Health Check: Imugene goes to the well after reporting more blood cancer ‘cures'

News.com.au

6 days ago

Imugene reports two more 'complete responders' in its cell therapy trial
Clever Culture Systems shares surge 17% on deal with Big Pharma Novo Nordisk
Compumedics shares vault 24% after full-year update
Imugene (ASX:IMU) will forge ahead with a planned pivotal US trial for its blood cancer therapy Azer-cel, having recorded more 'complete responses' in its phase 1b study.
There's also the matter of cash, with Imugene shares this morning entering trading halt amidst a capital raising reportedly targeting $35 million.
The trial is testing the company's CD-19 Car-T therapy on patients with relapsed diffuse large B-cell lymphoma.
This is an especially aggressive blood cancer and these patients have failed multiple therapies.
The company reports that of five further patients evaluated, two showed a 'complete response'.
A complete response is the disappearance of all cancer signs – a.k.a. a cure.
A further five showed a 'partial response' – at least a 50% cancer cell reduction.
This takes the total number of complete responses to six and partial responses to three, out of 12 patients.
The effect has endured for at least 60 days, with the first patient treated remaining cancer free at the 15-month mark.
'Allo 'allo, we're on to something
If approved, Azer-cel would be the first off-the-shelf Car-T therapy using donor cells rather than the patients' own material.
This is the allogeneic (allo), as opposed to autologous, method.
Car-T therapies involve taking T-cells out of blood and tricking them up with agents that bolster their cancer-busting abilities.
They are then re-introduced into the bloodstream.
The re-engineered cells pursue a target, in this case the CD-19 protein expressed by blood cancers.
Next stop: FDA
The ongoing study is being carried out at 13 US sites and the first of five planned local sites. The company in February treated the first Australian participant, at Sydney's Royal Prince Alfred Hospital.
The subjects were dosed with Azercel, combined alongside chemotherapy and the immunity agent interleukin 2.
Imugene plans to meet with the US Food & Drug Administration (FDA) in the December quarter, to discuss a pivotal registration study.
As of the end of March, Imugene held cash of $36 million.
Drug development is hideously expensive and the last raising is never the final one, and what better time to go to the well than after positive clinical results?
Imugene raised $53 million in 2023 and $80 million in 2020 and this year entered into a $20 million convertible note issue.
Imugene shares have lost 68% year to date, adjusting for a share consolidation that reduced its 7.46 billion shares on issue to a more respectable 219 million.
Clever Culture bulks up with fat-busting drug maker
Clever Culture Systems (ASX:CC5) has signed up Big Pharma Novo Nordisk for one of its automated agar plate reading devices to monitor ultra-clean drug making facilities.
The maker of the weight loss and diabetes drugs Ozempic and Wegovy, Novo Nordisk will acquire and appraise one of Clever Culture's AI-enabled device APAS Independence units, in view of a full global rollout across its facilities.
The AI-enabled APAS Independence devices automatically read the hundreds of agar plates required to ensure that pathogens don't enter aseptic facilities.
The units can manage 200 plates per hour, freeing up microbiologists to focus on the minority of plates that read positive.
To date Clever Culture has focused on 90 millimetre 'settle' plates that are left open, to absorb any nasties in the room.
A tweaked APAS also will read 55mm 'contact' plates, which are dabbed on surfaces, such as a gown or gloved fingertips.
Nova Nordisk will assess both settle and contact plate modules.
Courting Big Pharma
Clever Culture CEO Brent Barnes says the 'milestone' deal aligns with the company's focus on the big drug makers, most of which have centres to appraise new products.
To date Clever Culture also sold the devices to Astrazeneca, Bristol Myers Squibb and Thermo Fisher Pharma Services, while a fifth drug maker recently completed a 'successful evaluation'.
The five drug makers on the books represent a sales opportunity of between 60 to 80 units.
At last count the company had 13 APAS devices in the field, with foundation client Astrazeneca accounting for nine of them.
The company cites a 'pipeline' of 40 customers, representing upfront revenue of about $75 million and $15 million of recurring revenue.
The APAS unit sells for US$350,000, but Clever Culture then derives ongoing income from an annual software licence of US$30,000 (rising to US$50,000 with the contact plate modality).
There's also an annual hardware maintenance fee of $US15,000-25,000.
The FDA approved APAS Independence in May 2019 and European regulators followed suit in September 2021.
There's no snoozing at Compumedics
Sleep and neurological testing house Compumedics (ASX:CMP) has reported record revenue of $51 million for the year to June 2025, up 4%.
What's more, the company has returned to profitability, with underlying earnings of $3 million.
Compumedics also reports record sales orders of $63.4 million, up 22%. The key driving force was the growth of the US sleep diagnostics arm, up 39% to $53 million.
The company also affirmed current year guidance of revenue of at least $70 million and underlying earnings of around $9 million.
'This result reflects the step-change underway at Compumedics,' founder and executive chairman Dr David Burton says.
"We are building a more predictable, higher-margin business model and seeing consistent revenue growth, expanding margins and meaningful traction in the US."
Proteomics ain't horsing around
In time for the spring racing season, Proteomics International Laboratories (ASX:PIQ) says its oxidative stress test Oxidx can detect muscle damage in thoroughbreds.
As published in the peer-reviewed journal Veterinary Medicine and Science, the 'groundbreaking' results show Oxidx can identify and assess recovery from exercise-induced damage.
The study was based on 34 nags.
The company says up to 85% of thoroughbreds sustain at least one injury during their racing seasons, potentially because of undetected muscle injuries.
'Oxidative stress has been implicated in many disease and injury states, with levels often reflective of a person or animal's health condition.'
Via its 66% owned OxiDx Pty Ltd, Proteomics plans to launch Oxidx locally in the current half.
Proteomics has a commercialised diabetic kidney disease diagnosis and plans to launch an endometriosis assay locally in the current quarter.
No pay, no worries says Pacific Edge
Pacific Edge (ASX:PEB) reports resilient demand for its bladder cancer diagnostic in the US, despite authorities withdrawing reimbursement coverage.
The Kiwi-based company said US June quarter test volumes declined 12% to 5717, relative to the March quarter.
Asia Pacific volumes – including those derived here – rose 8.8% to 1183.
The company attributed the decline mainly to customers moving to its Cxbladder Triage product, from the discontinued Cxbladder Detect.
Cxbladder Triage tests accounted for 77% of total US assays, up from 22% in the March quarter.
Pacific Edge also said it had held positive discussions with Novitas, its US Medicare gatekeeper, about reinstating coverage.
This was 'based on evidence not considered in the review that led to the non-coverage decision.'