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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Immunomedics eyes the finish for their ADC in breast cancer
Company: Immunomedics (IMMU)
Therapy: Sacituzumab govitecan
Disease: Metastatic triple-negative breast cancer
News: IMMU announced that they have submitted a final application for approval for their antibody-drug conjugate sacituzumab govitecan in patients with metastatic, previously treated triple-negative breast cancer. IMMU based this filing on data obtained from a phase 1/2 trial that showed highly favorable efficacy, with licensing and other trials following shortly thereafter.
Looking forward: It is definitely aggressive for IMMU to pursue approval on the basis of such early-stage clinical data, but the response rates presented at SABCS were remarkable compared with historical findings, and the FDA has made it a point in recent years to grant conditional approval for strong response data in areas of high unmet need. So I wouldn't be too surprised if IMMU secures this approval. Overall, this sucks for Seattle Genetics (SGEN), which was forced to terminate a deal with IMMU last year.
Foundation Medicine lays the groundwork for major testing landscape
Company: Foundation Medicine (FMI)
Therapy: FoundationOne CDx
News: FMI announced that the Centers for Medicare and Medicaid Services approved their FoundationOneCDx test for ADLT status, meaning that this test will be covered by Medicare and Medicaid. This molecular testing platform provides useful mutational analysis information across a wide variety of solid tumors, allowing clinicians to personalize treatment selection based on individual tumor findings.
Looking forward: Considering cancer is a disease of old age, the inclusion of this test in Medicare reimbursement is a bigger deal than it may seem at first glance. Without this group, FMI would be relying on private payers, cutting out a huge source of revenue. In order to have FoundationOne see widespread adoption in the oncology community, doctors need to know that their patients won't suffer undue financial burden just to get their tumors tested.
Abeona updated on Sanfilippo B
Company: Abeona Therapeutics (ABEO)
Disease: Sanfilippo B syndrome
News: ABEO delivered a presentation of updated findings from their ongoing phase 1/2 trial investigating ABO-101 in patients with Sanfilippo B syndrome. ABO-101 is designed to correct the defective NAGLU gene that encodes an enzyme needed to process certain polysaccharides, leading to severe growth defects and other health problems. The first patient enrolled in cohort 1 demonstrated no evidence of liver damage or immune response to the pieces of viral vector used to deliver the gene therapy. Furthermore, as of 30 days post-treatment, NAGLU levels were normalized, with corresponding corrections in various clinical findings, such as liver size and levels of heparan sulfate.
Looking forward: Very interesting early data, providing a faint glimmer of efficacy and safety in a rare but challenging disease. Currently, there is no standard of care for Sanfilippo B syndrome, and gene therapies have been held up as the wave of the future for such inherited disorders. Of course, these data won't get the drug approved, not until there is stronger experience with the gene therapy. However, this is about as positive as you're going to get with such early findings!
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