SOT-201 / Sotio - LARVOL DELTA

SOT201, a cis-acting PD-1/IL-15 mutein-based immunocytokine… (Businesswire) - "SOTIO Biotech...announced it will present new preclinical...data...[at] PEGS Europe, in Lisbon."

Preclinical • Colorectal Cancer

Novel PD-1-targeted, activity-optimized IL-15 mutein SOT201 acting in cis provides antitumor activity superior to PD1-IL2v. (PubMed, J Immunother Cancer) - P1 | "SOT201 represents a promising therapeutic candidate that preferentially targets PD-1+ TILs, delivering balanced cytokine activity for reviving CD8+ Tex cells in tumors. SOT201 is currently being evaluated in the Phase I clinical study VICTORIA-01 (NCT06163391) in patients with advanced metastatic cancer."

Journal • Oncology • CD8 • IFNG • IL15 • STK11

SOT201, a novel cis-acting PD-1/IL-15 mutein-based immunocytokine that reinvigorates anti-tumor immunity qualitatively superior to PD-1/IL-2v-based IL-2/15Rβγ agonism (SITC 2024) - P1 | "Results SOT201 delivers attenuated RLI-15 mutein to PD1+ T cells via cis presentation, reinvigorates exhausted human T cells and induces a higher IFN-γ production than pembrolizumab in vitro. 246/1992. Some studies were performed according to animal welfare regulations by CrownBio (Bejing, China)."

Oncology • CD8 • IFNG • IL15 • IL2 • PD-1 • STK11

VICTORIA-01: a multicenter, open-label, phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced or metastatic solid tumors (SITC 2024) - P1 | "Background SOT201 is an immunocytokine consisting of a humanized monoclonal antibody against programmed cell death protein 1 (PD-1) and a low-activity variant of a receptor-linker-interleukin-15 fusion protein (RLI-15). A total of 40 patients are expected to be recruited.A Bayesian logistic regression model will be used to select the minimum reproducibly active dose (MRAD), maximum administered dose (MAD), effective dose approximating the maximum tolerated dose (MTD), and recommended phase 2 doses (RP2Ds), as appropriate.The main inclusion criteria are histologically or cytologically confirmed advanced or metastatic solid tumors; intolerance to or ineligibility for all available therapies; no liver metastases; measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; tumor tissue accessible for biopsy; and Eastern Cooperative Oncology Group performance score 0–1.The primary endpoints are the type, frequency, and severity of..."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • CD8 • IL15

SOTIO Showcases New Data on SOT201 Immunocytokine, VICTORIA-01 Clinical Study, and BOXR CAR-T Advancements at 2024 SITC Annual Meeting (Businesswire) - "SOTIO Biotech...today announced data supporting SOT201, its next-generation PD-1-targeting immunocytokine. The company also reported advancements in its BOXR cell therapy platform, introducing an innovative chimeric PGC-1α transgene to boost CAR T cell efficacy in patients with solid tumors. SOTIO will be presenting three posters highlighting these advancements at the 2024 Society for Immunotherapy of Cancer Meeting, taking place November 6–10 in Houston, TX, U.S."

P1 data • Preclinical • Oncology • Solid Tumor

SOTIO Announces Upcoming Poster Presentations at the 2024 SITC Annual Meeting (Businesswire) - "SOTIO Biotech...announced it will present three posters at the 2024 Society for Immunotherapy of Cancer Meeting taking place November 6 - 10, 2024, in Houston, TX. Data to be presented include the investigation of a novel chimeric PGC-1α transgene to enhance CAR T cell efficacy in patients with solid tumors. The VICTORIA-01 study is currently evaluating the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors, as well as data around SOT201, a next-generation clinical stage PD-1-targeting immunocytokine."

Clinical • P1 data • Oncology • Solid Tumor

SOTIO Announces First Patient Dosed in Phase 1 Clinical Study of SOT201 for Patients with Solid Tumors (Businesswire) - "SOTIO Biotech...announced the dosing of the first patient in its Phase 1, first-in-human clinical trial evaluating SOT201, a next-generation PD-1-targeting immunocytokine. The VICTORIA-01 study will evaluate the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors....The study is now enrolling patients at The University of Texas MD Anderson Cancer Center in Houston, Texas, led by principal investigator Dr. Aung Naing. Additional clinical sites across Europe – including in Belgium, Czech Republic and Spain – will initiate enrollment in the coming months."

Trial status • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: SOTIO Biotech AG | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: SOTIO Biotech AG

New P1 trial • Oncology • Solid Tumor

SOT201 is a novel cis-acting immunocytokine targeting IL-15Rβγ to reinvigorate PD-1+tumor infiltrating lymphocytes and potentiate anti-tumor efficacy (SITC 2023) - "Conclusions This data confirms SOT201 to be a promising therapeutic candidate molecule directed preferentially to the PD-1+ T cell tumor microenvironment. SOT201 is currently being prepared for evaluation in a Phase I clinical study in metastatic advanced cancer patients as well as for PD-1 resistant/refractory patients."

Clinical • Tumor-infiltrating lymphocyte • Oncology • CD8 • IL15 • PD-1 • STK11

SOTIO Presents Data on SOT201 Immunocytokine and Other Programs at SITC Annual Meeting (Businesswire) - "SOTIO Biotech...announced it will be presenting new preclinical data at the Society for Immunotherapy of Cancer’s 38th Annual Meeting....Data to be presented include new preclinical results supporting the continued development of SOT201, a next-generation PD-1-inhibiting cytokine that SOTIO is progressing toward a planned first-in-human study in the second quarter of 2024....Additional poster presentations at the meeting will include preclinical data on the synergistic effects of SOTIO’s IL-15 superagonist in combination with CAR T-cell therapies, as well as data on SOTIO’s IL-15 superagonist nanrilkefusp alfa."

New trial • Preclinical • Oncology

SOTIO Provides Update on Interim Data from Clinical Trials of Nanrilkefusp Alfa (Businesswire) - "SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, today announced it will discontinue the currently ongoing clinical trials of nanrilkefusp alfa as monotherapy and in combinations with pembrolizumab and cetuximab. Interim data from SOTIO’s clinical trials of nanrilkefusp alfa have shown insufficient efficacy to warrant further development in larger randomized trials in these specific indications and combinations. Interim data revealed no major safety issues in any of the trials....Based upon the interim data, effective immediately, enrollment in the AURELIO-03, AURELIO-04, and AURELIO-05 clinical trials will be stopped....SOTIO will continue to advance its immunocytokine platform including preclinical development of SOT201, a next-generation PD-1-inhibiting cytokine that is on track to enter Phase 1 clinical development in the second quarter of next year."

New P1 trial • Trial termination • Anal Carcinoma • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

SOT201 is a novel targeted IL-15Rbg agonist to alleviate PD-1-mediated immune cell suppression and potentiate anti-tumor efficacy (AACR 2022) - "SOT201 showed a superior potentiation of T cell stimulation over pembrolizumab in mixed lymphocyte reaction in vitro. These data represent a promising therapeutic candidate molecule leveraging the synergistic concerted action of anti-PD-1 blockage and simultaneous immune cell activation directed preferentially to the high PD-1+ T cell tumor environment. The therapeutic potential of SOT201 is currently being prepared for evaluation in a Phase I clinical study in metastatic advanced cancer patients as well as for PD-1 resistant/refractory patients as our clinical stage IL-2/IL-15Rβγ agonist SOT101 already showed a clinical benefit in these patients in its ongoing Phase I study."

Clinical • Oncology • CD8 • IL15 • PD-1 • PD-L1