First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

Biolojic uses its proprietary AI platform to design antibodies with new capabilities to cure disease, ushering in a new era of smart therapeutics

Biolojic Tel Aviv to focus on computational design of antibodies; Boston location will focus on drug development

BOSTON, April 5, 2022 /PRNewswire/ -- Biolojic Design, a unique technology company pioneering 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 time ever a computationally designed antibody will enter a clinical trial in patients. The trial will evaluate AU-007, a highly differentiated monoclonal antibody that was computationally designed by Biolojic and harnesses the power of the body's own interleukin-2 (IL-2) to eradicate solid cancer tumors. The antibody was transferred to Aulos Bioscience, a Biolojic spinoff that is now conducting clinical trials in Australia and is currently recruiting patients, with hopes of reporting 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 more than 10 years through an AI platform that uses computational biology and big data to guide the design of epitope-specific antibodies. His goal: to design antibodies that have a predetermined, desired effect on the function of a targeted protein. 

"Unlike the antibodies made by conventional antibody technologies, the promise of our approach is creating smart antibodies -- a sort of nanorobot that, like naturally occurring proteins, is able to adapt to changing situations," said Ofran. "We are finally at a stage to evaluate a computationally designed antibody in humans.  Through our work with Aulos Bioscience, the first computer-designed antibody in history will be administered to human patients."

"Our AI platform basically mimics the human immune system using AI," said Ofran. "For this program, we chose the IL-2 pathway, which is well-studied and extensively explored. The antibody that is entering the clinic now was designed based on our understanding of the IL-2 pathway. We know IL-2 activates the immune system to attack the tumor, but it can also inhibit this attack and in many cases leads to leakage from blood vessels, which can in turn lead to complications like 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 halt IL-2's ability to inhibit the immune system or to cause toxicities such as leakage of blood vessels or swelling in the lungs. This represents a new, promising direction for leveraging IL-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 computationally designed monoclonal antibody from the preclinical stage through 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 elimination in ten of 19 mice treated with AU-007 when used with PD-1 or PD-L1 checkpoint inhibitors in a murine 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 which is comprised of unique therapeutics enabled by its AI platform. These include a dual specific 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 is planning to start clinical trials with the first ever multi-specific antibody in 2023.

"Ultimately our approach is highly differentiated because our computationally designed antibodies do what no other antibody can do," said Micah Pearlman, Chief Operating Officer. "This allows us to create highly innovative and differentiated therapeutics while focusing on validated targets. Furthermore, we have a world-class team of advisors, biologists, immunologists, computational scientists and software engineers who are already executing several ambitious early-stage programs in the near-term, as we strengthen our AI platform to address the vast opportunity of treating multiple diseases with smart therapeutics. Our goal now is to expand our presence and leadership in the U.S. with Boston, Mass. as our base of operations for turning these nanorobots 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 CMO, Eli Lilly
• John Hastewell, PhD, Former Head of Novartis Institute for Biomedical Research Biologics 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 VP, Biologics Drug Discovery, Biogen
• Alan Roemer, Former co-founder and COO, Roivant
• Mace Rothenberg, MD, Former CMO, Pfizer

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

About Yanay Ofran
Yanay Ofran is a computational biophysicist and a biotech 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 findings and approaches he developed to predict and design the interactions between antibodies and proteins. Combining computational approaches with protein engineering technologies, Biolojic's platform has generated many novel promising drug leads with first- or best-in-class potential. Yanay is also the co-founder and chairman of Ukko, a biotech company that designs healthy and safe proteins for the food and agricultural sectors. In 2020, Yanay co-founded Aulos Biosciences to revolutionize the treatment of cancer with a computationally designed antibody. Yanay received his Ph.D. in molecular biophysics and biomedical informatics with distinction from Columbia University and was a professor of bioinformatics and biophysics at Bar Ilan University near Tel Aviv. He is the author of over 100 papers and patents.

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

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SOURCE Biolojic Design