Capecitabine

Caris reinforces the value of Whole Exome Sequencing and Whole Transcriptome Sequencing testing for cancer patients IRVING, Texas , March 24, 2026 /PRNewswire/ -- Caris Life Sciences ® (NASDAQ: CAI), a leading patient-centric, next-generation AI TechBio company and precision medicine pioneer, is recognizing Colorectal Cancer Awareness Month by highlighting the critical role of DPYD testing in helping to inform treatment for patients with colorectal cancer. Colorectal cancer remains one of the most commonly diagnosed cancers in the United States and is a leading cause of cancer-related death. Recent American Cancer Society data underscore the ongoing burden of the disease, including rising incidence in younger adults, reinforcing the need for earlier detection, more personalized care and greater awareness of testing that may influence treatment decisions. For many patients with colorectal cancer, fluoropyrimidine-based therapies such as capecitabine and fluorouracil remain a cornerstone of treatment. However, certain inherited variants in the DPYD gene can reduce dihydropyrimidine dehydrogenase (DPD) enzyme activity, increasing the risk of severe, and in some cases life-threatening, toxicity from these common therapies. The FDA has updated safety labeling for capecitabine and 5-FU to increase awareness of DPD deficiency risks and advises testing patients for genetic variants of DPYD prior to treatment initiation unless immediate therapy is necessary. Despite growing clinical awareness and guideline support for considering DPYD testing prior to treatment, screening remains inconsistent across care settings, leaving many patients and providers unaware of a risk that can have profound clinical consequences. Caris addresses this gap by incorporating DPYD reporting into Caris Assure®, its blood-based Whole Exome Sequencing and Whole Transcriptome Sequencing molecular profiling assay. This allows clinicians to assess not only tumor biomarkers, but also clinically relevant inherited variants from a single blood draw, streamlining care while expanding the actionable information available before treatment begins. By identifying inherited variants in the DPYD gene before therapy, physicians may be able to reduce the risk of serious toxicity associated with fluoropyrimidine-based chemotherapies. "In precision oncology, treatment selection is not only about identifying what may work but also understanding factors that may affect how safely a patient can receive therapy," said Caris President David Spetzler, MS, PhD, MBA . "During Colorectal Cancer Awareness Month, it is important to recognize that DPYD testing can provide clinically meaningful information before treatment begins, helping clinicians make more informed decisions for patients who may be candidates for fluoropyrimidine-based therapy." As the oncology community continues to advance more individualized care, Caris believes awareness of pharmacogenomic factors like DPYD status is an important part of the broader precision medicine conversation in colorectal cancer. Increasing education around biomarker-informed care may help support safer treatment planning and improve the patient's experience. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies and high-performance computing provides a differentiated platform for developing the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.  Caris was founded with a vision to realize the potential of precision medicine to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets.  Forward Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding our business, solutions, plans, objectives, goals, industry trends, financial outlook and guidance. In some cases forward-looking statements can be identified by words such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "potential," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or similar expressions.   You should not rely upon forward-looking statements as predictions of future events. 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Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: developments in the precision medicine industry; our future financial performance, results of operations or other operational results or metrics; development, analytical and clinical validation, timing and performance of future solutions by us and our competitors; commercial market acceptance for our solutions, including acceptance of preventive as well as diagnostic testing paradigms, and our ability to meet resulting demand; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions related to our solutions; risks related to data management, storage, and processing capabilities and our ability to integrate and deploy artificial intelligence and advanced data analytics technologies; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; reliance on third-party suppliers; risks related to data security, patient privacy, and compliance with healthcare data protection regulations as well as potential cybersecurity threats to our data platforms; our compliance with laws and regulations; the outcome of government investigations and litigation; risks related to our indebtedness; and our ability to hire and retain key personnel as well as risks, uncertainties, and other factors described in the section titled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 3, 2026, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law. Caris Life Sciences Media: Corporate Communications CorpComm@CarisLS.com 214.294.5606 View original content to download multimedia: SOURCE Caris Life Sciences

Company to disclose clinical safety and efficacy data for NG-350A in combination with chemoradiotherapy following 12-week active treatment period CAMBRIDGE, Mass.--(BUSINESS WIRE)--Akamis Bio, a clinical-stage oncology company working to advance the standard of care in colorectal cancer, today announced an upcoming poster presentation of initial clinical data from the FORTRESS study of NG-350A, an oncolytic immunotherapy for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22 in San Diego. The ongoing Phase 1b FORTRESS study ( NCT06459869 ) is assessing the anti-tumor effects of NG-350A plus chemoradiotherapy (CRT) following a 12-week active treatment period to establish whether NG-350A can improve response rates relative to expected outcomes from CRT alone. The trial is enrolling adult patients with pMMR LARC and at least one risk factor for local or distant recurrence. NG-350A is an intravenously delivered oncolytic immunotherapy 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. Poster Presentation Details Title: Phase 1b trial of NG-350A, a CD40 agonist antibody expressing adenoviral vector, in combination with chemoradiotherapy (CRT), in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC): Initial results from the FORTRESS study Session Title: Phase II and Phase III Clinical Trials Date and Time: April 20, 2:00PM – 5:00PM PST Location: Poster Section 52 Poster Number: 19 About NG-350A NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (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 the FORTRESS Study The Phase 1b FORTRESS study ( NCT06459869 ) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported, CEDAR study, which showed a significantly greater response rate in LARC patients treated with a combination of Akamis Bio’s first generation oncolytic immunotherapy and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS 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 treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint for the study is the proportion of patients achieving a response (complete clinical response [cCR] or near complete clinical response [ncCR]) at week 12. Key secondary endpoints include the incidence and severity of adverse events, characterization of the anti-tumor effects of NG-350A in combination with CRT (including clinical response outcome and magnetic resonance tumor reduction grade [mrTRG]), and measurement of levels of circulating tumor DNA (ctDNA) clearance. Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit . About Locally Advanced Rectal Cancer (LARC) Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States (US), and it has recently emerged as the leading cause of cancer-related death in patients under 50 years of age. There are 159,000 people newly diagnosed with CRC in the US each year, with approximately 30,000 of these people diagnosed specifically with LARC. 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 and/or into the lymph nodes. Approximately 95% of LARC patients have mismatch repair-proficient (pMMR) tumors indicating that their tumor cells have a functional DNA repair 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 for 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 . Contacts Media Contact: Jason Glashow Glashow Strategic Communications Jason.Glashow@akamisbio.com