C19-Immunobiogram

Inspiration

1) Nobody knows why some patients enter a severe clinical course and others maintain asymptomatic in Covid-19 infection 2) Nevertheless, it has been identified that the key factor related to morbimortality in Covid-19 infection is malfunction of the immune system. Cytokine storm, acute inflammation at the lungs and intravascular coagulopathy are the major causes of mortality. Functionality of the immune system could be the major difference between patients with bad clinical and good clinical evolution 3) The overwhelming evidence of lymphopenia in severe cases, mostly related to dramatic decrease in T-CD4 and T-CD8 cell subtypes, indicates that Tcell count and functioning is probably one of the most important pathogenic features of Covid-19 infection. T-cells should regulate the immune system cascade and in many patients, these mechanisms fail. Probably these are the patients that evolve towards a severe disease. But, to date T cell functioning is not being addressed 4) Immunomodulator drugs are used in Covid19 infection under a trial/error experience. There is no anticipated clue of its functioning for specific patients. It could be really useful to test in vitro the potency of Immunomodulator drugs over patient´s immune cells, specially T cells, because it could help clinicians anticipate which immunomodulator drug could be better for each patient

What it does

The novel in vitro diagnostic immunoassay, that would be named C19-Immunobiogram, would be applied to Covid-19 infection with a double functionality:

1) Prognosis tool: informing about the functionality of adaptative T-cell driven response to the disease, that is linked to morbimortality. The result would inform about which patients are at high risk of morbimortality due to malfunction of the immune system.

2) Treatment personalization tool: informative tool about the in vitro potency of a panel of immunomodulators over patient´s immune cells. These drugs are currently prescribed for severe cases under trial/error experience and we could offer anticipated information about how patient immune cells response to each immunomodulator drug tested. We have a panel that include hydroxychloroquine, tacrolimus, corticoids, mTOR inhibitors and jak-inhibitors

How I built it

Biohope is an early commercial stage R&D company dedicated to the development of precision medicine IVD tools and unique patient knowledge for inflammatory conditions and diseases in which the immune system function is directly linked to clinical outcomes.

Biohope lead product, Immunobiogram®, is a first-in-class, patented in vitro diagnostic device which: 1) evaluates the functionality of the immune system and 2) study the potency of each immunomodulator drug over the target immune cells, allowing for personalizing individual immuno-modulator therapy. Immunobiogram has been already developed and successfully tested in renal transplantation (see: https://biohope.eu/immunobiogram/). Also, it is being evaluated in Rheumatoid Arthritis.

We would apply the immunoassay to Covid-19 infection blood samples. Only a minor adaptation of the immunosuppressant drugs panel should be performed to cover the most promising drugs used in Covid-19 infection.

Challenges I ran into

• To obtain finance for the project, specifically at the beggining only for a proof of concept study

• To define a panel specific for Covid-19 infection, including immunomodulator drugs we already successfully performed before a set-up for Renal Transplantation or Rheumatoid Arthritis. Thus, we would build C19-Immunobiogram over our already developed core technology.

• To perform a proof of concept clinical study in 1-2 centers to evaluate if this novel C19-Immunobiogram test actually works in Covid-19 infection, It would include aprox 150 patients and would take 6 months of implementation in total (protocol design&preparation + ERC submission + recruitment period + sample analysis + statistical analysis)

• If successful, we would: 1) submit an European patent application 2) define a clinical plan and experimental plan to cover all aspects of the Technical File needed for CE marking of the novel test. 3) Adapt our production facility to manufacture this novel test 4) Find business partners for comertialization of the test we would manufacture in our facility, or perform a tech transfer to our partner facility.

Accomplishments that I'm proud of

We at Biohope are proud of having developed an IVD immunoassay (Immunobiogram for Renal Transplant), which is about to be CE marked, in four years from scratch

What I learned

So many things, difficult to sum up. To fund and lead Biohope has been the most intense professional experience in my life, alongside with caring of patients as an Internal Medicine Physician, when I was younger.

• To be perseverant and have patience
• To be flexible and adaptable to changing enviroments
• The importance of the emotions in team building and corporate governance
• A fit between professionals and corporate culture&enviroment is critical. It is a challenge when changes are needed and to be implemented quickly
• Honesty and clearness is mandatory in general governance
• There are many people which honestly will help in your way, some will be really at your side in the roller coaster of leading a start up. Some not, and should be identified as soon as possible, and it is not an easy task.

What's next for C19-Immunobiogram

To obtain some funds to perform a proof of concept clinical study in Covid-19 at 12-Octubre University Hospital of Madrid WE HAVE A PLAN we developed at the Hackaton: https://documentcloud.adobe.com/link/track?uri=urn%3Aaaid%3Ascds%3AUS%3A03de0452-e154-4421-873d-7cd2a45d2a14

Built With

• ivd