→ Copen­hagen-based IO Biotech said that its can­cer vac­cine has passed the high bar set for its in­ter­im fu­til­i­ty analy­sis in Phase II, show­ing “a sub­stan­tial­ly high­er” over­all re­sponse rate among non-small cell lung can­cer pa­tients when com­bined to Keytru­da than the PD-1 alone —which ac­cord­ing to the com­pa­ny in­duced his­tor­i­cal ORR of 39%.

In­ves­ti­ga­tors will car­ry on eval­u­at­ing IO-102 plus Keytru­da, with fi­nal da­ta ex­pect­ed by the end of the year. The can­di­date is an IDO-de­rived pep­tide se­quence de­signed to stir up T cell ac­tion against IDO — the en­zyme tar­get for an ill-fat­ed class of small mol­e­cule drugs. “In that sense you have flags on the sur­face of im­mune sup­pres­sive cells and [tu­mor cells] that our T cells can rec­og­nize and there­by ac­tu­al­ly get rid of those IDO pos­i­tive cells, hence a com­plete­ly dif­fer­ent MOA than IDO SMI,” CEO Mai-Britt Zoc­ca told End­points News.

IO Biotech is fund­ing the study while part­ner Mer­ck gets to share the re­sults. A cock­tail of IO102 and IO103 — which di­rects T cells against PD-L1 — is be­ing test­ed in com­bi­na­tion with Op­di­vo for melanoma pa­tients.

→ A month af­ter join­ing the hunt for an­ti­bod­ies that could treat Covid-19, Vir Biotech­nol­o­gy is en­list­ing WuXi Bi­o­log­ics to do the cell-line de­vel­op­ment, process and for­mu­la­tion de­vel­op­ment as well as ini­tial man­u­fac­tur­ing. The San Fran­cis­co-based start­up said it’s iden­ti­fied a num­ber of mon­o­clon­al an­ti­bod­ies that bind to SARS-CoV-2, iso­lat­ed from in­di­vid­u­als who had sur­vived SARS. A deal with WuXi — which gives the pow­er­ful CRO rights to com­mer­cial­ize in Chi­na — po­si­tions them for quick ad­vance­ment, CEO George Scan­gos said.

→ As­traZeneca has di­vest­ed an­oth­er gas­troin­testi­nal drug, col­lect­ing $52.5 mil­lion up­front from Red­Hill Bio­phar­ma for par­tial rights to Movan­tik. The drug, which was orig­i­nal­ly de­vel­oped by Nek­tar Ther­a­peu­tics to treat opi­oid-in­duced con­sti­pa­tion, gen­er­at­ed US sales of $96 mil­lion last year (Dai­ichi Sankyo shares some of the prof­its). As­traZeneca will con­tin­ue to sup­ply the drug for a while.

→ Parisian biotech Sci­pio bio­science, which helps re­search and clin­i­cal labs with sin­gle-cell se­quenc­ing, has se­cured €6 mil­lion in Se­ries A fund­ing. The mon­ey will fu­el the fi­nal de­vel­op­ment of its sin­gle-cell RNA-se­quenc­ing kit, as well as mar­ket­ing and busi­ness de­vel­op­ment ef­forts to pre­pare for com­mer­cial launch in 2022.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.