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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.