Lund, Sweden (Press Release) – BioInvent Inter­na­tional (BINV) announced today that patient recruitment into the trial can now start in the upcoming clin­i­cal Phase II study with the anti­body BI-505 in patients with multiple myeloma, as nec­es­sary regu­la­tory approvals have been obtained. The first patient is ex­pec­ted to be dosed in May.

Multiple myeloma is a bone marrow cancer which affects more than 120,000 people globally every year [1]. Initial treat­ment is often successful, but unfortunately, most patients will relapse and in 2015, nearly 90,000 patients died as a result of the disease [2]. BI-505 is a novel immuno-oncology treat­ment with the poten­tial to prevent or delay relapse of multiple myeloma.

"The start of this Phase II study is an important mile­stone in the devel­op­ment of BI-505, an anti­body with the poten­tial to offer multiple myeloma patients a longer and healthier life," says Anna Wickenberg, Vice Pres­i­dent of Clinical Development at BioInvent.

The clin­i­cal study will be conducted by BioInvent in col­lab­o­ration with investigators at the University of Pennsylvania in the United States. It aims to document the ability of BI-505 to deepen the thera­peutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing au­tol­o­gous stem cell trans­plan­ta­tion (ASCT) with high-dose mel­phalan as part of their standard of care. The study will enroll approx­i­mately 90 patients undergoing ASCT whereof half will receive BI-505 as an add-on treat­ment to their standard of care.

The study is open-label, ran­dom­ized, and in­cludes a control group receiving only standard treat­ment. The open-label design will allow for patient out­comes to be monitored on an individual basis throughout the study. The pri­mary efficacy evaluation of BI-505 will be made after 100 days with the pri­mary end­point being the proportion of patients in stringent com­plete response (sCR). Patients will there­after be followed over three years to document pro­gres­sion-free survival (PFS). As a sec­ond­ary end­point, patients will also be monitored for any residual, disease known as "Minimal Residual Disease" (MRD), to assess deep responses.

About BI-505

BI-505 is a human anti­body against ICAM-1 developed by BioInvent which will be clin­i­cally tested in cooperation with researchers at University of Pennsylvania as an immuno-oncological ther­apy to prevent or delay relapse in patients with multiple myeloma (a form of bone marrow cancer) undergoing stem-cell trans­plan­ta­tion. Preclinical data indicates im­proved activity against myeloma when BI-505 is admin­istered in com­bi­na­tion with Velcade® or Revlimid®. BI-505’s favourable safety profile has been dem­onstrated in a pre­vi­ous phase I trial. This and the unique mech­a­nism of action, “flagging” remaining myeloma cells for elimination by actively recruited macrophages, as well as the poten­tial to inhibit ICAM-1 dependent survival signals between myeloma cells and tumour stroma, indicate a unique possibility of improving the thera­peutic effect of stem-cell trans­plan­ta­tion and other cancer ther­a­pies.

About BioInvent

BioInvent Inter­na­tional AB develops immune on­col­ogy drugs. With one of the world’s largest anti­body libraries, and a unique, pro­pri­e­tary discovery method, BioInvent can identify the optimal cellular targets and anti­bodies for the treat­ment of various tumor types. BioInvent has also con­siderable ex­peri­ence in, and a facility for, process devel­op­ment and pro­duc­tion of anti­bodies for clin­i­cal studies. This makes it possible to develop pro­pri­e­tary drug projects and also to supply leading inter­na­tional pharma­ceu­tical com­pa­nies with effective tools for their drug devel­op­ment. BioInvent cur­rently has three pro­pri­e­tary projects in or close to clin­i­cal devel­op­ment and part­ner­ship agree­ments with seven global pharma­ceu­tical and bio­tech com­pa­nies. More in­­for­ma­tion is avail­able at www.bioinvent.com.

References

1. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide: Number of New Cancers in 2015.
2. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide: Number of Cancer Deaths in 2015.

The press release con­tains state­ments about the future, consisting of subjective assump­tions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and devel­op­ment work in the bio­tech segment, asso­ci­ated with risk and uncertainty. With this in mind, the actual out­come may deviate sig­nif­i­cantly from the scenarios described in this press release.

Source: BioInvent.