Regenacy Pharmaceuticals LLC

SHANGHAI, Sept. 28, 2022 /PRNewswire/ -- As the investment division of Viva Biotech, Viva BioInnovator is committed to being a collaborative platform for Innovative Biotech companies from around the world. Over the past 2 months, our portfolio companies progressed greatly. ABM Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ABM-1310 in China On September 16, 2022, ABM Therapeutics, a clinical-stage biopharmaceutical company that is invested and incubated by Viva BioInnovator, announced that the first patient has been successfully dosed with ABM-1310 in a multi-center phase I clinical trial in China. ABM-1310, ABM Therapeutic's proprietary clinical candidate developed as a next-generation BRAF inhibitor, is a highly selective, highly water-soluble, orally administrated, and brain-penetrant small molecule BRAF inhibitor. ABM-1310 phase I trial, conducted in China, is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ABM-1310 in Chinese patients with BRAF V600X mutated advanced solid tumors. F5 Therapeutics awarded First Servier FAST Discovery Award F5 Therapeutics, which invested and incubated by Viva BioInnovator, was recently awarded the first Servier FAST Discovery Award. Winning this award means F5 stood out from 23 applications, indicating the industry's recognition of F5's innovative treatment methods in the field of biomedicine. "Servier FAST Discovery Award" is co-sponsored by Servier and the California Life Sciences Association (CLSA) to support early-stage life science companies using innovative approaches in areas designated by the group: oncology, auto-immune diseases, genetically driven neurodegenerative, and movement disorders. F5 is transforming targeted protein degradation to advance drug discovery by utilizing the cell's normal protein regulation systems to remove disease-causing proteins that cannot be targeted by traditional approaches. The NExMods™ Platform (NEosubstrate Expression Modulators) represents a novel approach to "molecular glues" capable of delivering effective medicines to patients across diverse therapeutic areas: oncology, immuno-oncology, fibrosis, inflammation, and neurodegeneration. AceLink Therapeutics Receives Orphan Drug Designation for its Novel GCS inhibitor AL01211 for the Treatment of Fabry Disease AceLink Therapeutics, Inc. (AceLink), invested and incubated by Viva BioInnovator, is an innovative biopharmaceutical company developing transformative therapies for genetic diseases. On September 7, 2022, they announced that they received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for AL01211 as a treatment for Fabry Disease. AL01211 was selected based on its unique properties to effectively treat peripheral organs that Fabry disease affects by reducing the risk of off-target effects by preventing the crossing of the blood-brain barrier. HAYA Therapeutics won the "TOP 100 Swiss Startup Award 2022" and was successfully selected for the "Soonicorn Club 2022" On Sept. 7th, 2022, the "Top 100 Swiss Startup Award 2022," sponsored by Venturelab, was announced. HAYA Therapeutics, invested and incubated by Viva BioInnovator, was named TOP100 Swiss Startups' 8th Best Startup and came first in the Cardiovascular & Drug Discovery sectors. In addition, HAYA Therapeutics was recently included in the"SoonicornClub 2022", which names the top Swiss technology startups. The awards given demonstrate the industry's recognition of their potential in the field of biomedicine. Regenacy Pharmaceuticals Announces Completion of Enrollment for their Phase 2 Study in Diabetic Peripheral Neuropathy and $9.3 Million in Series B Financing Regenacy Pharmaceuticals Inc, invested and incubated by Viva BioInnovator, is a clinical-stage, biopharmaceutical company developing breakthrough treatments for diabetes and other peripheral neuropathies. On August 24, 2022, they announced completion of enrollment for the company's phase 2 study of ricolinostat, an oral selective deacetylase 6 (HDAC6) inhibitor for painful diabetic peripheral neuropathy (DPN). The company also announced the closing of a $9.3 million Series B financing led by Cobro Ventures. Arthrosi Completes AR882 Renal Impairment Study and its Phase 2b Study Enrollment Arthrosi Therapeutics, Inc., which invested and incubated by Viva BioInnovator, is a clinical-stage biotechnology company focused on the treatment and management of gout. On August 9, 2022, they announced the completion of their renal impairment study that utilizes the lead compound, AR882. AR882 is a potent and selective uricosuric agent which has shown effectiveness in lowering serum urate in patients with normal renal function and in patients with mild to severe renal impairment. On Aug. 23, 2022, Arthrosi announced the completion of enrollment for its global Phase 2b clinical study of AR882 for the treatment of chronic gout. The study, which exceeded the initial target enrollment of 120 patients, is designed to evaluate the safety and efficacy of AR882 in chronic gout patients who meet ACR/EULAR gout classification. About ABM Therapeutics ABM Therapeutics, a clinical-stage biopharmaceutical company with a mission to focus on the small molecule research and development of novel drugs for the treatment of cancer, and on brain cancer and cancer metastases. ABM has been building its broad and robust proprietary pipeline to construct a brain medicine R&D platform through collaboration with CROs. ABM's pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain. About F5 Therapeutics F5 is evolving targeted protein degradation to transform the landscape of drug discovery by utilizing the cell's normal protein regulation systems to remove disease causing proteins that cannot be targeted by traditional approaches. The NExMods™ Platform (NEosubstrate Expression Modulators) represents a novel approach to "molecular glues" capable of delivering impactful medicines to patients across diverse therapeutic areas: oncology, immuno-oncology, fibrosis, inflammation, and neurodegeneration. About AceLink Therapeutics Founded in 2018, AceLink Therapeutics is an innovative biopharma startup focusing on developing safe and effective medicines to address genetic diseases with high unmet needs. The company's initial focus is to develop novel therapeutics for Fabry disease. For more information, please visit . About HAYA Therapeutics HAYA Therapeutics is a precision therapeutics company that discovers and develops innovative tissue- and cell-selective genomic medicines for fibrotic diseases and other serious health conditions associated with aging, including cancer. The company's discovery engine focuses on long non-coding RNAs (lncRNAs) within the "dark matter" of the human genome -- key tissue and cell-specific drivers of fibrosis and other disease processes -- to identify novel targets and drug candidates with the potential for greater efficacy and safety than existing treatments. About Regenacy Regenacy Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company regenerating biological function by protein acetylation for the treatment of diabetic and other peripheral neuropathies and other chronic conditions. The company's selective inhibition technology provides superior safety profiles and potential enhanced efficacy compared to non-selective HDAC inhibitors. Regenacy selectively inhibits histone deacetylase 6 (HDAC6) to restore normal intracellular protein and organelle transport in peripheral neuropathies, and also has a portfolio of selective HDACs 1 and 2 inhibitors that have potential to treat major blood diseases such as leukemia, sickle cell disease, β-thalassemia, and cognitive dysfunction in neurological disorders. About Arthrosi Therapeutics Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase I and Phase II data showing industry leading efficacy rates and superior safety pro To learn more about Arthrosi, please visit View original content: SOURCE Viva Biotech Holdings

WALTHAM, Mass.--(BUSINESS WIRE)-- Regenacy Pharmaceuticals Inc, a clinical-stage biopharmaceutical company developing breakthrough treatments for diabetic and other peripheral neuropathies, announced completion of enrollment of the company’s phase 2 study of ricolinostat, an oral selective histone deacetylase 6 (HDAC6) inhibitor, in painful diabetic peripheral neuropathy (DPN). The company also announced the closing of a $9.3 million Series B financing led by Cobro Ventures with participation from Taiwania Capital Management Corporation, 3E Bioventures Capital, Yonjin Venture, and other undisclosed private investors. Painful DPN is characterized by debilitating symptoms that include pain, aberrant sensation, and loss of motor and sensory function. There is an important medical need for new treatments since available therapies do not address the full spectrum of signs and symptoms and offer only limited relief for many patients. Ricolinostat, and other HDAC6 inhibitors, have shown efficacy in animal models of DPN, chemotherapy-induced peripheral neuropathy (CIPN) and Type 2 Charcot Marie Tooth (CMT) disease, and have demonstrated a promising safety and tolerability profile. The ongoing double-blinded placebo-controlled clinical study, which recently completed enrollment, assesses the efficacy of ricolinostat in patients with painful DPN and other neuropathic symptoms. Initial results are expected to be available later this year. Regenacy plans to use the additional financing from this Series B to continue advancing the ricolinostat clinical development program. “Regenacy is committed to exploring ricolinostat’s unique and differentiating potential to address the underlying pathophysiology of small fiber neuropathies,” said David Michelson, M.D., Regenacy’s Chief Medical Officer. “The compelling data we have seen in preclinical studies indicate ricolinostat’s selective inhibition of HDAC6 may provide meaningful relief to patients suffering from painful DPN and other neuropathies, and we look forward to its continued progression in the clinic.” “We are energized by the ongoing support of our investors who share in our mission to address the underlying causes of peripheral neuropathy,” said John Rocha, Regenacy’s Chief Financial Officer. “This Series B positions Regenacy for continued progress as we uncover the potential of ricolinostat to restore peripheral nerve function.” “We at Regenacy believe that ricolinostat shows first-in-class potential to go beyond symptomatic treatment and instill lasting disease-modifying effects for patients with peripheral neuropathies,” said Simon Jones, Ph.D., Regenacy’s President and Chief Executive Officer. “This Series B financing comes at a pivotal stage in our clinical development, as we continue to evaluate ricolinostat in painful diabetic peripheral neuropathy while simultaneously advancing our joint venture Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. to investigate ricolinostat in patients with chemotherapy-induced peripheral neuropathy (CIPN) in China.” Concurrent with the financing, Todd Kaloudis, Managing Director at Cobro Ventures, has joined Regenacy’s Board of Directors. Additionally, Regenacy announced the appointment of William W. Chin, M.D., SVP of Clinical and Translational Science at Frequency Therapeutics, as Executive Chairman of the Board and Michael Huang, Managing Partner at Taiwania Capital, as Vice-Chairman, effective immediately. Mr. Huang has served on Regenacy’s Board since 2020, and Dr. Chin has served since 2018 and is Chairman of Regenacy’s Scientific Advisory Board. About Ricolinostat Ricolinostat, an oral, selective histone deacetylase 6 (HDAC6) inhibitor, has the potential to become the first-in-class treatment that reverses the underlying peripheral neuropathy, thereby relieving pain, numbness, motor function loss, and all other symptoms of the disease. Ricolinostat restores nerve function by inhibiting HDAC6, which reestablishes the transport function of microtubules in the axon of the nerve cell. A functioning microtubule transport system is the key to restoring nerve function because nerves rely on this network to supply the energy and nutrients necessary to maintain the nerve signaling in the ends of the nerves in the skin and muscles of the feet and hands. When this transport is disrupted by a disease like diabetes or neurotoxic drugs used in chemotherapy, nerve cells can malfunction and send random signals (pain, tingling, muscle spasms) or no signal at all (numbness, paralysis). Multiple preclinical animal models have demonstrated that HDAC6 inhibition restores nerve fibers, leading to the reversal of both pain and numbness in peripheral and other neuropathies, such as diabetic peripheral neuropathy (DPN), chemotherapy-induced peripheral neuropathy (CIPN) and Charcot-Marie-Tooth disease Type 2, an orphan-designated disease. About Regenacy Regenacy Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company regenerating biological function by protein acetylation for the treatment of diabetic and other peripheral neuropathies and other chronic conditions. The company’s selective inhibition technology provides superior safety profiles and potential enhanced efficacy compared to non-selective HDAC inhibitors. Regenacy selectively inhibits histone deacetylase 6 (HDAC6) to restore normal intracellular protein and organelle transport in peripheral neuropathies, and also has a portfolio of selective HDACs 1 and 2 inhibitors that have potential to treat major blood diseases such as leukemia, sickle cell disease, β-thalassemia, and cognitive dysfunction in neurological disorders.