AGC Biologics to manufacture CM-101 for Period II/III trials at their Copenhagen facility
TEL AVIV, Israel and SEATTLE, Wash., June 23, 2021 (Globe NEWSWIRE) — Chemomab Therapeutics, Ltd. (NASDAQ: CMMB), a clinical-phase biotech firm centered on the discovery and growth of innovative therapeutics for fibrosis-similar disorders with large unmet will need, and AGC Biologics, a primary world Biopharmaceutical Agreement Development and Production Organization (CDMO), these days declared an expanded partnership to manufacture CM-101, a Section II investigational drug focusing on Primary Sclerosing Cholangitis, Systemic Sclerosis, and Liver Fibrosis MoA (NASH). Less than phrases of the settlement, the organizations will get the job done collectively to optimize, upscale and lock the CM-101 production process in the direction of its tests in pivotal reports whilst AGC Biologics will manufacture the medical demo materials at its web-site in Copenhagen, to guidance stage II/III medical tests and start readiness.
“AGC is a large-high-quality partner with global production experience, and we are delighted to lengthen our extended-standing partnership as we continue on to progress in our scientific growth,” stated Adi Mor, Chief Government Officer. “CM-101 has tremendous likely in treating fibrosis and irritation, and we are enthusiastic to go on to scale up our manufacturing potential in advance of our Phase 3 registration-enabling trials.”
Mark Womack, Main Business enterprise Officer at AGC Biologics additional, “We are really pleased that Chemomab has entrusted us to manufacture CM-101, following profitable shipping of the early period source. Our Copenhagen website has the demonstrated expertise and knowledge to aid Chemomab in its journey in direction of sector supply of this important remedy.”
“The Copenhagen staff is psyched to support progress the manufacturing procedure for CM-101 to the subsequent period, and is on the lookout forward to a shut collaboration with the Chemomab crew,” suggests AGC Biologics Typical Manager, Copenhagen, Andrea C. Porchia.
AGC Biologics’ Copenhagen facility has more than 20 years’ working experience offering a extensive vary of mammalian and microbial programs, together with numerous commercially authorized products. The news comes a lot less than seven months after the announcement of a €160M growth undertaking that would double the creation potential in Denmark to address increasing market place demand from customers.
CM-101 is a initially-in-class monoclonal antibody that targets CCL24 and has been revealed to interfere with the underlying biology of liver, pores and skin and lung fibrosis making use of a novel and differentiated mechanism of motion. Pre-scientific evidence has revealed CM-101 to be an productive remedy with likely to fill the hole in today’s fibrotic disease treatment. CM-101 has been very well-tolerated in nutritious topics and in NAFLD people by using intravenous or subcutaneous administrations. Both of those routes of administration support very long dosing intervals and deliver proof of target engagement and organic exercise in people. CM-101 Section 2 security and efficacy trials in sufferers with PSC and Liver fibrosis (NASH) are presently ongoing and a 3rd Ph2, in Systemic sclerosis, is anticipated to initiate by the stop of 2021.
About AGC Biologics
AGC Biologics is a major global biopharmaceutical Agreement Growth and Production Firm (CDMO) with a solid motivation to provide the highest normal of provider as we operate side-by-aspect with our clientele and associates, just about every action of the way. We offer environment-class development and manufacture of mammalian and microbial-primarily based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our worldwide community spans the U.S., Europe and Asia, with cGMP-compliant services in Seattle, Washington Boulder, Colorado Copenhagen, Denmark Heidelberg, Germany Milan, Italy and Chiba, Japan and we currently employ a lot more than 1,700 personnel around the world. Our commitment to ongoing innovation fosters the specialized creativity to solve our clients’ most sophisticated issues, which include specialization in fast-track assignments and uncommon conditions. AGC Biologics is the associate of choice. To discover far more, pay a visit to www.agcbio.com.
About Chemomab Therapeutics Ltd.
Chemomab is a scientific-phase biotech company focusing on the discovery and progress of modern therapeutics for fibrosis-similar diseases with higher unmet have to have. Centered on the distinctive and pivotal part of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to bind and block CCL24 action. CM-101 has possible to handle multiple significant and existence-threatening inflammatory and fibrotic illnesses and is now undergoing scientific enhancement with most important focus for the orphan ailments, Primary Sclerosing Cholangitis (PSC) and Systemic Sclerosis (SSc).
For a lot more details on Chemomab, please visit www.chemomab.com.
Forward Hunting Statements
This push release incorporates “forward-wanting statements” inside the meaning of the Non-public Securities Litigation Reform Act. These ahead-seeking statements include, among other points, statements concerning the scientific development pathway for CM-101 the foreseeable future functions of Chemomab and its capacity to properly initiate and finish scientific trials and accomplish regulatory milestones the character, tactic and aim of Chemomab the development and business likely and probable added benefits of any product candidates of Chemomab and that the merchandise candidates have the prospective to handle large unmet requires of individuals with really serious fibrosis-similar disorders and situations. Any statements contained in this conversation that are not statements of historic truth may possibly be deemed to be forward-searching statements. These ahead-on the lookout statements are dependent upon Chemomab’s existing expectations. Ahead-on the lookout statements require threats and uncertainties. Because such statements deal with foreseeable future gatherings and are based on Chemomab’s recent expectations, they are issue to a variety of pitfalls and uncertainties and real outcomes, performance or achievements of Chemomab could vary materially from those people described in or implied by the statements in this presentation, such as: the unsure and time-consuming regulatory approval procedure pitfalls associated to Chemomab’s skill to properly take care of its operating costs and its bills Chemomab’s programs to acquire and commercialize its solution candidates, focusing on CM-101 the timing of initiation of Chemomab’s planned scientific trials the timing of the availability of data from Chemomab’s scientific trials the timing of any prepared investigational new drug application or new drug application Chemomab’s programs to investigation, create and commercialize its present-day and long run solution candidates the medical utility, probable added benefits and market place acceptance of Chemomab’s item candidates Chemomab’s commercialization, advertising and marketing and manufacturing capabilities and approach Chemomab’s capability to shield its mental residence placement and the need for additional money to carry on to progress these item candidates, which might not be accessible on favorable phrases or at all. Further hazards and uncertainties relating to Chemomab’s and its enterprise can be located beneath the caption “Hazard Factors” and in other places 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 ahead-looking statements contained herein to mirror any change in Chemomab’s expectations with regard thereto or any alter in events, circumstances or conditions on which any these kinds of statements are dependent.
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Make contact with: Matteo Pellegrino AGC Biologics email@example.com