ASX Health Stocks: Atomo sells more HIV Self-Tests; Actinogen begins Phase 2b trial on Alzheimer’s

Atomo announces more purchase orders for HIV Self-Tests
Actinogen says first patient was treated in Alzheimer’s disease study
Imugene has opened enrolment for expansion study in solid tumours

Atomo sells more HIV self-test kits

Atomo Diagnostics (ASX:AT1) rose 10% this morning after announcing purchase orders from Viatris Healthcare for approximately $570,000 worth of HIV Self-Tests.

These products are manufactured by Atomo under the Mylan brand for supply to several Low- and Middle-Income Countries (LMICs).

The orders are for manufacture in the coming months, and Atomo considers the revenue from these orders to be material.

“We are delighted to see Viatris, our global health partner, continues to secure orders across LMIC markets,” said Atomo’s founder and CEO, John Kelly.

“Recent growth in our global health markets mirrors anticipated growth here in Australia from emerging public health channels, and we are encouraged by the ongoing transition of diagnostic testing demand from healthcare facilities to self-test channels.”

Atomo offers the world’s first blood-based rapid diagnostic test (RDT) for HIV screening. Unlike clinical testing, the Atomo HIV Self Test provides results in just 15 minutes.

The Atomo HIV Self Test has been proven to be highly accurate, with a specificity and sensitivity level of 99.6%. The tests also allow users to comfortably carry them out in a private and discreet setting.

Today’s $570k purchase order from Viatris follows the $970k purchase order, also from Viatris, back in March.

Actinogen commences Phase 2b trial on Alzheimer’s

Actinogen Medical (ASX:ACW) also rose 10% this morning after announcing that the first patient was randomised and treated on Friday 12 April, in the XanaMIA Phase 2b clinical trial in patients with Alzheimer’s disease (AD).

The trial of 220 participants, with elevated levels of the blood biomarker pTau, measures the effects of a Xanamem 10mg daily dose versus placebo over a 36-week treatment period.

The trial has commenced at 13 Australian sites and will subsequently expand to the US.

The trial was designed to confirm that Xanamem is a safe and effective new treatment for Alzheimer’s disease. The primary endpoint is a cognitive test battery comprising seven different digital assessments.

Dr Steven Gourlay, Actinogen’s CEO and MD, said Xanamem represents a major opportunity for patients and the company.

“The clear priority for the next 18 months is to deliver high quality results from our on-going Phase 2 clinical trials in depression and Alzheimer’s disease, the first of which will report results in Q3 this year.”

Imugene opens expansion study

Meanwhile, Imugene (ASX:IMU) announced that enrolment has opened for an expansion study in the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial treating 10 bile tract cancer (cholangiocarcinoma) patients.

This follows the completion of the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing
virus, CF33-hNIS (VAXINIA).

That cohort has now been cleared with no safety signals seen to date. The cohort included patients with thymic carcinoma, triple negative breast cancer and cholangiocarcinoma.

Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs.

In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process.