An­tho­ny Coyle start­ed Pfiz­er’s Cen­ters for Ther­a­peu­tic In­no­va­tion with an eye to chang­ing the way the phar­ma gi­ant went about the busi­ness of drug dis­cov­ery. And then af­ter leav­ing last sum­mer and join­ing the great mi­gra­tion out of Big Phar­ma, he switched in­to a new role as biotech CEO — where he gets to take a more hands-on role in that strug­gle.

Coyle is at the helm of a new start­up called Pan­dion Ther­a­peu­tics, one of the lat­est ar­rivals in the bustling Cam­bridge, MA hub, where Po­laris seed­ed a group of about 12 re­searchers who have been look­ing to take some of the many lessons learned from im­muno-on­col­o­gy and then re­verse en­gi­neer­ing the tech­nol­o­gy for an­ti-in­flam­ma­to­ry or au­toim­mune drugs.

Jo Viney

“There have been tremen­dous ad­vances in un­der­stand­ing how the im­mune sys­tem in­ter­plays with the tu­mor,” Coyle tells me. And Pan­dion’s ob­jec­tives, in­spired in part by co-founder and im­munol­o­gy ex­pert David Sachs, “res­onat­ed with (chief sci­en­tist) Jo Viney and my­self.”

Viney was pre­vi­ous­ly se­nior vice pres­i­dent of drug dis­cov­ery and VP of im­munol­o­gy re­search for Bio­gen, and had ear­li­er worked at Am­gen.

“It will be fas­ci­nat­ing if we can shift the par­a­digm on de­vel­op­ing new drugs,” says the CEO.

The big idea here is that the com­pa­ny be­lieves it can cre­ate a set of bis­pe­cif­ic an­ti­bod­ies that will al­low for tar­get­ed, lo­cal­ized mod­u­la­tion of the im­mune sys­tem, with one arm of the bis­pe­cif­ic bind­ing to mol­e­cules ex­pressed at the site of in­flam­ma­tion.

That kind of work has ap­pli­ca­tions for in­flam­ma­to­ry bow­el dis­ease as well as au­toim­mune dis­eases of the liv­er, to start with.

Alan Crane

Po­laris en­tre­pre­neur­ship part­ner Alan Crane helped arrange the seed mon­ey and gath­ered the syn­di­cate to­geth­er for to­day’s an­nounce­ment of the $58 mil­lion launch round. Po­laris is in the co-lead po­si­tion with Ver­sant Ven­tures and Roche Ven­ture Fund. Glax­o­SmithK­line’s SR One and BioIn­no­va­tion Cap­i­tal al­so chipped in on the round.

The mon­ey should be enough to get be­yond the first 2 or 3 years of the start­up phase, says Coyle, with enough cash to move pro­grams out of the pre­clin­i­cal stage and in­to the clin­ic. And he wouldn’t be sur­prised to see the first part­ner­ship come to­geth­er this year, as the team dou­bles up in size.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.