• LBT Innovations has secured a major deal with AstraZeneca
  • Arovella has received positive pre-IND feedback from the FDA for its ALA-101 therapy
  • Amplia has been granted key patents in Japan and Europe for narmafotinib

 

LBT announces big deal with AstraZeneca

LBT Innovations (ASX:LBT) surged by 40% this morning after announcing a significant contract with the global pharma, AstraZeneca.

The agreement involves the sale of five APAS Independence instruments to AstraZeneca, with a contract value ranging between $3.4 million and $4.1 million, depending on the maintenance and support services chosen by AstraZeneca.

The bulk of this amount will be received as the instruments are installed over the next six months.

The APAS Independence instrument is an advanced microbiology automation system designed to streamline the process of analysing culture plates used in laboratories.

In addition to the initial purchase, AstraZeneca will also receive annual maintenance and support services for seven years.

The deal follows positive results from validation studies, demonstrating the effectiveness of the APAS technology in AstraZeneca’s manufacturing processes.

LBT says this milestone opens up potential for further orders from AstraZeneca and other large pharmaceutical companies.

LBT’s strategy focuses on large multinational pharmaceutical firms, aiming to secure multiple instrument sales across their operations.

 

Arovella given encouraging feedback by FDA

Arovella Therapeutics (ASX:ALA) has received encouraging feedback from the US FDA regarding its ALA-101 therapy.

This positive response came after a pre-Investigational New Drug (pre-IND) meeting, which is a crucial step before submitting an official IND application for new drugs.

The feedback from the FDA provided clear guidance for the development of ALA-101, which is designed to treat lymphoma and leukemia.

The FDA’s review covered key aspects of Arovella’s development plans and the proposed design for the initial clinical trial.

The pre-IND meeting outcome indicates that the FDA did not suggest any major changes to the development program, which is a significant milestone for the company.

Arovella is now preparing to submit its IND application for ALA-101 in early 2025.

 

Amplia gets patents in Japan and Europe

Meanwhile, Amplia Therapeutics (ASX:ATX) has been granted a key patent for its leading drug candidate, Narmafotinib, in Europe and Japan.

The patents protect a specific chemical form of Narmafotinib, which is noted for its stability and effectiveness.

The Japanese Patent Office confirmed the patent on July 18, and the European Patent Office is set to officially grant it on August 28.

With these patents, Amplia will secure protection for narmafotinib until at least 2040 in these major markets.

Narmafotinib is designed to target Focal Adhesion Kinase (FAK). Per Amplia’s website:

“FAK inhibitors have been described as a ‘heavy punch’ to cancer, showing promising potential when used in combination with existing ‘standard of care’ therapies in the treatment of solid cancers.”

 

FDA approves Island’s amendment for Phase 2a/b study

Island Pharmaceuticals Ltd (ASX: ILA), an antiviral drug development company, is making strides with its ISLA-101 clinical trial for dengue fever.

The US FDA has approved a key protocol amendment for the Phase 2a/b study, which will now be known as the PROTECT trial, short for PROphylactic and TrEatment Challenge Trial.

This new protocol will involve both a preventative and therapeutic approach, with the trial divided into two cohorts: the prophylactic (Phase 2a) and therapeutic (Phase 2b) arms.

The PROTECT study will involve 14 participants in total.

The prophylactic cohort will have 4 subjects randomly assigned to either the active drug or placebo in a 3:1 ratio, while the therapeutic cohort will include 10 subjects with an 8:2 active-to-placebo ratio.

The total cost for the Phase 2a/b trial has been substantially reduced to approximately US$1.08 million.