2018 was the year when we really started to see data read-outs from our clinical trials for our two immune activator programs.

ONCOS showed the first signs of efficacy in combination trials with both check-point inhibitors (CPIs) and chemotherapy.
TG became the first therapeutic cancer vaccine to clinically demonstrate T-cell activation towards a driver mutation, mutant RAS, combined with a clear signal of survival benefit in resected pancreatic cancer patients.

We now look forward towards 2019 and 2020 as we continue to progress our clinical program and unlock the full potential of both of these platforms.
It has been an exciting year in which oncolytic viruses have now clearly emerged as a future cornerstone immune activator to prime solid tumors to better respond to other therapies, such as checkpoint inhibitors.

In February, Merck & Co (MSD) acquired the Australian biotech Viralytics, a company in many ways resembling Targovax. This was subsequently followed by two other significant business development transactions in the oncolytic virus space together with several major IPOs and fundraisings.

Targovax followed suit, with data from the first six patients in both our mesothelioma and CPI refractory melanoma trials showing strong immune activation and early signals of clinical benefit. Notably, in the melanoma trial, we saw one patient achieving a complete response to the combination of ONCOS-102 and Keytruda, meaning that all signs of the cancer were gone by week 9.
Complete responses are very rare in this advanced and heavily pre-treated population, and the patient is now approaching one-year duration of treatment response. These data have been recognized internationally, and generated increased attention from the industry, as well as led to invitations to present at prestigious conferences.

As a result of our own emerging data and the growing interest in the oncolytic virus field, Targovax has during 2018 enforced its focus on the ONCOS program. We do this in order to maintain momentum and retain Targovax’s position as one of the leading independent oncolytic virus biotech companies. In practical terms, this means that our core focus over the coming years will be to progress the ONCOS-102 trials with full force, as well as to document and prepare our next generation of ONCOS viruses for the clinic.

In parallel, we remain committed to continue development of our mutant RAS neoantigen vaccines TG01 and TG02. It is really challenging to induce immune responses to driver mutations such as those which occur in RAS molecules - driver mutations such as these are key to enabling cancers to grow and spread. In the 32-patient phase I/II trial in resected pancreatic cancer, TG01 showed remarkable immune activation and strong signs of clinical efficacy, both in terms of longer survival and time to recurrence. Combined with the vaccine’s low toxicity and excellent tolerability, these data have led several international collaborative groups to approach Targovax for potential trial collaboration. These discussions are advancing, and we hope to be able to communicate more details around the next TG collaboration trial in 2019.

In summary, Targovax is demonstrating success on several fronts, with two unique technology platforms, three product candidates in clinical development, three next generation oncolytic viruses in the pipeline, and five ongoing immune-oncology combination trials. We are now entering an exciting new year in which we will present additional clinical data and take the next steps in launching new trial collaborations, with the aim of opening up revolutionary immunotherapies to more patients.