The increased occurrence of antibiotic-resistant pathogens is a critical concern corresponding to economic and societal challenges of high priority. Antimicrobial resistance (AMR) is responsible for 33,000 deaths per year, while bringing €1.5 billion per year in healthcare costs and productivity losses to the EU. Current solutions (biopharmaceuticals) are highly expensive and very few tackle the AMR scenario. Therefore, new approaches to tackle AMR focusing on low cost and relatively low time-to-market therapeutics must be pursued. Immunoglobulin Y (IgY) present in hen’s egg yolk is a potential alternative to the previously described biotherapeutics and can be obtained in higher amounts from a renewable and non-invasive matrix. However, given the complex nature of egg yolk, the current purification technologies are multi-step and mainly based on chromatography, being highly expensive and leading to low yields.
In the previously funded ERC Starting Grant (IgYPurTech) an alternative cost-effective process to purify IgY was developed. This process is based on two steps of induced precipitation with appropriate biopolymers. This innovative purification platform enables to produce high-quality IgY in higher amounts and at a significantly lower cost than other currently commercialized biotherapeutics. During this PoC Action – PureIgY – the developed purification process was scaled-up, chickens were immunized with a target antigen and specific anti-MRSA IgY antibodies were purified from hyperimmune eggs, obtaining specific IgY antibodies with a purity >98% and yield >80%. Furthermore, it was proved that purified anti-MRSA IgY antibodies are able to recognize the antigen, thus confirming their biological activity and possible therapeutic efficacy. The cytotoxicity of the purified IgY was appraised towards several human cell lines, demonstrating that IgY antibodies are non-cytotoxic.
Given the high potential of use of low-cost and high-purity IgY antibodies, RYA Purification Technologies (RYAPURTECH), an early-stage drug development start-up, was created during the PureIgY framework. RYAPURTECH aims to develop a portfolio of passive immunotherapies based on immunoglobulin Y (IgY) for the prophylaxis and treatment of infections caused by antimicrobial resistant (AMR) pathogens. Two business plans for two distinct products were developed: one regarding a more generic use of IgY antibodies to tackle MRSA infections and the other regarding IgY antibodies to tackle osteomyelitis, a rare disease caused by MRSA. Furthermore, the provisional patent PT115028 and PT115031 were converted into PCT applications (WO/2020/058937, WO/2020/058936). The Portuguese patent was granted (PT115028B) and the PCT applications were converted into European (EP3854814.4A EP19801094.4A) USA (US171268.854) and Japan (JP2021515542A) patent applications.
The outcomes of this PoC Action are a major step in contributing to strong economic benefits by decreasing the costs associated to the treatment of AMR bacterial infections and to reduce the time patients are hospitalized, while enhancing human health and decreasing the rate of mortality by severe infections. Furthermore, the creation of RYAPURTECH as an early-stage drug development spin-off will contribute to the creation of scientific employment and to improve the position of Europe in the biopharmaceuticals market.
