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BRISBANE, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing novel complement therapies for neuroinflammatory diseases of the body, brain, and eye, today announced the strengthening of its senior leadership team with the appointment of Shikhar Agarwal, M.B.A. as senior vice president, head of commercial, Sunil B. Mehta, Pharm.D as senior vice president of medical affairs and Myoung Kim, PHD, M.A., M.B.A. as vice president of health economics and outcomes research. “We are excited to welcome Shikhar, Sunil and Myoung to the Annexon family as we prepare for commercial development of our flagship programs in Guillain-Barré Syndrome (GBS) and geographic atrophy (GA),” said Douglas Love, president and chief executive officer of Annexon. “Attracting strong talent with extensive experience in developing winning product strategies and leading some of the most successful immunology product launches to-date is a win. These leaders will help Annexon to realize the significant market opportunities for our first-in-kind product candidates and allow us to achieve our mission of aiding millions of patients that are impacted by devastating neuroinflammatory diseases.” Shikhar Agarwal, M.B.A. is a seasoned leader with over 20 years in pharmaceutical marketing, market access, sales and commercial operations, and a track record of successfully leading portfolio strategy, organization build and product launch execution across therapeutic areas. Prior to joining Annexon, he was vice president, head of marketing at argenx SE, where he led the launch of VYVGART® in Myasthenia Gravis and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), delivering $400 million in first year revenue and achieving blockbuster status in second year of launch amidst multiple competitive launches. Prior to that he held commercial roles of increasing responsibility at Amgen Inc. across market access, marketing, sales and market research. Early in his career, he worked as a senior consultant at Proxicom, Inc., where he developed commercial and analytical solutions for Fortune 500 clients. Mr. Agarwal holds an M.B.A. from UCLA Anderson School of Management, and a B.S. from St. John’s College in Agra, India. Sunil B. Mehta, Pharm.D. brings 20 years of medical affairs experience including successfully building and leading U.S. and global medical affairs teams and infrastructure for product launches and fostering strong relationships with key opinion leaders across multiple therapeutic areas, including nephrology, hematology, rare neurological and autoimmune disorders. Prior to joining Annexon, he served as vice president and head of medical affairs at argenx where he successfully built and led highly competent medical affairs teams through the launches of VYVGART in Myasthenia Gravis and CIDP. For almost a decade Dr. Mehta also held various roles of increasing responsibility at Alexion in medical affairs and built the U.S. medical affairs teams in preparation of Myasthenia Gravis and neuromyelitis optica spectrum disorder launches. Prior to Alexion, he worked at Amgen in medical affairs roles of increasing responsibility. Dr. Mehta holds a Pharm.D. degree from Rutgers University. Myoung Kim, Ph.D., M.A., M.B.A. brings over 25 years of experience in health economics and outcomes research (HEOR) and observational research. Prior to Annexon, Dr. Kim was vice president and head of U.S. HEOR, real world evidence and population health at Novartis, where she led office- and field-teams spanning the entire portfolio. Prior to that she served a similar role as vice president of real-world value and evidence at Janssen Pharmaceuticals where she led value evidence generation and communication across the Janssen portfolio. Early in her career she also held increasing roles of responsibility at J&J Medical Devices and held positions at Bristol-Myers Squibb, Bayer Corporation, and Merck & Co. Dr. Kim holds a Ph.D. and an M.A. in health economics and policy from The Wharton School at the University of Pennsylvania. She also earned an M.B.A. of international business from the University of South Carolina and a B.A. from Seoul National University in Seoul, South Korea. About Annexon Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and Geographic Atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring their potential treatments to patients as quickly as possible. To learn more visit annexonbio.com .

enGene, Inc., a clinical-stage biotechnology company mainstreaming gene therapy through its novel platform for the delivery of therapeutics to mucosal tissues and other organs, today announced the appointment of Richard Bryce, MBChB, MRCGP, MFPM as its Chief Medical Officer, effective September 19, 2023. Dr. Bryce will oversee the clin­i­cal develop­ment of EG-70, enGene's lead product candidate for non-muscle invasive bladder cancer (NMIBC), as well as the devel­op­ment strat­e­gy for enGene's ther­a­peu­tic pipeline of tissue-targeted non-viral gene therapies. "We are thrilled to have Dr. Bryce join enGene during a pivotal period in our growth as we advance our Phase 1/2 registrational LEGEND study for EG-70 in NMIBC," said Jason Hanson, CEO of enGene. "We believe that the potential efficacy and ease of administration of EG-70 could transform how NMIBC is managed, and Dr. Bryce's extensive track record advancing oncology therapeutics through late-stage trials and approval makes him well positioned to lead this program, while also leveraging our Dually Derivatized Oligochitosan (DDX)® platform to expand our pipeline." Before joining enGene, Dr. Bryce was most recently Chief Medical Officer at Rain Oncology, a late-stage company developing precision oncology therapeutics, where he built a clinical development team and oversaw multiple clinical studies, including a global Phase 3 registrational study in dedifferentiated liposarcoma. Prior to that, he was Chief Medical & Scientific Officer at Puma Biotechnology, where he led the development strategy for neratinib. His leadership of this program resulted in FDA, EMA and multiple other global approvals, a diverse clinical development program, and an active translational program with several hundred scientific and clinical publications during his tenure. Earlier in his career, Dr. Bryce was Senior Director of Clinical Science for Onyx Pharmaceuticals, where he oversaw the Phase 3 registrational studies for carfilzomib. "I am excited to join the enGene team and share in its relentless focus on patient needs and dedication to the translation of innovative science into practical non-viral genetic medicines," said Dr. Bryce. "I believe EG-70 has the potential to change the treatment paradigm for NMIBC patients and clinicians, and I look forward to advancing the pivotal LEGEND study and expanding our pipeline of non-viral genetic medicines." Dr. Bryce obtained his Bachelor of Medicine and Bachelor of Surgery (MBChB) Degrees from the University of Edinburgh and is certified in the EU in primary care/general practice and pharmaceutical medicine. He holds numerous postgraduate specialist clinical qualifications including those from the Royal College of Obstetricians & Gynaecologists (RCOG) and the Royal College of Physicians (RCP). He also served as a Surgeon Lieutenant Commander in the Royal Navy.

MYTHIC THERAPEUTICS ANNOUNCES APPOINTMENT OF GILLES GALLANT BPHARM PHD POPQ AS CHIEF DEVELOPMENT OFFICER

VIRACTA THERAPEUTICS CSO, ELGUINDY ELECTED TO THE GOVERNING BOARD OF THE INTERNATIONAL ASSOC. FOR RESEARCH ON EPSTEIN-BARR VIRUS AND ASSOCIATED DISEASES

Appia Bio Appoints Margo Roberts, Ph.D. to its Board of Directors and Names Jason Damiano, Ph.D. as Chief Scientific Officer

SAN DIEGO, Aug. 16, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced the appointments of Flavia Borellini, Ph.D., and Jane F. Barlow, M.D., MPH, MBA, as independent members to Viracta's Board of Directors. "We are very pleased to welcome both Dr. Borellini and Dr. Barlow, two accomplished industry leaders with proven track records to the Viracta Board," said Roger J. Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. "Their collective experience in corporate strategy, oncology drug development and navigating the regulatory landscapes, in addition to their deep commercial and pricing experience, will be invaluable as we position Viracta for long-term success in new oncology modalities. We look forward to their guidance and contributions to our future initiatives." Dr. Borellini commented, "It is an honor to be a member of Viracta's Board. The Company has shown impressive clinical data and possesses a unique therapeutic approach with the potential to address unmet needs across multiple indications. I look forward to working with the fellow directors to provide valuable insights and counsel to the company's management team." Dr. Barlow added, "This is an exciting time for Viracta, and I am thrilled to be joining the Board. The company's EBV-positive lymphoma program has advanced into an innovative pivotal trial, while its solid tumor program is poised to enter the clinic later this year. It also has a strong financial foundation and the backing of a premier group of institutional and healthcare-focused investors, which I believe positions the company well for sustained success." Appointee Bios Flavia Borellini, Ph.D. , has more than 25 years of executive management experience in the pharmaceutical and biotechnology industry, with a particular focus on global development of targeted oncology drugs, from preclinical to commercial stage. She is the former Chief Executive Officer for Acerta Pharma, where she oversaw the successful development and approval of Calquence® (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia (CLL). During her career, Dr. Borellini has also held key senior level positions within AstraZeneca, most recently Global Franchise Head, Hematology, with responsibility for the hematology portfolio in the company's oncology business unit. While at AstraZeneca, she led the global development, approval, and commercialization of Tagrisso® (osimertinib), a first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for the treatment of non-small cell lung cancer (NSCLC) caused by the T790M mutation. Prior to her tenure with AstraZeneca, Dr. Borellini spent nearly seven years at Genentech, a member of the Roche Group. During this time, she led the global development, approval and launch of Zelboraf® (vemurafenib), a first-in-class BRAF inhibitor for the treatment of melanoma caused by the V600E BRAF mutation. Dr. Borellini also served as the program leader for Herceptin® (trastuzumab), a targeted treatment for HER2 receptor positive cancers, including breast cancer, and Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor for the treatment of NSCLC and pancreatic cancer. Dr. Borellini also serves on the Board of Directors of Kartos Therapeutics, Cantargia AP, and Revolution Medicines. Jane F. Barlow, M.D., MPH, MBA , is currently the Chief Executive Officer of Jane Barlow & Associates, LLC and a Board Director for ContraFect Corporation. She is Executive Vice President and Chief Clinical Officer at Real Endpoints, a market access consultancy, Senior Advisor to MIT's Center for Biomedical Innovation and serves on the biotech advisory board of Pictet Asset Management. Prior to her current roles, she was Associate Chief Medical Officer at CVS Health and Chief Medical Officer of CVS Health Government Services where she successfully implemented industry-leading clinical strategies supporting drug purchasing, distribution, and utilization management. Formerly, she served as Vice President of Clinical Innovation at Medco Health Solutions, leading the adoption of cutting-edge therapeutic programs through all aspects of pharmacy. Dr. Barlow has extensive experience in steering pharmaceutical development and commercialization by strategically weighing the value and economic impact that drug candidates bring to the healthcare ecosystem at large. Dr. Barlow previously served on the boards of Momenta Pharmaceuticals, Inc. (prior to and during its sale to Johnson and Johnson), TherapeuticsMD Inc., and SilverScript Insurance Company. Dr. Barlow received her medical degree from Creighton University School of Medicine and subsequently completed her residency in occupational and environmental medicine at The Johns Hopkins University, where she also earned her MPH She is a distinguished graduate of the United States Air Force School of Aerospace Medicine and served as Chief of Flight Medicine at the Beale and Maxwell Air Force Bases. Additionally, she holds an MBA from the University of Alabama. She is board-certified in occupational medicine and a fellow of the American College of Occupational and Environmental Medicine and the American College of Preventive Medicine. She is a diplomat of the American College of Physician Executives and a member of the American Medical Association. About Viracta Therapeutics, Inc. Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in two Phase 2 clinical trials for EBV-positive lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers. For additional information please visit www.viracta.com.

Diagnostic Industry Veteran Plans Immediate Start SAN DIEGO, Oct. 21, 2020 /PRNewswire Biocept, Inc . (Nasdaq: BIOC ), a leading commercial provider of molecular diagnostic tests and services, announces the appointment of Samuel D. Riccitelli to its Board of Directors, effective immediately. Mr. Riccitelli is joining the Board ahead of the planned retirement of Bruce A. Huebner, who will retire from the Biocept Board of Directors on November 30, 2020. Mr. Riccitelli brings to Biocept extensive experience in the molecular diagnostics industry, having served in executive-level positions and on the Boards of multiple publicly traded companies. At Biocept, he will initially serve on the Audit Committee and the Science and Technology Committee. "Sam's proven success with high-growth diagnostics companies, strong knowledge of the public equity markets and extensive corporate governance experience make him a welcome addition to our Board. We expect Sam will make significant contributions toward achieving our strategic growth initiatives and opening new opportunities as we build upon our position as a leader in molecular diagnostics and continue to rapidly grow," said Biocept Chairman David F. Hale. "We very much appreciate the many contributions Bruce has made as a valued member of our Board for the past seven years, consistently bringing to Biocept keen insights in diagnostics sales, marketing and reimbursement. We wish him well in his retirement." "This is an exciting time to join the Biocept Board as liquid biopsy moves toward the goal of becoming standard of care and the company is experiencing rapid growth with its infectious disease offering," said Mr. Riccitelli. "I see a substantial opportunity for Biocept and its proprietary Target Selector™ technology to play an ever-increasing role in improving clinical outcomes for patients. I look forward to working with the team in advancing Biocept's programs and delivering value to stockholders." Mr. Riccitelli has been in the healthcare industry for more than 35 years. He currently serves as an independent consultant to healthcare companies and is a Director of OrthoPediatrics Corp. (Nasdaq: KIDS ), a company focused on the orthopedic implant needs of children. He previously was Chief Executive Officer of Pathnostics, LLC, a molecular diagnostics company focused on improving antibiotic stewardship. Prior to that, he served as Chairman of Precipio, Inc., a publicly traded diagnostic services company, as President, Chief Executive Officer and Director of Signal Genetics, Inc., a publicly traded molecular diagnostic company acquired by miRagen Therapeutics, Inc., and as Executive Vice President and Chief Operating Officer of Genoptix, Inc., a publicly traded diagnostic company acquired by Novartis. Earlier in his career, Mr. Riccitelli held a number of R&D and general management positions at Becton, Dickinson and Company, and served as Vice President, General Manager and Director for BD Ventures, LLC, a venture capital fund. Mr. Riccitelli received a B.A. from Washington and Jefferson College and an M.S. in Engineering from The University of Texas. About Biocept Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient's disease and therapeutic options. In addition, Biocept conducts COVID-19 testing to support efforts to fight the pandemic. For additional information, please visit www.biocept.com .

SAN DIEGO, March 25, 2020 /PRNewswire Viracta Therapeutics, Inc. (the "Company"), a precision oncology company targeting virus-associated malignancies, today announced the appointment of Lisa Rojkjaer, MD, as Chief Medical Officer (CMO), effective May 1, 2020. Dr. Rojkjaer brings more than 15 years of clinical development and medical affairs expertise in biotechnology companies and large pharma to Viracta and is a board-certified hematologist. In her new role, Dr. Rojkjaer will oversee the clinical and medical affairs functions and will lead efforts to advance Viracta's lead program toward regulatory approvals for Epstein-Barr virus (EBV) positive lymphomas and expand the Company's pipeline into other virus-associated malignancies. "Viracta has grown substantially over the past year and our pipeline has many compelling opportunities to treat virus-associated cancers," said Ivor Royston, MD, President and Chief Executive Officer of Viracta. "Lisa's extensive experience in drug development and demonstrated track record of leading clinical teams at large organizations comes at an important time as we prepare for key clinical milestones with our lead program. Lisa's addition will strengthen our capabilities to bring novel therapies to patients in need and we're thrilled to welcome her to our team." Prior to joining Viracta, Dr. Rojkjaer served as Chief Medical Officer of Nordic Nanovector, a publicly traded precision oncology company located in Oslo, Norway, where she led the clinical development and medical affairs functions. Prior to that, she served in several senior positions focused on the advancement of small molecule and biologic programs, from Phase 1 - Phase 4 development, for hematology/immunology indications, and brings significant US and ex-US regulatory experience. She served as Global Clinical Program Head, Oncology Global Development at Novartis Pharmaceuticals, Chief Medical Officer at Molecular Partners, Vice President, Head of Clinical Development at Morphosys AG and both Director of Clinical Development, Hematology in the US and Head, Global Medical Affairs, Biopharmaceuticals for Novo Nordisk. Dr Rojkjaer received her medical degree from the University of Toronto and is board-certified in both internal medicine and hematology. Dr. Rojkjaer commented, "This is an exciting time at Viracta, with its oral drug combination in a Phase 2 clinical trial for EBV-positive lymphomas, and the expected expansion of the Company's approach into other virus-related cancers. I look forward to helping the Company realize its vision of driving the lead program toward approval and transforming the treatment paradigm for virus-associated cancers." About Viracta Therapeutics, Inc. Viracta is a precision oncology company targeting virus-associated malignancies. The Company's investigational lead molecule, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in a Phase 2 clinical trial for Epstein-Barr virus positive lymphomas. Viracta is pursuing application of this Kick and Kill platform approach in other EBV associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma and other viral related cancers.

January 28, 2020 09:00 AM Eastern Standard Time LEXINGTON, Mass.--( BUSINESS WIRE )--Fractyl Laboratories Inc. ( Fractyl ) today announced its first commercial partnership with HCA Healthcare UK (United Kingdom), making its Revita® treatment commercially available for the first time for patients with type 2 diabetes. HCA Healthcare UK is the largest provider of privately funded healthcare in the UK and is part of the US-based HCA Healthcare, the world’s largest private hospital group. “Our first commercial market in the UK represents a significant milestone for Fractyl. It demonstrates our evolution from developing the initial science and clinical evidence behind Revita to an organization now also focused on accelerating its availability for patients with type 2 diabetes who are seeking alternatives to current approaches” Revita is a first-in-class intervention designed to target insulin resistance and metabolic disease progression by resetting key pathways in the gut that drive metabolic disease. This minimally-invasive, outpatient, endoscopic procedure is a non-drug and non-surgical alternative that has been shown in clinical trials to enhance insulin sensitivity, lower HbA1c, and reduce liver fat to create long-lasting improvements in both blood sugar control and fatty liver disease to help patients with type 2 diabetes avoid further medication escalation. (1) “Our first commercial market in the UK represents a significant milestone for Fractyl. It demonstrates our evolution from developing the initial science and clinical evidence behind Revita to an organization now also focused on accelerating its availability for patients with type 2 diabetes who are seeking alternatives to current approaches,” said Harith Rajagopalan, M.D. Ph.D, co-founder and CEO of Fractyl. “This commercial availability is supported by data from several multinational clinical studies in hundreds of patients showing significant and sustained metabolic benefits from a single Revita DMR treatment.” “We are excited to be the first medical facility in the world to be able to offer the Revita procedure to our patients with type 2 diabetes,” said Miranda Dodd, CEO of The Princess Grace Hospital, part of the HCA Healthcare UK network where the Revita procedure will be performed. “Led by a specialist team of experts, our hope is that Revita will allow patients all over the UK – and internationally – to take back control of their lives with a single treatment.” “HCA Healthcare UK is an ideal inaugural hospital system partner in the UK market. HCA’s focus on bringing pioneering treatments to market aligns with Fractyl’s commitment to improving the health of patients suffering from metabolic diseases. We are thrilled with the strong support from physicians as well as the collaboration with HCA’s key stakeholders in making Revita available to their patients,” said Margaret Borys, Chief Commercial Officer of Fractyl. “This partnership and UK commercial availability represents an important first step in bringing Revita to patients around the world.” The commercial launch of Revita in the UK comes following a series of global clinical trials on the procedure, involving close to 300 patients at over 20 centers across three continents. The research published to date shows five important metabolic benefits for patients: improved overall insulin sensitivity, lowered HbA1c (by nearly 1%), weight loss, improved liver health (more than 35% reduction in liver fat, a key factor in the development of NAFLD/NASH) and increased ‘good’ (HDL) cholesterol (a parameter that correlates with a reduction of CV risk).2 Furthermore, reductions in HbA1c and liver fat were observed through 24 months of follow-up from a single outpatient Revita DMR procedure, indicating the potential for Revita DMR to offer durable improvements in both type 2 diabetes and NAFLD/NASH for a full two years thus far.3 Revita DMR has been shown to be safe and well tolerated with no long term adverse events in clinical studies to date. About Type 2 Diabetes in the U.K. Type 2 diabetes is a progressive disease, which can cause complications such as heart disease, stroke, liver and kidney damage. There are 3.8 million people living with type 2 diabetes in the UK, and the number diagnosed has more than doubled over the last 20 years.4 People with type 2 diabetes may attempt to control blood glucose levels with lifestyle changes and medications, but when these are ineffective, patients may face daily insulin injections. Patients who are looking for alternatives to adding more daily medications, including insulin,5 may find that Revita DMR offers a unique, non-drug alternative with compelling benefits beyond blood sugar control. About HCA Healthcare UK HCA Healthcare UK includes London Bridge Hospital, The Portland Hospital, The Harley Street Clinic, The Lister Hospital, The Princess Grace Hospital, The Wellington Hospital, Roodlane Medical Ltd, and Blossoms Healthcare. HCA UK also partners with leading NHS Trusts to provide care at The Christie Private Care, HCA UK at University College Hospital and Private Care at Guy’s. For more information, visit www.hcahealthcare.co.uk . About Fractyl and Revita® DMR Fractyl Laboratories is a private biotechnology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedural therapy to treat highly prevalent metabolic diseases. The Revita DMR procedure harnesses breakthrough insights in intestinal biology and leverages the body’s inherent regenerative capacity to reverse insulin resistance and metabolic diseases. Fractyl’s approach aims to improve the health of patients with metabolic diseases with device-based interventions for patients and healthcare systems. The Revita DMR System received a CE mark in the European Union in April 2016. It is approved for investigational use only by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs . _____________________________ (1.) Van Baar, et al. Gut , 2020; 69:295-303. (2.) Rajagopalan, et al. Diabetes Care , 2016; 39:2254-2261. (3.) Fractyl, Diabetes Technology Meeting , 2019. (4.) https://www.gov.uk/government/publications/health-matters-preventing-type-2-diabetes/health-matters-preventing-type-2-diabetes (5.) https://www.england.nhs.uk/diabetes/diabetes-prevention/