Intellect Neurosciences, Inc. and MRC Technology (MRCT) have announced that they have completed humanization of 82E1, a mouse monoclonal antibody to create a high-affinity stabilized IgG4 therapeutic antibody that binds the amino terminus of amyloid beta without binding to the amyloid precursor protein (APP).
Antibodies exist in several isoforms; IgG1 antibodies have the strongest potential to induce inflammation while IgG4 has the lowest potential.
The Intellect antibody, called IN-N01, is anticipated to promote the clearance of monomeric, oligomeric and plaque forms of amyloid beta, which accumulate in the brains of Alzheimer's patients or following traumatic brain injury and in the retina of the eye in patients with age-related macular degeneration, diabetic neuropathy and glaucoma.
Intellect Neurosciences and MRCT also have amended their Service Agreement to reduce Intellect’s cash outlay in exchange for equity. This reflects MRCT’s new strategy of risk sharing on exciting antibody projects.
“IN-N01 is an important addition to Intellect’s diversified preclinical pipeline,” commented Daniel G. Chain, PhD, Intellect’s Chairman and CEO.
Chain continued, “The recent Phase 3 data for bapineuzumab, an IgG1 antibody, despite failing to show improvement in clinical endpoints, demonstrated through the use of biomarkers the drug engaged the amyloid beta target and reduced neurodegeneration indicating both the need for earlier intervention and improved antibody-based therapies. We anticipate IN-N01 will have improved safety, which means that it can be used at higher, more frequent doses, that likely will result in clinical efficacy, especially if administered to presymptomatic patients.”
IN-N01 could be developed without further modification or empowered by chemically combining the antibody with a small molecule, such as an antioxidant, using Intellect’s CONJUMAB™ platform technology.
The company plans to evaluate IN-N01 in both contexts. Additionally, Intellect plans to test IN-N01 in combination with its tau monoclonal antibodies, TOC1- and TauC3.
“MRCT’s collaboration with the team at Intellect Neurosciences applying our unparalleled expertise to this important and timely project will be critical to the development of IN-N01 as a therapeutic antibody and we are confident in its potential success,” said Dr. Dave Tapolczay, MRCT’s CEO.
Dr. Tapolczay continued, “We believe Intellect Neurosciences is on track with a promising drug candidate and therefore were pleased to offset their cost of development by sharing in the risk.”