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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

A large Phase 3 trial will evaluate whether the M72/AS01E vaccine candidate can protect adolescents and adults from pulmonary tuberculosis Clinical trial site at University of the Witwatersrand, Johannesburg, South Africa, is first of up to 60 sites in seven countries The M72/AS01E vaccine candidate could be the first new TB vaccine in 100 years if proven effective CAMBRIDGE, Mass., March 19, 2024 /PRNewswire/ -- The Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate is now underway, with first doses given in South Africa, where TB takes a heavy toll. If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century. Globally, according to the World Health Organization, an estimated 10.6 million people fell ill with TB in 2022 and 1.3 million died — over 3,500 people per day. The disease primarily affects people in low- and middle-income countries, and those at highest risk are often living in poverty, with poor living and working conditions and undernutrition. In South Africa alone, around 280,000 people are diagnosed with TB each year. "The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries," said Emilio A. Emini, Ph.D., CEO of the Gates MRI. "Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine's potential." The Gates MRI, a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome. The M72/AS01E vaccine candidate has been in development since the early 2000s. It was originally designed and clinically evaluated by the biopharma company GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) and was funded by GSK and in part by the Gates Foundation. In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial and will provide the adjuvant post licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response. Making vaccines accessible and affordable for communities in areas of high disease burden in the long-term is a priority for all trial partners. The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3. To this end, the Gates MRI, GSK, Wellcome and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access, should the trial be successful; from supporting research and building an evidence-base for the potential impact of the vaccine and community requirements for uptake, to collaborating with multilateral, regional and country partners required to introduce the vaccine. Additionally, the trial funders are planning to establish an international advisory group comprised of representatives from all these groups to provide input on the overall program. Developing and ensuring access to global health products is a complex task. As such, global collaboration and strong partnerships are a core component of planning for future access to the candidate vaccine. "Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities," said Dr. Lee Fairlie, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand, Johannesburg, South Africa, and national principal investigator for the trial in South Africa. "South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals." At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine. "After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners' expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world," said Deborah Waterhouse, CEO, ViiV Healthcare and President, Global Health, GSK. While TB is one of the world's deadliest infectious diseases — and the leading cause of death amongst people living with HIV — the only available TB vaccine, BCG, dates back to 1921. It protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium. "If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic," said Alemnew Dagnew, M.D., who leads development of M72/AS01E at the Gates MRI. "I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative." Dagnew noted that TB is both a health problem and a socioeconomic problem. He said the disease primarily affects people during their prime working years, leaving families without income and children without parents. Almost half of TB-affected households face costs higher than 20% of their household income. "We must continue to move with urgency to develop and equitably deliver innovative tools with the potential to transform the prevention, diagnosis, and treatment of TB. The start of the Gates MRI's M72 TB vaccine candidate Phase 3 clinical trial marks a pivotal moment in the fight to end TB, which devastatingly afflicts the world's most vulnerable communities. We think this trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools. The Gates Foundation remains committed to supporting local and global partners to accelerate the solutions needed to save lives and reduce suffering from this preventable disease," said Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation. Alex Pym, Director of Infectious Disease at Wellcome, said: "While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB. Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful." It is anticipated that it will take up to five years to complete the trial, followed by data analysis and then preparation for submission of data to regulatory authorities. In GSK's Phase 2b trial, M72/AS01E provided approximately 50% protection (13/1626 versus 26/1663) against progression to active pulmonary tuberculosis for three years in Mycobacterium tuberculosis-infected HIV-negative adults, which was unprecedented in decades of TB vaccine research. The World Health Organization estimates that over a 25-year time span, that level of protection could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion for TB affected households. About the Bill & Melinda Gates Medical Research Institute (Gates MRI) The Bill & Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health. For further information please visit . For more information, contact: [email protected] Logo -

NEW YORK, March 19, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, March 26, 2024 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-833-630-1960 International: 1-412-317-1841 Webcast: Conference Replay About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. Contact: Investor Relations Contact: Ben Shamsian Lytham Partners 646-829-9701 [email protected] SOURCE Delcath Systems, Inc.