Pradigastat

SHANGHAI, Dec. 1, 2022 /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, 12 of Viva's portfolio companies have achieved significant results and progress: Focus-X Therapeutics successfully reached an acquisition agreement with Full-Life Technologies. Aleta Biotherapeutics, Domain, Triumvira, ABM Therapeutics, and QureBio made substantial progress on pipelines. BioCasting, Cybrexa, and Anji Pharmaceuticals reached agreements with other companies in their respective segments. DTx Pharma, HAYA Therapeutics, and AIxplorerBio have successively won awards. Keep reading for more details. Focus-X Therapeutics, a Viva Biotech Portfolio Company, Successfully Reached an Acquisition Agreement with Full-Life Technologies On Nov. 29, 2022, Focus-X Therapeutics (referred to here as "Focus-X"), a nuclide drug company that was invested in and incubated by Viva Biotech, successfully reached an acquisition agreement with Full-Life Technologies Co., Ltd. (referred to here as "Full-Life"). Under the terms of the acquisition, Full-Life will acquire Focus-X for US$245 million, including an upfront payment, potential development, regulatory, and sales-based milestone fees, and royalties on commercial sales. The acquisition is expected to close in the first quarter of 2023. When finished, this will be another pre-clinical acquisition of one of Viva's portfolio companies, after Dogma and Totient, which once again verifies the capabilities of project discovery and the professional post-investment support of Viva's investment team. Focus-X develops targeted radiopharmaceuticals to treat cancer based on its proprietary peptide engineering technology. They completed their angel round in the third quarter of 2020, which was led by Viva. In addition to financial support, Viva also provided Focus-X with comprehensive incubation services to help it realize the transformation from "concept to product." AIxplorerBio Won the "HCH Ventures Top Ten Overseas Talent Entrepreneurship Project" On November 28, AIxplorerBio, invested and incubated by Viva BioInnovator, was invited to participate in the 2022 Pudong New Area Innovation and Entrepreneurship Summit. Standing out from 300+ outstanding projects, AIxplorerBio won the "HCH Ventures Top Ten Overseas Talent Entrepreneurship Project." HCH2022 was co-hosted by Shanghai Association for Science & Tech, Pudong Technical and Economy Committee, and Zhangjiang Hi-tech Park Administrative Committee. AIxplorerBio continues to gather resources and talent advantages in the field of biomedicine and artificial intelligence in Pudong New Area and strives to accelerate the development of innovative drug R&D projects by introducing professional talents. BioCasting and Corning Life Sciences Build an in Vitro 3D Model of CAR-NK Cells Infiltrating a Tumor's Extracellular Matrix to Help Target and Kill Tumor Cells On November 22th, BioCasting-a company invested and incubated by Viva BioInnovator, announced jointly with Corning Life Sciences, and Olympus Microscopy the establishment of the "BioCasting Phenotypic Screening Platform Based on the Complex Disease Modeling and Bioimaging." All three companies will work together to build upyplatform. The screening platform will integrate BioCasting's complex disease modeling technology platform, Corning Life Sciences' high-quality biotechnology products, and global experience, and the excellent biological imaging solutions of Olympus Microscopy's to provide customers with the highest quality drug screening services. Aleta Biotherapeutics Receives Innovation Passport Designation for Biologic CAR T-Cell Therapy Engager ALETA-001 Aleta Biotherapeutics (Aleta), invested and incubated by Viva BioInnovator, is a privately held immuno-oncology company with novel biologic CAR T engagers that work in synergy with cell therapies to improve outcomes for patients. They announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) for Chimeric Antigen Receptor (CAR) T-cell therapy Engager candidate ALETA-001 for the treatment of patients suffering from the B-cell malignancies, non-Hodgkin lymphoma a (NHL) and Acute Lymphoblastic Leukemia (ALL), and who have failed to respond or have relapsed post-CD19 CAR T-cell therapy. ALETA-001 is expected to enter clinical development in 2023 with Cancer Research UK's Centre for Drug Development sponsoring and conducting a Phase 1/2a clinical trial. Exelixis and Cybrexa Therapeutics Establish Exclusive Collaboration Providing Exelixis the Right to Acquire CBX-12, a Potential First-in-Class Peptide-Drug Conjugate of Exatecan November 01, 2022 – ALAMEDA, Calif. & NEW HAVEN, Conn.–Exelixis, Inc. (Nasdaq: EXEL) and Cybrexa Therapeutics (Cybrexa), invested and incubated by Viva BioInnovator, announced that the companies have entered into an exclusive collaboration agreement providing Exelixis the right to acquire CBX-12 (alphalex exatecan), a clinical-stage, first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa's proprietary alphalex technology to enhance delivery of exatecan to tumor cells. CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase I inhibition by delivering exatecan, a highly potent, second-generation topoisomerase I inhibitor, directly to the tumor cells. This collaboration underscores Exelixis' commitment to expanding its clinical pipeline building upon its biotherapeutics and targeted drug therapy expertise. CBX-12 is composed of a pH-Low Insertion Peptide (pHLIP®), a linker and exatecan. As an antigen-independent therapy, CBX-12 may have broad utility in patients who are not eligible for antigen-targeted therapies, including monoclonal antibodies and antibody-drug conjugates (ADCs), and has potential for use in combination regimens with other anti-cancer agents and immunotherapies. DTx Pharma and HAYA Therapeutics are included in Clarivate's New "RNA Technology Companies to Watch" Report London, U.K., October 25, 2022: Clarivate Plc (NYSE:CLVT) announced the release of a new report called "RNA Technology Companies to Watch." The report comprehensively analyzes RNA companies' drug benefits, financing, and R&D activities to reveal emerging outstanding RNA companies in the medical field. Clarivate identifies seven innovators in the report, including DTx Pharma and HAYA Therapeutics, which are invested in and incubated by Viva BioInnovator. In addition, on November 13, Haya Therapeutics was awarded the "Seed-Stage Finance Raise of the Year" award at the European Lifestars Awards held by LSX. Domain Therapeutics to progress into clinical trials with its EP4R antagonist DT-9081 in solid tumors Strasbourg, France – Montreal, Canada, October 19th, 2022 – Domain Therapeutics ("Domain" or "the Company"), invested and incubated by Viva BioInnovator, a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs) in immuno-oncology (IO), announced that its proprietary IO candidate, DT-9081, has cleared its clinical trial applications (CTA) by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) in France and the AFMPS (Agence Fédérale des Médicaments et des Produits de Santé) in Belgium, enabling Domain to start its Phase I clinical trial. The first-in-human clinical trial is on track to initiate by the end of the year. Anji Pharmaceuticals and Population Health Partners Enter into Strategic Collaboration to Jointly Address High Prevalence Human Disease BOSTON, MA and NEW YORK – October 19, 2022 – Anji Pharmaceuticals, invested and incubated by Viva BioInnovator, and Population Health Partners announced that they have entered into a strategic collaboration, bringing together two complementary teams to jointly address high prevalence human diseases. The initial focus of the Anji/PHP collaboration is to accelerate development of the two lead clinical assets in Anji's pipeline. ANJ900 (delayed-release metformin) is an investigational agent currently in Phase 3 trials to enable safe use of metformin in Type 2 diabetes patients with advanced chronic kidney disease (CKD). ANJ908 (pradigastat) is a novel DGAT1 inhibitor which has completed a successful Phase 2 study in patients with chronic idiopathic constipation (NCT04620161). Triumvira Immunologics Announces Expansion of Cell Therapy Manufacturing Capabilities to Facility in South San Francisco and Previously Presents Initial HER2-Positive Solid Tumor Clinical Data at ESMO Austin, Texas, South San Francisco, and Hamilton, Ontario – October 19, Triumvira Immunologics ("Triumvira"), invested and incubated by Via Bio, a company focused on the development of novel, targeted autologous and allogeneic TCR-T Cell Therapeutics, a clinical-stage company focused on the treatment of solid tumors, announced a multi-year agreement with AmplifyBio to use its facilities in South San Francisco, California, to manufacture the company's pipeline of cell therapy candidates. Triumvira expects the facility to be fully operational by 2023. In September, Triumvira announced initial Phase 1/2 clinical data of TAC01-HER2 in HER2-positive solid tumors at the 2022 ESMO. The data showed that TAC01-HER2 was well tolerated in both dosing groups, and early signs of clinical activity were observed in the higher-dose group, with a disease control rate of 75%, including one partial ease. ABM Therapeutics receives IND approval by the FDA for MEK inhibitor ABM-168 and appoints Zane Yang, M.D. as Chief Medical Officer Shanghai, China / San Diego, USA, October 12, 2022 - ABM Therapeutics, invested and incubated by Viva BioInnovator, is biopharmaceutical company that focuses on small molecule research and development of novel drugs for the treatment of brain cancers. Recently, they announced that the U.S. Food and Drug Administration (FDA) has granted IND approval of ABM-168, a self-developed MEK1/2 inhibitor. This is also the second approved self-developed drug from ABM Therapeutics after ABM-1310. With this approval, ABM Therapeutics' upcoming Phase I clinical trial will recruit patients with advanced solid tumors, especially patients with concurrent brain metastases or primary brain tumors, aiming to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ABM-168 in such patients. On October 10, ABM Therapeutics announced the appointment of Dr. Zane Yang as the company's Chief Medical Officer (CMO) to lead the overall management of ABM Therapeutics. Dr. Yang will oversee the planning and execution of ABM's global clinical development strategies and participate in the creation and implementation of the company's business and development strategies. Dr. Yang has a rich professional and academic background with extensive experience in clinical research and development, as well as management. US FDA Approval of IND for Q-1801 by QureBio.Ltd SHANGHAI, China, Sep 24, 2022-- QureBio Ltd., invested and incubated by Viva BioInnovator, is a clinical-stage biopharmaceutical company focusing on bi-specific antibodies and other engineered bio-therapeutics for the treatment of cancer, inflammation, and other serious disorders. In September, they announced that the U.S. Food and Drug Administration has granted IND approval of Q-1801, a SIRPα/PD-L1 bi-specific antibody. Q-1801 is the first FDA-approved SIRPα/PD-L1 bi-specific antibody in the world. Approval of Q-1801, the second approved bispecific antibodies from QureBio.Ltd, has demonstrated its innovation capacity. About Focus-X Founded in 2020, Focus-X has developed a proprietary engineering platform to develop peptide radioligands that precisely deliver alpha or beta emitters to breakdown cancer cell DNA. The platform optimizes peptide radioligand vectors for key pharmaceutical attributes such as biodistribution, binding affinity, and in vivo stability. Such optimization can present significant challenges to other ligand targeting compounds such as antibodies. The company focuses on both validated targets and new mechanisms. About AIxplorerBio We are an AI-powered, structure-based drug R&D biotech company. We focus on the discovery and development of new medicines for immunological and neurodegenerative diseases. In the quest for the new medications, we are committed to creating a AI-powered, data-driven, structure-based, efficient drug R&D paradigm through introduction, cooperation and technological innovation. About BIOCAST Shanghai BIOCAST Co. Ltd ('BIOCAST') is a world leading Complex in vitro Model ('CIVM') solution provider. We offer biopharma/biotech clients high-quality disease-on-chip solutions, phenotypic image-based 3D assays and contract research services for their IND/NDA filling and internal Go/Not-Go decision. BIOCAST has a world-class team with an unmatched combination of imaging expertise, assay development experiences, 3D disease modeling and with the latest technologies and data analysis capabilities. We develop and implement one-stop CIVM solution to our clients, including phenotypic screening, MOA research, efficacy and toxicity study, translational medicine and biomarker discovery. About Aleta Biotherapeutics Aleta Biotherapeutics is an immune-oncology company with a portfolio and platform of novel off-the-shelf biologic CAR T engagers (CTEs) that work in synergy with cell therapies to improve outcomes for patients. Aleta's CTEs bridge CAR T-cell therapies to target multiple tumor antigens, binding to existing tumor antigens and changing the tumor antigen expression to match the CAR T receptor. Aleta's CTEs address the critical issues of tumor antigen loss, density and heterogeneity, which optimizes the potential for potent killing by separately administered cell therapies, including existing CAR19 T-cell therapies. About Cybrexa Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa investors include Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the standard of care in oncology. Cybrexa's robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are built on Cybrexa's alphalex™ technology platform, which enables intracellular delivery of highly potent anticancer treatments. Cybrexa is based in New Haven, Conn. and was founded in 2017. For more information about Cybrexa, please visit or follow us on LinkedIn and Twitter. About DTx Pharma DTx Pharma, Inc. is a privately-held biotechnology company based in San Diego, CA creating novel RNA-based therapeutics to treat the genetic drivers of disease. The company's proprietary delivery technology platform utilizes fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. In preclinical studies, DTx has demonstrated cellular uptake and broad activity of oligonucleotides in the retina, muscle, heart, neurons, T cells, and other specialized cell types. To learn more about DTx Pharma, 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 Domain Therapeutics Domain Therapeutics, a biopharmaceutical company operating in France and Canada, is dedicated to the discovery and development of new drug candidates targeting G Protein-Coupled Receptors (GPCRs), one of the most important classes of drug targets. The company focuses on developing high-value drug candidates to tackle GPCR-mediated immunosuppression in immune-oncology. About Anji Pharma Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients across the globe. Anji's asset-centric business model allows for speed and flexibility in building value, leveraging a clinical and regulatory core that operates with 'hub-and-spoke' efficiency. Anji has R&D expertise in Boston, Shanghai, and Berlin, and is preparing additional programs for early clinical development. For more info, visit . About Triumvira Immunologics Triumvira Immunologics, Inc. ("Triumvira") is a clinical-stage 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 headquartered in Austin, Texas with research facilities in Hamilton, Ontario. For more information, please visit . 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 QureBio Ltd. QureBio Ltd. is a clinical-stage biopharmaceutical company focusing on innovative biopharmaceuticals for urgent and unmet clinical needs, such as the treatment of refractory cancers, inflammation and other serious disorders. Founded by experienced scientists from the relevant fields, QureBio Ltd. has built up a series of proprietary technologies for engineered bio-macromolecules, including innovative platforms for bi-specific and tri-specific antibodies. SOURCE VIVA BIOTECH HOLDINGS / PORDA HAVAS

BOSTON & NEW YORK--(BUSINESS WIRE)-- Anji Pharmaceuticals and Population Health Partners today announced that they have entered into a strategic collaboration, bringing together two complementary teams to jointly address high prevalence human diseases. Anji Pharmaceuticals (‘Anji’) is an emerging global medicines company founded by CEO Dr. Brian Hubbard, who has led therapeutics discovery and development programs at the Broad Institute of MIT and Harvard, Merck, Novartis, and Millennium Pharmaceuticals. Anji co-founders also include CMO Dr. Dan Meyers, who has designed and led over 40 clinical trials; CSO Dr. Mike Serrano-Wu, who was part of discovery teams that identified daclatasvir, pradigastat, and 5 additional molecules which have reached clinical trials; and COO Dr. Yiwei Zong, an experienced investor and entrepreneur. Anji is progressing high potential late-stage clinical assets in Phase II and Phase III development. Population Health Partners (‘PHP’) is a global life-science investment firm founded by Dr. Clive Meanwell, who has led therapeutics development programs in his roles as Founder and CEO of The Medicines Company, and in a range of executive positions at Roche. Other Partners at PHP include Ian Read, former Chairman and CEO of Pfizer; Dr. Roy Berggren, former lead of McKinsey’s global Life Sciences practice; and Chris Cox, former head of Cadwalader Wickersham and Taft’s global corporate law practice. PHP will work with Anji to support their portfolio and to advise on strategic and operational matters as they advance clinical assets which have high potential to improve the lives and reduce the health burdens on millions of people with prevalent diseases and/or disease risk factors. “We’ve built Anji to be an agile asset-centric biopharma enterprise that can repeatedly unlock value of clinical programs where we see high validation and unmet need,” said Brian Hubbard, Ph.D., co-founder and CEO of Anji. “Teaming up with PHP is clearly one of those ‘1+1 = 3’ moments, where the deep skillsets of each will equip Anji to deliver life-changing medicines to patients even more quickly.” The initial focus of the Anji/PHP collaboration is to accelerate development of the two lead clinical assets in Anji’s pipeline. ANJ900 (delayed-release metformin) is an investigational agent currently in Phase 3 trials to enable safe use of metformin in Type 2 diabetes patients with advanced chronic kidney disease (CKD). Previous trials with ANJ900 demonstrated clinically meaningful glucose lowering with only one-third the plasma concentrations observed with currently marketed formulations of metformin. This finding points to the potential for expanded and improved treatment for CKD patients in whom metformin use is currently contraindicated. ANJ908 (pradigastat) is a novel DGAT1 inhibitor which has completed a successful Phase 2 study in patients with chronic idiopathic constipation (NCT04620161). This proof-of-concept study was performed across 25 clinical trial sites in U.S. and China and demonstrated the potential efficacy, safety, and dose range of pradigastat in patients who met the Rome IV criteria for constipation. Chronic idiopathic constipation affects nearly one in seven Americans, with nearly two million patients seeking pharmacotherapy options worldwide. Anji anticipates sharing preliminary results from the study later this year. “Anji has an extraordinary team – and an inspiring proven leader in Brian. Their ability to unpack the complexities of biology, chemistry, pharmacology, and clinical performance so that they can recognize high potential value and perform efficient drug development programs is highly impressive,” said Clive Meanwell, M.D., Chairman and Managing Partner of PHP. “We will put PHP’s knowledge and experience to work in order to help Anji create value, and produce a positive impact on prevalent diseases.” Locust Walk serves as an advisor to Anji and will work in concert with Anji and PHP to further the goals of the strategic collaboration. About Anji Pharma Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients across the globe. Anji’s asset-centric business model allows for speed and flexibility in building value, leveraging a clinical and regulatory core that operates with “hub-and-spoke" efficiency. Anji has R&D expertise in Boston, Shanghai, and Berlin, and is preparing additional programs for early clinical development. For more info, visit . About Population Health Partners, L.P. Population Health Partners, L.P. is a private equity firm committed to building great companies around important late-stage therapeutics and solving the health and economic challenges presented by prevalent diseases. While at The Medicines Company, leaders from Population Health Partners secured eight drug approvals involving 21 clinical trials and 91,000 randomized patients and were ranked #1 in the CNBC RQ 50 for biopharmaceutical R&D productivity. For more info, visit .