GoldenBiotech's New Drug Antroquinonol Receives FDA Approval on COVID-19 Phase 2 Clinical Trial in USA

Golden Biotechnology Corp. | July 02, 2020

Golden Biotechnology Corp. (GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, announced that the FDA approved its investigational new drug (IND) application for a Phase II clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in USA. GoldenBiotech has also applied for the US BARDA (Biomedical Advanced Research and Development Administration) CoronaWatch meeting. Future developmental planning of Antroquinonol in COVID-19 include joining the COVID-19 Candidate and Technologies Portal of the National Institutes of Health (NIH) and applying for the US emergency authorization (EUA) once it exhibits significant clinical results, all to expedite the meeting of the urgent market demand. The Phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients, as measured by the proportion of patients alive and free of respiratory failure (i.e., need for invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or extracorporeal membrane oxygenation [ECMO]) on Day 14. Dr. Today Su, Chief Executive Officer at GoldenBiotech, stated, "At present, physician can only provide supportive care such as oxygen supplementation, mechanical ventilation, and/or extracorporeal membrane oxygenator (ECMO) based on the clinical symptoms of the patients or enroll them in available clinical trials. Clearly, new and more effective drugs are still in need to fight the pandemic. Thus, it is imperative to provide immediate and ample supply to the world should our study improve the efficacy of any newly authorized treatments recommended as standard of care (SoC) for COVID-19." Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus nor the overall survival rate. We can see that by far there is no single drug that can simultaneously fight against the COVID-19 virus (SARS-CoV2) and the symptoms induced. Combination therapies adopted by other clinical trials may solve the shortcomings of single-drug therapies with slightly better efficacy, but the higher risk of adverse effects is inevitable.

Spotlight

Executive Summary: Medication reconciliation is one of the most significant challenges facing healthcare organizations today. An inaccurate medication history can follow a patient throughout every encounter during a hospital stay and beyond. Even small errors can negatively affect outcomes, greatly harm patients, and drive up the costs of care. Unfortunately, medication reconciliation is a complex process, making efforts to capture and pass along an accurate medication history difficult for clinicians.


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MEDICAL

Ambagon Therapeutics Launches With $85 Million Series A to Advance Pioneering Molecular Glue Platform and Progress Pipeline

Ambagon Therapeutics | January 07, 2022

Ambagon Therapeutics, a biotechnology company unlocking intrinsically disordered proteins and other difficult-to-target protein classes, announced an $85 million Series A to augment its drug discovery platform and to advance its pipeline of molecular glues. The financing was led by Nextech Invest. Ambagon was previously seeded by RA Capital Management, Droia Ventures, Inkef Capital, AbbVie Ventures, MRL Ventures Fund, and Mission BioCapital. Investors from the seed round joined the A round, along with new investor Surveyor Capital. Many disease-relevant proteins have regions of intrinsic disorder that cannot be targeted by conventional small molecule drugs. Several thousand proteins with such intrinsically disordered regions have been identified that interact with the hub protein 14-3-3. In binding to a disordered protein region, 14-3-3 induces order, conferring druggability. By stabilizing naturally occurring 14-3-3:client interactions, Ambagon aims to rapidly develop novel therapeutic candidates for difficult-to-drug proteins. The pipeline currently focuses on oncology, where many opportunities exist to engage currently-undruggable targets. Ambagon was founded by world leaders in 14-3-3 biology and drugging protein-protein interactions: Michelle Arkin, Professor and Chair of Pharmaceutical Chemistry and co-Director of the Small Molecule Discovery Center at UCSF, Luc Brunsveld, Professor of Chemical Biology at the Eindhoven University of Technology (TU/e), and Ambagon Chief Technology Officer Christian Ottmann, Associate Professor of Molecular Cell and Structural Biology, TU/e. Ambagon’s seasoned leadership team includes Chief Executive Officer Scott Clarke, previously CEO of Tizona Therapeutics and Trishula Therapeutics, and Chief Scientific Officer Nancy Pryer, previously CSO at Day One Biopharmaceuticals and Chief Development Officer at Nurix Therapeutics. “Our deep understanding of 14-3-3 biology has broad applications for drug discovery as it opens up disordered protein regions as therapeutic targets. Combined with our proprietary structural insights, curated chemical library, and bespoke drug discovery tools, our experienced drug development team is well placed to bring forward new medicines addressing previously undruggable targets.” Scott Clarke “Ambagon’s modular approach for leveraging 14-3-3 biology to enable drug discovery is not just unique, but uniquely well-conceived,” said Melissa McCracken, Partner, Nextech Invest. “We are excited to see such an exciting platform translate into a very rich pipeline.” “We are proud to continue to support Ambagon as it works to create first-in-class and best-in-class drugs through targeted stabilization of protein complexes,” said Adam Rosenberg, Ambagon’s Chair and RA Capital Venture Partner. “Since our seed investment, the team has developed an impressive proprietary dataset and systemic understanding of 14-3-3 interactions. Ambagon truly has the potential to change the narrative for disordered targets.” About Ambagon Therapeutics Ambagon Therapeutics is a biotechnology company pioneering methods to unlock intrinsically disordered protein targets using small molecules. Ambagon applies deep knowledge of 14-3-3 proteins and a proprietary suite of drug discovery tools to create molecular glues that stabilize 14-3-3:target complexes. These molecular glue stabilizers amplify native biology to restore or inhibit target function, potentiate target activity, or promote or block target degradation. Ambagon’s initial focus is on oncology, with five programs in discovery. It has locations in San Carlos, California, and Eindhoven, the Netherlands. About 14-3-3 Biology Ambagon’s platform harnesses the biology of the regulatory hub protein 14-3-3, which reads serine/threonine phosphorylation. With more than 3000 client proteins reported, 14-3-3 has a vast interactome, enabling the manipulation of a broad range of biology across indications. In binding its clients, 14-3-3 imposes order on disordered client protein sequences, conferring druggability on otherwise undruggable proteins and protein regions. About the Modular Ambagon Drug Discovery Platform By selectively stabilizing the interaction between 14-3-3 and a 14-3-3 client protein, Ambagon can create first-in-class drugs addressing high value targets inaccessible by other means, particularly those with a high degree of disorder, including transcription factors, adaptor/scaffolding proteins, and RNA binding proteins.

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MEDICAL

NuclixBio Announces a Collaborative Research Agreement with PharmAbcine

NuclixBio | March 15, 2022

NuclixBio Inc., a South Korean biotech company that focuses on research and development of mRNA therapeutics, announced today that it has signed a Collaborative Research Agreement with PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics. Under the agreement, both companies will conduct collaborative research utilizing NuclixBio's proprietary circular mRNA platform named 'ringRNA™' to develop novel mRNA therapeutics that can generate PharmAbcine's antibodies. These novel therapeutics will express antibodies intracellularly to target human TIE2 receptors present on epithelial cells. The newly developed drugs based on circular mRNA can have a better therapeutic effect compared to conventional linear mRNA-based therapies due to the proven prolonged half-life of circular mRNA. The circular form of mRNA also allows ribosomes, the particles that function to synthesize proteins, to continuously circulate around the loop of mRNA to produce a greater quantity of polypeptides, including therapeutic antibodies. Thus, the elongated half-life and therapeutic efficiency can improve patient convenience in terms of drug administration routes and intervals. This partnership will give both parties an extraordinary opportunity to utilize advanced proprietary technologies and provide tremendous growth opportunities, We are thankful for this strategic partnership and are looking forward to developing breakthrough therapeutic approaches that can both expand our pipeline and help patients with unmet medical needs." Dr. Jin-San Yoo, CEO of PharmAbcine. The distinctive feature of our mRNA platform is that we circularize the linear precursor RNAs and make them into circular mRNAs. This method allows more desirable protein expressions in in vivo settings, with higher stability and efficiency. Our ringRNA™ can be used in a wide range of indications, We are thrilled to have entered this collaborative agreement with PharmAbcine, one of the leading antibody-based therapeutic companies. We hope our collaborative work will show many possibilities and result in the rapid development and expansion of the pipeline assets." Dr. Hoyoung Kang, CEO of NuclixBio. About PharmAbcine Inc. PharmAbcine is a clinical-stage biotech company focusing on the development of fully human antibody therapeutics to treat neovascular disorders, tumors, and other medically unmet diseases. It provides therapeutic antibodies for a wide spectrum of indications from oncology, immuno-oncology, ophthalmology, pulmonology, to renal pathology. PharmAbcine has its own HuPhage library and innovative selection system. PharmAbcine's advanced 3G expression system accommodates high levels of antibody production and steady reproducibility. With these cutting-edge technology platforms, it provides state-of-the art antibody generation services. About NuclixBio NuclixBio, Inc. is a pre-clinical stage biotech company focusing on early-stage research and development of intracellularly targeted nucleic acid therapeutics that are based on proprietary platform technologies. With its own circular mRNA platform ringRNA™, NuclixBio has established additional strong therapeutics platform such as Ribo-TaP™ and Ribo-grAb™, and is currently developing targeted oncology and immuno-oncology therapeutics assets.

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INDUSTRIAL IMPACT

MindMed Announces Transitions to Management Team

Mind Medicine (MindMed) Inc. | December 30, 2021

Mind Medicine Inc. a leading biotech company developing psychedelic-inspired therapies, announced that its Chief Technology Officer, Bradford Cross, has transitioned from his role. "On behalf of the Board of Directors and Executive team, I would like to thank Bradford for his contributions to the Company and wish him all the best in his future endeavors. We remain dedicated to advancing our pipeline and ongoing digital therapeutics platform forward under the leadership of MindMed Chief Medical Officer, Dr. Daniel Karlin. We enter 2022 well positioned both financially and strategically to continue on our mission to transform mental health treatment." Robert Barrow, Chief Executive Officer and Director of MindMed Additionally, Don Gehlert, PhD will be transitioning from his role as CSO and will continue as a Senior Scientific Advisor. Mr. Barrow added "Don has been and will continue to be an integral part of our organization. While this represents a change in his title, our entire team will continue to work closely with Don and benefit from his incredible breadth of experience in developing innovative CNS therapeutics." About MindMed MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed's approach to developing the next generation of psychedelic-inspired medicines and therapies. MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

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MEDTECH

BIO-ISAC and New York Metro InfraGard Membership Alliance Announce Partnership

NY Metro InfraGard | April 28, 2022

The Bioeconomy Information Sharing and Analysis Center (BIO-ISAC) and New York Metro InfraGard Members Alliance® (NYM-IMA) today announced a partnership to address threats unique to the bioeconomy and enable coordination among stakeholders to facilitate a robust and secure industry. BIO-ISAC is a critical resource for cyber threat detection, prevention, protection, response, recovery and resilience in the bioeconomy. It helps spur the development and evaluation of defensive tools to address ongoing and emerging threats, and includes vulnerability identification and mitigation, and education and outreach, aimed at reducing risk to the nation's biosecurity infrastructure. BIO-ISAC partnering with NYM-IMA advances our efforts to strengthen our resilience from attacks on the public and private bioeconomy infrastructure. We look forward to developing our collaboration to further enhance, maintain and implement best practices and standards to improve global digital biosecurity." Nina Alli, board member of BIO-ISAC. The bioeconomy is defined as economic activity driven by research and innovation in the life sciences and biotechnology and enabled by technological advances in engineering and in computing and information sciences. A National Academies of Sciences, Engineering, and Medicine report published in 2020 values the bioeconomy at more than 5 percent of U.S. gross domestic product, or more than $950 billion.* The digitization of life sciences has resulted in the emergence of a complex ecosystem plagued with cybersecurity challenges. We are privileged to collaborate with the BIO-ISAC, a team of exceptionally talented technologists. We support their efforts and share their commitment to safeguarding the cybersecurity of the bioeconomy. To protect our bioeconomy adequately, we must constantly assess the current threat landscape and our response capabilities. This collaboration broadens our aperture, and we believe it will have a significant impact." Jennifer Gold, president, NY Metro InfraGard. The bioeconomy spans multiple U.S. Critical Infrastructure sectors, including Health Care and Public Health, Critical Manufacturing, Food and Agriculture, Chemical, Energy, Government Facilities, Information Technology, Water and Wastewater, and the Defense Industrial Base Sectors. BIO-ISAC members are bioeconomy-connected industry leaders, organizations, and academic institutions connected to Biomanufacturing, BioPharma, BioProducts (synthetic bio), software and hardware vendors, national security, and agriculture. BIO-ISAC also acts as the convening place for trusted international partners to collaborate on digital biosecurity and biological supply chain security issues. InfraGard is a partnership between the Federal Bureau of Investigation (FBI) and members of the private sector for the protection of U.S. Critical Infrastructure. Through seamless collaboration, InfraGard connects owners and operators within critical infrastructure to the FBI, to provide education, information sharing, networking, and workshops on emerging technologies and threats. InfraGard's membership includes business executives, entrepreneurs, lawyers, security personnel, military and government officials, IT professionals, academia and state and local law enforcement—all dedicated to contributing industry-specific insight and advancing national security.

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Spotlight

Executive Summary: Medication reconciliation is one of the most significant challenges facing healthcare organizations today. An inaccurate medication history can follow a patient throughout every encounter during a hospital stay and beyond. Even small errors can negatively affect outcomes, greatly harm patients, and drive up the costs of care. Unfortunately, medication reconciliation is a complex process, making efforts to capture and pass along an accurate medication history difficult for clinicians.

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