First patient dosed in clinical trial for unresectable melanoma: QBiotics

QBiotics Group Limited (QBiotics), a Brisbane-based life sciences company engaged in the development of novel small molecular anticancer pharmaceuticals, has recently announced dosing its first patient in the Phase Ib/IIa clinical trial of tigilanol tiglate in group with MSD’s KEYTRUDA for patients with unresectable melanoma.

As per credible reports, the QB46C-H06 open label, multi-center study would enroll roughly 22 patients with late-stage melanoma across some of the Australian sites over 2 years. Moreover, the study will test up to three intratumoural doses of the drug candidate at three dose levels, administered 3 weeks apart in combination with pembrolizumab dosed every 3 weeks, for up to 2 years.

The study is likely to evaluate the safety, optimal dose, and tumor response of tigilanol tiglate and pembrolizumab in patients with acute unresectable melanoma, who have already been exposed to immune checkpoint inhibitors.

Speaking on the latest accomplishment, QBiotics’ CEO and Managing Director, Dr. Victoria Gordon cited that the firm is pleased to be partnering with MSD in its fight against melanoma worldwide, and in Australia particularly.

Victoria added that the company hopes to see the results of the trial that the combination of KEYTRUDA and tigilanol tiglate may produce to improve the outcomes for patients.

While commenting on the successful commencement of the trial, Dr. Gordon further mentioned that the positive start of the trial is a significant milestone for QBiotics and is underpinned by positive outcomes for its QBC46-H01 Phase I evaluation using the drug candidate as a monotherapy in patients with a wide range of intractable solid tumors.

It was reported that in the Phase I study, a single injection of tigilanol tiglate presented an injected tumor response rate of 60%. Whereas, non-injected responses in distal tumors were witnessed in two patients with melanoma.

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