Forbius’ AVID200, a Novel TGF-beta 1 & 3 Inhibitor, Cleared by Health Canada to Commence Phase 1 Clinical Trial in Solid Tumors

Jennifer Schram Forbius (Formation Biologics), Portfolio News, Press Release

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SOURCE: Forbius
  • Expansion of ongoing AVID200 Phase 1 solid tumor trial to include patients at clinical sites in Canada
  • AVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal oncogenic TGF-beta isoforms
  • Best-in-class efficacy and safety potential by selectively targeting TGF-beta 1 & 3 while sparing TGF-beta 2, the isoform that promotes normal cardiac function

Austin, TX, and Montreal, QC (Apr. 29, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced that it has received a no objection letter from Health Canada for its clinical trial application (CTA) to conduct a Phase 1 trial in solid tumors with immuno-oncology candidate AVID200, a rationally designed and highly potent inhibitor of TGF-beta 1 & 3.

AVID200-03 (NCT03834662) is a Phase I, open-label, dose-escalation trial to establish the recommended phase 2 dose (RP2D) of AVID200 in patients with advanced or metastatic malignancies. The trial is currently enrolling patients at centers in the U.S. and will now be expanded to additional clinical sites in Canada to recruit a total of up to 36 patients.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors and represent promising immuno-oncology targets. These TGF-beta isoforms are implicated in T-cell suppression, fibrosis in the tumor microenvironment, and resistance to immunotherapeutics 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

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 older-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

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Media Relations

Claudia Resch, info@forbius.com

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Forbius Announces the First Patient Dosed in a Phase 1 Oncology Trial of AVID200, a Novel TGF-beta 1 & 3 Inhibitor