On a mis­sion to make or­gan trans­plants safer and more durable, Black­stone gifts Ta­laris a new CEO, leads $100M round

As a trans­plant sur­geon by train­ing, Suzanne Ild­stad un­der­stood the plight of her pa­tients all too well: The risk of or­gan re­jec­tion forces them to adopt im­muno­sup­pres­sion reg­i­mens, which in turn ex­pose them to in­fec­tions and car­dio­vas­cu­lar prob­lems they have to con­tend with. She knew that if the bone mar­row from a donor takes, any sub­se­quent or­gan trans­plant would, too.

“We dis­cov­ered a cell in the bone mar­row called the fa­cil­i­tat­ing cells that is CD8 pos­i­tive and T cell re­cep­tor neg­a­tive, and it helps the stem cell to take,” Ild­stad, di­rec­tor of the Uni­ver­si­ty of Louisville’s In­sti­tute of Cell Ther­a­py, said. “From that we de­vel­oped a method to process the bone mar­rows from hu­mans to es­sen­tial­ly take out the bad cells and leave in the good cells.”

That was 15 years ago. Ild­stad start­ed Re­generex, per­fect­ing the cell pro­cess­ing method on NIH and De­part­ment of De­fense grants. Their re­search even­tu­al­ly caught the eye of No­var­tis, which played a hand in up­grad­ing the man­u­fac­tur­ing fa­cil­i­ties and shap­ing a Phase II pro­to­col. But when the phar­ma gi­ant dis­band­ed its cell and gene ther­a­pies unit, Ild­stad found her­self search­ing for new fund­ing sources to bring the now Phase III-ready ther­a­py over the fin­ish line.

Dis­cus­sions even­tu­al­ly brought her to Clarus (now Black­stone Life Sci­ences), a ven­ture play­er with an ap­petite for just this type of deal, breath­ing life in­to a nom­i­nal­ly new com­pa­ny dubbed Ta­laris with $100 mil­lion to spend.

Aside from a new iden­ti­ty, Ta­laris is al­so un­veil­ing some Phase II that CEO Scott Re­quadt — who is tak­ing his first biotech ex­ec­u­tive role in 13 years as Clarus’ man­ag­ing di­rec­tor — calls “ex­cep­tion­al­ly ro­bust.”

Im­age: Scott Re­quadt (Ta­laris)

Ad­min­is­ter­ing Ta­laris’ per­son­al­ized ther­a­py, FCR001, to 37 pa­tients a day af­ter they re­ceived a liv­ing donor kid­ney trans­plant, in­ves­ti­ga­tors found that 26 — or 70% — of them were able to achieve im­mune tol­er­ance of their new or­gans and be free of im­muno­sup­pres­sion. And hav­ing fol­lowed those pa­tients for an av­er­age of five (longest 10) years, Re­quadt has the con­fi­dence to say: “We have 100% dura­bil­i­ty.”

“Since the mid 50s — since kid­ney trans­plants have been done — there’s less than 100 doc­u­ment­ed cas­es of that hav­ing oc­curred and there’s about 25,000 kid­ney trans­plants every year in the US alone. So you can do the math there,” he tells me. “So to get a 70% rate of be­ing able to be off im­muno­sup­pres­sion and to show no signs of re­jec­tion of the or­gan and have that be durable is quite re­mark­able.”

Ta­laris plans to ini­ti­ate a Phase III by the end of this year with an ex­pand­ed team of 50, with an eye to beef­ing up the cell pro­cess­ing team in Louisville and adding a few hires to the clin­i­cal de­vel­op­ment team in Boston, where Re­quadt spends two-thirds of his time.

In fact, the com­pa­ny has al­ready added a few se­nior lead­ers, in­clud­ing chief med­ical of­fi­cer Nan­cy Krieger, the for­mer clin­i­cal lead for FCR001 at No­var­tis. Car­los Yuraszeck is join­ing from Cel­gene as SVP of tech­ni­cal op­er­a­tions.

There’s more. The Se­ries A — com­ing from Lon­gi­tude Cap­i­tal and Qim­ing Ven­ture Part­ners USA along­side Black­stone Life Sci­ences — will fund two Phase II stud­ies what Ta­laris calls de­layed tol­re­ance and in au­toim­mune dis­eases, re­spec­tive­ly.

In the de­layed tol­er­ance tri­al, the com­pa­ny plans to re­cruit pa­tients who’ve pre­vi­ous­ly re­ceived a liv­ing kid­ney do­na­tion and are on im­muno­sup­pres­sion and see if they can go back to the kid­ney donor, take some stem cells, and cook up a per­son­al­ized con­coc­tion that can in­duce tol­er­ance af­ter the fact.

As for au­toim­mune dis­eases, Re­quadt says he’s en­cour­aged by the sub­set of pa­tients in the Phase II tri­al who didn’t see their au­toim­mune dis­eases — which led to the trans­plant in the first place — re­cur fol­low­ing ther­a­py.

“So it’s a small dataset, on­ly 7 pa­tients, but it gives us some great hope that this could have a broad­er ap­plic­a­bil­i­ty in help­ing peo­ple with a se­vere au­toim­mune or im­mune-me­di­at­ed dis­or­der to hit the re­set but­ton,” he said, mak­ing this “much more of a pipeline in a prod­uct.”

Top im­age: Suzanne Ild­stad. TA­LARIS

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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