Guardant blood test shows promise in predicting immunotherapy response; AstraZeneca's diabetes drug wins EU label expansion
→ The field of liquid biopsy is burgeoning, and each player (there are plenty) is doggedly pursuing consistency and accuracy — false positives induce unnecessary anxiety, and are costly. Late on Sunday, Guardant Health said its assay, Guardant360, showed in a study it can accurately detect microsatellite instability (MSI), a key biomarker used to predict response to immunotherapy regardless of tumor type. MSI is a change that occurs in the DNA of certain cells (such as tumor cells) in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different than the number of repeats that was in the DNA when it was inherited.
Researchers compared the results of 1,145 Guardant360 samples to MSI status determined using standard-of-care tissue testing; the Guardant360 results were aligned with standard testing in 98.4% of cases. In a cohort of 16 high MSI gastric cancer patients treated with checkpoint inhibitors, outcomes predicted by the Guardant test were consistent with responses for patients identified by tissue testing.”Unfortunately, less than half of all advanced colon cancer patients are tested for this important biomarker. And across all solid tumors, we suspect the testing rate is far lower, in part due to challenges of working with tissue samples,” said Jeeyun Lee, associate professor, division of hematology/oncology, Samsung Medical Center in a statement.”By incorporating these results into a simple blood test, we should be able to increase the number of patients who get this information and benefit from appropriate immunotherapy.”
→ AstraZeneca‘s $AZN SGLT2 diabetes drug, dapagliflozin, has won a label upgrade courtesy of the EMA. The drug, sold as Forxiga, will carry a label including positive cardiovascular (CV) outcomes and renal data from a late-stage trial involving adults with type 2 diabetes — a majority of whom had no existing cardiovascular disease. “For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke. In the Phase III DECLARE-TIMI 58 trial,Forxiga reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type-2 diabetes,” said Mene Pangalos, executive VP of BioPharmaceuticals R&D, in a statement.
→ UK-based drug developer Verona Pharma $VRNA has scored in a mid-stage study testing its dry powder inhaler formulation of ensifentrine in COPD patients. The positive study follows a failed Phase II trial testing the nebulizer formulation of the drug. Verona has touted the drug as the first potential therapy for respiratory diseases that acts as both a bronchodilator and anti-inflammatory agent in a solitary compound.
→ Squarex‘s lead drug, SQX770, has cleared a mid-stage trial testing the topical immunomodulator for the longterm prevention of recurrent cold sores (herpes labialis) and other infections caused by herpes simplex viruses. Data from the 139-patient study showed a single topical dose of SQX770 applied to the upper arm significantly extended time to next outbreak and reduced both the frequency and severity of outbreaks. “Our findings confirm and validate the results from two previous studies including a previous placebo controlled clinical trial and therefore, pave the road for the initiation of a Phase 3 trial,” said Squarex chief Jack Talley. “With no current preventative treatment options on the market for the millions of patients who suffer from recurrent HSV-1 outbreaks, we are excited to continue the clinical development and hopefully becoming the first and only choice for combating herpes labialis – cold sores or oral herpes.”
→ As 3-V Biosciences executes a strategic pivot to the increasingly crowded NASH field, the San Mateo biotech is also changing its name to Sagimet (a combination of Sagitta and metabolism) its new focus on the liver. To be sure, it will continue its research efforts in cancer with its fatty acid synthase inhibitor, but NASH will become much more top of mind now. Ascletis, the Chinese player best known for its hepatitis drugs, is endorsing this strategy by leading the second tranche of a $25 million Series E. Qianhai Ark, Kleiner Perkins and New Enterprise Associates (NEA) also participated.