Nanrilkefusp alfa

also known as SO-C101 · SOT101

Developed for: colorectal cancer · hepatocellular carcinoma · non-small cell lung carcinoma · ovarian cancer · skin squamous cell carcinoma · anus cancer · biliary tract cancer · castration-resistant prostate carcinoma
+12 more
· cervical cancer · cutaneous neuroendocrine carcinoma · gastric cancer · head and neck squamous cell carcinoma · melanoma · mesothelioma · renal cell carcinoma · small cell lung carcinoma · thymus cancer · thyroid cancer · triple-negative breast carcinoma · urinary bladder cancer
Investigated by: SOTIO Biotech AG · Merck Sharp & Dohme LLC · SOTIO Biotech a.s.

Trials 3

today NCT05619172 · Ph 2 NCT05256381 · Ph 2 NCT04234113 · Ph 1

2020202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial · 1 missed
Phase 1	NCT04234113	Jun 2019 → Aug 2024	anus cancer, biliary tract cancer, cervical cancer, cutaneous neuroendocrine carcinoma +14	SOTIO Biotech AG	Terminated	Missed primary
Phase 22 trials · 2 missed
Phase 2	NCT05619172	Dec 2022 → Mar 2024	colorectal cancer	SOTIO Biotech AG	Terminated	Missed primary
Phase 2	NCT05256381	Jun 2022 → Aug 2024	castration-resistant prostate carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung carcinoma +2	SOTIO Biotech AG	Terminated	Missed primary

News releases announcing trial results or a regulatory action · 3

Date	Issuer	Release
2023-10-13	SOTIO a.s.	Results SOTIO Provides Update on Interim Data from Clinical Trials of Nanrilkefusp Alfa sotio.com ↗ 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.
2022-05-26	SOTIO a.s.	Results Data from SOTIO’s Phase 1/1b AURELIO-03 Trial of SOT101 Demonstrate Clinical Benefit in Patients with Solid Tumors sotio.com ↗
2021-11-12	SOTIO a.s.	Results SOT101 Shows Clinical Benefit in Patients with Advanced Solid Tumors sotio.com ↗ In a combination of SOT101 with pembrolizumab in the AURELIO-03 study, the majority of the 13 patients with advanced/metastatic solid tumors had clinical benefit, including in checkpoint inhibitor (CPI) refractory patients.

All press releases naming this drug 15 releases

Date	Issuer	Release
2023-10-13	SOTIO a.s.	SOTIO Provides Update on Interim Data from Clinical Trials of Nanrilkefusp Alfa sotio.com ↗
2023-01-19	SOTIO a.s.	SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination with Cetuximab sotio.com ↗
2022-07-26	SOTIO a.s.	SOTIO Doses First Patient in AURELIO-04 Phase 2 Trial of SOT101 in Combination with KEYTRUDA® (pembrolizumab) sotio.com ↗
2022-05-26	SOTIO a.s.	Data from SOTIO’s Phase 1/1b AURELIO-03 Trial of SOT101 Demonstrate Clinical Benefit in Patients with Solid Tumors sotio.com ↗
2022-04-27	SOTIO a.s.	Oral Presentation of Interim Data from the AURELIO-03 Study of SOT101 at the 2022 ASCO Annual Meeting sotio.com ↗
2022-04-12	SOTIO a.s.	Interim Data from the Phase 1/1b AURELIO-03 Trial of SOT101 Presented at the AACR 2022 Annual Meeting sotio.com ↗
2021-12-08	SOTIO a.s.	SOTIO Announces Clinical Collaboration with MSD to evaluate IL-15 Superagonist, SOT101, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors sotio.com ↗
2021-11-12	SOTIO a.s.	SOT101 Shows Clinical Benefit in Patients with Advanced Solid Tumors sotio.com ↗
2021-11-03	SOTIO a.s.	SOTIO to Present New Data from Phase 1 Study of IL-15 Superagonist, SOT101, at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting sotio.com ↗
2020-11-04	SOTIO a.s.	SOTIO to Present New Data on the IL-15 superagonist SO-C101 at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting sotio.com ↗
2020-07-14	SOTIO a.s.	SOTIO Announces First Patient Dosed in Part B of Phase 1/1b Study with SO-C101 in Combination with Pembrolizumab in Patients with Solid Tumors sotio.com ↗
2020-06-22	SOTIO a.s.	SOTIO Presents New Data Showing Strong Anti-tumor Effect of IL-15 Superagonist SO-C101 in Mice at 2020 AACR Virtual Annual Meeting II sotio.com ↗
2020-06-15	SOTIO a.s.	SOTIO to Present New Preclinical Data on IL-15 Superagonist, SO-C101, at the 2020 AACR Virtual Annual Meeting II sotio.com ↗
2019-07-11	SOTIO a.s.	SOTIO initiates first-in-human clinical trial with IL-15 superagonist SO-C101 sotio.com ↗
2018-04-10	SOTIO a.s.	SOTIO to Present Translational Data of the IL-15 Superagonist SO-C101 at 2018 AACR Annual Meeting sotio.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

Field	Value	Cited text
Known as	Nanrilkefusp alfa	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05619172 ↗ 2 NCT04234113 ↗ NCT05256381 ↗
Known as	SO-C101	ChEMBL registry synonym — accepted as the source's own label CHEMBL5095385 ↗
Known as	SOT101	“A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer” NCT05619172 ↗
Modality	Protein / enzyme biologic	“A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15” NCT04234113 ↗
Route	Subcutaneous	“Subcutaneous (SC) injection.” NCT05256381 ↗