Latest news with #Atezolizumab
Yahoo
31-05-2025
- Business
- Yahoo
Xilio Therapeutics Announces Updated Phase 2 Data for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer
26% preliminary objective response rate observed in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases Deep and durable responses ongoing for up to 37 weeks through the data cutoff, accompanied by substantial decreases in tumor biomarkers and improvements in clinical symptoms MSS CRC patient with liver metastasis and previously reported confirmed partial response from Phase 1C (combination dose escalation) remains on treatment after more than 14 months Combination continued to demonstrate differentiated safety and tolerability profile with low incidence of colitis and other immune-related adverse events Data are being presented in a poster presentation today at the 2025 ASCO Annual Meeting WALTHAM, Mass., May 31, 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 updated data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic MSS CRC. The data will be presented in a poster session (abstract #3553) today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. 'These Phase 2 data for the combination of vilastobart and atezolizumab demonstrate a meaningfully differentiated safety and tolerability profile for an anti-CTLA-4 combination therapy, together with a preliminary 26% objective response rate in patients with late-line metastatic MSS CRC without liver metastases,' said Katarina Luptakova, M.D., chief medical officer of Xilio. 'Responses were deep and durable for up to 37 weeks and were accompanied by substantial decreases in tumor biomarkers such as circulating tumor DNA and improvements in clinical symptoms. Currently, no immunotherapy treatment options are available for patients with MSS CRC, an immunologically cold tumor type that is rising in incidence. We are very encouraged by these data demonstrating the potential of vilastobart, a next generation anti-CTLA-4, as a combination therapy not only for patients with MSS CRC but also a range of other tumor types traditionally resistant to treatment with immunotherapy.' 'These data further highlight the potential for vilastobart, a tumor-activated anti-CTLA-4, in combination with PD-(L)1 inhibitors to provide a meaningful clinical benefit for patients with metastatic MSS CRC without liver metastases, an area of significant and increasing unmet need, especially in younger people,' said Marwan G. Fakih, M.D., Professor in the Department of Medical Oncology and Therapeutics Research and Division Head, GI Medical Oncology at City of Hope. 'I am particularly excited to see the depth and durability of responses in these late-line patients, as well as the low incidence of colitis and other immune-related adverse events that are common dose-limiting adverse events for other anti-CTLA-4 agents. Beyond MSS CRC, I believe these data support the potential for vilastobart as a combination therapy across a range of tumor types, including those where toxicity has limited the significant opportunity for anti-CTLA-4 to date.' Updated Data from Phase 2 Trial for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic MSS CRC As of a data cutoff date of May 12, 2025, 44 patients with metastatic MSS CRC had been treated with the combination of vilastobart at 100 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W). The median age was 55 years (ranging from 25 to 82 years), and patients were heavily pre-treated, with 80% having previously received three or more prior lines of anti-cancer therapy. As of the data cutoff date, 44 patients were evaluated for response (per RECIST version 1.1 criteria), consisting of 27 patients without liver metastases and 17 patients with liver metastases. In patients with metastatic MSS CRC without liver metastases: Investigators reported a preliminary ORR of 26% consisting of seven PRs (six confirmed, including two confirmed after the data cutoff, and one unconfirmed), with six of these patients still on treatment as of the data cutoff date. Responders included a patient with peritoneal metastases as well as patients with both KRAS mutant and KRAS wild type tumors. In addition, investigators reported stable disease in five patients without liver metastases, with three of these patients remaining on treatment as of the data cutoff date. Responses were deep and durable, with reductions in target lesions of up to 71% from baseline and responders ongoing on treatment for up to 37 weeks as of the data cutoff date. Responses were accompanied by substantial decreases in tumor biomarkers for circulating tumor DNA (ctDNA) and carcinoembryonic antigen (CEA) levels. In addition, investigators observed improvements in clinical symptoms. In patients with metastatic MSS CRC with liver metastases, investigators reported stable disease in three patients, each of whom was still on treatment as of the data cutoff date. As of the data cutoff date, 44 patients were evaluable for safety. Across all patients treated, the combination of vilastobart at 100 mg Q6W and atezolizumab at 1200 mg Q3W was generally well-tolerated: Only three patients (7%) experienced colitis (one patient with Grade 1 colitis and two patients with Grade 3 colitis). In addition, only 11 patients (25%) required steroids or other immunosuppression for imAEs. Only two patients (5%) discontinued treatment for the combination of vilastobart and atezolizumab due to a treatment-related adverse event (AE). The most common treatment-related AEs (≥10% incidence) of any grade reported by investigators were fatigue (30%); infusion-related reactions (23%); diarrhea (18%); aspartate aminotransferase (AST) increase (14%); alanine aminotransferase (ALT) increase (11%); pruritus (11%); and pyrexia (11%). The only Grade 3 treatment-related AEs reported by investigators in more than one patient were the following (2 patients each (5%)): colitis; AST increase; ALT increase; infusion-related reactions; and white blood cell decrease. As previously reported, there were no Grade 5 treatment-related AEs and investigators reported only two Grade 4 treatment-related AEs (laboratory abnormalities of thrombocytopenia and neutropenia, one patient each) both of which resolved. Phase 1C (Combination Dose Escalation) Updates In the ongoing Phase 1C, the 150 mg Q6W dose level was recently cleared for vilastobart, and evaluation of patients enrolled in Phase 1C is ongoing. In addition, as previously reported, an MSS CRC patient with a metastatic liver lesion enrolled in Phase 1C achieved a confirmed partial response, including full resolution of the liver lesion. As of the data cutoff date, this patient was still on treatment after more than 14 months. Clinical Development Plans for Vilastobart In the ongoing Phase 2 trial, Xilio recently began enrolling a cohort of patients with metastatic MSS CRC at the 150 mg Q6W dose level for vilastobart. Xilio anticipates initially enrolling approximately 10 patients with metastatic MSS CRC without liver metastases in the Phase 2 trial at the 150 mg Q6W dose level for vilastobart, with the goal of further evaluating the efficacy and safety of the combination at this higher dose level. Xilio anticipates reporting additional data from the Phase 2 trial in the first half of 2026, including data for patients at the 150 mg Q6W dose level for vilastobart. Based on the encouraging Phase 1/2 data for vilastobart in patients with metastatic MSS CRC, Xilio is seeking opportunities to partner the vilastobart program to accelerate and expand further development. About Vilastobart 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 efficacy and safety of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) with and without liver metastases. Please refer to NCT04896697 on for additional details. 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 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 the potential for vilastobart to provide benefit as a combination therapy in any indication or at any dose level; the development plans for vilastobart and the timing thereof; the timing of clinical data for vilastobart; the ultimate efficacy and safety profile of vilastobart; the ability to partner the vilastobart program; 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 fund its operations beyond the first quarter of 2026, including 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. Tecentriq® is a registered trademark of Genentech USA, Inc., a member of the Roche Group. Investor and Media Contact Scott Young Vice President, Investor Relations and Corporate Communications investors@ in to access your portfolio
Globe and Mail
18-02-2025
- Business
- Globe and Mail
Liver Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, 'Liver Cancer Pipeline Insight' report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Liver Cancer pipeline landscape. It covers the Liver Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Liver Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive Liver Cancer Pipeline Report to explore emerging therapies, key Liver Cancer Companies, and future Liver Cancer treatment landscapes @ Liver Cancer Pipeline Outlook Report Key Takeaways from the Liver Cancer Pipeline Report In February 2025:- Imperial College London:- Open label, single arm, multi-centre studyof pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria. In February 2025:- Hoffmann-La Roche:- This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. In February 2025:- Eisai Inc.:- The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only). DelveInsight's Liver Cancer pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Liver Cancer treatment. The leading Liver Cancer Companies such as Arcus Biosciences, Yiviva, Virogin Biotech, Tvardi Therapeutics, GlaxoSmithKline, TORL Biotherapeutics, AVEO Pharmaceuticals, Teclison, Epizyme, Sirnaomics, Coherus Biosciences, Sinocelltech Ltd., Qurient Co, Hoffmann-La Roche, Can-Fite BioPharma, Omega Therapeutics, Novita Pharmaceuticals, Bristol-Myers Squibb and others. Promising Liver Cancer Therapies such as Atezolizumab, Bevacizumab, Tiragolumab, OH2 injection, MTL-CEBPA, Sorafenib 200mg, Lipiodol, Pemetrexed, Exatecan Mesylate, Brivanib, and others. Discover how the Liver Cancer treatment paradigm is evolving. Access DelveInsight's in-depth Liver Cancer Pipeline Analysis for a closer look at promising breakthroughs @ Liver Cancer Clinical Trials and Studies Liver Cancer Emerging Drugs Profile Namodenoson: Can-Fite BioPharma Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5'- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR). Namodenoson's mechanism of action is mediated via deregulation of the NF-κB and Wnt signal transduction pathways, resulting in the apoptosis of tumor cells. The protective effect of Namodenoson is mediated via down-regulation of the NF-kB signal transduction pathway and preventing apoptosis. Namodenoson has a potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation. The safety of Namodenoson has been demonstrated in preclinical studies, and Phase I and Phase II clinical studies demonstrating a favorable safety profile. Currently, the drug is in Phase III stage of its development for the treatment of advanced liver Cancer. YIV-906: Yiviva YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. Currently, the drug is in phase II stage of its clincal trial for the treatment of liver cancer. TTI-101: Tvardi Therapeutics TTI-101 is an orally bioavailable, small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), a transcription factor whose upregulation and activation governs many hallmarks of cancer, inflammation, and fibrosis. Preclinically, TTI-101 has demonstrated an excellent pharmacokinetic profile, potency in attenuating pY705-STAT3 phosphorylation, and efficacy in inhibiting tumor growth in xenograft and syngeneic tumor models. Currently, the drug is in phase II stage of clinical trial. STP707, our second key product, is in early-stage development for the treatment of solid tumors, liver cancer. STP707 is an intravenously administered TGF-ß1 and COX-2 inhibitor that leverages an RNAi-based response using the company's proprietary PNP delivery platform. Currently, the drug is in Phase I stage of its clinical trial for the treatment of liver cancer. BST02: BioSyngen BST02, a T cell therapy based on the expansion of the patient's own tumor infiltrating lymphocytes, falls within the category of adoptive immune cell therapy technology. It holds promise for the treatment of all types of liver cancer, offering new hope for patients. In contrast to traditional TIL therapies, BST02 offers numerous benefits, including the ability to overcome distance constraints due to its cryopreserved form and the reduced need for high doses of interleukin-2. Currently, the drug is in Phase I stage of its clinical trial for the treatment of liver cancer. The Liver Cancer pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Liver Cancer with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Liver Cancer Treatment. Liver Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Liver Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Liver Cancer market. Liver Cancer Companies Arcus Biosciences, Yiviva, Virogin Biotech, Tvardi Therapeutics, GlaxoSmithKline, TORL Biotherapeutics, AVEO Pharmaceuticals, Teclison, Epizyme, Sirnaomics, Coherus Biosciences, Sinocelltech Ltd., Qurient Co, Hoffmann-La Roche, Can-Fite BioPharma, Omega Therapeutics, Novita Pharmaceuticals, Bristol-Myers Squibb and others. Liver Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Oral Parenteral Subcutaneous Topical Transdermal Liver Cancer Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Download DelveInsight's latest report to gain strategic insights into upcoming Liver Cancer Therapies and key Liver Cancer Developments @ Liver Cancer Market Drivers and Barriers, and Future Perspectives Scope of the Liver Cancer Pipeline Report Coverage- Global Liver Cancer Companies- Arcus Biosciences, Yiviva, Virogin Biotech, Tvardi Therapeutics, GlaxoSmithKline, TORL Biotherapeutics, AVEO Pharmaceuticals, Teclison, Epizyme, Sirnaomics, Coherus Biosciences, Sinocelltech Ltd., Qurient Co, Hoffmann-La Roche, Can-Fite BioPharma, Omega Therapeutics, Novita Pharmaceuticals, and Bristol-Myers Squibb, and others. Liver Cancer Therapies- Atezolizumab, Bevacizumab, Tiragolumab, OH2 injection, MTL-CEBPA, Sorafenib 200mg, Lipiodol, Pemetrexed, Exatecan Mesylate, Brivanib, and others. Liver Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Liver Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in Liver Cancer drug development? Find out in DelveInsight's exclusive Liver Cancer Pipeline Report—access it now! @ Liver Cancer Emerging Drugs and Major Companies Table of Content Introduction Executive Summary Liver Cancer: Overview Pipeline Therapeutics Therapeutic Assessment Liver Cancer – DelveInsight's Analytical Perspective Late Stage Products (Phase III) Namodenoson: Can-Fite BioPharma Drug profiles in the detailed report….. Mid Stage Products (Phase II) YIV-906: Yiviva Drug profiles in the detailed report….. Early Stage Products (Phase I) STP707: Sirnaomics Mid Stage Products (Phase II) Preclinical Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products Liver Cancer - Collaborations Assessment- Licensing / Partnering / Funding Liver Cancer - Unmet Needs Liver Cancer - Market Drivers and Barriers Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. 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