Scott Gottlieb in the running for possible coronavirus czar; The drug Vanda sued the FDA over fails a pivotal study
→ Former FDA commissioner Scott Gottlieb is among a handful of candidates being considered for coronavirus czar, a new role that the Trump administration may set up to oversee the US’s response to the spreading outbreak, Politico reported. The president has yet to make the final decision, but has announced a press conference later today upon his return from India.
→ Days after a court ruled against Vanda in its lawsuit against the FDA over a partial clinical hold on tradipitant, the biotech said the drug has failed a Phase III study for pruritus associated with atopic dermatitis. While the neurokinin 1 antagonist missed the primary endpoint of reducing itching among all patients, Vanda pointed to “robust” antipruritic effect in the mild AD subpopulation as a reason to remain optimistic and said it will reassess its second, ongoing late-stage study.
→ Roche’s application seeking approval for a faster way to administer its oncology drugs Perjeta and Herceptin to help breast cancer patients has been accepted by the FDA. The Swiss drugmaker is looking to market a fixed-dose version of Perjeta+Herceptin with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous chemotherapy.
The SC administration of the cocktail takes roughly eight minutes for the initial loading dose and about five minutes for each subsequent maintenance dose. In contrast, it takes 150 minutes to infuse a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.
→ mRNA drug developer Translate Bio — which is eventually looking to knock Vertex Therapeutics off its cystic fibrosis perch — has scored the FDA’s fast track status for MRT5005. The drug, currently in a Phase I/II trial, is engineered to be delivered directly into the lung to address the underlying cause of CF, regardless of genetic mutation.
→ While researchers at MIT and Novo Nordisk are in the very early stages of developing a leopard tortoise-inspired capsule that delivers an insulin shot to the stomach, Israel-based Oramed is years ahead with its oral insulin treatment. The company’s lead drug — ORMD-0801 — was successful in the second and final cohort of a Phase IIb trial testing its ability to reduce blood sugar levels against a placebo. Data on the drug, which has the potential to be the first commercially available oral insulin capsule for the treatment of diabetes, pave the way for a late-stage study, Oramed said on Wednesday.
→ Seattle-based startup Oisin has raised $3 million to fund its preclinical work on tackling age-related diseases through clearing senescent cells. While the older approaches tend to be small molecule drugs and have run into safety troubles, Oisin employs an alternative tech, using a lipid nanoparticle to encode a “suicide gene” that’s only active on cells that highly express p53 or p16 transcription factors.
“We target cells with genetic information (DNA), based on their transcriptional activity instead of surface markers or chemistry,” CEO Matthew Scholz wrote to Endpoints News. “This affords us exquisite specificity and virtually no off-target effects or toxicity.”A spinout dubbed OncoSenX is testing an oncology drug designed on this platform, while Oisin is in the process of selecting a lead indication.
→ French biotech Advanced BioDesign, which is focused on developing therapies designed to overcome tumor resistant cancers, has raised an additional €9 million ($9.8 million) in financing from its long-standing investor Xerys Funds. The money will be used to take its lead experimental compound, designed to treat acute myeloid leukemia, into the clinic next year.