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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Le­vo Ther­a­peu­tics miss­es pri­ma­ry end­point in PhI­II tri­al of Prad­er-Willi drug — the lat­est set­back in a dis­as­ter-prone field

Marking yet another setback in the Prader-Willi Syndrome field, Levo Therapeutics failed to hit its primary endpoint in a Phase III study of intranasal carbetocin. But the biotech is now shifting its focus to the secondary endpoints in an effort to pluck victory out of the jaws of defeat.

The disorder, characterized by a false sense of starvation, is caused by the absence or deletion of a father’s chromosome 15. Illinois-based Levo’s potential therapy involves a selective oxytocin-receptor agonist.