Urologic Neoplasms

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. 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Versavo® (bevacizumab) is indicated for the treatment of several types of cancers including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer Versavo® is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK Previously, Dr. Reddy’s launched Versavo® in India in 2019 and subsequently in other countries such as Thailand, Ukraine, Nepal and Jamaica. In Colombia, the product was launched under the brand name Persivia®. HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced the launch of Versavo® (bevacizumab) in the United Kingdom (UK). Dr. Reddy’s Versavo® is a (bevacizumab) biosimilar of Avastin®1 and indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer2. Versavo® is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK. It is available in strengths of 100mg and 400mg single use vials. Dr. Reddy’s launched Versavo® in India in 2019. Subsequently, Versavo® was introduced in other markets such as Thailand, Ukraine, Nepal, and Jamaica under the same brand name. In Colombia, the product was launched under the brand name Persivia®. Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: “The launch of Versavo® in a highly regulated market underscores our capability for global clinical development of high-quality biosimilar products. Versavo® is a potential treatment option for patients with different types of cancers. This launch reinforces our commitment to bring more biosimilar and other critical biological products to meet the unmet needs of patients, and strengthens our focus on oncology.” About Dr. Reddy’s Versavo®: Versavo® is bevacizumab biosimilar from Dr. Reddy's. Bevacizumab is the first antiangiogenic therapy proven to slow metastatic disease progression in patients with cancer. It is a humanized recombinant antibody that targets human vascular endothelial growth factor (VEGF), leading to deterred angiogenesis and tumor growth3. About Dr. Reddy’s biosimilars programme: Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and long-term growth. Over the last 25 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 25 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In July 2023, our proposed rituximab biosimilar application was accepted for review by the USFDA, EMA and MHRA. About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update any information contained herein. 1 Avastin® is a registered trademark of Roche. 2 3 View source version on businesswire.com: Contacts INVESTOR RELATIONS RICHA PERIWAL richaperiwal@drreddys.com MEDIA RELATIONS USHA IYER ushaiyer@drreddys.com Source: Dr. Reddy’s Laboratories Ltd. View this news release online at:

According to GlobalData, there will be 123,846 cervical cancer cases in the eight major markets (UK, US, France, Germany, Spain, Italy, Japan, and urban China) by 2030. Credit: Ground Picture via Shutterstock. Asieris Pharmaceuticals has announced positive data indicating the Phase III trial of its cold light photodynamic drug-device combination Cevira (APL-1702) achieved its primary endpoint in participants with cervical high-grade squamous intraepithelial lesions (HSIL). HSIL are precancerous lesions linked to human papillomavirus (HPV) that can lead to cervical cancer. The results were presented at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, US, which was held 16-18 March. Cevira also demonstrated a tolerable safety profile. The therapy stimulates the body’s production of the photosensitiser protoporphyrin IX (PPIX), which selectively accumulates in tumour tissue, and upon exposure to specific wavelengths, triggers tumour cell apoptosis. The primary endpoint, which evaluated the response rate six months after administering Cevira, showed a statistically significant improvement of 89.4% compared to the placebo group. See Also: Dr. Reddy’s Laboratories files patent for 6-substituted pyridazine compounds for treating diseases dependent on SMARCA2/SMARCA4 The drug also showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the Cevira group compared to placebo. Cevira was developed through Phase I and II clinical trials by Norway-based Photocure ASA, with Asieris gaining commercialisation rights in July 2019. The Phase III trial (NCT04484415) enrolled 402 HSIL patients, defining the primary endpoint of response as the conversion of cervical epithelial tissue pathology to normal, or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance. Long-lasting infection with certain types of HPV, a common sexually transmitted infection, is the main cause of cervical cancer. If left untreated, HPV can be linked to 95% of cervical cancer cases, according to the World Health Organization. The China-based biotech now plans to submit a new drug application for Cevira in Q2 2024, according to Asieris’ chief development officer Linda Wu. According to a report on GlobalData’s Pharma Intelligence Center, the number of cervical cancer cases in the eight major markets (UK, US, France, Germany, Spain, Italy, Japan, and urban China) will reach 123,846 by 2030. GlobalData is the parent company of Clinical Trials Arena. In the announcement accompanying the data, Linda Wu said: “The study not only demonstrates remarkable efficacy but also exhibits a favourable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. “Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible.” The company also has other cancer candidates in the pipeline. Earlier this year, a Phase II trial of its repurposed antibiotic drug APL-1202 achieved its primary endpoint in participants with muscular invasive bladder cancer (MIBC). The drug is already approved to treat oesophagal squamous cell carcinoma in China and is also being reviewed by the US Food and Drug Administration to treat the same type of cancer.