FDA endorses Novavax's pivotal trial design for flu vaccine; Forty Seven bags funding for myelodysplastic syndromes program
→ Following a stream of setbacks with its RSV vaccine, Novavax is touting some regulatory progress of another candidate for a change. The FDA has apparently green-lighted the Phase III trial design for NanoFlu, its adjuvanted, recombinant quadrivalent flu vaccine targeting the elderly (65 or older). The trial is expected to begin in a couple of months and generate top-line data in the first quarter of 2020.
→ The anti-CD47 work that Forty Seven has been doing in myelodysplastic syndromes has caught the attention of The Leukemia & Lymphoma Society, which now wants to help accelerate the development of the early-stage 5F9 program. “Despite incredible advancements for patients with other hematological malignancies, the treatment landscape in MDS has remained unchanged for many years, with no new FDA-approved therapies since 2006,” LLS CSO Lee Greenberger said in a statement. So far, the biotech — founded by Stanford’s Irv Weissman — has demonstrated an impressive overall response rate of 100%, more than half of which were complete responses. LLS is offering $6 million to fund the upcoming trial and $3 million more for milestones, eyeing a BLA filing as early as 2021.
→ Leap Therapeutics‘ $LPTX anti-DKK1 antibody, DKN-01, in tandem with Merck‘s $MRK flagship checkpoint inhibitor Keytruda in a study improved outcomes in patients with gastroesophageal junction and gastric cancer whose tumors are DKK1-high and who had not previously been treated with PD-1/PD-L1 immunotherapies. “Outside of rare microsatellite instable tumors and EBV-associated cancers the response rates to immune checkpoint inhibitors are low and median progression-free survival remains short, in the range of 6-8 weeks,” said Samuel Klempner, assistant professor, Massachusetts General Hospital Cancer Center and Harvard Medical School in a statement. “This study…suggests that elevated DKK-1 expression is a potential predictive biomarker. DKN-01 warrants further study in gastroesophageal cancers in combination with immune checkpoint inhibitors and with chemotherapy.”