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Multidrug-resistant bacteria cause the deaths of more than 700,000 people annually. To combat antibiotic-resistant superbugs and prevent a projected 10 million annual deaths by 2050, Australia-based Recce Pharmaceuticals has engineered an entirely new class of antibiotics — a feat that hasn’t been achieved in 30 years.
Recce’s lead candidate, RECCE® 327, is a fast-acting, broad-spectrum antibiotic polymer that overwhelms bacteria by simultaneously interfering with numerous bacterial pathways. The result is potent bactericidal properties.
However, advancing the clinical development of RECCE® 327 requires the ability to detect and quantify the drug in vivo. This necessitates the creation of a custom monoclonal antibody that can reliably detect the RECCE® 327 polymer compound in complex biological matrices with precision.
But there was a problem. Such an antibody not only didn’t exist, but other monoclonal antibody development suppliers had failed.
Recce Pharmaceuticals Executive Director and Chief Scientific Officer, Dr. Michele Dilizia, explains that monoclonal antibody suppliers “[were] unsuccessful because they centred on traditional approaches and conventional methods.”
We sat down with Dr. Dilizia in an exclusive interview where she reveals “the qualities that allowed ProteoGenix to succeed where other suppliers failed…” Understanding these complex antibody challenges requires a deeper look into Recce Pharmaceuticals and its innovative drug pipeline.
Founded in Sydney, Australia, Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) is a biotechnology leader developing a new class of synthetic polymer-based anti-infectives to combat antibiotic-resistant superbugs.
The clinical potential of their drug pipeline isn’t going unnoticed. Global health and regulatory authorities have acknowledged RECCE® 327, RECCE® 435, and RECCE® 529 as promising candidates against critical bacterial threats, with accelerated approval pathways granted for RECCE® 327 to treat severe infections. In Australia, regulators have also authorized its limited use by healthcare providers under specific conditions.
This innovative class of synthetic polymers targets bacterial membranes and disrupts essential cellular processes, rapidly eliminating bacteria across all growth phases. By attacking multiple sites simultaneously, these compounds significantly reduce the likelihood of drug resistance, offering a powerful approach to combating superbugs.
However, developing a unique monoclonal antibody to detect RECCE® 327, a polymer consisting of repeating small molecules, was a barrier that Recce Pharmaceuticals historically struggled to overcome. Here is why.
RECCE® 327 is “a complex synthetic polymer comprising a mixture of some hundreds of various copolymer compounds,” explains Dr. Dilizia. What’s more, the synthetic polymer is within “a matrix that has similar chemical groups and moieties.”
Therefore, custom antibodies needed to recognize unique epitopes on RECCE® 327 without binding to a common chemical element shared across the polymer’s matrix—a challenge complicated by the molecule’s size and chemical similarity to its surroundings.
Dr. Dilizia recalls, “The approach and its methodologies [from former suppliers] were not suitable for providing antibodies for our test article.”
The result? The delivered custom antibodies inadvertently targeted the common element, rendering them useless for Recce’s pharmacokinetic studies. Recce’s in-house efforts were also impractical due to the project’s technical complexity. “We needed custom monoclonal antibody services that could deliver highly specific antibodies and tailored assays,” Dr. Dilizia recalls.
This set the stage for ProteoGenix to overcome this critical roadblock.
After unsuccessful attempts with other vendors, Recce turned to ProteoGenix for their proven expertise in complex antibody projects.
“The key benefit of partnering with ProteoGenix was being able to hold scientific discussions with their expert team to explore the overall approach and methods, versus the ‘one size fits all’ approach offered by other providers,”
Unlike suppliers offering generic workflows, ProteoGenix provided a tailored strategy to address the unique challenges of RECCE® 327.
This collaborative approach made ProteoGenix an extension of Recce’s team, fully aligned with their scientific and regulatory objectives.
To meet Recce’s challenge, ProteoGenix deployed a sophisticated hybridoma-based strategy. “Developing antibodies that only recognized RECCE® 327’s unique epitopes required extreme specificity,” Dr. Dilizia notes. The complexity of the small-molecule polymer, coupled with a common chemical element in its matrix, demanded innovative methods.
ProteoGenix developed an innovative solution. They created a hapten by conjugating RECCE® 327 to a protein, creating an immunogenic antigen. This was a critical step given the small molecule’s limited epitope size.
They then implemented a multi-step process that included:
ProteoGenix’s custom monoclonal antibody development solution, backed by scientific expertise, was pivotal to overcoming the challenge.
ProteoGenix delivered six murine IgG hybridomas with exceptional specificity for RECCE® 327, detecting the antibacterial compound without cross-reacting with its common chemical element.
These antibodies enabled Recce to develop robust pharmacokinetic assays, essential for drug development and regulatory approval.
“An indication of [the delivered antibodies] great value can be obtained when considering the critical role of antibodies to assess a drug’s pharmacokinetic parameters – eg, Absorption, Distribution, Metabolism and Excretion,” — Dr. Dilizia
With these tools, Recce was able to:
“This pharmacokinetic milestone brought RECCE® 327 one step closer to market entry,” explains Dr. Dilizia. “It reinforced our scientific credibility and provided the data required for regulatory clearance.”
Reflecting on the collaboration, Dr. Dilizia highlights ProteoGenix’s scientific partnership.
“The key benefit of partnering with ProteoGenix was being able to hold scientific discussions with their expert team to explore the overall approach and methods, versus the ‘one size fits all’ approach offered by other providers.”
The partnership has lasting value:
“I would highly recommend the services of ProteoGenix to other researchers,” — Dr. Dilizia
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