Gibson Oncology LLC

New Designation Marks Milestone in Glioblastoma Treatment Decades in the Making with Glioma Treatment that Crosses Blood Brain Barrier at Ten Times Concentration Needed to Kill Cancer Cells GERMANTOWN, Md.--(BUSINESS WIRE)--Amarex today announced its work on behalf of Gibson Oncology has resulted in an Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for the drug LMP744. LMP744 treats gliomas, readily crossing the blood brain barrier (BBB) at 10 times the concentration required to kill cancer cells and sustains a high concentration for over 24 hours per dose. “For decades glioblastoma brain cancer patients have not seen appreciable increases in overall survival rates with Temodar, the current standard of care treatment,” said Mr. Randall Riggs, President & CEO of Gibson Oncology. “Our goal is to advance both LMP400 and LMP744 to market via the shortest and quickest path, thus benefiting cancer patients in need.” Obtaining ODD for LMP744 for all gliomas underscores the promising and novel treatment of the drug to inhibit two cancer targets: TOPO 1 and downregulate cMyc overexpression through the drug’s potent binding of the G4 quadruplex of cMyc. “This crucial designation could not come at a more critical time for the families who are fighting this disease,” said Dr. Kush Dhody, President, Amarex. “Reaching this milestone sets the company up for future success and, most importantly, poises Gibson Oncology to continue its path to commercialization of this life-saving treatment.” Through a multi-year collaboration with cMyc expert, Dr. Danzhou Yang of Purdue University, Gibson Oncology discovered that LMP400, which received ODD earlier in the year, and LMP744 are potent nM inhibitors of both TOPO 1 and cMyc oncogene. Together, the teams determined that LMP744, a small molecule, selectively targets two well-known drivers of human cancers, cMyc oncogene and TOPO 1. The discovery of this compound’s unique anti-cancer mechanism of action (MOA) allowed Gibson Oncology to better position LMP744 and LMP400 to cancer targets with high unmet medical needs. Presently, LMP744 and LMP400 is positioned to enter a Phase 2 human clinical trial in recurrent gliomas in collaboration with the National Institutes of Health (NIH). Gibson Oncology believes it is important to leverage the Orphan Drug Designation both drugs have received from the FDA for all gliomas, not just glioblastomas, which includes children with gliomas. Rapid regulatory advancement empowers LMP400 and LMP744 to the shortest and quickest path to market, thus benefiting cancer patients in need. About Gibson Pharmaceuticals Gibson Oncology is a private biotechnology company with a unique portfolio of five small molecules for cancer therapy discovered at the National Cancer Institute and Purdue University. These agents have both TOPO 1 as well as cMyc activity and already have had five clinical trials completely supported by the NCI in recurrent solid tumors and lymphomas. Our lead agent, LMP744, is currently positioned for a Phase 2 trial in first recurrent glioblastoma patients, and LMP400 in first recurrent glioma patients with PTEN deficiency. Gibson has a second generation of newly invented and patented drugs, also showing combined TOPO 1 and cMyc activity known as the 7-Azaindenoisoquinolines (the AZAs). Discovered by Dr. Mark Cushman at Purdue University and exclusively licensed to Gibson, these agents also show TOPO 1 effects not by traditional camptothecin mechanisms found in older drugs like Irinotecan and Topotecan. Gibson has demonstrated that the AZAs work on cMyc inhibition epigenetically through the G-quadruplex. About Amarex Clinical Research, LLC Amarex Clinical Research, LLC, is a global, full-service Contract Research Organization (CRO) with significant expertise conducting clinical research. The leadership team’s combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit . Contacts Media Contact: Kalli DeWeese Kdeweese@nsf.org

MIAMI, FL / ACCESSWIRE / March 14, 2023 / Gibson Oncology, a privately held Oncology preclinical and clinical development company advancing novel, targeted small molecule compounds that inhibit topoisomerase I and bind the G4 quadruplex in the cMyc promoter to inhibit cMyc expression as potent anticancer agents, welcomes two well-accomplished and experienced individuals within the life sciences industry, Dr. Fred Mermelstein and Dr. Mark Baganz. "We are delighted to have Dr. Fred Mermelstein and Dr. Mark Baganz join Gibson's Board of Directors. We look forward to their valuable contributions as Gibson further develops its oncology portfolio that uniquely attacks cancer through a dual mechanism: inhibition of TOPO 1 protein and reduction of cMyc expression levels through selective binding to G4 quadruplexes formed in the cMyc promoter region," stated Randall B. Riggs, President and CEO. Dr. Baganz is a corporate leader, entrepreneur, and board-certified diagnostic radiologist. He is the Founder and President of Chesapeake Medical Imaging, a subspeciality patient-centric diagnostic radiology practice with 12 locations in Maryland employing over 150 people. He was co-Founder and is a current Advisory Board member of SecureRAD-Purview, a medical IT and telehealth company and the sponsor of the Horos Project, an open-source medical image viewing platform with over 100,000 users on all continents and in over 170 countries. Fred Mermelstein, Ph.D., currently serves as President and CEO of Dynamic Cell Therapies since its founding in 2020 and Chairman of the board of Courage Therapeutics since its founding in 2019. Between 2003 - 2010, Dr. Mermelstein founded Javelin Pharmaceuticals, Inc. (JAV), until its sale to Hospira, Inc., now Pfizer. He served as the CEO and President of Javelin, which developed Dyloject, an injectable anti-inflammatory for the treatment of post-operative pain. He founded PolaRx Biopharmaceuticals, Inc., in 1997, where he also served as Chief Scientific Officer until 1999, and on the team responsible for bringing Trisenox (Arsenic Trioxide for the treatment of Acute Promyelocytic Leukemia) to NDA completion, now marketed and sold worldwide by Teva. He also served on the board of NX Development Corp., between 2011 - 2018 which brought Gliolan to the market in the United States prior to its acquisition by SBI Pharma, Inc. Between 2008 and 2018, Dr. Mermelstein was a co-founder and served as Chairman of the Board of Pear Tree Pharmaceuticals, until its sale to Dare Biosciences, Inc. Dr. Mermelstein serves on several boards, including Harvard Institute of RNA Medicine, Rogosin Institute and Cornell-Weill Medical Center. About Gibson Oncology: Gibson Oncology is developing a novel class of proprietary drug candidates currently in clinical trials for the treatment of difficult-to-treat tumors. Our product candidates are first-in-class based upon dual activity at cMyc and TOPO-1 which will improve safety and efficacy and offer future approaches for treating several cancers. There are currently five (5) ongoing clinical studies funded by the National Institute of Health in patients with solid tumors and lymphomas. Additionally, Gibson has developed proprietary second-generation product candidates expanding modes of delivery and treatment approaches in both pediatric and adult populations. For more information, please visit . Contact Information Randall B. Riggs President & CEO rriggs@gibsononcology.com (502) 345-8911 SOURCE: Gibson Oncology, LLC View source version on accesswire.com:

Mr. Rongen appointed as CEO and member of the Board bringing 30 years of executive leadership experience and expertise across a number of therapeutic areas Bolstered expertise on Board of Directors with addition of Dr. Rogers who brings significant leadership and expertise spanning both public and private sectors in health care and the biopharmaceutical industry DELRAY BEACH, FL / ACCESSWIRE / January 17, 2023 / Adolore Biotherapeutics, Inc. ("Adolore" or the "Company"), a biotechnology company focused on developing breakthrough opioid-free pain relieving (analgesic) treatments for chronic pain, today announced the appointments of Roelof Rongen, MSE, MBA as Chief Executive Officer and Director, and Mark C. Rogers, MD, MBA as a member of the Company's Board of Directors. "We are delighted to welcome Roelof and Mark at this pivotal time in the evolution of Adolore," commented Roy C. Levitt, MD, Founder and Executive Chairman of Adolore Biotherapeutics. "The addition of these well-known and well-respected industry leaders represents clear acknowledgement of the solid foundation of our breakthrough platform technology leveraging our novel gene therapy approach for the treatment of chronic pain and other nervous system diseases and conditions. Roelof and Mark are distinguished trailblazers in the biopharmaceutical industry and bring business, operational and financial acumen, along with a wealth of business contacts, all of which we believe will be invaluable to Adolore as we drive the Company through its next stage of growth." Mr. Rongen added, "The Adolore team has developed a cutting-edge approach to opioid-free pain relief and their data is incredibly compelling. I, along with the leadership team, are committed to advancing this innovative gene therapy toward anticipated IND filings and clinical studies. I am pleased to join the Company and look forward to building on the momentum generated thus far." Dr. Rogers added, "I am very excited to be joining Adolore's Management team and Board, at what I believe is a very important transitional period for the Company. Adolore's gene therapy approach has received validation and recognition by the NIH and Adolore's osteoarthritis program is fully funded by the NIH's HEAL program to combat the opioid crisis. I look forward to working closely with Roy, Roelof and the rest of the senior management team to advance the Company's development programs and achieve its ambitious goals, thus creating life-changing products for patients with chronic pain." Roelof Rongen, MSE, MBA Mr. Rongen is a serial entrepreneur and R&D / Commercial Development leader with extensive experience across many therapeutic areas and functions. He founded and progressed Matinas BioPharma (omega-3 and lipid-crystal nano-particle drug delivery) into a public company (NYSE:MTNB); and he was integral to the development and commercialization of blockbuster products such as Humira® and Lovaza®. Prior to founding Matinas BioPharma, Mr. Rongen was the architect behind Trygg Pharma which facilitated Norway's Aker Group's entry into the prescription omega-3 business. Before his work with Aker, he was VP for IP and Portfolio Management at Reliant Pharmaceuticals (acquired by GlaxoSmithKline) where he in-licensed Lovaza® and led development and pre-launch activities. Earlier in his career, Mr. Rongen was Global Product Director for Humira® and other Immunology Programs at BASF Pharma (acquired by Abbott/Abbvie). Mr. Rongen started his professional career as a management consultant at Arthur D. Little's Technology Innovation Management practice in Amsterdam, the Netherlands, followed by his work in New York City as biotech/pharmaceutical consultant at The Wilkerson Group (acquired by IBM). Mr. Rongen holds a Master of Science in Engineering (MSE) in Molecular Sciences (with Biotechnology/Bio-Process Technology focus) graduate degree from Wageningen University in the Netherlands and an MBA from Kellogg GSB at Northwestern University. Mark C. Rogers, MD, MBA Dr. Rogers is a physician, serial entrepreneur, professor, and hospital administrator, who brings leadership and expertise in health care and the biopharmaceutical industry spanning both private and public sectors with significant board and operational experience. Most notably, Dr. Rogers was CEO of Duke Hospital and Health Network before joining Perkin Elmer as Chief Technology Officer (NYSE:PKI) where he was in charge of the company's human genome sequencing program, amongst other responsibilities. He then moved into medical venture capital becoming CEO of Paramount Capital. Later, before founding Gibson Oncology, Dr. Rogers served as founder, Chairman, and CEO of numerous companies including Innovative Drug Delivery Systems, a pharmaceutical development company with three pain-related drugs which went public and was acquired for approximately $230 million. He was founder and Chairman of Aptamera, an oncologic pharmaceutical development company that was acquired by a London public company Antisoma. He was founder and Chairman of Cardiome, a NASDAQ listed cardiac arrhythmia company that reached an $800 million-dollar market capitalization while Dr. Rogers was Chair. He also was Executive Chair of PolaRX which developed Arsenic Trioxide as a cure for Acute Promyelocytic Leukemia and which, after FDA approval, was subsequently sold to a large pharmaceutical company for $100 million. Dr. Rogers trained in four medical specialties (critical care, pediatrics, cardiology, and anesthesiology) and was a Professor and Chair at Johns Hopkins at age 37. The author of well over 100 papers and Editor of 12 books, he is a member of the National Academy of Medicine, is a former Fulbright scholar, and former Chair of the Reagan-Udall Foundation, the U.S. Congress public advisory group on the FDA. Dr. Rogers earned his undergraduate degree at Columbia University, his Medical Doctorate from SUNY and his MBA from the Wharton School at Pennsylvania University. About Adolore Biotherapeutics, Inc. Adolore Biotherapeutics, Inc., is a biotechnology company focused on developing novel therapies for the treatment of chronic pain and other pain and nervous system conditions or disorders. Our best-in-class lead programs are long-acting locally acting gene-therapies that are opioid-free Disease Modifying Anti-Pain therapies (DMAPs) for the treatment of a variety of chronic pain indications. The Company's two current CA8* gene therapy programs are in preclinical development for treatment of patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and chronic osteoarthritis knee pain, affecting a large number of patients that is often treated with opioids due to the lack of alternatives, thus contributing to the ongoing opioid crisis. For more information, visit adolore.com. Forward Looking Statements To the extent this announcement contains information and statements that are not historical, they are considered forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words "believe," "expect," "anticipate," "intend," "estimate," "project," "will," "should," "may," "plan," "intend," "assume" and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks and uncertainties include, but are not limited to, those associated with drug development. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Investor Relations Contact JTC Team, LLC Jenene Thomas 833-475-8247 adolore@jtcir.com SOURCE: Adolore Biotherapeutics, Inc. 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