Check Up: Imugene’s oncolytic virus VAXINIA granted FDA’s Fast Track, but how effective is this novel therapy?

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• Imugene surges after oncolytic virus VAXINIA was given FDA’s Fast Track designation
• But could oncolytic virus really kill cancer cells?
• The best performing ASX health stocks over the past month

The shares of Imugene (ASX:IMU) rose by as much as 30% on Tuesday after the company’s novel cancer-killing virus, CF33-hNIS (VAXINIA), was granted Fast Track designation by the US FDA.

The Fast Track was granted based on the promising data from Imugene’s Phase 1 MAST trial where low doses of VAXINIA were administered to patients suffering with bile duct cancer.

Bile duct cancer is a rare disease in which malignant (cancer) cells form in the bile ducts. This cancer is known to be difficult to treat, and typically responds poorly to drugs.

VAXINIA meanwhile is a type of oncolytic virus, and is billed as a novel form of immunotherapy to infect and destroy hard-to-treat cancer cells.

According to studies, this therapy offers a promising approach because cancer cells often have impaired antiviral defences that make them susceptible to infection.

Once the cancer cell is infected, these oncolytic viruses deliver therapeutic payloads directly to the tumours and cause the cancer cells to “burst” — killing them and releasing cancer antigens.

These antigens can then stimulate immune responses that can seek out and eliminate any remaining tumour cells nearby, and potentially anywhere else in the body.

Here’s a quick video on how oncolytic viruses work:

Also read: Imugene: We need to talk about bloody cancer, and then kill it

But are oncolytic viruses actually effective?

VAXINIA was developed by LA-based City of Hope, one of the largest cancer research organisations in the US which has exclusively granted patent rights of VAXINIA to Imugene.

So far, evidence on the effectiveness of oncolytic viruses to treat cancers is still very sparse.

However, a recent study showed that a combination of pembrolizumab, an immunotherapy drug, along with the oncolytic virus DNX-2401, was safe and could benefit select patients.

In the study, 49 patients with glioblastoma received the combination drug, and those who responded did have longer survival times. In addition, a little more than half of all study participants reached the 12-month survival checkpoint.

Despite these encouraging results, cancer treatment using oncolytic viruses still remains a niche field.

“It’s going to take a while for these things to get more respect,” said Dr Howard Kaufman, a cancer surgeon at Harvard Medical School.

Best performing ASX biotechs over the past couple of weeks

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4DX Medical (ASX:4DX)

4DMedical has been surging after announcing that its XV LVAS scanning device has been included into the US Centers for Medicare & Medicaid Services (CMS).

The inclusion today means that from 1 January 2024, XV LVAS scans conducted in a US hospital outpatient facility for Medicare patients can be billed to CMS.

CMS has accepted the reimbursement request and finalised assignment of the Category III CPT code for XV LVAS to the rate of US$299 per scan.

A few days later, the company said it has received clearance for its CT-based ventilation product, CT LVAS, from the US FDA.

The clearance will expand and broaden patient accessibility of functional lung imaging in the US, following the recent CT LVAS rollout in Australia.

4DX’s XV LVAS uses X-rays to create detailed images of lung movement and function during breathing. It gives clinicians a clearer picture of lung health for pulmonary disorders including asthma, COPD, cystic fibrosis, and even cancer.

InteliCare Holdings (ASX:ICR) 

In a major strategic leap forward, Perth-based SaaS company, InteliCare,  announced a Memorandum of Understanding (MoU) with Australia’s largest independent not-for-profit aged care provider, Bolton Clarke.

Bolton Clarke operates 88 residential aged care homes and 38 retirement villages across the country and serves more than 130,000 clients through its community care programs.

Under the MOU, InteliCare’s platform will be implemented through selected Bolton Clarke sites and services where it will be assessed and then, in collaboration with InteliCare, enhanced and tailored to meet the requirements of each environment.

A key player in the aged, disability and healthcare sectors, InteliCare’s AI-driven care platform allows carers and care providers to track activity levels, patterns of behaviour, health metrics, and sleep.

LBT Innovations (ASX:LBT)

The developer of clinical and diagnostic technology rose after announcing that Damian Lismore will retire from the board following the company’s Annual General Meeting (AGM) on Wednesday.

LBT is in advanced stages of a restructuring following a $4m cap raise.

The company’s first product, MicroStreak, was a global first in the automation of culture plate specimen processing.

The second product, the Automated Plate Assessment System (APAS Independence) uses LBT’s intelligent imaging and machine learning software to automate the imaging, analysis and interpretation of culture plates following incubation.

IDT Australia (ASX:IDT)

IDT has been rising after saying it is well placed to benefit from the rapid growth in the medicinal cannabis and psychedelic markets, given that IDT is one of the select few facilities that comply with the recently introduced GMP regulations.

During the last quarter, IDT’s potential sales pipeline also continued to grow, with the company generating 75 potential sales leads and signing confidentiality agreements with 15 potential clients.

In the quarter, the company also submitted proposals worth an additional $11.3 million, and secured sales contracts worth $1.2 million.

Neuren Pharma (ASX:NEU)

The market darling has been surging after reporting that its  Rett Syndrome drug, DAYBUE, generated net sales in Q3 of US$66.9 million, up from US$23.2 million in Q2.

The company also guided the market for net sales of DAYBUE in Q4 of between US$80 million and US$87.5 million.

Neuren reported that 800 patients used DAYBUE as at 30 September, and this surge in initial demand has exceeded pre-launch expectations.

Around 81% of patients remain on DAYBUE treatment at four months, while 80% of lives are now covered by formal reimbursement plans.

The company also reported separately that all study visits are complete in its Phase 2 clinical trial of NNZ-2591 in Phelan-McDermid syndrome (PMS).

Top-line results from the trial are expected to be available in December.

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