Novel data confirm optimal drug-like properties of BiXAb antibodies

“Proof-of-concept preclinical studies on BMX-002 have demonstrated the advantageous properties of our lead candidate, with optimal manufacturability, e.g. good expression level in CHO cells similar to that of parental antibodies, structural integrity and thermal stability, and lack of aggregation,” said Zhukovsky. “We are delighted to have been selected to present at the next-generation therapeutics event, where key players in the therapeutic development field were discussing the best antibody platforms.”

The company notes that it was the start-up company selected to present at the event and, in so doing, it unveiled a case study and novel data demonstrating that its optimized bispecific antibodies possess excellent drug-like properties, optimal functional activity and can be assembled without extensive antibody engineering—that is, they confer “plug-and-play” properties (i.e. modularity).

Biomunex admits there are a number of different bispecific antibody platforms, but it maintains that very few are capable of producing bispecific antibodies with good manufacturability and also lack of steric hindrance when binding its two targets—properties that the company says are required for successfully producing new therapeutic candidates.

“Moreover, the vast majority of bispecific antibody formats do not permit the use of existing antibodies; instead they require the selection of binding domains from specially prepared antibody libraries,” the company noted in a news release, “which does not allow the plug-and-play approach, a very attractive feature for pharmaceutical companies.”

Zhukovsky presented data on 10 different BiXAb antibodies, representing several therapeutic programs at Biomunex. In accelerated degradation studies, the biophysical properties of BMX-002, a therapeutic candidate in Biomunex’ lead program, remained unchanged for over one month, reportedly demonstrating the excellent stability of BiXAb molecules. Moreover, BMX-002 exhibited synergistic activity on its two targets and demonstrated superior in-vivo efficacy and survival compared to that of the anti-EGFR + anti-HER2 mAbs combination. As BiXAbs are stable, do not degrade or aggregate for extended periods of time and demonstrate modularity and excellent functional activity, the BiXAb platform is highly attractive for therapeutic development, the company says.

During the past couple years of research, Biomunex says it has been engaged in the optimization of the bispecific antibody format licensed from European academic collaborators “into a robust and unique proprietary platform for the generation of therapeutic antibodies with superior activity and drug-like properties.” Biomunex continues to expand its intellectual property position on the BiXAb platform and its proprietary antibodies, and as part of this effort, at the beginning of 2016, Biomunex filed two patent applications for its two lead BiXAb antibodies.

“Our BiXAb platform is an excellent choice for the generation of therapeutic antibodies. It provides a substantial advantage over most of the competing formats. We have shown that products generated based on our proprietary platform will bear the manufacturing, stability and activity profiles that antibody developers, pharma and biotech companies are looking for,” said Dr. Pierre-Emmanuel Gerard, CEO of Biomunex. “These promising results will help us nominate our first development candidate for the treatment of pancreatic and other solid tumor cancers in 2016. They will also facilitate the advancement of our second program, directed at the treatment of hematological malignancies and exploiting the clinically demonstrated power of immune checkpoint inhibitors.”