Race Oncology Ltd (ASX:RAC) has expanded its potential market with the development of an improved and novel formulation for its cancer drug Zantrene®, which enables peripheral intravenous (IV) delivery.
This improved formulation developed in collaboration with the University of Wollongong provides clinicians with an easier-to-use alternative to the current central line formulation of Zantrene and is particularly well suited to solid tumour patients.
Race has signed a contract with Societal CDMO Inc to produce the new RC220 IV formulation to the FDA's current Good Manufacturing Practice (cGMP) standard that is required for use in clinical trials.
This new Zantrene IV formulation provides Race with additional IP patent protection for Zantrene, valid until 2043.
Investors have recognised the significance of the development, pushing shares as much as 6.25% higher this morning to A$2.04.
“Major advance”
RAC CSO Dr Daniel Tillett said: “The development of the RC220 IV formulation is a major advance for Race.
“The chemical properties of Zantrene make developing a peripheral formulation highly complex and challenging.
“I am extremely proud of the Race team and our collaborators in developing the new RC220 formulation and believe this is a pivotal step in bringing the promise of Zantrene to clinical and commercial reality.”
Clinical significance
Administration of Zantrene has until now required the use of an invasive central venous catheter (central line) that must be performed in a hospital setting.
Peripheral IV administration can provide a better quality of life for patients with less pain and lifestyle disruption as it enables patients to be treated outside of a major hospital or within their own homes.
Peripheral IV infusion in an outpatient setting is often preferred by both the patient and the treating oncologist.
RAC CMO Dr David Fuller said: “The availability of a peripherally administered formulation of Zantrene is a major step forward and will allow Race to more effectively explore multiple opportunities in the solid tumour and cardioprotection space.”
Commercial significance
Peripheral IV formulations have a significant commercial advantage, as central line administration requires highly skilled healthcare personnel, and simpler peripheral IV formulations are attractive in resource-constrained healthcare environments.
An additional commercial benefit of the new peripheral IV formulation is the ability to deliver Zantrene more rapidly to the patient, minimising occupancy of expensive oncology infusion chairs and providing the patient with a better treatment experience.
A more immediate impact of the RC220 IV formulation is improved patient recruitment potential for future clinical trials. Only a minority of solid tumour patients are willing to participate in clinical trials that require central line infusions.
In a competitive oncology trial environment where the patient has many suitable trials to choose between, comfort and quality of life are important non-clinical factors that strongly influence the patient's choice of trial enrolment.
Forward plan
The final RC220 drug product is expected to be delivered by the end of the June quarter of 2023 at a contracted cost of US$611,900.
Prior to that, a new international patent will be submitted in the early June quarter of 2023.
Delaying patent submission for as long as possible maximises the effective on-patent life of RC220 and hence its future commercial value.
Collaborative activities are continuing at the University of Wollongong and other sites to develop additional formulations of Zantrene that can be delivered orally and/or less frequently (ie longer acting formulations).