On November 5, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that it will present the first clinical data from its Phase 1a oncology trial with AVID200 in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2019in National Harbor, Maryland (Nov. 6-10) (Press release, Forbius, NOV 5, 2019, View Source [SID1234550324]).

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AVID200 is a first-in-class, selective inhibitor of TGF-beta 1 & 3, the main pathogenic TGF-beta isoforms. AVID200 spares TGF-beta 2 for optimal safety.

The presentation will feature results from a Phase 1a monotherapy dose-escalation trial in patients with advanced solid tumor malignancies (AVID200-03, NCT03834662). The highest tested dose level was 30 mg/kg (1100 mg/m2)administered iv q3w, and the maximum tolerated dose (MTD) was not reached. Pharmacokinetics (PK), target engagement results as well as preliminary clinical efficacy will also be disclosed in the poster presentation.

Details of the Presentation:

Title:

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)

Presenter:

Dr. Timothy Yap, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center

Poster Viewing:

Friday, Nov. 8 / 12:30 – 2:00 p.m. and 6:30 – 8:00 p.m.

Saturday, Nov. 9 / 12:35 – 2:05 p.m. and 7:00 – 8:30 p.m.

Location:

Prince George’s Exhibition Halls AB

About TGF-beta 1 & 3

TGF-beta 1 & 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, Nature Comm., 2018; Tauriello, Nature, 2018; Mariathasan, Nature, 2018).

About AVID200 and the AVID200-03 Trial (NCT03834662)

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 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 & 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.