NM-SPECIFICA

Specifica, a privately held antibody engineering company focused on innovative in vitro antibody library and discovery tools, announced the publication of two peer-reviewed articles describing its Generation 3 Antibody Discovery Platform^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. As described in these articles, Specifica has overcome both of these concerns.

In the Mabs article¹ , Specifica explains the scientific rationale behind the new Gen 3 platform. Specifica’s Gen 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 Gen 3 platform, both phage and yeast display are employed. The results described in this article demonstrate the power of the platform to directly generate a broad diversity of specific antibodies (100-1000 different clusters) with high affinity (20% subnanomolar) and few developability issues.

The Nature Communications article² , published this week, compares antibodies generated against SARS-CoV-2 using the Gen 3 platform with hundreds of other antibodies described in the literature, from over 50 different laboratories. Specifica’s Gen 3 antibodies out-performed all other antibodies sourced from naïve libraries, showed better performance than the majority of immune-sourced antibodies, and were comparable to the very best immune SARS-CoV-2 antibodies in terms of affinity and viral neutralization, with developability properties as good as the best already approved antibodies.

“These two papers validate the Gen 3 platform’s best-in-class status, fulfilling the original promise of naive antibody libraries made over 30 years ago, namely, to eliminate the use of animals or immune sources to generate powerful antibodies,” said Andrew Bradbury, co-founder and CSO of Specifica.

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 patented⁵ 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 Gen 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 lauched 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 https://www.tandfonline.com/doi/full/10.1080/19420862.2021.1980942 (2021)
2 https://www.nature.com/articles/s41467-021-27799-z (2022).
3 https://www.nature.com/articles/d41573-021-00079-7 (2021).
4 https://www.fortunebusinessinsights.com/monoclonal-antibody-therapy-market-102734 (2021).
5 US patent 10,954,508 (2020).

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