OMP-336B11 / Mereo Biopharma - LARVOL DELTA

GITRL-Fc biomarker and mechanism study: GITRL-Fc reduces Treg frequency in tumors and requires effector function for inhibition of tumor growth (AACR 2018) - "Biomarker analysis showed that loss of Tregs, activation of T cells and Fc-mediated effector function are key elements in the mechanism of action of the molecule. We have identified potential biomarkers to be used for PD and potential predictive analysis in clinical trial patient samples."

Biomarker • IO Biomarker • Colorectal Cancer

Effect of aging on the antitumor activity of GITRL-Fc (AACR 2018) - "On the other hand, GITRL-Fc deficient in effector function (mIgG2a (N297A)) did not deplete Tregs in the tumor but did retain some antitumor growth activity, indicating a role for GITR signaling in the mechanism of efficacy by GITLR-Fc. In conclusion, the results demonstrate the potential for the aging of the immune system to impact the efficacy observed with immunotherapy agents and highlight the potential benefits of conducting efficacy studies with both young and older mice."

IO Biomarker • Oncology

In vitro functional activity of OMP-336B11, a GITRL-Fc fusion protein, on primary human immune cells (AACR 2018) - "In conclusion, OMP-336B11 is designed to induce effective GITR activation and also to mediate depletion of GITR-high cells. OMP-336B11 is currently undergoing phase I clinical study."

Preclinical • Oncology

OncoMed announces second quarter 2018 financial results and operational highlights (Nasdaq) - "...the company expects to publish the final results of the Phase 1a single-agent navicixizumab study in all-comers solid tumor patients, which included several late-stage ovarian cancer patients, by the end of 2018... [and to] report data from the Phase 1a dose-escalation portion of the trial, designed to assess safety and tolerability of escalating doses of etigilimab monotherapy, in the fourth quarter of 2018...Data from the Phase 1a trial [of GITRL-Fc (OMP-336B11)] are expected to be presented in 2019."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

OncoMed pharmaceuticals announces fourth quarter and full year 2016 financial results (OncoMed Press Release) - "Key potential upcoming milestones and events by program [for] Immuno-Oncology pipeline: [1] Initiate dosing of patients in the Phase 1 clinical trial of anti-TIGIT (OMP-313M32) in the first half of 2017; [2] File an IND for OncoMed’s wholly owned GITRL-Fc trimer (OMP-336B11) program in the first half of 2017."

Anticipated IND • Anticipated new P1 trial • Oncology

OncoMed announces third quarter 2018 financial results and operational highlights [GITRL-Fc] (GlobeNewswire) - P1, N=30; NCT03295942; Sponsor:OncoMed Pharmaceuticals; "Enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. The company is pleased that enrollment in this trial has been robust to date...Data from the Phase 1a trial are expected to be presented in 2019."

Enrollment status • P1 data • Oncology • Solid Tumor

OMP-336B11: Expiry of patents in US and ex-US in 2036 and 2038 (OncoMed) - Annual Report 2017

Patent • Oncology