NM-SPECIFICA

Specifica, a privately held antibody engineering company focused on innovative in vitro antibody library and discovery tools, announced the recent granting of two new patents by the United States Patent and Trademark Office claiming “Antibody libraries with maximized antibody developability characteristics” for methods related to the construction of its Generation 3 Antibody Discovery Platform, as well as libraries created using the methods. The technology behind the patents is also described in two recent publications^1,2 .

Antibodies are the fastest growing class of therapeutics, representing nine of the top twenty best-selling drugs³ . The global antibody therapy market is projected to grow from $178.50 billion in 2021 to $451.89 billion in 2028 at a CAGR of 14.1%⁴ . Traditionally, therapeutic antibodies have been generated by harvesting immune responses, either from in-bred or transgenic mice, or from immune human subjects. Although there has been a long-standing interest in using in vitro antibody library approaches that avoid the use of animals, there have been two main concerns with antibodies from in vitro libraries: binding affinities tend to be lower, and poor developability characteristics are common, complicating their development as successful drugs. The two granted patents cover the Specifica Generation 3 Antibody Discovery Platform which overcomes both of these issues.

The patents, US10954508B2 and US11254931B2, claim antibody libraries that generate antibodies with maximized antibody developability characteristics and methods to generate them. Specifica’s Generation 3 antibody libraries combine the use of well-behaved antibodies already validated in the clinic as frameworks, with scaffold-compatible binding loop sequences (CDRs) from natural antibodies, devoid of most sequence liabilities to improve developability. In selection campaigns with the Generation 3 platform, both phage and yeast display are used to generate a broad diversity of specific antibodies with high affinity and few developability issues, without the need for further affinity maturation or development in most cases.

“The granting of these two patents really validates the innovation behind our Generation 3 platform and recognizes the cutting-edge science carried out by the Specifica team. We love to innovate and have now made over 100 libraries since our founding, giving us a deep understanding of the issues involved in constructing the highest quality antibody libraries,” said Andrew Bradbury, co-founder and CSO of Specifica. “Together with the publications, I believe these patents cement Specifica’s status as providing the best-in-class solution for in vitro antibody discovery.”

About Specifica

Specifica is a rapidly growing antibody engineering company providing best-in-class in vitro antibody discovery libraries, selection and informatics tools, and discovery and optimization services to the pharmaceutical industry. Specifica’s patented Generation 3 Antibody Library Discovery Platform yields drug-like antibodies, with broad diversity, high affinities, and few biophysical liabilities directly from selections, minimizing the need for downstream affinity and biophysical engineering. In addition to in-house antibody library designs, Specifica also collaborates closely with partners to create custom libraries in which essential elements are optimized according to partner needs. The power of the Generation 3 Platform may be accessed by engaging Specifica to execute antibody discovery campaigns, or by full transfer of the platform technology in-house. In 2021, Specifica executed agreements with 10 new companies, and initiated 16 new discovery and optimization programs, expanding on 5 of its existing partnerships. Additionally, in cooperation with its software partner OpenEye, Specifica launched AbXtract, a new suite of antibody informatics tools. Specifica is headquartered in Santa Fe, New Mexico. For more information, please visit www.specifica.bio and follow Specifica on Twitter and LinkedIn.

1 Teixeira, A. A. R. et al. Drug-like antibodies with high affinity, diversity and developability directly from next-generation antibody libraries. MAbs 13 , 1980942, doi:10.1080/19420862.2021.1980942 (2021).
2 Ferrara, F. et al. A pandemic-enabled comparison of discovery platforms demonstrates a naïve antibody library can match the best immune-sourced antibodies. Nature Communications 13 , doi:10.1038/s41467-021-27799-z (2022).
3 Mullard, A. FDA approves 100th monoclonal antibody product. Nat Rev Drug Discov , doi:10.1038/d41573-021-00079-7 (2021).
4 https://www.fortunebusinessinsights.com/monoclonal-antibody-therapy-market-102734 (2021).
5 Bradbury, A. R. M., Erasmus, M. F. & Teixeira, A. Antibody libraries with maximized antibody developability characteristics. US patent 10,954,508 (2020).

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