Hope Medical Center

Dr. Wakelee is a world-renowned expert in the research and treatment of lung cancerOncoC4’s SAB now includes 6 distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced the appointment of thoracic medical oncologist Heather A. Wakelee, MD, FASCO to the OncoC4 Scientific Advisory Board (SAB) made up of distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy. Dr. Wakelee, currently a Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute, brings over 20 years of experience in clinical strategy. “We are honored to welcome Heather to the OncoC4 SAB, an international expert with decades of leadership experience in the treatment of lung cancer,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “Her research and clinical understanding in thoracic oncology will provide invaluable guidance as we advance multiple clinical products, including gotistobart, a late-stage next-generation CTLA-4 inhibitor for immunotherapy-resistant non-small cell lung cancer.” Dr. Wakelee added, "OncoC4 is developing novel immunotherapies targeting CTLA-4 and CD24 to break cancer resistance. By leveraging universal pathways, OncoC4 has the potential to change the treatment paradigm for many common and aggressive cancers with high unmet needs. I am excited to join the OncoC4 SAB at this important stage, and partner with the team to help shape the clinical development of their innovative clinical and preclinical pipeline.” Heather A. Wakelee, MD, FASCO brings over 20 years of clinical experience specializing in the treatment of lung cancer, thymoma, and mesothelioma. Currently she serves as Deputy Director of the Stanford Cancer Institute and is the Division Chief of Medical Oncology. She was the President of the International Association for the Study of Lung Cancer (IASLC) and is active in several national and international organizations related to lung cancer and thymoma. She remains actively engaged in lung cancer and thymoma clinical trials, translational work and population sciences used to explore these diseases. She is the Principal Investigator on numerous clinical trials and has held advisory board roles with multiple international pharmaceutical companies. Dr. Wakelee is a board-certified physician in medical oncology. She completed a fellowship in oncology and a residency in internal medicine at Stanford University. She holds a medical degree from Johns Hopkins University, and a Bachelor of Arts from Princeton University in Molecular Biology. OncoC4’s SAB, made up of transformative leaders in cancer and immunology include: Michael Caligiuri, MD (Chair) – President, City of Hope Medical Center An international leader in hematology and oncology and Fellow of the National Academy of Medicine who also served as President of the American Association for Cancer Research (AACR) Lieping Chen, PhD – Endowed Professor, Yale University Fellow of the National Academy of Science (NAS) whose discovery of B7H1/PD-L1 ushered in a new era in patient care of cancer Jeffrey S Weber, MD PhD – Deputy Director, New York University Cancer Fellow of the AACR Academy who performed the first randomized studies that unequivocally demonstrated the power of immunotherapy to treat cancer Kunliang Guan, PhD – Emeritus Professor, University of California, San Diego (UCSD) OncoC4 co-founder who was awarded the John D. and Catherine D. MacArthur Fellowship for his pioneering contributions in key cancer biology pathways Kun He, PhD – President R&G, US Master statistician responsible for overseeing the final statistical review of pivotal studies during his time at the Food and Drug Agency (FDA) Heather A. Wakelee, MD, FASCO – Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute Past President of the IASLC and global expert in the clinical treatment of thoracic malignancies About OncoC4Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the potential treatment of cancer. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has two first-in-class clinical stage siglec 10 programs, including AI071, a Phase 2 ready siglec 10 agonist designed for difficult to treat immune related adverse events, and ONC841, a Phase 1 ready siglec 10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: www.oncoc4.com. CONTACTS OncoC4Investor Contact:Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.comMedia Contact:Mari PurpuraLifeSci Advisorsmpurpura@lifesciadvisors.com

BUDAPEST, Hungary I January 16, 2024 I VRG Therapeutics Plc. announces successful in vivo efficacy results of their CAR-T project with patented chlorotoxin analogue targeting glioblastoma, encouraging further development. VRG Therapeutics (VRG Tx), a biotechnology R&D company focused on miniprotein pharmaceuticals and cellular & gene therapy (CGT) products has announced that their proprietary chlorotoxin (CTX) analogue, CTXA8, applied as a targeting molecule in chimeric antigen receptor T (CAR-T) cells, shows efficacy in an in vivo heterotopic glioblastoma murine model. CTXA8 has been developed leveraging VRG Tx’s AI-powered miniprotein platform. The promising preclinical results give a solid background to speed up the allogenic gamma-delta CAR-T (γδCAR-T) program. The company is committed to proceed with the project towards clinical development and is looking for a co-development partner with expertise in CAR-T preclinical and clinical development. CAR-T therapy targeting brain tumors: CAR-T cells are modified white blood cells expressing a chimeric antigen receptor (CAR) against a specific tumor antigen that holds the potential of identification and elimination of cancer cells. The extraordinary therapeutic effect experienced with CAR-T cell therapies targeting hematological malignancies have drawn interest in developing similar products for solid tumors, including brain tumors. High overexpression of MMP2 protein on tumor cells is a recently utilized new target in CAR-T therapy in glioblastoma. The expected increased safety and efficacy of CTXA8-based CAR-T therapy can be explained by the enhanced affinity and selectivity of CTXA8 versus original CTX towards MMP2 overexpressing tumors, such as glioblastoma. VRG Tx’s animal in vivo proof of concept (PoC) study: VRG Tx established a heterotopic xenograft mice model to demonstrate the effectiveness and safety of its CTXA8-targeting CAR-T cell therapy that is designed to treat patients with glioblastoma multiforme (a common type of brain tumor). The mouse model closely mirrors the clinical trial that is currently ongoing with CAR-T cells targeting the original CTX (NCT04214392, City of Hope Medical Center). CTXA8-CAR-T cells showed effective tumor growth inhibition compared to non-specific T cell controls at three different dose levels. The highest dose of administered CTXA8-CAR-T resulted in over 60% inhibition of tumor growth including two individuals with complete tumor remission. The animals did not show any signs of toxicity or body weight loss during the study indicating promising safety features. VRG Tx’s allogenic CAR-T therapy targeting brain tumors: VRG Tx is currently looking for a co-development partner experienced in allogenic CAR-T development, to step into preclinical phase with its proprietary CTXA8 analogue applied in allogenic cell therapy applications. Based on the same MoA, in vitro results of VRG Tx’s CTXA8- γδCAR-T cells show efficacy and high durability against glioblastoma multiforme cells. About VRG Tx’s Miniprotein platform utilizing ISEP and WISDOM technologies: VRG Tx’s proprietary miniprotein technology leverages artificial intelligence (AI) and pioneers in protein engineering to create CGT and peptide-based applications. The Wetlab-verified In Silico Design of Miniproteins (WISDOM) and Individual Sequence Enrichment Pattern (ISEP) technologies build on the evolutionary conserved structures of natural peptides and applies both in silico and in vitro high throughput screenings. Combining AI-powered interaction modelling with NGS-based advanced analytics, VRG Tx designs novel therapeutic candidates with unprecedented selectivity and affinity in an extremely fast discovery process. Miniproteins combine the benefits of small molecules and biologics. About VRG Tx: VRG Therapeutics is an original biopharmaceutical research and development company located in Budapest, Hungary. VRG Tx’s vision is to leverage its unique miniprotein ISEP and WISDOM technologies to create cure for diseases through targets and mechanisms of action that are beyond the reach of conventional biopharma approaches. For more information, please visit www.vrgtherapeutics.com . SOURCE: VRG Therapeutics

Results suggest that more childhood cancer survivors may benefit from a heart-saving medication called carvedilol, even long after their cancer treatment is over LOS ANGELES--(BUSINESS WIRE)-- Physicians at City of Hope, one of the largest cancer research and treatment organizations in the United States, in cooperation with the Children’s Oncology Group (COG), have conducted the largest clinical trial to date seeking to reduce the risk of people who have survived childhood cancer from developing heart failure. The findings published in The Lancet Oncology show that the blood vessel relaxing medication carvedilol is safe for childhood cancer survivors to take and may improve important markers of heart injury sustained as a result of chemotherapy exposure. This press release features multimedia. View the full release here: Physicians at City of Hope Children's Cancer Center, in cooperation with the Children’s Oncology Group (COG), have conducted the largest clinical trial to date seeking to reduce the risk of people who have survived childhood cancer from developing heart failure. The findings published in The Lancet Oncology show that the blood vessel relaxing medication carvedilol is safe for childhood cancer survivors to take and may improve important markers of heart injury sustained as a result of chemotherapy exposure. (Photo Credit: City of Hope) One devastating long-term side effect from a class of chemotherapy called anthracycline is increased risk of heart failure where the heart can’t pump enough blood to meet the body’s needs. This is a delayed process where the heart undergoes gradual changes over time characterized by the thinning of the heart muscle and enlargement of its chambers. Unfortunately, after the onset of heart function decline, the downward cascade is irreversible, highlighting an urgent need for early prevention strategies. “The growing number of childhood cancer survivors makes the development of early interventions imperative. Just helping children survive cancer isn’t enough. We also need to optimize patients’ health so that they don’t have to face life-threatening side effects decades after they are cancer free,” said Saro H. Armenian, D.O., M.P.H., Barron Hilton Chair in Pediatrics at City of Hope Children’s Cancer Center and corresponding author of The Lancet Oncology study. Physicians from City of Hope led the randomized, double-blind Phase 2B clinical trial conducted at 30 COG-member hospitals in the United States and Canada (COG Study ID: ALTE1621). Some 182 enrolled participants took relatively low doses of carvedilol or equivalent placebo for two years. There were no significant differences in side effects between the two study arms, and carvedilol appeared to be well-tolerated. Although the clinical trial did not achieve its goal of decreasing the thinning of the heart muscle and enlargement of its chambers, there were significant improvements in heart left ventricular end-systolic wall stress, which is an earlier biomarker of worsening heart health. “The greatest benefit was seen in participants who were very long-term survivors, as well as in those who were highly adherent to the study medication. Moreover, of the eight patients who developed clinically significant decline in heart function while on the study, six were randomized to placebo and two were receiving carvedilol,” Armenian said. “Our research sets the stage for a Phase 3 clinical trial that may demonstrate a significant benefit for certain patients who are at an especially high risk of irreversible heart function decline after completion of cancer therapy.” Douglas S. Hawkins, M.D., COG group chair and a hematology-oncology professor at Seattle Children’s Hospital, added, “Conducting this study across 30 institutions and among long-term survivors of childhood cancer illustrates the strengths of the COG network. An intervention study on this scale would not be feasible outside of COG. Future research will need to focus on the optimal timing, duration and population for carvedilol intervention.” This study is an important first step toward developing future studies that will seek to optimize the long-term well-being and health of survivors who are expected to live for decades after their initial cancer diagnosis. The Lancet Oncology study entitled “Effect of carvedilol versus placebo on cardiac function in anthracycline-exposed survivors of childhood cancer: a randomised, controlled, phase2b trial (PREVENT-HF)” was supported by the National Cancer Institute of the National Institutes of Health (U10CA180886), the NCI Community Oncology Research Program (UG1CA189955), St. Baldrick’s Foundation, The Leukemia & Lymphoma Society, The Altschul Foundation, Rally Foundation and American Lebanese Syrian Associated Charities. Part of this data was presented at the American Society of Clinical Oncology on June 5, 2023, and International Symposium on Late Complications After Childhood Cancer on June 15, 2023. City of Hope Children’s Cancer Center has a Childhood, Adolescent and Young Adult Cancer Survivorship Program that provides specialized follow-up care for patients who were diagnosed with a childhood cancer or who underwent a bone marrow transplantation before they turned 40. In collaboration with City of Hope’s Department of Supportive Care Medicine, the program helps each survivor stay as healthy as possible by preventing problems from happening or catching them early, when they are most treatable. About City of Hope City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn. About The Children’s Oncology Group (COG) COG (childrensoncologygroup.org) is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Supported by the National Cancer Institute, one of the National Institutes of Health, COG unites over 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Today, more than 90% of the 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcomes for all children with cancer.