• Amplia’s pancreatic cancer drug shows progress
  • Universal Biosensors wins a new $450,000 tender in Italy
  • HitIQ secures a second US patent for mouthguard technology


 

Big progress for Amplia’s pancreatic cancer drug

Amplia Therapeutics (ASX:ATX) jumped 11% this morning after the company provided an update on its ACCENT trial for advanced pancreatic cancer.

The trial, which tests a drug called narmafotinib combined with standard chemotherapy, has just hit a major milestone.

Recently, a fifth patient in the trial showed a confirmed partial response, meaning their tumour size decreased by at least 30% and remained stable over two months, with no new tumours appearing.

The trial started with 26 patients, and the goal was to see at least six of them achieve this level of tumour reduction before expanding to a second group of 24 patients.

With five patients now meeting this target, only one more confirmed response is needed to proceed with the next phase of recruitment.

So far, the trial has observed a 38% response rate among the patients who were evaluated at the four-month mark.

Narmafotinib, Amplia’s leading drug, is a targeted therapy designed to inhibit a protein called FAK, which is often over-expressed in pancreatic cancer.

 


UBI secures tender for Xprecia Prime in Italy

Universal Biosensors (ASX:UBI) also jumped 7% this morning after revealing that its distribution partner in Italy has won another tender for Xprecia Prime.

The new contract involves supplying two Health Authorities in northern Italy with over 45,000 test strips and 53 Xprecia Prime devices annually for the next three years.

The deal is worth more than $450,000, and is the second tender win for Xprecia Prime in Italy within the past few months.

The Xprecia Prime is a compact device for monitoring blood coagulation.

It provides quick, accurate results for prothrombin time (PT) and International Normalised Ratio (INR), helping doctors manage patients’ vitamin K antagonist dosages to prevent dangerous bleeding or clotting issues.

 

HitIQ secures second US patent for mouthguard technology

HitIQ (ASX:HIQ), a company specialising in concussion-management technology, has just received approval for the second US patent for its Nexus technology.

This new patent is for a flexible design feature that allows the company’s instrumented mouthguards to fit various shapes and sizes, whether for custom, 3D-formed mouthguards or more generic ones.

The innovation ensures that HIQ’s mouthguard technology can be adapted to fit all users comfortably, from professional athletes to everyday sports enthusiasts.

HITIQ CEO Mike Vegar explained that the company’s patent strategy aims to move instrumented mouthguard technology from research tools to widely used commercial devices.

“This IP goes a long way to ensuring functionality, comfort and manufacturing efficiency across all of the targeted product markets,” said Vegar.

 

Clinuvel modifies trial protocol to improve participation

Meanwhile, Clinuvel Pharma (ASX:CUV) has made some important updates to its vitiligo study involving lead drug Scenesse.

Vitiligo is a disease that causes loss of skin color in patches.

Clinuvel’s Phase III trial, dubbed CUV105, is investigating how well Scenesse works with narrowband ultraviolet B (NB-UVB) therapy compared to NB-UVB alone.

Responding to feedback from clinicians, the company has decided to make several changes.

Now, patients who start with NB-UVB alone will eventually have the option to receive Scenesse treatment, which may encourage them to stay in the study. This change aims to improve patient motivation and retention.

Additionally, the criteria for joining the study have been relaxed. Patients with vitiligo lesions on visible areas like the face, scalp, and neck can now be included. This broadens the scope of the study.

The updated protocol also extends the recruitment period, and Clinuvel now expects to enrol the final patients by June 30, 2025.

The core goals of the study, which include assessing how well the combination therapy repigments the skin, remain the same.