VVN-539

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

HONG KONG, July 28, 2023 /PRNewswire/ -- In the face of ever-changing circumstances, technological innovation remains the eternal driving force behind the long-term growth of biopharmaceutical companies. It continuously breathes life into these enterprises, enabling them to successfully transition from concept to reality in research and development, and ultimately achieve commercial success. Recently, there have been exciting developments in Viva 's seven investment and incubation enterprises: DTx Pharma has reached an acquisition agreement with Novartis; Riparian has signed an exclusive licensing and research agreement with Pfizer; Arthrosi has completed a round of financing; AceLink, VivaVision Biotech, and Domain Therapeutics have all made significant strides in their respective research fields; and HAYA has appointed a new clinical advisory board chairperson. Riparian Pharmaceuticals Announces Exclusive License Agreement and Research Agreement with Pfizer for Novel Cardiovascular Programs WATERTOWN, Mass.-- Riparian Pharmaceuticals, a Viva Biotech portfolio company, is a biotechnology company focused on discovering novel therapeutics for cardiovascular diseases. Riparian today announced it has entered into an exclusive license agreement and research agreement with Pfizer. In exchange for exclusive rights to a Riparian preclinical program, Pfizer will make upfront and milestone payments, as well as pay royalties on sales of resulting therapeutics. As part of the research agreement, Pfizer will support Riparian's efforts to discover further drug targets leading to vasoprotection and will have an option on such targets. Dr. Zhixiong Ye, CSO of Viva Biotech, said, "Since September 2018, Viva Biotech has been investing and incubating Riparian, embarking on a long-term collaboration with their team in the discovery of novel targets, as well as compound design, synthesis, and testing. Leveraging our years of experience in First-in-class drug development and unique platform advantages, combined with our comprehensive one-stop service capabilities, we have supported Riparian in developing high-quality clinical drug candidates under the guidance of our seasoned team of scientists." DTx Pharma Reached the Acquisition Agreement with Novartis SAN DIEGO, July 17, 2023 -- DTx Pharma, invested and incubated by Viva BioInnovator (VBI), is a preclinical stage biotechnology company addressing the delivery challenges of oligonucleotide therapeutics with its Fatty Acid Ligand Conjugated OligoNucleotide (FALCON™) platform. DTx Pharma utilizes its groundbreaking FALCON™ platform, a conjugated oligonucleotide technology using fatty acid ligands, to tackle the delivery challenges of oligonucleotide therapies. According to the terms of the agreement, Novartis will provide an upfront payment of $500 million, with an additional payment of up to $500 million upon the achievement of specified milestones. The FALCON platform represents a significant advancement as it facilitates the delivery of small interfering RNA (siRNA) therapeutic drugs to tissues beyond the liver, enhancing their activity and enabling more effective biologic distribution and cellular uptake of siRNA drugs. Notably, DTx Pharma's lead pipeline candidate, DTx-1252, is currently undergoing preclinical development and has obtained FDA orphan drug designation for treating Type 1A Charcot-Marie-Tooth disease (CMT1A). In addition to the promising CMT1A project, Novartis will also gain exclusive rights to the FALCON platform and two other early-stage projects aimed at addressing neuro-muscular and central nervous system indications. Dr. Han Dai, CIO of Viva Biotech and head of Viva BioInnovator, stated, "We are thrilled to have been a part of DTx Pharma's growth story, supporting them from concept validation to preclinical research, and actively participating in multiple rounds of financing. This acquisition is yet another testament to the strategic foresight and expert post-investment support provided by Viva's investment team." Arthrosi Secures $75M in Series D Financing SAN DIEGO, July 11, 2023 -- Arthrosi Therapeutics, invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biotechnology company. Recently they announced the successful securing of $75 million in Series D financing. This round is led by Guangrun Health Industry (Hong Kong) Co. Limited and backed by a consortium of investors, including Reichstein Biotech (HK) Co. Limited, a subsidiary of ApicHope Pharmaceuticals. The participation of these notable investors underscores their continued confidence and commitment to the development of AR882. This financing represents another milestone in the development of AR882, a highly potent and selective next-gen URAT1 inhibitor delivered in a once-daily immediate-release oral capsule. AR882 has the potential to change the treatment paradigm for gout, addressing critical aspects such as serum uric acid (sUA) levels, flares, and tophi reduction. AceLink Therapeutics has been granted FDA approval to commence Phase 2 clinical trials of AL1211 for patients with Fabry disease. NEWARK, Calif. -- AceLink Therapeutics, Inc., a clinical-stage biopharmaceutical company incubated and invested by Viva BioInnovator (VBI), is working on the development of a next-generation oral substrate reduction therapy (SRT) to address significant unmet medical needs and improve the quality of life for patients with inherited glycosphingolipid metabolic disorders. On June 21st, the company announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate Phase 2 clinical trials for its leading project, AL1211. VVN539, a dual-target innovative drug for glaucoma independently developed by VivaVision, reached the primary research endpoint in the Phase II clinical trial in the United States Recently, VivaVision Biotech-an innovative ophthalmic drug company, which is invested and incubated by Viva BioInnovator (VBI), announced that its dual-target drug VVN539 has reached the primary study endpoint in the US phase II clinical trial for patients with open-angle glaucoma or ocular hypertension. Compared with the vehicle group, the 0.04% VVN539 dose group achieved statistical significance and clinical significance at all time points, and the intraocular pressure reduction range was about 5-6 mmHg. The 0.02% VVN539 dose group also achieved statistically significant reductions in IOP compared to the vehicle group at most time points. No significant treatment-related adverse events were observed in the study. Domain Therapeutics announces nomination of first-in-class PAR2 NAM candidate, DT-9045, to unlock new cancer treatment possibilities STRASBOURG, France, and MONTREAL, Canada, June 5, 2023 -- Domain Therapeutics ("Domain" or "the Company"), invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biopharmaceutical company developing innovative drug candidates in immunooncology targeting G Protein-Coupled Receptors (GPCRs). On June 5th, Domain announced the nomination of a drug candidate, a Negative Allosteric Modulator (NAM) of protease-activated receptor 2 (PAR2), DT-9045, with first-in-class potential for immuno-oncology, particularly for fibrotic tumors. Domain nominated DT-9045 as a first-in-class PAR2 NAM clinical candidate based on its added value, unique properties, and greater therapeutic potential in comparison to biologics targeting PAR2 currently in the clinic by several competitors. DT-9045 has demonstrated proof-of-concept efficacy in syngeneic models potentiating the antitumor activity of an anti-PD1 treatment. HAYA Therapeutics has named medical doctor Douglas L. Mann as the chairperson of clinical advisory board LAUSANNE, Switzerland, and SAN DIEGO -- On June 20th, HAYA Therapeutics, a precision medicine company incubated and invested by Viva BioInnovator (VBI), specializing in the development of targeted therapies for tissue and cell-specific long non-coding RNA (lncRNA), announced the appointment of Dr. Douglas L. Mann as the chairperson of clinical advisory board. Dr. Mann, a renowned expert in cardiology, clinical researcher, and cardiovascular investigator, joining the team is expected to accelerate the advancement of HAYA Therapeutics' heart failure candidate drug, HTX-001, towards clinical trials. About Riparian Pharmaceuticals Riparian Pharmaceuticals, Inc., is a privately held biotechnology company founded to discover drug targets and therapeutics that impact endothelial dysfunction and vascular inflammation. These two processes underly and drive several cardiometabolic diseases. Riparian has raised $6M in combined investment and research services from Viva Biotech and JMCR Partners, as well as support from research foundations including the National Institutes of Health and the Massachusetts Life Science Center. About DTx Pharma DTx Pharma, Inc. is a privately held biotechnology company, addressing the challenges associated with delivering RNA-based therapeutics beyond the liver with the company's proprietary Fatty Acid Ligand Conjugated OligoNucleotide (FALCON™) technology platform. The FALCON platform leverages fatty acids for enhanced biodistribution and cellular uptake to tissues and cell types throughout the body. In preclinical studies, FALCON siRNAs have demonstrated potent and durable repression of target genes in the peripheral nervous system (PNS), skeletal muscle, heart, skin, and CNS. FALCON siRNAs can be delivered by intravenous, subcutaneous, and intrathecal routes of administration and can be manufactured at a relatively low cost. The company has a pipeline focused on PNS, CNS, and neuromuscular diseases. DTx Pharma has raised more than $115M in combined investment from several of the world's leading healthcare investors including RA Capital Management, Access Biotechnology, Surveyor Capital (a Citadel company), Eli Lilly and Company, Friedman Bioventure, Viva Biotech Holdings, as well as support from research foundations including the CMT Research Foundation (CMTRF) and the National Institutes of Health. To learn more about DTx Pharma, please visit and follow DTx on LinkedIn and Twitter @DTxPharma. About Arthrosi 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 1 and Phase 2b data showing industry-leading efficacy rates and superior safety profiles. 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 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 Domain Therapeutics Domain Therapeutics is a cutting-edge biopharmaceutical company operating in both France and Canada, dedicated to discovering and developing innovative candidate drugs targeting G-protein-coupled receptors (GPCRs). GPCRs represent one of the most significant drug target classes today. The company＇s primary focus is on developing high-value candidate drugs to tackle GPCR-mediated immune suppression in the field of immuno-oncology. In early 2022, the company successfully raised 39 million euros to advance the development of these high-value candidate drugs. 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 Viva Biotech Holdings Established in 2008, Viva Biotech (01873.HK) provides one-stop services ranging from early-stage Structure-Based Drug R&D to commercial drug delivery to global biopharmaceutical innovators. We offer leading early-stage to late-phase drug discovery expertise by integrating our dedicated team of experts, cutting-edge technology platforms, and state-of-the-art equipment in X-ray crystallization, Cryo-EM, ASMS, SPR, HDX, CADD, and much more. Our business covers all aspects of therapeutic strategies and drug modalities, including small molecules and biologics across the pharma and biotech spectrum. The experienced chemistry team, led by senior medicinal chemists and drug discovery biologists, provides services for drug design, medicinal chemistry (hit to lead and lead optimization), custom synthesis, chemical analysis and purification, kilogram scale-up, peptide synthesis and corresponding bioassays. With our subsidiary, Langhua Pharma, we offer our worldwide pharmaceutical and biotech partners a one-stop integrated CMC (Chemical, Manufacturing, and Control) service from preclinical to commercial manufacturing. Additionally, Viva embedded an equity for service (EFS) model to high potential startups to address unmet medical needs. SOURCE Viva Biotech Holdings