• Positive data from Stage 1 of the Phase IIa clinical trial (QB46C-H07) evaluating QBiotics' small molecule, tigilanol tiglate in 11 (10 evaluable) patients with advanced Soft Tissue Sarcoma (STS).
• An Objective Response Rate (ORR) of 80% was achieved, based on the Best Observed Response (BOR) at any time during the study, indicating 8 out of 10 evaluable patients saw either complete ablation (100% reduction in volume) or partial ablation (≥30% reduction in volume) of treated tumours.
• 22 of the 27 (81%) injected tumours across all patients showed complete or partial ablation (14 showing complete ablation and 8 showing partial ablation).
• None of the 14 completely ablated tumours recurred at 6 months, indicating tigilanol tiglate may provide durable responses.

QBiotics Group Limited (QBiotics) is pleased to announce final efficacy and safety data from the first of its two stage, Phase IIa clinical trial in patients with Soft Tissue Sarcoma (STS).

STS is a rare type of cancer that generally forms as a painless lump (tumour) in any one of the soft tissues in the body. There were approximately 128,000 new cases of STS globally in 2023, with the incidence growing at 0.54% per year.^[1]

QBiotics' CEO and Managing Director, Stephen Doyle commented, "We are delighted with the outcomes from Stage 1 of our Phase IIa Soft Tissue Sarcoma trial. Tigilanol tiglate met both its primary and secondary endpoints and delivered patients an impressive 80% Objective Response Rate in injected tumours. Importantly, none of the 14 fully ablated (destroyed) tumours had recurred by the 6-month follow-up period, suggesting tigilanol tiglate may provide long-term benefit for patients. Given soft tissue sarcoma is a challenging cancer to treat, achieving this level of clinical activity is highly encouraging."

"Our thanks to every trial patient, and also to the trial Investigators, Dr. Edmund Bartlett and his team at Memorial Sloan Kettering Cancer Center in New York. Given the positive results from Stage 1 of the trial – and compelling investigator reports that tigilanol tiglate may improve responses to systemic therapies in metastatic STS – we have moved ahead with the expansion arm of the study, announced late last year."

Dr. Edmund Bartlett, Principal Trial Investigator at Memorial Sloan Kettering Cancer Center commented, "The clinical activity of tigilanol tiglate, which we observed in multiple types of soft tissue sarcoma, was encouraging. I look forward to expanding our experience with this treatment and determining how to integrate it into the care of patients with soft tissue sarcoma."