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Pharmacology and human Phase 1 safety and dose escalation studies using anti-GP88 in aggressive breast cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44CA224718-02
Agency Tracking Number: R44CA224718
Amount: $1,889,054.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-01
Award End Date (Contract End Date): 2023-02-28
Small Business Information
Columbia, MD 21045-2006
United States
DUNS: 963442723
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 884-4100
Business Contact
Phone: (410) 884-4100
Research Institution

In 2017, ~200,000 new cases of breast cancer (BC) and ~40,000 related deaths are expected in the US. ~30,000
of these are patients with aggressive triple negative BC (TNBC) or anti-estrogen/aromatase inhibitor resistant
(AE/AI) BC that do not have targeted therapy and rely on radiotherapy and aggressive chemotherapy. A new
approach that benefits these patients and provides increased life expectancy needs to be developed. We have
identified GP88, a glycoprotein that is produced by cancer cells and stimulates their growth and survival leading
to formation of more aggressive tumors. GP88 is found in BC but not in normal breast tissue. There is compelling
biological and clinical evidence to suggest that GP88 can be used to develop novel targeted therapy with
companion diagnostics that could impact treatment and improve survival of TNBC and AE/AI BC patients. We
have developed a tissue test to identify patients with tumors expressing GP88 and an anti-GP88 (AG1) to block
the action of GP88 on tumor tissues to a) inhibit tumor growth and b) increase the efficacy of current BC drugs.
We have safety and efficacy data in animals and will in our Phase 1 develop a dosing strategy in mice before
moving into human studies as part of the Phase 2. Additionally, a blood test has been developed to monitor
patients while on treatment. Using AG1 as the therapy with two companion diagnostic tests, we will carry out a
phase IA/B clinical trial in humans to determine safety of AG1 manufactured under GMP in the Phase 2 and will
collect tumor tissue and blood on all patients to evaluate for GP88 expression (tissue) and concentration (blood).

* Information listed above is at the time of submission. *

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