Head and Neck 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. 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

Data will demonstrate ability of the assay to predict recurrence in patients treated for head & neck cancer Adela's Chief Scientific Officer to chair Plenary Session FOSTER CITY, Calif., March 19, 2024 /PRNewswire/ -- Adela, Inc., an innovator in blood testing for minimal residual disease monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, today announced data will be presented at the American Association for Cancer Research (AACR) Annual Meeting from April 5-10, 2024 from its tissue-agnostic minimal residual disease (MRD) assay. These data demonstrate the feasibility of the assay for cfDNA cancer signal quantification and prognostic prediction in HPV-positive and HPV-negative head & neck cancers following treatment. Data will also be presented on the analytical performance of Adela's platform. In addition, Daniel De Carvalho, Ph.D., Adela's Chief Scientific Officer, has been selected to serve as Chair of the Plenary Session "Discovery Science in Early Cancer Biology and Interception". Dr. De Carvalho will also present in the session "New Liquid Biopsy Technologies for Detection and Characterization of Cancer". Adela plans to commercialize its first product, a tissue agnostic test for minimal residual disease (MRD) monitoring, in 2025. The product will be based on Adela's genome-wide methylome enrichment platform, which utilizes the company's patented technology, cfMeDIP-seq, originally developed by Dr. De Carvalho at University Health Network's Princess Margaret Cancer Centre, in collaboration with investigators at Sinai Health System. Adela's technology efficiently captures extensive, biologically-relevant genomic information to maximize test performance and improve treatment decisions. It can be applied across the entire cancer care continuum and is initially being developed for MRD and multi-cancer early detection. Presentation Details Abstract # 2427: The development of a tissue-agnostic genome-wide methylome enrichment MRD assay for applications across the cancer care continuum for head and neck malignancies Geoffrey Liu1 Mon Apr 8, 2024 9 am-12:30 pm PT Section 40 Poster Board Number 23 Abstract # 5024: Analytical performance of a genome-wide methylome enrichment platform to detect minimal residual disease from plasma-derived cell-free DNA Hestia Mellert2 Tues Apr 9, 2024 9am – 12:30pm PT Section 40 Poster Board Number 11 Discovery Science in Early Cancer Biology and Interception Dr. Daniel De Carvalho (Chair) Sat April 6, 2024 4:15 PM PT Hall GH New Liquid Biopsy Technologies for Detection and Characterization of Cancer Dr. Daniel De Carvalho Tues April 9, 2024 12:30 – 2:00 PM PT Ballroom 20 CD About Adela Adela is developing best-in-class technology to accelerate the diagnosis and improve the management of cancer through blood tests for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Adela's genome-wide methylome enrichment platform, which utilizes the company's patented cfMeDIP-seq platform, efficiently captures extensive, biologically-relevant genomic information to maximize test performance and improve treatment decisions. The company's platform specifically isolates the information-rich (methylated) regions of the genome through a high-affinity enrichment process, enabling it to capture and preserve more genomic material for sequencing compared to other platforms that use enzymatic or chemical treatment (bisulfite conversion). This comprehensive view of the methylome significantly increases the opportunities for Adela's products to detect cancer signals in the blood compared to approaches that target a smaller set of genomic regions. It also enables enhanced prognostic and predictive abilities, as well as dynamic monitoring in patients over time. Adela's approach to MRD testing is tissue agnostic, eliminating the burden of acquiring a tumor sample. Adela's investors are F-Prime Capital, OrbiMed, Deerfield Management, Decheng Capital, RA Capital Management, and Labcorp. Find more information at adelabio.com. 1 Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada 2 Adela, Inc. Foster City, CA SOURCE Adela

NATICK, Mass.--(BUSINESS WIRE)-- AffyImmune Therapeutics, Inc., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls. This press release features multimedia. View the full release here: Matt Britz, CEO, AffyImmune (Photo: Business Wire) “Matt has been an instrumental part of AffyImmune’s growth in the past two years,” said Simone Song, Chairperson of the Board of Directors, AffyImmune, and Founder and Senior Partner at ORI Capital. “AffyImmune is a company incubated by ORI Capital. Matt has executed a focused business strategy supported by insights generated from our big data platform ORIzon, which has led to promising early clinical results for AffyImmune’s lead program AIC100 in advanced thyroid cancer. Matt is well-suited to lead AffyImmune as CEO as the Company accelerates clinical development of AIC100 in thyroid cancer, and in other indications with high unmet medical need. I am also thrilled to welcome Pete to our leadership team at a critical time as we scale up CMC efforts to support our ongoing trial and potential indication expansion. Pete’s extensive BLA experience will be invaluable as AffyImmune moves to the next stage of growth.” “I’m honored to lead AffyImmune’s efforts in advancing affinity-tuned CAR T therapies, building upon the solid foundation we’ve established in the last few years,” said Britz. “Together, we're well-positioned to make significant advancements in addressing the challenges of solid cancers to improve patient outcomes." Matt Britz joined AffyImmune in June 2021 as Senior Vice President (SVP), Business Development and was promoted to Chief Operating Officer in January 2022. He brings 28 years of demonstrated experience in life sciences, and was previously SVP and Head of Business Development at Minerva Biotechnologies, where he led teams across corporate development, manufacturing, clinical operations and regulatory affairs. Prior to Minerva Biotechnologies, Matt held scientific, consulting, and business development positions at Merck, Pfizer, Equinox Group, Health Advances, and Envoy Therapeutics, and played a crucial role in the acquisition of Envoy Therapeutics by Takeda. Matt has expertise leading teams in the initial stages of drug discovery all the way through to development and commercialization. Matt has an MBA from Washington University St. Louis, and a BS in Chemical Engineering and Biology from MIT. Pete Gelinas brings over 15 years of extensive experience in Manufacturing and CMC Product Development to AffyImmune. Previously, he served as the Head of Manufacturing and Technical Operations at ElevateBio, where he led technology transfer, CMC strategy, and oversight of routine clinical manufacturing. During his tenure at bluebird bio, he led both the MSAT and CMC teams for Skysona, a treatment for Cerebral Adrenoleukodystrophy (CALD). He has executed numerous late-phase global technology transfer deals and played a pivotal role in driving the drug product process validation efforts critical to the successful Marketing Authorization Application (MAA) for Zynteglo. Peter has also held various positions at the Connell O’Reilly Cell Manipulation Core Facility (CMCF) at Dana Farber Cancer Institute (DFCI), where he contributed to the development and manufacturing of several gene and cell-based therapies. “I am thrilled to join AffyImmune at this next stage of growth, with the opportunity to contribute my expertise in manufacturing to advance this pipeline for patients with solid cancers,” said Gelinas. “I look forward to making a difference in the lives of patients and their families, and to deliver our life-changing therapies in areas with high unmet medical need.” About AffyImmune Therapeutics AffyImmune is a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies to transform the lives of patients with cancer. The Company’s proprietary technology utilizing ICAM1/LFA-1 interaction can potentially address all critical CAR T challenges such as toxicity, antigen loss, T-cell trafficking and exhaustion, while also allowing in vivo tracking of the CAR T cells. Its lead candidate, AIC100, is a ICAM1-directed CAR T therapy being developed for patients with advanced thyroid cancer. AffyImmune is developing a focused pipeline of therapeutics targeting ICAM-1 in oncologic indications with high unmet medical need. AffyImmune is based in Natick, MA. For more information, visit .