HONG KONG,Oct. 30,2024 -- 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 Biotech's portfolio companies have new updates. Keep reading for more details.
Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes
October 15,2024,Germantown,MD. Seraxis Inc.,a clinical stage regenerative medicine company invested by Viva BioInnovator (VBI),has received FDA's allowance of 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 reprogrammed stem cell-derived pancreatic product candidate allowed by 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 in China and Granted Fast Track Designation by the FDA
According to ApicHope Pharmaceutical,Arthrosi Therapeutics,Inc. ("Arthrosi"),a portfolio company incubated by Viva Biotech,has achieved outstanding results in a Phase II clinical trial for the investigational gout treatment AR882. Developed in collaboration with ApicHope Pharmaceutical,this Class I novel drug showed promising outcomes for treating primary gout with hyperuricemia and has now entered Phase II clinical trials in China.
The Phase II clinical trial primarily aimed to explore the optimal dosing of AR882 capsules for treating primary gout with hyperuricemia and to preliminarily assess the drug's efficacy and safety. The primary endpoint was the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks of treatment. By week six,AR882 demonstrated significant efficacy,with the 75mg dose of AR882 showing superiority over Febuxostat (P<0.001). AR882 exhibited an excellent safety profile,with no severe 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 19,Arthrosi Therapeutics announced that it received FDA Fast Track Designation for AR882 in Tophaceous Gout.
Antag Therapeutics Announces FDA Clearance 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 pioneer novel treatments for obesity and invested and incubated by Viva BioInnovator (VBI),announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule,AT-7687. This milestone enables Antag Therapeutics to initiate its Phase I clinical trial,which will evaluate the safety,tolerability,and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects. The study will also explore AT-7687 as a monotherapy and in combination with semaglutide,a GLP-1 receptoragonist,in healthy obese individuals.
Cybrexa Therapeutics Announces First Patient Dosed with First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Trial in Ovarian Cancer
NEW HAVEN,Conn. – October 7,2024 – Cybrexa Therapeutics,invested and incubated by Viva BioInnovator (VBI),a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide-drug conjugate (PDC) therapeutics,announced that the first patient has been dosed in a Phase 2 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 potent,established topoisomerase 1 (TOP1) inhibitor,directly to tumor cells while sparing healthy tissue. This trial initiation follows promising Phase 1 results,which demonstrated CBX-12's broad activity across ovarian,breast,non-small cell lung cancer (NSCLC),thymic,gallbladder,and colorectal cancers,along with a manageable safety profile.
Basking Biosciences Doses First Patients in Phase 2 Clinical Trial of Reversible Thrombolytic BB-031 for Acute Ischemic Stroke
Columbus,Ohio – Sept. 10,2024 – Basking Biosciences (Basking),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 presenting with acute ischemic stroke (AIS).
HAYA Therapeutics Announces Collaboration with Lilly to Discover Novel Regulatory Genome Targets for Obesity and Related Metabolic Conditions Using Proprietary RNA Platform
LAUSANNE,Switzerland & SAN DIEGO,HAYA Therapeutics,SA,a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics for chronic diseases,announced a multi-year agreement with Eli Lilly and Company to apply HAYA's advanced RNA-guided regulatory genome platform to support preclinical drug discovery efforts in obesity and related metabolic conditions. The partners will identify multiple regulatory genome derived RNA-based drug targets to address these chronic conditions.
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 $1 billion in pre-clinical,clinical and commercial milestone payments,as well as royalties on product sales.
About Seraxis
Seraxis is bringing transformative therapies to the millions of people worldwide struggling with the management of insulin-requiring diabetes and the associated life-threatening complications. Seraxis' lead program,SR-02,is a novel islet replacement therapy for patients of insulin-requiring diabetes with concurrent immunosuppression therapy. This therapy is the foundation of Seraxis follow-on therapies for patients without immune suppression. Frazier Life Sciences,Polaris Partners,Eli Lilly and Company,the T1D Fund and others are investors in Seraxis. Visit www.seraxis.com.
About Arthrosi
Arthrosi Therapeutics,Inc.,headquartered in San Diego,CA,is focused on developing AR882,a potentially best-in-class,highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels,flares and tophi in patients with gout. In the U.S.,an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. In Phase II studies,AR882 demonstrated encouraging efficacy and safety compared to standard of care (SOC),while Phase IIb results showed impressive success in the complete elimination 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 groundbreaking solutions that address unmet medical needs. For more information,please visit https://antagtherapeutics.com.
About Cybrexa Therapeutics
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 is on a mission 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 built on Cybrexa's alphalex™ technology platform,which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven,Connecticut and was founded in 2017. For more information,please visit www.cybrexa.comor follow us on LinkedIn and X.
About Basking Biosciences
Basking Biosciences,a clinical-stage biopharmaceutical company,was founded to solve the biggest need in acute thrombosis – for a rapid-onset,short-acting thrombolytic drug capable of reopening blocked arteries,and whose activity can be quickly reversed in the event of a bleeding 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 safer,more effective,and able to significantly expand the population receiving acute revascularization therapy.
About HAYA Therapeutics
HAYA Therapeutics is a precision medicines company developing programmable therapeutics targeting regulatory RNAs derived from the dark genome,a cell information processing unit,to reprogram pathological cell states for a broad range of diseases,including cardiovascular and metabolic diseases and cancer. The company is using its innovative platform to gain novel insights into the biology of disease cell states and the long non-coding RNAs (lncRNAs) that regulate them. HAYA's lead therapeutic candidate is HTX-001,in development for the treatment of heart failure. HAYA is also developing a pipeline of lncRNA-targeting precision therapies for the cell-specific treatment of diseases in other tissues.