On April 29, 2020 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that it will report complete safety and biomarker data from its Phase 1 oncology trial with AVID200 in a virtual poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2020 (Virtual Format, May 29 – Jun. 2) (Press release, Forbius, APR 29, 2020, View Source [SID1234556757]).
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The Phase 1 clinical study (AVID200-03, NCT03834662) in patients with advanced solid tumor malignancies was designed to assess the safety, PK and pharmacodynamic response of escalating doses of AVID200 administered intravenously q3w as a monotherapy.
Doses of 5 – 30 mg/kg were well tolerated, led to peripheral target engagement, TGF-beta pathway biomarker modulation as well as immune activation.
The Phase 1 results serve as a proof-of-principle that AVID200-mediated selective inhibition of TGF-beta 1 & 3 is feasible in the clinic and support the company’s strategy to develop AVID200 across a broad range of immune-oncology and fibrosis indications.
Details of the Presentation:
Title: AVID200, First-in-Class TGF-beta 1 & 3 Selective and Potent Inhibitor: Safety and Biomarker Results of a Phase 1 Monotherapy Dose Escalation Study in Patients with Advanced Solid Tumors
Presenter: Dr. Timothy Yap, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center
Poster Viewing: Available on demand beginning May 29 at 8:00 AM ET
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 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 & 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.