Lineberger Comprehensive Cancer Center

ACT-IOP-003 is an implantable iontophoretic product designed to safely achieve high concentration of gemcitabine in the pancreas, via non-circulatory pathways and with little to no systemic drug exposure or associated toxicity. Demonstrated dramatic results in an orthotopic patient-derived xenograft murine model of human pancreatic cancer in which 100% of treated tumors averaged 40% volume reduction. Study expected to start mid-2024. CARY, N.C.--(BUSINESS WIRE)-- Focal Medical, Inc., (“Focal”) a privately held biopharmaceutical company developing a targeted therapeutic system to treat inoperable tumors and to deliver genomic medicines, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application to initiate a Phase 1b clinical trial of ACT-IOP-003, the Company’s first targeted therapeutic product. The trial will evaluate the safety and tolerability of targeted delivery of gemcitabine to locally advanced nonresectable (LANR) pancreatic tumors. The clinical trial is expected to start mid-2024. This press release features multimedia. View the full release here: Focal Medical’s Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) (Photo: Business Wire) “Pancreatic cancer is a devastating disease with a very poor prognosis,” said Dr. William Daunch, Chief Technology Officer of Focal. “Once a locally advanced tumor is not resectable, treatment options are limited and these patients experience a significantly reduced survival outlook compared to resectable cases. Our thesis, which we have demonstrated in animal models of pancreatic cancer, is that localized delivery of high concentrations of gemcitabine via our implantable iontophoretic device can reduce tumor volume to a point where surgical removal may be possible, while also minimizing systemic exposure and associated toxicity. If successful, we may offer the opportunity of extended survival for the significant number of pancreatic cancer patients presenting with nonresectable disease.” Pancreatic adenocarcinoma, which represents more than 90 percent of pancreatic cancer diagnoses, is an especially challenging disease to treat. According to The American Cancer Society, the incidence of pancreatic cancer in the U.S. is more than 62,000 cases annually and it represents the third leading cause of cancer death. Patients whose tumors are resectable have the best chance for cure and, for these patients, surgical resection with or without neoadjuvant chemotherapy, is the standard of care. Treatment options for locally advanced nonresectable tumors comprise a variety of systemic chemotherapy regimens, which are rarely curative unless there is dramatic response to chemotherapy that allows the tumor to be resected. The multi-center, open label, modified dose escalation phase 1b clinical trial will assess the safety, tolerability, and clinical activity of the implantable ACT-IOP-003 targeted therapeutic product delivering gemcitabine directly into the pancreas to treat LANR pancreatic cancer. Eligible patients would be enrolled into one of two cohorts, receiving treatment either once or twice weekly over 8 weeks (approximately 5 patients per cohort). Up to 12 patients may be enrolled in the study which is expected to start mid-2024. “Clinicians who treat pancreatic cancer need new and more powerful tools in their armamentarium to address this terrible disease,” commented Jen Jen Yeh, M.D., Focal Medical Co-founder and Non-executive Director, and Professor and Vice Chair of Research, Department of Surgery and Director of the Pancreatic Cancer Center of Excellence at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. “The novel approach that the Focal Medical system employs to drive gemcitabine directly and selectively into the pancreas may offer new hope for patients.” Michael Aldridge, CEO of Focal added, “The FDA’s clearance of Focal’s IND for ACT-IOP-003 for pancreatic cancer is an important achievement for the Company. We remain focused on our important mission to provide hope for patients suffering with this devastating disease.” About Focal Medical Focal Medical, Inc. is a privately held, biopharmaceutical company developing novel therapeutic products based on its innovative and patent protected targeted therapeutic system. The Company’s lead product is a targeted therapeutic product delivering gemcitabine (an FDA approved chemotherapeutic) actively and directly to the pancreas by non-circulatory pathways to treat pancreatic cancer. Focal Medical is expanding its product focus into therapies for other solid tumors and genomic medicine products. Its products utilize its innovative energy-based targeted therapeutic system. Focal Medical’s patented iontophoresis delivery system enables the internal, site-specific delivery of therapeutics actively, directly, and selectively to the target organ using non-circulatory pathways. The technology thus addresses certain significant challenges and limitations of traditional systemic drug delivery including systemic toxicity and barriers to therapeutic effect. Please visit our website at: .

Five Recipients Are Advancing Research And Transforming Patient Care SAN ANTONIO, Dec. 6, 2023 /PRNewswire/ -- Susan G. Komen®, the world's leading breast cancer organization, will present awards to four dedicated physician scientists and a pioneering research advocate for their work to drive discoveries and improve breast cancer patient outcomes. They will be recognized tonight at the Susan G. Komen Breast Cancer Research Awards event in San Antonio. The awardees are Olufunmilayo F. Olopade, MBBS, FAACR, FASCO; Daniel F. Hayes, MD, FASCO, FACP; Sara M. Tolaney, MD, MPH; Gaorav P. Gupta, MD, PhD, and Patricia A. Spears, BS, FASCO. Continue Reading Susan G. Komen® recognizes these innovative and successful physicians and scientists for their efforts in the advancement of the field of breast cancer at the 2023 San Antonio Breast Cancer Research Symposium "This year's recipients are distinguished leaders in their fields and have dedicated their careers to improving outcomes so the next person diagnosed with breast cancer can have a more personalized treatment plan and a better long-term outcome, and for this, the entire breast cancer community is grateful for their contributions," said Ann Partridge, MD, MPH, Co-Chief Scientific Advisor at Susan G. Komen, and Vice Chair of Medical Oncology at Dana-Farber Cancer Institute. Susan G. Komen Brinker Awardees Komen established the Brinker Award in 1992 to honor leaders in basic science and clinical research. This evening's awardees have made significant contributions in breast cancer research and clinical practice, both of which are critical to fighting this disease. They have advanced our understanding of the mechanisms underlying the genesis of breast cancer (Basic Science) and have pioneered advances in breast cancer care (Clinical Research). Olufunmilayo F. Olopade, MBBS, FAACR, FASCO, received the Brinker Award for Scientific Distinction in Basic Science. Dr. Olopade's research has identified cancer-predisposing gene variants that are prevalent in certain ancestral populations, leading to ground-breaking translational work in hereditary breast cancer and cancer risk assessment. Her work has substantially improved our ability to identify women at high risk for breast cancer, greatly increasing the odds of prevention and early detection, including for women living in under-resourced communities around the world. Dr. Olopade is the Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics, Founding Director of the Center for Clinical Cancer Genetics and Associate Dean for Global Health at The University of Chicago. She is also a Komen Scholar. Daniel F. Hayes, MD, FASCO, FACP, received the Brinker Award for Clinical Research. Dr. Hayes has created tumor biomarker tests that are used around the world to assess prognosis and predict chemotherapy response, recurrence, and treatment side effects in patients. His work has accelerated the development of precision care and treatment for breast cancer patients and enabled precise monitoring of patients after therapy, so that they receive the treatment that is best for them individually. Dr. Hayes is the Stuart B. Padnos Professor of Breast Cancer Research at the University of Michigan Rogel Cancer Center and Professor of Internal Medicine at the University of Michigan Medical School Division of Hematology/Oncology. Susan G. Komen Rising Star Researchers This award is new in 2023 and is given to mid-career investigators, whose work shows potential to significantly impact the field of breast cancer research and who demonstrate strong leadership potential in the breast cancer community. Sara M. Tolaney, MD, MPH, is recognized for her significant contributions to the development of novel treatment regimens that improve breast cancer outcomes while involving less toxic therapies, thus enhancing patient quality of life. She serves as the Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, as well as the Associate Director of the Susan F. Smith Center for Women's Cancers. She is a Senior Physician at Dana-Farber and an Associate Professor of Medicine at the Harvard Medical School. Gaorav P. Gupta, MD, PhD, is renowned for his seminal research on the interplay between genome integrity pathways and breast cancer initiation, progression and response to therapy. His research will translate to innovative ways of monitoring treatment, including the use of non-invasive "liquid biopsy" tests to monitor treatment and to personalize radiotherapy and other cancer treatments. He is an Associate Professor at the University of North Carolina at Chapel Hill and the Associate Chair for Research in the Department of Radiation Oncology, and co-leader of the Breast Cancer Program at the Lineberger Comprehensive Cancer Center. Susan G. Komen Research Advocacy Champion Also new in 2023, the Research Advocacy Champion Award is presented to an emerging or established leader in research advocacy who is highly effective in ensuring that the unique and valuable perspectives of breast cancer patients, survivors and co-survivors are integrated into the scientific dialogue to drive progress, improve patient outcomes, and help realize Komen's vision of a world without breast cancer. Patricia A. Spears, BS, FASCO , scientific research manager and director of the Patient Advocates for Research Council at UNC Lineberger Comprehensive Cancer Center and Komen Advocates in Science, is a renowned cancer research patient advocate who brings her personal experience as a breast cancer survivor of 20-plus years, a recent liver cancer survivor and a laboratory scientist to her advocacy work. She is honored for her decades-long commitment to research advocacy and manner in which she has advanced breast cancer research by sharing patient insights with researchers, advancing clinical trials, communicating research to the public, and mentoring the next generation of patient advocates. "The field of breast cancer is better today because of these five outstanding individuals and their dedication to furthering our understanding of the disease, to discovering new therapies, and to ensuring people diagnosed with breast cancer can live their fullest and best lives. I am thrilled that Komen is recognizing each of them for the countless ways they have impacted millions of people affected by breast cancer," said Jennifer A. Pietenpol, Ph.D., co-Chief Scientific Advisor at Susan G. Komen and Chief Scientific and Strategy Officer and Executive Vice President for Research at Vanderbilt University Medical Center. About Susan G. Komen® Susan G. Komen® is the world's leading nonprofit breast cancer organization, working to save lives and end breast cancer forever. Komen has an unmatched, comprehensive 360-degree approach to fighting this disease across all fronts and supporting millions of people in the U.S. and countries worldwide. We advocate for patients, drive research breakthroughs, improve access to high-quality care, offer direct patient support and empower people with trustworthy information. Founded by Nancy G. Brinker, who promised her sister, Susan G. Komen, that she would end the disease that claimed Suzy's life, Komen remains committed to supporting those affected by breast cancer today, while tirelessly searching for tomorrow's cures. Visit komen.org or call 1-877 GO KOMEN. Connect with us on social at . CONTACT: Amy Jo Steinbruecker Susan G. Komen [email protected] SOURCE Susan G. Komen for the Cure

WALTHAM, Mass., Dec. 4, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company will host an in-person investor event, along with a live webcast, on Monday, December 11, 2023, at 7:00 a.m. PT / 10:00 a.m. ET during the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California. The event will include new data for both the axatilimab and revumenib programs, and members of the Syndax management team will be joined by the following key opinion leaders: Daniel Wolff, M.D., Professor of Hematology, Department of Internal Medicine III of the University of Regensburg Eytan M. Stein, M.D., Chief, Program for Drug Development in Leukemia, Department of Medicine, Memorial Sloan Kettering Cancer Center Ghayas C. Issa, M.D., Assistant Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center Joshua F. Zeidner, M.D., Associate Professor of Medicine, Chief, Leukemia Research, University of North Carolina, Lineberger Comprehensive Cancer Center Neerav N. Shukla, M.D., Chief, Pediatric Translational Medicine Service, Memorial Sloan Kettering Cancer Center The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website or directly through the meeting link here. For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website at for a limited time. About Syndax Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a highly selective inhibitor of the menin–KMT2A binding interaction, and axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. For more information, please visit or follow the Company on Twitter and LinkedIn. Syndax Contacts Sharon Klahre Syndax Pharmaceuticals, Inc. [email protected] Tel 781.684.9827 SNDX-G SOURCE Syndax Pharmaceuticals, Inc.