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.

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 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 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma (Press release, Hutchison China MediTech, OCT 13, 2025, View Source [SID1234656583]). Results of the Phase III part of the study will be presented on Friday, October 17, 2025 during the European Society for Medical Oncology ("ESMO") Congress in Berlin, Germany.

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FRUSICA-2 is a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma (NCT05522231). A total of 234 patients were randomized into a group that received fruquintinib plus sintilimab combination therapy, or into a group that received axitinib or everolimus monotherapy. As of the progression free survival ("PFS") final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months.

The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response (DoR) was 23.7 vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria.

The safety profile of the fruquintinib and sintilimab combination was tolerable and consistent with the known profiles of each individual treatment. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 71.4% of patients in the fruquintinib plus sintilimab group compared to 58.8% for patients in the axitinib/everolimus group.

"The FRUSICA-2 trial results provide compelling evidence that fruquintinib and sintilimab may offer a valuable new treatment option for patients with advanced renal cell carcinoma," said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study. "These findings show the combination’s potential to address a critical unmet need for this patient population, delivering consistent benefits across varied patient profiles and prognostic risk groups."

"The FRUSICA-2 study suggests that fruquintinib and sintilimab could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma," said Professor Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study. "These results point to the combination’s potential to enhance clinical outcomes, providing a new option for managing this challenging disease."

Supported by data from FRUSICA-2, a New Drug Application (NDA) for the combination of fruquintinib and sintilimab in patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment has been accepted for review by the China National Medical Products Administration (NMPA).

About Kidney Cancer and Renal Cell Carcinoma
It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[1] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[2] Approximately 90% of kidney tumors are renal cell carcinoma.

The safety and efficacy of fruquintinib for the investigational uses discussed above have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.

About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to limit off-target kinase activity and improve drug exposure to achieve sustained target inhibition.[3]

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. The combination of fruquintinib and sintilimab has received conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA.

On October 13, 2025 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported it will host a virtual roundtable discussion with recognized key opinion leaders in oncology (Press release, Fore Biotherapeutics, OCT 13, 2025, View Source [SID1234656582]). The Fore-sponsored webcast event will take place on Wednesday, October 15, 2025, at 12:00 p.m. ET.

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"We are honored to bring together this distinguished group of medical oncology leaders to share their perspectives on the potential role of plixorafenib in monotherapy indications including BRAF V600 progressive or recurrent primary CNS tumors, solid tumors with BRAF fusions, and other BRAF altered tumors, including thyroid," said William Hinshaw, Chief Executive Officer of Fore. "This discussion reinforces our conviction in plixorafenib’s potential to make a meaningful difference in a patient population with very limited options."

The roundtable discussion will be moderated by William Hinshaw, Chief Executive Officer of Fore and will feature Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore, along with three recognized oncology experts:

Macarena De La Fuente, M.D., Chief of Neuro-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Lead CNS Investigator, Phase 2 FORTE Trial
Eric Sherman, M.D., Head and Neck Medical Oncologist, Memorial Sloan Kettering Cancer Center
Patrick Y. Wen, M.D., Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, Professor of Neurology, Harvard Medical School
To access the webcast of the roundtable discussion go to the "Events" section or the homepage of the Company’s website or click here. An archived replay of the webcast will be available on the Company’s website beginning approximately two hours after the event.

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore Bio believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.