Ver­sant backs new ap­proach to gam­ma delta T cells, co-leads Lava's $18.9M round

With im­muno-on­col­o­gy dom­i­nat­ing pipelines these days, the field of gam­ma delta T cells — once a tiny area of study — is gain­ing some steam. The newest play­er to the space is La­va Ther­a­peu­tics, a tiny biotech in the Nether­lands that just got $18.9 mil­lion co-led by Ver­sant Ven­tures and Gilde Health­care to de­vel­op its un­usu­al take.

Gam­ma delta T cells are tar­gets for re­search for their po­ten­tial to in­vade tis­sue and per­haps be bet­ter at in­fil­trat­ing tu­mors, which would be a ground­break­er in im­muno-on­col­o­gy. Where CAR-Ts have proved ef­fec­tive in blood can­cers, it’s been a chal­lenge get­ting them in­to tu­mors And while check­point ther­a­pies like Keytru­da and Op­di­vo re­quire an en­vi­ron­ment with a heavy mu­ta­tion load to be ef­fec­tive, gam­ma delta cells – at least in the pre­clin­i­cal work — don’t. Gam­ma delta cells have the es­sen­tial prop­er­ties to get in­side tu­mors to do their work.

Hans van der Vli­et

Lots of com­pa­nies, in­clud­ing blue­bird bio’s new ac­qui­si­tion TC Bio­pharm, are tak­ing the cell ther­a­py ap­proach to get­ting gam­ma delta T cells where they need to be. But La­va has dif­fer­ent plans. The com­pa­ny’s brand new head of R&D, Paul Par­ren, tells me La­va is de­vel­op­ing bi-spe­cif­ic an­ti­bod­ies that bind to the tu­mor cell on one side and the gam­ma delta cells on the oth­er.

“The gam­ma delta cells are known to in­fil­trate tu­mors al­ready, but they may not be ful­ly ac­ti­vat­ed once they’re in,” Par­ren said. “Tu­mors have all kind of sup­pres­sive mech­a­nisms that can turn down T cell ac­tiv­i­ty. Our bi-spe­cif­ic an­ti­body adds ex­tra ac­ti­va­tion, killing the tu­mor.”

To date, the com­pa­ny has demon­strat­ed proof of prin­ci­ple for the gam­ma delta plat­form, build­ing on the sci­en­tif­ic dis­cov­er­ies of the re­search team head­ed by Hans van der Vli­et, an on­col­o­gist at VU Uni­ver­si­ty Med­ical Cen­ter and Can­cer Cen­ter Am­s­ter­dam who al­so serves as La­va’s CSO.

Bi-spe­cif­ic an­ti­bod­ies have been ham­pered in the past by man­u­fac­tur­ing is­sues, but Par­ren said La­va’s ver­sion can ac­tu­al­ly be both po­tent and cost-ef­fec­tive to pro­duce. Al­though the com­pa­ny isn’t go­ing in­to specifics on in­di­ca­tions, Par­ren said they plan to tack­le both blood can­cers and sol­id tu­mors. The new funds should car­ry the com­pa­ny through dis­cov­ery work, hope­ful­ly cov­er­ing the ex­pens­es un­til La­va se­lects the pro­grams to ad­vance through the clin­ic.

Par­ren just joined the com­pa­ny this week as ex­ec­u­tive vice pres­i­dent and head of R&D, with the an­nounce­ment of his re­cruit­ment tied to La­va’s new fi­nanc­ing. He’s prob­a­bly best known for his time at Gen­mab, where he’s spent 16 years as head of pre­clin­i­cal de­vel­op­ment and re­search. When asked what was be­hind his move to a small start­up, Par­ren said he was up for the chal­lenge of ear­ly-stage re­search.

“I like to cre­ate new things, and be at the fore­front of in­no­va­tion,” Par­ren said. “On the one hand it’s still very ex­cit­ing at Gen­mab, as you get to see things you cre­ate move through the clin­ic. But for me, be­ing in a small com­pa­ny al­lows you to be more cre­ative and be more chal­lenged. When you run in­to prob­lems, you have to solve them your­self. I like that.”

Im­age: Paul Par­ren. KNECT365 LIFE SCI­ENCES via YOUTUBE

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

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.