Molecular diagnostics firm Caris Life Sciences has launched a next-generation sequencing-based assay to analyze the whole exome of 22,000 DNA genes. Known as MI Exome, it builds on the existing whole transcriptome sequencing product MI Transcriptome that analyzes 22,000 RNA genes, as well as its microbiome analysis.
With accelerated approval in hand for Trodelvy (sacituzumab govitecan-hziy) to treat metastatic triple-negative breast cancer (mTNBC), Immunomedics Inc. is looking ahead to data related to the next indication for the antibody-drug conjugate (ADC) – urothelial tumors – “in the near future,” Chairman Behzad Aghazadeh told investors during a conference call.
Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy designation and priority review, moved along faster thanks to the objective response rate (ORR) and duration of response (DoR) turned up by Morris Plains, N.J.-based Immunomedics in a single-arm, multicenter phase II study. Continued approval may be contingent on verifying clinical benefit in the confirmatory phase III experiment called Ascent, recently halted by the independent data safety monitoring committee due to compelling evidence of efficacy across multiple endpoints.
Although the product pipeline for vaccines and therapeutics targeting COVID-19 is top of mind right now, investors are also keeping a close eye on companies involved in the development of medicines targeting cancer and the central nervous system. According to financings tracked by BioWorld and deals and grants logged in Cortellis, the therapeutic areas of cancer, neurology and psychiatric attracted the highest amounts of investments last year with a collective $101.9 billion and $27.5 billion raised, respectively.