Trillium Therapeutics (TRIL) Approved by FDA to Commence TTI-621 Phase 1 in olid Tumors and Mycosis Fungoides

August 17, 2016 7:06 AM EDT
Get Alerts TRIL Hot Sheet
Trade TRIL Now!
Join SI Premium – FREE

Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.

Trillium Therapeutics Inc. (Nasdaq: TRIL) announced that the US Food and Drug Administration (FDA) has provided the company clearance to initiate a Phase 1 clinical trial of its lead drug candidate, TTI-621 (SIRPaFc), in solid tumors and mycosis fungoides. Patient enrollment is anticipated to commence by the end of the year. Trillium is developing TTI-621 as a novel checkpoint inhibitor of the innate immune system, and the drug is currently being evaluated in an ongoing Phase 1 dose escalation study in patients with relapsed or refractory hematologic malignancies.

"The FDA's acceptance of this IND application is another important milestone for our company, as the study of TTI-621 in select tumor types could lead to a more thorough understanding of its mechanism of action, and may bring us one step closer to a much needed treatment option for patients," said Dr. Niclas Stiernholm, chief executive officer of Trillium Therapeutics. "We seek to gain insight into the tumor micro-environment before, during and after treatment with TTI-621. This will help us learn how to best use TTI-621 CD47 blockade in combination with other anti-cancer drugs and better design the commercial development path for this agent."

In the multicenter, open-label, Phase 1 trial, TTI-621 will be delivered by intratumoral injection in patients with relapsed and refractory, percutaneously-accessible cancers. Patients will be enrolled in sequential dose cohorts to receive intratumoral injections of TTI-621 that increase in dose and dosing frequency to characterize safety, pharmacokinetics, pharmacodynamics and preliminary evidence of antitumor activity. In addition, detailed evaluation of serial, on-treatment tumor biopsies of both injected and non-injected cancer lesions will help characterize tumor microenvironment changes anticipated with CD47 blockade.

Serious News for Serious Traders! Try Premium Free!

You May Also Be Interested In

Related Categories

Corporate News, FDA, Management Comments

Add Your Comment