QBiotics wins FDA orphan status for rainforest-derived cancer drug

2024-02-16

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QBiotics wins FDA orphan status for rainforest-derived cancer drug

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来源: Pharmaceutical Technology

Tigilanol tiglate is a chemical found in the seeds of the pink fruit of the blushwood tree. Image credit: Shutterstock/petrmalinak.

Australian biotech QBiotics has won an orphan drug designation for a drug based on a chemical obtained from the blushwood tree, which is being investigated as a treatment for a rare group of cancers called soft tissue sarcoma.

Qbiotics will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, the potential for seven years of market exclusivity for the given indication.

A veterinary formulation of the drug, tigilanol tiglate, is already approved for use in the US, UK, and Australia under the trade name Stelfonta.

QBiotics started life as EcoBiotics, which was established in 2000 to discover potential drugs from Queensland’s tropical rainforest. QBiotics itself was founded in 2004 as a subsidiary of EcoBiotics, and the two groups merged in 2017. The company has signed several biodiscovery agreements covering the rainforest areas in the country in the past decade.

The company has not disclosed how it scales tigilanol tiglate – a chemical found in the seeds of the pink fruit of the blushwood tree. Tigilanol tiglate is administered directly into a solid tumour mass by intratumoural injection.

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The drug candidate works by disrupting blood vessels keeping the tumour alive and directly killing cancer cells by oncosis. QBiotics states that tigilanol tiglate also induces tumour site healing and can even be administered systemically to induce indirect anti-tumour responses.

QBitotics’ Phase II clinical trial in soft tissue sarcoma (NCT05755113) is ongoing with ten participants estimated to be enrolled. The primary endpoint is tumour ablation.

Soft tissue sarcoma is the broad term for rare cancers that grow in soft tissues anywhere in the body. There are several targeted therapies approved to treat soft tissue sarcoma – last month, Adaptimmune applied to the FDA for approval of afami-cel. If approved, it would be the first T-cell therapy for a type of soft tissue sarcoma.

QBiotics is exploring its lead candidate as a monotherapy and in combination with MSD’s checkpoint inhibitor Keytruda (pembrolizumab) following a partnership with the company signed in 2020. A Phase I/II trial with the treatment paradigm is ongoing in advanced melanoma.

As per the company, a dose-escalation Phase I trial in 22 patients with a range of solid tumours treated with tigilanol tiglate, demonstrated a complete response of 18%. Stable disease was seen in 64% of the treatment group, and the remaining 22% demonstrated partial response.

QBiotics is conducting further clinical trials with tigilanol tiglate as a monotherapy in squamous cell carcinoma, head and neck tumours (NCT05608876), and advanced melanoma (NCT05234437).

A model by GlobalData estimates that there were just over 125,000 new cases of soft tissue sarcoma globally in 2023, with incidence growing at 0.54% per year.

GlobalData is the parent company of Pharmaceutical Technology.

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