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Adecto Pharmaceuticals awarded Phase II NCI SBIR grant to continue development of an ADAM8 cancer diagnostic

BOSTON, Mass. (Sept 1, 2022) - We are excited to announce that Adecto Pharmaceuticals has been awarded its second Phase II $2M Small Business Innovation Research (SBIR) grant from the National Cancer Institute. This award will support the continued development of an immunohistochemistry (IHC)-based assay for detection of ADAM8-positive tumors in patients to be used as both a companion diagnostic to an ADAM8-targeted therapy we are developing and as an important new tool for patient prognosis. 

With Phase I funding, a prototype assay based on Adecto’s highly specific anti-human ADAM8 monoclonal mouse ADP2 antibody was developed and validated in a panel of human primary breast cancer samples containing all known subtypes. The results of this analysis showed that ~30% of all breast cancers express ADAM8 and could likely benefit from an ADAM8-targeted therapy. Furthermore, for the most abundant hormone-positive, HER2-negative breast cancer subtype, the ADP2 IHC assay revealed an ADAM8 highly positive subpopulation at risk of particularly poor survival, establishing this assay’s value in patient prognosis. 

The ADP2 assay takes advantage of existing well-accepted clinical diagnostic technology and can be easily added to the standard molecular screening of patient biopsies without the need for collecting any additional patient samples; this allows for rapid introduction into pathology laboratories and access for patients. Importantly, the ADP2 antibody shares the same epitope as our humanized ADAM8 therapeutic AD100 antibody, a critical specificity and safety feature that ensures only cancers confirmed to express this specific epitope of ADAM8 on their surface will be chosen for treatment with AD100. As a prognostic tool, this assay could be used to identify high-risk vs low-risk patients and guide the selection of more aggressive treatment regimens where needed, while sparing those with lower risk from unnecessarily toxic regimens.

We are grateful for the recognition and support from the NIH SBIR program. The current grant will allow us to complete pre-clinical studies, generating a CLIA-validated assay ready to enter clinical testing. Given the evidence that high ADAM8 expression correlates with poor survival or aggressive phenotype in a number of common solid tumors, including those of the breast, colon, stomach, liver, pancreas, lungs, head and neck, and bones, this IHC assay could help improve the outcome for a substantial section of the population affected by cancer. 

Company Summary
Adecto Pharmaceuticals is a small, privately-owned, company focused on the development of products for the detection and treatment of ADAM8-expressing cancers. The cell surface ADAM8 protein is a critical driver of the growth and spread of many aggressive cancers. Adecto’s initial focus is on breast cancer with a plan to expand to other oncology indications in the future. Globally, over 2 million patients are estimated to be affected by an ADAM8-positive cancer.

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