Leena Gand­hi steps out of Keytru­da spot­light and in­to a top re­search job at I/O lag­gard Eli Lil­ly

Two weeks ago, Leena Gand­hi was in the spot­light at AACR with the lat­est land­mark da­ta on Mer­ck’s Keytru­da/chemo com­bo for front­line lung can­cer. That pack­age end­ed up out­shin­ing a ri­val play from Bris­tol-My­ers Squibb as Mer­ck con­tin­ued to con­sol­i­date its lead po­si­tion in the field. 

To­day, we find out that Gand­hi, an in­ves­ti­ga­tor at the Perl­mut­ter Can­cer Cen­ter at NYU Lan­gone Health and a Dana-Far­ber vet, has been re­cruit­ed by none oth­er than Eli Lil­ly to head up its im­muno-on­col­o­gy re­search work. Or per­haps, more to the point, the I/O work that Lil­ly plans to get start­ed on. And she’s the lat­est in a se­ries of new hires that points to Lil­ly’s brew­ing in­ter­est in forg­ing new on­col­o­gy deals.

Dan Skovron­sky

As of now, Lil­ly has been large­ly by­passed on the glob­al I/O su­per high­way as it pairs up its tar­get­ed can­cer agents with the lead play­ers. But in its Q1 call a few days ago, new R&D chief Dan Skovron­sky and the ex­ec­u­tive team made it clear that the com­pa­ny is prepar­ing to hatch some I/O deals to beef up its can­cer drug pipeline. And Gand­hi is clear­ly cen­tral to that process.

“(W)e need to be ac­tive ex­ter­nal­ly and you can count us,” said CEO Dave Ricks. 

Sue Ma­ho­ny

Lil­ly has a rep as a fair­ly re­li­able big phar­ma drug de­vel­op­er, field­ing a string of new drugs in re­cent years. It’s made a huge in­vest­ment in­to Alzheimer’s dis­ease, with noth­ing to show for it. And while em­i­nent­ly re­li­able on the da­ta, a big plus for di­a­betes R&D, Lil­ly’s de­vel­op­ment group has been a slow and pon­der­ous per­former, of­ten late to every big new mar­ket­ing niche it tries to tack­le.

These new re­searchers will be charged with chang­ing that rep.

“We men­tioned we’ve on-board­ed two physi­cians re­cent­ly, one from Duke and the oth­er from the Memo­r­i­al Sloan Ket­ter­ing and you will see us con­tin­u­ing to bring­ing more ex­ter­nal tal­ent,” said Eli Lil­ly on­col­o­gy chief Sue Ma­ho­ny dur­ing the call, high­light­ing the ar­rival of Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter’s Mau­ra Dick­ler, re­cruit­ed as Lil­ly’s new VP of late-phase de­vel­op­ment in on­col­o­gy.

Gand­hi ar­rives at Lil­ly June 25.


Im­age: Leena Gand­hi. NYU LAN­GONE HEALTH

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

WIB22: Suma Kr­ish­nan co-found­ed a com­pa­ny to de­vel­op a treat­ment for ‘the worst dis­ease you’ve nev­er heard of’

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

After spending time with patients who were diagnosed with what some call “the worst disease you’ve never heard of,” Suma Krishnan dedicated herself to finding a treatment.

Krishnan, who is the co-founder and chief operating officer of Krystal Biotech, spearheaded a gene therapy gel that showed promise in a late-stage clinical trial for dystrophic epidermolysis bullosa. The FDA is reviewing whether to approve the therapy and will decide by February.

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WIB22: She re­shaped mi­graine sci­ence and led key tri­als for new drugs, but Sheena Au­ro­ra isn’t done

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

For decades — even centuries — migraines were considered a disorder suffered by hysterical women.

Even when the father of modern-day migraine research pioneered a new understanding of migraine as a biological phenomenon having to do with blood vessels, he focused on explaining the condition for men but described women migraine sufferers, who make up the vast majority of the patient population, as inadequate wives and mothers.

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