United Laboratories, Inc.

Pictured: Novo Nordisk's headquarters in Denmark/iStock, Ole Schwander At least 15 generic versions of Novo Nordisk’s top-selling weight-loss and diabetes drug semaglutide are being developed in China, potentially threatening the Danish pharma’s dominance in one of its major target markets, according to Reuters. Citing clinical trial records, Reuters noted that at least 11 of these upcoming competitors are in late-stage studies. The frontrunner, a gene engineering and biochemical drugs company called Hangzhou Jiuyuan Gene Engineering, announced that its developmental generic has achieved comparable efficacy and safety to Ozempic. The Chinese company announced in April 2024 that it had filed for approval for the candidate and is expecting a decision in the latter half of 2025. Semaglutide’s patent protections in China are set to expire in 2026, which could open the Chinese market up to these generic competitors. Aside from Hangzhou Jiuyuan Gene Engineering, several other companies are developing their own weight-loss candidates, including United Laboratories, Huadong Medicine and CSPC Pharmaceutical Group. However, Novo has mounted a legal effort to extend its patent in the country. The pharma is also challenging a previous patent ruling that found its protections over semaglutide to be invalid, according to Reuters. “Ozempic has witnessed unprecedented success in mainland China,” Karan Verma, healthcare research and data analyst at Clarivate, told Reuters. “With patent expiry so close, Chinese drugmakers are looking to capitalize (on) this segment as soon as possible.” Novo’s semaglutide is a GLP-1 receptor agonist that works by mimicking the GLP-1 hormone and activating its corresponding receptor, inducing the release of insulin from the pancreas in response to blood sugar levels. The drug won U.S. approval in December 2017 for type 2 diabetes as Ozempic, which was subsequently approved in China in 2021. In June 2023, the FDA signed off on the use of semaglutide for chronic weight management, for which it carries the brand name Wegovy. Novo is expecting a similar obesity indication in China this year. The impending Chinese generic semaglutide competition comes as Novo expands its footprint in China. In March 2024, the Danish pharma announced that it was pumping around $556 million, or ¥4 billion, in a sterile preparations expansion project. The investment will help Novo meet the demands of the Chinese market for its products, including Ozempic and Wegovy, while also boosting its global manufacturing capacity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Investors feature leading brain tumor venture philanthropy funds including the Brain Tumor Investment Fund (BTIF) and The Sontag Innovation The along with MEDA Angels, Varia Ventures and private investors. Investment catalyzed by positive results from Phase 2a study of SurVaxM in newly diagnosed glioblastoma (ndGBM) published in the Journal of Clinical Oncology. Funding will support the ongoing Phase 2b clinical study and subsequent registration-related initiatives. BUFFALO, N.Y., Jan. 9, 2024 /PRNewswire/ -- MimiVax, Inc., a biotechnology company focused on the development of SurVaxM, a survivin-targeted vaccine therapy for glioblastoma and other cancers, today announced new investments from the venture philanthropy arms of leading brain tumor patient organizations, VC, private and existing investors. Continue Reading MimiVax Announces New Investments to Support Clinical Development of SurVaxM in Glioblastoma Post this (PRNewsfoto/MimiVax, LLC) The investments from the Brain Tumor Investment Fund (BTIF), an affiliate of the National Brain Tumor Society (NBTS), the Sontag Innovation Fund, LLC, a subsidiary of the Sontag Foundation, the MEDA Angels, LLC, Varia Ventures and private investors will support the ongoing phase 2b clinical study, subsequent registration-related work and prepare the company for commercialization of SurVaxM for ndGBM. Glioblastoma is a rare but deadly cancer with median overall survival of only about 16 months. SurVaxM was developed to bring a paradigm shift to a field that has seen little advancement in decades. MimiVax is rapidly enrolling subjects in its SURVIVE trial [NCT05163080], a randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM among patients with ndGBM at 11 cancer centers across the USA. This follows the successful Phase 2a study published in the Journal of Clinical Oncology having met its primary endpoint, achieving a median overall survival (mOS) of 25.9 months – and further reporting that 41% of the patients receiving SurVaxM survived at least 3 years, with several long term progression-free survivors. Investment funding is designed to help MimiVax achieve its goal of revolutionizing the landscape of brain tumor treatment. "We are honored to receive significant investments from The Brain Tumor Investment Fund, The Sontag Innovation Fund, MEDA Angels, Varia Ventures along with our private investors. "Their confidence in our mission further propels our efforts to make a meaningful impact in the lives of those affected by brain tumors," said Michael Ciesielski, CEO, MimiVax, Inc. The Brain Tumor Investment Fund, known for its dedication to funding pioneering solutions in neuro-oncology, expressed enthusiasm about the partnership. "Brain tumor patients and caregivers desperately need better outcomes. The results seen in previous trials of SurVaxM make us optimistic for the SURVIVE Phase 2b trial and the potential for a new treatment on the horizon" said John Higgins, Managing Director of BTIF. The MEDA Angels, (part of the Tech Coast Angels (TCA) network) are a health-care focused investor group founded by physician, payers and scientist-angel investors, supported by a team of regulatory, reimbursement, legal and financial advisors. "We knew the grave unmet need for game-changing therapy for glioblastoma, a devasting brain cancer with so limited average survival time of 16 months. After review of MimiVax' approach, targeting a strong epitope and the data through their Phase 2a, we became confident they were well worth backing." -MEDA Angels The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is proud to have MimiVax as a portfolio company. "There is an extraordinary unmet need for new treatments that make a major impact in the brain tumor space. We are excited to play a role in the development of promising therapies like SurVaxM" said Scott Davis, Managing Director of the Sontag Innovation Fund. MimiVax extends its gratitude to The Brain Tumor Investment Fund, The Sontag Innovation Fund, MEDA Angels, Varia Ventures and our private investors for their support and confidence in the company's vision. This investment fortifies MimiVax's position as a key player in the quest for innovative solutions in the fight against brain tumors. About MimiVax, Inc MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. The Company was formed to develop and commercialize its lead candidate SurVaxM. For more information on MimiVax, visit or email [email protected]. About SurVaxM SurVaxM is a first-in-class, patented immunotherapy that targets survivin, a cell-survival protein. SurVaxM is delivered subcutaneously and stimulates a patients' own immune response to control tumor growth and prevent future disease recurrence. Because survivin is present in many forms of cancer, SurVaxM could potentially have wide therapeutic applicability. About the Brain Tumor Investment Fund The Brain Tumor Investment Fund (BTIF) is the non-profit venture philanthropy arm of the National Brain Tumor Society (NBTS), the largest patient advocacy organization in the United States committed to curing brain tumors and improving the lives of patients and families. BTIF BTIF) invests in innovative biotechnology, pharmaceutical, and medical device companies developing promising new treatment opportunities for patients with brain cancer. () About The Sontag Innovation Fund The Sontag Innovation Fund, a wholly-owned venture subsidiary of The Sontag Foundation, one of the largest private funders of brain cancer research in the United States, made the investment. The Sontag Innovation Fund invests in early stage and innovative technologies with the potential to drive cures and improve the quality of life or life expectancy for brain cancer patients. () About MEDA Angels The MEDA Angels are a healthcare-focused angel investor group that invests liberally across mid-seed and Series A healthcare opportunities: both disease management and prevention. Importantly, many startups see an investment by MEDA as validation of the merits of their technology, as potential users, and payer friendly products. () About Varia Ventures Varia Ventures is a next generation venture capital platform for professional organizations interested in building wealth for themselves and their members through investing in a portfolio of highly curated, emerging companies, originating from their organizations. Varia's platform blends insights from key opinion leaders, strategic partners, and industry experts through its "end-to-end" technology solution designed to support early stage companies while providing compelling investment opportunities to its investors. () SOURCE MimiVax, Inc.

PORTLAND, Ore.--(BUSINESS WIRE)-- EndoSound®, Inc., an Oregon-based medical device innovator developing technologies that enhance access, reduce cost, and increase the safety of endoscopic ultrasound (EUS) procedures, announced that the company received an investment from the American Gastroenterological Association (AGA), AGA’s new venture capital fund, GI Opportunity Fund 1. “AGA’s commitment to driving innovation expanded through our venture fund and we’re proud to support emerging companies, like EndoSound, that are transforming care for patients with digestive disease. Technology that can increase patient access to care and procedure safety while also lowering health care costs is truly exceptional,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. EndoSound was granted Food and Drug Administration (FDA) Breakthrough Device designation in July 2021. The EndoSound Vision System® (EVS®) is a disruptive EUS platform whose attachable transducer and supportive components transforms a conventional upper endoscope into a fully functional endoscopic ultrasound device. EUS is an imaging technology like CT, MRI and point of care ultrasound. It is critical to the diagnosis and treatment of a variety of benign and malignant diseases particularly those of the liver, gallbladder, and the pancreas. The cost of existing systems has limited the availability of this crucial modality in the United States and around the world. “As a practicing GI physician, the support of the AGA is an enormous validation for our mission,” says Stephen Steinberg, MD, CEO and President of EndoSound, Inc. “We were initially honored as winners of the AGA’s Tech Summit 2022 Shark Tank. This investment is an even greater testament to their belief in our team and technology. We could not be more pleased with a partner who shares similar values and a desire to provide the utmost innovative technologies to the GI community, its physicians, and their patients.” By eliminating the burden of cost, the EVS will provide physicians with a technological option that can enable care for their patients in a greater number of locations and settings. This brings the potential for enormous benefits to patients, payers, and providers by reducing costs in the healthcare system. The EVS is not cleared by the FDA. “We are excited to continue to build our fund’s portfolio of early-stage, high-growth GI companies with our recent investment in Endosound, a company with technology that converts any endoscope into an endoscopic ultrasound,” said Andrea Vossler, co-founder and managing director, Varia Ventures. About EndoSound EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms an upper endoscope into a fully functional EUS scope. It is comprised of an experienced team of scientists, engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market. About AGA The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice, and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. For more information, visit . The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. About Varia Ventures Varia Ventures is a next-generation venture capital platform for professional organizations interested in building wealth for themselves and their members through investing in a portfolio of highly curated, emerging companies originating from their organizations. Varia's platform blends insights from key opinion leaders, strategic partners, and industry experts through its "end-to-end" technology solution designed to both support early-stage companies while providing compelling investment opportunities to its investors. For more information, visit variaventures.com.