Forbius Completes Phase 1 Oncology Dose-Escalation with AVID200, First-in-Class TGF-beta 1 and 3 Inhibitor: Well Tolerated, Target Inhibition Demonstrated at All Dose Levels, Data Reported at SITC
Tags:
Phase 1
Oncology
AUSTIN, Texas and MONTREAL--(BUSINESS WIRE)--Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, today presented the first Phase 1 clinical data from its oncology development program with AVID200, in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019 in National Harbor, Maryland (Nov. 6-10).
AVID200 is a first-in-class, selective inhibitor of TGF-beta 1 and 3, the main pathogenic TGF-beta isoforms. AVID200 spares TGF-beta 2 for optimal safety.
The AVID200-03 trial (NCT03834662) is an open label, multicenter, dose-escalation study of AVID200 monotherapy following a standard 3 + 3 design in patients with advanced or metastatic solid tumor malignancies and no other treatment options.
In the presentation entitled “AVID200, first-in-class TGF-beta 1 and beta 3 selective inhibitor: Results of a Phase 1 monotherapy dose escalation study in solid tumors and evidence of target engagement in patients (Abstract # P856)”, Dr Timothy Yap, Associate Professor, MD Anderson Cancer Center, and a PI in the trial detailed the following:
Ilia Tikhomirov, CEO of Forbius, commented: “With this Phase 1a dose-escalation study we have shown that selective inhibition of TGF-beta isoforms 1 and 3 via AVID200 leads to efficient blockade of the TGF-beta pathway with potentially best-in-class tolerability. We look forward to reporting additional clinical data from across the AVID200 program.”
About TGF-beta 1 and 3
TGF-beta 1 and 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo®) and pembrolizumab (Keytruda®) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).
About AVID200 and the AVID200-03 Trial (NCT03834662)
AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 and 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 and 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.
AVID200's selectivity for TGF-beta 1 and 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of earlier-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.
AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.
About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer
Forbius is a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer. We are focused on the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.
Forbius’ team of TGF-beta biology experts designed a proprietary platform of TGF-beta inhibitors with best-in-class potency and selectivity against the principal disease-driving isoforms 1 and 3. This novel class of TGF-beta inhibitors has proven highly active in preclinical models of fibrosis and cancer and was well-tolerated in long-term toxicology studies. Forbius’ lead TGF-beta 1 and 3 inhibitor, AVID200, is undergoing Phase 1 clinical trials in two fibrotic indications as well as in solid tumors.
Forbius' lead program targeting EGFR is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate (ADC) with a novel tumor-selective mode of action. This program is undergoing Phase 2a clinical trials in EGFR-overexpressing solid tumors.
Contacts
Ilia Tikhomirov, CEO, Forbius ir@forbius.com
Ilia Tikhomirov, CEO, Forbius ir@forbius.com
