QBIOTICS REPORTS 80% OBJECTIVE RESPONSE RATE IN INJECTED TUMOURS IN STAGE 1 OF PHASE IIA CLINICAL TRIAL OF TIGILANOL TIGLATE FOR SOFT TISSUE SARCOMA

BRISBANE, Australia, June 25, 2025 /PRNewswire/ --

• 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." 

ABOUT TRIAL QB46C-H07

QB46C-H07 (Clinical trial registration, NCT05755113) is a Phase IIa, open label, clinical trial evaluating the preliminary efficacy and safety of intratumoural tigilanol tiglate in patients with a range of advanced and/or metastatic STS. QB46C-H07 is being conducted in two stages: Stage 1 is a pilot trial in 10 patients. Stage 2 is an expansion trial. The results of Stage 1 are reported here.

Eleven patients were administered tigilanol tiglate (0.5 mg tigilanol tiglate/cm3 tumour volume) to one or more of their tumours. Ten patients were included in the response evaluable population (where patients had a tumour assessment at both baseline and at 28 days post-treatment).

The primary efficacy endpoint was Objective Response Rate (ORR) of injected tumours, compared to baseline. ORR was defined as the proportion of patients who achieved complete ablation (100% reduction in volume) or partial ablation (≥ 30% reduction in volume) of treated tumours and/or tumour segments following one or more treatments (up to 5 treatments) with tigilanol tiglate. Patients who achieved a ≥ 30% reduction in volume, irrespective of the number of treatments they received, were considered to have a response to tigilanol tiglate.

Secondary endpoints include safety and tolerability assessments, and pharmacokinetics.

Exploratory endpoints include local rate of recurrence at the injection site at 6 months post-initial injection, and assessment of tumour response in biopsy samples. Surgical specimens and blood samples were used to assess changes in tumour biomarkers.

Efficacy and Safety Outcomes

The ORR was 80% indicating 8 out of 10 evaluable patients achieved either complete or partial ablation of their treated tumours or tumour segments at any time during the study (Best Observed Response, BOR). There was a median of 2 treatments of tigilanol tiglate per patient (range 1 to 5). At the tumour level, 22 of 27 (81%) treated tumours showed either complete or partial responses as the Best Observed Response. 14 out of 27 tumours (52%) demonstrated complete ablation, while 8 out of 27 tumours (30%) demonstrated partial ablation.

These results indicate a high level of efficacy for tigilanol tiglate in achieving complete or partial tumour ablation. Importantly, none of the complete responses (n=14) recurred by 6 months, the follow-up period, indicating tigilanol tiglate may provide durable responses.

All 11 tigilanol tiglate treated patients were included in the safety evaluation. Tigilanol tiglate was well tolerated. Most of the Adverse Events (AEs) were expected and related to the local action of the drug (e.g. local pain, swelling, necrosis).

Conclusions

Overall, the study results indicate tigilanol tiglate is well tolerated and shows promising efficacy in reducing tumour volume, with 80% of patients experiencing complete (100%) ablation or partial (≥30%) ablation of their tumours. The absence of tumour recurrence in cases achieving a complete response further underscores tigilanol tiglate's potential as an effective treatment option for soft tissue sarcomas and possibly other solid tumours.

The promising tumour responses reported here, together with observations that three patients exhibited better than expected responses to subsequent systemic therapy (as presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024),^[2] have supported the progression of the QB46C-H07 study to Stage 2. The trial expansion (referred to as Stage 2) aims to further investigate the clinical utility and therapeutic potential of tigilanol tiglate in patients with STS. Stage 2 of the trial is opening shortly at Memorial Sloan Kettering Cancer Center in New York, USA.

References

1. GlobalData®, American Cancer Society, Cancer Australia, Cancer Research UK, Canadian Cancer Society.
2. Bartlett et al, 2024. The Connective Tissue Oncology Society (CTOS) Annual Meeting, Nov 13-16, 2024, San Diego, USA.

NOTES FOR EDITORS

ABOUT QBIOTICS

QBiotics is an unlisted, public, Australian life sciences company that seamlessly connects scientific discovery, development and commercialisation to harness the power of nature to treat diseases of high unmet need.  

Our current clinical focus is on novel treatments for cancer and debilitating chronic wounds. We also have an early-stage antibiotics program.

QBiotics' lead molecule, tigilanol tiglate, is a novel, small molecule with the potential to treat a broad range of solid tumours. It is currently in Phase II clinical trials in two indications: soft tissue sarcoma (STS) and head and neck cancer (HNC). Tigilanol tiglate was granted Orphan Drug Designation by the US FDA for the treatment of STS in February 2024.

A veterinary formulation of tigilanol tiglate (STELFONTA®) is approved for the treatment of canine mast cell tumours (MCTs), in major global markets, including the USA, Europe, and Australia. QBiotics has partnered with Virbac, a global animal health company, to distribute STELFONTA®.

Our wound healing drug candidate, EBC-1013, is a small molecule, which targets multiple pathways to accelerate healing, improving outcomes in chronic and acute wounds and burns. A first-in-human Phase I clinical trial in venous leg ulcers is open for recruitment. 

For more, head to: QBiotics.com or LinkedIn.

BRISBANE, Australia, June 25, 2025 /PRNewswire/ --

• 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." 

ABOUT TRIAL QB46C-H07

QB46C-H07 (Clinical trial registration, NCT05755113) is a Phase IIa, open label, clinical trial evaluating the preliminary efficacy and safety of intratumoural tigilanol tiglate in patients with a range of advanced and/or metastatic STS. QB46C-H07 is being conducted in two stages: Stage 1 is a pilot trial in 10 patients. Stage 2 is an expansion trial. The results of Stage 1 are reported here.

Eleven patients were administered tigilanol tiglate (0.5 mg tigilanol tiglate/cm3 tumour volume) to one or more of their tumours. Ten patients were included in the response evaluable population (where patients had a tumour assessment at both baseline and at 28 days post-treatment).

The primary efficacy endpoint was Objective Response Rate (ORR) of injected tumours, compared to baseline. ORR was defined as the proportion of patients who achieved complete ablation (100% reduction in volume) or partial ablation (≥ 30% reduction in volume) of treated tumours and/or tumour segments following one or more treatments (up to 5 treatments) with tigilanol tiglate. Patients who achieved a ≥ 30% reduction in volume, irrespective of the number of treatments they received, were considered to have a response to tigilanol tiglate.

Secondary endpoints include safety and tolerability assessments, and pharmacokinetics.

Exploratory endpoints include local rate of recurrence at the injection site at 6 months post-initial injection, and assessment of tumour response in biopsy samples. Surgical specimens and blood samples were used to assess changes in tumour biomarkers.

Efficacy and Safety Outcomes

The ORR was 80% indicating 8 out of 10 evaluable patients achieved either complete or partial ablation of their treated tumours or tumour segments at any time during the study (Best Observed Response, BOR). There was a median of 2 treatments of tigilanol tiglate per patient (range 1 to 5). At the tumour level, 22 of 27 (81%) treated tumours showed either complete or partial responses as the Best Observed Response. 14 out of 27 tumours (52%) demonstrated complete ablation, while 8 out of 27 tumours (30%) demonstrated partial ablation.

These results indicate a high level of efficacy for tigilanol tiglate in achieving complete or partial tumour ablation. Importantly, none of the complete responses (n=14) recurred by 6 months, the follow-up period, indicating tigilanol tiglate may provide durable responses.

All 11 tigilanol tiglate treated patients were included in the safety evaluation. Tigilanol tiglate was well tolerated. Most of the Adverse Events (AEs) were expected and related to the local action of the drug (e.g. local pain, swelling, necrosis).

Conclusions

Overall, the study results indicate tigilanol tiglate is well tolerated and shows promising efficacy in reducing tumour volume, with 80% of patients experiencing complete (100%) ablation or partial (≥30%) ablation of their tumours. The absence of tumour recurrence in cases achieving a complete response further underscores tigilanol tiglate's potential as an effective treatment option for soft tissue sarcomas and possibly other solid tumours.

The promising tumour responses reported here, together with observations that three patients exhibited better than expected responses to subsequent systemic therapy (as presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024),^[2] have supported the progression of the QB46C-H07 study to Stage 2. The trial expansion (referred to as Stage 2) aims to further investigate the clinical utility and therapeutic potential of tigilanol tiglate in patients with STS. Stage 2 of the trial is opening shortly at Memorial Sloan Kettering Cancer Center in New York, USA.

References

NOTES FOR EDITORS

ABOUT QBIOTICS

QBiotics is an unlisted, public, Australian life sciences company that seamlessly connects scientific discovery, development and commercialisation to harness the power of nature to treat diseases of high unmet need.  

Our current clinical focus is on novel treatments for cancer and debilitating chronic wounds. We also have an early-stage antibiotics program.

QBiotics' lead molecule, tigilanol tiglate, is a novel, small molecule with the potential to treat a broad range of solid tumours. It is currently in Phase II clinical trials in two indications: soft tissue sarcoma (STS) and head and neck cancer (HNC). Tigilanol tiglate was granted Orphan Drug Designation by the US FDA for the treatment of STS in February 2024.

A veterinary formulation of tigilanol tiglate (STELFONTA®) is approved for the treatment of canine mast cell tumours (MCTs), in major global markets, including the USA, Europe, and Australia. QBiotics has partnered with Virbac, a global animal health company, to distribute STELFONTA®.

Our wound healing drug candidate, EBC-1013, is a small molecule, which targets multiple pathways to accelerate healing, improving outcomes in chronic and acute wounds and burns. A first-in-human Phase I clinical trial in venous leg ulcers is open for recruitment. 

For more, head to: QBiotics.com or LinkedIn.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

QBIOTICS REPORTS 80% OBJECTIVE RESPONSE RATE IN INJECTED TUMOURS IN STAGE 1 OF PHASE IIA CLINICAL TRIAL OF TIGILANOL TIGLATE FOR SOFT TISSUE SARCOMA

HONG KONG, Dec. 29, 2025 /PRNewswire/ -- CNN's Tomorrow Transformed examines how society and businesses are changing through innovation and technology, and what this means for the future. The latest episode examines the diverse innovations driving a cleaner future – from making the aviation industry greener through sustainable jet fuel to advancing solar efficiency and developing revolutionary hydrogen power solutions.

Tomorrow Transformed travels to Sydney, Australia, to explore the global energy revolution being led by the University of New South Wales (UNSW). Known as a "hotbed of innovation" in photovoltaics, the institution is home to Professor Martin Green, the "father of solar energy," whose PERC Cell design is used in over 90% of solar cells installed worldwide. At UNSW, Professor Ned Ekins-Daukes and PhD student Jamie Harrison are demonstrating how thermodynamics can be used to harvest energy as heat leaves the earth's surface for the cold sky. While solar now provides the cheapest energy in history, researchers are pushing further to eliminate manufacturing bottlenecks. Vince Allen, co-founder of the startup SunDrive, is pioneering a shift away from expensive and rare silver in solar cell production, replacing it with copper - a material that is 1000 times more abundant and 100 times cheaper.

The journey continues to Cape Town, South Africa, where HYENA (Hydrogen Energy Applications) is reimagining how the world's most abundant element can provide reliable power to the African continent. CNN speaks with HYENA co-founder Jack Fletcher to explore how their "Power Pod" technology uses hydrogen to offer a quieter, more efficient, and significantly cleaner alternative to traditional diesel generators. By converting available fuels like LPG into electricity via a chemical process rather than combustion, the system drastically reduces emissions and eliminates the noise of a standard engine.

Lastly, Tomorrow Transformed visits Hong Kong-based biofuels company, EcoCeres, in the southern region of Johor in Malaysia. A global leader in sustainable aviation fuel (SAF), EcoCeres is helping to power a more environmentally friendly future for air travel through advanced, low carbon jet fuel made from renewable resources.

In its state-of-the-art biorefinery, the company is re-engineering waste and residue oil, known as 'feedstock', from food factories, palm oil mills and restaurants across the region. The end product is an eco jet fuel that has the right freezing point and structure for flying at cruising altitude, ready to be pumped directly into waiting airplanes. At full capacity, the biorefinery will be able to produce 420,000 tonnes of fuel per year, with large quantities of SAF powering partner airlines including Cathay Pacific, Qantas and British Airways.

Matti Lievonen, CEO of EcoCeres, though proud of the science behind transforming waste feedstock into a viable jet fuel alternative, states that the real innovation is in the system his company has in place. EcoCeres is actively expanding its presence across Southeast Asia to complement its existing refinery and strong feedstock network in China and is looking to replicate this model in other markets.

In the very near future, the next flight you take may be powered by recycled cooking oil from a restaurant in Beijing, street food stalls in Malaysia or from a factory that produces your favourite brand of potato chips.

Tomorrow Transformed trailers: https://bit.ly/3KWFFfF
Tomorrow Transformed images: https://bit.ly/4jb0DE9 

Airtimes for 30-minute special:
Sunday, 28^th December at 5am, 12pm and 8pm HKT

About CNN International  

CNN's portfolio of news and information services is available in seven different languages across all major TV, digital and mobile platforms, reaching more than 379 million households around the globe. CNN International is the number one international TV news channel according to all major media surveys across Europe, the Middle East and Africa, the Asia Pacific region, and Latin America and has a US presence that includes CNNgo. CNN Digital is a leading network for online news, mobile news and social media. CNN is at the forefront of digital innovation and continues to invest heavily in expanding its digital global footprint, with a suite of award-winning digital properties and a range of strategic content partnerships, commercialised through a strong data-driven understanding of audience behaviours. CNN has won multiple prestigious awards around the world for its journalism. Around 1,000 hours of long-form series, documentaries and specials are produced every year by CNNI's non-news programming division. CNN has 36 editorial offices and more than 1,100 affiliates worldwide through CNN Newsource. CNN International is a Warner Bros. Discovery company.

HONG KONG, Dec. 29, 2025 /PRNewswire/ -- CNN's Tomorrow Transformed examines how society and businesses are changing through innovation and technology, and what this means for the future. The latest episode examines the diverse innovations driving a cleaner future – from making the aviation industry greener through sustainable jet fuel to advancing solar efficiency and developing revolutionary hydrogen power solutions.

Tomorrow Transformed travels to Sydney, Australia, to explore the global energy revolution being led by the University of New South Wales (UNSW). Known as a "hotbed of innovation" in photovoltaics, the institution is home to Professor Martin Green, the "father of solar energy," whose PERC Cell design is used in over 90% of solar cells installed worldwide. At UNSW, Professor Ned Ekins-Daukes and PhD student Jamie Harrison are demonstrating how thermodynamics can be used to harvest energy as heat leaves the earth's surface for the cold sky. While solar now provides the cheapest energy in history, researchers are pushing further to eliminate manufacturing bottlenecks. Vince Allen, co-founder of the startup SunDrive, is pioneering a shift away from expensive and rare silver in solar cell production, replacing it with copper - a material that is 1000 times more abundant and 100 times cheaper.

The journey continues to Cape Town, South Africa, where HYENA (Hydrogen Energy Applications) is reimagining how the world's most abundant element can provide reliable power to the African continent. CNN speaks with HYENA co-founder Jack Fletcher to explore how their "Power Pod" technology uses hydrogen to offer a quieter, more efficient, and significantly cleaner alternative to traditional diesel generators. By converting available fuels like LPG into electricity via a chemical process rather than combustion, the system drastically reduces emissions and eliminates the noise of a standard engine.

Lastly, Tomorrow Transformed visits Hong Kong-based biofuels company, EcoCeres, in the southern region of Johor in Malaysia. A global leader in sustainable aviation fuel (SAF), EcoCeres is helping to power a more environmentally friendly future for air travel through advanced, low carbon jet fuel made from renewable resources.

In its state-of-the-art biorefinery, the company is re-engineering waste and residue oil, known as 'feedstock', from food factories, palm oil mills and restaurants across the region. The end product is an eco jet fuel that has the right freezing point and structure for flying at cruising altitude, ready to be pumped directly into waiting airplanes. At full capacity, the biorefinery will be able to produce 420,000 tonnes of fuel per year, with large quantities of SAF powering partner airlines including Cathay Pacific, Qantas and British Airways.

Matti Lievonen, CEO of EcoCeres, though proud of the science behind transforming waste feedstock into a viable jet fuel alternative, states that the real innovation is in the system his company has in place. EcoCeres is actively expanding its presence across Southeast Asia to complement its existing refinery and strong feedstock network in China and is looking to replicate this model in other markets.

In the very near future, the next flight you take may be powered by recycled cooking oil from a restaurant in Beijing, street food stalls in Malaysia or from a factory that produces your favourite brand of potato chips.

Tomorrow Transformed trailers: https://bit.ly/3KWFFfF
Tomorrow Transformed images: https://bit.ly/4jb0DE9 

Airtimes for 30-minute special:
Sunday, 28^th December at 5am, 12pm and 8pm HKT

About CNN International  

CNN's portfolio of news and information services is available in seven different languages across all major TV, digital and mobile platforms, reaching more than 379 million households around the globe. CNN International is the number one international TV news channel according to all major media surveys across Europe, the Middle East and Africa, the Asia Pacific region, and Latin America and has a US presence that includes CNNgo. CNN Digital is a leading network for online news, mobile news and social media. CNN is at the forefront of digital innovation and continues to invest heavily in expanding its digital global footprint, with a suite of award-winning digital properties and a range of strategic content partnerships, commercialised through a strong data-driven understanding of audience behaviours. CNN has won multiple prestigious awards around the world for its journalism. Around 1,000 hours of long-form series, documentaries and specials are produced every year by CNNI's non-news programming division. CNN has 36 editorial offices and more than 1,100 affiliates worldwide through CNN Newsource. CNN International is a Warner Bros. Discovery company.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

CNN's Tomorrow Transformed explores global innovations powering a greener future