Gilead Sciences, Inc. | August 05, 2022
Gilead Sciences, Inc. and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.
The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.
MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.
“The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.”
“We are excited to be joining Gilead. MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.”
Eliot Charles, Chairman of MiroBio
Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.
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, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California
CELL AND GENE THERAPY
Merck and Orna Therapeutics | August 17, 2022
Merck known as MSD outside the United States and Canada, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology.
Under the terms of the agreement, Merck will make an upfront payment to Orna of $150 million, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results. In addition, Orna will be eligible to receive up to $3.5 billion in development, regulatory, and sales milestones associated with the progress of the multiple vaccine and therapeutic programs, as well as royalties on any approved products derived from the collaboration. Orna will retain rights to its oRNA-LNP technology platform and will continue to advance other wholly owned programs in areas such as oncology and genetic disease. Merck will also invest $100 million of equity in Orna’s recently completed Series B financing round.
Orna’s proprietary oRNA technology creates circular RNAs from linear RNAs by self-circularization. oRNA molecules have been shown to have greater stability in vivo than linear mRNA and have the potential to produce larger quantities of therapeutic proteins inside the body. Newly synthesized oRNA molecules are more compactly packaged into custom lipid nanoparticles which Orna has engineered to target key tissues in the body. Preclinical data, including presentations at the 2022 American Society of Gene & Cell Therapy Annual Meeting, have demonstrated the potential of oRNA expression and delivery as an approach for further development in multiple areas, including vaccines and oncology therapeutics.
“This broad strategic collaboration brings together Merck’s significant expertise in nucleic acid biology, clinical development, and manufacturing with Orna’s compelling circular RNA technology to explore the opportunity to develop a new generation of potential vaccines and therapeutics. We look forward to working with the talented scientific and technical teams at Orna."
Fiona Marshall, senior vice president and head of discovery, preclinical and translational medicine at Merck Research Laboratories
“We are thrilled to collaborate with Merck, a company committed to breakthrough science, which has recognized the potential our platform can bring to patients. Our oRNA technology plus novel delivery solutions are designed to unlock the full potential of RNA in therapeutics and vaccines,” said Tom Barnes, Chief Executive Officer of Orna. “The combined expertise of Orna and Merck aims to accelerate the development of RNA therapeutics for patients in need of better treatment options.”
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
About Orna Therapeutics
Orna Therapeutics was founded on groundbreaking research by Alex Wesselhoeft, Ph.D., and Daniel G. Anderson, Ph.D. from MIT and built by MPM Capital and BioImpact Capital, an investment management affiliate of MPM. Orna’s proprietary circular RNA (oRNA) is engineered as linear RNA that self-circularizes. By taking a line and turning it into a circle, oRNA exhibits numerous advantages over traditional linear mRNA therapies such as simplified production, increased protein expression, and a superior immunogenicity profile. With proprietary lipid nanoparticles including those from Orna’s joint venture with ReNAgade Therapeutics, an RNA delivery company, our technologies expand the possibilities of what RNA therapeutics can achieve.
Thermo Fisher Scientific Inc. | August 23, 2022
Thermo Fisher Scientific Inc., the world leader in serving science, opened its largest single-use technology manufacturing site in Greater Nashville. The $105 million, 400,000-square-foot facility enables the company to help meet rapidly growing demand for the bioprocessing materials needed to produce vaccines and breakthrough therapies for cancer and other diseases. This new site is part of Thermo Fisher’s $650 million multi-year investment to expand its bioprocessing production capabilities.
“Customers depend on our best-in-class technologies, services and expertise. This continued investment in bioprocessing manufacturing allows us to better serve them in delivering greater supply through scalable solutions. As the largest single-use manufacturing site in Thermo Fisher’s network and one of the largest in the world, the Lebanon facility near Nashville enables customers to bring medicines to patients faster than ever before.”
Daniella Cramp, senior vice president and president, bioproduction, Thermo Fisher Scientific
The Lebanon facility will manufacture customizable, single-use BioProcess Containers and fluid transfer assembly systems that are in high demand by biopharma companies. The completed site will include 92,000 square-feet of clean room and will also include a dedicated line for the recently released Thermo Scientific DynaDrive™ Bioreactor. The site location is bringing critical materials closer to biopharma customers in the region, with Nashville among the top ten fastest-growing biotech hubs in the U.S.1
The Lebanon site currently employs approximately 300 people, and the completed facility will create 1,400 new jobs in roles across engineering, procurement, quality, warehousing, site leadership and more. This site is part of Thermo Fisher’s global bioprocessing supply network that expands across 100 countries to help ensure critical medicines reach patients. The Thermo Fisher network of sites have enabled more than 12 billion COVID-19 vaccine doses and partnered with customers to supply its technology and materials for many currently approved COVID vaccines and therapeutics.
“Tennessee’s strong business climate and thriving healthcare sector make our state the ideal location for a company like Thermo Fisher Scientific to thrive,” said Governor Bill Lee. “I thank Thermo Fisher for its decision to invest in Wilson County and create new jobs across the region so that Tennessee continues to lead the nation in innovation and opportunity.”
“Tennessee is emerging as a global leader in biotechnology, and new investment from Thermo Fisher Scientific will bring even more innovation to the region,” said Senator Marsha Blackburn. “This new facility will provide high-paying jobs to Tennesseans and create cutting-edge technology to keep our research and development communities thriving.”
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.