Company
Business Model and Partnering Strategy
1. Co-Development Partnerships
Companion and stratification diagnostic development with pharmaceutical companies for BH3 mimetics and targeted oncology agents, leveraging PRIMABS-Dx as a validated platform CDx technology.
2. Clinical Trial Services
Revenue from sponsored clinical trials, providing patient stratification, pharmacodynamic monitoring, and biomarker-driven endpoint assessment for oncology drug development programs.
3. CLIA Testing & Licensing
Commercial CLIA laboratory services for physician-ordered testing, plus licensing of proprietary assays, algorithms, and intellectual property to diagnostic companies and healthcare systems.
4. Regulated IVD Products
Revenue from sponsored clinical trials, providing patient stratification, pharmacodynamic monitoring, and biomarker-driven endpoint assessment for oncology drug development programs.
Team Leading to Next Milestones
Leadership
Strategic Milestones
01
Expand AML/MM Validation
Complete multi-center clinical validation studies`
02
Solid Tumor Extension
Adapt PRIMABS-Dx for lung, ovarian, and breast cancers
03
Strategic Partnerships
Formalize co-development agreements with pharma partners
04
Regulatory Pathway
Initiate FDA breakthrough device designation discussions
Our team combines biotech development expertise with strong scientific advisory from leading cancer centers
Michael Cardone, PhD – Founder & CEO; previously founder of Merrimack. Pharmaceuticals.”
Kevin Kelly, MD, PhD – Scientific Advisor/PI; heme oncology therapy at USC/Keck.
Michael Andreeff, MD, PhD (Founding Scientific Advisor) Professor, Key Opinion Leader at MD Anderson
Peter Rock, MBA ( CFO) biotech. CFO/COO/CBO of Pharma companies including DYAX.
Alan D’Andrea, MD (Founding Scientific advisor) at Dana Farber, National Academy of Sciences..
Duncan Whitney, PhD – Business/Scientific Advisor; Previously VP/CSO, Exact Sciences, Veracyte, J & J.
Publication
Development of a Novel Biomarker Platform for Profiling Key Protein-Protein Interactions to Predict the Efficacy of BH3-Mimetic Drugs. Cancers (Basel). 2025 doi: 10.3390/cancers17111852.
Sequential azacitidine plus lenalidomide in previously treated elderly patients with acute myeloid leukemia and higher risk myelodysplastic syndrome. Leuk Lymphoma. 2016; doi10.3109/10428194.2015.1091930.
Anti-apoptotic BCL-2 family proteins confer resistance to calicheamicin-based antibody-drug conjugate therapy of acute leukemia. Leuk Lymphoma. 2020 doi: 10.1080/10428194.2020.1786553.
Reduced occurrence of tumor flare with flavopiridol followed by combined flavopiridol and lenalidomide in patients with relapsed chronic lymphocytic leukemia (CLL). Am J Hematol. 2015 doi: 10.1002/ajh.23946.
A Phase I/II Trial of Carfilzomib, Pegylated Liposomal Doxorubicin, and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2019. doi: 10.1158/1078-0432.CCR-18-1909.
Mitochondrial priming of chronic lymphocytic leukemia patients associates BclxL dependence with alvocidib response. /leu.2014.206. Epub 2014 Jul 3.PMID: 24990615
Rationally derived drug combinations with the novel Mcl-1 inhibitor EU-5346 in breast cancer. Cancer Res Treat. 2019 doi: 10.1007/s10549-018-5022-5.
Mcl-1 dependence predicts response to vorinostat and gemtuzumab ozogamicin in acute myeloid leukemia. Leuk Res. 2014 doi: 10.1016/j.leukres.2014.02.007.
Mcl-1 confers protection of Her2-positive breast cancer cells to hypoxia: therapeutic implications. Breast Cancer Res. 2016 doi: 10.1186/s13058-016-0686-4.PMID: 26921175
Mcl-1 mediates TWEAK/Fn14-induced non-small cell lung cancer survival and therapeutic response. Mol Cancer Res. 2014 Apr;12(4):550-9. doi: 10.1158/1541-7786
Mitochondrial Profiling of Acute Myeloid Leukemia in the Assessment of Response to Apoptosis Modulating Drugs. PLoS One. 2015 doi: 10.1371/journal.pone.0138377.
BH3 profiling discriminates response to cytarabine-based treatment of AML. Mol Cancer Ther. 2013. doi: 10.1158/1535-7163.MCT-13-0692.
Hydroxyquinoline-derived compounds and analoguing of selective Mcl-1 inhibitors using a functional biomarker. Bioorg Med Chem. 2013 doi: 10.1016/j.bmc.2013.08.017.