First-Ever Computer-Designed Antibody, Created by Biolojic Design, Enters Human Clinical Trial in Cancer Patients | Antibody

First-ever computer-designed antibody, created by Biolojic Design, enters human clinical trial in cancer patients

Biolojic uses its proprietary AI platform to engineer antibodies with new abilities to cure disease, ushering in a new era of smart therapies

Biolojic Tel Aviv will focus on computational antibody design; Boston site will focus on drug development

BOSTON, MA, United States I April 5, 2022 I Biolojic Design, a unique technology company pioneering the computational design of human antibodies to develop smart therapeutic solutions for multiple diseases using advanced AI technology and validated biological insights, today announced that for the first-ever times a computer-designed antibody will enter a clinical trial in patients. The trial will evaluate AU-007, a highly differentiated monoclonal antibody that was computer engineered by Biolojic and harnesses the power of the body’s interleukin-2 (IL-2) to eradicate solid cancerous tumors. The antibody has been transferred to Aulos Bioscience, a Biolojic spin-off that is currently conducting clinical trials in Australia and recruiting patients, hoping to report interim data later this year.

Computational design of antibodies such as AU-007 is a novel approach that Biolojic Design Founder and CEO Yanay Ofran has been developing for over 10 years through an AI platform that uses computational biology and big data to guide the design of epitope-specific antibodies. Its goal: to design antibodies that have a predetermined and desired effect on the function of a targeted protein.

“Unlike antibodies made by conventional antibody technologies, the promise of our approach is to create smart antibodies – a kind of nanorobot that, like natural proteins, is able to adapt to changing situations,” Ofran said. . “We are finally at a stage of evaluating a computer-designed antibody in humans. Thanks to our work with Aulos Bioscience, the first computer-designed antibody in history will be administered to human patients.”

“Our AI platform essentially mimics the human immune system using AI,” Ofran said. “For this program, we chose the IL-2 pathway, which is well studied and widely explored. The antibody now entering the clinic was designed based on our understanding of the IL pathway. 2. We know that IL-2 activates the immune system to attack the tumor, but it can also inhibit this attack and in many cases cause blood vessels to leak, which in turn can lead to complications such as pulmonary edema, which can be life threatening. Knowing this, we programmed our antibody to activate IL-2 to fight the tumor, but at the same time shut down IL-2’s ability to inhibit the immune system or cause toxicities such as leaking blood vessels or swelling of the lungs.This represents a promising new direction for taking advantage of IL-2.2.”

AU-007 is being developed by Aulos Biosciences, a company created by Biolojic Design and ATP (Apple Tree Partners), a leading life sciences venture capital firm, through a $40 million commitment in Series A funding to advance the computer-designed monoclonal antibody from preclinical to clinical proof of concept. Preclinical data presented by Aulos at a recent Antibody Biology and Engineering conference demonstrated significant tumor growth inhibition, including complete tumor clearance in ten of 19 mice treated with AU-007 when used with PD-1 or PD-L1 checkpoint inhibitors in a mouse model of cancer.

Biolojic Design also has partnerships with Nektar Therapeutics for the development of antibodies against autoimmune diseases and Eli Lilly for the development of antibodies that fight diabetes. The company also has its own preclinical portfolio that includes unique therapies made possible by its AI platform. These include a specific double antibody targeting IL-13 and TSLP; a conditional agonist/antagonist targeting IL-2 for autoimmune diseases; super engagers, which are ultimately a 4-in-1 engager for immuno-oncology; and molecular exchangers, which are simple IgG antibodies designed to bind small molecules and release them under predefined conditions also in oncology. Biolojic plans to start clinical trials with the first-ever multispecific antibody in 2023.

“Ultimately, our approach is highly differentiated because our computer-designed antibodies do what no other antibody can,” said Micah Pearlman, chief operating officer. “This allows us to create highly innovative and differentiated therapies while focusing on validated targets. Additionally, we have a world-class team of advisors, biologists, immunologists, computer scientists and software engineers who are already running several ambitious early-stage programs in the near term as we build our AI platform to address the vast opportunity to treat multiple diseases with smart therapies. Our goal now is to expand our presence and leadership in the United States with Boston, Mass. as a base of operations to turn these nanobots into smart drugs.”

Biolojic Design has assembled an impressive team of advisors including:

  • Eugene Bauer, PhD, former CMO and founder of Dermira, former dean of Stanford Medical School
  • Tim Garnett, MD, Former Chief Marketing Officer, Eli Lilly
  • John Hastewell, PhD, former director of the Novartis Institute for Biomedical Biologics Research Center
  • Michael Hayden, MD, PhD, former CSO of Teva Pharmaceuticals, Killam Professor, UBC
  • Michael Kalos, PhD, former CSO Oncology, Eli Lilly
  • Nils Lonberg, PhD, former SVP, Oncology Discovery at BMS
  • Werner Meier, PhD, Former Vice President, Biologic Drug Discovery, Biogen
  • Alan Roemer, Former Co-Founder and COO, Roivant
  • Mace Rothenberg, MD, former CMO, Pfizer

Aulos Bioscience’s poster presentation of preclinical data on AU-007, the computer-designed antibody originally created by Biolojic Design, is available at www.aulosbio.com.

About Yanay Ofran
Yanay Ofran is a computational biophysicist and biotechnology entrepreneur. His scientific work focuses on the application of AI and computational biology to the study of genomes, diseases and drugs. Yanay founded Biolojic Design based on the discoveries and approaches he developed to predict and engineer antibody-protein interactions. Combining computational approaches with protein engineering technologies, Biolojic’s platform has generated many promising new drugs with first-in-class or best-in-class potential. Yanay is also co-founder and president of Ukko, a biotechnology company that designs healthy and safe proteins for the food and agricultural sectors. In 2020, Yanay co-founded Aulos Biosciences to revolutionize cancer treatment with a computer-designed antibody. Yanay obtained his doctorate. in Molecular Biophysics and Biomedical Informatics with honors from Columbia University and was Professor of Bioinformatics and Biophysics at Bar Ilan University near Tel Aviv. He is the author of more than 100 articles and patents.

About Biolojic Design
Biolojic Design is committed to curing patients by designing and developing a pipeline of breakthrough therapeutic products. Powered by AI, Biolojic’s technology designs single and multispecific antibodies precisely targeting predefined epitopes to execute novel biological programs. Focusing on cancer and autoimmune diseases that involve the immune system, Biolojic is developing a pipeline of antibodies designed to unlock the full potential of well-studied pathways. To learn more, please visit www.biolojic.com

THE SOURCE: Biological design

Abdul J. Gaspar