P1, N=260, Recruiting, invoX Pharma Limited | N=177 --> 260 | Trial completion date: May 2025 --> Oct 2027 | Trial primary completion date: May 2025 --> Oct 2027

5 months ago

Enrollment change • Trial completion date • Trial primary completion date

FS222

over2years

FS222, A Tetravalent Bispecific CD137 and PD-L1 Targeting Antibody, Modulates Anti-Tumor Immunity Preclinically and Demonstrates Pharmacology in Patients in an Ongoing Phase I Trial (EACR 2023)

Based on preclinical PK/PD, selected PD and biomarker endpoints have been incorporated into the FIH study design.ConclusionFS222 mechanism of action, as described in preclinical studies, appeared to translate to the emerging clinical pharmacology profile observed in patients in the Phase I study. Use of bioinformatics analysis pipelines enabled efficient handling of clinical pharmacology data.

over 2 years ago

P1 data • Preclinical • PD(L)-1 Biomarker • IO biomarker

CD8 (cluster of differentiation 8) • TNFRSF9 (TNF Receptor Superfamily Member 9) • FCGR2A (Fc fragment of IgG receptor IIa)

FS222

3years

First-in-human study to evaluate the safety and clinical activity of FS222, a tetravalent bispecific antibody targeting PD-L1 and CD137, in patients with advanced solid tumors (ESMO-IO 2022)

The CR remained persistent 10 months later. Conclusions Thus far, FS222 has demonstrated manageable tolerability and early signs of antitumor activity.

3 years ago

Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker

CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • TNFRSF9 (TNF Receptor Superfamily Member 9)

PD-L1 underexpression • PD-L1-L

FS222

4years

A First-in-Human Phase 1 Study of FS222, a CD137/PD-L1 tetravalent bispecific antibody, in patients with advanced malignancies. (ESMO-IO 2021)

Legal entity responsible for the study F-star Therapeutics. Funding F-star Therapeutics.

4 years ago

Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker

TNFRSF9 (TNF Receptor Superfamily Member 9)

FS222

over5years

FS222, a CD137/PD-L1 tetravalent bispecific antibody exhibits low toxicity and anti-tumor activity in colorectal cancer models. (PubMed, Clin Cancer Res)

By targeting CD137 agonism to areas of PD-L1 expression, predominantly found in the tumour microenvironment, FS222 has the potential to leverage a focused, potent and safe immune response augmenting the PD-(L)1 axis blockade.

over 5 years ago

Preclinical • Journal • PD(L)-1 Biomarker

PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)

PD-L1 expression

FS222