Oligometastatic Disease

NG-350A is a next generation, systemically administered immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody in both primary and metastatic tumor sites Proof-of-concept FORTRESS trial combines NG-350A with standard-of-care chemoradiotherapy in adult patients with locally advanced rectal cancer and at least one risk factor for local or distant recurrence CAMBRIDGE, MA, USA I April 03, 2025 I Akamis Bio, a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform to deliver novel immunotherapeutic payloads to solid tumors, today announced enrollment of the first patient in the proof-of-concept FORTRESS study of NG-350A in locally advanced rectal cancer (LARC). FORTRESS is a multi-center, open-label, non-randomized, Phase 1b study designed to measure clinical complete response (cCR) rates in patients with LARC. The study builds upon the Akamis Bio-supported, CEDAR study, which showed a significantly greater complete response rate in LARC patients treated with a combination of Akamis Bio’s first generation immunotherapy and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. Prior clinical studies of NG-350A have demonstrated a favorable safety profile for the therapy, with no observed transgene-related or off-target toxicities. “We have previously demonstrated that intravenously administered T-SIGn® therapeutics can reach both primary and metastatic tumor sites to drive local expression of immunotherapeutic payloads,” said Oliver Rosen, MD, Akamis Bio’s chief medical officer. “The results from prior clinical studies have provided what we believe is a clear roadmap for the design of the FORTRESS trial, where our aim is to demonstrate the safety and efficacy of NG-350A in LARC in order to advance a new therapeutic approach that can improve the current standard of care for patients living with this disease.” About the FORTRESS Trial The Phase 1b FORTRESS trial ( NCT06459869 ) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The study is planning to enroll approximately 30 patients aged eighteen and older with histologically confirmed adenocarcinoma of the rectum which is locally advanced (clinical stage II-III based on pelvic MRI). During the 12-week active study treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint for the study will be the proportion of patients achieving a clinical complete response (cCR) at week 12. Key secondary endpoints will include the incidence and severity of adverse events, clinical response (CR) outcome, and MRI-based tumor regression grade (mrTRG). About NG-350A NG-350A is a clinical-stage, intravenously delivered T-SIGn® therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression. About LARC Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States with about 145,000 people newly diagnosed each year. Amongst the incident colorectal cancer population, about 45,000 people are diagnosed specifically with rectal cancer of which approximately 60 percent have locally advanced rectal cancer (LARC). LARC is defined by the spread of the rectal cancer to nearby tissues or lymph nodes. In patients with LARC, tumors have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs or structures and/or into the lymph nodes. About T-SIGn ® Akamis Bio’s T-SIGn® therapeutics are based on a replication competent, chimeric group B adenovirus backbone which has been adapted via directed evolution to home specifically to both primary and metastatic epithelial-derived solid tumor tissue following intravenous delivery. Once at the tumor site, T-SIGn® therapeutics can drive the intratumoral expression of multiple transgene payloads, turning solid tumor cells into “drug factories” while leaving healthy tissue unaltered and intact. The intratumoral expression of immunologically active biomolecules and therapeutic proteins can result in the remodeling of the solid tumor microenvironment, triggering robust antitumor immune responses. T-SIGn® therapeutics have the potential to be used in the monotherapy setting, as well as in combination with other immuno-oncology agents to target the key mechanisms that tumors use to evade the immune system. About Akamis Bio Headquartered in Cambridge, Massachusetts, Akamis Bio is a clinical-stage oncology company developing systemically administered immunotherapies to treat solid tumors, initially in patients with locally advanced rectal cancer (LARC). Its proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform is designed to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors, with its lead clinical-stage program, NG-350A, driving intratumoral expression of a CD40 agonist monoclonal antibody. To learn more, please visit www.akamisbio.com . SOURCE: Akamis Bio

First cancer center in Oklahoma and fourth VA medical center to offer advanced MRI-guided radiation therapy to treat cancer. DENVER, June 13, 2023 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the VA Oklahoma City Healthcare System has selected MRIdian MRI-guided radiation therapy system to expand radiation therapy services at the Oklahoma City VA Medical Center. This will be the first cancer center in Oklahoma and the fourth VA medical center offering Veterans access to MRIdian's advanced MRI-guided radiation therapy to treat cancer. The MRIdian system will enable the Oklahoma City VA Medical Center to provide precision MRI-guided radiation therapy technology to Veterans seeking personalized treatment for a broad range of cancer, including pancreas, prostate, lung, liver, breast, and oligometastatic disease. Other VA medical centers that will be offering MRIdian MRI-guided radiation therapy include Louis Stokes Cleveland Medical Center (VA Northeast Ohio Healthcare System), Lt. Colonel Charles S. Kettles VA Medical Center (VA Ann Arbor Healthcare System), and Michael E. DeBakey Medical Center (VA Houston Healthcare system). The Veterans Health Administration is America's largest integrated healthcare system, providing care at 1,298 healthcare facilities, including 171 medical centers. The VA is leading the fight against cancer through precision oncology by developing and applying new technologies, tools, research knowledge, and best-practice therapies. Their scientific and medical breakthroughs are shared inside and outside their healthcare system to benefit Veterans and all Americans. "ViewRay is proud to be working with VA Oklahoma City Healthcare System, a talented group of clinicians committed to bringing patients the benefit of precise and personalized radiation therapy," said Paul Ziegler, ViewRay Executive Vice President and CCO. "We are excited to see another VA healthcare system join the growing MRIdian community. Expanding the availability of MRIdian's short-course non-invasive therapy with fewer side effects and better quality of life is an important advancement for our Veterans." The MRIdian system provides oncologists with outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions without relying on implanted markers. MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins by providing continuous real-time tracking of the target and organs at risk. This allows for delivering the prescribed dose to the target while sparing surrounding healthy tissue and critical structures. This results in minimizing toxicities typically associated with conventional radiation therapy. To date, over 31,000 patients have been treated with MRIdian. Currently, 62 MRIdian systems are installed at hospitals around the world, where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: Disclaimer: Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations. Safety Statement The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation and magnetic resonance imaging with your doctor to make sure radiation treatment is right for you. About ViewRay ViewRay, Inc. (Nasdaq: VRAY) designs, manufactures, and markets the MRIdian® MRI-Guided Radiation Therapy System. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian's high-definition MR was purpose-built to address specific challenges, including beam distortion, skin toxicity, and other concerns that potentially may arise when high magnetic fields interact with radiation beams. ViewRay and MRIdian are registered trademarks of ViewRay, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Private Securities Litigation Reform Act. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, ViewRay's financial guidance for the full year 2023, anticipated future orders, anticipated future operating and financial performance, treatment results, therapy adoption, innovation, and the performance of the MRIdian systems. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to commercialize the MRIdian Linac System, demand for ViewRay's products, the ability to convert backlog into revenue, the timing of delivery of ViewRay's products, the timing, length, and severity of the COVID-19 pandemic, including its impacts across our businesses on demand, our operations and global supply chains, the results and other uncertainties associated with clinical trials, the ability to raise the additional funding needed to continue to pursue ViewRay's business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates, and overall market conditions. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to ViewRay's business in general, see ViewRay's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with the Company's other filings with the SEC. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. SOURCE ViewRay, Inc.

TUESDAY, May 2, 2023 -- A patient-centered, multidisciplinary approach is strongly recommended for decision-making regarding treatment for oligometastatic non-small cell lung cancer (NSCLC), according to a clinical practice guideline issued jointly by the American Society for Radiation Oncology and European Society for Radiotherapy and Oncology and published online April 25 in Practical Radiation Oncology . Puneeth Iyengar, M.D., Ph.D., from UT Southwestern in Dallas, and colleagues addressed five key questions relating to use of local and systematic therapy in the management of oligometastatic NSCLC. Recommendations were based on a systematic literature review. The authors note that a patient-centered, multidisciplinary approach is strongly recommended for all decision-making regarding potential treatment based on a lack of significant randomized phase 3 trials. Definitive local therapy integration is relevant if technically feasible and clinically safe to all disease sites (five or fewer). Definitive local therapies are conditionally recommended in synchronous, metachronous, oligopersistent, and oligoprogressive conditions for extracranial disease. The only primary definitive local therapy modalities recommended for use in management of oligometastatic disease are radiation and surgery ; indications are provided for choosing one over the other. For systemic and local therapy integration, sequencing recommendations are provided. Recommendations are also provided for optimal technical use of hypofractionated radiation or stereotactic body radiation therapy as definitive local therapy. "Despite the widespread enthusiasm in the field of oligometastatic disease, the quality of evidence supporting the integration of definitive local therapy into a multimodality treatment strategy is still lower as compared to indications such as locally advanced NSCLC," a coauthor said in a statement. "To compensate for this lack of highest-quality evidence, recommendations of this guideline were established by a broad consensus." Several authors disclosed financial ties to the pharmaceutical industry. Abstract/Full Text (subscription or payment may be required) Posted May 2023