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NeoGenomics to Highlight RaDaR ST MRD Assay at ESMO Congress 2025

On October 14, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company’s circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development.

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Building on NeoGenomics’ established molecular capabilities, the RaDaR ST assay uses whole-exome sequencing data from tumor samples and advanced bioinformatics to create patient-specific MRD panels. By leveraging high-depth sequencing and personalized panel design, the assay delivers highly sensitive and specific detection of ctDNA from plasma samples, providing real-time insights into tumor dynamics and treatment response.

"We stand by our commitment to clinical validation and interventional studies utilizing NeoGenomics’ MRD technology, as reflected in three new posters from our European collaborators presented at this year’s ESMO (Free ESMO Whitepaper) congress," said Tony Zook, Chief Executive Officer. "We are excited to continue our long-standing support of drug development and interventional clinical trials, now with our RaDaR ST assay. Pharmaceutical sponsors are seeking partners who can deliver both innovation and operational excellence across every stage of oncology trials. NeoGenomics meets that need with RaDaR ST, providing patient-specific insights in real time to help drive faster, more informed decisions and advance cancer research more effectively."

As MRD gains traction as a preferred solution to monitor responses to next-generation therapies, NeoGenomics’ launch of RaDaR ST strengthens its position as a partner to biopharma organizations seeking to advance precision oncology. The company will feature RaDaR ST and its broader oncology testing and research capabilities at booth #4012.

(Press release, NeoGenomics Laboratories, OCT 14, 2025, View Source [SID1234656662])

Akamis Bio Receives FDA Fast Track Designation for NG-350A for the Treatment of Mismatch Repair-Proficient Locally Advanced Rectal Cancer

On October 14, 2025 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, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NG-350A for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC).

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. NG-350A is currently being evaluated in combination with chemoradiotherapy in the actively recruiting Phase 1b FORTRESS study (NCT06459869) in pMMR LARC patients.

"The NG-350A Fast Track designation from FDA is a recognition of the significant unmet need for new therapies to treat locally advanced rectal cancer (LARC)," said Oliver Rosen, M.D., chief medical officer at Akamis Bio. "The global incidence of LARC continues to rise, with a particularly alarming increase of this cancer among younger populations. Patients with mismatch repair-proficient tumors account for approximately 90% of LARC cases, and this population has the greatest need for evolution in the standard of care to include treatments that may enable patients to avoid surgical interventions."

The FDA grants Fast Track designation to facilitate the development and expedite the review of new drugs that may fill an unmet medical need for serious or life-threatening conditions. A drug receiving the designation may be eligible for more frequent meetings and communications with the FDA to discuss development plans, ensure the collection of appropriate data needed to support approval, and enable a rolling review of an application for marketing authorization. This may lead to earlier drug approval and access for patients. Drugs receiving Fast Track designation may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

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 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 complete 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 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). Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit www.FortressStudy.org.

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. Approximately 90% of LARC patients have mismatch repair-proficient (pMMR) tumors which have a functional DNA repair system.

(Press release, Akamis Bio, OCT 14, 2025, View Source [SID1234656661])

Pilatus Biosciences Announces Issuance of Foundational Global Patent Covering Novel CD36-Targeted Immunotherapy

On October 14, 2025 Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported the granting of its foundational patent in Europe and Australia, entitled "Methods for Modulating Regulatory T Cells and Inhibiting Tumor Growth."

Pilatus has an exclusive license on the patent from the Ludwig Institute for Cancer Research Ltd and the University of Lausanne, Switzerland, based on work by Dr. Ping-Chih Ho’s laboratory at the Ludwig Lausanne Branch. The patent covers Pilatus’ first-in-class antibody program targeting CD36, a key metabolic checkpoint expressed on regulatory T cells (Tregs) that play a critical role in suppressing anti-tumor immune responses.

This intellectual property milestone provides broad protection for the company’s pioneering work in Treg modulation through metabolic reprogramming, representing a new therapeutic strategy in immuno-oncology.

Tregs are essential for maintaining immune balance but can also enable tumor immune evasion by suppressing effector T cell activity within the tumor microenvironment. CD36, a fatty acid transporter highly expressed on Tregs acts as a metabolic gatekeeper that supports their survival and suppressive function under hypoxic and nutrient-deprived tumor conditions.

Pilatus’ antibody program is designed to disrupt CD36-mediated lipid uptake and signaling in Tregs, thereby reawakening the immune system’s ability to attack tumors without triggering systemic autoimmunity. This approach builds upon discoveries made in the laboratory of Dr. Ping-Chih Ho, Full Member at LICR Lausanne, and forms the scientific foundation for Pilatus’ proprietary pipeline of metabolic checkpoint inhibitors.

Nobel Prize Underscores the Field’s Importance

This announcement comes at a particularly timely moment: the 2025 Nobel Prize in Physiology or Medicine was awarded for groundbreaking discoveries in Regulatory T cell biology, underscoring the growing recognition of immune regulation as a cornerstone of modern medicine.

In fact, one of this year’s Nobel Laureates, Prof. Shimon Sakaguchi, the discoverer of Tregs, was a recent keynote speaker at the Ho Lab anniversary symposium in Lausanne, where he presented on "Targeting Tregs for Cancer Immunotherapy."

"The recognition of Treg biology by the Nobel Committee highlights the importance of immune regulation in health and disease," said Dr. Ping-Chih Ho, Co-Inventor and Full Professor and member at the Ludwig Institute for Cancer Research at University of Lausanne. "Our CD36 discoveries bridge metabolic control and immune suppression, paving the way for transformative treatments in oncology and beyond."

"This patent issuance solidifies Pilatus’ leadership position in metabolic checkpoint immunotherapy," said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. "By targeting the metabolic dependencies of regulatory T cells, we are developing a new class of therapies designed to unlock potent and durable anti-tumor immunity, while demonstrating synergistic potential with PD-1 blockade to benefit patients with difficult to treat cancers."

(Press release, Pilatus Biosciences, OCT 14, 2025, View Source [SID1234656660])

Synnovation to Present SNV1521 (PARP1) Phase 1 Study Results at the European Medical Oncology (ESMO) Congress 2025 and Announces Clinical Collaboration with DualityBio to Evaluate the Combination of SNV1521 with Duality’s HER3 ADC, DB-1310

On October 14, 2025 Synnovation Therapeutics, a precision medicine company focused on the discovery and development of best-in-class targeted medicines, reported that it will be presenting the initial results from a Phase 1 Trial of SNV1521, a next-generation, CNS-penetrant PARP1-selective inhibitor, at the 2025 Annual Meeting of the European Society for Medical Oncology in Berlin, Germany.

"We look forward to sharing the first clinical dataset for our PARP-1 selective inhibitor, SNV1521, with the scientific community in Berlin," said Kevin O’Hayer, M.D., Ph.D., Senior Vice President, Head of Clinical Development at Synnovation. "We have generated encouraging anti-tumor activity and a differentiated safety and PK profile that supports best-in-class potential and further development as a monotherapy and in combination with novel targeted and cytotoxic agents."

Patricia LoRusso, D.O, Ph.D, Associate Center Director for Innovative Medicine at Yale Cancer Center, will present the initial results on Friday, October 17, 2025. The details of the presentation are below:

Oral Presentation:

Title:

First results from a phase 1 trial of SNV1521, a next generation, CNS-penetrant, PARP1-selective inhibitor in patients (pts) with molecularly selected advanced solid tumors (Abstract #923MO)

Presenter:

Patricia LoRusso, DO, PhD

Details:

Developmental Therapeutics Mini Oral Session

Friday, October 17, 2025; Heidelberg Auditorium

10:25 – 10:30 AM EST (4:25 – 4:30 PM CET)

"PARP1 selective agents offer the promise of delivering effective PARP inhibition while mitigating the hematologic and GI toxicity associated with first generation PARP inhibitors," said Patricia LoRusso, D.O., Ph.D., Associated Center Director for Innovative Medicine at Yale Cancer Center. "By optimizing PARP1 selectivity and potency, SNV1521 has the potential to emerge as a best-in-class agent with a differentiated safety profile compared to standard of care and PARP inhibitors in development."

Synnovation also announced a clinical collaboration with DualityBio to evaluate the combination of SNV1521 with Duality’s HER3-directed antibody-drug conjugate (ADC), DB-1310. DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles (UCLA) presented the first-in-human Phase I/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.

"The combination of cytotoxic agents with PARP inhibitors has shown clear preclinical synergy, however, overlapping hematologic toxicity has so far hindered the successful co-development." said Wenqing Yao, Ph.D., CEO and Co-Founder at Synnovation. "This collaboration provides an exciting opportunity to evaluate the combination of two potentially best-in-class therapies—a heme-sparing, PARP1-selective inhibitor, SNV1521, and the HER3-targeting ADC, DB-1310—with the aim of demonstrating synergistic efficacy and improving patient outcomes".

(Press release, Synnovation Therapeutics, OCT 14, 2025, View Source [SID1234656659])

BostonGene Showcases AI-Powered Multimodal Analytics at ESMO Congress 2025 to Advance Cancer Research and Drug Development

On October 14, 2025 BostonGene, developer of the leading AI foundational model for cancer and immune system, reported the acceptance of four abstracts at the ESMO (Free ESMO Whitepaper) Congress 2025. This premier global oncology meeting brings together clinicians, researchers, patient advocates and industry experts to advance cancer science and care. The Congress showcases the latest breakthroughs in translational research and clinical practice, featuring practice-changing data across multiple tumor types and serves as a vital platform for the pharmaceutical and biotechnology sectors. The ESMO (Free ESMO Whitepaper) Congress 2025 will take place October 17–21 in Berlin, Germany.

BostonGene session details are as follows:

Title: Transcriptomic Tumor Microenvironment Subtypes in Cervical Cancer Reveal Prognostic and Therapeutic Opportunities
FPN: 1167P
Date and time: October 18 | 12:00-12:45 CEST
Presenter: Andrey Kravets, Senior Bioinformatician, BostonGene

Leveraging its proprietary multimodal platform, BostonGene developed a tumor microenvironment-based classification system to identify targetable features of cervical cancers. RNA-seq and proteomics data from open-source datasets were evaluated to determine HPV gene expression, associated protein and signaling pathway activity, and correlations with patient survival. This analysis supports the use of precision therapy strategies to improve patient outcomes.

Title: Integrated analysis of KRAS mutations and MTAP loss in pancreatic cancer reveals potential for combined blockade of KRAS and PRMT5
FPN: 2248P
Date and time: October 19 | 12:00-12:45 CEST
Presenter: David Hong, MD, The University of Texas MD Anderson Cancer Center

BostonGene performed genomic and transcriptomic profiling of 437 public and 119 internal pancreatic adenocarcinoma samples using its automated pipelines, identifying frequently co-occurring MTAP mutations in KRAS-mutated tumors. These findings support the strategy of combining PRMT5 and RAS inhibitors in patients harboring both KRAS mutations and MTAP loss. The correlation of MTAP deletion and fibrotic tumor microenvironment also supports treatment strategies that combine PRMT5 inhibitors with immune checkpoint blockade.

Research conducted in collaboration with MD Anderson Cancer Center

Title: ERK/MAPK, RTK, ABL, and WNT Signaling Pathways as Potential Therapeutic Targets in Undifferentiated Pleomorphic Sarcoma
FPN: 2713P
Date and time: October 20 |12:00-12:45 CEST
Presenter: Neal S. Chawla, Associate Director of Clinical Research, Sarcoma Oncology Center

Using RNA-seq data of over 1,000 sarcoma samples and publicly accessible drug response data, BostonGene applied its proprietary analytics platform to derive a gene signature to describe features of undifferentiated pleomorphic sarcoma (UPS). Through this analysis, BostonGene identified that samples with UPS-like features, while associated with worse survival outcomes, also exhibited heightened sensitivity to compounds targeting RTK/RAS/RAF/MEK, ABL, and WNT pathways, highlighting new therapeutic avenues for these aggressive tumors.

Research conducted in collaboration with the Sarcoma Oncology Center

Title: Clinical Benefit Analysis of DNG64-CAR-V Gene Therapy Predicts Successful Efficacy Endpoints for a Planned Phase 2 Basket Study for CCNG1 Expressing Tumors
FPN: 2702P
Date and time: October 20 | 12:00-12:45 CEST
Presenter: Anmol Dia Agarwal, BA, Sarcoma Oncology Center

BostonGene led the clinical testing and data analysis for a study examining the efficacy and safety of DNG64-CAR-V, an RNA vector consisting of a SIG targeting peptide and encoding a CCNG1 inhibitor gene, for treating patients with advanced sarcoma, pancreatic cancer and breast cancer. Using BostonGene’s proprietary multimodal analytics pipeline, it was determined that all patient groups qualified for a Phase 2 basket study to further examine the efficacy and safety of combination regimens of DNG64-CAR-V.

Research done in collaboration with Sarcoma Oncology Center

To learn more or to schedule a meeting with BostonGene during the event, please contact Hannah Oman at [email protected]. For more information, please visit the ESMO (Free ESMO Whitepaper) Congress 2025 website.

(Press release, BostonGene, OCT 14, 2025, View Source [SID1234656658])