Erasmus MC

Study utilized GeneCentric’s RNA-based FGFR Predictive Response Signature (FGFR-PRS) and showed it could identify twice as many patients with an activated FGFR pathway compared to patients with FGFR DNA alteration biomarkers DURHAM, N.C.--(BUSINESS WIRE)-- #GeneCentric -- GeneCentric Therapeutics , a company making precision medicine more precise through RNA-based diagnostics, announced today that results from the GARNER (Genomic Analysis of high-Risk Non-muscle invasive bladder cancER) study were published in Clinical Cancer Research . The GARNER study, the largest high-risk non-muscle invasive bladder cancer (HR-NMIBC) patient cohort ever assembled with both clinical and genomic detail, investigated fibroblast growth factor receptor (FGFR) DNA alteration (ALT) frequency and activation in HR-NMIBC and the clinical outcomes associated with standard-of-care Bacillus Calmette-Guérin (BCG) treatment. The study was conducted by the Erasmus MC Urothelial Cancer Research Group (EUCRG) at the Erasmus MC Cancer Institute. Janssen Research & Development, LLC, a Johnson & Johnson company, and GeneCentric collaborated to perform genomic testing. Although many HR-NMIBC patients respond to BCG treatment, 50-70% have a recurrence, and up to 20% progress to muscle-invasive bladder cancer (MIBC) or locally advanced/metastatic disease. Alternative therapies including FGFR-targeting agents are being investigated. While eligibility for FGFR-targeted therapies has focused on patients who are FGFR ALT (+), DNA alterations may not fully identify all patients who could potentially benefit from FGFR-targeted therapy. In this study, GeneCentric’s novel RNA-based FGFR-PRS identified approximately two-fold more patients with an activated FGFR pathway compared to those who were FGFR ALT (+). “GeneCentric is intensely focused on developing RNA-based signatures, because DNA alterations and other biomarkers may have limitations in identifying all patients who could potentially benefit from targeted therapies,” said Kirk Beebe, PhD, Chief Scientific Officer at GeneCentric. “The GARNER study allowed us to apply the FGFR-PRS to tumors from a high-risk group of patients with bladder cancer to show that the prevalence of FGFR-PRS positive tumors was much higher than the number of tumors identified with FGFR DNA alterations. Beyond HR-NMIBC, we have developed gene signatures for a broad range of targeted therapies, with a vision for this approach eventually becoming the paradigm for patient selection as an adjunct or in place of DNA alteration testing.” Findings related to the FGFR-PRS from the study include: The FGFR alteration frequency (i.e., FGFR ALT (+)) in HR-NMIBC tumors was 31%. The frequency of FGFR-activated tumors using the FGFR-PRS was more than twice as high as FGFR ALT+ at 75%. This enrichment of tumors that may be FGFR-activated identified by the FGFR-PRS compared to FGFR-altered tumors was also observed in more advanced-stage disease (muscle-invasive and metastatic urothelial cancer). About the GARNER Study The GARNER study is the largest HR-NMIBC real-world patient cohort ever assembled with both clinical and genomic detail and the first study of the broader GARNER Bladder Cancer Program. The study is comprised of a cohort of almost 1,200 NMIBC patients who underwent surgery and adjuvant BCG treatment. The study was conducted by Tahlita Zuiverloon, MD, PhD, Principal Investigator at the Department of Urology at Erasmus MC Urothelial Cancer Research Group (EUCRG) at the Erasmus MC Cancer Institute. Janssen Research & Development, LLC, a Johnson & Johnson company, and GeneCentric Therapeutics performed retrospective genomic analysis of longitudinal samples collected in this study. About GeneCentric GeneCentric Therapeutics, Inc., a leader in RNA-based genomic biomarker and next-generation companion diagnostics development, is based in Durham, North Carolina. They have developed a deep pipeline of gene signatures and related diagnostic tests by parsing the complexity of tumor biology using their RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform and AI technology to identify responder populations to oncology therapeutics. Using their ExpressCT (Expression Signatures Through Circulating Tumor Signals) platform, these signatures can be applied to liquid biopsy. GeneCentric commercializes its technology through strategic collaborations with biopharmaceutical and diagnostics companies in applications throughout preclinical testing, clinical drug development and diagnostic test commercialization lifecycle phases. For more information, visit or follow us on LinkedIn . Contacts Robin Fastenau Robin.Fastenau@GeneCentric.com

Preliminary finding of stable disease in two out of three patients at 6 months in the first subject cohort Combination of Ampligen and Imfinzi continues to be generally well-tolerated with no severe adverse events or dose-limiting toxicities OCALA, Fla., Sept. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced positive preliminary data from the Phase 1b/2 study (“DURIPANC”) evaluating the combination of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center (“Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival (“PFS”) requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS. Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects. Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: “First of all, we have observed improvements in quality of life and we saw no toxicity at all — with ‘quality of life’ recognized as an indicator of stable disease. As a comparison, approximately 80% of patients at Erasmus with similar disease, but who did not receive the treatment, showed disease progression after only three months. While this new data is extremely preliminary, it is also highly encouraging. To have multiple patients with metastatic pancreatic cancer who still have stable disease after six or seven months of maintenance therapy is remarkable — as is having stable disease for 15 or more months after starting FOLFIRINOX. Based on the changes we have seen in immune infiltration into metastatic lesions, I am optimistic that there is a chance that these patients could still have partial or complete responses to this therapy.” “Ampligen continues to demonstrate its synergistic potential as a combination therapy with checkpoint inhibitors and these data — following the positive data from the Dutch-government approved Early Access Program — underscore Ampligen’s potential for the treatment of late-stage pancreatic cancer, where there remains a significant and lethal unmet need,” commented AIM Chief Executive Officer Thomas K. Equels. Read more at ClinicalTrials.gov NCT05927142 — “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect” Learn more about the clinical collaboration between AIM, AstraZeneca and Erasmus MC. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date does not guarantee that Ampligen will be approved as a combination therapy for late-stage pancreatic cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

CHICAGO, Aug. 1, 2024 /PRNewswire/ -- The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), welcomed thousands of laboratory experts to ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo) from July 28-August 1. The meeting featured groundbreaking advances in diagnostic research and technology that exemplify the essential role that the field of laboratory medicine plays in patient care. As of Thursday, August 1, 18,000 laboratory medicine professionals had registered for ADLM 2024, a 6% increase in attendance since the last time the ADLM Annual Meeting was in Chicago in 2022. More attendees are expected today, the last day of the meeting. One highlight of the meeting was a special session where representatives from ADLM, the American Medical Association, and the Children's Hospital Association detailed how the FDA's final rule placing laboratory developed tests under FDA oversight will negatively impact patient care. The session featured a caregiver and patient advocate who shared her perspective on why laboratory developed tests are crucial to timely diagnoses and treatment. Attendees also had the opportunity to see five plenary talks led by life sciences pioneers. In the opening plenary, Dr. Patrick Bossuyt — the 2024 Wallace H. Coulter Lectureship awardee — drew on his experiences leading efforts to improve diagnostic tests to make a compelling case for why we need strong clinical trials of laboratory tests. On Monday, Dr. Kojo S.J. Elenitoba-Johnson, chair of the department of pathology and laboratory medicine at Memorial Sloan Kettering Cancer Center, described how proteomic data can help healthcare professionals better understand how lymphomas form and drive development of precision oncology therapies. Tuesday's plenary speaker, Dr. Ron H.N. van Schaik, discussed the successes and challenges of implementing pharmacogenetics as a diagnostic tool in routine healthcare. Van Schaik is head of the department of clinical chemistry at Erasmus MC - University Medical Center Rotterdam. On Wednesday, Dr. Sharon Hillier, a professor at the University of Pittsburgh, explored the development of new products for HIV prevention, including those that can be used on demand and those that would minimize systemic exposure to antiretroviral drugs. In today's closing keynote, Dr. Diana Greene Foster, a professor at the University of California, San Francisco, discussed the mental health, physical health, and socioeconomic consequences affecting people who are unable to get an abortion. As part of ADLM's Disruptive Technology Award competition, biotech innovators presented novel technologies that could help more patients get accurate diagnoses. Mercy BioAnalytics won the competition with its liquid biopsy platform that detects ovarian cancer in its earliest stages by measuring tumor-derived extracellular vesicles. The ADLM 2024 Clinical Lab Expo boasted nearly 900 exhibitors and covered an astonishing 271,003 net square feet — a 5% increase in exhibit space since the last time the meeting was held in Chicago. This dynamic exhibit featured cutting-edge tests from all laboratory medicine disciplines, including artificial intelligence, molecular diagnostics, automation, point-of-care testing, mass spectrometry, mobile health, and much more. "We are thrilled to see attendance at ADLM 2024 continue to increase after the COVID-19 pandemic," said ADLM CEO Mark J. Golden. "With the FDA publishing its final rule on laboratory developed tests, this has been a challenging year for laboratory medicine professionals. The meeting provided a vital opportunity for attendees to learn more about what the rule means for their labs and patient care. Additionally, the meeting offered essential education on everything from lab basics to cutting-edge topics such as data science. I hope attendees return home inspired and eager to implement what they've learned this week in their work, and I am excited to see what next year's meeting will bring." ADLM 2025 will be held in Chicago from July 27-31, 2025. About ADLM 2024 ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo) offered 5 days packed with opportunities to learn about exciting science from July 28-August 1 in Chicago. Plenary sessions explored the projected consequences of ending abortion protection, new HIV prevention options, lymphoma biomarkers and therapeutic targets, pharmacogenetic testing in precision health, and the need for clinical trials of laboratory tests. At the ADLM 2024 Clinical Lab Expo, nearly 900 exhibitors filled the show floor of the McCormick Place Convention Center in Chicago, with displays of the latest diagnostic technology, including but not limited to artificial intelligence, point-of-care testing, and automation. About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit . Christine DeLong ADLM Associate Director, Communications & PR (p) 202.835.8722 [email protected] Molly Polen ADLM Senior Director, Communications & PR (p) 202.420.7612 (c) 703.598.0472 [email protected] SOURCE Association for Diagnostics & Laboratory Medicine (ADLM)