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Biohope Embarks on Study of Renal Transplantation IVD, Looks to Expand into RA

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NEW YORK (360Dx) – Spanish diagnostics firm Biohope is about to commence a large-scale study of its flagship Immunobiogram in vitro diagnostic for determining the best immunosuppressive treatment for patients undergoing kidney transplantation.

The €3.8 million ($4.5 million) project, called Transbio, has been funded through the EU's Horizon 2020 program and will run through 2019. Biohope recently completed a pilot phase of the two-year study in partnership with two Spanish hospitals that yielded positive results.

CEO Isabel Portero said that the firm's assay, which relies on culturing peripheral blood mononuclear cells in a three-dimensional, semi-solid matrix, should also be applicable in other indications where immunosuppressive therapies are used, such as rheumatoid arthritis.

The company views renal transplantation, though, as an application where an improvement in treatment selection could lead to the uptake of Immunobiogram for other purposes.

"Kidney transplantation is a highly scientific area with a tremendous social impact," Portero said. "What happens with the immune system in context of transplantation is a worst-case scenario," she said. "If you have a positive impact there, you can move into other areas."

Portero noted that Spain is an "important country" for renal transplantation in Europe. According to the National Transplant Organization, roughly 3,000 kidney transplants were performed there last year, though half of the patients ultimately reject the transplants in the decade following the procedure.

This was one of the reasons that Portero, who previously worked as a medical director at numerous hospitals and biotechs, including Merck and Pfizer, founded Biohope two years ago, with the aim to develop a test for the personalization of immunosuppressive treatments.

The resulting Immunobiogram assay requires 10 ml of blood drawn from a patient. Once cultured in the company's hydrogel matrix platform, the samples are exposed to different stimulants representing various immunosuppressive treatments. Based on responses to those treatments, users can determine the most efficient therapies or combinations of therapies for a particular transplant patient. Because of its design, the company believes Immunobiogram could be used as part of a point-of-care device.

"We personalize the treatment of rejection, because rejection is triggered with immunosuppressive drugs," said Portero. "We evaluate patterns of resistance for each patient and at the end of the day we can say this patient is more sensitive to this medication and is resistant to this medication," she said. "This is what our IVD does."

In November 2015, the startup received an initial €50,000 award through Horizon 2020 to establish the technical and commercial feasibility of its approach, and last year, it received its grant for Transbio, which commenced this January.

The company recently carried out an initial study of Immunobiogram in collaboration with the transplantation units of the Hospital Puerta de Hierro and La Paz University Hospital, both in Madrid. It reported the results of the study, called BH-Pilot, to its scientific advisory board at the European Society of Organ Transplantation, held in Barcelona last month.

Specifically, Biohope and its partners used Immunobiogram to select therapies for 35 patients who had received a kidney transplant, plus seven healthy controls. The company's blood-based test enabled clinicians to gauge response to drugs most commonly used in such patients. Portero said the company was "encouraged" by the results and plans to publish them in early 2018. She also considered it a milestone for the firm, which has moved from being a startup with a small lab to an SME (small-to-medium enterprise) employing 12 people in two years.

"We've been able to do the proof of concept for Immunobiogram and move to the clinical scenario," Portero added. "We have finished our first study with two important clinics in Madrid, and we now have clinical data on real patients."

Now the company is preparing to commence the second phase of the Transbio project, which will see it collaborate with the renal transplantation units of nine university hospitals across five EU countries. According to Portero, this phase of the project will begin at the beginning of 2018.

Objectives of Transbio include optimizing the prototype of the Immunobiogram kit, in order to reduce the price of the test. This will include narrowing down the number of markers used in the test to the most relevant ones. According to the project's website, this part of Transbio will involve 60 patients. Biohope and its partners will then validate the test in about 300 patients in order to generate the data necessary for Immunobiogram's clearance by European regulatory authorities.

The hospitals taking part in the validation include the Hospital Puerta de Hierro, Hospital Vall d´Hebron, and Hospital del Mar in Spain; Antwerp University Hospital in Belgium; Universitätsklinikum Essen in Germany; Medica University Borowska in Poland; Azienda Ospedaliero at the Universitaria di Parma in Italy; the University Hospital of Copenhagen in Denmark; and the Institute for Clinical and Experimental Medicine in the Czech Republic.

A third objective of Transbio will be the development of a bioinformatics platform based on the clinical validation study data. Biohope aims to develop software that will analyze and deliver the test results. This will involve the combination of patient clinical history, with markers measured using Immunobiogram in addition to enzyme-linked immunosorbent assays, flow cytometry, and urine analysis. The resulting analysis should enable the production of an immunological response profile for the patients in the study, according to the company.

Finally, the project aims to assemble a commercialization strategy, including a plan for achieving regulatory compliance in the EU.

"Our hope is that Immunobiogram would be a test capable of helping physicians in a difficult task of choosing the right medication for each patient," said Portero. "We want to provide an important piece of information that is lacking now to anticipate response of each patient to medication available."

Following the conclusion of Transbio, Biohope hopes that Immuniobiogram could obtain CE-IVD marking for clinical use by 2021, she added.

Its plans to develop a similar assay for selecting therapies for rheumatoid arthritis patients are next in the pipeline, and Portero speculated that its RA test could reach a similar stage several years after that. The company recently kicked off a crowdfunding campaign, using Capital Cell, a Barcelona-based platform focused on raising funds for life sciences companies, to raise €350,000 to adapt the transplant test for use in RA.

In the description of the round, Biohope said that it has a valuation of €8.2 million, before any investments or financing. and that it believes the test could generate revenues of €7.6 million by 2025, growing to €32.2 million by 2027, at which point it will seek to license the test to a pharmaceutical partner, a strategy it will pursue for its transplantation test as well.

Portero said that the point of the crowdfunding is to both give people affected by RA the chance to invest personally in the company, as well as to source the funds necessary to launch the project. She said that in coming months, though, Biohope will seek an unspecified amount of financing from investors. As such, the crowdfunding campaign will represent the only possibility for individuals to invest directly in Biohope.

"What we evaluate is the immune response of the patient to the different immunosuppressants in the market," said Portero. "The immune system is the key player in rejection in transplantation and is the key player in rheumatoid arthritis as the major cause of the disease," she said. "We hope to be able to tell the rheumatologist that this patient is resistant to this medication, but is more sensitive to this one."