Nimble Science Ltd.

Company Announces Opening of a Second R&D site in Philadelphia, PA, and the Appointments of Shelley Allen as Head of Drug Discovery, and Munir Mosaheb as Head of Biology PHILADELPHIA--(BUSINESS WIRE)-- Nimble Therapeutics today announced the opening of a second R&D site in Philadelphia, PA. The new site, located in B+Labs, a hub for scientific innovation in University City Philadelphia, will focus on progressing Nimble’s growing pipeline of orally-delivered peptide therapeutics into clinical development. The Philadelphia site will synergize with activities at Nimble’s main R&D site in Madison, WI, which is focused on leveraging its proprietary platform to optimize oral peptide therapeutics at unprecedented scale and speed. In addition to the new site, Nimble also announced the appointment of two senior leaders to spearhead the drug discovery efforts and catalyze the build out of the Philadelphia site and team. Shelley Allen will join as Head of Drug Discovery and will lead the advanced optimization and characterization of clinical candidate peptides and their progression into the clinic. Munir Mosaheb will join as Head of Biology and will lead the pharmacological, immunological and translational aspects of Nimble’s drug discovery programs. Shelley has over 25 years of experience in the discovery and development of high-impact medicines. She joined Nimble from Think Bioscience where she was VP, Medicinal Chemistry, and responsible for establishing drug discovery teams and capabilities to develop their internal programs. Previously, Shelley spent 22 years with Array Biopharma / Pfizer in roles of increasing responsibility, contributing to the discovery of several clinical candidates including oncology therapeutics Vitrakvi® and Tukysa®. As director of medicinal chemistry at Pfizer, she led teams and programs from lead discovery to IND in the kinase space. Shelley began her career at Rhone-Poulenc Rorer after completing undergraduate studies at DeMontfort University of Leicester. She has published > 40 scientific papers and patents and is active in the American Chemical Society community. Munir has over 15 years of experience in developing and applying novel immunological insights in academic and biotech settings. Most recently Munir was the Head of Translational Biology and Immunology at Senda Biosciences (now Sail Biomedicines), where he built a Translational Biology team and led platform and program development, and IND-enabling preclinical data generation. Prior to Senda, Munir received broad training across diverse aspects of immunology. He explored molecular vaccinology during his time at Merck & Co. and the Wetzler lab at BU, studied T cell biology while at the Flavell lab at Yale, and immuno-oncology and cell trafficking as a post-doctoral fellow in the von Andrian lab at Harvard. "We are pleased to open our second R&D site in the Philadelphia area," said Jigar Patel, founder & CEO of Nimble Therapeutics. "This is a reflection of the growing maturity of our internal pipeline of orally-delivered peptide therapeutics, and the need to build additional capabilities as we progress candidates into the clinic.” “I’m thrilled to have Shelley and Munir join us at this exciting stage in the journey of Nimble,” said Pete Gough, CSO of Nimble Therapeutics. “They both bring a wealth of experience in the key areas of immunology, drug discovery and pre-clinical development and will be instrumental in building and leading the teams that will take our programs into the clinic.” "As a medicinal chemist of 25 years, I am incredibly impressed by the power and unprecedented speed of the Nimble platform to identify and optimize oral therapeutic peptides. I’m very much looking forward to partnering with our team in Madison to deliver a robust pipeline of clinical candidates to patients,” said Shelley. “Despite the progress we’ve made with parenteral biological therapies for the treatment of immune-mediated diseases over the past couple of decades, patients want oral medicines. Because of our platform, Nimble is uniquely placed to become a leader in developing oral peptide therapeutics as next-generation treatments for these patients and I’m excited to be part of the team to help this vision become reality,” said Munir. About Nimble Therapeutics Nimble is a biotechnology company dedicated to delivering on the promise of oral peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble is advancing its internal pipeline and continues to support several partnered programs. The Nimble platform combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful machine learning and computational methods. Nimble is located in Madison, WI and Philadelphia, PA. For more information, visit .

MADISON, Wis.--( BUSINESS WIRE )--Nimble Therapeutics announced that Dan Flynn and Brian Cali have joined the company’s Board of Directors. Both bring deep entrepreneurial and drug development track records that will guide Nimble as it continues to pursue its internal pipeline. Dr. Flynn has over 40 years of experience in the discovery and development of high-impact medicines. He recently retired from Deciphera Pharmaceuticals, a company he founded in 2003. At Deciphera, Dr. Flynn held positions of Chief Executive Officer, Executive Vice President, and Chief Scientific Officer where he oversaw the progression of several molecules through clinical trials, including Qinlock® for the treatment of gastrointestinal stromal tumors. Before founding Deciphera, Dr. Flynn held senior roles with various companies including Millennium Pharmaceuticals, Amgen Inc. and the Monsanto Company, G.D. Searle Unit. Dr. Flynn is currently Adjunct Professor of Medicinal Chemistry at the University of Kansas-Lawrence. He has served as the National Chair for the Division of Medicinal Chemistry of the American Chemical Society, is an American Chemical Society Fellow, and founder of the Bioorganic and Medicinal Chemistry Foundation. He is a member of the Board of Directors and Scientific Advisory Boards of several biotech companies. Dr. Flynn received both his B.S. in pharmacy and Ph.D. in medicinal chemistry from the University of Kansas and completed post-doctorate training in synthetic organic chemistry at Indiana University. Dr. Cali has over 25 years of pharma biotech experience. He co-founded Ironwood Pharmaceuticals in 1998 where he held leadership roles across R&D and corporate development and helped drive the company’s transformation from an early discovery stage startup to a commercial stage company with a market leading gastrointestinal (GI) disease product (Linzess ® ) and a diverse pre-commercial pipeline. Brian also led the investor engagement and financing efforts that enabled the creation of Cyclerion, an Ironwood spinout, in 2019. He currently serves on the Board of Directors of Jnana Therapeutics, a role he has held since 2018. He holds a B.S. from Cornell University, a Ph.D. in Cell and Molecular Biology from the University of Wisconsin-Madison and was a postdoctoral fellow at the Whitehead Institute. "We are pleased to welcome Daniel and Brian to our Board of Directors at this important stage of Nimble’s evolution," said Jigar Patel, founder & CEO of Nimble Therapeutics. "Both are renowned pharma biotech entrepreneurs, having founded and successfully led companies that have developed novel small molecule or peptide-based drugs. We look forward to their guidance as we work to bring breakthrough medicines into clinical development, and ultimately to patients in need.” "Daniel and Brian are valuable additions to Nimble’s board, and their expert guidance will be paramount to the company as it continues to concentrate on developing and progressing its internal pipeline,” said Board Chair Dan Zabrowski. “It is an exciting time to be joining Nimble as they seek to leverage their incredibly versatile technology and team to develop best-in-class / first-in-class peptide-based medicines for the treatment of important diseases.” said Dr. Flynn. “Nimble has a paradigm shifting platform and I am impressed with what they have already accomplished. I look forward to helping the company as their efforts toward their own pipeline intensify, and they push towards the clinic and beyond.” said Dr. Cali. About Nimble Therapeutics Nimble is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble is advancing its internal pipeline and continues to support several partnered programs. The Nimble platform combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful machine learning and computational methods. Nimble is located in Madison, WI and Philadelphia, PA. For more information, visit www.nimbletherapeutics.com .

GHENT, Belgium--(BUSINESS WIRE)-- MRM Health, a clinical-stage biopharmaceutical company, announced today that it has received regulatory and ethics committee approval to start an observational, cross-sectional clinical trial to study the role of the small intestinal microbiome in Parkinson’s Disease (PD) and to identify PD-specific microbial and metabolic fingerprints in small intestinal fluid and blood. The clinical research is being conducted in close collaboration with Nimble Science and the University of Calgary, Canada. The clinical study is expected to enroll up to 100 subjects, including an age-matched healthy volunteer cohort. The trial will run in Calgary Parkinson’s Research Initiative (CaPRI) with Dr. Davide Martino and is registered on Clinicaltrials.gov with number NCT06003608. MRM Health develops rationally-designed consortium therapeutics through its proprietary CORAL® technology, comprising well-characterized commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. MRM Health’s breakthrough, scalable and standardized cGMP manufacturing platform enables the manufacturing of complete consortia as a single drug substance, which is designed to overcome historical limitations of microbiome therapy and establish a new standard for effective consortia therapeutics development. MRM Health recently obtained positive phase 2a clinical data with MH002 in Ulcerative Colitis and has an ongoing clinical study in Pouchitis. In addition to its clinical programs in Inflammatory Bowel Diseases and the program in Parkinson’s Disease, the Company has preclinical programs in autoimmune disorders and in metabolic diseases, being developed through a partnership with IFF Nutrition Biosciences. Sam Possemiers, Chief Executive Officer at MRM Health, said: “We are excited to collaborate with Nimble Science and the Calgary Parkinson’s Research Initiative on this project and to use the innovative SIMBA capsule to sample the small intestinal content. We expect that the data generated in this study will provide unique insights into the composition of the small intestinal microbiome, which is so far largely unexplored, and its connection to the pathophysiology of Parkinson’s Disease. It will feed into our existing program and enable us to fine-tune and accelerate the development of novel Live Biotherapeutic Products for the treatment of this progressive, neurodegenerative disease.” Dr. Davide Martino, from the Calgary Parkinson’s Research Initiative and Principal Investigator of the study, said: “There is a high unmet medical need for safe and effective treatments for this seriously debilitating disease, and novel therapeutic modalities will be very welcomed by patients and caregivers, especially if they are disease modifying. This observational study is expected to help generate novel hypotheses to potentially impact the pathophysiology of Parkinson’s Disease and provide disease modifying therapy.” Sabina Bruehlmann, Chief Executive Officer at Nimble Science Inc., said: “We are emboldened to use our Small Intestine MicroBiome Aspiration (SIMBA) system to gather more data in order to better understand the role of the microbiome in the small intestine of Parkinson’s Disease patients. Performing the study in collaboration with MRM Health will enable the integration of multi-omic data from the SIMBA capsule with additional ‘omics data.’” The SIMBA system is a single-use, ingestible passive capsule that allows for the non-invasive sampling of small intestinal contents. It is designed to open and absorb intestinal content after having passed the acid stomach environment and to mechanically seal before passing into the large bowel. It has distinct markers built in to allow radiographic tracking of its passage throughout the GI system. The SIMBA capsule was developed and validated by Nimble Science and has already shown its promise in retrieving specific small intestine material in previous studies. About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program, MH002, is in preparation for pivotal clinical development in Ulcerative Colitis, upon obtaining positive clinical results in a phase 2a clinical trial, and is being evaluated in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable, and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at . About Nimble Science Nimble Science is a digital health company delivering first-in-class at home capsule based small intestinal fluid biopsy and multi-omic microbiome data capabilities via its SIMBA™ GI Health platform. Nimble’s SIMBA™ capsule has been clinically validated to collect an uncontaminated sample from the deepest and previously inaccessible regions of the small intestine – housing one of the most bioactive and critical microbial environments. Nimble’s technology, ease of administration and actionable health data insights are unparalleled in comparison with competing solutions, and Nimble has been actively partnering with industry leaders around the world to empower breakthrough health innovation spanning pharmaceuticals, diagnostics and consumer health R&D programs. To learn more, please visit the website at . About Parkinson Disease Parkinson's disease is a progressive, irreversible brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. Current treatment aims to manage the symptoms and improve the quality of life for patients. Medications like levodopa and dopamine agonists can help alleviate motor symptoms by replenishing dopamine levels in the brain. There is still a high remaining unmet need for new therapies and interventions to improve the management of Parkinson's disease and enhance the overall well-being of affected individuals. No disease-modifying treatment is available to date. View source version on businesswire.com: Contacts MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 info@mrmhealth.com Stern Investor Relations Stephanie Ascher Stephanie.ascher@sternir.com +1 212-362-1200 Source: MRM Health View this news release online at: