Immune System Diseases

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

HOUSTON, March 19, 2024 /PRNewswire/ -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the progress of a clinical program under development using a fibroblast-based pancreatic beta cell spheroid that secretes insulin in vitro upon glucose stimulation. The development and reproducibility of this work demonstrates that an organoid composed of fibroblasts, beta cells and other components can successfully and durably secrete insulin. "This early proof of concept is encouraging and may lead to a new and durable potential allogeneic treatment option for people with insulin-dependent diabetes," said Hamid Khoja, Ph.D., Chief Scientific Officer. "We look forward to confirming these early results and in vivo utility. We will then determine whether to designate the program as an early phase pre-clinical project for developing a minimally invasive therapeutic for type 1 diabetes." About Diabetes Diabetes mellitus is a chronic heterogeneous metabolic disease characterized by elevated blood glucose levels due to abnormalities in either insulin production or insulin action that impacts more than 37 million people in the United States and over 500 million people worldwide. Type 1 diabetes, an autoimmune disorder in which the immune system destroys the pancreatic beta cells that produce insulin, accounts for 10% of diabetes cases worldwide, and type 2 diabetes, in which the body does not respond to insulin, accounts for the remaining 90% of diabetes cases. With such a high and growing prevalence of the disease, over 200 million individuals are dependent on consistent and often daily insulin therapy for their health. To date, durable, long-term, and economical treatment options are not available. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential of organoids composed of fibroblasts, beta cells and other components to successfully and durably secrete insulin and to treat insulin-dependent diabetes, and our expectations regarding plans for our current and future product candidates and programs. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, . These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) the ability of FibroBiologics to continue to meet Nasdaq listing requirements; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) the ability to effectively manage the business as a result of the super-voting proxy given to the Board of Directors; (d) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; and (e) the unpredictable relationship between R&D and preclinical results and clinical study results. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.  About FibroBiologics Based in Houston, FibroBiologics is a cell therapy and regenerative medicine company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit . Investor Relations: Nic Johnson or Harrison Seidner, Ph.D. Russo Partners (646) 942-5599 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected] General Inquiries: [email protected] Logo -

FN Media Group Presents GlobalInvestmentDaily.com Market Commentary LONDON , March 19, 2024 /PRNewswire/ -- The U.S. Federal Drug Administration (FDA) has now designated psilocybin, a classical compound found in "magic mushrooms," as a "breakthrough therapy" for the treatment of major depressive disorder three times. And the world's largest clinical trial ever into the use of psilocybin for treating depression at London hospital in what scientists are hailing as a "milestone" in mental health research. Mentioned in today's commentary includes: Johnson & Johnson (NYSE: JNJ), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), Atai Life Sciences N.V. (NASDAQ: ATAI), AbbVie Inc. (NYSE: ABBV). This new frontier in treatment has kickstarted a multi-trillion-dollar industry geared at fixing the brain through therapy. Johnson and Johnson has gone all in on its fastest-growing drug for depression, SPRAVATO, which is the only FDA-approved psychedelic medicine on the market. In its Q4 2023 earnings released in January, JNJ reported a 74.1% increase in sales of SPRAVATO worldwide and views the drug as its next billion-plus product. And some of the core team members behind the development of the SPRAVATO have now joined a small, but emerging NYSEAmerican-listed company, CYBIN (CYBN, CYBN.NE). CYBIN has now been granted "Breakthrough Therapy Designation", and is the first adjunctive psychedelic-based therapy for Major Depressive Disorder (MDD) ever to receive this FDA designation. Oppenheimer initiated coverage on CYBN last year, saying it was encouraged by the results so far and believed the stock would have room to run further with new results. It has a price target of $4. H.C.Wainwright & Co. took it further, with a price target of US $10.00 per share, after the recent Small Pharma acquisition. But with impressive Phase 2 results showing remission after only two doses and a coveted FDA designation, this small company is now poised for much greater attention from investors. Phase 2: Behind the Breakthrough Therapy Designation CYBIN is developing differentiated, next-generation therapeutics that hope to offer fast, sustained therapeutic effects that are safe and tolerable, with efficacy in only 1-2 doses and short in-clinic times. The company is on the leading edge of transformational psychedelic therapeutics, developing novel and proprietary therapeutics to improve clinical outcomes and patients' mental health and well-being. The emerging biopharmaceutical company already has clinical validation of the novel, proprietary CYB003 molecule, which demonstrates a rapid-acting and robust psychedelic profile at a low dose. And it's been pounding the patent pavement, too. In August, CYBIN agreed to acquire Small Pharma Inc in an all-share transaction that creates an international clinical-stage leader in novel psychedelic therapeutics. The companies' combined portfolios, at closing, will include two proprietary, advanced clinical programs in development for depression and anxiety disorders with demonstrated safety and efficacy. The combined portfolio creates the industry's largest, most advanced, well protected DMT program. The combined company has the intellectual property strength of 29 patents granted and 158 patents pending in the psychedelic drug development sector. That is the largest portfolio in the industry. Phase 2 topline efficacy data for the company's CYBOO3 was one of the biggest drivers of value for CYBIN in the near-term, and the results were even better than expected. Now that it's been granted "Breakthrough Therapy Designation", CYBIN is targeting the potential for its CYB003 to achieve "Best-in-Class Status", and it's confident it has a solid shot at this. In targeting depression, CYBIN's CYB003 is hoping to offer a lifeline to a chronic illness that victimizes some 280 million people around the world. They are also targeting what is now recognized as the leading cause of disability in the world, which costs the global economy an estimated $1 trillion in lost productivity annually. Nowhere But Up: The Next Near-Term Catalysts CYBIN plans to initiate its Phase 3 study of CYBOO3 in MDD in the middle of this year, with the Phase 2 study of CYB004 in Generalized Anxiety Disorder (GAD) launched on March 15. For the Phase 2 proof-of-concept study of CYB004, CYBIN is using its proprietary DMT molecule, which was developed for the treatment of GAD, following the FDA's clearance of its new drug application in January. "We are building on foundational investigative work from our Phase 2a trial of intravenous SPL026 (DMT) which showed preliminary evidence of effectiveness treating anxiety with rapid onset of antidepressant effects and reduction in anxiety scores," Drysdale said in a press release. "The molecular structure of psilocybin, a naturally occurring psychedelic compound found in 'magic mushrooms,' allows it to penetrate the central nervous system and the scientific and medical experts are just beginning to understand its effects on the brain and mind and its potential as therapeutics for mental illnesses," according to Johns Hopkins Center for Psychedelic and Consciousness Research. This is a space where proprietary IP is absolutely essential, and Cybin now has 29 patents granted and 158 patents pending. CYBIN (CYBN, CYBN.NE) is a clear leader in the biotech race for an alternative to the antidepressant empire, and now it has breakthrough therapy status, and is the first adjunctive therapy known to achieve this for massive depressive disorder. Big Pharma is Racing for a Piece of the Pie Johnson & Johnson (JNJ) is a global leader in healthcare, with a diverse portfolio that spans pharmaceuticals, medical devices, and consumer health products. Within this vast array, Janssen, its pharmaceutical branch, has made significant strides in mental health with esketamine, marketed as Spravato. This nasal spray, a derivative of the anesthetic ketamine, represents a significant breakthrough, gaining FDA approval for use in treatment-resistant depression. The approval of Spravato underscores J&J's commitment to addressing complex mental health challenges. AbbVie (ABBV) emerged as a standalone biopharmaceutical entity following its split from Abbott Laboratories in 2013. Focused on discovering treatments for a wide range of diseases, including rheumatoid arthritis and various cancers, AbbVie's acquisition of Allergan expanded its reach into the burgeoning field of psychedelics for mental health. Allergan, known for its pioneering work in this area, has enriched AbbVie's pipeline with potential psychedelic-based therapies. Atai Life Sciences (ATAI) is at the forefront of transforming mental health care, prioritizing the development of treatments for mental health disorders. Atai's innovative strategy encompasses a wide array of compounds, including psychedelics. The company's collaborative approach, partnering with leading firms to accelerate the development of groundbreaking therapies, exemplifies its commitment to pioneering advancements in mental health treatment. Compass Pathways (CMPS) is pioneering the therapeutic use of psilocybin, focusing its research efforts on addressing treatment-resistant depression. The company's clinical trials and research initiatives are part of a larger mission to establish psilocybin therapy as a validated treatment option, highlighting the potential of psychedelics to offer profound therapeutic benefits. Compass's dedication to rigorous scientific inquiry and ethical research practices positions it as a leader in the psychedelic research community, contributing valuable insights that could reshape mental health care. MindMed (MNMD) tands as an innovator in the neuro-pharmaceutical industry, delving into the therapeutic potential of psychedelics for treating a range of mental health conditions. MindMed's exploratory work with substances such as LSD, MDMA, DMT, and psilocybin is driven by a vision to unlock new treatment pathways for conditions like anxiety, depression, and addiction. Recent advancements in MindMed's research highlight the company's role in pioneering the use of psychedelics as therapeutic agents, underscoring the potential of these substances to revolutionize mental health care. ** IMPORTANT NOTICE AND DISCLAIMER -- PLEASE READ CAREFULLY! ** PAID ADVERTISEMENT. This article is a paid advertisement. GlobalInvestmentDaily.com and its owners, managers, employees, and assigns (collectively "the Publisher") is often paid by one or more of the profiled companies or a third party to disseminate these types of communications. In this case, the Publisher has been compensated by Cybin, Inc. ("Cybin" or "Company") to conduct investor awareness advertising and marketing. Cybin paid the Publisher two hundred and fifty thousand US dollars to produce and disseminate one article profiling the Company over a period of one week. This compensation should be viewed as a major conflict with our ability to be unbiased. 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This communication is not, and should not be construed to be, personalized investment advice directed to or appropriate for any particular investor. Any investment should be made only after consulting a professional investment advisor and only after reviewing the financial statements and other pertinent corporate information about the company. Further, readers are advised to read and carefully consider the Risk Factors identified and discussed in the advertised company's SEC, SEDAR and/or other government filings. Investing in securities, particularly microcap securities, is speculative and carries a high degree of risk. Past performance does not guarantee future results. This communication is based on information generally available to the public and on interviews with company management, and does not (to the Publisher's knowledge, as confirmed by Cybin) contain any material, non-public information. The information on which it is based is believed to be reliable. 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