Royal North Shore Hospital

SAN MATEO, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CRGX), a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts in cancer research, immunology, and CAR T-cell therapy. The SAB will be chaired by Robbie Majzner, MD, co-founder of CARGO and Director of the Pediatric and Young Adult Cancer Cell Therapy Program within the Departments of Pediatric Oncology and Medical Oncology at Dana Farber Cancer Institute and the Division of Hematology/Oncology at Boston Children’s Hospital. The SAB will provide strategic counsel and critical expertise as CARGO advances its mission to develop the next generation of transformational CAR T-cell therapies. “The formation of our distinguished SAB reaffirms our commitment to advance innovative cell therapies designed to address resistance mechanisms and increase the length of time that patients remain in remission,“ said Michael Ports, PhD, CARGO’s Chief Scientific Officer. “We look forward to leveraging the collective expertise of our SAB as we advance our platform technologies and our pipeline of next-generation, potentially transformative CAR T-cell therapies to make a meaningful impact on the lives of those affected by cancer." CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved autologous CAR T-cell therapies, including limited durability, safety concerns and manufacturing supply constraints. The SAB will play a critical role in supporting CARGO’s research and development priorities as the company builds upon the development of its lead program CRG-022, an autologous CD22 directed CAR T-cell product, by leveraging their proprietary platform technologies, including engineered CD2 co-stimulation technology, to enable the development of multi-specific and multi-functional cellular therapy candidates that are engineered to address mechanisms that strongly associate with poor response and disease progression. “The SAB stands out by bringing together several highly accomplished translational investigators each with CAR T-cell experience that bridges both the laboratory and the clinic,” said Robbie Majzner, MD, co-founder of CARGO and Scientific Advisory Board Chair. “They are uniquely suited to advise CARGO on their scientific goals and directions that will lead to better outcomes for patients.” Members of the CARGO Scientific Advisory Board are listed below; full bios are available on the CARGO website. Robbie Majzner, MD, co-founder of CARGO and Scientific Advisory Board Chair, and Director of the Pediatric and Young Adult Cancer Cell Therapy Program within the Departments of Pediatric Oncology and Medical Oncology at Dana Farber Cancer Institute and the Division of Hematology/Oncology at Boston Children’s Hospital Stephen Gottschalk, MD, Chair of the Department of Bone Marrow Transplantation and Cellular Therapy at St Jude Children’s Research Hospital Andras Attila Heczey, MD, Professor, Department of Pediatrics of Baylor College of Medicine, Section of Pediatric Hematology and Oncology Marcela Maus, MD, PhD, Associate Professor at Harvard Medical School, the Paula O’Keefe Chair in Oncology, Director of Cellular Immunotherapy at Massachusetts General Hospital (MGH) Cancer Center, Attending Physician in the Hematopoietic Cell Transplant and Cell Therapy Division of Oncology at MGH Cameron Turtle, MBBS, PhD, Professor and CLEARbridge Chair in Cancer Immunotherapy in the Faculty of Medicine and Health at the University of Sydney; Clinical academic physician at Royal North Shore Hospital, Sydney, Australia About CARGO Therapeutics CARGO Therapeutics is a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at . Find more information at cargo-tx.com Follow us on LinkedIn: CARGO Therapeutics Follow us on Twitter: @CARGOTx Media Contact: Maura Gavaghan maura@redhousecomms.com Investor Contact: Laurence Watts laurence@gilmartinir.com

Highlights Presentation at American Society of Clinical Oncology (ASCO) demonstrates potential to detect breast cancer using plasma lipidomic biomarker signature Results reduce the complexity and advance commercial viability of BCAL test BCAL laboratory now operational to advance clinical research, analytical and clinical validation studies Pathway for laboratory developed test (LDT) to be available to patients and medical community SYDNEY, June 6, 2023 /PRNewswire/ -- BCAL Diagnostics Limited (ASX:BDX) (BCAL or Company) today announced the presentation of data demonstrating the potential for detection of early breast cancer using a plasma lipidomic biomarker signature. BCAL is developing a non-invasive blood screening test that is intended to be used alongside breast cancer screening methods, such as mammography. The poster, "Lipidomic Signature From Plasma to Detect Localised Breast Cancer," was presented at the 2023 ASCO Annual Meeting (Chicago, 2-6 June 2023). "Our study demonstrated that the plasma lipid signature performance was highly accurate and comparable to the plasma-enriched extracellular vesicles (EV) cohort, a more time intensive and complex step," said Dr. Gillian Lamoury, Royal North Shore Hospital. "These findings strongly support the utility of the lipid signature in plasma to effectively distinguish people with localised breast cancer from healthy controls." The use of plasma enables a method that is routine for blood sampling, which decreases the cost of delivery and increases patient access to the test. "Breast cancer is the most common cancer among women and the second most common cause of death from cancer, but with early diagnosis and intervention, clinical outcomes can be improved, and lives saved," said Dr. John Hurrell, CEO, BCAL Diagnostics. "An effective and accurate blood test to detect localised breast cancer may increase the detection rate and improve patient outcomes. We are encouraged by the results of this study which was designed to reduce the complexity and advance the commercial viability of BCAL's novel blood test, BCAL Dx, for breast cancer detection." About the Study Following previous studies of lipid signatures derived from plasma-enriched extracellular vesicles that effectively distinguished people with localized breast cancer from cancer-free controls, BCAL aimed to investigate the utility of the lipid signature directly in plasma samples eliminating the EV enrichment step. Lipids were extracted from enriched EVs from plasma samples donated by fasted people with localised breast cancer and control samples (n=793) and analysed by high resolution liquid chromatography-mass spectrometry (LC-MS). Over 400 manually curated lipids were quantified. Following variable selection, a lipid signature capable of distinguishing breast cancer samples from controls was derived. The lipid signature was modelled on each of the cohorts using leave-one-out internal cross-validation. Researchers then analysed the lipids in cancer and control (n=256) plasma samples corresponding to patients from Cohorts 3 and 4 previously used for EV preparations, and applied the signature derived using EVs on plasma lipidomic data. EV samples of people with breast cancer were distinguished from controls with an area under the curve (AUC) of 0.77-0.89 across four cohorts. When the lipid signature was assessed directly from plasma the test achieved a comparable AUC of 0.84. Assessing the markers directly from plasma samples would make the test more scalable, higher throughput and easier to perform. The study demonstrated the high performance of a lipid biomarker signature derived from plasma enriched EVs for early detection of localised breast cancer. The results suggest that the lipidomic signature could potentially be assessed directly from plasma samples instead of EVs reducing the test complexity. Ongoing studies will optimise the plasma lipidomic signature and prospectively compare the test against mammographic and pathological diagnoses. Plasma Liquid Signature Performance is Comparable to EVs The Company continues to make significant clinical development progress and has conducted multiple studies of more than 1,200 patients. The test will initially complement current imaging technologies, such as the mammogram, particularly for women in the high-risk category due to breast tissue density or genetic predisposition. BCAL recently announced the opening of its new development and clinical services laboratory that will utilize the newest Liquid Chromatography Mass Spectrometry (LCMS) platforms to continue to advance the findings of the Company's clinical research to-date and the progress made by BCAL Diagnostics' US development partner, Precion Inc. to establish and validate workflows and test protocols. This new laboratory will also serve as the testing site for the ongoing and planned analytical and clinical validation studies and will establish the quality systems and protocols to be compliant with ISO 15189, CLIA accreditation, NPAAC (National Pathology Accreditation Advisory Council) certifications and requirements of the Therapeutic Goods Act 1989 (Cth). The successful completion of these studies and receipt of the accreditations will allow the BCAL blood test to be available to the medical community and patients as an in-house developed test, also known as a laboratory-developed test or LDT. Patient samples will be collected and forwarded to BCAL's laboratory, where they will be tested for the proprietary BCAL lipid signature that is expressed by breast cancer cells. To learn more about BCAL Diagnostics or to participate in BCAL's research, you can register your interest online at . This ASX announcement has been approved for release by the Board of BCAL. About BCAL Diagnostics Limited (BCAL) BCAL Diagnostics Limited is an Australian biotechnology company committed to improved health outcomes for women. Over the past decade, BCAL has developed a non-invasive blood screening technology that is initially intended to be used alongside breast cancer screening methods. The technology will initially complement current imaging technologies, such as the mammogram, while BCAL further progresses the development of a monitoring and screening test suitable for women of all ages and backgrounds in any location. With more than two million new cases of breast cancer diagnosed globally each year, a substantial opportunity exists for BCAL to improve patient outcomes. BCAL has partnered with Precion Inc. to optimize protocols and procedures for the clinical studies required for regulatory approvals across several jurisdictions, commercialization and market entry points. Founded in 2010, BCAL is headquartered in Sydney and listed on the Australian Securities Exchange (ASX:BDX). For more information: SOURCE BCAL Diagnostics Limited

HIGHLIGHTS Amplia's highly selective FAK inhibitor AMP945, when used in combination with FOLFIRINOX, enhances survival in a preclinical model of pancreatic cancer FOLFIRINOX is the most widely used treatment for pancreatic cancer patients in the US, Canada and most European countries This new data supports clinical studies investigating the combination of AMP945 in a second major treatment regimen in pancreatic cancer Amplia has filed a patent to cover the use of FAK inhibitors in combination with FOLFIRINOX and related treatment regimes MELBOURNE, Australia, May 29, 2023 /PRNewswire/ -- Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") is pleased to announce new data showing the efficacy of its investigational FAK inhibitor, AMP945, in a preclinical model of pancreatic cancer, when used in combination with FOLFIRINOX treatment. FOLFIRINOX, a combination of four chemotherapies used in the treatment of pancreatic cancer patients, is currently a widely-used treatment in many major markets around the world including the US. New data from preclinical studies conducted in the laboratory of Prof. Paul Timpson at the Garvan Institute of Medical Research in Sydney, demonstrate that mice treated with AMP945 in addition to FOLFIRINOX show improved overall survival compared to those treated with FOLFIRINOX alone. The data, available in the Meeting Abstracts for the forthcoming American Society of Clinical Oncology meeting in Chicago, USA, (here)[1] describe studies in mice bearing pancreatic cancer tumours derived from a human patient. AMP945 was given in the days preceding FOLFIRINOX treatment (given on a 12-day cycle) resulting in a statistically significant increase in survival (up to 35% approx.) compared to FOLFIRINOX-only treated mice. Dr Chris Burns, Amplia's CEO and Managing Director commented: "The exciting results from this mouse study further indicate the potential of AMP945 in pancreatic cancer treatment when used in combination with standard-of-care therapies. In light of this data, we have filed a patent to cover the use of FAK inhibitors, and particularly AMP945, in combination with FOLFIRINOX and related treatment regimes." With this data, and the Company's previously reported preclinical data demonstrating the benefit of combining AMP945 with gemcitabine and nab-paclitaxel, AMP945 has shown promising activity in models of pancreatic cancer with the two most common first-line chemotherapy regimens for treatment of the disease. Prof. Nick Pavlakis, a medical oncologist at the Royal North Shore Hospital in Sydney, and an investigator in the current ACCENT trial, commented: "FOLFIRINOX is employed under certain conditions in Australia and more broadly in the USA and Europe, and the data from this study, coupled with the developing safety and tolerability data from Amplia's current ACCENT trial, provide strong support to undertake a future clinical study of AMP945 with FOLFIRINOX." This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics. About AMP945 AMP945 is an orally bioavailable small molecule FAK inhibitor with a best-in-class profile. The compound is currently undergoing a Phase 1b/2a trial in pancreatic cancer patients in combination with gemcitabine and nab-paclitaxel (the ACCENT trial) in Australia. More information about the ACCENT trial, including a list of participating sites, can be found via our website and at ClinicalTrials.gov under the identifier NCT05355298. About FOLFIRINOX FOLFIRINOX is combination chemotherapy consisting of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin used in the treatment of pancreatic cancer. In Australia, FOLFIRINOX is reserved for younger, fitter patients whereas in other countries (e.g. US, UK, Canada, France) it is standard-of-care therapy where it has been shown to result in a median overall survival of 11.1 months. Related chemotherapies such as FOLFOX and FOLFIRI are used to treat colorectal cancer and other gastric cancers. About Amplia Therapeutics Limited Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer immunology and Amplia has a particular development focus in fibrotic cancers such as pancreatic cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit and follow Amplia on Twitter (@ampliatx) and LinkedIn. SOURCE Amplia Therapeutics