Personalised cancer vaccines are now a possibility thanks to major improvements in genomic sequencing. This technique has given scientists a clearer understanding of cancer-specific mutations, opening up potentially more targets for treatment. “This possibility did not exist even 10 years ago when we were only able to deal with one single target at a time,” explains TK-NEO project coordinator Fabio Palombo, chief scientific officer at Neomatrix, a spin-off of Italian research firm Takis. “We now know that some tumours like melanoma may have up to 1 000 mutations, which could be targets for a personalised cancer vaccine.” Previous work carried out by Takis demonstrated that a personalised cancer vaccine was effective in preclinical animal models. In pre-clinical studies, human lung cancer in a humanised mouse model was eliminated within 60 days of treatment. The vaccine – TK-NEO – is targeted for use as a therapeutic vaccination in patients with locally advanced or metastatic solid tumours. This builds on recent improvements in cancer therapy, which came with the discovery that releasing the brakes of immune responses, the so-called immune checkpoint inhibitors, can impact the tumour. “We reasoned that we could stimulate more comprehensive and robust responses with a personalised cancer vaccine,” says Palombo. The method for producing this patient-specific DNA-based cancer vaccine was secured by patent and shared in scientific literature. The challenge now is translating the success of these preclinical animal models to the clinic. “This is not straightforward, and requires an investment of millions of euro,” adds Palombo.
Moving to clinical trials
The 6-month TK-NEO project sought to prepare the groundwork for this next step. This was achieved by assessing the feasibility of carrying out future tests, and determining the cost of further clinical development and eventual commercialisation. “Funding allowed us to develop a viable business plan,” notes Palombo. This was a complex process given the challenges facing Takis. “The paradox is that while pharmaceutical production often needs to be scaled up to be economically viable, we need to produce different drugs for different patients on a smaller scale,” says Palombo. “We addressed this issue by designing new infrastructure, ensuring that the process can be profitable.” The project also helped the team to identify and tackle additional scientific and technical challenges. “Our current efforts are devoted to discussions with regulatory agencies on the safety requirements for entering the clinic,” he adds. “We have also addressed the technical issues related to the feasibility of pharmaceutical production.”
TK-NEO is in line with a general trend towards personalised medicine, which includes cancer treatments. One notable immunotherapy approach is CAR-T, where a patient’s T cells, a type of immune system cell, are changed in the laboratory so they will attack cancer cells. “This was initially developed in an academic lab and then industrialised by big pharmaceutical companies,” explains Palombo. “Further advances in genomic sequencing and bioinformatic science mean that we are confident about our chances of developing a new therapeutic approach.” The firm’s strategy, moving forward, is to license the Intellectual Property of TK-NEO to a large pharma company, after completion of clinical validation trials. These trials will demonstrate the applicability and safety of the firm’s approach.
TK-NEO, cancer, melanoma, pharmaceutical, immunotherapy, medicine, vaccine, preclinical