Gary Glick, cred­it: Uni­ver­si­ty of Michi­gan

At­las Ven­ture has an­oth­er block­buster biotech flip to boast about — while keep­ing an up­start in the port­fo­lio. And it’s a big one.

Just a lit­tle more than a year af­ter the At­las-in­cu­bat­ed IFM Ther­a­peu­tics achieved liftoff with a $27 mil­lion A round, with a co-lead in­vest­ment from Abing­worth, Bris­tol-My­ers Squibb has stepped in with a buy­out. Bris­tol-My­ers re­searchers are now carv­ing out the work the biotech has done on two pro­grams pro­mot­ing an in­nate im­mune re­sponse to can­cer, and spin­ning out the sig­nif­i­cant re­main­der in­to a new com­pa­ny al­so helmed by IFM co-founder Gary Glick.

To com­plete the deal, Bris­tol-My­ers is pay­ing a whop­ping $300 mil­lion up­front, with a lit­tle more than $1 bil­lion in mile­stones on each of the pre­clin­i­cal pro­grams. And there’s an un­spec­i­fied pay­ment due to se­cure an op­tion on one of its in­nate im­mune sys­tem pro­grams that al­so caught the bio­phar­ma’s eye as well as more biobucks for any oth­er drugs the are de­vel­oped out of the tech­nol­o­gy.

IFM was aimed at a prime tar­get when it jumped in­to view last sum­mer. The two lead can­cer projects look to use small mol­e­cules to ac­ti­vate NL­RP3 and STING, revving up in­nate im­mune re­spons­es that can play a com­ple­men­tary role with adap­tive im­mune ther­a­pies, like Bris­tol-My­ers’ big PD-1 drug Op­di­vo, which thwart a mech­a­nism can­cer cells use to evade an at­tack by im­mune sys­tem T cells. In­nate im­mu­ni­ty at­tacks as an im­me­di­ate guard — or first line of de­fense — against an in­vad­ing pathogen, and among oth­er things can re­cruit cells to the fight.

The biotech now will go on to con­cen­trate on the flip side of that coin: Rein­ing back in­nate im­mune at­tacks, tamp­ing down cy­tokine pro­duc­tion and re­duce chron­ic in­flam­ma­tion tied to au­to-in­flam­ma­to­ry con­di­tions like NASH, IBD and gout. And that work in­cludes NL­RP3 and some re­lat­ed mem­bers of the NLR fam­i­ly.

It’s that NL­RP3 an­tag­o­nist that Bris­tol-My­ers wants an op­tion on.

Thomas Lynch

Bris­tol-My­ers is pay­ing more than 10 times the A-round in cash for this com­pa­ny, which will not go un­no­ticed in At­las cir­cles to­day. At­las part­ner Jean-François Formela was chair­man of the com­pa­ny.

For Bris­tol-My­ers, which is look­ing to reignite its once-dom­i­nant check­point ef­fort, it rep­re­sents an­oth­er op­por­tu­ni­ty to steal a march against a slew of ri­vals all look­ing to sec­ond- and third-gen­er­a­tion tie-ups as they an­gle to keep and grow a ma­jor seg­ment of the mar­ket. Its busi­ness de­vel­op­ment group un­der Paul Bion­di has a cold and steady eye when it comes to tech deals, look­ing for ways to gain an ad­van­tage in core fields through this kind of ex­ter­nal ac­qui­si­tion.

“Tar­get­ing in­nate im­mu­ni­ty path­ways rep­re­sents a po­ten­tial­ly dif­fer­en­ti­at­ed ap­proach in im­muno-on­col­o­gy de­signed to ini­ti­ate and aug­ment im­mune re­spons­es that may help the body’s nat­ur­al de­fens­es bet­ter rec­og­nize and at­tack tu­mors,” said Thomas Lynch, ex­ec­u­tive vice pres­i­dent, chief sci­en­tif­ic of­fi­cer, Bris­tol-My­ers Squibb. “The ad­di­tion of STING and NL­RP3 ag­o­nist pro­grams broad­ens our abil­i­ty to in­ves­ti­gate ad­di­tion­al path­ways across the im­mune sys­tem and com­ple­ments our im­muno-on­col­o­gy port­fo­lio. We look for­ward to ad­vanc­ing the de­vel­op­ment of these im­por­tant pro­grams ini­ti­at­ed by Gary Glick, his lead­er­ship team and lead­ing aca­d­e­m­ic and in­dus­try ex­perts across im­munol­o­gy and on­col­o­gy.”

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.