Xilio Therapeutics to Present Initial Phase 2 Data for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI
Xilio Therapeutics (XLO) announced plans to present initial Phase 2 data for vilastobart (XTX101), their tumor-activated anti-CTLA-4 therapy, in combination with atezolizumab for metastatic microsatellite stable colorectal cancer at ASCO GI in January 2025. The company also reported preliminary Phase 1 data for XTX301, their tumor-activated IL-12 therapy, showing improved tolerability with no dose-limiting toxicities across 34 patients treated at doses from 5 µg/kg to 60 µg/kg.
The company completed an additional $8.2 million private placement with Gilead, reaching the maximum $25 million investment under their March 2024 agreement. With these proceeds, Xilio expects to fund operations into Q3 2025.
Xilio Therapeutics (XLO) ha annunciato piani per presentare i dati iniziali della Fase 2 per vilastobart (XTX101), la loro terapia anti-CTLA-4 attivata da tumore, in combinazione con atezolizumab per il cancro colorectal metastatico stabile ai microsatelliti, all'ASCO GI a gennaio 2025. L'azienda ha inoltre riportato dati preliminari dalla Fase 1 per XTX301, la loro terapia IL-12 attivata da tumore, mostrando una tollerabilità migliorata senza tossicità limitanti alla dose in 34 pazienti trattati con dosi variabili da 5 µg/kg a 60 µg/kg.
L'azienda ha completato un ulteriore collocamento privato di 8,2 milioni di dollari con Gilead, raggiungendo il massimo investimento di 25 milioni di dollari ai sensi del loro accordo di marzo 2024. Con questi proventi, Xilio prevede di finanziare le operazioni fino al terzo trimestre del 2025.
Xilio Therapeutics (XLO) anunció planes para presentar los datos iniciales de la Fase 2 para vilastobart (XTX101), su terapia anti-CTLA-4 activada por tumores, en combinación con atezolizumab para el cáncer colorrectal metastásico estable en microsatélites, en el ASCO GI en enero de 2025. La compañía también informó los datos preliminares de la Fase 1 para XTX301, su terapia de IL-12 activada por tumores, que mostró una mejor tolerabilidad sin toxicidades limitantes de dosis en 34 pacientes tratados con dosis de 5 µg/kg a 60 µg/kg.
La compañía completó una colocación privada adicional de 8.2 millones de dólares con Gilead, alcanzando la inversión máxima de 25 millones de dólares bajo su acuerdo de marzo de 2024. Con estos fondos, Xilio espera financiar sus operaciones hasta el tercer trimestre de 2025.
Xilio Therapeutics (XLO)는 vilastobart (XTX101), 이들의 종양 활성화 항-CTLA-4 치료제와 atezolizumab의 병용요법에 대한 초기 2상 데이터를 2025년 1월 ASCO GI에서 발표할 계획을 발표했습니다. 회사는 5 µg/kg에서 60 µg/kg까지의 용량으로 치료받은 34명의 환자에서 용량 제한 독성이 없는 개선된 내약성을 보여주는 XTX301에 대한 예비 1상 데이터도 보고했습니다.
회사는 Gilead와 820만 달러의 추가 사모펀드를 완료하여 2024년 3월 협약에 따라 최대 2500만 달러의 투자에 도달했습니다. 이 자금을 통해 Xilio는 2025년 3분기까지 운영 자금을 지원할 것으로 예상하고 있습니다.
Xilio Therapeutics (XLO) a annoncé ses projets de présenter les premières données de la Phase 2 pour vilastobart (XTX101), leur thérapie anti-CTLA-4 activée par les tumeurs, en association avec l'atezolizumab pour le cancer colorectal métastatique stable aux microsatellites, lors de l'ASCO GI en janvier 2025. L'entreprise a également rapporté des données préliminaires de la Phase 1 pour XTX301, leur thérapie IL-12 activée par les tumeurs, montrant une meilleure tolérabilité sans toxicités limitantes de dose chez 34 patients traités avec des doses de 5 µg/kg à 60 µg/kg.
L'entreprise a complété un placement privé supplémentaire de 8,2 millions de dollars avec Gilead, atteignant l'investissement maximum de 25 millions de dollars dans le cadre de leur accord de mars 2024. Avec ces recettes, Xilio prévoit de financer ses opérations jusqu'au troisième trimestre 2025.
Xilio Therapeutics (XLO) gab bekannt, dass sie im Januar 2025 auf dem ASCO GI erste Daten der Phase 2 für vilastobart (XTX101), ihre tumoraktivierte anti-CTLA-4-Therapie in Kombination mit Atezolizumab für metastasierenden mikrosatellitenstabilen kolorektalen Krebs, präsentieren werden. Das Unternehmen berichtete auch über vorläufige Daten der Phase 1 für XTX301, ihre tumoraktivierte IL-12-Therapie, die eine bessere Verträglichkeit ohne dosislimitierende Toxizität bei 34 Patienten, die mit Dosen von 5 µg/kg bis 60 µg/kg behandelt wurden, zeigte.
Das Unternehmen hat eine zusätzliche Kapitalbeschaffung in Höhe von 8,2 Millionen Dollar mit Gilead abgeschlossen und damit die maximale Investition von 25 Millionen Dollar gemäß ihrem Vertrag im März 2024 erreicht. Mit diesen Einnahmen erwartet Xilio, die Operationen bis zum dritten Quartal 2025 zu finanzieren.
- No dose-limiting toxicities reported in XTX301 Phase 1 trial across all dose levels
- Completed $25 million total investment from Gilead
- Cash runway extended into Q3 2025
- Early evidence of responses in cold tumors reported for vilastobart-atezolizumab combination
- 68% of trial patients required 3+ prior lines of therapy, indicating late-stage treatment population
- Maximum tolerated dose for XTX301 not yet established
Insights
The preliminary Phase 1 data for XTX301 (IL-12) demonstrates a promising safety profile, with no dose-limiting toxicities reported across 34 patients at doses up to 60 µg/kg. The sustained interferon gamma signaling without tachyphylaxis is particularly noteworthy, as this has been a limiting factor for other IL-12 therapies. The absence of measurable activated XTX301 in peripheral circulation suggests successful tumor-targeted activation, potentially minimizing systemic toxicity.
The upcoming Phase 2 data presentation for vilastobart (XTX101) in combination with atezolizumab for MSS colorectal cancer at ASCO GI could be pivotal. MSS CRC represents approximately 95% of colorectal cancer cases and historically shows poor response to immunotherapy. Early evidence of responses in these "cold tumors" could indicate a significant therapeutic advancement.
The additional
The completion of Gilead's equity investment signals strong institutional confidence in Xilio's platform. The extended cash runway into Q3 2025 is important for a clinical-stage biotech with a
The promising preliminary data from both XTX301 and vilastobart programs could catalyze value inflection points. Success in MSS colorectal cancer would address a substantial market opportunity, potentially driving significant value creation. The clean safety profile of XTX301 and evidence of targeted activation could differentiate it from competing IL-12 approaches.
Announces preliminary Phase 1 data for XTX301, a tumor-activated IL-12, demonstrating an improved tolerability profile over historical data for rhIL-12, with no dose-limiting toxicities
Completed additional private placement with Gilead for purchase of remaining equity investment in connection with XTX301 partnership
WALTHAM, Mass., Dec. 19, 2024 (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 plans to present initial data from its ongoing Phase 2 trial for vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco, California from January 23-25, 2025. In addition, today the company announced preliminary data from Phase 1 dose escalation for XTX301, an investigational tumor-activated IL-12.
“We are encouraged by the early evidence of responses in patients with cold tumors, including MSS colorectal cancer, reported for the combination of vilastobart and atezolizumab in Phase 1C dose escalation earlier this year, and we look forward to sharing initial Phase 2 data for the combination in MSS CRC at ASCO GI in January,” said Katarina Luptakova, M.D., chief medical officer of Xilio. “In addition, the preliminary Phase 1 data we reported today for XTX301, our tumor-activated IL-12, highlight its promising clinical profile, including no dose-limiting toxicities reported to date and consistent interferon gamma signaling observed throughout treatment cycles.”
ASCO GI Presentation Details for Vilastobart (anti-CTLA-4)
Xilio will present initial data from its ongoing Phase 2 trial for vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic MSS CRC:
- Title: Phase 1/2 study of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with advanced solid tumors and in MSS CRC
- Abstract Number: 206
- Presentation Date: Saturday, January 25, 2025
- Poster Session C: Cancers of the Colon, Rectum, and Anus
- Time: 7:00 AM-7:55 AM PST
- Location: Moscone West, San Francisco, CA
In November 2024, Xilio presented encouraging initial data from the ongoing Phase 1C dose escalation trial for the combination of vilastobart and atezolizumab in patients with advanced solid tumors. For more information, read the press release here.
Preliminary Data from Ongoing Phase 1 Trial for XTX301 (IL-12)
As of the data cutoff date of November 25, 2024, 34 patients with advanced solid tumors had been treated with XTX301 at doses ranging from 5 µg/kg to 60 µg/kg administered once every three weeks (Q3W) or once every six weeks (Q6W). Patients were generally heavily pre-treated, and approximately
A maximum tolerated dose has not yet been established. Xilio continues to enroll patients in Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion of its ongoing Phase 1 clinical trial of XTX301 in patients with advanced solid tumors.
In addition, preliminary results as of the data cutoff date showed:
- Sustained interferon gamma (IFNɣ) signaling without evidence of tachyphylaxis throughout treatment cycles. Tachyphylaxis has historically limited other IL-12 agents.
- Evidence of dose-dependent pharmacology with T cell, natural killer (NK) cell and NKT cell proliferation.
- Consistent with the tumor-activated design of XTX301, no measurable activated XTX301 was detected in peripheral circulation across all dose levels and schedules.
- Across all dose levels and schedules, no Grade 4 or Grade 5 treatment-related adverse events (AEs) were reported by investigators and no patients experienced a dose limiting toxicity or a dose reduction due to a treatment-related AE.
- In addition, across all dose levels and schedules, the majority of treatment-related AEs were Grade 1 or 2 and most commonly consisted of flu-like symptoms, cytokine release syndrome, increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and decreased blood cell counts.
Additional Private Placement with Gilead
On December 18, 2024, Xilio issued and sold an aggregate of approximately
About Vilastobart (XTX101) and the Phase 1/2 Combination Clinical Trial
Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.
About XTX301 and the Phase 1 Clinical Trial
XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic “cold” tumors towards an inflamed or “hot” state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated 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 using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines, antibodies, bispecifics and immune cell engagers. 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 initial data from the ongoing Phase 2 trial for vilastobart in combination with atezolizumab in patients with advanced MSS CRC; expectations regarding the clinical profile of XTX301; the period in which Xilio expects to have cash to fund its operations; and Xilio’s strategy, goals, 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, general market conditions; 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 advancement of multiple early-stage immune cell engager programs; interim or preliminary preclinical or clinical data or results, which 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, which may not support further development of such product candidates; actions of regulatory agencies, which 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 ability to obtain and maintain sufficient cash resources to fund its operations; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; Xilio’s ability to maintain its clinical trial collaboration with Roche to develop vilastobart in combination with atezolizumab; and Xilio’s ability to maintain its license agreement with Gilead to develop and commercialize XTX301. 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.
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Investor and Media Contact
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Vice President, Investor Relations and Corporate Communications
investors@xiliotx.com
FAQ
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