ASX Health Stocks: AFT Pharma jumps 13pc on FDA submission, Imugene up 10pc on CAR-T progress

The ASX 200 Health Index (XHJ) is up by 1.30% at the time of writing, compared to the broader index which is higher by 0.5%.

The US FDA has accepted the New Drug Application (NDA) for Maxigesic IV, AFT Pharma’s (ASX:AFP) intravenous form of its patented pain relief medicine which was filed in August this year.

The filing was based on positive data from two Phase 3 studies of Maxigesic IV this year, which demonstrated that treatment with Maxigesic IV was tolerated better compared to ibuprofen or paracetamol alone.

The studies were done on 276 patients following bunionectomy surgery, and 232 patients undergoing general, orthopaedic, or plastic surgery.

Maxigesic IV is already licensed to UK-based Hikma Pharmaceuticals, and the FDA filing today has triggered milestone payments for AFP to the tune of US$3.6 million, which will be realised in the first half.

In total, the licensing agreement with Hikma will see AFT benefit from upfront, regulatory and commercial milestone payments of up to US$18 million, and a profit share from product sales.

“The NDA acceptance marks an important milestone for our company,” declared AFT CEO, Dr Hartley Atkinson.

“It is a major step towards bringing much needed innovation in non-opioid, post-operative pain management and addressing the current opioid crisis, which is responsible for many deaths in the US each year.”

AFT Pharma share price today:

Other ASX health stocks with notable announcements

Immuno-oncology specialist, Imugene (ASX:IMU), surged 10% today following its announced collaboration with another immuno-oncology company, Eureka Therapeutics.

The collaboration will evaluate Eureka’s anti-CD19 ARTEMIS T-cell therapy in combination with Imugene’s CD19-expressing oncolytic virus for the treatment of solid tumours.

In preclinical studies conducted by the City of Hope Comprehensive Cancer Center, scientists successfully combined CAR-T therapy with an oncolytic virus to eliminate solid tumours in mice.

T-cell and CAR-T therapies have so far not achieved much success in solid tumours, in part because of a lack of tumour-specific targets.

But studies demonstrated that the virus could enter the tumour cells and force them to express the CD19 protein on the cell surface, presenting a target for anti-CD19 T-cells to pursue and kill.

“By combining oncolytic virus and CAR T-cell therapies, we have developed a ‘mark and kill’ approach to treating solid tumours with T-cell therapies,” explained Saul Priceman, assistant professor at City of Hope.

Medtech Next Science (ASX:NXS) signed a multi-year distribution agreement with NASDAQ-listed TELA Bio to supply a white labelled version of NXS’ proprietary XPERIENCE No Rinse Antimicrobial Solution.

XPERIENCE is a no-rinse solution designed to help prevent surgical site and post-operative infections by rinsing away debris and microorganisms.

The 10-year deal grants TELA exclusive rights across the US plastic reconstructive surgery market for the sale and marketing of the white-labelled version of XPERIENCE.

Meawnwhile, a couple of capital raisings were announced today, with Patrys (ASX:PAB) announcing a $7.8m raise and Hexima (ASX:HXL) a $10m institutional placement.