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DRUG:

Nerofe (84AA-API 14AA)

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Other names: 84AA-API 14AA, Tumor-Cells Apoptosis Factor, TCApF, dTCApFs
Associations
Company:
Immune System Key
Drug class:
Apoptosis stimulant, Immunomodulator, Angiogenesis inhibitor
Related drugs:
Associations
4ms
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML (clinicaltrials.gov)
P1, N=18, Recruiting, Immune System Key Ltd | Phase classification: P1b --> P1 | Trial completion date: Dec 2022 --> Aug 2025 | Trial primary completion date: Dec 2022 --> Jun 2025
Phase classification • Trial completion date • Trial primary completion date • Metastases
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ST2 (Suppression Of Tumorigenicity)
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Nerofe (84AA-API 14AA)
over1year
Transformation of immunosuppressive mtKRAS tumors into immunostimulatory tumors by Nerofe and Doxorubicin. (PubMed, Oncotarget)
It was observed that the combination of Nerofe and DOX downregulated KRAS signaling via miR217 upregulation, resulting in enhanced apoptosis of tumor cells. In addition, the combination of Nerofe and DOX also resulted in activation of the immune system against tumor cells, manifested by an increase in the immunostimulatory cytokines IL-2 and IFN-γ as well as the recruitment of NK cells and M1 macrophages to the tumor site.
Journal
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KRAS (KRAS proto-oncogene GTPase) • IFNG (Interferon, gamma) • IL2 (Interleukin 2) • MIR217 (MicroRNA 217)
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KRAS mutation
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doxorubicin hydrochloride • Nerofe (84AA-API 14AA)
over1year
Phase I study of NEROFE and doxorubicin in KRAS-mutated ST2-positive solid tumors. (ASCO 2023)
Recent advances targeting KRAS G12C with sotorasib and adagrasib are encouraging but limited to a small subset of patients. Enrollment to DL1 began in Q1 2023 (NCT05661201). Clinical trial information: NCT05661201.
P1 data
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KRAS (KRAS proto-oncogene GTPase) • MAPK1 (Mitogen-activated protein kinase 1) • IL33 (Interleukin 33) • MIR217 (MicroRNA 217) • ST2 (Suppression Of Tumorigenicity)
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KRAS mutation • KRAS G12C • KRAS G12
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doxorubicin hydrochloride • Lumakras (sotorasib) • Krazati (adagrasib) • Nerofe (84AA-API 14AA)
almost2years
NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors (clinicaltrials.gov)
P1, N=24, Recruiting, Georgetown University | Not yet recruiting --> Recruiting
Enrollment open
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KRAS (KRAS proto-oncogene GTPase) • ST2 (Suppression Of Tumorigenicity)
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KRAS mutation
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doxorubicin hydrochloride • Nerofe (84AA-API 14AA)
almost2years
New P1 trial
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KRAS (KRAS proto-oncogene GTPase) • ST2 (Suppression Of Tumorigenicity)
|
KRAS mutation
|
doxorubicin hydrochloride • Nerofe (84AA-API 14AA)
over2years
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML (clinicaltrials.gov)
P1b, N=18, Recruiting, Immune System Key Ltd | Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: May 2022 --> Dec 2022
Trial completion date • Trial primary completion date
|
ST2 (Suppression Of Tumorigenicity)
|
Nerofe (84AA-API 14AA)