Drug intelligence / Profile preview

HST-1011 + cemiplimab

Development stage
Unknown
Lead developer
HotSpot Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

A combination therapy consisting of HST-1011, an orally bioavailable small molecule **CBL-B inhibitor**, and **cemiplimab** (brand name Libtayo), an intravenously administered monoclonal antibody targeting the immune checkpoint protein **PD-1**. HST-1011 blocks the immune signaling checkpoint CBL-B to enhance T-cell and NK-cell activation and overcome immune suppression in the tumor microenvironment. Cemiplimab is an FDA-approved immune checkpoint inhibitor that binds PD-1, preventing its interaction with PD-L1/PD-L2 and restoring T-cell activity. The combination is under investigation in a phase 1/2 study (SOLAR1; NCT05662397) for the treatment of advanced solid tumors in patients relapsed on or refractory to approved anti-PD(L)1 therapies or standard treatments.

Other names
cemiplimab-rwlc
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)CBLB (CBL-B)

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