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

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.

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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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

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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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

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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