Dynavax and Sinovac Partner to Develop COVID-19 Vaccine Candidate

BioSpace | April 16, 2020

California-based Dynavax Technologies has entered the race alongside Sinovac Biotech to develop a vaccine candidate against COVID-19. The two companies will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018. Dynavax’s CpG 1018 is the adjuvant used in its Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration in 2017. Earlier this month, Dynavax donated 10,000 doses of Heplisav-B to help protect healthcare professionals on the front lines of the COVID-19 response against hepatitis B, a deadly virus spread through contact with infected blood and bodily fluids, which can live on surfaces for at least seven days. The use of an adjuvant in a vaccine is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose. That will allow more vaccine doses to be produced, which therefore contributes to the protection of people. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which it has seen in Heplisav-B. CpG 1018 provides a well developed technology and a significant safety database, potentially accelerating the development of a coronavirus vaccine, the company said.

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INDUSTRIAL IMPACT

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp. | November 24, 2022

Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence. Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes. Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039. “We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.” Dr. Howard Verrico, CEO About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.

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INDUSTRIAL IMPACT

Gilead and MacroGenics Announce Oncology Collaboration to Develop Bispecific Antibodies

Gilead and MacroGenics | October 18, 2022

Gilead Sciences, Inc. and MacroGenics announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART® platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes. A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics. MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing. “MacroGenics’ bispecific expertise naturally complements Gilead’s portfolio strengths in immuno-oncology and our growing hematology franchise. We believe MGD024, with its potential to reduce CRS and permit intermittent dosing through a longer half-life, could translate to more patient-friendly dosing and enhanced clinical outcomes for people living with AML and MDS. This partnership is the latest in our efforts to develop and advance transformative new cancer therapies as we deepen our portfolio across oncology indications.” Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Development, Gilead Sciences Scott Koenig, MD, PhD, President, and CEO, MacroGenics said, “Rapid advances over the last decade have made CD123 a very promising target in oncology research. Advancing our bispecific DART molecule, MGD024, through a strategic collaboration with the team at Gilead will accelerate our ability to drive further development of MGD024 to the potential benefit of people living with blood cancers.” MacroGenics will be responsible for the ongoing Phase 1 study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points. The Phase 1 study will include a dose escalation segment and an expansion segment that is intended to evaluate MGD024 as monotherapy and in combination with other therapies across multiple indications. About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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CELL AND GENE THERAPY

Q² Solutions Launches Innovative Self-Collection Safety Lab Panel in Collaboration With Tasso

Q² Solutions and IQVIA, Tasso | October 07, 2022

Q² Solutions, a wholly owned subsidiary of IQVIA and a leading global clinical trial laboratory services organization, today announced the launch of the first self-collection safety lab panel for U.S. clinical trial participants by a leading global clinical trial laboratory. Developed in collaboration with Tasso Inc, a leader in clinical-grade blood collection solutions, this unique offering combines industry leading laboratory services, patient focused logistics and cutting-edge, self-collection technology. Participants in clinical trials can now provide a blood specimen for lab testing in the comfort of their own home, without the need to visit an investigator site or have a healthcare professional visit them. The first test panel available through this collaboration is designed to help monitor liver function by measuring the levels of select enzymes and proteins in the blood. The panel includes tests for ALT AST ALP total bilirubin, direct bilirubin, total protein, and albumin. “The global pandemic has accelerated the use of decentralized approaches in clinical trials. We at Q² Solutions are highly motivated to find ways to reduce patient burden related to laboratory testing, and I’m delighted that, through our collaboration with Tasso, we could make the self-collection liver panel a reality. Soon we will launch more than a dozen safety tests, and we are determined to continue to expand our catalog of tests available via the self-collection of blood.” Brian O’Dwyer, CEO of Q² Solutions “We are thrilled to be working with a leader like Q² Solutions on this important initiative to make laboratory testing truly patient-centric,” said Erwin Berthier, PhD, CTO and Co-Founder of Tasso. “Our clinical-grade remote sampling technology enables decentralized laboratory testing without sacrificing sample quality, a key hurdle that home testing has faced in the past. Together, Q² Solutions and Tasso are developing important solutions that make clinical trials better for both patients and sponsors.” This self-collection liver panel was developed with trial participants at the heart of the design. The offering includes easy to use at-home self-collection kits with instructions and videos, a methodology for direct-to-patient delivery, as well as simplified specimen processing and shipping requirements. About Q² Solutions Q² Solutions is a leading global clinical trial laboratory services organization that provides comprehensive testing, project management, supply chain, biorepository, biospecimen, and consent tracking solutions. Leveraging our next generation technologies, we deliver agile and precise services designed to meet the diverse needs of our clients. We provide scientific expertise and innovative solutions for ADME, bioanalytical, genomics, vaccines, and central laboratory services, including flow cytometry, anatomic pathology, immunoassay, molecular, companion diagnostics and translational science, with meticulous regional and global clinical trial implementation support and high-quality data delivery. At Q² Solutions, our work is rooted in research, grounded in collaboration, and guided by our passion to turn the hope of patients and caregivers around the world into the help they need. About IQVIA IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 82,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. About Tasso Trusted diagnostics made easy. Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time. Headquartered in Seattle, Washington, Tasso is privately held and funded by grants, investments, and co-development deals with various industry leaders.

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