Opal Biosciences is an Australian biotechnology company and an innovative player in infectious disease treatment. Opal is currently seeking to diversify its focus by considering commercial opportunities within the Australian biotechnology and pharmaceutical industry. Opal’s strategic focus is now directed towards growing Australia’s vaccine and pharmaceutical manufacturing capability which has become evident as a sovereign need during the recent pandemic
The 2020-2021 year saw significant change in the emphasis of the Company towards the opportunities in manufacturing in Australia.
The COVID-19 pandemic aggravated the supply chain problems already faced by small Australian life sciences companies and raised the awareness for more capability to develop and manufacture medicines and vaccines on our shores.
During the year work progressed on BDM-I development however the solubility restrictions of the molecule delayed progress. While there is still a high unmet need for new infection treatments, the commercial model is unattractive and capital raising for such a portfolio is challenging.
In February 2021 the large GSK-owned Victorian manufacturing plant at Boronia was listed for sale. Opal lodged an Expression of Interest (EOI) in March 2021 to retain the site for pharmaceutical manufacturing and to retain its skilled workforce following GSK’s exit in 2022/23. The EOI was supported by many letters from Australian industry specialists, companies and groups, to convert the site to a life sciences precinct, where small and mid-sized companies and academic institutions and medical research institutes could congregate to facilitate the development and manufacture of their pharmaceutical and vaccine products.
The EOI was followed by presentations by Opal to the federal Department of Industry, federal Department of Health, and Victorian government, both to raise awareness of the site sale and consequent potential loss of the manufacturing capabilities and skilled workforce of the site.
Once Charter Hall was announced as the successful buyer of the site, Opal submitted a new EOI with more letters of support and introduced potential site tenants to demonstrate the demand for facilities and the potential of the life sciences precinct concept.
Subsequent to year end, the precinct concept is being investigated through a feasibility study. Opal is developing a business plan directed to achieve the investment required to transition onto its nominated portion of the Boronia site, should the precinct proceed.
As an important part of our strategy change to expand into manufacturing the acquisition of Formulytica Pty Ltd was to be a first step. This was announced in May 2021 together with a capital raise under an Information Memorandum. The IM was subsequently withdrawn and all funds were returned to Applicants. The engagement with the new GSK site owners at Boronia coincided with the capital raise, and due to the latter’s priority, and the absence of reference to the Boronia site in the IM, all funds raised were returned to applicants.
The main activities in the antimicrobial program during the year were studies in the development of the molecule, BDM-I as a human therapeutic.
A key mouse study provided information relating blood and tissue levels to a wide range dosages of BDM-I (including repeat dosing) showing no adverse effects. The studies conducted showed that blood and tissue concentrations were insufficient in the animal model used. This was due to the poor solubility of the BDM-I compound and its high plasma protein binding, directing next efforts towards investigation of the water soluble compounds.
Glycosylated derivatives of BDM-I have been synthesized by the CSIRO Manufacturing Unit, Clayton, Victoria. The molecules were designed to retain the antimicrobial activity of BDM-I but be more water soluble and hence easier to formulate into drug products. Potentially these could also have better absorption and achieve higher serum concentrations. It is anticipated that these new molecules will be screened for activity against Neisseria gonorrhoea in the Australian Research Council (ARC) Research Hub to Combat Antimicrobial Resistance and other pathogens in the coming months. The Hub commencement was delayed by COVID-19.
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