Biologics Discovery and Development

KLUS Pharma has a proprietary discovery and development platform for therapeutic antibodies, which provides full coverage on all key steps in preclinical development, including target discovery, antibody engineering, validation, and manufacturing. 

  • Our proprietary platform enables the discovery and development of antibodies against a wide range of therapeutic targets, including GPCRs, integral membrane proteins, and cell surface proteins. Mouse hybridoma technology with high throughput screening allows for the rapid generation of diverse and precise antibodies. Animal immunization and yeast display enable us to develop common light chain bispecific antibodies. In addition, our phage display platform is powered by a naïve scFv library constructed with racially diverse human PBMC. With a size larger than 1 x 10¹⁰, our library can produce fragments with sub-nM affinity.

  • Selected antibodies undergo function development and optimization to receive further improvements in affinity maturation, humanization, Fc engineering, and bispecific engineering. 

  • Our in-house validation team evaluates all antibody candidates for in vivo efficacy, PK/PD properties, and safety.

  • Our manufacturing capabilities provide a reliable supply of antibody products for preclinical and clinical studies, and include cell line development, 20 L pilot run with upstream process optimization, GMP quality system based on single-use processes, two 2,000 L mammalian bioreactors, and cold-chain solutions for storage and transportation.  

 
Antibody-Drug Conjugates (ADC)

KLUS Pharma has demonstrated outstanding efficacy and safety with our third-generation ADC platform. In addition to high affinity and internalization activity, our lead candidates also have wider therapeutic windows than benchmarks.

 

The design and development of our ADCs is based on proprietary conjugation technology. To address the current challenges of activity loss and systemic toxicity, we use novel conjugation chemistry to link antibody to cytotoxic payload. This highly stable, irreversible conjugation reduces unwanted hydrolysis reactions and lowers the risk of systemic exposure to the payload. The result is that our ADCs are able to achieve higher efficacy with lower toxicity. Our conjugation reaction was fully developed to support batch production of payloads up to 100 grams. 

 

Since our conjugation technology is compatible with most antibodies and payloads, we have built a library of novel linkers and payloads that can be used to rapidly develop ADCs with the following advantages:

  • Third-generation: Homogenous and tunable DAR ranging from 2 to 8. 

  • Linker: Highly stable and hydrophilic, site-specific, cleavable or uncleavable.  

  • Payload: High potency and versatile MOA, includes tubulin binders, DNA alkylating agents, and novel topoisomerase I inhibitors. 

 
bispecific antibody.png
Bispecific Platform 

At KLUS Pharma, we believe that optimal drug design can ultimately lead to the best therapeutic result. Since there is no single best approach to bispecific antibody design, our development platform supports a variety of bispecific formats, including common light chain, scFv-IgG, scFv-Fab IgG, and others. Each bispecific antibody is tested with different formats in order to maximize its efficacy. This strategy has proved useful for selecting the optimal bispecific design for different functions:

  • Combinations with immuno-oncology

  • Effector cell recruitment 

  • Blockade of two different ligands or pathways 

  • Tissue-specific delivery or function improvement 

 

In addition, excellent in vivo stability was observed with our bispecific antibodies, comparable to that of monoclonal antibodies. Efficient production as high as 4.5 g/L is achievable with our current manufacturing capabilities. 

 

©2021 by KLUS Pharma Inc.