The grant worth USD 910,000 is executed by the Foundation for the National Institutes of Health, a US not-for-profit organization managing the precompetitive collaboration between the National Institutes of Health, National Cancer Institute, US Food and Drug Administration (US-FDA), and 12 pharmaceutical companies comprising AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Genentech/Roche, Gilead, GlaxoSmithKline, Janssen, Novartis, Sanofi, and Pfizer, as part of the Beau Biden Cancer Moonshot Initiative accelerating cancer research.
PACT seeks to provide a systematic approach to cancer biomarker investigation in clinical trials by supporting development of standardized assays.
Immuno-oncology focuses on using an individual's immune system to help fight their cancer using a class of drugs, ICIs, to target either of the immune regulatory proteins PD-1 or PD-L1.
At present, of those deemed eligible to receive an ICI, less than 30% will benefit from these drugs.
Unfortunately, a similar number will experience significant and sometime fatal side effects when these therapies are used.
Current testing modalities cannot predict who will and won't respond and generally require an invasive tumor biopsy.
Development of a predictive test, one that only requires a small blood sample, will help oncologists to successfully deploy these drugs as well as enable the pharmaceutical companies to further understand and develop IO therapies to expand their benefits.
In 4Q21, OBD expects to launch the "EpiSwitch ICI Response Test" as an LDT to allow access for oncologists who want to use it immediately and to start shaping the market.
The test, which is a predictive diagnostic of likely response in cancer patients considered for monotherapy treatment with immune checkpoint inhibitors, has been in full development since 2018.
More than 800 blood samples from multiple cohorts of patients have been analyzed, including several studies where the outcomes were blinded to validate the predictive abilities of this technology.
The aim of the test is to help oncologists deploy ICI drugs more successfully as well as enable pharmaceutical companies to further understand and develop IO therapies to expand their benefits.
The two-year USD 910,000 PACT Grant awarded to OBD will fund extended application of this technology to the analysis of primary and acquired resistance to ICI in several trials, including over 186 longitudinal samples from an observational trial, encompassing at least four separate ICI therapies and seven common cancer types.
The project will further validate this first-generation immune health assay for predicting response as well as monitoring resistance to ICI monotherapies.
It will also evaluate key differences in predictive profiles of the patients treated with a combination therapy of ICI and an epigenetic drug.
In awarding the PACT grant, the reviewers highlighted the strengths of OBD's success in applying the EpiSwitch platform for biomarker discovery, the prior experience of the team, the clinical practicality of non-invasive EpiSwitch testing from blood and the high relevance of the 3D genomic epigenetic modality.
OBD's EpiSwitch 3D genomics platform is well-known amongst the consortium's pharmaceutical companies and has been used for practical patient stratification in prognostic, predictive and early diagnostic applications across immuno-oncology, autoimmune and neurodegenerative indications.
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