Trial to Test AI-Designed Cancer Antibody Therapy

(PDPics, Pixabay)

5 Apr. 2022. A clinical trial is set to begin evaluating a synthetic antibody treatment for solid tumor cancer designed with machine learning algorithms. The study is conducted in Australia by Aulos Bioscience Inc., based in Larkspur, California, testing the antibody created by Biolojic Design in Boston.

Biolojic Design uses computational techniques, including machine learning algorithms from artificial intelligence, to design synthetic antibodies with therapeutic properties for treating cancer. The company says its technology searches for natural antibodies that bind to desired epitopes or binding sites on target cells, then applies algorithms to predict mutations that correct deficiencies in the natural antibody. The resulting synthetic antibody, says Biolojic, is tolerated in the body like a natural entity, but performs without adverse effects produced by its natural precursor.

Aulos Bioscience was spun-off from Biolojic Design in Jan. 2021 for clinical development and commercialization of Biolojic’s synthetic antibodies, starting with a treatment for solid-tumor cancers code-named AU-007. This antibody, says Aulos Bio, is similar to interleukin-2, or IL-2, a natural cytokine protein that attacks tumors, but designed to correct for properties that can cause serious adverse effects in cancer patients.

Testing alone and with chemotherapy

“We know IL-2 activates the immune system to attack the tumor,” says Biolojic Design founder and CEO Yanay Ofran, in a company statement released through Cision, “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.”

The early- and mid-stage clinical trial is enrolling 60 patients with advanced or metastatic solid tumor cancer at three sites in Australia. The study is testing AU-007 first on its own, to determine a safe and tolerated dose for cancer patients, then with the chemotherapy drug aldesleukin, to find a safe and tolerated dose of the two therapies in combination, tracking participants for 28 days. From there, the trial assesses efficacy of AU-007 and aldesleukin together, with the study team looking for presence and concentrations of AU-007 in participants’ blood samples, as well as anti-tumor activity using a standard measure of treatment response.

Biolojic Design was founded in 2010 by Ofran, a professor of systems biology and functional genomics at Bar Ilan University in Ramat Gan, Israel. The company is also developing synthetic antibodies that bind to two or more targets it calls multibodies. Biolojic says multibodies are designed to address multiple targets in different tissues or at different times, using and/or logic similar to semiconductors.

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