→ 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.

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.