URAT1

ABP-745 is an oral small molecule drug that also has potential applications for other anti-inflammatory diseases JIANGSU, China--(BUSINESS WIRE)-- Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical trial of ABP-745, an anti-inflammatory oral small molecule drug, for the treatment of acute gout. Atom also has submitted an IND application for a Phase 1 clinical of ABP-745 in China. The studies will be conducted concurrently in the U.S. and China. Preclinical trial results showed that ABP-745 can significantly reduce the levels of inflammatory factors in animals, and compared with similar drugs, it has good efficiency and significant safety improvement. While the early clinical indication for ABP-745 will be for the treatment of acute gout, based on its positive inhibitory effects on various inflammatory factors, it will also be used for development of other related indications. Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Biosciences, said, “The IND clearance of ABP-745 is important progress in the anti-inflammatory research field of Atom Bioscience’s clinical development. We expect to begin the Phase 1 trial for acute gout in the U.S. soon. In the future the company will increase investment in multiple inflammatory indications to address unmet clinical needs and enrich and improve the company product line.” Acute gout is characterized by sudden severe pain and swelling in joints, usually in the lower extremities, triggered by the build-up of urate crystals. The formation of the urate crystals is caused by hyperuricemia, an excessive level of uric acid in the blood greater than 7 mg/dL which leads to the development of chronic gout and repeated episodes of acute gout flare-ups. Gout is one of the most common types of inflammatory arthritis affecting more than 50 million people worldwide. The disease has a large and growing patient population in the U.S., Europe, Asia and Latin America. If left untreated, chronic gout can seriously affect patients’ quality of life and is associated with other serious comorbidities, including kidney function injury, increasing the probability of sudden cardiac death. Atom is developing ABP-671, an oral small molecule URAT1 inhibitor, for treatment of chronic gout. The drug, which is designed to lower uric acid levels, is in multicenter Phase 2b/3 clinical trials worldwide, including the U.S. About Atom Bioscience Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in Phase 2b/3 clinical development for treatment of chronic gout . Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of anti-inflammation, and is expected to be in Phase 1 clinical trials soon. For more information, please visit: or atombp.us. View source version on businesswire.com: Contacts Business Development Contact: Roy J. Wu, MBA Sr. Vice President, Business Development Atom Bioscience and Pharmaceutical Co., Ltd Email: roy.wu@atombp.com Source: Atom Bioscience View this news release online at:

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

— At 6 months patients treated with AR882 75 mg showed significantly higher response rate of at least one complete target tophi dissolution — — On track to initiate pivotal phase 3 program in early 2024 — SAN DIEGO, Nov. 8, 2023 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company developing treatments for gout that dissolve uric acid crystals and prevent joint damage, today announced new clinical data from its phase 2 AR882-203 study in patients with tophaceous gout. The late-breaking data will be presented as an oral presentation at the American College of Rheumatology (ACR) Convergence 2023 meeting, being held in San Diego, CA on November 10-15, 2023. 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. In the intent-to-treat population, AR882 demonstrated a significant decrease in sUA at 3 months. Notably, in the 75 mg AR882 group, 86% and 64% of patients achieved sUA levels below 6 and 5 mg/dL, respectively, compared to 77% and 69% in the 50 mg AR882 + allopurinol group and 46% and 23% in the allopurinol group. Significantly higher response rates in total crystal volume reduction were observed by Dual Energy Computed Tomography (DECT) imaging. Specifically, the AR882 75 mg group showed a notable reduction in total urate crystal volume (-8.3 cm3, baseline 15.6 cm3) compared to allopurinol (-1.2 cm3, baseline 11.5 cm3) or combination (-0.9 cm3, baseline 4.7 cm3) on DECT at Month 6. (Figure 1 illustrates DECT images of one severe gout patient's crystal burden at baseline (left) and at 6 months following QD treatment of 75 mg AR882) Consistent with DECT imaging, AR882 75 mg demonstrated significantly higher response rate of at least 1 complete target tophi dissolution by caliper measurement than allopurinol 300 mg, or allopurinol 300 mg in combination with AR882 50 mg. These clinical findings, highlighted via both DECT and caliper, underscore the effectiveness of AR882 in reducing urate crystal burden, further substantiating its potential as a groundbreaking therapeutic solution for patients. "We are excited to share new data from our phase 2 tophaceous gout study at ACR highlighting its potential to significantly improve the standard of care for a broad range of patients living with gout," said Arthrosi's Chief Executive Officer Litain Yeh, PhD. "Importantly, in the case of patients with tophaceous gout, there remains a high unmet need for a safe, efficacious and convenient therapy to reduce sUA levels below 5 mg/dL, which has been established in the literature as necessary to quickly resolve and reduce debilitating symptoms associated with tophi and flares." Details for the presentations are below: Title: 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 Session Title: Late-Breaking Abstracts Abstract Number: #1651889 Date/Time: Wednesday, November 15 / 7:30am - 7:45am PST Arthrosi will present three additional posters at ACR highlighting results from its previously completed phase 2b AR882-202 study evaluating AR882 in chronic gout patients. The Phase 2b study was a global, multicenter, 12-week, randomized, double-blind, placebo-controlled study of 140 gout patients who met the gout classification according to the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (EULAR). Title: Efficacy and Safety of AR882, a Selective Uric Acid Transporter 1 (URAT1) Inhibitor, in Gout Patients with Various Baseline Characteristics Following 12-Week Treatment in Patients Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I Abstract Number: #1553555 Date/Time: Sunday, November 12 / 9:00am - 11:00am PST Title: Pharmacokinetics and Pharmacodynamics of AR882 Following 12-Week Treatment in Patients with Gout Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II Abstract Number: #1553704 Date/Time: Monday, November 13 / 9:00am - 11:00am PST Title: AR882, A Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Pro Multiple Doses Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II Abstract Number: #1552575 Date/Time: Monday, November 13 / 9:00am - 11:00am PST All four poster presentations will be available in the "Publications" section of Arthrosi's website: . About the AR882-203 Phase 2 Study The Phase 2 study of AR882 in patients with tophaceous gout was a six-month, 1:1:1 randomized, global, placebo-controlled study of 42 patients with subcutaneous tophi. The mean baseline sUA among the participants ranged between 9.1-9.6 mg/dL. In the study, patients received a once daily dose of either 75 mg AR882, 50mg AR882 + allopurinol, or allopurinol up to 300mg. Serum uric acid levels (< 6, <5, <4, or <3 mg/dL) were evaluated monthly through month 6, and safety and tolerability were assessed throughout the study. Tophi measurements with calipers were completed every 4 weeks for 6 months. Patients were also imaged using Dual-Energy Computed Tomography (DECT), DECT a specialized imaging technique that is able to differentiate and identify uric acid crystals in the joints and soft tissue, allowing for quantifying uric acid crystals and tophi at baseline and 6 months. The primary efficacy endpoint was sUA change at 3 months. Secondary endpoints included complete resolution of at least one target tophus with no new tophi and no tophus showing progression. Safety assessments, including vital signs and electrocardiograms, were collected throughout the study. About Gout: In the U.S., an estimated 10 million individuals are diagnosed with gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. Elevated sUA levels often signify an imbalance in production or excretion of uric acid and acts as an early indicator of potential gout development. Consistent, elevated sUA levels have been identified as a precursor to gout attacks and related complications. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies. 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 anticipates initiating pivotal phase 3 program in early 2024. Investor Contact: Stern Investor Relations, Inc. Alex Lobo 212-698-8802 Alex.lobo@sternir.com