Transgene and BioInvent to Present
Translational Data and Updated Clinical Results on Armed Oncolytic Virus BT-001, at ESMO 2025

On October 13, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported it will jointly present a poster on translational data and updated clinical results from the Phase I study of BT-001 at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting. ESMO (Free ESMO Whitepaper) will take place in Berlin, Germany, from October 17 to 21, 2025 (Press release, Transgene, OCT 13, 2025, View Source [SID1234656590]).

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Key findings of the abstract include:

– Intra-tumoral (IT) BT-001 injection in combination with intravenous (IV) pembrolizumab was well tolerated with a manageable safety profile.

– The data show encouraging and sustained anti-tumor activity in patients with advanced refractory tumors. One patient with PD(L)-1 resistant melanoma and one patient with heavily pretreated and Immune Checkpoint Inhibitor (ICI)-naive leiomyosarcoma showed partial response (iPR) lasting 6 and 16 months respectively, among the 13 patients who received the combination of IT BT-001 (at 107 pfu/mL and 108 pfu/mL) and IV pembrolizumab.

– Tumor shrinkage was observed in both injected and non-injected lesions.

– BT-001 could be an effective option to improve the response to ICI in refractory patients.

The abstract is available on the ESMO (Free ESMO Whitepaper) website (here). The poster will be presented on October 20 during ESMO (Free ESMO Whitepaper) 2025 and will also be available to view on Transgene’s website.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine.

BT-001 is being co-developed as part of a 50/50 collaboration between Transgene and BioInvent. In the Phase I part of this study, BT-001 was well tolerated both as monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab)*.

The Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation study evaluating BT-001 as a single agent and in combination with pembrolizumab*. The last patient in the Phase I part was enrolled in August 2024.

Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, as well as PD(L)-1 expression in the tumor microenvironment (ESMO 2024, access press release here).

*KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

AstraZeneca furthers ambition to redefine cancer care with first data from four major pivotal trials at ESMO

On October 13, 2025 AstraZeneca reported its ambition to redefine cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, October 17-21, 2025 (Press release, AstraZeneca, OCT 13, 2025, View Source [SID1234656589]).

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More than 95 abstracts will feature nine approved and nine potential new medicines from the Company including two abstracts featured in a late-breaking Presidential Symposium and 26 oral presentations.

Key presentations include:

DESTINY-Breast11 Phase III trial of Enhertu followed by paclitaxel, trastuzumab and pertuzumab (THP) when used in the neoadjuvant setting in patients with high-risk, locally advanced HER2-positive early-stage breast cancer (Presidential Symposium 1 Abstract #291O).
DESTINY-Breast05 Phase III trial of Enhertu (trastuzumab deruxtecan) as post-neoadjuvant therapy in patients with HER2-positive early breast cancer with high risk of disease recurrence (Presidential Symposium 1 Abstract #LBA1).
TROPION-Breast02 Phase III trial of Datroway (datopotamab deruxtecan) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option (Proffered Paper Abstract #LBA21).
POTOMAC Phase III trial of Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) (Proffered Paper Abstract #LBA108).
MATTERHORN: Final overall survival (OS) results from the Phase III trial of perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers (Proffered Paper Abstract #LBA81).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "We are advancing a broad portfolio of new treatments to transform patient care in breast cancer and sharing meaningful progress at ESMO (Free ESMO Whitepaper) with data from TROPION-Breast02, DESTINY-Breast11 and DESTINY-Breast05. We are also sharing data from our next wave of potential new Oncology medicines including saruparib in combination with novel hormonal agents in prostate cancer, our folate receptor targeted antibody drug conjugate torvu-sam in ovarian cancer, and rilvegostomig in non-small cell lung cancer."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The momentum of our industry-leading oncology portfolio continues with presentations of the first data from four major pivotal trials at this year’s ESMO (Free ESMO Whitepaper). Beyond the key data in breast cancer for Enhertu and Datroway, the POTOMAC results for Imfinzi demonstrate the benefits of treating early-stage bladder cancer with immunotherapy and illustrate our strategy to bring novel treatments to early cancer settings where patients can benefit most."

Additional highlights include:

FONTANA Phase I/IIa first-in-human trial of AZD5335, a folate receptor α (FRα)-targeting antibody drug conjugate, in patients with platinum-resistant recurrent ovarian cancer (Mini Oral Abstract #1065MO).
PETRANHA Phase I/II trial of saruparib plus androgen receptor pathway inhibitors in patients with metastatic prostate cancer (Mini Oral Abstract #2384MO).
ARTEMIDE-01 Phase I/II trial of rilvegostomig in patients with checkpoint inhibitor-naïve metastatic NSCLC (Mini Oral Abstract #1853MO).
FLAURA2: Exploratory OS analysis of patients with poor prognostic factors in the FLAURA2 Phase III trial of Tagrisso (osimertinib) plus chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) (Proffered Paper Abstract #LBA77).
CAPItello-281: Phase III trial of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) in PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) (Proffered Paper Abstract #2383O).
TROPION-PanTumor03: First results from the bladder cancer cohort of the TROPION-PanTumor03 Phase II trial of Datroway plus rilvegostomig (Mini Oral Abstract #3072MO).
BEGONIA: Final results from the BEGONIA Phase Ib/II trial of Datroway plus Imfinzi in patients with previously untreated unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) (Mini Oral Abstract #555MO).
AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialise Enhertu and Datroway, collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza (olaparib), and collaborating with HUTCHMED to develop and commercialise Orpathys (savolitinib). Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen’s clinical stage anti-TIGIT antibody, COM902.

Key AstraZeneca presentations during ESMO (Free ESMO Whitepaper) Congress 20251

Lead Author

Abstract Title

Presentation details (CEST)

Antibody drug conjugates

Harbeck, N

DESTINY-Breast11: neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC)

Abstract #291O

Presidential 1

18 October 2025

4:30 PM

Geyer, C

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): Interim analysis of DESTINY-Breast05

Abstract #LBA1

Presidential 1

18 October 2025

4:52 PM

Dent, R.

First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase 3 TROPION-Breast02 trial

Abstract #LBA21

Proffered Paper Session

19 October 2025

9:25 AM

Loibl, S

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: additional analysis of DESTINY-Breast09 in key subgroups of interest

Abstract #LBA18

Proffered Paper Session

19 October 2025

8:30 AM

Rha, SY

Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase 2 TROPION-PanTumor03 study

Abstract #3072MO

Mini Oral Session

17 October 2025

4:10 PM

Oaknin, A

First-in-human study of AZD5335, a folate receptor α (FRα)-targeted antibody-drug conjugate, in patients with platinum-resistant recurrent ovarian cancer

Abstract #1065MO

Mini Oral Session

19 October 2025

10:53 AM

Schmid, P

Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment (tx) for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Final results from the phase 1b/2 BEGONIA study

Abstract #555MO

Mini Oral Session

20 October 2025

10:50 AM

Raghav, K

Trastuzumab deruxtecan (T DXd) in patients (pts) with HER2-positive (HER2+) metastatic colorectal cancer (mCRC): Final analysis of DESTINY-CRC02, a randomized, phase 2 trial

Abstract #737P

Poster Session

Peng, Z

Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who received prior anti-HER2 treatment (Tx) other than / in addition to trastuzumab in DESTINY-Gastric06 (DG-06)

Abstract #2105P

Poster Session

Shen, L

Risk of hepatitis B virus reactivation (HBVr) in patients (pts) with past or resolved HBV or inactive chronic HBV infection treated with trastuzumab deruxtecan (T-DXd) in the DESTINY-Gastric06 (DG-06) trial

Abstract #2175P

Poster Session

Pietrantonio, F

Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) plus paclitaxel (PTX) in second-line (2L) treatment of patients (pts) with HER2+ unresectable/metastatic gastric cancer (GC)/gastroesophageal junction adenocarcinoma (GEJA): Additional data from DESTINY-Gastric04 (DG-04)

Abstract #2099P

Poster Session

Makker, V

Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) Part 1 final analysis

Abstract #957P

Poster Session

Lee, J-Y

Trastuzumab deruxtecan (T-DXd) in pretreated patients (pts) with HER2-expressing solid tumors: exploratory biomarker analysis of DESTINY-PanTumor02 (DP-02) Part 1

Abstract #145P

Poster Session

Immuno-oncology

Tabernero, J

MATTERHORN Phase III trial of Imfinzi (durvalumab) perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers

Abstract #LBA81

Proffered Paper Session

17 October 2025

2:00 PM

De Santis, M

Durvalumab (D) in Combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, High-risk Non-muscle-invasive Bladder Cancer (NMIBC): Results from the Phase 3, Open-label, Randomised POTOMAC Trial

Abstract #LBA108

Proffered Paper Session

17 October 2025

2:10 PM

Larkin, J

First results from RAMPART: An international phase 3 randomised-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL

Abstract #LBA93

Proffered Paper Session

18 October 2025

9:20 AM

Aghajanian, C

Durvalumab + paclitaxel/carboplatin + bevacizumab followed by durvalumab, bevacizumab + olaparib maintenance in patients with newly diagnosed non-tBRCA-mutated advanced ovarian cancer: final overall survival from DUO-O/ENGOT-ov46/GOG-3025

Abstract #LBA44

Mini Oral Session

19 October 2025

11:31 AM

Goss, G

CCTG BR.31: Adjuvant durvalumab (D) in resected non-small-cell lung cancer (NSCLC): final overall survival (OS) and minimal residual disease (MRD) analyses

Abstract #LBA68

Mini Oral Session

20 October 2025

3:20 PM

Heymach, J

Association of radiomic features ± on-treatment ctDNA detection with treatment outcomes in patients with resectable NSCLC: exploratory analyses from AEGEAN

Abstract #LBA70

Mini Oral Session

20 October 2025

3:50 PM

Wermke, M

Tarlatamab with first-line chemoimmunotherapy for extensive stage small cell lung cancer (ES-SCLC): DeLLphi-303 study

Abstract #2757O

Proffered Paper Session

18 October 2025

8:30 AM

Loibl, S

Durvalumab in Combination with Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC) – Long-term Analysis from the GeparNuevo Trial

Abstract #292MO

Mini Oral Session

19 October 2025

10:15 AM

Van der Heijden, M

Health-related quality of life (HRQoL) from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC)

Abstract #3069MO

Mini Oral Session

17 October 2025

4:00 PM

Sangro, B

Pooled efficacy and safety outcomes with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the combined China extension and global cohorts in the Phase 3 HIMALAYA study

Abstract #1494P

Poster Session

Westin, S

Durvalumab plus carboplatin/paclitaxel followed by durvalumab for endometrial cancer: Tumour mutational burden-high subpopulation efficacy analyses from the DUO-E trial

Abstract #1117P

Poster Session

Leal, TA

Global quantitative assessment of multidisciplinary team (MDT) care in early-stage NSCLC

Abstract #1794P

Poster Session

Reck, M

Neoadjuvant durvalumab (D) + chemotherapy (CT) followed by either surgery (Sx) and adjuvant D or CRT and consolidation D in patients (pts) with resectable or borderline resectable stage IIB–IIIB NSCLC: interim analysis (IA) of the phase 2 MDT-BRIDGE study

Abstract #LBA65

Proffered Paper Session

18 October 2025

9:15 AM

Maruki, Y

CELEBRATE Study (JCOG2107E): A Multicenter, Open-label, Phase III Trial of Etoposide, Carboplatin, and Durvalumab in First-line Treatment of Unresectable or Recurrent Digestive NEC

Abstract #1734TiP

Poster Session

Oudard, S

A phase IIIb, open-label, single-arm, global study of perioperative durvalumab (D) with neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or gemcitabine/cisplatin (gem/cis) in patients with muscle-invasive bladder cancer (MIBC) (NIAGARA-2)

Abstract #3133eTiP

ePoster Session

IO Bispecifics

Chul Cho, B

Efficacy and Safety of Rilvegostomig, an Anti-PD-1/TIGIT Bispecific Antibody, for Checkpoint Inhibitor (CPI)-Naïve Metastatic Non-Small-Cell Lung Cancer (mNSCLC): ARTEMIDE-01

Abstract #1853MO

Mini Oral Session

20 October 2025

10:25 AM

Slomovitz, BM

A randomized Phase 3 study of first-line (1L) trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2-expressing, mismatch repair-proficient (pMMR), primary advanced or recurrent endometrial cancer (EC): DESTINY-Endometrial01/GOG-3098/ENGOT-EN24

Abstract #1223TiP

Poster Session

Naidoo, J

ARTEMIDE-Lung04: A Phase 3, randomised, double-blind, global study of rilvegostomig or pembrolizumab monotherapy as first-line (1L) treatment for patients with metastatic non-small cell lung cancer (mNSCLC) and programmed cell death ligand-1 (PD-L1) expression ≥50%

Abstract #2025TiP

Poster Session

Tumour drivers and resistance

Jänne, PA

FLAURA2: exploratory overall survival (OS) analysis in patients (pts) with poor prognostic factors treated with osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) as first-line (1L) treatment for EGFR-mutated (EGFRm) advanced NSCLC

Abstract #LBA77

Proffered Paper Session

17 October 2025

4:56 PM

Mayer, E

Patient-reported outcomes (PROs) from the SERENA-6 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1m during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC)

Abstract #486MO

Mini Oral Session

20 October 2025

10:25 AM

Arriola, E

Molecular residual disease (MRD) analysis from the LAURA study of osimertinib (osi) in unresectable (UR) stage III EGFR-mutated (EGFRm) NSCLC

Abstract #1817MO

Mini Oral Session

20 October 2025

2:55 PM

Park, YH

Visual symptom questionnaire results from SERENA-6, a Phase 3 study of switch to camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) at emergence of ESR1m during first-line (1L) therapy for patients (pts) with HR+/HER2- advanced breast cancer (ABC)

Abstract #528P

Poster Session

Chu, Q

SAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osi

Abstract #1955P

Poster Session

Rotow, J

MET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Interim analysis of a global real world (rw) study

Abstract #1967P

Poster Session

Yu, Y

ctDNA analysis in phase 3 SACHI trial: Savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI)

Abstract #1954P

Poster Session

DNA Damage Response

Azad, AA

First interim efficacy analysis of the Phase 1/2 PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC)

Abstract #2384MO

Mini Oral Session

17 October 2025

2:35 PM

Fizazi, K

A Phase 3 study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281

Abstract #2383O

Proffered Paper Session

19 October 2025

11:19 AM

Rugo, HS

Capivasertib with fulvestrant as first- and second-line endocrine therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the Phase 3 CAPItello-291 trial

Abstract #526P

Poster Session

Gao, Q

Final overall survival (OS) analysis of L-MOCA: olaparib maintenance monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC)

Abstract #1090P

Poster Session

AI Trials

Gonuguntla, HK

Real-World Validation of AI-defined Lung Nodule Malignancy Score (qXR-LNMS) in Predicting Risk of Lung Cancer: Interim results from Phase 2

Abstract #2978P

Poster Session

Theolytics to Present Ongoing Phase I/IIa OCTOPOD-IV Trial of THEO-260 in Ovarian Cancer at ESMO 2025

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.

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

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.

Lupin Announces Presentation of Phase 1 Data on LNP3693 (STING agonist) at the ESMO Congress 2025

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:
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