Healthcare Newsletter October 2020
In our last month newsletter, we summarized developments around the much-awaited COVID-19 vaccine. COVID-19 has been a stark reminder of risk at the One Health convergence and the stark need for innovation capacity in anti-infectives. We discuss below our enthusiasm around Pfizer acquiring anti-infectives and key approvals pointing to a pharma embrace of the therapeutic area, Bayer digging deeper in cell and gene therapies with a big buy, Asian companies dominating biosimilar developments, medical device M&A led by opportunistic deals and encouraging developments in NGS based companion diagnostics.
“Approval of two NGS based companion diagnostic tests including a liquid biopsy is testimony to power of collaborations between pharma and diagnostic companies to power the remaining wave of personalized medicine. Patients for AstraZeneca’s Tagrisso and Bayer’s Vikrakvi stand to gain with possibility of more informed clinical decision making”
The first companion diagnostic HER2 assay for Herceptin® was approved in 1998 and its success propelled big pharma to invest in companion diagnostics. The criticality of sensitive and specific companion diagnostics for patient selection was emphatic when FDA rejected ChemGenex pharmaceuticals’ Omapro due to lack of companion tests to identify the targeted leukemia population. To date, the FDA has approved 44 companion diagnostics as the personalized medicine sphere continues to extend beyond oncology into multiple therapeutic areas. Companion diagnostics have been a key enabler of personalized medicine wave and continue to power targeted therapeutics for patient cohorts most likely to benefit.
Recently, US Food and Drug Administration (FDA) approved the Guardant360 CDx a next-generation sequencing (NGS) based liquid biopsy test for AstraZeneca’s TAGRISSO® (osimertinib). It is a significant development as this is the first companion diagnostic test that combines both technologies – NGS and liquid biopsy. Liquid biopsies have paved the way for non-invasive testing in lieu of traditional tissue based diagnostics that has been characteristic of oncology care. Compared to traditional testing for a single mutation, NGS allows high-throughput profiling through large panel genetic sequencing. The Guardant360 CDx assay detects mutations in 55 tumor genes. As a companion diagnostic, the test will help identify patients with specific mutations of the epidermal growth factor receptor (EGFR) gene in metastatic non-small cell lung cancer (NSCLC) patients for guiding use of TAGRISSO. Additionally, with a simple blood draw the test will also provide additional information on critical genomic information and other solid tumor biomarkers that will guide clinical decision making on treatment for metastatic NSCLC patients. The test received breakthrough designation from the FDA and was approved based on data from over 5000 patient samples. The Guardant360 CDx is a great example of the highly impactful role that ecosystem partners such as diagnostic solutions providers are playing to expand clinical possibilities in oncology care.
Another NGS based companion diagnostic was also approved in October. Roche received FDA clearance for the only companion diagnostic for Bayer’s Vitrakvi (larotrectinib), CDx genomic test developed by FoundationOne a Roche subsidiary. FoundationOne® CDx will help identify neurotrophic receptor tyrosine kinase (NTRK) gene fusion positive patients for treatment with Vitrakvi. The test is performed on DNA isolated from tissue specimens from patients with solid tumors eligible for treatment with Vitrakvi. Again, reflecting the potential of NGS, the assay can detect several mutations in addition to NTRK gene fusions. The test analyzes 324 genes for substitutions, insertion and deletion alterations (indels) and copy number alterations (CNAs) and genomic signatures across all solid tumors, including the three NTRK gene fusions ((NTRK1, NTRK2 and NTRK3) relevant for informing treatment decisions. The test has been developed as part of the global collaboration between Bayer and FoundationOne for the development of Next-Generation Sequencing (NGS) based companion diagnostics that was forged in May 2019. More details of the approval can be found here. This is again a great landmark on both counts, potential of NGS in oncology care and personalized medicine, as well as, need for expanded collaborations between pharma and diagnostic companies to truly realize the value.
Finally, the month also witnessed critical developments on use of AI in diagnostics in a way that it can again push the boundaries of drug discovery, therapeutic possibilities and personalized medicine. Imbio inked partnerships with two major partners – Siemens Healthineers and Genentech. The Siemens Healthineers collaboration will provide access to Imbio’s AI algorithms to physicians worldwide through an Open Apps interface on Siemens’ syngo.via platform. On the other hand, through the multiyear partnership Genentech will leverage Imbio’s medical imaging AI technology along with its expertise in imaging biomarkers and integrate it with Genentech’s pulmonary disease expertise. This partnership will leverage of power of imaging diagnostics for research, clinical trials, and will power drug development to deliver more personalized healthcare. Power of NGS and AI emphatically call for breaking down of silos in drug discovery, diagnostics development and clinical practice. While we look forward to realizing the promise of personalized medicine and acceleration potential of NGS and AI, we also seek a future where such several more of such collaborations thrive and are the new normal.
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