BOSTON, MA, July 9, 2025 – 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.

Highlights

  • Virtual Private Network (VPN): Users connect to the cluster, provide some credentials and are then able to access internal tools.
  • Single Sign-On: A tool like Kerberos allows you to use the same account across various components.
  • Home-grown user accounts: You implement an authentication system and users have a separate username/password for your computing infrastructure.

Asimov, the synthetic biology company building a full-stack platform to program living cells, announced today it has been awarded a contract as part of the Defense Advanced Research Projects Agency (DARPA) Automating Scientific Knowledge Extraction (ASKE) opportunity.

Through ASKE, Asimov will work to develop a physics-based artificial intelligence (AI) design engine for biology. The goal of the initiative is to improve the reliability of programming complex cellular behaviors.

“To achieve truly predictive engineering of biology, we require dramatic advances in computer-aided design. Machine learning will be critical to bridge genome-scale experimental data with computational models that accurately capture the underlying biophysics. As genetically engineered systems grow in complexity, they become difficult for humans to design and understand. For simple genetic systems with only a couple of genes, synthetic biologists typically use high-throughput screening and basic optimization algorithms. But to engineer more complex applications in health, materials, and manufacturing, we need radically new algorithms to intelligently design the DNA and simulate cell behavior.”

Alec Nielsen, Phd, Asimov CEO
Over the past 50 years, DARPA has been a world leader in spurring innovation across the field of AI, including statistical-learning and rule-based approaches. We are proud to work with DARPA to advance the state-of-the-art in AI-assisted genetic engineering.

Asimov’s founders previously built a hybrid genetic engineering and computer-aided design platform called Cello to program logic circuit behaviors in cells. The ASKE opportunity will seek to support an ambitious expansion in the types of biological behaviors that can be engineered.

Asimov’s approach will leverage “multi-omics” cellular measurements, structured biological metadata, and novel AI architectures that combine deep learning, reinforcement learning, and mechanistic modeling. Over the past year, the company has ramped up hiring in experimental synthetic biology, machine learning, and data science to accelerate development of their genetic design platform.

Highlights

Headering 3

DARPA recently announced a multi-year investment of $2B into innovative artificial intelligence research called the AI Next campaign. A part of this wide-ranging AI strategy is DARPA’s Artificial Intelligence Exploration program, which was developed to help expeditiously move pioneering AI research from idea to exploration in fewer than 90 days. DARPA’s ASKE opportunity is part of this program and is focused on developing AI technologies that can reason over rich models of complex systems.

“Over the past 50 years, DARPA has been a world leader in spurring innovation across the field of AI, including statistical-learning and rule-based approaches. We are proud to work with DARPA to advance the state-of-the-art in AI-assisted genetic engineering.”

Alec Nielsen, PhD, Asimov CEO
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