HONG KONG, October 30, 2024 /PRNewswire/ — Even in a constantly changing situation, technological innovation remains the most critical element for the long-term development of biopharmaceutical companies. This continuous innovation keeps companies current and drives R&D evolution and commercialization success. Recently, Viva Biotech portfolio companies received new updates. Keep reading for more details.
Seraxis Announces FDA IND Clearance for Clinical Study of SR-02 Islet Replacement for Type 1 Diabetes
October 15, 2024, Germantown, Maryland. Seraxis Inc., a clinical-stage regenerative medicine company invested by Viva BioInnovator (VBI), has received approval from the FDA for an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first pancreatic product candidate derived from reprogrammed stem cells cleared by the FDA for testing in humans as a potential functional cure for insulin-requiring diabetes.
Arthrosi Therapeutics and ApicHope Pharmaceutical Co-Developed Gout Treatment AR882 Achieves Promising Phase II Clinical Results China and achieved Fast Track designation by the FDA
According to ApicHope Pharmaceutical, Arthrosi Therapeutics, Inc. (“Arthrosi”), a portfolio company incubated by Viva Biotech, has achieved exceptional results in a Phase II clinical trial for the investigational gout treatment AR882. Developed in collaboration with ApicHope Pharmaceutical, this new Class I drug has shown promising results in the treatment of primary gout with hyperuricemia and has now entered Phase II clinical trials in China.
The phase II clinical trial mainly aimed to explore the optimal dosage of AR882 capsules to treat primary gout with hyperuricemia and to preliminarily evaluate the efficacy and safety of the drug. The primary endpoint was the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks of treatment. At week 6, AR882 demonstrated significant efficacy, with the 75 mg dose of AR882 showing superiority over febuxostat (P < 0.001). AR882 had an excellent safety profile, with no serious adverse events reported. Mild to moderate side effects observed included diarrhea, headache, and upper respiratory infections. Importantly, AR882 did not interfere with the management of patients' comorbidities, which remained stable throughout the trial.
On August 19Arthrosi Therapeutics announced that it has received Fast Track designation from the FDA for AR882 for the treatment of tophaceous gout.
Antag Therapeutics Announces FDA Authorization of Investigational New Drug (IND) Application for Lead Molecule AT-7687
Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the glucose-dependent insulinotropic polypeptide (GIP) receptor to launch new treatments for obesity and invested and incubated by Viva BioInnovator (VBI), announced that the Food and Drug Administration (FDA) of the United States has accepted its investigational new drug (IND) application for its lead molecule, AT-7687. This important milestone allows Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability and pharmacokinetics of AT-7687 in healthy lean and obese subjects. The study will also explore AT-7687 as monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals.
Cybrexa Therapeutics Announces First Patient Received CBX-12 Peptide-Drug Conjugate in Phase 2 Ovarian Cancer Trial
NEW HAVEN, CT. – October 7, 2024 – Cybrexa Therapeutics, invested in and incubated by Viva BioInnovator (VBI), a clinical-stage oncology biotechnology company developing a new class of peptide-drug conjugate (PDC) therapeutic treatments targeting tumors, announced that the first patient has been dosed in as part of a phase 2 treatment. clinical trial evaluating CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a first-in-class PDC that uses Cybrexa’s proprietary alphalex™ technology to enhance the delivery of exatecan, a recognized potent topoisomerase 1 (TOP1) inhibitor, directly to tumor cells while sparing healthy tissues . This trial launch follows promising Phase 1 results, which demonstrated broad activity of CBX-12 in ovarian, breast, non-small cell lung (NSCLC), thymic, gallbladder and colorectal, as well as a manageable safety profile.
Basking Biosciences doses first patients in phase 2 clinical trial of reversible thrombolytic BB-031 for treatment of acute ischemic stroke
Columbus, Ohio – September 10, 2024 – Basking Biosciences (Basking), invested in and incubated by Viva BioInnovator (VBI), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, announced that the first patients have been dosed in RAISE, a phase 2 clinical trial evaluating BB -031. in patients with acute ischemic stroke (AIS).
HAYA Therapeutics Announces Collaboration with Lilly to Discover Novel Regulatory Genomic Targets for Obesity and Related Metabolic Conditions Using a Proprietary RNA Platform
LAUSANNE, Swiss & SAN DIEGOHAYA Therapeutics, SA, invested in and incubated by Viva BioInnovator (VBI), a biotechnology company pioneering RNA-guided precision regulatory genome targeting therapies for chronic diseases, announced a multi-year agreement with Eli Lilly and Company to apply HAYA’s advanced RNA-guided technology. genome regulatory platform to support preclinical drug discovery efforts against obesity and related metabolic conditions. The partners will identify multiple genome-derived RNA-based regulatory drug targets to treat these chronic diseases.
Under the terms of the collaboration, HAYA will receive an upfront payment, including an equity investment, and is eligible to receive up to an aggregate amount 1 billion dollars in preclinical, clinical and commercial milestone payments, as well as royalties on product sales.
About Seraxis
Seraxis provides transformative therapies to the millions of people around the world who struggle with managing insulin-requiring diabetes and its associated life-threatening complications. Seraxis’ lead program, SR-02, is a novel islet replacement therapy for patients with insulin-requiring diabetes with concomitant immunosuppressive therapy. This therapy forms the basis of Seraxis follow-up therapies for patients without immunosuppression. Frazier Life Sciences, Polaris Partners, Eli Lilly and Company, T1D Fund and others are investors in Seraxis. Visit www.seraxis.com.
About Arthrosi
Arthrosi Therapeutics, Inc., headquartered in San Diego, Californiais focused on the development of AR882, a potentially best-in-class, highly potent and selective next-generation URAT1 inhibitor to reduce serum urate levels, flares and tophis in patients with gout. In the United States, an estimated 13 million people are diagnosed with gout and approximately 2 million of these patients have visible tophi. In Phase II studies, AR882 demonstrated encouraging efficacy and safety relative to standard of care (SOC), while Phase IIb results showed impressive success in complete removal of tophi. Arthrosi is currently advancing AR882 into Phase III clinical trials.
About Antag Therapeutics
Antag Therapeutics is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies for obesity and cardiometabolic diseases through GIP receptor antagonism. As a pioneer in exploring the potential of GIP receptor antagonists, the company is dedicated to advancing science and improving patient outcomes by delivering breakthrough solutions that address unmet medical needs. For more information, please visit hhttps://antagtherapeutics.com.
About Cybrexa Therapeutics
Cybrexa is a privately held clinical-stage biotechnology company pioneering antigen-independent, tumor-targeted peptide-drug conjugate (PDC) therapies. The company is led by a dynamic team of high-performing life sciences entrepreneurs and seasoned drug development scientists. Cybrexa’s mission is to create therapeutics that revolutionize the standard of care in oncology, and its robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are based on Cybrexa’s alphalex™ technology platform, which allows the intracellular delivery of very powerful anticancer treatments. Cybrexa is based in New Haven, CT and was founded in 2017. For more information, please visit www.cybrexa.com or follow us on LinkedIn and X.
About Basking Biosciences
Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to address the greatest need in acute thrombosis: a fast-acting, short-acting thrombolytic drug capable of reopening blocked arteries and whose activity can be quickly reversed if a problem arises. hemorrhagic complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be more safe, more effective and capable of significantly reducing and expanding the population receiving acute revascularization treatment.
About HAYA Therapeutics
HAYA Therapeutics is a precision medicines company developing programmable therapies targeting dark genome-derived regulatory RNAs, a cellular information processing unit, to reprogram diseased cellular states for a wide range of diseases, including cardiovascular and metabolic diseases and cancer. The company uses its innovative platform to gain new insights into the biology of diseased cellular states and the long non-coding RNAs (lncRNAs) that regulate them. HAYA’s lead therapeutic candidate is HTX-001, which is being developed for the treatment of heart failure. HAYA is also developing a pipeline of precision therapies targeting ncRNAs for cell-specific treatment of diseases in other tissues.
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SOURCE Viva Biotech