Piero Di Lorenzo – Kicks offthe vaccine manufacturing against Covid-19Sky TG 24 – 15th March

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Published on April 24, 2020 by

PRESENTER:
We have a guest now, we’re with the President of IRBM, Piero di Lorenzo. [IRBM is] an Italian company in Pomezia that works in the molecular biotechnology sector and has been working with Oxford University to develop a potential coronavirus vaccine. Good evening, President, and of course thank you for being with us.

PIERO DI LORENZO:
Good evening.

PRESENTER:
Let’s just take stock with you of where we are with this potential vaccine.

PIERO DI LORENZO:
We’ll be starting production tomorrow morning and, just to let you know how things have developed, when in December the Chinese isolated and sequenced the virus and… our partner the Jenner Institute at Oxford University immediately synthesized the “spike” protein gene. The spike protein is the one that covers the Covid-19 virus, the bad protein that creates the contagion, and once the University of Oxford had synthesized this gene we were brought in because we joined two forms of expertise together, the Jenner Institute’s expertise, as it is familiar with the whole family of adeno-viruses, having developed the vaccine 10 years ago for the MERS Coronavirus, for which it is currently carrying out phase 3 tests, therefore the final tests, on healthy volunteers in Saudi Arabia… and we have contributed our expertise in adeno-viruses. The adeno-virus is a vehicle, known as shuttle, that is loaded with the Spike protein gene synthesized in Oxford and, thus deactivated, has to introduce it into the body. This way the body recognizes it as a foreigner entering the body and creates antibodies. It therefore creates antibodies to react against the false infection and, if the active gene of the spike protein should arrive, the one that actually causes the disease, the body would be prepared with the antibodies to fight it. We have therefore characterized the adeno-virus, this shuttle, which is a common cold virus, further deactivated, and following the purification process we are ready to start production of the first 1000 doses, we’re starting tomorrow morning, and for the tests on mice. We expect to start with the mice by the beginning of May and expect to complete this phase within a month so we’ll then be ready to move onto healthy volunteers.

PRESENTER:
You foresaw my question, but just to understand what you were saying, to help me and our viewers understand, essentially I get the feeling that you are particularly optimistic and that we might see results within a couple of months, a month and a half therefore.

PIERO DI LORENZO:
Let’s say two and half to three months, we aren’t “particularly” optimistic, just “moderately” optimistic, because we’re starting to produce a vaccine that has already been tested in two protocols, already tested on 2 platforms, because the synthesization part has already been tested by the Jenner Institute in the context of the MERS vaccine, and the use of the adeno-virus characterized by us, in this specific case, simply replicates what we did five years ago when we developed the Ebola vaccine and produced it in our laboratories.

PRESENTER:
So you said two and a half to three months? Obviously if all goes well. What will the next steps be after that? Will it be made available to hospitals if tested? How will this vaccine be marketed or used after that?

PIERO DI LORENZO:
The animal testing is followed by three phases: phase 1, phase 2, phase 3 of clinical trials on humans. Phase 1 (with 10, 15 patients. 10-15 healthy volunteers); phase 2, after that, with 150-200, and the last phase with 700, 800, 1000 tests. Normally, according to the protocols validated by regulatory agencies, each of these phases can take over a year. One complete phase from animal testing to the end of phase 3 can take 5 or 6 years. However, these protocols, these timings, can be shortened, even drastically, by national and international regulatory authorities in the event that a pandemic, like the one we’re having now, is perceived to be out of control, at which point the regulatory authorities could intervene and order us to avoid certain tests to start commercial production immediately.

PRESENTER:
Perfect.

PIERO DI LORENZO:
We hope this will happen. We hope we won’t get to that point.

PRESENTER:
Of course, thank you for your contribution and explanations. I wish you and your team good luck in your work, let’s hope things turn out for the best. Thank you President, keep up the good work and good evening.

PIERO DI LORENZO:
Good evening to you [unclear]
Hyderabad based Biological

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