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Gilead Sciences to Acquire Mirobio

By MiroBio, Press Release
Press Release.

 

Acquisition Provides Gilead with MiroBio’s Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform

MiroBio’s Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead’s Inflammation Research and Development Strategy

Foster City, Calif. and Oxford, U.K., August 4, 2022 – Gilead Sciences, Inc. (Nasdaq: GILD) 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 (BTLA) 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,”

said Eliot Charles, Chairman of MiroBio.

“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.”

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.

Cowen is acting as financial advisor to Gilead. Centerview Partners is acting as financial advisor to MiroBio. Davis Polk & Wardwell LLP, Mayer Brown LLP, and Mishcon de Reya LLP are serving as legal counsel to Gilead and Goodwin Procter LLP and Wilson Sonsini Goodrich & Rosati are serving as legal counsel to MiroBio.

 

About MiroBio

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.

For more information on MiroBio, please visit the company website: www.mirobio.com

 

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.

 

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the transaction; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio’s product pipeline and successfully commercialize MiroBio’s products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead Contacts:

Jacquie Ross, Investors
investor_relations@gilead.com

Hayley Home, Media
Hayley.Home@gilead.com

MiroBio Contact:

Tom Donovan, Media
tom@tenbridgecommunications.com

MiroBio Continues Expansion of Executive Leadership Team with Key Appointments to Advance Development of Checkpoint Agonist Antibodies for Autoimmune Disease

By MiroBio, Press Release
Press Release.

 

  • Sanjay Keswani, MBBS, FRCP to join company as Chief Medical Officer bringing extensive experience in drug development and life sciences leadership
  • Lynne Murray, Ph.D., MBA appointed as Chief Scientific Officer after leading MiroBio’s R&D efforts since October 2020
  • Enhanced leadership team will support the clinical development of lead assets MB272 and MB151 and advance pipeline of checkpoint agonist antibodies designed to treat autoimmune disease

OXFORD, United Kingdom, March 8, 2022 – MiroBio, a biotechnology company advancing checkpoint agonist therapies to restore immune balance, today announced two key additions to its leadership team. Sanjay Keswani, MBBS has joined the company as Chief Medical Officer to lead clinical development activities and strategy, and Lynne Murray, Ph.D., MBA will assume the role of Chief Scientific Officer directing the advancement of MiroBio’s discovery platform.

“We are thrilled to have Sanjay and Lynne join MiroBio’s executive leadership team as we advance a potentially transformative therapeutic approach for patients suffering from autoimmune diseases,” said Dr. Carolin Barth, M.D., CEO of MiroBio. “MiroBio’s inhibitory receptor agonist approach represents a promising new mode of action for treating these complex diseases. With our enhanced leadership team, we look forward to moving our therapies into the clinic and delivering our ultimate goal of providing durable remission to patients with autoimmune diseases.”

Dr. Sanjay Keswani is an accomplished physician-scientist with broad R&D expertise in multiple therapeutic areas and is a former neurology faculty member at the Johns Hopkins Hospital as well as an elected Fellow of the Royal College of Physicians, United Kingdom. Dr. Keswani has held senior executive positions in the pharmaceutical industry, including at Roche, where he was Senior Vice President and Global Head of Neuroscience, Ophthalmology and Rare Diseases Research and Early Development, and most recently Annexon Biosciences, where he served as Executive Vice President and Chief Medical Officer. He has been instrumental in the development of multiple approved medicines, including Cymbalta, Aimovig, Emgality, Risdiplam and Faricimab. Dr. Keswani graduated in medicine at St. Bartholomew’s Hospital and holds a First-class Honors degree from St. Mary’s Hospital, London in molecular immunology. He completed his residency in neurology at Johns Hopkins, where he also ran a R01-funded neuroimmunology research lab.

Dr. Murray has served as Senior Vice President of Research and Development for MiroBio since October 2020 and brings substantial experience in the discovery and development of pharmaceuticals from preclinical to Phase 2 in both large pharmaceutical and small biotech environments. Prior to joining MiroBio she served as Head of Regeneration at AstraZeneca’s early respiratory & immunology department. Over her tenure, she led multiple large and small molecule programs and gained significant business development experience in the partnering & strategy department at AZ. Before this, she was Director of Pharmacology at a U.S.-based biotech, Promedior and also held a research position at Janssen, Philadelphia after her postdoc at UCLA. Dr. Murray received her MBA from Judge Business School of the University of Cambridge and holds a Ph.D. in immunology and pathology from Imperial College London. She is an author of numerous publications and patents.

Miro Bio’s pipeline is built on 15 years of foundational research and focuses on targets with the greatest potential in autoimmunity. The company’s lead program, MB272, targets the immune receptor BTLA and will undergo clinical research in 2022. MiroBio’s PD-1 agonist program, MB151, is progressing in preclinical development with clinical plans being developed for 2023.

About Checkpoint Agonist Antibodies

MiroBio is creating a new class of therapies for autoimmune disease: Checkpoint agonist antibodies. These therapies are designed to precisely restore a balanced immune response and prevent the body from attacking its own cells. Checkpoint pathways are powerful regulators of immune cell function. Each has its own role in specific types of immune cells and differing activity in disease. By selectively activating, or agonizing, the appropriate checkpoint receptor, MiroBio’s therapies can deliver a highly potent inhibitory signal to overactive immune cells without being broadly immunosuppressive.

About MiroBio (www.mirobio.com)

MiroBio is a biotechnology company advancing a new class of precision therapies designed to address the immune imbalance that drives autoimmune disease. Its proprietary drug discovery platform, I-ReSToRE, comprehensively evaluates inhibitory receptors for therapeutic potential and designs checkpoint agonist antibody candidates that precisely modulate immune signalling to restore health. MiroBio’s pipeline includes several candidates against validated and novel targets with potential in a variety of autoimmune diseases. MiroBio is based in Oxford, U.K.

For more information about MiroBio contact:

Ten Bridge Communications

TBCMiroBio@tenbridgecommunications.com

Dr. Carolin Barth Joins MiroBio as CEO to Lead Precision Immunology Company Focused on Checkpoint Agonist Antibodies

By MiroBio, Press Release
Press Release.

 

  •     Former Novartis executive to lead emerging biotech with a novel precision approach to autoimmune disease, supported by recent senior appointments
  •     MiroBio is exclusively focused on checkpoint agonists produced by its unique discovery engine that comprehensively maps inhibitory checkpoint signaling pathways
  •     Clinical initiation with BTLA agonist program anticipated in 2022 with a rich checkpoint agonist pipeline in earlier stages of development

Oxford, U.K. – 21 September 2021 – MiroBio, a biotechnology company advancing a new class of precision therapies designed to address the immune imbalance that drives autoimmune disease, today announced the appointment of Carolin Barth, M.D., as chief executive officer. Dr. Barth will lead MiroBio through the next major stage of its growth as its lead program, MB272, transitions into clinical development. Dr. Barth’s appointment follows other recent senior appointments to support operational expansion including Julian Hirst, formerly of Immunocore, as chief financial officer and Lynne Murray, Ph.D., formerly of AstraZeneca, as senior vice president of research & development.

MiroBio is uniquely focused on a new area of precision immunology using checkpoint agonist antibodies. Each of MiroBio’s candidates is designed to selectively activate a specific immune checkpoint pathway, with the goal of restoring immune homeostasisCheckpoint receptor pathways are powerful regulators of immune reactivity. Currently approved checkpoint inhibitor therapies use receptor antagonism to ‘take the brakes off’ the immune system to fight cancer. By contrast, MiroBio’s therapies are designed to specifically activate inhibitory checkpoint pathways through receptor agonism. This approach is intended to dampen the immune overactivity that drives immune-mediated inflammatory diseases and restore a balanced immune state. MiroBio’s most advanced program, MB272, targets the immune receptor BTLA and is readying for Phase 1 initiation in early 2022. A PD-1 agonist program, MB151, is also in preclinical development, followed by a growing pipeline of checkpoint agonist antibodies in earlier-stage development.

“It is the ideal time for Carolin to assume leadership of MiroBio,”

said Eliot Charles, Ph.D, executive chairman of MiroBio.

“The Company is approaching the clinic with an exciting pipeline that represents the most substantial portfolio in an important new class of autoimmune therapies. MiroBio has built its proprietary drug discovery and development engine to comprehensively evaluate the more than 70 inhibitory checkpoints for new drug programs. Carolin’s strategic mindset and wealth of experience in the successful development and commercialization of several ground-breaking therapies, particularly in the areas of immunology and autoimmune disease, will be invaluable as MiroBio seeks to deliver these promising new medicines to patients.  Together with MiroBio’s other recent hires, I am confident that the team is exceptionally well-suited to drive the Company’s next stages of growth and longer-term success.”

Dr. Barth most recently served at Novartis as global head of commercial and pipeline strategy, cell and gene. She held roles at Novartis of increasing responsibility over 17 years, including serving as global program head for several development programs and commercial launch leader in the areas of dermatology, rheumatology and chronic myeloid leukemia. As global head, dermatology she played an instrumental role in the development and commercialization of transformational antibody therapies such as COSENTYX and XOLAIR.

“I am very excited to join MiroBio – a company that stands out for its deep expertise, focus, and bold vision for delivering a new, better class of therapies for autoimmune disease. With its agonist antibody design expertise and unique approach to understanding both checkpoint pathway function and its potential in a wide variety of disease settings, I believe MiroBio can deliver several best-in-class new medicines that offer patients more efficacious and safer treatment options,”

said Dr. Barth.

“I look forward to working with the MiroBio team to continue building the entrepreneurial and patient-centric culture that will help us succeed through a critical phase of growth and development.”

MiroBio’s drug discovery engine combines proprietary discovery and development technologies with strategic mapping of the inhibitory signalling landscape across immune cell types and diseases. It builds on 15 years of deep foundational research at the University of Oxford and is designed to deliver best-in-class agonistic antibodies in addition to an unmatched understanding of inhibitory checkpoint pathways. MiroBio antibodies are uniquely designed to robustly agonize a specific immune checkpoint receptor. MiroBio’s pathway database is informed by a growing global collaborator network that allows the Company to catalogue diseased inhibitory receptor states which will inform the future selection of patient populations for clinical trial enrichment and highly targeted indications.

Dr. Barth’s appointment follows the recent appointments of other senior strategic leaders to oversee the financial and R&D functions of MiroBio. CFO Julian Hirst previously served as corporate finance director and head of investor relations at Immunocore where he played an instrumental role in raising over $930 million in three private rounds, a venture debt financing and an IPO. He previously spent over 20 years in investment banking including leading the European technology corporate finance team at UBS where he was a managing director. SVP of R&D Dr. Lynne Murray joined MiroBio from AstraZeneca where she was head of regeneration, early respiratory and immunology. Dr. Murray’s earlier roles at AstraZeneca were in the partnering & strategy department and as head of fibrosis biology at MedImmune, where she established MedImmune/AstraZeneca’s fibrosis pipeline that delivered multiple assets into the clinic.  Before that, she served as a director of pharmacology at Promedior and in R&D at antibody developer Centocor.

About Checkpoint Agonist Antibodies

MiroBio is creating a new class of therapies for autoimmune disease: Checkpoint agonist antibodies. These therapies are designed to precisely restore a balanced immune response and prevent the body from attacking its own cells. Checkpoint pathways are powerful regulators of immune cell function. Each has its own role in specific types of immune cells and differing activity in disease.  By selectively activating, or agonizing, the appropriate checkpoint receptor, MiroBio’s therapies can deliver a highly potent inhibitory signal to overactive immune cells without being broadly immunosuppressive.

MiroBio is comprehensively mapping the 70+ inhibitory checkpoint receptor pathways with its proprietary discovery engine, I-ReSToRE, to identify therapeutic opportunities for autoimmune disease. MiroBio’s antibody engineering capabilities and depth of expertise in inhibitory checkpoint signalling pathways are the foundation for its scientific leadership in this vast new area of precision immunology.

About MiroBio (www.mirobio.com)

MiroBio is a biotechnology company advancing a new class of precision therapies designed to address the immune imbalance that drives autoimmune disease. Its proprietary drug discovery engine, I-ReSToRE, comprehensively evaluates inhibitory receptors for therapeutic potential and designs checkpoint agonist antibody candidates that precisely modulate immune signalling to restore health. MiroBio’s pipeline includes several candidates against validated and novel targets with potential in a variety of autoimmune diseases. MiroBio is based in Oxford, U.K.

For more information about MiroBio contact:

Ten Bridge Communications

TBCMiroBio@tenbridgecommunications.com