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

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.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.