Antibodies are poised to remain the most attractive modality for the development of high value-added therapeutics. Three of the top four products ranked by sales are antibody therapies, and this trend is expected to continue through 2026 and beyond, with the split between biologics and small molecules within top 100 products estimated to be 55/45 (EvaluatePharma® World Preview 2020).  Within the next decade, bispecific and multi-specific antibodies are expected to dominate in the antibody therapeutic field, and the focus on immunotherapeutics will increase.

Oncology is projected to be the one of the major drivers of worldwide pharmaceutical sales, with sales projections of $ 294 Bn in 2026, comprising close to 21 % of industry sales. The 2019 sales were nearly $ 140 Bn or over 16 % of pharmaceutical sales, more than double compared to the next ranked therapeutic area (Evaluate Pharma 2020).  Double-digit growth is expected to continue over the next 5 years.

Another promising therapeutic area is immune-mediated inflammatory diseases with sales projections in main indications over $ 71 Bn in 2026. Pharmaceutical sales in this area in 2019 were close to $ 61 Bn with the sales share of antibody therapeutics nearly 72% (Evaluate Pharma 2020).

The importance of bi-and multi-specific antibody therapeutics  

Over the last two decades Immunotherapy has changed the way we think about cancer treatments and brought dramatic improvements to the clinical outcomes of cancer patients. Cancer immunotherapy has been advancing on numerous fronts, with an emphasis on the development of monoclonal antibodies (mAbs) targeting immune checkpoint inhibitor and agonist receptors, and on chimeric antigen receptor (CAR) T-cell therapy. Taking advantage of the clinical successes of mAbs and the developments in antibody engineering, new antibody-based therapeutics, such as bispecific (bsAb) and multi-specific antibodies, have emerged. Such antibodies can engage two or more antigens at once creating avenues to exploit new therapeutic strategies beyond the reach of monospecific antibodies, whether they are used as single agents or in combination.

Bispecific or multispecific antibodies open the way to potentially superior potency through novel mechanisms of action such as redirected T cell activation and killing, modulation of receptor signaling, and simultaneous targeting of multiple immune checkpoint receptors. They can potentially exert functional activities that cannot be achieved by monoclonal antibody combinations and can more selectively target specific cell populations. In addition, bsAb could potentially bring a higher level of safety as compared to monotherapy or combination of single agent antibodies by lowering off-target binding through a better tumor targeting.

The bsAb field has tremendously advanced in recent years as evidenced by the recent clinical approvals. There are currently numerous bispecific immunotherapies in clinical and preclinical development. Advances in bioengineering, and specifically in antibody engineering, have led to the development of numerous technological platforms that generated a remarkable variety of bsAb formats. Two main therapeutic approaches currently dominate the application of bsAb in the immuno-oncology field. The first aims at targeting simultaneously two receptors/ligands for co-inhibiting redundant signaling pathways. The second aims at harnessing, mobilizing and redirecting immune effector cells in the tumor microenvironment.

 

BIOMUNEX is capitalizing on all these novel advancements in the treatment of cancer and is building a portfolio of innovative therapeutics. Biomunex proprietary bi- and multi-specific technology, BiXAb®, is solving all the technical challenges associated with current bsAbs platforms to create the next generation bispecific antibodies with high efficacy and safety profiles. Biomunex is not only developing the BiXAb® that have the potential to augment the existing monospecific antibody therapeutics or their combinations, by creating new synergies between its constitutive parts that cannot be attained by mere combinations, but is also creating bsAb, which target innovative receptors on immune or tumor cells.