Camurati-Engelmann Syndrome

Poster presentations to highlight new quantitative and serologic diagnostic methods for Celiac Disease detection and determination of intestinal mucosal health New tools may serve as companion diagnostics for identifying seroactive patients and for monitoring the efficacy of Latiglutenase, the Company’s Celiac Disease therapeutic program BOCA RATON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference (DDW 2024) taking place May 18-21, 2024, in Washington, D.C. The first presentation, titled, “A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation,” will highlight VCIEL, a new quantitative composite scale, combining the histologic scales of villus height to crypt depth ratio (Vh:Cd) and density of intraepithelial lymphocytes (IEL), designed to enhance the accuracy and precision for measuring small intestinal mucosal health of celiac disease (CeD) patients with particular benefit for histologic endpoint measurements in clinical trials. The second presentation, titled, “Dynamics of Serologic Change to Gluten in Celiac Disease Patients,” will report research involving the largest database of CeD clinical results and will explore key issues related to the diagnostics of CeD, such as the effects of resuming a gluten-containing diet on seropositivity and the correlation between two different tTG-IgA assays. “The abstracts accepted for presentation at DDW 2024 showcase significant advancements in the field of gastroenterology, particularly in the precision diagnosis and management of celiac disease through the innovative VCIEL scale that our team has developed,” stated James Sapirstein, Chairman and CEO of First Wave BioPharma. “The invitation to present our findings on the VCIEL scale for measuring mucosal health of the small intestine as well as our research on the impact of gluten reintroduction as a diagnostic intervention for serologic measurements at one of the most influential meetings on gastrointestinal disease validates the potential for our work to advance better understanding and treatment of celiac disease,” said Jack Syage, PhD, President and Chief Operating Officer of First Wave. Details on the presentations are as follows: Presentation Title: A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation Presenters: Jack Syage, PhD. President & Chief Operating Officer, First Wave BioPharma Jennifer Sealy-Voyksner, PhD., Vice President R&D, First Wave BioPharma Session Title: Celiac Disease and Gluten Related Disorders Date and Time: May 19, 2024, from 12:30 PM to 1:30 PM EDT Presentation Title: Dynamics of Serologic Change to Gluten in Celiac Disease Patients Presenters: Jack Syage, PhD. President & Chief Operating Officer, First Wave BioPharma Jennifer Sealy-Voyksner, PhD., Vice President R&D, First Wave BioPharma Session Title: Celiac Disease and Gluten Related Disorders Date and Time: May 19, 2024, from 12:30 PM to 1:30 PM EDT About Celiac Disease Celiac disease is a chronic, hereditary autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing malabsorption, gastrointestinal dysfunction and debilitating symptoms. Over the course of a lifetime, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Celiac disease is a global disease and affects approximately 1% of the population worldwide and is increasing in prevalence with improved diagnostic tools and improved awareness. About First Wave BioPharma, Inc. First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies – latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit . Forward-Looking Statements This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether any financing or licensing transaction may be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, FL 33431 Phone: (561) 589-7020 info@firstwavebio.com Media contact: Tiberend Strategic Advisors, Inc. David Schemelia (609) 468-9325 dschemelia@tiberend.com

─Treatment with CM-101 Improves Additional Biomarkers of Fibrosis and Inflammation, `Reinforcing and Extending Initial Study Results─ ─Provides New Insights into CM-101 Activity in NASH Patients at Greater Risk of Progressive Disease, Providing Further Support for CM-101's Direct Anti-inflammatory and Anti-fibrotic Dual Mode of Action─ ─Demonstrates Improvements in Key Biomarkers Associated with Other Fibrotic Liver Diseases Including Primary Sclerosing Cholangitis─ TEL AVIV, Israel, June 21, 2023 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported topline results from secondary analyses of its Phase 2a liver fibrosis trial assessing CM-101, its first-in-class CCL24-neutralizing antibody, in patients with non-alcoholic steatohepatitis (NASH). The results were included in a late-breaking poster presentation at the 2023 EASL Congress in Vienna, Austria.1 Overall, the data showed improvements across an additional set of inflammatory and fibrotic biomarkers that are consistent with the positive clinical results Chemomab released in January. Additionally, in NASH patients at greater risk of disease progression, CM-101 treatment resulted in a greater biomarker response than in NASH patients with lower risk disease or in placebo-treated patients. Adi Mor, PhD, Chemomab co-founder, CEO and CSO, commented, "These additional analyses of our liver fibrosis data in NASH patients are very encouraging. They supplement and extend our initial data results, showing a consistent pattern of improvement in CM-101-treated patients in biomarkers associated with fibrogenesis and inflammation. We are especially pleased to see that CM-101 treated-patients with higher FAST scores—those at greater risk of progressive disease—tended to demonstrate greater biomarker improvements than those with lower FAST scores. Additionally, we consider these data to be highly relevant to our ongoing CM-101 Phase 2 trial in primary sclerosing cholangitis (PSC), demonstrating improvements in biomarkers that are also associated with the inflammation and fibrogenesis found in PSC patients. Notably, our PSC trial involves the evaluation of significantly higher doses of CM-101, with patient dose cohorts of 10mg/kg and 20mg/kg administered intravenously, compared to the liver fibrosis study in NASH patients, which used a subcutaneous dose of 5mg/kg." The new analyses assessed additional biomarkers and also used the FibroScan-AST (FAST) score to categorize study patients based on progressive disease risk, thereby enabling the evaluation of CM-101 activity in the main target population of patients with more active disease.2 FAST is a validated score composed of non-invasive FibroScan® and AST measurements that is used to identify patients with a high risk of NASH progression.3 The results showed that: FAST scores were improved in a higher proportion of CM-101-treated patients than in placebo patients. CM-101-treated patients with higher FAST scores demonstrated greater improvements in key fibro-inflammatory biomarkers, such as Pro-C3, than patients with lower FAST scores or placebo patients. CM-101-treated patients with higher FAST scores showed improvements in several fibro-inflammatory biomarkers generally comparable to those achieved in several recent successful NASH clinical trials. In these secondary analyses, CM-101-treated patients showed improvements in an additional set of biomarkers associated with active fibrosis and inflammation: FIB-4, an index for determining NASH status that includes age, platelet count, AST and ALT levels, was improved in CM-101-treated patients vs. placebo patients. AST/ALT ratio, a liver enzyme ratio, was improved in CM-101-treated patients vs. placebo patients. Neutrophil-to-Lymphocyte Ratio (NLR), an indicator of inflammation, was improved in CM-101-treated patients vs. placebo patients, and NLR was further improved in groups with higher FAST scores. PRO-C3, which captures active fibrogenesis and correlates with fibrotic disease severity, was improved in CM-101-treated patients vs. placebo patients and was further improved in groups with higher FAST scores. As an overall indicator of fibrogenesis and fibrotic disease, PRO-C3 is also considered a "bridge" to PSC and other anti-fibrotic indications. Scott L. Friedman, MD, Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York City, is an expert on the fibrosis associated with chronic liver disease and a co-author of the EASL poster. Dr. Friedman noted, "It is encouraging that consistent positive improvements are seen across a range of fibro-inflammatory biomarkers in both CM-101 Phase 2a study analyses. The greater improvement in biomarkers in the higher FAST score-enriched subgroup provides further evidence of CM-101's potential to have a positive impact on fibrotic diseases such as NASH and PSC, whose pathophysiology may be associated with the dual fibro-inflammatory mechanism that CM-101 is intended to address." In January, the company reported that the Phase 2a liver fibrosis trial met its primary endpoint of safety and tolerability and that CM-101 achieved reductions in secondary endpoints that included a range of liver fibrosis biomarkers and physiologic assessments. The EASL poster also summarized these results, including: CM-101 treatment demonstrated a favorable PK-target engagement profile. CM-101 treatment was associated with improvements in multiple fibrosis biomarkers and with a reduction in FibroScan liver stiffness stage. CM-101 treatment was associated with improvements in more than one liver fibrosis-related biomarker—almost 60% of CM-101 patients responded in at least three biomarkers, compared to no placebo patients. Higher levels at baseline of CM-101's target—the soluble chemokine CCL24—in CM-101-treated patients were associated with greater reductions in fibrosis-related biomarkers and a greater likelihood of being a multiple biomarker responder. About the Phase 2 Liver Fibrosis Trial in NASH Patients The randomized, placebo-controlled trial enrolled 23 NASH patients with stage F1c, F2 and F3 disease who were randomized to receive either CM-101 (14 patients) or placebo (9 patients). Patients received eight doses of 5 mg/kg of CM-101 or placebo, administered by subcutaneous (SC) injection once every two weeks, for a treatment period of 16 weeks. This trial was primarily designed to assess the safety and tolerability of the SC formulation of CM-101 and to evaluate the drug's impact on liver fibrosis biomarkers relevant to both NASH and other rare fibro-inflammatory conditions that are the focus for the company, such as primary sclerosing cholangitis. For more information on the initial trial results, click here. Poster presentation: Phase 2a study of CM-101, a CCL24 neutralizing antibody, in patients with nonalcoholic steatohepatitis: A proof- of-concept study June 21-24, 2023, 9-17:00 CEST every day: Poster-Late-Breaker, LBP-28 NASH patients at risk for disease progression defined as FAST scores NAS≥4; F≥2. Woreta TA, Van Natta ML, Lazo M, Krishnan A, Neuschwander-Tetri BA, Loomba R, et al. (2022) Validation of the accuracy of the FAST™ score for detecting patients with at-risk nonalcoholic steatohepatitis (NASH) in a North American cohort and comparison to other non-invasive algorithms. PLoS ONE 17(4): e0266859. About Chemomab Therapeutics Chemomab is a clinical stage biotechnology company discovering and developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique and pivotal role of the chemokine CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to neutralize CCL24 activity. In preclinical and clinical studies to date, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. To date, Chemomab has reported encouraging results from three clinical trials, including a Phase 2 liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. A Phase 2 trial in primary sclerosing cholangitis patients is ongoing, with topline data expected in the latter part of 2024. For more information on Chemomab, visit chemomab.com. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, statements regarding the clinical development pathway for CM-101; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab's current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including those found under the caption "Risk Factors" and elsewhere in Chemomab's filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law. SOURCE Chemomab Therapeutics, Ltd.

BASEL, Switzerland--( BUSINESS WIRE )--Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today the FDA cleared an IND application for ALE.C04 as a monotherapy and in combination with pembrolizumab, in a first-in-human clinical trial in recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) that is expected to start during the second half of 2023. “With ALE.C04 we aim to treat solid tumors in a unique way. By targeting exposed CLDN1 on cancer cells our antibody remodels the extracellular matrix favoring T- and NK-cell trafficking, which in turn directly kills CLDN1 + tumor cells and breaks the check-point inhibitor resistance in immune-excluded tumors,” said Dr. Luigi Manenti, Chief Medical Officer of Alentis . “ The high unmet medical need, strong scientific rationale and our compelling preclinical and translational data makes HNSCC an ideal first indication for ALE.C04 as a monotherapy and in combination with anti-PD-1 treatment.” Dr. Roberto Iacone, Chief Executive Officer of Alentis added, “The IND clearance for ALE.C04 is an important step for Alentis as it marks our entry into the oncology space. The planned Phase 1/2 study will tell us a lot about the anti-tumor efficacy of our antibody to treat CLDN1+ tumors . We are the leading company targeting CLDN1 across organ fibrosis and cancer. ” About ALE.C04 ALE.C04 is a first-in-class monoclonal antibody developed to specifically target exposed CLDN1 on cancer cells. This investigational antibody is designed to treat cancer in two ways: remodeling of the extracellular matrix, leading to improved NK and T-cell trafficking and direct tumor cell killing through the effector function. This unique mechanism of action provides ALE.C04 with therapeutic potential as a monotherapy and, in combination with check-point inhibitors. About Head and Neck Squamous Cell Carcinoma HNSCC is the sixth most common type of cancer worldwide and its incidence continues to rise. Besides surgery, chemotherapy and/or radiation therapy additional approved therapies include cetuximab, and pembrolizumab. Pembrolizumab monotherapy has shown an overall survival improvement in first line setting. However, the need for new treatment options remains high. About Alentis Therapeutics Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors and organ fibrosis. Alentis is the only company pioneering a novel approach to modify and reverse the course of disease by targeting CLDN1, a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis was founded in 2019 based on ground-breaking research in the laboratory of Prof. Thomas Baumert, MD at the University of Strasbourg and the French National Institute of Health (Inserm). Alentis is headquartered in pharma-biotech hub Basel, Switzerland with an R&D subsidiary in Strasbourg, France and clinical operations in the US. Visit https://alentis.ch