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Health & Biotech
Having commercialised its prostate cancer imaging tool with resulting strong revenue, Telix Pharmaceuticals (ASX:TLX) could have its second key product on market in 2025.
To enable this Telix has filed a biologics licensing application with the US Food & Drug Administration (FDA) for its kidney cancer imaging agent TLX250-CDx (Zircaix).
Based on positron emission tomography (PET), Zircaix is intended to assist in the non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.
“If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the US, further building on Telix’s successful urology imaging franchise,” the company says.
Under the FDA’s protocols, the agency will advise of the decision date following a standard 60-day administrative review of the application.
Given Zircaix has FDA breakthrough designation, it is eligible for fast-track review.
“Telix continues to target a full US commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC,’ says Telix CEO for precision medicine Kevin Richardson.
The application follows the results of the company’s pivotal phase III trial, Zircon, which reported an 86% sensitivity and 87% specificity across 284 evaluable patients.
Sensitivity is the ability to detect the disease, while specificity is the ability to rule out false positives.
A further appraisal from three independent radiologists showed a high “predictive value” of 93%.
“Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation,” the company says.
Telix’s prostate cancer imaging agent gallium-68 (68Ga) – Illucix – was approved by the FDA in December 2021.
It also has the nod from the Australian Therapeutic Goods Administration (TGA) and Health Canada.
IIlucix generated $364 million of revenue in the June 2024 half, up 65% year -on-year and a net profit of $29.7 million (compared with a previous $14.3 million loss).
Meanwhile, Telix has awarded CEO Chris Behrenbruch a 68% increase in his base annual salary, to $799,092 with a total package (including super and other benefits) of $892,985.
The short-term variable reward goes from $152,208 to $879,001 with the long-term reward increased from $237,825 to $1.198 million.
The pay jump sounds like quite a kick-up – and indeed it is.
But few investors will be complaining given Telix shares have climbed almost 150% this year.
Behrenbruch also owns around 7% of the company, worth $580 million at today’s price of $24.43 (down 2%).
Turning to other kidney news, Dimerix (ASX:DXB) has completed patient recruitment for the first stage of its phase III trial, aimed at winning approval for its kidney drug candidate DMX-200.
Dimerix said the 144th patient had been recruited and dosed for its trial dubbed Action 3, which tackles the rare kidney disease focal segmental glomerulosclerosis (FSGS).
The company expects full study recruitment of 286 adult patients in the September quarter.
After a medication stabilisation period, the 144 candidates will be put randomly on either on DMX-200 or placebo.
The trial custodians will collect the patient data after 35 weeks’ treatment – in August 2025 – with interim analysis results expected “shortly thereafter”.
The results are blinded, which means the company, clinicians and patients do not know which patients are on the active treatment and which ones are on the sham.
The company says DMX-200 is the most advanced FSGS asset in a phase III trial globally “and is attracting strong interest from potential commercial partners”.
The compound has orphan drug designation, which opens the way for potential fast-track commercialisation and approval.
To date, 14 patients have completed the full two-year treatment and have elected to remain on an additional two-year open label (unblinded) extension study.
This means they get the active treatment and not a placebo.
Dimerix shares rose 3% to 34 cents.
Diagnosis house Proteomics International Laboratories (ASX:PIQ) says its Promarkerendo blood test can pinpoint the hard-to-detect women’s disease endometriosis with high accuracy.
Endometriosis occurs when tissue similar to the lining of the uterus grows outside of it. A chronic condition affecting millions of women worldwide, it often takes an average of seven years to diagnose.
The disease currently is diagnosed by way of a laparoscopy followed by histopathology, by which a camera is inserted into the pelvis through a small cut in the abdominal wall to obtain a biopsy.
The company points to a write-up in the esteemed journal Human Reproduction, such peer-reviewed publications being the standard way to validate clinical results.
As outlined in the tome, the company collaborated with the Royal Women’s Hospital and the University of Melbourne to analyse plasma samples from 805 participants, across two independent clinical populations.
Three diagnostics were developed with the best one distinguishing severe endometriosis from control samples with “near perfect accuracy”.
Proteomics CEO Dr Richard Lipscombe said the results were a “significant step towards non-invasive, personalised care for a condition that has long been underserved by current medical approaches.”
The company is pursuing “multiple avenues” to bring its test to market, with an initial targeted launch date in Australia in the June 2025 quarter.
Proteomics shares bounded 20% to 73 cents.
Health & Biotech
Health & Biotech
Health & Biotech
