On October 13, 2025 Lupin Limited (Lupin) reported that it will present data from its Phase 1a clinical trial evaluating LNP3693, a STING agonist, at the ESMO (Free ESMO Whitepaper) Congress in Berlin, Germany, from October 17 to October 21, 2025 (Press release, Lupin, OCT 13, 2025, View Source [SID1234656584]). The presentation, titled "A phase 1 dose escalation study of LNP3693 (STING agonist) in patients with advanced or metastatic solid tumors & lymphoma," will be featured in the Investigational Immunotherapy session (Presentation Number 1553P). It can be viewed on October 19, 2025, from 09:00 to 17:00 CEST.

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LNP3693 is an investigational parenteral STING agonist. The presentation will provide qualitative insights into its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with solid tumors.

"This marks another important milestone for us. Following our successful presentation of LNP7457, a PRMT5 inhibitor, at ASCO (Free ASCO Whitepaper) in June 2025, it is a privilege to present the findings of another Phase 1 clinical trial for LNP3693, a STING agonist, at ESMO (Free ESMO Whitepaper). ESMO (Free ESMO Whitepaper)’s acknowledgment of the clinical research conducted in India underscores the proficiency of our team in oncology drug discovery, research, and clinical development," said Vinita Gupta, CEO, Lupin.

Details of the Presentation:

Date and Time: Sunday, October 19, 2025, 09:00-17:00 (CEST)
Session Title: A Phase 1 Dose Escalation Study of LNP3693 (STING Agonist) in Patients with Advanced or Metastatic Solid Tumors & Lymphoma
Category: Investigational Immunotherapy
Clinical Trial Registration Number: CTRI/2023/10/059147
Presentation Number: 1553P
Complete data has been provided for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 and will be addressed during the official session.

All regular abstracts accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 will be published online via the ESMO (Free ESMO Whitepaper) website on Monday, October 13, at 6:05 p.m. ET (12:05 a.m. CEST). All accepted abstracts will be published online in the ESMO (Free ESMO Whitepaper) Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

More information regarding the ESMO (Free ESMO Whitepaper) Congress 2025 can be viewed at:
View Source

On October 13, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 22-26, 2025 in Boston (Press release, Nuvalent, OCT 13, 2025, View Source [SID1234656600]).

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Details of the poster presentation are as follows:

Title: Preclinical intracranial activity of NVL-330, a selective HER2 tyrosine kinase inhibitor
Abstract Number: B057
Authors: Yuting Sun*1, Kristin L. Andrews1, Anupong Tangpeerachaikul1, Michael J. Walsh1, Nancy E. Kohl2, Joshua C. Horan1, Henry E. Pelish1
Session: Poster Session B
Session Date and Time: Friday, October 24, 2025, 12:30-4:00 p.m. ET
Location: Exhibit Hall D

*Presenter, corresponding author; 1Nuvalent, Inc., Cambridge, MA, USA; 2Kohl Consulting, Wellesley, MA, USA

On October 13, 2025 Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, reported positive results from a completed Phase 2 trial evaluating NOUS-209 in combination with pembrolizumab for patients with microsatellite instability high (MSI-H) metastatic colorectal cancer (mCRC) who are refractory to anti-PD-1 therapy (Press release, NousCom, OCT 13, 2025, View Source;utm_medium=rss&utm_campaign=nouscom-presents-positive-phase-2-results-of-nous-209-immunotherapy-combined-with-pembrolizumab-in-msi-h-metastatic-colorectal-cancer-patients-refractory-to-anti-pd-1-therapy-at-esmo-2025 [SID1234656585]). Results from this Phase 2 trial will be presented in a poster session at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, taking place in Berlin, Germany, from 17 to 21 October 2025.

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Study Highlights:

NOUS-209 is an off-the-shelf viral vector-based immunotherapy targeting frameshift peptides specifically expressed on deficient mismatch repair (dMMR)/MSI-H tumors, thereby harnessing the power of the immune system to recognize and eliminate MSI-H cancer cells.
Anti-PD-1 therapy is the approved first-line standard of care in dMMR/MSI-H mCRC, but resistance or relapse can develop, requiring the development of new treatment options.
In this Phase 2 trial, NOUS-209 combined with pembrolizumab was administered to 20 evaluable patients with dMMR/MSI-H mCRC who had progressed on prior anti-PD-1 treatment (77% had received prior single agent anti-PD-1 therapy, 23% received combination therapy with anti-CTLA-4). The median number of prior lines was 2 (1-7).
The primary endpoint was Objective Response Rate (ORR); secondary endpoints included progression-free survival (PFS) and safety, with immunogenicity as an exploratory endpoint.
Key Results:

ORR was 15% (3 partial responses), with a disease control rate (DCR) of 70% (11 stable disease, 6 progressive disease).
Median progression-free survival (PFS) was 6.4 months.
Safety profile remained favorable, with no emerging findings.
Robust immune activation was detected in 80% of patients.
Seven patients (32%) were retreated with NOUS-209 at 6 months; among those, 86% remained in stable disease and 14% had a partial response, with the latter demonstrating induction of a strong, durable and polytopic T cell immune response with a desired effector memory phenotype and correlating with clinical response.
"There remains a high unmet need for effective therapies that can overcome anti-PD-1 resistance and provide durable disease control. These data are promising in this difficult-to-treat patient population given the modest clinical benefit of approved options in the same setting," said Javier Ros, MD PhD, from Vall d’Hebron University Hospital.

"These clinical data are very encouraging. NOUS-209 combined with pembrolizumab has demonstrated meaningful disease control and immune activation in patients who have exhausted anti-PD-1 therapy," said Dr. Sven Gogov, Chief Medical Officer of Nouscom.

"We are excited by the overall positive clinical dataset emerging from the completed clinical trials of NOUS-209, not only in MSI-H mCRC patients but also the Phase 1b/2 results in Lynch Syndrome carriers that were presented earlier this year at AACR (Free AACR Whitepaper). These results support our commitment to advancing NOUS-209 into a registration-enabling study for cancer interception in Lynch Syndrome carriers," said Dr. Marina Udier, Chief Executive Officer of Nouscom.

Details of the abstract and presentation at ESMO (Free ESMO Whitepaper):

Nous-209 immunotherapy with pembrolizumab for microsatellite instability high (MSI-H) metastatic colorectal cancer, refractory to anti-PD-1: Phase II trial results

Poster Number: 802P
Session: Colorectal Cancer Poster Session
Session Time/ Place: Sunday October 19 / 12:00-12:45 (CEST) / Hall 25
The abstract is available on the ESMO (Free ESMO Whitepaper) website.

On October 13, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company’s lead program across major jurisdictions (Press release, Atossa Therapeutics, OCT 13, 2025, View Source [SID1234656601]). The Israeli patent (No. 304863), titled, "Methods for Making and Using Endoxifen," was granted on July 2, 2025, with priority to multiple U.S. provisional applications filed in 2017–2018.

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The allowed claims in Israel include oral, delayed-release (enteric) dosage forms comprising at least 90% by weight Z-endoxifen, with optional impurity limits (<2%), defined release characteristics in gastric and intestinal media, dose strengths (e.g., 1–4 mg and 8 mg), and pharmacokinetic performance targets (e.g., plasma exposures and steady-state levels). The claims also cover manufacturing methods that enrich the Z-isomer via stepwise crystallization and solvent control. These protections align with Atossa’s quality-by-design approach to deliver a consistent, high-purity Z-endoxifen product.

In parallel, Atossa received a Certificate of Patent Renewal from the Israel Patent Office confirming fee payment and renewal status for Patent No. 304863, further supporting the life-cycle management of Z-endoxifen IP in this jurisdiction.

"Strong, durable patents are foundational to our Z-endoxifen strategy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics Chairman and CEO. "This new protection in Israel, together with our broader global filings, covers what we believe are the critical elements of product quality, performance, and manufacturing needed to bring Z-endoxifen to patients and to create long-term value for shareholders."

About the Patent Scope in Israel
The granted patent includes: (i) enteric oral formulations with ≥90% Z-endoxifen; (ii) optional impurity and residual-solvent limits; (iii) stability and delayed-release attributes (acid resistance and intestinal release); (iv) dose ranges including 1–4 mg and 8 mg; (v) PK targets such as steady-state plasma levels and exposure ranges; and (vi) a multi-step crystallization process to enrich the Z-isomer. Collectively, these claims support Atossa’s global protection for Z-endoxifen composition, performance, and process.

On October 13, 2025 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported it will present a Trials in Progress Poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21 (Press release, Theolytics, OCT 13, 2025, View Source [SID1234656586]). Dr Margaret Duffy, CSO and Dr Matilde Saggese, CMO will be attending and will showcase the OCTOPOD-IV Phase I/IIa clinical trial of THEO-260, a novel oncolytic immunotherapy, given by intravenous delivery in patients with ovarian cancer.

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Details of the ESMO (Free ESMO Whitepaper) presentation are:

Phase I/IIa, open-label, dose finding, safety and exploratory trial of THEO-260, a novel oncolytic immunotherapy, by intravenous delivery in patients with high grade serous or endometrioid ovarian cancer
· Presenter: Matilde Saggese, MD, MD (Res), CMO at Theolytics
· Presentation Number: 1238eTiP
· Session: Trials in Progress: – eTrial in Progress
· Session Time/ Place: Poster Session 2, Saturday 18 October 2025 [Messe Berlin]

The abstract is available online on the ESMO (Free ESMO Whitepaper) website.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase II dose and demonstrate THEO-260’s differentiated cancer-associated fibroblast ‘CAF-lytic’ mechanism of action in patients through comprehensive biomarker analysis.

Recruitment at UK clinical sites is ongoing and expansion into further international sites is planned (including Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

Matilde Saggese, MD, MD (Res), Theolytics’ CMO, said, "Recruitment is now well under way for our first ever clinical trial with THEO-260. Ovarian cancer remains a leading cause of cancer-related death amongst women, but with THEO-260’s differentiated mechanism of action in targeting and eliminating ovarian patient cancer cells and cancer-associated fibroblasts, whilst triggering immunogenic cell death and promoting T-cell activation, we hope that we can deliver a therapy that transforms outcomes for women with this devastating disease."

Patients with epithelial ovarian cancer almost invariably develop platinum-resistant disease, for which the prognosis is very poor. Treatment in this setting is challenging due to the complexity of the tumour microenvironment (TME) and most immunotherapies including checkpoint blockade have not proven effective. This may be attributed to an immune suppressed and stromal rich TME, with up to 60% of the tumour volume comprising cancer-associated fibroblasts (CAFs). THEO-260 is a novel oncolytic immunotherapy specifically evolved to target stromal rich tumours. In preclinical studies, THEO-260 has been shown to kill cancer cells and CAFs, trigger immunogenic cell death, and promote T-cell activation.