Repertoire Immune Medicines, Inc.

COVID-19 mRNA vaccines have sparked interest in the potential of mRNA technology, but they have also put producers at the centre of licensing lawsuits. Credit: wacomka / Shutterstock. mRNA-based innovator pharmaceuticals have experienced a massive increase in licensing agreement deal values following success with the technology in Covid-19 vaccines, which helped to curtail the pandemic. Data and analytics provider GlobalData identified an 800% increase in deal values between 2019 and 2024 so far and has noted that key companies are continuing to invest heavily in the development of mRNA-based pharmaceuticals. GlobalData is Pharamceutical Technology’s parent company. However, recent lawsuits filed by GSK against mRNA vaccine producers Pfizer , BioNTech and most recently (15 October) Moderna , have put the licensing of mRNA-based pharmaceuticals in the spotlight. In its lawsuit, GSK has alleged the use of its technology without proper licenses. GSK is suing Moderna in two lawsuits regarding its mRNA vaccines: Spikevax for Covid-19 and mResvia for RSV. The British pharma giant alleges that Moderna ignored patents relating to lipid nanoparticles used in mRNA vaccine formulation technology. See Also: FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment Glaukos eyes FDA approval for ocular therapy after Phase III win It follows a similar lawsuit against Pfizer and BioNTech filed in April in which GSK alleges the companies were in violation of five patents relating to mRNA vaccine technology. Pfizer/BioNTech’s Covid-19 vaccine, known as Comirnaty, was approved by the FDA in August 2021 and was the first mRNA vaccine to enter the global market. It was followed by the approval of Moderna’s Spikevax in January 2022, although an emergency use authorization (EUA) had made Moderna’s vaccine available earlier. Ophelia Chan, business fundamentals senior analyst at GlobalData, has pointed to Covid-19 vaccines as a turning point for the mRNA sector. “The Covid-19 pandemic highlighted the key advantages of mRNA technology in vaccine development, including rapid production, precise immune targeting and streamlined manufacturing factors that drove the success of mRNA-based Covid-19 vaccines,” she said. mRNA Covid-19 vaccine sales declined significantly in 2023 compared to 2022. However, GlobalData reported that 2023 still saw Moderna’s Spikevax generate around $18.4bn in global revenue , while Pfizer and BioNTech’s Comirnaty generated around $42.4bn. Considering the reasons behind the jump in licensing deal values, Chan added: “Licensing agreement deal values for mRNA-based pharmaceuticals have doubled since 2023 , reaching $3.8bn as major players like GSK and Bristol Myers Squibb invest in mRNA therapeutics to address unmet medical needs.” In April, Bristol Myers Squibb entered into a multi-year, $1.87bn strategic collaboration with Repertoire Immune Medicines looking to develop mRNA-based tolerising vaccines. Meanwhile, GSK and Curevac contributed to the jump in licensing value in July, with a new licensing agreement worth up to $1.57bn. Beyond licensing, GlobalData also expects the sector to see growth across mRNA sales, predicting that the global sales of innovator mRNA-based drugs will rise from $22bn in 2023 to $26.2bn in 2030.

Chris Schade appointed as Board Chairperson Lynne Parshall, Robert Plenge, M.D., Ph.D., and Nancy Simonian, M.D., appointed to Board of Directors CAMBRIDGE, Mass., July 17, 2024 /PRNewswire/ -- Alltrna, a Flagship Pioneering company unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, today announced the appointment of Chris Schade, Growth Partner at Flagship Pioneering, as Chairperson of the Board, succeeding Noubar Afeyan, Ph.D., Co-Founder of Alltrna and Founder and CEO of Flagship Pioneering. In addition, Alltrna also announced the appointments to the company's Board of Directors of Lynne Parshall, founding Chief Operating Officer of Ionis Pharmaceuticals, Robert Plenge, M.D., Ph.D., Executive Vice President, Chief Research Officer and Head of Research at Bristol Myers Squibb, and Nancy Simonian, M.D., Founding CEO of Syros Pharmaceuticals. They join Board Directors Michelle Werner, Alltrna CEO and Flagship Pioneering CEO-Partner, and Lovisa Afzelius, Ph.D., MBA, Alltrna Co-Founder and Flagship Pioneering General Partner. "As a Co-Founder of Alltrna and Board Chairperson since 2018, I've been honored to guide Alltrna from ideation to platform creation to in vivo preclinical proof-of-concept," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder of Alltrna. "As Alltrna looks to bring its first tRNA medicines into the clinic, Chris' expertise in company development, partnering, and financing will be indispensable. With Chris leading the Board and the additions of Lynne, Robert, and Nancy, Alltrna is exceptionally well-positioned to fulfill this enormous opportunity leveraging the unique biology of tRNA to scale the development of genetic medicines for many diseases." "Noubar's extraordinary vision as Board Chairperson during Alltrna's critical formative years have brought us to our leadership position in the genetic medicines community today, and Chris's diverse experience and insights in helping grow biotech companies will be invaluable as we build on this momentum to pioneer tRNA medicine and further build Alltrna and its platform to support innovation and scale," added Michelle C. Werner, CEO of Alltrna and CEO-Partner of Flagship Pioneering. "I also look forward to working closely with Lynne, Robert, and Nancy and leveraging their extensive experience to advance our first universal medicine for Stop Codon Disease to the clinic." "I am honored to be Chairperson and look forward to continuing to work with Michelle and Lovisa at this pivotal time as Alltrna charts its path to clinical trials and beyond," said Chris Schade, Board Chairperson, Alltrna and Growth Partner, Flagship Pioneering. "With proof-of-concept in vivo data showing its platform can be leveraged to engineer and modify tRNAs for universal readthrough of a shared genetic mutation found in thousands of rare diseases, Alltrna is leading the field in turning tRNA's sophisticated biology into scalable genetic medicines. I am also thrilled to welcome Lynne, Robert, and Nancy to Alltrna's Board of Directors. Their diverse expertise spanning all aspects of drug development, from translational research to operations and strategy, will serve Alltrna well as the company advances this completely new class of RNA medicines." Christian S. Schade Mr. Schade has more than 30 years of private and public pharmaceutical and biotechnology industry experience, as well as broad corporate finance expertise from his tenure in investment banking. Prior to Flagship, he served as the Chairman and CEO of Aprea Therapeutics Inc. (NASDAQ: APRE), a clinical-stage biopharmaceutical company. Prior to Aprea, Schade's previous roles include CEO of Novira (acquired by Johnson & Johnson), Executive Vice President (EVP) and Chief Financial Officer (CFO) of Omthera Pharmaceuticals, Inc. (NASDAQ: OMTH, acquired by AstraZeneca Plc), EVP and CFO at NRG Energy Inc. (NYSE: NRG), and Senior Vice President of Administration and CFO at Medarex, Inc. (NASDAQ: MEDX, acquired by Bristol Myers Squibb). Before Medarex, Schade served as Managing Director at Merrill Lynch in London and held various corporate finance and capital markets positions in New York and London for both Merrill Lynch and JP Morgan Chase & Co. Schade currently serves as Chair of the Board of Directors of Omega Therapeutics, Inc. (NASDAQ: OMGA), and serves on the Boards of Ring Therapeutics, Valo Health, and Integra LifeSciences Inc. (NASDAQ:IART), where he chairs the Audit and Finance Committees. Lynne Parshall Ms. Parshall is a seasoned biotechnology leader with more than 35 years in industry. An attorney by training, she spent more than 30 years as the founding Chief Operating Officer of Ionis Pharmaceuticals and subsequently as a Strategic Advisor to the CEO, overseeing legal, finance, business development, portfolio management, strategic planning, manufacturing, regulatory, alliance management, and other functions. While at Ionis she was responsible for raising more than $6 billion in financing from equity-based securities and corporate partner transactions. Ms. Parshall has sat on numerous public and private company Boards of Directors and has extensive Audit Committee and corporate governance experience. She currently is on the Boards of Ionis Pharmaceuticals (NASDAQ: IONS), Cytokinetics (NASDAQ: CYTK), Foghorn Therapeutics (NASDAQ: FHTX), Ring Therapeutics, Repertoire Immune Medicines, and Celdara Medical. She was previously Chair of the Board of Akcea Therapeutics prior to its acquisition. Prior to working in industry, she was a partner at the Cooley law firm with a practice focusing on securities law and biotechnology corporate partnering. Robert Plenge, M.D., Ph.D. Dr. Plenge is Executive Vice President, Chief Research Officer and Head of Research at Bristol Myers Squibb (BMS). He leads scientific activities across eleven research sites around the world all focused on transforming patients' lives through science. Prior to his current role, Dr. Plenge served as head of Discovery & Translational Sciences at BMS, which spanned all therapeutic areas at the company. He joined BMS as part of the acquisition of Celgene in November 2019. At Celgene, he served as Vice President, Immunology & Inflammation portfolio, Research & Early Development. Prior to joining Celgene, Dr. Plenge was Vice President and Head of Translational Medicine at Merck. Prior to his roles in industry, he was an Assistant Professor of Medicine at Harvard Medical School and an Associate Member of the Broad Institute while practicing clinical rheumatology and running a research laboratory at Brigham & Women's Hospital. Dr. Plenge is an author of more than 125 manuscripts published in peer-reviewed journals and a recipient of several academic and corporate awards. He currently serves on the Board of Directors for the PhRMA Foundation. Nancy Simonian, M.D. Dr. Simonian is a physician-scientist who has dedicated her career to developing drugs for people with serious diseases. She is the Founding CEO and a member of the Board of Directors of Syros Pharmaceuticals, a biopharmaceutical company committed to advancing novel approaches to treating cancer based on altering gene expression. Prior to Syros, she was Chief Medical Officer at Millennium Pharmaceuticals and Vice President of Clinical Development at Biogen. At Millennium, Dr. Simonian oversaw the successful development of VELCADE® to treat multiple myeloma, and mantle cell lymphoma, NINLARO® to treat multiple myeloma and ENTYVIO® to treat inflammatory bowel disease. At Biogen, she played a central role in developing AVONEX® and TYSABRI® for multiple sclerosis. Dr. Simonian started her career as an assistant professor at Harvard Medical School and Massachusetts General Hospital. She currently serves as a Director of Syros (NASDAQ: SYRS) and the Damon Runyon Cancer Research Foundation. She previously served as a Director of Seagen (NASDAQ: SGEN; acquired by Pfizer in 2023), Evelo (NASDAQ: EVLO), and ArQule (NASDAQ: ARQL; acquired by Merck in 2020). About Stop Codon Disease Stop Codon Disease encompasses thousands of rare and common diseases that stem from premature termination codons (PTC) also called nonsense mutations, where the code for an amino acid has been mutated into a premature "stop" codon. This results in a truncated or shortened protein product with no or altered biological activity that causes disease. Approximately 10% of all people with a genetic disease have Stop Codon Disease, representing approximately 30 million people worldwide. Alltrna is engineering tRNA medicines that can read these PTC mutations and deliver the desired amino acid, thereby restoring the production of the full-length protein. About Alltrna Alltrna unlocks tRNA biology to treat disease. The company's platform incorporates AI/ML tools to develop and deliver diverse programmable molecules with broad therapeutic potential. Alltrna has an unprecedented opportunity to advance a single tRNA medicine to readthrough premature stop codons and unify treatment across a wide range of diseases with the same underlying genetic mutations. Alltrna was founded in 2018 by Flagship Pioneering. For more info, visit . About Flagship Pioneering Flagship Pioneering invents and builds bioplatform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $75 billion in aggregate value. To date, Flagship has deployed over $3.8 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 40 companies, including Foghorn Therapeutics (NASDAQ: FHTX), Moderna (NASDAQ: MRNA), Sana Biotechnology (NASDAQ: SANA), Generate Biomedicines, Inari, Indigo Agriculture, and Tessera Therapeutics. Media Contacts Jessica Yingling, Ph.D., Little Dog Communications Inc., [email protected], +1.858.344.8091 Josephine Zorbo, Ph.D., Flagship Pioneering, [email protected] SOURCE Alltrna

Pictured: 3d illustration of antibodies attacking virus cell in the bloodstream iStock/Christoph Burgstedt Immunology-focused biotech Santa Ana Bio announced Thursday that it has launched with a $168 million war chest to advance two of its programs into the clinic next year designed to treat inflammatory diseases. Founded in 2022, the Alameda, Calif.-based biotech emerged from stealth with both Series A and B financing rounds. Santa Ana’s $43 million Series A was led by founding investor Versant Ventures and included TPG’s Life Science Innovations fund and GV. The company’s $125 million Series B was led by GV and included new investors Andreessen Horowitz (a16z) Bio + Health, RTW and Access Biotechnology. Santa Ana plans to use a proteomic, transcriptomic and genomic approach to find disease-specific subpopulations with targets on “disease-causing cell types” only that aim to leave healthy cells unaffected. The approach seeks to address shortcomings in current biological treatment, such as heterogeneity, safety and durability. The company contends that the vast majority of biologics in autoimmune diseases target cytokines, which are the messengers for disease but not the root causes, while current treatments don’t discriminate between diseased and healthy tissues. The biotech is advancing three programs, including SAB01, which is bi-specific and blocks c-Kit only in the presence of an undisclosed anchor target. Santa Ana plans to start Phase I trials next year in chronic inducible urticaria, a common inflammatory skin condition that causes itchy bumps. Santa Ana plans to advance other candidates, including SAB03, which agonizes PD-1 and is intended to suppress high, medium and low-expressing PD-1 pathogenic T cells. Phase I testing will also start next year in a variety of severe inflammatory conditions. The startup also has an antibody-drug conjugate (ADC) program, dubbed SAB05, which uses a novel technology for antibody-glucocorticoid conjugates, with this approach designed to safely harness the therapeutic effect of glucocorticoids with the goal of not causing any collateral damage associated with the drugs. However, Santa Ana did not provide a timeline for when this asset will enter clinical testing. “Precision medicines offer the ability to target defined cell types and pathways to disrupt the pathogenic biology driving disease,” Santa Ana CEO Peter Emtage said in a statement. “By identifying pathogenic cell types and pathways, and leveraging our deep protein engineering capabilities including monoclonal, bi-specific antibodies and ADCs, we aim to expand the reach of biologics to patients across numerous inflammatory diseases.” Santa Ana has emerged from stealth as the immunology and inflammatory (I&I) space continues to heat up. Biogen purchased Human Immunology Biosciences in May 2024, paying $1.15 billion upfront and $650 million in potential milestones. The deal adds candidates for treating IgA nephropathy (IgAN) and primary membranous nephropathy (PMN) to Biogen’s pipeline. In April, Vertex Pharmaceuticals acquired Alpine Immune Sciences for $4.9 billion and Bristol Myers Squibb inked a $1.8 billion, multi-year collaboration with Repertoire Immune Medicines. The global immunology market is projected to grow from $103.2 billion in 2024 to $257.4 billion by 2032. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.