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Imugene's VAXINIA Shows Sustained Complete Response in Bile Tract Cancer Patient

• A patient with bile tract cancer in Imugene's Phase 1 MAST trial maintains a complete response for over two years, highlighting the potential of VAXINIA. • The Bile Tract Cancer Expansion part of the MAST trial has cleared its first cohort with no dose-limiting toxicities, allowing for full enrollment. • Imugene has received FDA Fast Track Designation and Orphan Drug Designation for VAXINIA in treating bile tract cancer, expediting development and approval. • A US patent extension to 2040 has been granted for Imugene's CF33 oncolytic virotherapy, including VAXINIA and CHECKVacc, strengthening its market position.

Imugene Limited (ASX:IMU) has announced a significant milestone in its Phase 1 MAST trial, where a patient with bile tract cancer has maintained a complete response for over two years following treatment with VAXINIA (CF33-hNIS). This novel cancer-killing virus is being evaluated for safety and efficacy in the ongoing trial.
The company has confirmed that the Bile Tract Cancer Expansion part of the MAST trial has successfully cleared its first cohort of three patients. These patients experienced no dose-limiting toxicities (DLTs), paving the way for full enrollment of up to 10 patients in this expansion cohort.

Regulatory Milestones for VAXINIA

Imugene has received key regulatory designations from the FDA for VAXINIA. In November 2023, the FDA granted Fast Track Designation for the VAXINIA MAST clinical program in the treatment of Bile Tract Cancer. This designation facilitates closer collaboration with the FDA, potentially accelerating the program's development and approval process through avenues like accelerated approval and priority review. Furthermore, in September 2024, VAXINIA was granted Orphan Drug Designation by the FDA for the same indication.

Patent Protection Extended

Imugene has also secured a patent extension to 2040 from the US Patent and Trademark Office. This patent protects the company's oncolytic virotherapy CF33, which includes VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1), reinforcing its intellectual property position.

Management Commentary

"Imugene receiving this patent extension to 2040 from the US patent office is a significant milestone for the CF33 family of oncolytic viruses," said Leslie Chong, CEO of Imugene. "The US is the core healthcare market, and we are delighted to strengthen the patent life."
Chong added, "We're also very pleased to see the two-year milestone reached for the Bile Tract Cancer patient who has maintained a complete response in our MAST study. Most importantly this is an outstanding result for the patient given the limited treatment options available, but also demonstrates the excellent potential of the CF33 oncolytic virus for this and other cancer types. We continue to enroll into the bile tract cancer expansion of the MAST trial."
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Imugene's VAXINIA Shows Durable Complete Response in Bile Tract Cancer Patient

Imugene's VAXINIA (CF33-hNIS) demonstrates a complete response in a bile tract cancer patient for over two years in the Phase 1 MAST trial.
The Bile Tract Cancer Expansion part of the MAST trial has cleared its first cohort, showing no dose-limiting toxicities and is open for full enrollment.

Imugene's VAXINIA Shows Sustained Complete Response in Bile Tract Cancer Patient

Imugene's VAXINIA (CF33-hNIS) demonstrates a complete response in a bile tract cancer patient for over two years in the Phase 1 MAST trial, highlighting its potential efficacy.
The Bile Tract Cancer Expansion part of the MAST trial has cleared its first cohort with no dose-limiting toxicities, allowing for full enrollment of up to 10 patients.

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Reference News

[1]
Imugene: Bile Cancer Patient Maintains Full Response | Mirage News
miragenews.com · Nov 6, 2024

Imugene's Phase 1 MAST trial patient with bile tract cancer remains in complete response for over two years. The trial e...

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