Am­gen-part­nered Im­mat­ics bags a $58M round to fund its first clin­i­cal steps on new T-cell tech for can­cer

Back at the be­gin­ning of this year, Am­gen stepped up with a bil­lion-dol­lar smor­gas­bord of mile­stones to en­list Im­mat­ics in a cam­paign to cre­ate some next-gen, T-cell en­gag­ing bis­pecifics for can­cer. And to­day Am­gen came back to the ta­ble to help the biotech put to­geth­er a $58 mil­lion round so it could move its first two in-house drugs through their ini­tial paces in the clin­ic.

Im­mat­ics us­es a plat­form tech dubbed Xpres­i­dent to iden­ti­fy the tar­gets on can­cer cells they want to ze­ro in on. One of their lead­ing pro­grams is for IMA101, ex­pand­ing spe­cif­ic en­doge­nous T cells, which set out in Phase I in Au­gust. Just a few days ago, their close col­lab­o­ra­tors at MD An­der­son launched a Phase I study of IMA201, Im­mat­ics’ TCR can­di­date that reengi­neers T cells to ex­press an ex­oge­nous re­cep­tor — the adop­tive cell ther­a­py ap­proach that has be­come fa­mous in the wake of the first CAR-T ap­proval.

Pe­ter Cham­bré

But as any­one pur­su­ing next-gen tech would tell you, the first-gen CAR-T drugs are lim­it­ed in scope. Im­mat­ics chair­man Pe­ter Cham­bré says that Im­mat­ics is a part of the sec­ond wave of com­pa­nies now look­ing to use new and bet­ter tar­get iden­ti­fi­ca­tion tech with adop­tive ap­proach­es that can make these drugs use­ful, and safe, in treat­ing a wide range of sol­id tu­mors.

The ba­sic ap­proach screens tu­mor can­cer types to “iden­ti­fy those tar­gets ex­clu­sive­ly pre­sent­ed on can­cer cells,” says the chair­man, and then com­par­ing it to nor­mal tis­sue to en­sure they’re us­ing dis­ease spe­cif­ic tar­gets.

“It al­lows us to iden­ti­fy a sig­nif­i­cant num­ber of tar­gets on sol­id tu­mors we think of­fers the po­ten­tial of ex­pand­ing adop­tive cel­lu­lar ther­a­pies in­to sol­id tu­mors,” adds Cham­bré.

That’s no easy task. And it’s not cheap.

With the help of dievi­ni Hopp Biotech — the in­vest­ment ve­hi­cle dri­ven by Ger­man bil­lion­aire Di­et­mar Hopp, who has a big ap­petite for biotech bets — Im­mat­ics has built up a staff of 100 in Ger­many, with a sub­sidiary op­er­a­tion in Hous­ton work­ing with part­ners at MD An­der­son un­der Harpreet Singh with 50 more work­ers.

Hopp and Am­gen are both back for this new round, with Welling­ton Part­ners, AT Impf GmbH and oth­ers step­ping in along­side.

With this lat­est round, Cham­bré adds, Im­mat­ics has now raised $230 mil­lion since it was found­ed 17 years ago. Their jour­ney in­clud­ed some mis­steps along the way, and now they have enough cash to see if this ap­proach works in hu­mans.

It’s a big step.

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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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.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

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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