Could you introduce Virostatics?

In the last 15 years, we have worked on developing small molecule compounds with unique activity and safety profiles that respond to unmet needs – in oncology, we typically look at aggressive cancers without a cure or with limited treatment availability; in virology, we also target viruses with high unmet needs or new viruses, including the Corona virus.

How do you split your focus between the two fields – virology and oncology?

Virostatics’ legacy comes from HIV/AIDS, where we induced the first case of functional cure – the well-known “Berlin” patient. However, the AIDS market became crowded, so we developed greater expertise in oncology over the years. When the Covid pandemic hit, however, we re-established our virology lab; here, we developed unique expertise in providing testing services for third parties who wish to do in-vitro testing of drugs, biologics, disinfectants or devices, for all SARS-CoV-2-variants and on all surfaces – from solids to liquids.

Could you tell us about Virostatics’ pipeline?

We are developing a new class of molecules called CDK4/6/9 inhibitors, used in the treatment of aggressive tumors; our tests show that the new class of inhibitors work in every type of breast cancer that had become resistant to previous CDK 4/6 inhibitors treatments. The current first-line therapy for metastatic breast cancers are in fact the CDK 4/6 inhibitors; however, patients eventually become resistant to this treatment and presently need to switch to the much-more invasive chemotherapy. Taken from a very initial concept, we screened libraries of thousands of drugs to come up with the best candidate: our novel, oral CDK4/6/9 inhibitor, called VS 2-370, is currently in advanced pre-clinical development.

How do you find the drug development climate in Italy?

Italy benefits from a vibrant academic scene, as well as a rich plethora of start-ups, including in the biotech sector. What we are missing is the next step of taking ideas to the market at a large scale. Drug developers like Virostatics are rare, unfortunately. It is difficult to find competent people in this field, but more importantly, what we are missing is an R&D-driven pharma industry. The Italian pharma industry counts a few great names, but we are missing the culture of bringing a drug from pre-clinical to leading the market. This is why we need to seek out partners in the UK, Switzerland, or the US, rather than Italy. While a company like Chiesi might find big investments, Italy lacks investors for the 2-6 million euros capital size. Between big producers, distributors, APIs, proprietary drugs holding Pharmas, and the academia or start-up community, there is a big hole – this is the Achilles’ hill of Italian drug development.

Has the pandemic changed mindsets around investing in high-risk pharma development?

One would be tempted to argue that the pandemic created more willingness to invest in addressing health challenges in the future; also, there is a large cash opportunity in Italy, with over 200 billion euros from the EU. Thirdly, we have a prime minister who is well familiarized with the EU mechanisms and knows how to leverage opportunities. But besides these three pluses, we have a cultural minus: we are not used to thinking about long-term investments as we are skilled to facing emergencies. Cultural change is the slowest to occur, which is why I don’t expect a dramatic change driven by the pandemic.

What field of research do you think will bring the most promising therapies for cancer?

Gene therapy or precision medicine have received a lot of attention, but I don’t expect the next big breakthrough to come from here. Small molecules will continue to surprise us, because the targets are endless and we’ve only just scratched the surface. Vaccines, both therapeutic and preventive, in combination with AI, could be the next big wave since the discovery of small molecules. We are discovering more of the intricate connections between anatomy, histology, molecular biology, and immunology of cancers; what we are lacking is an understanding of how cancers evade the immune system and how to tackle cancers by inducing an appropriate immune response. The complexity of our immune systems exceeds our brain (collective) capacity to understand how exactly the target interacts with the body’s defence system. AI could thus guide the new generation of immunology-based drugs.