Clinical-stage immuno-oncology company Imugene (ASX: IMU) is celebrating more than two years’ “complete response” for one of its bile tract cancer trial therapy subjects in its CF33 MAST VAXINIA study.
The outcome validates a January conclusion regarding the subject who had then passed the 430 day CR response marker for Imugene’s MAST trial therapy to treat Metastatic Advanced Solid Tumours.
The company had said in January that its Phase-1 study trials had indicated “positive early signals” from 38 heavily pre-treated patients who has been dosed with the company’s novel oncolytic virotherapy CF33-hNIS (VAXINIA).
The MAST trials involve delivering the oncolytic virus by one of two pathways, either as a monotherapy or in combination with checkpoint inhibitors and is currently in the dose-escalation phase.
In light of the latest milestone, the cohort review committee has cleared the first cohort of three trial subjects who were evaluated for safety and freedom from dose-limiting toxicities, thus clearing the way for expansion of the bile tract cancer VAXINIA trial, with enrolments now being available for up to 10 new patients.
In November last year, Imugene announced that its MAST clinical program to evaluate the safety and efficacy of CF33-hNIS (VAXINIA) had been granted Fast Track designation from the US Food and Drug Administration (FDA).
The Fast Track designation involves increased opportunity for liaison with the FDA, which include rolling and accelerated reviews and approval priorities. The company now intends to press its foot down towards the speedy development and review of drugs which treat serious conditions and can often lead to earlier drug approvals, and most importantly, patient access.
More recently, in September Imugene received “Orphan Drug Designation” (ODD) from the FDA for the company’s CF33-hNIS (VAXINIA) virotherapy for treating cholangiocarcinoma, a rare and aggressive form of bile tract cancer.
The ODD status is intended to accommodate and promote development of drugs for rare diseases - which typically have reduced overall market demand but nonetheless still meet urgent needs - despite affecting fewer than 200,000 people in the US.
The designation can clear a path towards a number of additional incentives including tax credits, potential access to grant funds and administrative fees waivers. Significantly, there is also the lucrative prospect of receiving seven years of market exclusivity.
In other important news - and a reflection of the company’s revolutionary science in the sphere of oncolytic therapy - the US Patent and Trademark Office (USPTO) has granted extension to 2040 for Imugene’s patent application 16/324,541.
The protection applies to the method of composition and method of use of CF33 VAXINIA which is the core of Imugene’s oncolytic virotherapy CF33 and includes VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1).
The extension stretches protection coverage from the year 2037 out to 2040.
Imugene receiving this patent extension to 2040 from the US patent office is a significant milestone for the CF33 family of oncolytic viruses. The US is the core healthcare market, and we are delighted to strengthen the patent life. 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 and most importantly, this is an outstanding result for the patient given the limited treatment options available and demonstrates the excellent potential of the CF33 oncolytic virus for this and other cancer types.
Imugene’s CEO, Leslie Chong
The multicentre Phase 1 MAST trial began by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours and who have had at least two prior lines of standard of care treatment.
The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in pre-clinical laboratory and animal models.
Overall, the study aims to recruit cancer patients across about 10 trial sites in the United States and Australia and now, in view of the safety clearance, Imugene continues to enrol into the bile tract cancer expansion of the MAST trial.
If ever there was a “heaven-sent opportunity” for some people living with certain cancers, the results from these ground-breaking trials could be the making of it.
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