Artesunate/Pyronaridine Phosphate

PROVIDENCE, R.I., Dec. 7, 2024 /PRNewswire/ -- EpiVax, Inc., a leader in preclinical immunogenicity risk assessment for biologic and peptide therapeutics, celebrates a productive 2024 marked by scientific innovation, service diversification, and corporate growth. This year, EpiVax expanded the breadth of its immunogenicity risk assessment services with the launch of many new capabilities in the ISPRI™ ( Immunogenicity Screening and Protein Re-engineering Interface) Toolkit and many new assessment offerings. Notably, EpiVax released the ISPRI Downselect™, Quantify™, Analyze™, Evaluate™, Complete™, Optimize™, and Design™ fee-for-service analyses – options that assess biologic modalities at different stages of preclinical development, enabling the ranking of individual candidates, modality-specific benchmarking, sequence optimization and in-depth risk analyses with enhanced accuracy, and more. Class I analysis was also added to the ISPRI toolkit this year for selected gene therapy and CAR-T clients. Further, EpiVax advanced its PANDA® Screening program to support sponsors entering the FDA's Abbreviated New Drug Application (ANDA) pathway for generic peptides and their impurities. Key updates included the release of enhanced adaptive in vitro assay offerings and the Innate Immune Response Assay, establishing EpiVax as a "one stop shop" (featuring in silico, in vitro and innate assessment) for generic drug developers. Additionally, EpiVax and FDA-initiated a new contract to develop standardized controls for T cell assays which will help to improve the specificity and sensitivity of such assays industry-wide. This work was accompanied by notable contributions to the field with the publication of several highly cited articles by the EpiVax team in 2024. As a result of the expanded offerings, EpiVax immunogenicity risk assessment bookings surged nearly 60% over 2023, driven by a doubling of new clientele across the ISPRI™ Access, ISPRI™ Fee-for-Service, and PANDA® service verticals. This success supported an 18% headcount expansion, including strategic leadership additions to continue driving the company's new offerings. Looking to 2025, guided by nearly three decades of "fearless science", EpiVax is prepared to build on this year's achievements by further integrating artificial intelligence and machine learning enhancements to existing platforms, expanding laboratory capability, and adding scientific expertise that will be announced later in the new year. About EpiVax EpiVax is a leader in preclinical immunogenicity assessment and sequence optimization for peptide therapeutics, biologic therapeutics, and vaccines. EpiVax partners with a global roster of companies, agencies, and academics to accelerate immunogenicity risk assessment, immune modulation and rapid vaccine design. Press Contact Sarah Moniz Director, Business Development EpiVax [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AMPLIFY-201, a phase I trial evaluating treatment response to the ELI-002 vaccine, is the first study to read out using ctDNA to enroll and monitor patients with solid tumors PANDA study shows ctDNA status in patients with gastric and gastroesophageal cancers is strongly associated with recurrence risk and pathologic response AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the publication of two new studies in Nature Medicine evaluating Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera.™ The first study shows results from the single-arm, phase I AMPLIFY-201 trial evaluating the ELI-002 cancer vaccine. The study enrolled a total of 25 patients (20 pancreatic, 5 colorectal), 21 of whom were Signatera-positive after locoregional treatment. Signatera dynamics were also used as a secondary endpoint to assess tumor biomarker response, together with serum tumor antigens. This study is the first of its kind to have utilized circulating tumor DNA (ctDNA)-positivity in conjunction with other tumor biomarkers for enrollment, highlighting the use of Signatera for detecting early evidence of anti-tumor activity of a drug candidate to help assess for a dose response. The study reported that tumor biomarker responses were observed in 21/25 patients (84%), and ctDNA clearance was observed in 6/25 patients (24%). In contrast, serum tumor antigens declined but did not clear, highlighting the potential utility of ctDNA to be used as a reliable surrogate biomarker for treatment efficacy. “We are excited about our partnership with Natera, which has resulted in a successful prospective, phase I clinical trial focused on trial enrichment by enrolling Signatera-positive patients and monitoring therapy response in patients receiving a cancer vaccine,” said Christopher Haqq, MD, PhD, Elicio Therapeutic, Inc’s executive vice president, head of research and development, and chief medical officer. “We are optimistic about the potential for this study to improve outcomes for patients with pancreatic and colorectal cancer, who face clinical challenges and are often incurable when ctDNA is detected after treatment.” A second study published in Nature Medicine, called PANDA, is a single-arm, open-label, phase II study that investigated preoperative atezolizumab plus chemotherapy in patients with resectable, non-metastatic gastric and gastroesophageal junction adenocarcinoma. The study included 20 patients who underwent surgery and were evaluated for safety, pathologic response, and survival endpoints, and Signatera was used to detect and monitor ctDNA dynamics in all 20 patients. The PANDA study found that ctDNA clearance after neoadjuvant therapy correlated with pathologic response in 11/11 patients, while 3/6 patients with poor pathologic response remained ctDNA-positive (P=0.029). None of the patients with complete pathologic response (pCR) were ctDNA-positive, and among the nonresponders who were ctDNA negative (n=3), the study reported superior long-term outcomes. Additionally, ctDNA-positivity at the MRD and follow-up time points was associated with a recurrence rate of 100%. “We’re pleased to see these excellent results from the PANDA study which demonstrate the strong correlation between ctDNA and pathologic response pre-surgery and the therewith associated recurrence risk, highlighting the potential utility of Signatera in gastric and gastroesophageal cancers,” said Myriam Chalabi MD, PhD, medical oncologist, Netherlands Cancer Institute, and principal investigator of the PANDA study. “PANDA and AMPLIFY-201 add to the growing number of studies supporting the use of Signatera across various GI indications, showing the promise of tumor-informed ctDNA testing to help personalize treatment strategies,” said Alexey Aleshin, general manager of oncology and early cancer detection at Natera. “These studies also point to the valuable insights longitudinal ctDNA monitoring can provide in the evaluation of novel therapies.” About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and .