Canakinumab

Event will take place on Wednesday, June 26, 2024 in New York CARMIEL, Israel, June 13, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, today announced that it will host an in-person investor day at the Lotte Palace New York Hotel in New York on Wednesday, June 26, 2024 at 8:30 a.m. Eastern Daylight Time (EDT). The investor day will feature presentations by the following key opinion leaders: Aleš Linhart, DSc, FESC (Charles University, Prague), who will discuss the treatment landscape for Fabry disease and perspectives on Elfabrio® (pegunigalsidase alfa), a plant cell-expressed PEGylated recombinant α-Galactosidase-A enzyme approved for adult patients with Fabry disease. Naomi Schlesinger, MD (University of Utah), who will discuss the current treatment landscape for uncontrolled gout and top-line results from the First-in-Human Phase I single ascending dose clinical trial of PRX-115, a plant cell-expressed recombinant PEGylated uricase. In addition, the event will include a corporate overview and strategy presentation by Dror Bashan, Protalix's President and Chief Executive Officer. A live question and answer session will follow the formal presentations. To register for the event, please click here. About Aleš Linhart, DSc, FESC Aleš Linhart, DSc, FESC is currently heading the Department of Cardiovascular Medicine of the First Medical Faculty and General University in Prague, Czech Republic and serves as vice-dean for international affairs of the First Faculty of Medicine of Charles University in Prague. He obtained his MD degree at Charles University in Prague, received his training in cardiology and vascular medicine at General University Hospital in Prague and Broussais Hospital in Paris, France. In 2004 he was appointed professor at Charles University in Prague. His research focuses mainly on Fabry disease, metabolic cardiomyopathies, noninvasive cardiac imaging, and atherosclerosis. He is member of several scientific societies, namely Czech and European Society of Cardiology (ESC). He served as the chairman of the Working Group on Myocardial and Pericardial Diseases of the ESC and is the immediate past president of the Czech Society of Cardiology. He authored or co-authored more than 450 scientific peer-reviewed papers, 85 book chapters, and three monographs. About Naomi Schlesinger, MD Naomi Schlesinger, MD is the Harold J, Ardella T, and Helen T Stevenson Presidential Endowed Chair of Rheumatology, Professor and Chief Division of Rheumatology, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT. She is a previous Chief of the Division of Rheumatology at Rutgers-Robert Wood Johnson Medical School and Director of Rutgers Robert Wood Johnson Medical School Gout Center. Dr. Schlesinger is a previous President of the NJ Rheumatology Association and current President of the Utah Rheumatology Association and was the recipient of the 2015 Rheumatologist of The Year award by the Arthritis Foundation - NJ Chapter. Dr. Schlesinger is a noted authority in the field of gout, having published many papers regarding the diagnosis, treatment, and better understanding of the pathogenesis of gout. Dr. Schlesinger's research has won recognition, including the work titled: Efficacy of canakinumab (ACZ885), a fully human anti-Interleukin (IL)-1beta monoclonal antibody, in the prevention of flares in gout patients initiating allopurinol therapy, which was selected as one of the five highest-ranking abstracts that will likely shape our treatment paradigms for years to come in the 2010 ACR/ ARHP Annual Scientific Meeting and the work titled: Erectile dysfunction is common among gout patients, which was selected (one of 13) for inclusion in the official 2014 EULAR Press Conference from over 4000 abstracts. Other pioneering work includes the treatment of gout flares with topical ice, seasonality of gout, diagnosing gout using ultrasound, understanding the pathogenesis of bone erosions in gout, and the importance of anti-inflammatory treatment in gout. Dr. Schlesinger serves as the American College of Rheumatology (ACR) abstract Co-Chair on metabolic and crystal arthropathies, a member of the ACR Global Engagement Special Committee (GESC), and a member of the ACR Annual Meeting Planning Committee (AMPC). She is a Co-Director of the International Gout and Hyperuricemia Center, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. She serves as a consultant to pharmaceutical companies in the field of gout. About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX-115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX-119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Investor Contact Mike Moyer, Managing Director LifeSci Advisors 617 308 4306 [email protected] Logo: SOURCE Protalix BioTherapeutics, Inc.

Mina Kim appointed Chief Executive Officer and to Board of Directors ACELYRIN Founder Shao-Lee Lin, M.D., Ph.D., steps down as Chief Executive Officer Shephard (Shep) Mpofu, M.D., MRCP, FRCP named Chief Medical Officer, Gil Labrucherie, the company’s Chief Financial Officer, additionally named Chief Business Officer, and Sanam Pangali named Chief Legal Officer and Head of People LOS ANGELES, May 09, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that ACELYRIN’s founder Shao-Lee Lin, M.D., Ph.D. has stepped down as Chief Executive Officer and that Mina Kim, chief legal and administrative officer at ACELYRIN, has been appointed Chief Executive Officer and to the company’s Board of Directors (the “Board”). Ms. Kim brings more than 20 years of operational and leadership experience across a range of industries including synthetic biology, immunotherapy, renewable energy, and aviation. Ms. Kim played a pivotal role in ACELYRIN’s initial public offering and has served as ACELYRIN’s Chief Legal and Administrative Officer since November 2022. Prior to that, she served as Chief Legal Officer and Head of Corporate Development at Zymergen, Inc., where she led the company’s corporate strategy and business development teams and built its legal team. She also oversaw Zymergen’s 2021 IPO process and the company’s eventual sale to Ginkgo Bioworks. Bruce Cozadd, chair of the ACELYRIN Board of Directors, said, “ACELYRIN is at an inflection point having recently announced early but exciting data for lonigutamab in thyroid eye disease and a positive late-stage trial for izokibep in psoriatic arthritis. The Board and Shao-Lee believe now is the right time to make these changes as we focus on prioritizing our portfolio to enable future success. Mina’s significant experience overseeing corporate strategy and corporate development, coupled with her knowledge of ACELYRIN’s pipeline and operations, make her the right person to lead ACELYRIN into its next chapter. The Board is confident that under Mina’s leadership ACELYRIN will realize its potential, driving value for shareholders and transforming patients’ lives.” “I am honored to serve as the next Chief Executive Officer of ACELYRIN,” said Ms. Kim. “With encouraging data across our pipeline, we are continuing to advance our core mission of making a meaningful difference for patients. At the same time, we remain committed to reviewing our strategy, making disciplined decisions about portfolio prioritization and being responsible stewards of capital to best position our assets for successful development and potential commercialization in the future. I am excited to continue working with our employees and partners in this new capacity.” Cozadd continued, “On behalf of the Board, I would like to recognize Shao-Lee for her vision in leading ACELYRIN from inception through to becoming a well-capitalized public company. She has built a talented and accomplished team, and created a promising portfolio of clinical stage programs, each with the potential to fulfill ACELYRIN’s mission of delivering meaningful new medicines for patients. We wish her all the best in the future.” “Since the founding of ACELYRIN, we have been singularly focused on making a meaningful impact on patients’ lives by pursuing innovative approaches to speed the development of life-changing therapies,” said Dr. Lin. “Building and leading ACELYRIN to this moment in its history has been a tremendous honor and privilege. It is time for the next stage of evolution for the company. I wish the team every success in the continued pursuit of our mission to make meaningful new medicines for patients.” In addition to Ms. Kim’s appointment, Shephard (Shep) Mpofu, M.D., MRCP, FRCP, who most recently served as ACELYRIN’s Senior Vice President of Development, has been promoted to the role of Chief Medical Officer, Gil Labrucherie, who serves as ACELYRIN’s Chief Financial Officer, has been named Chief Business Officer in addition to Chief Financial Officer, and Sanam Pangali, who most recently served as ACELYRIN’s Senior Vice President, Corporate Legal, has been promoted to Chief Legal Officer and Head of People. Business Update and Key Upcoming Milestones In a separate press release ACELYRIN provided an update on various corporate milestones and announced that it will forego hosting the previously scheduled Q1 2024 earnings call. The company will file the related quarterly report on Form 10-Q no later than May 14, 2024. The press release can be found on the investor relations section of the company’s website. About Mina KimMina Kim has served as the Chief Legal and Administrative Officer of ACELYRIN, INC. since 2022. From 2020 to 2022, Ms. Kim was the Chief Legal Officer and Head of Corporate Development at Zymergen, Inc., where she oversaw corporate strategy, business development, corporate & SEC reporting, intellectual property, litigation and employment, compliance, regulatory, public policy, and sustainability. She led Zymergen’s 2021 IPO process and later sale to Ginkgo Bioworks. Prior to Zymergen, Ms. Kim served as Senior Vice President of Corporate Strategy and General Counsel at Atara Biotherapeutics. Before Atara, Ms. Kim was General Counsel at Sunrun where she led the 2015 IPO. Earlier in her career she was Vice President, Legal at BBAM, LLC, General Counsel of Fly Leasing, Assistant General Counsel at Williams-Sonoma, and an Associate at the law firm Davis Polk & Wardwell. She holds a JD from Harvard Law School and a BA in History from Dartmouth College. About Shep MpofuShep Mpofu has served as Senior Vice President, Development and Translational Sciences of ACELYRIN, INC. since October 2023. Prior to ACELYRIN he spent nearly 20 years at Novartis AG, where he most recently served as Chief Medical Officer for its Gene Therapy Franchise. At Novartis he held positions of increasing responsibility in the immunology, rheumatology and dermatology franchises, which culminated with global leadership of clinical development for canakinumab and secukinumab. He is a UK General Medical Council Board-certified rheumatologist, who previously practiced at several institutions in the UK. He is a Fellow of the Royal College of Physicians UK, and he obtained his MB.Ch.B (Bachelor of Medicine and Bachelor of Surgery degrees) from the Godfrey Huggins School of Medicine at the University of Zimbabwe. About Gil LabrucherieGil has served as the Chief Financial Officer of ACELYRIN, INC. since 2022. He was previously Chief Financial Officer and Chief Operating Officer of Nektar Therapeutics where he led a team of more than 150 professionals in financial accounting and public reporting, business and strategic planning, corporate legal, intellectual property, government affairs, information technology and supply chain management. Prior to that he was the Senior Vice President and General Counsel at Nektar, Vice President of Corporate Development at E2open, Inc. and Senior Director of Corporate Development at AltaVista Company. He began his career as corporate counsel at Wilson Sonsini Goodrich & Rosati. Gil holds a JD from the University of California Berkeley School of Law and a BA from the University of California Davis. He is also a CFA charterholder. About Sanam PangaliSanam Pangali has served as Senior Vice President, Corporate Legal of ACELYRIN, INC. since October 2023 and previously served as Vice President, Corporate Legal. Prior to joining ACELYRIN in 2022, she served as General Counsel, Vice President and Corporate Secretary at Snapdocs, Inc., a technology company in the mortgage lending space, from 2020 to 2021. Before that, she served as Senior Director & Associate General Counsel at Principia Biopharma Inc. through its September 2020 acquisition by Sanofi. Earlier in her career, she led the corporate and commercial contracting legal functions at Sunrun Inc., from 2016 to 2019 and prior to that was Director & Assistant General Counsel at affiliates TerraForm Power and SunEdison Inc. from 2013 to 2016, spanning mergers and acquisitions, project finance and development. Ms. Pangali began her legal career as a Senior Associate at Morrison & Foerster LLP for six years working in the firm’s Business and Finance practice groups, advising clients in capital markets, venture capital, mergers and acquisitions, project finance and corporate governance matters. She holds a JD from the University of Pennsylvania Carey Law School and a BA in Political Science, with a Minor in Economics, from the University of California, San Diego. About ACELYRIN, INC.ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharma company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN has two programs in late-stage clinical development. Lonigutamab is a subcutaneously delivered monoclonal antibody targeting IGF-1R advancing into Phase 2b/3 development for the treatment of thyroid eye disease. Izokibep is a next generation inhibitor of IL-17A in Phase 2b/3 development for the treatment of psoriatic arthritis, hidradenitis suppurativa and uveitis. For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X. Forward Looking StatementsThis press release contains forward-looking statements including, but not limited to, statements related to ACELYRIN’s focus on prioritizing its portfolio to ensure future success, driving value for shareholders and transforming patients’ lives; the therapeutic potential of ACELYRIN’s product candidates; future development and commercialization of ACELYRIN’s assets; ACELYRIN working to advance the development of lonigutamab and izokibep; and other statements that are not historical fact. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates; the timing and results of ACELYRIN’s clinical trials, including the risk that future clinical trial results could differ materially and adversely from prior clinical trial results or data; maintaining and defending intellectual property protection; delays or failures to secure adequate supply of its product candidates; the sufficiency of ACELYRIN’s cash resources; legal proceedings; and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law. ACELYRIN, INC. Contact:Tyler MarciniakVice President of Investor Relations, Communications and Advocacyinvestors@acelyrin.commedia@acelyrin.com