QBiotics Group Limited, an Australian life sciences firm that focuses on developing novel wound healing and anticancer therapies, has recently signed an agreement with MSD (Merck & Co., Inc.) to assess the use of its lead drug candidate, tigilanol tiglate, in combination with Keytruda® (pembrolizumab) on patients suffering from unresectable melanoma.
According to reliable sources, the Phase I/II open label 'QBC46-H06' trial would be an expansion and dose escalation study with the primary goal to establish the combination therapy’s maximum tolerated dosage. Meanwhile, the secondary end-point involves the assessment of tumor responses in both uninjected tumors and injected tumors, along with clinical efficacy parameters.
Speaking on the development, Dr. Victoria Gordon, CEO & Managing Director, QBiotics, said that the company is delighted to collaborate with MSD. At this moment, patients suffering from unresectable melanoma that have previously received checkpoint inhibitors have a handful of effective treatment options.
With the help of this program, the company hopes that the combined result of Keytruda and tigilanol tiglate will generate favorable additive anti-tumor immune responses as well as enhance patient outcomes.
Moreover, this trial comes right on the back of some positive Phase I data where tigilanol tiglate as a monotherapy showcased a 27% treatment response rate. It also showed an 18% inclusive response with complete tumor destruction across a broad range of solid tumor types. As a matter of fact, two melanoma patients with complete responses also displayed an abscopal (anenestic) response, added Dr. Gordon.
Prior to this news, QBiotics had made headlines when it announced that it has successfully commercialized the first drug for tigilanol tiglate, with the release of STELFONTA® at the Virbac Oncology Summit Webinar Event across the European market. STELFONTA® now comes as the first pharmaceutical therapy for all types of canine non-metastatic MCT (mast cell tumors).