Harpreet Singh. Allogeneic Cell Therapies Summit

The chief sci­en­tist at Ger­man/US biotech hy­brid Im­mat­ics is mov­ing to the helm. Here's his to-do list

Just a few months af­ter launch­ing their 4th clin­i­cal tri­al for a unique brand of cell ther­a­pies, the Ger­man-US hy­brid biotech Im­mat­ics is pro­mot­ing the biotech’s long-time chief sci­en­tist and co-founder to the helm.

Harpreet Singh, CSO and head of the Hous­ton branch of the com­pa­ny — which is al­lied with in­ves­ti­ga­tors at MD An­der­son — has been pro­mot­ed to over­all CEO, a post which gives him over­sight of a grow­ing slate of tri­als for adop­tive T cell ther­a­pies, bis­pecifics with a group of part­ners that in­cludes Am­gen, Roche and Gen­mab as well as an off-the-shelf ap­proach to these new can­cer ther­a­pies. 

Di­et­mar Hopp Di­et­mar Hopp Stiftung

Ger­man bil­lion­aire Di­et­mar Hopp backed the com­pa­ny ear­ly and joined Am­gen and oth­er in­vestors to push the fund­ing at Im­mat­ics past the $230 mil­lion mark in the fall of 2017. Cell ther­a­pies are a hot are­na, but Im­mat­ics has been work­ing on dif­fer­en­ti­at­ing them­selves with more spe­cial­ized tar­get­ing of their own T cell drugs us­ing a broad­er range of in­tra­cel­lu­lar tar­gets — cre­at­ing what they’ve billed as a next-gen ap­proach to the per­son­al­ized CAR-T ther­a­pies that have now made their way to the mar­ket. And they have sol­id tu­mors in their sights.

I asked Singh what he planned to do now at the 19-year-old biotech, which has trav­eled a long road since spin­ning out of the Uni­ver­si­ty of Tübin­gen, Ger­many. And not sur­pris­ing­ly he has quite a lot on the to-do list, in­clud­ing see­ing about a pos­si­ble new part­ner­ship, the roll­out of their first batch of ear­ly-stage da­ta and more. Here, in his own words, is what he has planned:

I want Im­mat­ics to be­come the glob­al leader in TCR-based im­munother­a­py – and we are on an ex­cel­lent track get­ting there. While we clear­ly are al­ready THE world-lead­ing com­pa­ny in the dis­cov­ery of nov­el I/O tar­gets and TCRs, we do not see our­selves just as a plat­form com­pa­ny but ded­i­cat­ed to de­vel­op­ing clin­i­cal-stage prod­ucts that will de­liv­er the pow­er of T cells to can­cer pa­tients. We cur­rent­ly have 4 adop­tive cell ther­a­py (ACT) clin­i­cal tri­als un­der­way with MD An­der­son Can­cer Cen­ter and work­ing in­tense­ly on mov­ing our al­lo­gene­ic ACT as well as our TCR Bis­pecifics can­di­dates in­to the clin­ic. On top of this, our part­ners such as Am­gen, Roche and Gen­mab are al­so mov­ing – in col­lab­o­ra­tion with us – fur­ther bis­pe­cif­ic can­di­dates to­wards first-in-man tri­als. And we are con­sid­er­ing to en­ter an­oth­er strate­gic al­liance with a large play­er in the field of cell ther­a­py.

We see the biggest need in sol­id can­cers where we have iden­ti­fied five fac­tors to over­come the chal­lenges in this field and we ad­dress all of them. These in­clude (1) lever­ag­ing the best tu­mor tar­gets, (2) the best T-cell re­cep­tors, (3) un­leash­ing an un­prece­dent­ed lev­el of T cells against can­cer cells, (4) specif­i­cal­ly tar­get­ing the tu­mor mi­croen­vi­ron­ment and fi­nal­ly (5) uti­liz­ing mul­ti­ple TCRs si­mul­ta­ne­ous­ly. The lat­ter has not been done be­fore. At the AACR Im­mune Cell Ther­a­pies Con­fer­ence in San Fran­cis­co (19-22 Ju­ly), we will share with the pub­lic first da­ta from our AC­Tolog mul­ti-T cell prod­uct clin­i­cal tri­al demon­strat­ing for the first time how we have re­placed more than half (!) of the pa­tient’s rel­e­vant im­mune cells with mul­ti­ple adop­tive­ly in­fused T-cell pop­u­la­tions di­rect­ed to a num­ber of de­fined can­cer as well as tu­mor stro­ma tar­gets – these tar­gets ac­tu­al­ly con­firmed to be ex­pressed in the in­di­vid­ual pa­tient who we have treat­ed.

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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