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

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.