NIA Small Business Showcase: AivoCode, Inc.
AivoCode, Inc. is an emerging biotechnology company focused on critical neurological diseases such as brain injury, Alzheimer’s disease (AD), and other neurodegenerative conditions. AivoCode’s technology is based on novel and proprietary ligands that specifically recognize molecular changes in neurological conditions. These ligands are identified by a unique and unbiased target discovery platform. AivoCode currently has two ongoing drug development programs based on two targets identified through its platform. The traumatic brain injury (TBI) program is in investigational new drug (IND)-enabling studies, and the AD program is in lead discovery.
One of the hallmarks of AD is the progressive loss of neuronal cells, which is ultimately fatal. Several lines of investigations implicate the role of vascular dysfunction, characterized by the loss of mural cells (pericytes) and compromised blood-brain barrier, in the pathogenesis of this disease. This early event leads to neuroinflammation and the subsequent amyloid pathology commonly observed in AD patients.
The unique unbiased screening approach employed by AivoCode to probe the vasculature in AD has identified a novel target, connective tissue growth factor (CTGF), which is involved in vascular dysfunction and neuroinflammation. The expression of CTGF is elevated starting from an early stage of AD and is accessible from systemic circulation, obviating the need to traverse the blood-brain barrier. AivoCode is developing a proprietary, single-domain therapeutic antibody to neutralize this target, inhibit neuroinflammatory pathways, and reverse vascular dysfunction.
The global market for AD treatment will more than double in value from $4.9 billion in 2013 to an estimated $13.3 billion by 2023. The increasing prevalence of AD and mild cognitive impairment across the aging population, together with advances in diagnostic capability and increased social awareness of the disease, will contribute further to market growth.
AivoCode’s therapy is based on active targeting to the abnormal brain vasculature, which is an early event in the disease; repairing the compromised blood-brain barrier; and inhibiting the neuroinflammatory pathways. In addition, single-domain antibodies offer advantages over conventional monoclonal antibodies, including smaller size, improved stability, and better penetration through tissue and barriers, including the blood-brain barrier. The anticipated efficacy, combined with the apparent lack of toxicity and side effects, will give the therapy a substantial competitive advantage in this market, where the standard-of-care therapies are ineffective and routinely result in adverse events. AD is complex, so people living with the disease likely will need combination therapies. AivoCode’s therapy can be combined with other disease-modifying drugs.
Company Milestones
Scientific
- 2016: AivoCode founded
- 2016-2017: High-impact publications of key findings in TBI and AD
- 2019: Lead optimization of TBI drug candidate completed
- 2020: Demonstrated proof of concept in animal models of AD
- 2021: Completed single-domain antibody identification for targeting CTGF
- 2023: Conduct lead identification and in vivo validation in models of AD
Business
- 2016: Received a Phase I Small Business Innovative Research (SBIR) grant from the National Science Foundation (NSF) for a TBI platform
- 2017: Received a Phase II SBIR grant from NSF for developing the TBI platform
- 2019: Received a Phase I SBIR grant from NIH for developing a small-molecule therapy for TBI
- 2020: Secured an angel investment to progress TBI therapeutic candidate development
- 2021: Received a Phase I SBIR grant from NIH for identifying a therapeutic for AD
- 2022: Filed a key patent application covering lead compounds for multiple indications
Financial Overview
AivoCode has raised $2 million, including majority non-dilutive SBIR funding and angel investment. The company currently has a $1 million seed investment for completing lead identification and optimization in 12 months. AivoCode plans to raise a Series A investment of $5 million to $10 million to IND-enabling studies for AD and other rare disease candidates.
Intellectual Property
AivoCode’s intellectual property consists of first-in-class therapeutic molecules and targeting ligands for broad neurological indications. The targeting ligands are particularly suited for payload delivery into affected brain regions and can help make off-patent drugs proprietary and rescue drugs that have failed because of insufficient efficacy or toxicity. AivoCode has established licensing agreements with Sanford Burnham Prebys Medical Discovery Institute that provide the company with exclusive rights to ligands to target neuroinflammation and neurotrauma.
Product Development and Regulatory Strategy
AivoCode’s first product is a small-molecule therapeutic in preclinical safety studies for treatment of TBI. The nanobody program for AD is in the lead identification stage, and AivoCode plans to complete the lead discovery by Q1 of 2023.
Commercialization Strategy
AivoCode is currently seeking a seed investment for the AD program to complete lead discovery and to generate additional targets to build a portfolio comprising novel therapeutic agents for other neurological indications. AivoCode will seek partnership with one of the larger companies to conduct clinical studies and post-approval marketing.
Company Details
La Jolla, CA
Industry: Therapeutics
Management Team:
- Chief Executive Officer: Aman Mann, Ph.D.
- Chief Scientific Officer: Sazid Hussain, Ph.D.
- Executive Chairman: Erkki Ruoslahti, M.D., Ph.D.
Point of Contact:
Aman Mann, Ph.D.
Email Aman Mann
(832) 287-7308