BioNTech nabs PhI antibody and a new US base out of bankruptcy; Pfizer wins conditional drug OK
→ BioNTech is buying MabVax’s labs $MBVX and a clinical asset out of bankruptcy as the German mRNA company establishes a satellite operation in San Diego. The biotech, which has evidently been kicking around a monster IPO, acquired the bankrupt operation’s lead candidate, MVT-5873, “as well as other pre-clinical antibody assets to expand and complement its existing antibody portfolio.” That lead Phase I program is described as an IgG1 monoclonal antibody targeting sialyl Lewis A (SLeA), “an epitope expressed in pancreatic and other GI cancers that plays a role in tumor adhesion and metastasis formation.” No terms were given, but BioNTech made clear in its statement that they plan to use the new base to help with their clinical development plans in the US.
→ After Pfizer $PFE secured accelerated US approval for its TKI cancer drug lorlatinib last November for certain patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) — the US drugmaker on Tuesday said the EU had also backed the drug, granting it conditional approval. The drug will be sold under the brand name Lorviqua in the region. “Lorviqua is our second lung cancer medication approved in Europe within two months and our third biomarker-driven medicine for lung cancer,” said Andreas Penk, regional president of oncology international developed markets at Pfizer, in a statement.
→ Moderna $MRNA revealed in its quarterly report today that its longtime partner Merck has decided to sideline work on its preclinical RSV vaccine mRNA-1777. The pharma giant instead has chosen to file an IND on another RSV candidate — mRNA-1172 — which uses another proprietary Merck formulation. They’re now planning a Phase I.
→ Although Regeneron $REGN reported that one of its star experimental cancer drugs was linked to two deaths in a small study in its first-quarter earnings call on Tuesday, the Eylea-maker did report good news on its monoclonal antibody Dupixent, which generated about $374 million in quarterly sales. European Union regulators have expanded the approval of Dupixent in patients with asthma, in addition to its existing approval for atopic dermatitis, Regeneron said.