ASX Health Stocks: Invion demonstrates efficacy, Biotron gets feedback from the FDA

Invion demonstrates high efficacy of INV043 when used as a combined therapy
Biotron gets positive feedback from US FDA
Biome stocks its Probiotics range on Priceline’s shelves

Invion demonstrates efficacy

Cancer fighter Invion (ASX:IVX) was up 7% this morning, after reporting that combining its therapy INV043 with immune checkpoint inhibitors (ICI) showed significant efficacy.

Findings from its third Proof-of-Concept (PoC) study conducted at the Hudson Institute in Victoria showed that INV043 combined with ICI resulted in approximately 65% reduction of tumour size in mice.

The study also found the combination therapy achieved clear tumour stabilisation and regression, and that tumours were significantly smaller than those in mice that received monotherapy.

These results indicate that combining INV043 with ICI could enhance clinical response in “cold” tumours (a tumour that is unlikely to trigger a strong immune response) like TNBC (triple-negative breast cancer).

Invion says that new markets could open up as a result of these findings, with new collaboration opportunities to develop IP (intellectual property) to extend the patent life of ICIs.

The global ICI market is forecast to grow at 16.8% CAGR to reach US$141 billion by 2030.

Invion share price today:

Biotron gets feedback from the FDA

Biotron (ASX:BIT) has just received guidance from the US FDA for the development of its lead antiviral drug, BIT225, a potential treatment for COVID-19 infection in adults.

The FDA’s guidance was received in response to Biotron’s pre-IND (investigational new drug) briefing and request in March.

At that time, Biotron had specific questions relating to regulatory requirements for progression to filing an IND application for the drug’s COVID-19 indication.

Biotron’s CEO, Dr Michelle Miller, said the FDA’s response has now given a clear indication of the regulator’s interest in BIT225.

“The FDA responses were constructive, highly informative, and provide direction in the design of the proposed Phase 2 clinical trial,” Miller said.

“The FDA responses also indicate that we are on the right path to the clinic. Our confidence levels for this new class of anti-SARS-Cov-2 drug remain high,” she added.

Biotron share price today:

Other notable health stock announcements

Biome Australia (ASX: BIO)

Microbiome health company, Biome, has signed a material distribution agreement with Priceline to sell Biome’s Activated Probiotics as a core range in Priceline’s 370 pharmacies across Australia.

The Priceline distribution agreement, along with practitioner channel growth, takes Biome’s distribution footprint to circa 3,000 distribution points.

This is a 20% increase since March 31, and brings the total increase in distribution points to 50% since Biome’s IPO in November last year.

Zelira Therapeutics (ASX:ZLD),

Medicinal cannabis company, Zelira, has completed the patient enrolment for its IRB (institutional review board)-approved trial to study diabetic nerve pain.

This trial will evaluate the efficacy, safety and tolerability of Zelira’s proprietary cannabis product against a multi-billion dollar ‘Big Pharma’ company drug (undisclosed).

A total of 20 patients in the investigative drug arm have now been completely enrolled, with clinical trial results expected in the second half of 2022.

Telix Pharma (ASX:TLX)

Telix’s prostate cancer imaging agent, Illuccix, has been granted Transitional Pass-Through Payment Status by the US Centers for Medicare and Medicaid Services (CMS).

From 1 July, CMS and commercial health insurers will recognise the Level II code assigned to Illuccix for reimbursement.

The approval will also enable CMS to provide separate payments for the radiopharmaceutical and the PET-CT scan, when performed with Illuccix in the hospital outpatient setting.