Latest news with #EGFR-targeted


Business Wire
30-07-2025
- Health
- Business Wire
Accelerating Impact: AstraZeneca and Revna Biosciences Expand Access to Lung Cancer Treatment in Ghana
ACCRA, Ghana--(BUSINESS WIRE)--The strategic partnership between AstraZeneca and Revna Biosciences is rapidly transforming the landscape of lung cancer care in Ghana. Since the initial announcement in April 2025, the collaboration has made remarkable progress in improving the patient journey—from early diagnosis to molecular testing and now, access to life-saving treatment. Putting patients first: RevnaBio & AstraZeneca deliver EGFR-targeted therapy to Ghana, setting a new standard in cancer care. In a landmark development, AstraZeneca launched one of their targeted therapies for EGFR mutated Lung Cancer patients in Ghana. This milestone marks a pivotal moment in the partnership's mission to bring cutting-edge, targeted therapies to patients in the sub-Saharan African region. 'This collaboration exemplifies how a synergized biomedical ecosystem such as RevnaBio's can help address long-standing institutional voids that have limited access to advanced molecular diagnostics and targeted therapies in this region,' said Dr. Derrick Edem Akpalu, Co-Founder & CEO of Revna Biosciences. 'By integrating advanced diagnostics, data, and treatment pathways, we are enabling a new standard of care for patients who have historically been underserved.' Transforming Cancer Care Through Strategic Execution Revna and AstraZeneca have rapidly translated a shared vision into tangible outcomes across diagnostics, data, and treatment infrastructure: Oncology Treatment Capacity Building: Convened a strategic Lung Cancer Symposium and Training Workshop to strengthen diagnostic capacity by equipping pathologists and oncology leaders with advanced tools and protocols for precision lung cancer diagnostics. Clinical Workflow Optimization: Operationalized EGFR biomarker testing within diagnostic workflows at leading cancer centers, advancing precision oncology and enabling targeted therapy selection at the point of care. Enabling Patient Access: Built a scalable infrastructure that connects cutting-edge molecular diagnostics to personalized treatment pathways, accelerating time-to therapy. Future-Ready Platform: Established real-time data integration to enhance clinical decision-making while building a scalable foundational framework for regional research into molecular profiling, treatment response, and resistance mechanisms. 'We are proud to see this partnership with Revna Biosciences already delivering meaningful impact for patients in Ghana,' said Dr. Khomotso Mashilane, the Medical Director African Cluster at Astrazeneca. 'By combining advanced diagnostics with access to targeted anti-cancer therapies, we are helping to ensure that patients receive the right treatment at the right time. This is a testament to the power of science and collaboration in transforming cancer care.' Voices from the Frontline 'As a triple board-certified physician, I've seen firsthand how delayed diagnosis and limited access to targeted therapies can impact outcomes,' said Dr. Preetivi Ellis, Co-Founder and Medical Head of Revna Biosciences. 'This partnership is a game-changer. We are not only treating today's patients more effectively—we are also building the genomic and real-world data infrastructure that will shape the future of cancer care.' A Shared Ethos: Today's Patients, Tomorrow's Promise This collaboration is deeply aligned with RevnaBio's ethos: caring for today's patients while gleaning genomic and real-world insights that pave the way for better diagnostics and therapies for tomorrow. By embedding precision medicine into the heart of Ghana's healthcare system, RevnaBio and AstraZeneca are setting a new standard for cancer care for the region. About AstraZeneca AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to transforming the future of healthcare by unlocking the power of what science can do. The company delivers life-changing medicines across oncology, cardiovascular, renal and metabolism, respiratory, and rare diseases. About Revna Biosciences Revna Biosciences is a dual ISO-accredited precision medicine company advancing genomic research through Africa's unparalleled genetic diversity. The company's synergized ecosystem leverages its multidisciplinary laboratory facility to seamlessly integrate advanced molecular diagnostics, biobanking, and clinical and translational research services as a foundation for precision medicine advancement. With a biobank comprising samples across infectious diseases, cardiovascular diseases, oncology, rare diseases, and more, Revna supports translational science, biomarker discovery, population genetics, pharmacogenomic studies, and clinical trial optimization. Its digital platform, ROBIN, integrates real-world evidence, phenotypic data, and cross-border logistics to streamline early-phase to late-phase R&D, diagnostics validation, and population-specific therapy development for global health innovation.
Yahoo
13-05-2025
- Health
- Yahoo
EnGeneIC launches groundbreaking new Australian trial for innovative cancer therapy, with international trial site in Singapore to follow
First Patient dosed in Phase I/IIa Basket Trial for Solid Tumours at Mater Hospital, North Sydney Recruitment to open this month at Frankston Hospital, Victoria Further site to follow at Curie Oncology, Singapore SYDNEY, May 12, 2025 (GLOBE NEWSWIRE) -- EnGeneIC Pty Ltd, a Sydney-based biotechnology company and leader in innovative cancer therapies, has announced the successful dosing of the first patient in its open-label, multicentre, Phase I/IIa clinical trial at Mater Hospital, Sydney. The trial (ENG19) is an essential next step in progressing EnGeneIC's novel platform technology through the clinic and to market. It will assess the safety and efficacy of EGFR-targeted EDVTM (EnGeneIC Dream Vector) nanocells carrying the super-cytotoxic drug PNU-159682, together with EDVs loaded with an immune-stimulating adjuvant in patients with advanced solid tumours expressing Epidermal Growth Factor Receptor (EGFR). This groundbreaking study targets patients for whom second-line therapy is no longer working or for whom first- and/or second-line treatments are not appropriate. The trial will focus on EGFR-positive cancers that are difficult to treat and have a poor prognosis, including but not limited to non-small cell lung cancer (NSCLC), mesothelioma, kidney and bladder cancer, pancreatic cancer, head and neck cancer, medullary thyroid cancer, and triple-negative breast cancer. Professor Fran Boyle and Dr. Luke Ardolino are Investigators for the trial at the Mater Hospital. Commenting on the significance of this trial, Professor Boyle said: 'We are thrilled to be part of this innovative study, which has the potential to offer new hope to patients suffering from aggressive EGFR-expressing cancers. The treatment combines cutting-edge technology with a promising therapeutic approach, which has the potential to change the way we treat these challenging cancers.' As part of the expansion of the trial, EnGeneIC will open recruitment at Frankston Hospital, Victoria, this month under the guidance of Principal Investigator, Professor Vinod Ganju before adding further Australian sites. Additionally, the trial will be launched internationally at Curie Oncology in Singapore, where Dr. Su Pin Choo will lead the study and EnGeneIC collaborator, Singapore Advanced Medicine (SAM, Dr. S. K. Djeng) will serve as EnGeneIC's local representative, as required by the Health Sciences Authority, Singapore. Dr Himanshu Brahmbhatt, co-CEO of EnGeneIC commented: 'The EDV nanocell therapy is a globally unique technology that stimulates a complete orchestra of anti-tumor responses, individual to every patient. In early clinical studies, even patients who had exhausted all treatment options have responded. Most anti-cancer therapies are designed to hit only one tumor specific target, but the difficulty lies in the fact that as the cancer progresses, it becomes highly heterogeneous resulting in some cells escaping the therapy. This means that the multi-drug and/or immunotherapy-resistant tumor keeps coming back.' 'In this clinical trial, we aim to identify which cancer indications show a favourable outcome. This trial will accelerate the development of this potentially life-changing treatment for patients, by EnGeneIC's engagement with a committed group of investigators and clinical sites. It is a huge step for us as we take EDV therapy forward in larger, defining, clinical trials for these unresponsive low survival cancers,' he added. EnGeneIC's EDV nanocells form the backbone of the company's ongoing commitment to revolutionise cancer therapy by utilising advanced nanotechnology to improve both the precision and efficacy of treatments to stimulate an anti-tumor immune response and to overcome the drug resistance that plagues successful treatment of low survival tumour types. For more information about the trial or to inquire about participation, please visit or contact Stephen Parker whose details are listed below. The trial is registered on the Australia and New Zealand clinical trial site About EnGeneIC EnGeneIC is a clinical stage biopharmaceutical company focused on developing novel cancer therapies based on its proprietary platform of EnGeneIC Dream Vector (EDV) nanocells. These nanocells are designed to deliver highly potent drugs directly to cancer cells, providing targeted treatment while minimizing damage to healthy tissue and at the same time stimulate a powerful anti-tumour innate and adaptive immune response. The company's approach aims to improve the quality of life and extend survival for cancer patients by offering new and more effective therapies for hard-to-treat cancers. For media inquiries, please contact: Stephen ParkerBusiness Operations sparker@
Yahoo
07-04-2025
- Business
- Yahoo
ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate
ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors that was created from ALX Oncology's proprietary linker-payload platform ALX2004, the company's first ADC, was fully designed and developed in-house by ALX Oncology scientists Company expects to initiate Phase 1 clinical trials of ALX2004 in mid-2025, with initial safety data available in 1H 2026 SOUTH SAN FRANCISCO, Calif., April 07, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ('ALX Oncology' or the 'Company') (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives, today announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company's potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors. Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025. 'Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment,' said Jason Lettmann, Chief Executive Officer at ALX Oncology. 'We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimize the targeted delivery of a powerful chemotherapy payload to tumor cells while minimizing systemic toxicity. The resulting, highly differentiated molecule has demonstrated potent anti-tumor activity in preclinical models and is a strategic addition to our clinical pipeline, which also includes multiple trials evaluating our lead therapeutic candidate, evorpacept.' EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads. Utilizing the company's proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect. ALX Oncology plans to conduct an R&D call focused on ALX2004 in Q2 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025. About ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives. ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at and on LinkedIn @ALX Oncology. Cautionary note regarding forward-looking statementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission (SEC), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultantewebb@ Media Contact: Audra Friis, Sam Brown, 519-9577 Sign in to access your portfolio