Asimov Announces IND Approval And Clinical Dosing Of Bispecific Antibody Produced Using CHO Edge Expression System
Boston, MA – Asimov, the synthetic biology company advancing the design and manufacture of therapeutics, announced the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for a bispecific antibody produced using its CHO Edge expression system. Additionally, the company announced that the first patients have been dosed with the therapeutic in an ongoing Phase 1 clinical trial.
“This regulatory filing demonstrates the ability of our CHO Edge system to reliably express next-generation biologics including bispecifics, and provides validation of our AI-driven cell line and bioprocess design tools,” said Alec Nielsen, co-founder and CEO of Asimov. “With over 30 therapeutic partners having utilized our CHO Edge system to produce advanced biologics, we are excited to pursue additional regulatory filings this year as we help our partners advance more medicines to the clinic.”
While the number of complex biologics under development has grown rapidly, the majority of biologics are still produced using trial-and-error approaches and relatively low-titer cell lines. By utilizing predictive modeling and molecule-specific expression optimization, Asimov’s CHO Edge system routinely achieves 8-11 g/L clones across biologic modalities. The system leverages a GS knock-out CHO host, a hyperactive transposase, a library of characterized genetic parts for vector design, and advanced AI and biophysics models to design and optimize the vector.
In recent months, Asimov has been building a network of partners to provide customers with the ability to accelerate and optimize biologics production from cell line development through GMP manufacturing. Today’s regulatory milestone comes on the heels of a collaboration with Cytiva to provide customers with an integrated offering for optimized biologics production, and a partnership with LOTTE Biologics focused on scaling to GMP manufacturing.
For more information about the CHO Edge system, visit https://www.asimov.com/CHO or sign up for the free webinar about Asimov’s AI-driven cell line development and bioprocess design.