The ability of BI-505 to prevent or delay relapse of multiple myeloma (MM) to be in­ves­ti­gated in clin­i­cal study conducted by leading clinicians at University of Pennsylvania

Lund, Sweden (Press Release) – BioInvent Inter­na­tional AB (OMXS: BINV) com­pleted a strategic analysis of its ICAM-1 targeted phase II anti­body BI-505 with thought leaders to garner sup­port on the devel­op­ment of BI-505.

Based on the analysis of BI-505’s data, a clear direction emerged that BI-505 is uniquely positioned to in­crease the poten­tial depth and quality of response in patients receiving standard of care treat­ment for mul­ti­ple myeloma. Many MM patients initially achieve a good response from existing ther­apy; how­ever, patients can eventually relapse and succumb to the cancer as a consequence of myeloma cells that remain in the patient after treat­ment (minimal residual disease).

BioInvent intends to conduct a Phase IIa study in MM patients that have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT) to in­ves­ti­gate the ability of BI-505 to in­crease the depth and quality of response after ASCT in com­bi­na­tion with standard of care. Results from the open-label trial will be compared to a historical data from a matched cohort of patients. The intention is to recruit approx­i­mately 30 patients, and study start is planned for early 2016. The study will be conducted as an investigator sponsored study in close col­lab­o­ra­tion with leading clinicians at the Abramson Cancer Center of the, University of Pennsylvania.

“There is a great need within the multiple myeloma patient pop­u­la­tion for targeted treat­ment options which could deepen the responses that can be achieved with cur­rently avail­able treat­ments. BI-505 has a unique mech­a­nism of action which could target residual disease that eventually leads to relapse in this pop­u­la­tion, and the planed study will address this hypothesis”, said Brendan Weiss MD an Assistant Professor of Med­i­cine at the University of Pennsylvania in Philadelphia.

“BI-505 may be uniquely positioned to prevent or delay relapse of multiple myeloma. This patient need is cur­rently not addressed effectively by other treat­ment options and relapse eventually occurs in patients. We are delighted with the oppor­tu­ni­ty to conduct a clin­i­cal study with the University of Pennsylvania prior to progressing to a larger clin­i­cal trial”, stated Michael Oredsson, Pres­i­dent and CEO of BioInvent.

As a consequence of this strategic analysis of the poten­tial of BI-505 in MM patients post ASCT, BioInvent will conclude the its smoul­der­ing myeloma study. Smoul­dering myeloma does not constitute a relevant com­mer­cial devel­op­ment oppor­tu­ni­ty for BioInvent, and the mech­a­nism of action of BI-505 is not believed to be as relevant in this indi­ca­tion.

About BioInvent

BioInvent Inter­na­tional AB is a research-based pharma­ceu­tical com­pany focused on the discovery and devel­op­ment of inno­va­tive anti­body-based drugs against cancer.

The com­pany has unique expertise in anti­body drug devel­op­ment from initial concept to late clin­i­cal phase. The screen­ing tool, F.I.R.S.T.TM, and the anti­body library, n-CoDeR®, are two patented tools that enable identi­fi­ca­tion of relevant human anti­bodies and disease targets during the discovery phase. BioInvent has also con­siderable ex­peri­ence in and a facility for process devel­op­ment and pro­duc­tion of anti­bodies for clin­i­cal studies. The scope and strength of this plat­form is also used to develop anti­body-based drugs in col­lab­o­ration with partners who finance the devel­op­ment of the new drug, and provide BioInvent with the right to mile­stone payments and royalties on sales. These partners in­clude Bayer Pharma, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Servier and Xoma. More in­­for­ma­tion is avail­able at www.bioinvent.com.

About BI-505, MM and MRD

Minimal residual disease (MRD) status is in­creas­ingly con­sidered to be the most important predictor of mul­ti­ple myeloma relapse. Preclinical data with BI-505 indicates that its macrophage-mediated mech­a­nism is effective at killing the small numbers of myeloma cells that will cause relapse. In addi­tion, myeloma cells are critically dependent on adhesive inter­actions with stromal cells for survival and for devel­op­ment of drug-resistance. Thus, BI-505 targeting of ICAM-1 could help overcome MRD by concerted mech­a­nisms. The pre­vi­ously shown favourable clin­i­cal safety profile of BI-505 also makes it suitable for treat­ment of this patient pop­u­la­tion.

The unmet medical need in patients with residual disease is high and avail­able MM drugs may be unsuitable either due to toxicity or low beneficial effects, often both.

It is believed that current and new drugs in clin­i­cal devel­op­ment for MM will not adequately address this need in the treat­ment of MM patients.

The press release con­tains state­ments about the future, consisting of subjective assump­tions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same was 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.

Information disclosed in this press release is provided herein pursuant to the Swedish Financial Instruments Trading Act. The in­­for­ma­tion was submitted for publication at 8.40 a.m. CET, on 19 March, 2015.

Source: BioInvent.