Connective Tissue Diseases

2024 Harrington Prize for Innovation in Medicine Recognizes Pioneering Work in Immunology CLEVELAND, March 19, 2024 /PRNewswire/ -- The eleventh annual Harrington Prize for Innovation in Medicine has been awarded to Arlene H. Sharpe, MD, PhD, Kolokotrones University Professor and Chair of the Department of Immunology at Harvard Medical School. The award recognizes her breakthrough discoveries in immune regulation, which have established foundational principles in immunology and led to new cancer therapies that act by boosting the immune response to cancer. The Harrington Prize for Innovation in Medicine, established in 2014 by the Harrington Discovery Institute at University Hospitals and the American Society for Clinical Investigation (ASCI), honors physician-scientists who have moved science forward with achievements notable for innovation, creativity and potential for clinical application. Dr. Sharpe's research in immunology has led to significant advances in medical treatments. Her work helped identify key pathways that restrain the activity of T lymphocytes (immune cells) to fight cancer. Her work defined the PD-1 pathway and its immunoinhibitory functions as well as the inhibitory functions of CTLA-4 to restrain the activity of the immune system. Dr. Sharpe's research thus laid the foundation for the development of 'immune checkpoint inhibitors', drugs that target PD-1 and related pathways. These therapies, including pembrolizumab and nivolumab, have been approved by the FDA for treating numerous types of cancer. They work by preventing inhibition of T cell function, thereby unleashing the body's immune system to fight cancer cells more effectively. This approach has become a cornerstone in cancer treatment strategies. "Dr. Sharpe's body of work has shaped our understanding of the role of the T cell in regulating the immune response. Her innovative scientific discoveries are among the best examples of bench-to-bedside work in the past three decades," said Benjamin D. Humphreys, MD, PhD, Joseph Friedman Professor of Renal Diseases in Medicine and Chief, Division of Nephrology, Washington University in St. Louis and 2023-2024 President of the ASCI. "Immune checkpoint inhibitors are drugs that allow for dramatic remission, and even cures, of cancers that had previously been considered untreatable. Dr. Sharpe's foundational insights have thus been harnessed to transform cancer therapy. Her work provides a beautiful example of physician impact through creative science," said Jonathan S. Stamler, MD, President, Harrington Discovery Institute, Robert S. and Sylvia K. Reitman Family Foundation Distinguished Professor of Cardiovascular Innovation and Professor of Medicine and of Biochemistry at University Hospitals and Case Western Reserve University. A committee composed of members of the ASCI Council and the Harrington Discovery Institute Scientific Advisory Board reviewed nominations from leading academic medical centers globally before selecting the 2024 Harrington Prize recipient. In addition to sharing the Prize's $20,000 honorarium, Dr. Sharpe will deliver the Harrington Prize Lecture at the 2024 AAP/ASCI/APSA Joint Meeting on April 5, will be a featured speaker at the 2024 Harrington Scientific Symposium May 22-23, and will publish an essay in the Journal of Clinical Investigation. The Harrington Prize has recognized outstanding and diverse innovations in medicine: 2014: Harry Dietz, MD, Johns Hopkins University, for his contributions to the understanding of the biology and treatment of Marfan syndrome, a disorder leading to deadly aneurysms in children and adults. 2015: Douglas R. Lowy, MD, The National Cancer Institute, in recognition of his discoveries that led to the development of the Human Papillomavirus vaccine to prevent cervical cancer. 2016: Jeffrey M. Friedman, MD, PhD, The Rockefeller University, for his discovery of leptin, which controls feeding behavior and is used to treat related clinical disorders. 2017: Jointly awarded to Daniel J. Drucker, MD, Mount Sinai Hospital, Canada, Joel F. Habener, MD, Massachusetts General Hospital, and Jens J. Holst, MD, DMSc, University of Copenhagen, Denmark, for their discovery of incretin hormones and for the translation of these findings into transformative therapies for major metabolic diseases such as diabetes. 2018: Helen H. Hobbs, MD, UT Southwestern Medical Center, for the discovery of the link between a gene mutation (PCSK9) and lower levels of LDL, which has improved the treatment of high cholesterol. 2019: Carl H. June, MD, University of Pennsylvania, for advancing the clinical application of CAR T therapy for cancer treatment, and for his sustained contributions to the field of cellular immunology. 2020: Stuart H. Orkin, MD, Harvard University, for breakthrough discoveries on red blood cells that offer new treatments for patients with sickle cell disease and beta-thalassemia, which are among the most common genetic disorders. 2021: Warren J. Leonard, MD, and John J. O'Shea, MD, NIH, for their respective contributions to the field of immunology, from fundamental discovery to therapeutic impact. 2022: James E. Crowe Jr., MD, and Michel C. Nussenzweig, MD, PhD, for their groundbreaking work, which has elucidated fundamental principles of the human immune response and enabled the use of human antibodies to treat COVID-19. 2023: Jean Bennett, MD, PhD, and Albert M. Maguire, MD, for their groundbreaking translational research to restore sight in inherited genetic diseases. SOURCE Harrington Discovery Institute

PALO ALTO, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has paid off the remaining balance of approx. $1,300,000 under the convertible debentures (the “Convertible Debentures”) previously issued and sold to YA II PN, Ltd. (“Yorkville”) in March 2023. Scilex has also voluntarily made an early payment in the aggregate amount of $15,000,000 under the senior secured promissory note (the “Oramed Note”) issued to Oramed Pharmaceuticals Inc. (Nasdaq: ORMP, “Oramed”) in September 2023. “This is a pivotal moment for Scilex, signaling our readiness to embrace new opportunities and transform the lives of patients with acute and chronic pain while addressing the opioid crisis. With a stronger balance sheet, we are well-positioned to pursue collaborations, expand our current commercialization efforts, and bring additional innovative opioid sparing treatments to market,” said Jaisim Shah, Chief Executive Officer and President of Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com. For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. Facebook: https://www.facebook.com/scilex.pharm LinkedIn: https://www.linkedin.com/company/scilex-holding-company Email: info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, expected to launch in the first half of 2024. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica for which Scilex has completed a Phase 3 study and has granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022 and a Phase 2 clinical trial is expected to commence in 2024. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s ability to repay the remaining balance of the Oramed Note, Scilex’s belief that it is well-positioned to pursue collaborations, expand commercialization efforts and bring additional innovative products to market, Scilex’s expectation to launch Gloperba® in the first half of 2024 and plans to initiate a Phase 2 clinical trial in 2024 for SP-104. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

The collaboration exemplifies DDF's commitment to advancing gastrointestinal cancer research and treatment options for patients. FORT LAUDERDALE, Fla., March 19, 2024 /PRNewswire/ -- Debbie's Dream Foundation: Curing Stomach Cancer (DDF) announces an unprecedented collaboration with Memorial Sloan Kettering Cancer Center (MSK) that marks a significant leap forward in the field of gastric cancer research. Through the visionary efforts and support of DDF, a research fellowship grant has been established at MSK under the guidance of Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology Service at MSK. The "Debbie's Dream Foundation Gastric Cancer Investigator" fellowship will focus on patient care, research, and education specifically for esophageal and gastric cancers. The collaboration is a testament to the shared commitment of DDF and MSK to fueling groundbreaking research and providing top-notch cancer care. Continue Reading Debbie's Dream Foundation: Curing Stomach Cancer Dr. Yelena Janjigian, a distinguished member of DDF's Scientific Medical Advisory Board, emphasized the importance of the DDF and MSK's partnership in shaping the future of gastric cancer research. "This fellowship signifies a commitment to excellence in gastroesophageal cancer research. With the support of DDF, we can provide dedicated time and resources to focus on advancing translational studies. This collaboration is pivotal in our collective efforts to better understand and treat esophageal and gastric cancers." Andrea Eidelman, Chief Executive Officer of DDF, expressed her pride in continuing to fund research that propels the organization's mission forward. "At DDF, we are deeply committed to advancing the landscape of gastric cancer research. This partnership with MSK is a significant step towards realizing our vision of a world without stomach cancer. Through the 'Debbie's Dream Foundation Gastric Cancer Investigator fellowship, we aim to make impactful strides in biomarker development, laboratory research, and translational studies in gastroesophageal cancer." DDF plans to contribute nearly $600,000 to fund this initiative over a three-year period, reinforcing the commitment to long-term support for innovative research. MSK will provide regular progress reports, ensuring transparency and accountability throughout the fellowship. Upon completion of the funding, MSK will recognize DDF for its invaluable contribution to advancing cancer research and patient care. Since 2014, DDF, in partnership with the American Association for Cancer Research (AACR), has invested $1.45 million in research grants to pioneering scientists in the United States. The 2023 AACR-Debbie's Dream Foundation Innovation and Discovery Grant recipients include Drs. Eunyoung Choi, Brent Allen Hanks, and Ryan H. Moy are exploring new targets and biomarkers for gastric cancer. Highlighting a significant milestone, DDF also celebrated Dr. Valerie O'Brien's recent discovery, funded by the 2018 Debbie's Dream Foundation-AACR Fellowship, of a precancerous cell type linked to H. pylori infection, offering new insights and therapeutic directions for gastric cancer. For more information about DDF programs and initiatives, please visit . About Debbie's Dream Foundation: Curing Stomach Cancer DDF is a 501(c)(3) non-profit organization dedicated to raising awareness about gastric cancer, advancing research funding, and providing international education and support to patients, families, and caregivers. DDF's ultimate goal is to make the cure for stomach cancer a reality. DDF was founded in 2009 by Debbie Zelman after she was diagnosed with stage IV incurable gastric cancer in 2008 and given only weeks to live. Debbie is considered a pioneer by many for bringing awareness to the plight of stomach cancer patients worldwide, as well as to the lack of federal funding for stomach cancer research. She did all of this while receiving hundreds of rounds of chemo and daily oral treatments. Debbie passed away on December 23, 2017, at 50, almost a decade later. As a result of her leadership, DDF now has a Scientific and Medical Advisory Board of world-renowned doctors and chapters throughout Canada and Germany. DDF strives to continue Debbie's mission to make her dream a reality. To learn more, visit . Media Contact Brittnay Starks, Communications Director Debbie's Dream Foundation: Curing Stomach Cancer (954) 475-1200 [email protected] SOURCE Debbie's Dream Foundation: Curing Stomach Cancer