XTX202 / Xilio Therap - LARVOL DELTA

Xilio Therapeutics Announces Pipeline and Business Updates and First Quarter 2025 Financial Results (GlobeNewswire) - "R&D expenses were $8.3 million for the quarter ended March 31, 2025, compared to $10.4 million for the quarter ended March 31, 2024. The decrease was primarily driven by decreased clinical development activities for XTX202, a masked IL-2, as a result of discontinuing further investment in XTX202, decreased personnel-related costs due to lower headcount and decreased manufacturing costs for XTX301, partially offset by increased spending related to early stage programs and indirect research and development, increased clinical development activities for vilastobart and manufacturing activities for XTX501 in connection with IND-enabling studies."

Commercial • Colorectal Cancer • Oncology

XTX202-01: XTX202 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=93 | Completed | Sponsor: Xilio Development, Inc. | N=189 ➔ 93 | Trial completion date: Feb 2026 ➔ Mar 2025 | Trial primary completion date: Feb 2026 ➔ Mar 2025 | Active, not recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRAF

Xilio Therapeutics Announces…Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "R&D expenses were $8.8 million for the quarter ended December 31, 2024, compared to $11.7 million for the quarter ended December 31, 2023....The year-over-year decrease was primarily driven by decreased clinical development activities for XTX202, a masked IL-2, as a result of discontinuing further investment in XTX202, decreased spending related to early-stage programs and indirect research and development costs, decreased personnel-related costs and decreased manufacturing costs for XTX301, partially offset by increased clinical development activities for vilastobart and XTX301."

Commercial • Oncology • Solid Tumor

Phase 1/2 study of XTX202, a tumor-activated IL-2βγ, in advanced solid tumors. (ASCO 2024) - P1/2 | "Background: Aldesleukin requires high systemic doses (up to 8.4 million IU/kg = 0.518 mg/kg per weekly cycle) to achieve therapeutic benefit; however, such doses typically result in severe toxicities. Clinical and translational data demonstrated tumor-specific activation of XTX202, as supported by PK, tumor BA and PD data. Importantly, in a heavily pretreated population the safety profile observed at 4 mg/kg, as well as dose dependent, durable anti-tumor activity positions XTX202 for combination approaches not otherwise feasible with high dose IL-2. Updated data from Ph 2 will be presented."

Metastases • P1/2 data • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8

XTX202-01: XTX202 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=189 | Active, not recruiting | Sponsor: Xilio Development, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Feb 2026 | Trial primary completion date: Apr 2024 ➔ Feb 2026

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRAF

Xilio Therapeutics Announces $11.3 Million Private Placement Equity Financing (GlobeNewswire) - "As part of the strategic portfolio reprioritization and workforce reduction, Xilio plans to: focus on rapidly advancing clinical development for XTX301 and XTX101 and leveraging the company’s promising research platform to advance differentiated bispecific and cell engager molecules; discontinue further investment in XTX202 as a monotherapy; and undertake efforts to further reduce its expenses and streamline its operations, including a reduction in headcount of 15 employees, representing approximately 21% of the company’s current workforce."

Pipeline update • Oncology • Solid Tumor

Xilio Therapeutics Announces $11.3 Million Private Placement Equity Financing (GlobeNewswire) - P2 | N=189 | NCT05052268 | Sponsor: Xilio Development, Inc. | "Additional Data from Phase 2 Clinical Trial for XTX202....As of a data cutoff date of March 6, 2024: A total of 17 RCC patients and 20 melanoma patients were administered XTX202 in the Phase 2 trial in an outpatient setting at dose levels of 1.4 mg/kg once every three weeks (Q3W) or 4 mg/kg Q3W; In 26 patients evaluable for anti-tumor activity at both dose levels, stable disease (SD) continued to be the best response. Investigators reported SD of at least nine-weeks duration in 7 RCC patients (70% disease control rate) and in 9 melanoma patients (56% disease control rate). In addition, XTX202 continued to be generally well-tolerated with safety data consistent with previously reported results. Xilio plans to present the full data set at a future medical meeting."

P2 data • Oncology • Renal Cell Carcinoma • Solid Tumor

Xilio Therapeutics Highlights Recent Advances Across Clinical Pipeline and Encouraging Preliminary Phase 1 Safety Data for XTX301, a Tumor-Activated IL-12, Further Validating the Promise of Its Tumor-Activated Immuno-Oncology Therapies (GlobeNewswire) - "Xilio continues to enroll patients at the 4.0 mg/kg dose in its ongoing Phase 2 monotherapy trial for XTX202 in patients with metastatic renal cell carcinoma or unresectable or metastatic melanoma."

Enrollment status • Oncology • Solid Tumor

Xilio to Host Virtual Investor Conference Call and Webcast on Monday, November 6, 2023 to Review Progress Across Pipeline, Including Phase 1/2 Clinical Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, Presented at the SITC Annual Meeting (GlobeNewswire) - "Xilio Therapeutics, Inc...today announced that it will host an investor conference call and webcast on November 6, 2023 at 8:00 a.m. ET to review progress across its pipeline of tumor-activated molecules, including Phase 1/2 clinical data for XTX202, an investigational tumor-activated, engineered, beta-gamma IL-2, which will be presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place in San Diego, California from November 1-5, 2023."

P1/2 data • Oncology • Solid Tumor

XTX202–01/02–001, Phase 1/2 first-in human study of XTX202, a masked, tumor-activated IL-2βγ, in patients with advanced solid tumors: results from phase 1 (SITC 2023) - P1/2 | "Trial Registration NCT05052268 Background Aldesleukin requires high systemic doses (8. 8 mg/kg with toxicity manageable in the outpatient setting. Updated clinical data, PK and comprehensive PD data (peripheral blood and available tumor biopsies) will be presented."

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • IL2

Xilio Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors (GlobeNewswire) - "In addition, subject to obtaining sufficient additional capital, Xilio today announced plans to:...(i) Report initial Phase 2 data for XTX101 in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in approximately 20 additional patients (40 patients total) in the first quarter of 2025; (ii) Report Phase 2 monotherapy data for XTX202 in approximately 20 patients treated at the 4.0 mg/kg dose with metastatic RCC or unresectable or metastatic melanoma in the second quarter of 2024; (iii) Report Phase 1 safety and PK/PD data for XTX301 in advanced solid tumors in the second half of 2024."

P1 data • P2 data • Colorectal Cancer • Renal Cell Carcinoma

Xilio Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors (GlobeNewswire) - P1/2 | N=189 | NCT05052268 | Sponsor: Xilio Development, Inc. | "The data were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting....As of a data cutoff date of October 26, 2023, 62 patients with advanced solid tumors had been administered XTX202....Data demonstrated evidence of a dose-dependent increase in disease control rate (DCR). Among the 42 response-evaluable patients treated across all dose levels, investigators reported stable disease (SD) of at least 9-weeks duration in 13 patients (31% DCR) across a range of solid tumors, including cold tumors: melanoma (n=3); renal cell carcinoma (RCC) (n=2); non-small cell lung cancer (n=2); colorectal cancer (n=2); and myoepithelial carcinoma, vaginal cancer, testicular cancer and squamous penile cancer (n=1 each). Among the six response-evaluable patients treated at the 2.8 mg/kg dose level or higher, investigators reported SD of at least 9-weeks duration in three patients (50% DCR)."

P1/2 data • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Penile Cancer • Renal Cell Carcinoma • Testicular Cancer • Vaginal Cancer

Xilio Therapeutics Announces Upcoming Presentations at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (GlobeNewswire) - "Xilio Therapeutics...announced upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place in San Diego, California from November 1-5, 2023. The company plans to present preliminary anti-tumor activity, safety, pharmacokinetic and pharmacodynamic data from its Phase 1/2 clinical trial for XTX202, a tumor-activated, engineered, beta-gamma biased IL-2, as well as preclinical data for XTX301, a tumor-activated, engineered IL-12."

P1/2 data • Preclinical • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and Second Quarter 2023 Financial Results (GlobeNewswire) - "Xilio will host a live virtual program on Thursday, August 17, 2023, at 12:30 p.m. ET spotlighting XTX101, including highlights from the recently reported Phase 1 monotherapy data for XTX101 and clinical development plans in MSS CRC....R&D expenses were $13.2 million for the quarter ended June 30, 2023, compared to $16.2 million for the quarter ended June 30, 2022. The decrease was primarily driven by decreased manufacturing and clinical development activities for XTX101 and decreased manufacturing and preclinical activities for XTX301. These decreases were partially offset by increases in clinical activities for XTX202 and XTX301."

Commercial • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and Second Quarter 2023 Financial Results (GlobeNewswire) - "Xilio anticipates reporting preliminary anti-tumor activity, safety, pharmacokinetic and pharmacodynamic data from the Phase 1/2 clinical trial in early November 2023. The company anticipates the reported data will include at least 20 evaluable patients across a range of solid tumors treated at dose levels of 1.0 mg/kg or higher across all cohorts in the Phase 1/2 clinical trial. In addition, Xilio today announced the acceptance of an abstract for XTX202 at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting on November 1-5, 2023. XTX301: tumor-activated, engineered IL-12...Xilio anticipates reporting preliminary safety data from the Phase 1 clinical trial into the third dose level in the fourth quarter of 2023."

P1 data • P1/2 data • Oncology • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and First Quarter 2023 Financial Results (GlobeNewswire) - "R&D expenses were $16.1 million for the quarter ended March 31, 2023, compared to $14.9 million for the quarter ended March 31, 2022. The increase was primarily driven by increased clinical development activities for XTX202, increased clinical development and manufacturing activities for XTX301, increased personnel-related costs, and increased costs related to the company’s earlier-stage programs. These increases were partially offset by decreases in manufacturing activities for XTX202, preclinical development activities for XTX301 and clinical development activities for XTX101."

Commercial • Genito-urinary Cancer • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and First Quarter 2023 Financial Results (GlobeNewswire) - "Xilio recently initiated patient dosing at an initial dose of 1.4mg/kg in a Phase 2 clinical trial evaluating XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment....Xilio anticipates reporting preliminary anti-tumor activity, safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1/2 clinical trial in the third quarter of 2023. The company anticipates the reported data will include approximately 15-20 evaluable patients across a range of solid tumors treated at the 1 mg/kg dose or higher across all cohorts in the Phase 1/2 clinical trial."

P1/2 data • PK/PD data • Trial status • Genito-urinary Cancer • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

XTX202-01: XTX202 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=189 | Recruiting | Sponsor: Xilio Development, Inc. | N=120 ➔ 189

Enrollment change • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

XTX202, a tumor-selective protein-engineered IL-2, exhibited enhanced anti-tumor activity in combination with checkpoint inhibition in mice (SITC 2022) - P1/2 | "Background High-dose recombinant human interleukin-2 (IL-2, aldesleukin) is approved for the treatment of renal cell carcinoma (RCC) and melanoma based on durable responses. Clinical testing of XTX202 is ongoing ( NCT05052268 ). Ethics Approval All animal procedures were either approved by an Institutional Animal Care and Use Committee and conducted in accordance with the National Institutes of Health Guide for the Care and Use of Laboratory Animals."

Checkpoint inhibition • Combination therapy • Preclinical • Bladder Cancer • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • CD8 • IL2 • STAT5

Xilio Therapeutics Announces Pipeline and Business Updates for the Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "Xilio anticipates multiple milestones for XTX202 through the end of 2023: (i) Initiate patient enrollment in a Phase 2 clinical trial evaluating XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma in April 2023; (ii) Report preliminary anti-tumor activity, safety, PK and PD data from the Phase 1/2 clinical trial in the third quarter of 2023. Xilio anticipates the reported data will include approximately 15-20 patients across a range of solid tumors treated at the 1 mg/kg dose or higher across all cohorts in the Phase 1/2 clinical trial."

P1/2 data • PK/PD data • Trial status • Genito-urinary Cancer • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and Third Quarter 2022 Financial Results (GlobeNewswire) - "Xilio anticipates multiple milestones for XTX202 through the end of 2023: Initiate patient enrollment in a monotherapy expansion cohort of the Phase 1 clinical trial in the fourth quarter of 2022; Initiate patient enrollment in a Phase 2 monotherapy clinical trial in the first half of 2023; Report preliminary anti-tumor activity and safety data from the Phase 1/2 clinical trial in the third quarter of 2023."

Enrollment status • P1/2 data • Trial status • Oncology • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and Third Quarter 2022 Financial Results (GlobeNewswire) - "Upcoming Presentations: Xilio will present a poster outlining preclinical data demonstrating anti-tumor activity and sustained memory T-cell response in mice for XTX202 in combination with immune checkpoint blockade at the Society for Immunotherapy in Cancer 37th Annual Meeting....Uli Bialucha, Ph.D., Xilio’s chief scientific officer, will present at the 14th Annual Protein & Antibody Engineering Summit (PEGS) Europe meeting and will highlight preclinical data for XTX301, a tumor-activated IL-12, and Xilio’s emerging research portfolio developing tumor-activated multifunctional biologics."

Preclinical • Oncology • Solid Tumor

A first-in-human, multicenter, phase 1/2, open-label study of XTX202, a masked and tumor-selective recombinant human interleukin-2 (IL-2) protein, in patients with advanced solid tumors. (ASCO 2022) - P1/2 | "Part 2b will enroll patients with unresectable or metastatic melanoma who have received immune-checkpoint therapy with an anti-PD-1 therapy and an anti-CTLA-4 therapy to determine the efficacy of XTX202 monotherapy in this population. Enrollment to the study began in January 2022."

Clinical • P1/2 data • Genito-urinary Cancer • Immune Modulation • Inflammation • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • IL2

Xilio Therapeutics Announces Encouraging Preliminary Phase 1 Dose-Escalation Data for XTX101, a Tumor-Selective Anti-CTLA-4, and Reports Pipeline and Business Updates and Second Quarter 2022 Financial Results (GlobeNewswire) - "Xilio anticipates multiple milestones through the end of 2023: XTX202 - Report data from Part 1A of the trial (monotherapy dose-escalation cohort) supporting the RP2D in the first half of 2023...Initiate patient enrollment in Part 1B (monotherapy expansion cohort) in the fourth quarter of 2022...Report preliminary data from Part 1B of the trial (monotherapy expansion cohort) in the second half of 2023...Following the determination of a RP2D, Xilio anticipates initiating a Phase 2 monotherapy trial in the first half of 2023 designed to evaluate the safety and efficacy of XTX202 in patients with melanoma and renal cell carcinoma (RCC). Xilio anticipates enrolling a total of approximately 35 patients across both cohorts in the Phase 2 clinical trial."

Enrollment status • P1 data • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Xilio Therapeutics Announces Initiation of Patient Dosing in Phase 1/2 Clinical Trial of XTX202 for the Treatment of Patients with Solid Tumors (GlobeNewswire) - "Xilio Therapeutics...announced that the first patient has been dosed in the company’s Phase 1/2 clinical trial evaluating XTX202 for the treatment of solid tumors. XTX202 is a modified form of IL-2 that is designed to localize activity in the tumor microenvironment (TME), with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity....The Phase 1/2 clinical trial is a first-in-human, multi-center, open-label trial that will evaluate XTX202 as a monotherapy in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor