Fluorouracil

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. 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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

Theriva Biologics (NYSE: TOVX), a Rockville, Maryland-based clinical-stage company, announced that the US FDA has agreed to the proposed design of a Phase III trial evaluating oncolytic virus candidate drug VCN-01 in combination with gemcitabine and nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma. The regulatory alignment, following a Type B End-of-Phase II meeting, clears a path for Theriva to finalize its pivotal protocol and seek funding or partnerships to initiate the study. The proposed Phase III is a randomized, double-blind trial comparing VCN-01 plus gemcitabine/nab-paclitaxel against gemcitabine/nab-paclitaxel plus placebo in patients with metastatic PDAC. The trial will use overall survival as its primary endpoint, with progression-free survival among the key secondary endpoints. The design incorporates an adaptive framework with pre-specified interim analyses, allowing for potential sample size re-estimation or early efficacy determination. The company said the FDA agreed on the proposed dosing of VCN-01 administered in repeated “macrocycles,” enabling patients to receive more than two doses of the oncolytic virus across the course of treatment. The Phase III design tracks closely with the VIRAGE trial, a Phase IIb, open-label, randomized study that compared VCN-01 plus standard-of-care chemotherapy against chemotherapy alone in metastatic PDAC. Theriva reported in 2025 that VIRAGE met its primary endpoints, with patients receiving VCN-01 showing improved overall survival, progression-free survival, and duration of response relative to the chemotherapy-only arm. The company noted that patients who received two doses of VCN-01 had greater improvements in OS and PFS than those receiving a single dose. VCN-01, also known by its non-proprietary name zabilugene almadenorepvec, is a systemically administered oncolytic adenovirus engineered to selectively replicate within tumor cells. The virus expresses hyaluronidase, which degrades hyaluronic acid in the tumor stroma — a dense extracellular matrix that characterizes pancreatic tumors and acts as a physical barrier to drug delivery and immune cell infiltration. By lysing tumor cells and remodeling the stromal microenvironment, VCN-01 is designed to enhance the penetration of co-administered chemotherapy and increase tumor immunogenicity. Systemic intravenous delivery is intended to allow the virus to reach both primary tumors and metastatic sites. VCN-01 has been administered to 142 patients across multiple company- and investigator-sponsored trials in cancers including PDAC, head and neck squamous cell carcinoma, ovarian cancer, colorectal cancer, and retinoblastoma. Metastatic PDAC remains among the most treatment-resistant solid tumors. The current first-line standard of care consists of either gemcitabine plus nab-paclitaxel or FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin), both of which were established as standards more than a decade ago. Median overall survival with gemcitabine/nab-paclitaxel in the metastatic setting is approximately 8.5 months based on the pivotal MPACT trial. No oncolytic virus therapy has been approved for pancreatic cancer, and few biologic agents have demonstrated survival benefits in this indication in randomized studies. The FDA’s agreement on the Phase III protocol is consistent with scientific advice Theriva previously received from the Committee for Medicinal Products for Human Use of the European Medicines Agency. Both agencies indicated that a single, high-quality randomized trial could support a potential biologics licensing application for VCN-01 in metastatic PDAC, if results are positive. The dual regulatory alignment on a single pivotal study is notable, as it could streamline the development path if the company secures the necessary funding. Theriva stated it is now finalizing the Phase III protocol and pursuing strategic funding opportunities and partnerships to support the trial. The company did not disclose a timeline for trial initiation or expected enrollment size. For a clinical-stage company with a market capitalization typical of small-cap oncology biotechs, the capital requirements of a randomized, double-blind Phase III study in metastatic PDAC — a setting that demands large patient numbers and extended follow-up for overall survival — represent a material challenge. The next milestones to watch are protocol finalization, any partnership or funding announcements, and the eventual disclosure of detailed VIRAGE data at a medical conference or in a peer-reviewed publication. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website