UGCG

- This first in human clinical study demonstrated that AL01211 was generally safe and well-tolerated at single doses up to 60 mg and at multiple doses up to 30 mg - AL01211 displayed dose dependent pharmacokinetics and the ability to effectively reduce the disease biomarkers glucosylceramide and globotriaosylceramide in healthy volunteers - Topline results from a Phase 2 study of AL01211 in patients with Fabry disease are expected in the second half of 2024 NEWARK, Calif.--(BUSINESS WIRE)-- AceLink Therapeutics, Inc., a clinical-stage biopharmaceutical company developing next generation oral substrate reduction therapies (SRTs), today announced that the findings from their Phase 1 study of AL01211 in healthy volunteers have been published in the peer-reviewed journal Clinical Pharmacology in Drug Development, a journal of the American College of Clinical Pharmacy. AL01211 is a potent, oral, glucosylceramide synthase (GCS) inhibitor being developed for the treatment of Fabry disease and Type 1 Gaucher disease. In contrast to other GCS inhibitors in development, AL01211 has minimal central nervous system penetration (CNS), allowing therapeutic benefits to peripheral organs while avoiding the risk of CNS-associated adverse effects. “These results highlight the transformative potential of AL01211 as a best-in-class GCS inhibitor,” said Jerry Shen, Ph.D., Chief Executive Officer and Founder of AceLink Therapeutics. “Our Phase 1 study provided the critical safety and biomarker data to support our ongoing Phase 2 clinical trial in patients with Fabry Disease. We expect to have topline results of the Phase 2 trial in the second half of 2024.” In the published Phase 1 study, AL01211 was evaluated with a single ascending dose arm and a multiple ascending dose arm to determine the safety, pharmacokinetics (PK), and pharmacodynamic (PD) effects in healthy volunteers. Overall, AL01211 was generally safe and well-tolerated with no serious adverse events. At a 30 mg dose level, plasma glucosylceramide and globotriaosylceramide were reduced from baseline levels by 78% and 52%, respectively, thus supporting AL01211’s further clinical development. “These data reinforce our commitment to provide more convenient and more effective therapeutic options to patients suffering from glycosphingolipid storage diseases such as Fabry disease,” said Michael Babcock, Ph.D., VP of Research and Early Development. “In our trial, AL01211 demonstrated dose-dependent PK and PD effects with a clear correlation between AL01211 exposure and reduction in disease biomarkers. The insights gained from this study have set us up nicely to test the therapeutic benefits of AL01211 in patients.” In October 2023, AceLink Therapeutics dosed its first patient in a Phase 2 open-label study evaluating the safety, PK, and PD of AL01211 in males with classic Fabry disease who have not been previously treated. Topline results from this study are expected in the second half of 2024. About AL01211 AL01211 is a proprietary, non-brain penetrant GCS inhibitor with excellent potency (single-digit nanomolar IC50), great selectivity, and other favorable drug properties that support once-daily oral administration. AL01211 offers a much-needed oral small molecule therapy as an alternative to the frequent intravenous infusions required with enzyme replacement therapy. About GCS inhibitors GCS catalyzes the first step in the synthesis of glycosphingolipids, a group of bioactive molecules that play important roles in various cellular processes and diseases. GCS inhibitors reduce the synthesis of glycosphingolipids, thereby exerting beneficial effects to diseases such as Fabry and Gaucher disease, which are caused by the pathogenic accumulation of these lipids. About AceLink Therapeutics, Inc. 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 .

HONG KONG, Dec. 4, 2023 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva's portfolio companies have new updates. Keep reading for more details. Phenomic Enters Strategic Collaboration with Boehringer Ingelheim to Discover Novel Targets for Stroma-Rich Cancer Therapies, and Enters into Strategic Research Collaboration with Astellas for Solid Tumor Cell Therapies TORONTO & WALTHAM, Mass.--(BUSINESS WIRE)--On Nov. 29th, Phenomic AI ("Phenomic"), invested and incubated by Viva BioInnovator (VBI), announced that they have entered into a strategic collaboration and licensing agreement with Boehringer Ingelheim to discover targets important in stroma-rich cancers. The partners will leverage Phenomic's expertise in target identification and stromal biology based on its scTx® single-cell transcriptomics platform which will greatly enhance Boehringer's efforts to develop first-in-class medicines to transform the lives of people with cancer by delivering meaningful advances with the ultimate goal to cure a range of cancers. Phenomic will receive upfront and near-term payments of approximately $9 million including research funding and collaboration milestones. Phenomic is also eligible to receive more than USD $500 million in licensing fees as well as clinical, regulatory and commercial milestones in addition to royalties on future product sales. On Nov. 30th, Phenomic has entered into a strategic research collaboration with Astellas Pharma Inc., "Astellas" through Xyphos Biosciences, Inc. (a wholly owned subsidiary of Astellas). For this collaboration, Phenomic and Astellas will explore the ability of antibodies, developed by Phenomic and directed at a novel target of the tumor stroma identified with Phenomic's scTx platform, to enhance cell therapy approaches for the treatment of solid tumors. Under the terms of the agreement, Phenomic will receive an upfront payment, full research funding, and a milestone payment. Astellas will receive a first right to negotiate a license to these antibodies during the term of the agreement. AmacaThera Closes Series A Extension to Advance Clinical Development of Long Acting, Localized, Non-Opioid Therapeutics to Improve Post-Surgery Patient Care Toronto, ON — AmacaThera, invested and incubated by Viva BioInnovator (VBI), is a leader in the development of novel injectable, localized therapeutics based upon its AmacaGel delivery platform. Recently they announced the closing of a CAD$4.0 million financing round, with a new lead investor, supported by existing investors; BDC Capital's Women in Technology Venture Fund, Inveready, Lumira Ventures, StandUp Ventures, and MaRS IAF. The proceeds will be used to accelerate the clinical development of the lead clinical candidate, AMT-143, and also to advance multiple pipeline programs targeting the local, injectable, sustained release market. The Phase II clinical trial application of VVN461 for the treatment of postoperative inflammation in cataract was approved by the U.S. FDA, VivaVision Ranks on 2023 Top 100 Chinese Healthcare Front-Runners List, and Offically Opens its New Neadquarters in Wenzou Recently, VivaVision, an innovative ophthalmic drug company, announced that the FDA approved the Phase II clinical trial application (IND) of VVN461, the company's self-developed drug, for the treatment of postoperative inflammation after cataract. VVN461 is a potent JAK1 immunomodulator independently developed by VivaVision, and there is increasing evidence showing that the JAK-STAT signaling pathway is essential for inflammation and immune response. VVN461 can inhibit multiple inflammatory cytokine pathways with high activity to treat postoperative inflammation of cataracts. The results of human pharmacokinetic studies showed that VVN461 ophthalmic solution had low exposure in plasma, indicating that VVN461 ophthalmic solution had a high safety profile due to low systemic toxicity while exerting local anti-inflammatory effects. Besides, VivaVision was named on the "2023 Top 100 Chinese Healthcare Front-Runners List", released in the 2023 BioShanghai Biopharmaceutical Industry Investment Forum and Future Medical Industry Forum. Genhouse Bio's SHP2 Inhibitor GH21 Combined with EGFR Inhibitor Osimertinib Approved for Clinical Trial On November 20, 2023, in Suzhou, China – VBI portfolio company Genhouse Bio announced that its novel protein tyrosine phosphatase SHP2 allosteric inhibitor GH21, in combination with the orally administered epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor osimertinib, has received NMPA approval for clinical trial in China. Genhouse Bio is dedicated to developing the next generation of global anti-tumor small molecule drugs using a combination technology platform. Based on in vitro and in vivo pre-clinical studies, GH21, when used as a monotherapy and/or in combination with other anti-tumor drugs, is effective against various solid tumors with EGFR mutations. Currently, GH21 is undergoing Phase I/II clinical trials in both China and the United States, with the clinical trials in the U.S. led by strategic partner HuYa Bio-International. GH21 has demonstrated favorable pharmacokinetics and safety profiles, and has shown efficacy even at low doses. Arthrosi to Present Positive Phase 2 Data for its Novel Selective Urat1 Inhibitor AR882 in Patients with Tophaceous Gout at ACR Convergence 2023 Arthrosi Therapeutics, Inc. (Arthrosi), invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biotechnology company. Recently, they announced new clinical data from its phase 2 AR882-203 study in the American College of Rheumatology (ACR) Convergence 2023 meeting, the world's largest and most prestigious rheumatology conference, including a presentation, named "AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography" and three additional posters. In the forthcoming late-breaking oral presentation, Dr. Robert Keenan MD, MPH, MBA, Chief Medical Officer of Arthrosi, will unveil compelling new clinical findings from the phase 2 trial. The data showcases the strong efficacy of AR882, demonstrating significant reduction of tophi, crystal burden, flare rates, in addition to lowering sUA among patients suffering from tophaceous gout. AceLink Announces First Patient Dosed in Phase 2 Trial of AL01211 in Fabry Disease NEWARK, Calif.--(BUSINESS WIRE)--AceLink Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biopharmaceutical company developing the next generation of oral substrate reduction therapies (SRTs). On Nov. 1st, 2023, they announced that the first patient has been dosed with AL01211 in its Phase 2 trial in China in patients with Fabry disease. AL01211 is a novel, oral, non-brain penetrant glucosylceramide synthase (GCS) inhibitor being developed to treat glycosphingolipid storage diseases, including Fabry Disease and Type 1 Gaucher Disease. In Phase 1 trials, AL01211 was generally well tolerated without significant adverse events. Triumvira Immunologics Announces First Patient Dosed in Phase II of TACTIC-2 Cell Therapy Trial for the Treatment of HER2+ Gastric and GEJ Cancers AUSTIN, Texas and HAMILTON, ON and SOUTH SAN FRANCISCO, Calif., Oct. 26, 2023 /PRNewswire/ -- Triumvira Immunologics, invested and incubated by Viva BioInnovator (VBI), is a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. Recently they announced that the first patient has been dosed in Phase II of its Phase I/II study TACTIC-2 (NCT04727151) investigating the safety and efficacy of autologous TAC-T cell lead asset, TAC01-HER2, in targeting HER2 in relapsed or refractory gastric and gastroesophageal junction (GEJ) tumors. TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). Deka Biosciences Closes USD $20 Million Series B2 Financing Led by MPM BioImpact GERMANTOWN, Md., Sept. 28, 2023 /PRNewswire/ -- Maryland-based biotech company Deka Biosciences ("Deka") today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm. The proceeds of the financing will support the advancement of Deka's pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK210 (EGFR). Additionally, Detlev Biniszkiewicz, Ph.D. of MPM-BioImpact, will join the Deka board. About Phenomic AI Phenomic AI ("Phenomic") is a biopharmaceutical company dedicated to overcoming the tumor stroma, a complex barrier that drives poor outcomes in the majority of solid tumors. The company is applying its proprietary single-cell transcriptomics platform, known as scTx®, to advance a first-of-its-kind approach to solid cancer drug discovery and development. scTx identifies novel drug targets and provides new insights into previously inaccessible tumor biology. Through its unique platform, Phenomic is developing a robust portfolio of potential first-in-class drug candidates to treat challenging stroma-rich solid cancers. The company was founded by pioneering artificial intelligence experts and experienced drug developers and is led by a world-class team with deep expertise in immuno-oncology, cancer, stromal biology, artificial intelligence, and machine learning. Learn more about the Phenomic team, platform and pipeline at . About AmacaThera AmacaThera Inc., a resident company of Johnson & Johnson Innovation, JLABS @ Toronto is a clinical-stage company transforming therapeutics to make a difference in patient health. AmacaGel, our unique, injectable hydrogel platform, provides localized sustained drug delivery for improved patient outcomes across multiple therapeutic areas, including post-surgical pain management, cancer and other hard-to-reach, unmet medical needs. For more information, visit . About VivaVision Biotech VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. VivaVision's current pipeline includes VVN001 for treating dry eye syndrome, VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. VivaVision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases. For more info., visit . About Genhouse Bio Genhouse Bio is a clinical-stage biotech company focusing on the development of global next-generation anti-cancer therapeutics, headquartered in the Suzhou Industry Park . The senior management team of Genhouse has multiple years of experience in new drug development, clinical research and corporate management. Genhouse has a clear focus on original innovation and overcoming those "undruggable" targets. Genhouse has established intergrated in-house drug development platforms. With these platforms, Genhouse has started to build a highly innovative anti-cancer pipeline and out-licensed the ex-China rights of its SHP2 inhibitor GH21 to HUYABIO , an international biotech company. Genhouse will continue to advance more innovative pipeline programs into global development. About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, was established in 2018. The company's goal is to develop potential treatments aimed at uric acid levels and minimizing joint damage for gout patients. Arthrosi's research and development have produced end of phase 2b data. For more information about Arthrosi, please visit . About AceLink Therapeutics, Inc. 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 Triumvira Immunologics Triumvira Immunologics, Inc. ("Triumvira") is a leading clinical-stage solid tumor cell therapy company developing unique, non-gene edited, first-in-class targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. The company's proprietary T cell Antigen Coupler (TAC) technology is a robust and versatile platform that activates natural T cell functions differently from cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies. Triumvira is developing a broad pipeline targeting promising tumor-associated antigens such as HER2, Claudin 18.2, GUCY2C and GPC3. Triumvira is headquartered in Austin, Texas, with research facilities in Hamilton, Ontario, and GMP manufacturing facilities in South San Francisco, California. About Deka Biosciences Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, and testing. Deka has developed disease specific Diakines™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient's immune response to different Diakines™, Deka hopes to maximize the impact of its Diakines™ by building specific targeted therapies for everyone. SOURCE Viva Biotech Holdings

- Plan to enroll patients across six sites throughout China - - Topline results are expected in 2H 2024 - NEWARK, CA, USA I October 31, 2023 I AceLink Therapeutics, Inc., a clinical-stage biopharmaceutical company developing the next generation of oral substrate reduction therapies (SRTs), announced today that the first patient has been dosed with AL01211 in its Phase 2 trial in China in patients with Fabry disease. AL01211 is a novel, oral, non-brain penetrant glucosylceramide synthase (GCS) inhibitor being developed to treat glycosphingolipid storage diseases, including Fabry Disease and Type 1 Gaucher Disease. In Phase 1 trials, AL01211 was generally well tolerated without significant adverse events. “We are delighted to initiate enrollment in our Phase 2 study for patients with Fabry disease at one of the most renowned academic centers in China,” said Dr. Pedro Huertas, M.D. Ph.D., Chief Medical Officer of AceLink Therapeutics. “Today’s achievement reflects the dedication and hard work of our talented team and the unwavering support from our investigators. We believe AL01211, as the best-in-class GCS inhibitor, will provide a meaningful therapeutic benefit for the disorders of glycosphingolipid metabolism. We look forward to providing updates as the trial progresses and remain committed to bringing this promising therapy one step closer to those patients who need it most.” The Phase 2 open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and treatment effects of AL01211 in males with classic Fabry disease who have not been previously treated. AceLink plans to enroll 18 patients across six sites throughout China. Dr. Nan Chen at Shanghai’s Ruijin Hospital is serving as the Principal Investigator leading the efforts. AceLink expects topline results in 2H 2024. “Despite the advancements made over the years, a significant gap remains in the treatment landscape for Fabry disease. Enzyme replacement therapy necessitates frequent IV infusions, which is an inconvenience for patients. Long-term enzyme replacement treatment may slow down disease progression, but cardiac, renal, and other complications still develop in most patients,” said Dr. Nan Chen, Professor of the Department of Nephrology at Ruijin Hospital. “AceLink’s proprietary GCS inhibitor provides patients with a convenient, oral option that overcomes the challenges of current treatment modalities. I am excited to have dosed the first patient in the company’s Phase 2 program for AL01211 and am dedicated to maintaining the highest standards throughout the trial.” About AL01211 AL01211 is a proprietary, non-brain penetrant GCS inhibitor with excellent potency (single-digit nanomolar IC 50 ), great selectivity, and other favorable drug properties that support once-daily oral administration. AL01211 offers a much-needed oral small molecule therapy as an alternative to enzyme replacement therapy for Fabry disease obviating frequent intravenous infusions. About GCS inhibitor GCS catalyzes the first step in the synthesis of glycosphingolipids, a group of bioactive molecules that play important roles in various cellular processes and diseases. GCS inhibitors reduce the synthesis of glycosphingolipids, thereby exerting beneficial effects to diseases such as Fabry and Gaucher diseases, which are caused by the accumulation of these lipids. About AceLink Therapeutics, Inc. Founded in 2018, AceLink Therapeutics is a clinical stage pharmaceutical company developing the next generation of oral substrate reduction therapies (SRTs) to address significant unmet medical needs and improve the quality of life of patients with inherited disorders of glycosphingolipid metabolism. The company is developing a pipeline of breakthrough therapeutics including a Phase 2 program for Fabry Disease and Type 1 Gaucher Disease. For more information, please visit www.acelinktherapeutics.com . SOURCE: AceLink Therapeutics