Bristol Myers Squibb (BMY)

[chmcnfunds]

Tom Lynch outlines his comeback strategy for Bristol-Myers’ badly bruised R&D organization

by john carroll
April 28, 2017 08:44 AM EDT
Updated: 08:56 AM


Thomas Lynch
When Tom Lynch took the top R&D job at Bris­tol-Myers Squibb, he got one of the best — and at the same time, one of the hard­est — jobs in biotech.

It was one of the best be­cause Bris­tol-Myers built what is widely con­sid­ered one of the most in­no­v­a­tive re­search groups for a bio­pharma of its size, in a heavy­weight class not known for home­made break­throughs. It was one of the hard­est be­cause the group had just de­railed, giv­ing up its first-place po­si­tion in im­muno-on­col­ogy in a hard fall on a mis­guided late-stage ef­fort on lung can­cer.

That’s how Lynch ended up with the job.

Dur­ing yes­ter­day’s Q1 call with an­a­lysts, Lynch — who made an un­usual move from the board to head of R&D — out­lined his strat­egy for what comes next. How can Bris­tol-Myers re­trieve its lead po­si­tion?

As Lynch noted to a group that in­cluded some ex­pe­ri­enced skep­tics, his board­room po­si­tion gave him a bird’s eye view of the com­pany’s op­er­a­tions. For a first in­ter­view with an­a­lysts, he pro­vided an im­pres­sive, de­tailed strat­egy out­line, rec­og­niz­ing the weak­nesses in Bris­tol-Myers’ I/O ef­forts and of­fer­ing ways to deal with those weak­nesses in the clinic.

Lynch’s game plan cen­ters on the com­pany’s work on next-gen com­bos, look­ing to build on Op­divo (PD-1) and Yer­voy (CTLA-4) — with all its faults — with new com­bos and less toxic al­ter­na­tives now in the clinic.

In Lynch’s words, here’s the strat­egy:

— (F)irst, ac­cel­er­at­ing the de­liv­ery of our next wave of I-O as­sets like IDO, which we re­cently pre­sented data on at AACR. We’ll also be pre­sent­ing early re­sults for LAG-3, GITR, and the In­cyte IDO at ASCO this year.

— Sec­ond, un­der­stand­ing the bi­ol­ogy of I-O re­sis­tance, both in­trin­sic re­sis­tance and ac­quired, and bring­ing a laser-like focus to over­com­ing this. We will focus on ex­pand­ing into tumor types where I-O hasn’t had a broad im­pact yet, tu­mors like breast can­cer, col­orec­tal can­cer, and prostate can­cer. We will use our next-wave as­sets to cre­ate op­tions for pa­tients who progress on their ini­tial I-O ther­apy.

— Third, we will con­tinue to de­velop com­bi­na­tion reg­i­mens, in­clud­ing I-O/I-O com­bi­na­tions, I-O/tar­geted com­bi­na­tions, and I-O/chemother­apy com­bi­na­tions where these make sense.

— And fourth, we will ac­cel­er­ate the de­vel­op­ment of our most promis­ing as­sets in the car­dio­vas­cu­lar, im­muno-sci­ence, and fi­bro­sis pipeline. As [CEO] Gio­vanni [Caforio] men­tioned, we re­cently pre­sented promis­ing Phase II data on our FGF21 asset in pa­tients with NASH at the In­ter­na­tional Liver Con­gress. The re­sults showed an im­prove­ment across mul­ti­ple as­pects of NASH, in­clud­ing a sig­nif­i­cant re­duc­tion in liver fat ver­sus placebo.

He fol­lowed up by cit­ing an ex­panded re­la­tion­ship with Cy­tomX to build a less toxic CTLA-4, a move that could even­tu­ally have major im­pli­ca­tions for con­tenders like As­traZeneca, and all the big ri­vals cur­rently in the mar­ket, from Merck to Roche and Pfizer/Merck KGaA. IDO com­bi­na­tions will play a role here as well.

Geoff Meacham at Bar­clays ob­serves that it seems that the biggest op­por­tu­nity is in “cold tu­mors, breast, ovar­ian, colon, et cetera. To fol­low up on the ear­lier com­ment, CTLA-4 com­bos, do you guys feel, at this point, CTLA-4 com­bos plus a PD-L1 is going to be a com­po­nent of that?”

Lynch:

So we think we have mul­ti­ple op­por­tu­ni­ties to look at com­bi­na­tions of I-O/I-O agents in these cold tu­mors. We pre­sented data with our IDO asset, as you men­tioned, and we also will be pre­sent­ing ini­tial data at ASCO this year with our GITR com­pound, which could be the type of agent that might play a role in the cold tumor space.

Tim An­der­son at Bern­stein also ze­roed in on grow­ing ques­tions about the fu­ture of PD-1, CTLA-4 com­bos. “A bear’s point of view could say that this fore­tells prob­lems with Yer­voy and Op­divo, specif­i­cally in front-line lung.”

Lynch:

I think the first is that again, just em­pha­siz­ing how com­plex and dif­fi­cult a dis­ease lung can­cer is to treat, it’s highly un­likely that there’s going to be one ap­proach that’s going to fit every pa­tient who pre­sents in first-line. We be­lieve strongly that Yer­voy/Op­divo is cer­tainly one of the op­tions that needs to be pur­sued and de­vel­oped, and we’re look­ing at that in first-line lung can­cer. And we’re also look­ing at it in the set­ting of what ap­pro­pri­ate bio­mark­ers might be im­por­tant in eval­u­at­ing the po­ten­tial for this com­bi­na­tion and for re­ally all of our drugs in first-line lung can­cer.

Fi­nally, on new R&D in­vest­ments:

“(W)e’ve got to ex­e­cute our pipeline. We’ve got to de­velop our next-gen­er­a­tion drugs. And to do that, we’re going to need to in­vest in tumor bi­ol­ogy and trans­la­tional med­i­cine as well as data and an­a­lyt­ics.”

So there’s the plan. Tak­ing over at R&D now is like jump­ing on a rolling truck at Bris­tol-Myers, which spent $5 bil­lion on re­search last year. You can grab the wheel, but then you have to man­age the mo­men­tum. That won’t be easy.
________________________________________________
https://endpts.com/tom-lynch-outlines-his-comeback-strategy-for-bristol-myers-badly-bruised-rd-organization/

BMY