nectin-4-Targeting Antibody-drug Conjugate ( ADC ) for the Treatment of Recurrent or Metastatic Cervical Cancer This phase I/II, multicenter, open-label, clinical study was led by Professor Zhang Jian of Fudan University Shanghai Cancer Center, and Professor Yang Huijuan of Fudan University Shanghai Cancer Center represented the study team to give an in-depth report at the meeting. The study results were highly recognized by experts on site. Further clinical study data are expected to provide more treatment options for patients with recurrent or metastatic cervical cancer. Clinical Findings The systemic treatment drug options and efficacy for recurrent or metastatic cervical cancer are relatively limited. The cervical cancer cohort in the phase I/II study of 9MW2821 enrolled patients with Nectin-4-positive recurrent or metastatic cervical cancer who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease. Eligible patients received intravenous 9MW2821 1.25mg/kg on days 1, 8 and 15 of each 28-day cycle until confirmed disease progression, death, intolerable adverse effects or withdrawal from the study. As of September 25, 2023, in the cervical cancer expansion cohort of the study, the detection rate of Nectin-4 expression was 89.67%, and the rate of Nectin-4 IHC 3+ was 67.82%. A total of 40 patients were enrolled in the study, 57.5% of the patients had previously received platinum-based doublet chemotherapy combined with bevacizumab, and 60% of the patients had previously received platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy. In terms of efficacy, the overall response rate (ORR) and disease control rate (DCR) of 37 patients evaluable for efficacy were 40.54% and 89.19%, respectively, with one complete response (2.70%) and 14 partial responses (37.84%). Median progression-free survival (PFS), overall survival (OS), and duration of response (DOR) were not reached yet. Among patients with Nectin-4 IHC 3+, the ORR and DCR of 26 patients evaluable for efficacy were 50.00% and 92.31%, respectively. Among patients on or after doublet platinum-containing chemotherapy, the ORR and DCR of 21 patients evaluable for efficacy were 38.10% and 85.71%, respectively. In terms of safety, treatment-related adverse events (TRAEs) occurred in 92.50% of participants. Grade3-4 TRAEs occurred in 70.00% of participants, with neutropenia (40.00%), rash (17.50%) and gamma-glutamyl transferase increased (12.50%) being the most frequently reported. Nodeaths related to treatment were reported. The above study results indicate that 9MW2821 has controllable safety and positive efficacy in patients with cervical cancer. About 9MW2821 9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first product to enter clinical study among the products with the same target developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors. The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. The phase II clinical study for the indication of esophageal carcinoma will continue enrollment and evaluation, and communication for the initiation of phase III clinical study will be expedited. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma. About Cervical Cancer Cervical cancer is the 4th most common neoplasm and the 4th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed. 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

OcuTerra's hopes and DR:EAMs are circling the drain. OcuTerra Therapeutics’ investigational eye drops failed to improve disease severity or progression in a phase 2 diabetic retinopathy trial, prompting the Boston-based biotech to look at strategic alternatives. The double-masked phase 2 trial, dubbed DR:EAM for “Diabetic Retinopathy: Early Active Management,” assessed the safety and efficacy of a daily high and low dose of nesvategrast (OTT166), a selective small-molecule RGD integrin inhibitor administered as an eye drop. Nesvategrast is currently the only asset listed in OcuTerra’s pipeline.   The biotech pitted the investigational eye drop against placebo for 24 weeks among 225 adults with moderately severe to severe non-proliferative diabetic retinopathy (NPDR), an early stage of the disease, or mild proliferative diabetic retinopathy with minimal vision loss. DR:EAM failed to hit the main efficacy goal: a statistically significant percentage of patients that had a greater than two-step improvement on an ophthalmologic disease severity scale known as the Diabetic Retinopathy Severity Scale (DRSS). The trial also missed a secondary endpoint, failing to show nesvategrast had significant impact on the progression of disease as measured by DRSS. Another secondary endpoint—preventing the onset of vision threatening events stratified by level of disease severity at baseline—did show a statistically significant improvement in patients with DRSS level 47 and 53 (moderately severe and severe NPDR, respectively) by week 24. Data also found nesvategrast to be safe and well tolerated. “We plan to review the full dataset from the DR:EAM study to evaluate the future of the nesvategrast program," OcuTerra CEO Kerrie Brady said in a March 14 release. The private biotech now plans to assess strategic alternatives, according to the release. Diabetic retinopathy is caused by blood vessel damage in the retina and can lead to blindness. OcuTerra designed nesvategrast to be a noninvasive treatment option for preserving vision and preventing progression, according to the company’s website.

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