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

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Ver­sant-backed, Bris­tol My­ers-stamped Re­pare Ther­a­peu­tics guns for $100M IPO

With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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