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.

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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])

On October 14, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that the Co-PSMA (NCT06907641)1 Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent’s Hospital Sydney, has achieved its primary endpoint with a statistically significant higher number of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions detected using 64Cu-SAR-bisPSMA compared to standard-of-care (SOC) 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) in patients with low prostate-specific antigen (PSA) levels.

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Co-PSMA’s official study title is "Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". This Phase II IIT is evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA who are candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.

The Co-PSMA trial has successfully met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA PET/CT detects significantly more lesions per patient than the SOC, 68Ga-PSMA-11 PET/CT. This result supports the hypothesis that 64Cu-SAR-bisPSMA can improve early detection of recurrence and staging of prostate cancer in patients with low PSA who are candidates for curative salvage therapy. Full analysis of all data generated in the Co-PSMA trial is underway, and results of this study will be presented at an upcoming international conference.

The Co-PSMA topline results corroborate findings from the COBRA trial2, which investigated the diagnostic performance of 64Cu-SAR-bisPSMA in patients with biochemical recurrence (BCR) of prostate cancer who had a negative or equivocal SOC scan at study entry. In the COBRA study, a subset of participants underwent follow-up SOC PSMA PET imaging. Only 60% of these participants had a positive SOC PSMA PET, while 70% of participants had a positive 64Cu-SAR-bisPSMA PET on same-day imaging and 90% on next-day imaging. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA was also higher (26.3 lesions on same-day imaging, 52.6 on next-day imaging) than that detected by SOC PET agents (20 lesions). The COBRA trial results showed that 64Cu-SAR-bisPSMA was able to identify lesions more than 6 months earlier than SOC PSMA PET agents, with 6 months being the last follow-up visit for that trial.

The Co-PSMA trial further builds on the growing body of evidence of the enhanced diagnostic performance of 64Cu-SAR-bisPSMA compared to SOC PSMA PET agents, which are known to have low sensitivity, especially in patients with low PSA levels3,4. Improvements in sensitivity, as with all diagnostic agents, play a pivotal role in guiding more informed treatment decisions, enabling earlier and more accurate detection of prostate cancer recurrence and ultimately improving patient outcomes.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "Achieving the primary endpoint in the Co-PSMA trial, which was a head-to-head trial against a SOC competing product, is yet another important step in the development of 64Cu-SAR-bisPSMA as we look to further validate this agent as best-in-class through two registrational trials with two Fast Track Designations (FTDs) under our belt for diagnostic applications and a strong focus on commercialisation.

"We look forward to Prof Emmett releasing the full Co-PSMA trial data at world-leading congresses as we continue to adhere to the highest standards of clinical research in our aspirations to bring a best-in-class diagnostic option to men with prostate cancer with clear evidence of superiority. We have already seen in the first-in-human PROPELLER trial an improved diagnostic performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 on same-day imaging, including a higher number of lesions identified and 2-3 times higher tumour uptake and tumour-to-background ratio5. We then showed in the COBRA trial that approximately twice the amount of lesions was identified on 64Cu-SAR-bisPSMA PET on next-day vs. same-day imaging, and vs. SOC PSMA PET2. 64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range, something that SOC PSMA PET agents often fail to achieve2, 6-9. This improvement was driven by a substantially increased tumour-to-background ratio and lesion uptake over time with next-day imaging2.

"The current market for PSMA PET imaging in the US alone is around US$2 billion per year, and this is expected to further grow to over US$3 billion by 2029. However, this entire market is currently served by products that have low sensitivity, while the development pipeline of new products, excluding 64Cu-SAR-bisPSMA, offers no differentiation from the existing agents, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. We believe that with the clinical and logistical benefits offered by 64Cu-SAR-bisPSMA we could not only become the new SOC in PSMA PET but grow the market opportunity further by diagnosing prostate cancer earlier, while lesions are still very small.

"We look forward to continuing to work with Prof Emmett, a world-renowned thought leader in the radiopharmaceutical space, in our home city of Sydney on progressing clinical development of the 64Cu-SAR-bisPSMA product, including our CLARIFY and AMPLIFY Phase III trials. This partnership will ensure we continue to generate the highest quality of data supporting our New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) as the next step towards our mutual goal of improving treatment outcomes for men with prostate cancer."

(Press release, Clarity Pharmaceuticals, OCT 14, 2025, View Source [SID1234656623])

On October 14, 2025 Nusano, a physics company transforming the production of radioisotopes, and Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, reported the signing of a multi-isotope supply agreement to support Ariceum’s novel radiotherapeutic pipeline.

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The agreement gives Ariceum access to Nusano-produced radioisotopes, including actinium-225 (Ac-225) and lutetium-177 (Lu-177).

"Radiotherapeutics have the potential to redefine the standard of care in oncology," said Manuel Sturzbecher-Höhne, Chief Technology Officer of Ariceum Therapeutics. "This agreement further strengthens our ability to advance 225Ac-SSO110, which is currently being investigated in a Phase 1/2 trial in patients with extensive-stage small cell lung cancer and Merkel cell carcinoma. Reliable access to actinium-225 ensures we can deliver on our commitment to developing transformative therapies for patients facing these aggressive and underserved cancers."

The Nusano radioisotope production platform combines time-proven technology from universities and world-class research centers with the company’s patented particle acceleration technology. The result is the first significant advancement in radioisotope production in decades – a platform that’s smaller and more efficient than existing methods, and capable of the simultaneous manufacturing of up to 12 different radioisotopes.

"Nusano’s production capabilities are designed to stabilize supply chains and enable innovation," said Chris Lowe, CEO of Nusano. "Our scalable production allows us to work with drug developers from the earliest stages through commercial drug availability. We look forward to working with Ariceum on their current and future therapeutic candidates."

(Press release, Nusano, OCT 14, 2025, View Source [SID1234656644])

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.

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"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])

On October 14, 2025 Aanastra, Inc., a biotechnology company leveraging its proprietary targeted peptide delivery technology (PEP-NP) to advance in vivo targeting and reprogramming of cells with RNA therapeutics, reported multiple presentations showcasing preclinical data in its lead programs for anti-CD19 in vivo CAR-T (AAN-14x) and for in vivo P53 rescue in P53 mutant tumors (AAN-53x), at upcoming conferences.

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"Among the broad applications of the PEP-NP technology, we are particularly excited by the preclinical data in our in vivo CAR-T program as well as our ability to target wide-ranging P53 driver mutations in our P53 program for which no therapy exists today ," said Neil Desai Ph.D., Founder and CEO at Aanastra. "These preclinical data highlight the remarkable versatility of the PEP-NP targeted peptide RNA delivery technology, from in vivo reprogramming of immune cells to cause B cell depletion, to in vivo restoration of mutant tumor suppressor function directly in tumors, all with a mRNA approach. Importantly the PEP-NP system can completely bypass the liver, without immunogenicity or safety issues upon repeat administration, uses no lipid, viral or protein components, and is fully owned by Aanastra."

Featured Presentations and Conferences:

Advancing Cell and Gene Therapies for Cancer Conference, Philadelphia, PA, Oct 15-16, 2025

Poster presentation title: In Vivo CAR-T generation of anti-CD19 CAR-T-cells using CAR mRNA delivered with the PEP-NP peptide-based (non-lipid, non-viral) delivery system targeted to CD3/CD5+ T-cells
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

Poster presentation title: P53 mutant tumor regression across P53 mutations with AAN-53x, a P53 mRNA delivered with the PEP-NP tumor-targeted peptide (non-lipid) delivery system
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

mRNA Vaccines and Therapeutics Summit, Barcelona, Spain, Oct 23-24, 2025

Oral Presentation Title: A novel peptide-based nanoparticle platform for systemic targeted delivery of therapeutic mRNA : invivo CAR-T cell engineering and Tumor selectivity
Presenter: Gilles Divita, Ph.D.
Date and Time: Oct 23, 2025, 4.40 pm – 5.20pm. CET

About P53
Known as the "Guardian of the Genome," P53 is a crucial tumor suppressor that preserves DNA integrity by regulating DNA repair and cell division. Loss of functional p53 causes DNA damage to accumulate, driving uncontrolled cell growth and tumor development. It is mutated or inactivated in over 50% of cancers, affecting 400,000 new U.S. patients annually and over 10 million globally. Mutations span hundreds of variants, making broad therapies difficult. These mutations are markers of poor prognosis and key cancer drivers. No existing treatments restore p53 function across this spectrum, leaving a significant unmet need. Aanastra’s RNA-based approach using its targeted PEP-NP delivery offers a promising strategy to broadly restore p53 function, potentially transforming outcomes for aggressive, treatment-resistant cancers.

About In vivo CAR-T
In vivo CAR-T therapy engineers a patient’s T cells inside the body to target and destroy cancer cells, avoiding the costly, complex ex vivo CAR-T process that today is available to less than 20% of eligible patients in the US. Current lentiviral methods for in vivo CAR-T allow only single treatments due to immune responses against viral components. Lipid nanoparticle (LNP)-based mRNA delivery enables transient CAR expression that could be repeated but is limited by liver toxicity and immune related side effects like inflammation. These safety and dosing challenges can restrict sustained treatment effects. Aanastra’s PEP-NP system efficiently targets CAR RNA to T cells for safe, repeat dosing without these toxicities, potentially overcoming current limitations and expanding access for hematological cancers and autoimmune diseases.

About PEP-NP
Aanastra’s PEP-NP technology is based on short, amphipathic peptides that form stable nanoparticles with RNA for efficient delivery. These peptides are designed with distinct hydrophobic and hydrophilic regions, adopting α-helical conformations facilitating membrane interaction and cellular entry. Importantly, PEP-NP peptides can include specific receptor-targeting domains, enabling precise cell and tissue targeting without using antibodies or other large proteins. This antibody-free targeting allows rapid design flexibility and avoids immunogenicity associated with protein-based ligands. PEP-NP nanoparticles can enter cells though a non-endosomal mechanism, enhancing RNA release into the cytoplasm for effective therapeutic action. Together, these features make PEP-NP a highly versatile, scalable, and safe platform for delivering diverse RNA payloads for treating cancer, autoimmune, and genetic diseases.

(Press release, AANASTRA, OCT 14, 2025, View Source [SID1234662316])