Pharma Focus Asia

QBiotics announces clinical collaboration with MSD in targeting unresectable melanoma

Monday, August 17, 2020

QBiotics Group Limited (QGL), specializing in life sciences and developing novel cancer and wound healing pharmaceuticals, is pleased to announce its partnership with MSD (trademark of Merck & Co., Inc. in Kenilworth in New Jersey in the US) for an evaluation of the use of its main molecule of the tiglate tigilanol in combination with Keytruda ® (pembrolizumab) in patients with unresectable melanoma.

Dr. Victoria Gordon , President and CEO of QBiotics, said: “We are delighted to report on this collaboration with MSD. Effective treatment options are currently limited for patients with unresectable melanoma who have previously received checkpoint inhibitors. We hope through this program to see a possibility of improved outcomes for these patients, with more anti-tumor immune responses when tigilanol tiglate is combined with Keytruda. "

The open-label phase I / II trial 'QBC46-H06' constitutes a dose escalation and expansion study with the essential objective of determining the maximum tolerated dose or the maximum possible dose of this therapy in combination. Secondary measures include evaluation of tumor responses in both injected and non-injected tumors, as well as evaluation of clinical efficacy parameters. Patients with unresectable melanoma who have been exposed to checkpoint inhibitors are eligible for this study.

Dr. Gordon added, “This trial follows encouraging data from Phase I where tigilanol tiglate monotherapy had a 27% response rate to treatment *, of which 18% was complete response with complete tumor destruction on a wide variety of solid tumor types [2] . Two patients with melanoma exhibited, in addition to a complete response, an abscopal response (anamnestic). Melanoma is the second human application we are considering for tigilanol tiglate as an extension of our Phase I / II clinical trial started in December 2019 in patients with squamous cell carcinoma of the head and neck (HNSCC). "

Tigilanol tiglate is a small molecule given by intratumoral injection directly into the mass of a solid tumor. Once injected, it exhibits a multimodal mode of action, including rapid but extremely localized inflammatory responses, increased permeability with destruction of the tumor endothelium and rapid death of tumor cells by oncosis .

* 27% response rate to treatment (n = 6); 18% complete response rate (n = 4) 2 .

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