Xilio Therapeutics to Present Phase 2 Data for Vilastobart Highlighting Response Rate in Patients with MSS mCRC and High Plasma Tumor Mutational Burden as a Late-Breaking Presentation at SITC 40th Annual Meeting

Xilio Therapeutics to Present Phase 2 Data for Vilastobart Highlighting Response Rate in Patients with MSS mCRC and High Plasma Tumor Mutational Burden as a Late-Breaking Presentation at SITC 40th Annual Meeting




Xilio Therapeutics to Present Phase 2 Data for Vilastobart Highlighting Response Rate in Patients with MSS mCRC and High Plasma Tumor Mutational Burden as a Late-Breaking Presentation at SITC 40th Annual Meeting

WALTHAM, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) — Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that it will present a late-breaking poster presentation for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 5-9, 2025 in National Harbor, Maryland. The Phase 2 data will highlight response rate for vilastobart in combination with atezolizumab in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) and high plasma tumor mutational burden.

Poster presentation details are as follows:

Abstract Title: Plasma Tumor Mutational Burden (pTMB) Enriched for Response to Vilastobart in Combination with Atezolizumab in Patients with Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)
Late-Breaking Abstract Number: 1315
Presentation Date: Friday, Nov. 7, 2025
Poster Hall Hours: 9:00 a.m.-7:00 p.m. EST
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center Gaylord

The poster will be available on November 7, 2025 under the “Our Approach—Presentations & Publications” section of the Xilio Therapeutics website at www.xiliotx.com.

About Xilio Therapeutics

Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans to present data related to Xilio’s clinical program for vilastobart; and Xilio’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s ability to advance multiple early stage masked T cell engager programs; initial, preliminary or interim preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s need to obtain additional cash resources to advance its pipeline of tumor-activated I-O molecules; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; and Xilio’s ability to maintain its collaboration or partnership agreements with AbbVie, Gilead and Roche. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Investor Contact  
Alex Lobo, Precision AQ
alex.lobo@precisionaq.com

Media Contact  
Josie Butler, 1AB
josie@1abmedia.com

Xilio Therapeutics to Present Phase 2 Data for Vilastobart Highlighting Response Rate in Patients with MSS mCRC and High Plasma Tumor Mutational Burden as a Late-Breaking Presentation at SITC 40th Annual Meeting

Xilio Therapeutics to Present Phase 2 Data for Vilastobart Highlighting Response Rate in Patients with MSS mCRC and High Plasma Tumor Mutational Burden as a Late-Breaking Presentation at SITC 40th Annual Meeting




Xilio Therapeutics to Present Phase 2 Data for Vilastobart Highlighting Response Rate in Patients with MSS mCRC and High Plasma Tumor Mutational Burden as a Late-Breaking Presentation at SITC 40th Annual Meeting

WALTHAM, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) — Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that it will present a late-breaking poster presentation for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 5-9, 2025 in National Harbor, Maryland. The Phase 2 data will highlight response rate for vilastobart in combination with atezolizumab in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) and high plasma tumor mutational burden.

Poster presentation details are as follows:

Abstract Title: Plasma Tumor Mutational Burden (pTMB) Enriched for Response to Vilastobart in Combination with Atezolizumab in Patients with Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)
Late-Breaking Abstract Number: 1315
Presentation Date: Friday, Nov. 7, 2025
Poster Hall Hours: 9:00 a.m.-7:00 p.m. EST
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center Gaylord

The poster will be available on November 7, 2025 under the “Our Approach—Presentations & Publications” section of the Xilio Therapeutics website at www.xiliotx.com.

About Xilio Therapeutics

Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans to present data related to Xilio’s clinical program for vilastobart; and Xilio’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s ability to advance multiple early stage masked T cell engager programs; initial, preliminary or interim preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s need to obtain additional cash resources to advance its pipeline of tumor-activated I-O molecules; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; and Xilio’s ability to maintain its collaboration or partnership agreements with AbbVie, Gilead and Roche. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Investor Contact  
Alex Lobo, Precision AQ
alex.lobo@precisionaq.com

Media Contact  
Josie Butler, 1AB
josie@1abmedia.com

Nouscom to Present New Positive Phase 1b/2 Clinical and Translational Data on NOUS-209 Immunogenicity and Cancer Interception Potential in Lynch Syndrome Carriers at SITC 2025

Nouscom to Present New Positive Phase 1b/2 Clinical and Translational Data on NOUS-209 Immunogenicity and Cancer Interception Potential in Lynch Syndrome Carriers at SITC 2025




Nouscom to Present New Positive Phase 1b/2 Clinical and Translational Data on NOUS-209 Immunogenicity and Cancer Interception Potential in Lynch Syndrome Carriers at SITC 2025

  • Lynch Syndrome (LS) is a common hereditary condition that greatly increases lifetime risk of colorectal, endometrial, urothelial and other cancers
  • NOUS-209 is an off-the-shelf immunotherapy designed to harness the power of the immune system to recognize and eliminate cancerous cells before tumors develop
  • Additional results from Phase 1b/2 trial of NOUS-209 in LS carriers demonstrating effective boosting of immune response through annual retreatment to be presented in an oral late-breaker presentation at SITC 2025
  • Further validation of NOUS-209 mechanism of action enabling broad targeting of primary and metachronous tumors in LS carriers to also be presented
  • Findings support advancement of NOUS-209 to FDA and EMA aligned registration-enabling clinical study for cancer interception in LS carriers

BASEL, Switzerland – 30 October 2025 – Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, today announced it will give an oral late-breaker as well as a poster presentation of additional results from a Phase 1b/2 trial evaluating NOUS-209 in Lynch Syndrome (LS) carriers at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting being held in National Harbor, MD, USA on November 5-9, 2025. The company will also present further data validating NOUS-209 mechanism of action (MoA) in LS carriers at the SITC meeting.

Oral Presentation Details:

Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers: Annual Revaccination Boosts T Cell Immunity Informing Future Cancer Interception Strategies

  • Session: Clinical Oral Abstract Session 2
  • Date & Time: Saturday, November 8, 2025, 1:45 PM – 3:00 PM ET
  • Location: Gaylord National Resort & Convention Center, Potomac Ballroom

Poster Presentations Details:

Poster #118 – NOUS-209 Mechanism of Action Validation
Title: NOUS-209 Enables Broad Targeting of Primary and Metachronous Tumors in Lynch Syndrome

  • Session: Poster Hall
  • Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
  • Location: Prince George’s ABC

Poster #1336 – NOUS-209 Clinical Data
Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers

  • Session: Poster Hall
  • Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
  • Location: Prince George’s ABC

All abstracts are available on the SITC website https://www.sitcancer.org/2025/abstracts/titles-and-publications

LS is a common inherited condition caused by DNA repair gene mutations. It affects approximately 1 in 300 people, leading to a significantly increased lifetime cancer risk of up to 80%. While current LS disease management relies on frequent screenings or preventive surgery, cancer interception with NOUS-209 aims to train the immune system to recognize and eliminate cancerous cells before they fully develop, grow and spread.

NOUS-209 is an off-the-shelf immunotherapy designed to target tumors with specific genetic deficiencies known as mismatch repair deficiency (dMMR) and/or microsatellite instability (MSI). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which serve as tumor-specific neoantigens. Because these FSPs are exclusively found in cancerous cells, they are readily recognizable by the immune system and therefore are ideal targets for immunotherapy. NOUS-209 encodes 209 unique FSP neoantigens shared across multiple MSI tumor types, enabling its potential to treat a broad range of MSI-associated cancers.

Following positive Type B and C meetings with the US Food and Drug Administration (FDA), Nouscom has a clear path forward for the advancement of NOUS-209 into a registration-enabling Phase 2/3 clinical study for cancer interception in LS carriers.

The clinical trial NCT05078866 was led by researchers at The University of Texas MD Anderson Cancer Center, in collaboration with the Cancer Prevention Clinical Trials Network (CP-CTNet) and sponsored by the National Cancer Institute (grant # UG1CA242609). The activities are coordinated by the iCAN-PREVENT consortium of MD Anderson Cancer Center.

—–


About NOUS-209 
NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR) and high microsatellite instability (MSI-H). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which are unique to cancerous cells and absent in healthy cells. NOUS-209 is comprised of two proprietary viral vectors able to deliver 209 shared FSP neoantigens and train the immune system to recognize and attack cancerous and precancerous cells before tumors can develop.

Phase 1b/2 data (NCT05078866) demonstrated the safety of NOUS-209 and its ability to stimulate potent immune responses in LS carriers1, supporting its advancement into a registration-enabling Phase 2/3 trial in cancer interception. It also demonstrated clinical activity including objective responses and strong disease control in combination with pembrolizumab in a difficult-to-treat patient population of advanced dMMR and/or MSI-H metastatic CRC (mCRC) patients refractory to anti-PD-1 therapy2. NOUS-209 is also being studied in a randomized Phase 2 study in combination with pembrolizumab for the first line treatment of advanced dMMR and/or MSI-H mCRC. Data published from the successfully completed Phase 1b trial were published in Science Translational Medicine3.


About Lynch Syndrome 
Lynch Syndrome (LS) is a common inherited condition that significantly increases a person’s risk of developing cancer over their lifetime, especially colorectal cancer (CRC) (up to 50% risk, compared to 2% for general population), endometrial cancer (up to 50% risk, compared to 1-2% for general population) and urothelial cancer (up to 25% risk, compared to 1-2% for general population)4,5,6,7. LS also elevates the risk of developing other cancers including gastric, ovarian, prostate and pancreatic. LS is caused by inherited mutations in specific genes responsible for repairing DNA, leading to the buildup of harmful genetic errors that can accumulate, triggering development of tumors. Currently, managing LS is limited to frequent screenings – such as colonoscopy to try to catch cancer early, but which will not prevent cancer incidence8 – or elective surgery, which is invasive, expensive, and negatively impacts quality of life. As a pioneering approach to cancer interception, Nouscom’s investigational immunotherapy, NOUS-209, is designed to train the immune system to recognize and stop cancer before it develops. 


About Cancer Interception 
Cancer interception is an innovative approach that aims to stop cancer in its earliest stages before tumors fully develop and spread. Unlike traditional therapies that target established cancers, interception strategies harness advancements in immuno-oncology that can train the immune system to recognize and eliminate precancerous and cancerous cells. This approach is particularly crucial for those with high-risk genetic conditions such as LS who are predisposed to developing MSI-associated cancers.


About Nouscom 
Nouscom is a clinical-stage biotech company pioneering next-generation neoantigen-targeted immunotherapies to treat cancer at all stages, from early cancer interception to late-stage metastatic disease. Its proprietary viral vector platform enables broad and durable immune activation by delivering optimized neoantigens that train the immune system to recognize and fight cancer. Nouscom’s lead program, NOUS-209, is an off-the-shelf immunotherapy in advanced clinical development for cancer interception in LS and the treatment of MSI-mCRC. The company’s clinical stage portfolio also includes NOUS-PEV, a personalized neoantigen immunotherapy, with published data from a successfully completed Phase 1b trial9
For more information on Nouscom, please visit the company’s website at www.nouscom.com or follow us on LinkedIn. 

References 

  1. Willis et al, Cancer Res (2025) 85 (8_Supplement_1): 6427.
  2. Abstract is available on the ESMO website, here
  3. D’Alise et al., Science Translational Medicine, 2022. 
  4. Dominguez-Valentin et al., Genetics in Medicine, 2020.  
  5. Dominguez-Valentin et al., The Lancet, 2023.  
  6. Strafford, Reviews in Obstetrics & Gynecology, 2012.
  7. Richters et al., World Journal of Urology, 2020. 
  8. Ahadova et al., International Journal of Cancer 2020. 
  9. D’Alise et al., Clin Cancer Research, 2024. 

Contacts
Nouscom
Rick Davis, COO
info@nouscom.com
+41 61 201 1835

MEDiSTRAVA
Sylvie Berrebi, Sandi Greenwood, Mark Swallow
nouscom@medistrava.com
+44 (0)203 928 6900

# # #

Nouscom to Present New Positive Phase 1b/2 Clinical and Translational Data on NOUS-209 Immunogenicity and Cancer Interception Potential in Lynch Syndrome Carriers at SITC 2025

Nouscom to Present New Positive Phase 1b/2 Clinical and Translational Data on NOUS-209 Immunogenicity and Cancer Interception Potential in Lynch Syndrome Carriers at SITC 2025




Nouscom to Present New Positive Phase 1b/2 Clinical and Translational Data on NOUS-209 Immunogenicity and Cancer Interception Potential in Lynch Syndrome Carriers at SITC 2025

  • Lynch Syndrome (LS) is a common hereditary condition that greatly increases lifetime risk of colorectal, endometrial, urothelial and other cancers
  • NOUS-209 is an off-the-shelf immunotherapy designed to harness the power of the immune system to recognize and eliminate cancerous cells before tumors develop
  • Additional results from Phase 1b/2 trial of NOUS-209 in LS carriers demonstrating effective boosting of immune response through annual retreatment to be presented in an oral late-breaker presentation at SITC 2025
  • Further validation of NOUS-209 mechanism of action enabling broad targeting of primary and metachronous tumors in LS carriers to also be presented
  • Findings support advancement of NOUS-209 to FDA and EMA aligned registration-enabling clinical study for cancer interception in LS carriers

BASEL, Switzerland – 30 October 2025 – Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, today announced it will give an oral late-breaker as well as a poster presentation of additional results from a Phase 1b/2 trial evaluating NOUS-209 in Lynch Syndrome (LS) carriers at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting being held in National Harbor, MD, USA on November 5-9, 2025. The company will also present further data validating NOUS-209 mechanism of action (MoA) in LS carriers at the SITC meeting.

Oral Presentation Details:

Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers: Annual Revaccination Boosts T Cell Immunity Informing Future Cancer Interception Strategies

  • Session: Clinical Oral Abstract Session 2
  • Date & Time: Saturday, November 8, 2025, 1:45 PM – 3:00 PM ET
  • Location: Gaylord National Resort & Convention Center, Potomac Ballroom

Poster Presentations Details:

Poster #118 – NOUS-209 Mechanism of Action Validation
Title: NOUS-209 Enables Broad Targeting of Primary and Metachronous Tumors in Lynch Syndrome

  • Session: Poster Hall
  • Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
  • Location: Prince George’s ABC

Poster #1336 – NOUS-209 Clinical Data
Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers

  • Session: Poster Hall
  • Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
  • Location: Prince George’s ABC

All abstracts are available on the SITC website https://www.sitcancer.org/2025/abstracts/titles-and-publications

LS is a common inherited condition caused by DNA repair gene mutations. It affects approximately 1 in 300 people, leading to a significantly increased lifetime cancer risk of up to 80%. While current LS disease management relies on frequent screenings or preventive surgery, cancer interception with NOUS-209 aims to train the immune system to recognize and eliminate cancerous cells before they fully develop, grow and spread.

NOUS-209 is an off-the-shelf immunotherapy designed to target tumors with specific genetic deficiencies known as mismatch repair deficiency (dMMR) and/or microsatellite instability (MSI). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which serve as tumor-specific neoantigens. Because these FSPs are exclusively found in cancerous cells, they are readily recognizable by the immune system and therefore are ideal targets for immunotherapy. NOUS-209 encodes 209 unique FSP neoantigens shared across multiple MSI tumor types, enabling its potential to treat a broad range of MSI-associated cancers.

Following positive Type B and C meetings with the US Food and Drug Administration (FDA), Nouscom has a clear path forward for the advancement of NOUS-209 into a registration-enabling Phase 2/3 clinical study for cancer interception in LS carriers.

The clinical trial NCT05078866 was led by researchers at The University of Texas MD Anderson Cancer Center, in collaboration with the Cancer Prevention Clinical Trials Network (CP-CTNet) and sponsored by the National Cancer Institute (grant # UG1CA242609). The activities are coordinated by the iCAN-PREVENT consortium of MD Anderson Cancer Center.

—–


About NOUS-209 
NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR) and high microsatellite instability (MSI-H). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which are unique to cancerous cells and absent in healthy cells. NOUS-209 is comprised of two proprietary viral vectors able to deliver 209 shared FSP neoantigens and train the immune system to recognize and attack cancerous and precancerous cells before tumors can develop.

Phase 1b/2 data (NCT05078866) demonstrated the safety of NOUS-209 and its ability to stimulate potent immune responses in LS carriers1, supporting its advancement into a registration-enabling Phase 2/3 trial in cancer interception. It also demonstrated clinical activity including objective responses and strong disease control in combination with pembrolizumab in a difficult-to-treat patient population of advanced dMMR and/or MSI-H metastatic CRC (mCRC) patients refractory to anti-PD-1 therapy2. NOUS-209 is also being studied in a randomized Phase 2 study in combination with pembrolizumab for the first line treatment of advanced dMMR and/or MSI-H mCRC. Data published from the successfully completed Phase 1b trial were published in Science Translational Medicine3.


About Lynch Syndrome 
Lynch Syndrome (LS) is a common inherited condition that significantly increases a person’s risk of developing cancer over their lifetime, especially colorectal cancer (CRC) (up to 50% risk, compared to 2% for general population), endometrial cancer (up to 50% risk, compared to 1-2% for general population) and urothelial cancer (up to 25% risk, compared to 1-2% for general population)4,5,6,7. LS also elevates the risk of developing other cancers including gastric, ovarian, prostate and pancreatic. LS is caused by inherited mutations in specific genes responsible for repairing DNA, leading to the buildup of harmful genetic errors that can accumulate, triggering development of tumors. Currently, managing LS is limited to frequent screenings – such as colonoscopy to try to catch cancer early, but which will not prevent cancer incidence8 – or elective surgery, which is invasive, expensive, and negatively impacts quality of life. As a pioneering approach to cancer interception, Nouscom’s investigational immunotherapy, NOUS-209, is designed to train the immune system to recognize and stop cancer before it develops. 


About Cancer Interception 
Cancer interception is an innovative approach that aims to stop cancer in its earliest stages before tumors fully develop and spread. Unlike traditional therapies that target established cancers, interception strategies harness advancements in immuno-oncology that can train the immune system to recognize and eliminate precancerous and cancerous cells. This approach is particularly crucial for those with high-risk genetic conditions such as LS who are predisposed to developing MSI-associated cancers.


About Nouscom 
Nouscom is a clinical-stage biotech company pioneering next-generation neoantigen-targeted immunotherapies to treat cancer at all stages, from early cancer interception to late-stage metastatic disease. Its proprietary viral vector platform enables broad and durable immune activation by delivering optimized neoantigens that train the immune system to recognize and fight cancer. Nouscom’s lead program, NOUS-209, is an off-the-shelf immunotherapy in advanced clinical development for cancer interception in LS and the treatment of MSI-mCRC. The company’s clinical stage portfolio also includes NOUS-PEV, a personalized neoantigen immunotherapy, with published data from a successfully completed Phase 1b trial9
For more information on Nouscom, please visit the company’s website at www.nouscom.com or follow us on LinkedIn. 

References 

  1. Willis et al, Cancer Res (2025) 85 (8_Supplement_1): 6427.
  2. Abstract is available on the ESMO website, here
  3. D’Alise et al., Science Translational Medicine, 2022. 
  4. Dominguez-Valentin et al., Genetics in Medicine, 2020.  
  5. Dominguez-Valentin et al., The Lancet, 2023.  
  6. Strafford, Reviews in Obstetrics & Gynecology, 2012.
  7. Richters et al., World Journal of Urology, 2020. 
  8. Ahadova et al., International Journal of Cancer 2020. 
  9. D’Alise et al., Clin Cancer Research, 2024. 

Contacts
Nouscom
Rick Davis, COO
info@nouscom.com
+41 61 201 1835

MEDiSTRAVA
Sylvie Berrebi, Sandi Greenwood, Mark Swallow
nouscom@medistrava.com
+44 (0)203 928 6900

# # #

Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value

Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value




Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value

BOSTON, Oct. 30, 2025 (GLOBE NEWSWIRE) — Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that its Board of Directors has determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue development of solnerstotug and initiate a comprehensive review of strategic alternatives aimed at maximizing shareholder value. The Company is exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations.

In connection with this strategic review, the Company expects to implement a workforce reduction to preserve cash, the details of which will be disclosed separately. The Company plans to retain a small team of employees to assist in exploring strategic alternatives, maintaining compliance with regulatory and financial reporting requirements, and managing the orderly cessation of development activities.

“We have seen solnerstotug demonstrate clinical activity in a patient population with significant unmet need,” said John Celebi, President and Chief Executive Officer of Sensei. “However, after careful review of future funding needs and the current capital markets environment, we have determined not to initiate a new clinical study. Our role now is to steward the Company and its assets with care, including an orderly wind-down of the ongoing Phase 1/2 clinical trial and preservation of shareholder value.”

The Company does not intend to provide updates on the strategic alternatives process unless and until its Board of Directors has approved a specific transaction or otherwise determines that disclosure is appropriate or required by law. The Company has not set a definitive timeline for this process and there can be no assurance that the exploration of strategic alternatives will result in any transaction being announced or consummated.

About Sensei Biotherapeutics
Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. The Company is currently pursuing strategic alternatives to maximize shareholder value. For more information, please visit www.senseibio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the Company’s strategic alternatives process, the entry into or completion of any strategic alternative transaction, workforce reduction plans, and ability to maximize shareholder value. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in strategic review processes, such as the risk that no suitable strategic alternative will be identified or consummated; risks associated with workforce reductions and operational wind-down activities; risks regarding the Company’s estimates of expenses and cash requirements; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on August 5, 2025 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com

Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value

Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value




Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value

BOSTON, Oct. 30, 2025 (GLOBE NEWSWIRE) — Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that its Board of Directors has determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue development of solnerstotug and initiate a comprehensive review of strategic alternatives aimed at maximizing shareholder value. The Company is exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations.

In connection with this strategic review, the Company expects to implement a workforce reduction to preserve cash, the details of which will be disclosed separately. The Company plans to retain a small team of employees to assist in exploring strategic alternatives, maintaining compliance with regulatory and financial reporting requirements, and managing the orderly cessation of development activities.

“We have seen solnerstotug demonstrate clinical activity in a patient population with significant unmet need,” said John Celebi, President and Chief Executive Officer of Sensei. “However, after careful review of future funding needs and the current capital markets environment, we have determined not to initiate a new clinical study. Our role now is to steward the Company and its assets with care, including an orderly wind-down of the ongoing Phase 1/2 clinical trial and preservation of shareholder value.”

The Company does not intend to provide updates on the strategic alternatives process unless and until its Board of Directors has approved a specific transaction or otherwise determines that disclosure is appropriate or required by law. The Company has not set a definitive timeline for this process and there can be no assurance that the exploration of strategic alternatives will result in any transaction being announced or consummated.

About Sensei Biotherapeutics
Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. The Company is currently pursuing strategic alternatives to maximize shareholder value. For more information, please visit www.senseibio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the Company’s strategic alternatives process, the entry into or completion of any strategic alternative transaction, workforce reduction plans, and ability to maximize shareholder value. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in strategic review processes, such as the risk that no suitable strategic alternative will be identified or consummated; risks associated with workforce reductions and operational wind-down activities; risks regarding the Company’s estimates of expenses and cash requirements; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on August 5, 2025 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com

WeightWatchers Schedules Third Quarter 2025 Earnings Conference Call

WeightWatchers Schedules Third Quarter 2025 Earnings Conference Call




WeightWatchers Schedules Third Quarter 2025 Earnings Conference Call

NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) — WW International, Inc. (NASDAQ: WW) (“WeightWatchers,” “WW,” or the “Company”) will release its results for the third quarter 2025 ended September 30, 2025, before market open on Thursday, November 6, 2025.

WeightWatchers will host a conference call to discuss results at 8:30 a.m. ET the same day. The webcast of the conference call will be available on the Company’s corporate website, corporate.ww.com, under Events and Presentations. A replay of the webcast will be available on this site for at least 90 days.

About WeightWatchers
WeightWatchers is the global leader in science-backed weight management, offering an integrated support system that combines scientific expertise and human connection. With more than 60 years of experience, WeightWatchers is the most studied commercial weight management program in the world, delivered through its No. 1 U.S. doctor-recommended weight-loss program. Its holistic, personalized approach also includes U.S.-based clinical interventions, medications when clinically appropriate, and a global network of coaches and community support. Since 1963, the company has surrounded its members with the support they need to reach and sustain their goals, wherever they are on their journey. Members can access these solutions directly, or through WeightWatchers for Business’ full-spectrum platform for employers, health plans, and payers. In a landscape crowded with contradictory advice, isolating apps, and one-size-fits-all solutions, WeightWatchers offers a proven path forward, grounded in empathy and designed to help every member feel better in their body and live a longer, healthier life. For more information, visit weightwatchers.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and beliefs, as well as a number of assumptions concerning future events. These statements are subject to risks, uncertainties, assumptions and other important factors. Readers are cautioned not to put undue reliance on such forward-looking statements because actual results may vary materially from those expressed or implied. The reports filed by the Company pursuant to United States securities laws contain discussions of these risks and uncertainties. The Company assumes no obligation to, and expressly disclaims any obligation to, update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are advised to review the Company’s filings with the United States Securities and Exchange Commission (which are available on the SEC’s EDGAR database at www.sec.gov and via the Company’s website at corporate.ww.com).

For more information, contact:
John Mills or Anna Kate Heller
WeightWatchers@icrinc.com

WeightWatchers Schedules Third Quarter 2025 Earnings Conference Call

WeightWatchers Schedules Third Quarter 2025 Earnings Conference Call




WeightWatchers Schedules Third Quarter 2025 Earnings Conference Call

NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) — WW International, Inc. (NASDAQ: WW) (“WeightWatchers,” “WW,” or the “Company”) will release its results for the third quarter 2025 ended September 30, 2025, before market open on Thursday, November 6, 2025.

WeightWatchers will host a conference call to discuss results at 8:30 a.m. ET the same day. The webcast of the conference call will be available on the Company’s corporate website, corporate.ww.com, under Events and Presentations. A replay of the webcast will be available on this site for at least 90 days.

About WeightWatchers
WeightWatchers is the global leader in science-backed weight management, offering an integrated support system that combines scientific expertise and human connection. With more than 60 years of experience, WeightWatchers is the most studied commercial weight management program in the world, delivered through its No. 1 U.S. doctor-recommended weight-loss program. Its holistic, personalized approach also includes U.S.-based clinical interventions, medications when clinically appropriate, and a global network of coaches and community support. Since 1963, the company has surrounded its members with the support they need to reach and sustain their goals, wherever they are on their journey. Members can access these solutions directly, or through WeightWatchers for Business’ full-spectrum platform for employers, health plans, and payers. In a landscape crowded with contradictory advice, isolating apps, and one-size-fits-all solutions, WeightWatchers offers a proven path forward, grounded in empathy and designed to help every member feel better in their body and live a longer, healthier life. For more information, visit weightwatchers.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and beliefs, as well as a number of assumptions concerning future events. These statements are subject to risks, uncertainties, assumptions and other important factors. Readers are cautioned not to put undue reliance on such forward-looking statements because actual results may vary materially from those expressed or implied. The reports filed by the Company pursuant to United States securities laws contain discussions of these risks and uncertainties. The Company assumes no obligation to, and expressly disclaims any obligation to, update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are advised to review the Company’s filings with the United States Securities and Exchange Commission (which are available on the SEC’s EDGAR database at www.sec.gov and via the Company’s website at corporate.ww.com).

For more information, contact:
John Mills or Anna Kate Heller
WeightWatchers@icrinc.com

MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting

MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting




MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting

NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced that late-breaking data demonstrating durable clinical activity of AgenT-797, allo-INKTs, in advanced solid tumors will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 7–9, 2025, in National Harbor, Maryland.

The presentation, titled “AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings” (LBA #1344), will highlight updated safety and efficacy results from the company’s ongoing Phase 1 study of AgenT-797 in patients with advanced solid tumors. AgenT-797 is an off-the-shelf iNKT cell therapy designed to reprogram the immune system and overcome resistance to conventional immunotherapies.

Presentation details:

  • Title: AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings
  • Author: Dr. Benjamin Garmezy, Assistant Director of Genitourinary Research for Sarah Cannon Research Institute at SCRI Oncology Partners
  • Abstract Number: 1344
  • Location: Prince George ABC Exhibit Halls, Gaylord National Resort & Convention Center, National Harbor, MD
  • Dates/Time: Saturday, November 8th | poster attendance from 12:15–1:45 p.m. ET and 5:10–6:35 p.m. ET

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse.

Its lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for AgenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law.

Contacts

Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
Source: MiNK Therapeutics

MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting

MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting




MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting

NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced that late-breaking data demonstrating durable clinical activity of AgenT-797, allo-INKTs, in advanced solid tumors will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 7–9, 2025, in National Harbor, Maryland.

The presentation, titled “AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings” (LBA #1344), will highlight updated safety and efficacy results from the company’s ongoing Phase 1 study of AgenT-797 in patients with advanced solid tumors. AgenT-797 is an off-the-shelf iNKT cell therapy designed to reprogram the immune system and overcome resistance to conventional immunotherapies.

Presentation details:

  • Title: AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings
  • Author: Dr. Benjamin Garmezy, Assistant Director of Genitourinary Research for Sarah Cannon Research Institute at SCRI Oncology Partners
  • Abstract Number: 1344
  • Location: Prince George ABC Exhibit Halls, Gaylord National Resort & Convention Center, National Harbor, MD
  • Dates/Time: Saturday, November 8th | poster attendance from 12:15–1:45 p.m. ET and 5:10–6:35 p.m. ET

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse.

Its lead candidate, AgenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for AgenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law.

Contacts

Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
Source: MiNK Therapeutics