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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.