Pfizer, Astellas win priority review for Xtandi sNDA; Hemispherx changes its name
→ The FDA has granted Pfizer $PFE and Astellas priority review for a label expansion for Xtandi, the prostate cancer drug it grabbed in the $14 billion acquisition of Medivation. An approval here, for metastatic hormone-sensitive prostate cancer, would make the drug available to patients earlier in their treatment regimen, the companies said. In two Phase III studies, the drug was shown to improve progression-free survival when used in conjunction with androgen deprivation therapy.
→ Hemispherx Biopharma is putting all its eggs in the Ampligen basket, and it’s changing its name to reflect that. The company’s new name, AIM ImmunoTech, stands for “amplified immunological modulation” — the technology that its lead drug is based on. Correspondingly it will be trading on the NYSE under $AIM instead of $HEB.
→ Boston biotech HotSpot Therapeutics, which is working molecules to treat serious autoimmune and metabolic diseases, is buying out its partner Macroceutics. HotSpot’s technology is engineered to isolate ‘regulatory hotspots’ — a “family of pockets that sit remote from the active site on a protein and are used by nature to control protein function,” to develop medicines. Macroceutics is provider of DNA-encoded library (DEL) screening technology, which molecules to be synthesized and screened against a protein of interest. “Using the rich structural information delivered by our platform, we have a roadmap for the design of customized chemical scaffolds. DEL technology allows us to translate these insights into millions of tailored scaffolds quickly, accelerating hit expansion and lead optimization efforts,” Geraldine Harriman, co-founder and Chief Scientific Officer of HotSpot Therapeutics said in a statement. No financial details were disclosed.