Ann: FDA clears Imugene IND for onCARlytics first-in-class study, page-131

One certain thing - IMU is getting some much wanted press from it latest announcements.

ASX Health Stocks: FDA approves Imugene's Phase 1 trial; Noxopharm says it can fight skin disease - *

ASX Health Stocks: FDA approves Imugene’s Phase 1trial

US FDA approves Imugene’s Phase 1

Immuno-oncologybiotech Imugene(ASX:IMU) jumped 9% this morning after receiving a US FDA Investigational New Drug (IND) clearance to initiate a Phase 1 clinical study of its oncolytic virotherapy candidate, onCARlytics.

Theclearance allows Imugene to start patient recruitment and dosing of CARlytics(CF33-CD19) combined with blinatumomab in patients withadvanced or metastatic solid tumors.

Previousstudies have shown that Imugene’s CF33-CD19 oncolytic virus, when combined withblinatumomab (sold under brand name Blincyto and developed by US-based Amgem)has the potential to eradicate solid tumours that otherwise cannot be treatedwith Blincyto therapy alone.

ImugeneCEO Leslie Chong said that starting this study is a significant milestone forclinicians treating patients with solid tumour cancers, which to date have beenuntreatable with CD19-targeting biological drugs.