Scott Requadt (Talaris)

Ta­laris Ther­a­peu­tics bags an­oth­er $115M to curb im­muno­sup­pres­sion in or­gan trans­plant pa­tients

Just over a year af­ter se­cur­ing a $100 mil­lion Se­ries A round, Ta­laris Ther­a­peu­tics is back with a $115 mil­lion Se­ries B to fu­el its mis­sion of mak­ing or­gan trans­plants safer.

CEO Scott Re­quadt said he’s seen “dra­mat­ic progress” since the Se­ries A. In the last 18 months, the biotech has crossed the Phase III start­ing line with its lead drug, FCR001, in liv­ing donor kid­ney trans­plant re­cip­i­ents. Plus, it “laid the ground­work” for two Phase II stud­ies, he not­ed.

Trans­plant pa­tients are of­ten put on im­muno­sup­pres­sion reg­i­mens to pre­vent re­jec­tion of the do­nat­ed or­gan, which ex­pos­es them to in­fec­tions.

“Covid has changed every­thing for all of us. But in par­tic­u­lar, it’s a per­fect storm for or­gan trans­plant re­cip­i­ents be­cause they’re on chron­ic im­muno­sup­pres­sion,” Re­quadt said. The goal, he added, is to re­store im­mune tol­er­ance with­out the body re­ject­ing the or­gan.

Suzanne Ild­stad

To do so, the com­pa­ny’s pro­cess­ing bone mar­row. The ap­proach is the brain­child of Suzanne Ild­stad, di­rec­tor of the Uni­ver­si­ty of Louisville’s In­sti­tute for Cel­lu­lar Ther­a­peu­tics, who launched Re­generex in 2002 to build out the idea. No­var­tis helped up­grade man­u­fac­tur­ing and shape a Phase II pro­to­col be­fore shut­ting down its cell and gene ther­a­pies unit in 2016.

When fund­ing ran dry, Ild­stad turned to Clarus (now Black­stone Life Sci­ences), which led a $100 mil­lion Se­ries A to pro­pel her work to Phase III. Re­quadt, who spent 13 years as Clarus’ man­ag­ing di­rec­tor, be­came CEO of the nom­i­nal­ly new com­pa­ny, Ta­laris.

“It was one of the most unique things that I’ve seen as an in­vestor in 13 years,” he told End­points News. “And so I de­cid­ed to put up my hands and be­come a first-time CEO.”

Re­quadt plans on dump­ing Ta­laris’ re­cent Se­ries B in­to its on­go­ing Phase III tri­al in liv­ing donor re­cip­i­ents, as well as prospec­tive Phase II tri­als in dif­fuse sys­temic scle­ro­sis and pa­tients who have pre­vi­ous­ly re­ceived a liv­ing donor kid­ney trans­plant. The Phase III will en­roll up to 120 donor-re­cip­i­ent pairs at 15 sites in the US, Re­quadt said. He de­clined to com­ment on the time­line of the tri­al, which is still in ear­ly stages. Both Phase II tri­als are ex­pect­ed to be­gin next year.

In a Phase II study, 70% of 37 liv­ing donor kid­ney trans­plant pa­tients giv­en FCR001 were weaned off all of their im­muno­sup­pres­sion treat­ments, ac­cord­ing to Ta­laris. And out of 7 pa­tients with a pre-ex­ist­ing au­toim­mune dis­ease who quit im­muno­sup­pres­sion, none had a re­cur­rence, ac­cord­ing to the com­pa­ny.

In the up­com­ing Phase II de­layed tol­er­ance tri­al, re­searchers will test whether they can re­cruit pa­tients who re­ceived trans­plants in the last 12 months, take some cells from their donors, and make a prod­uct to in­duce im­mune tol­er­ance.

“Ini­tial­ly, we’re go­ing to fo­cus on pa­tients who are with­in 12 months of a trans­plant, but we may well ex­plore… longer de­lays down the line,” Re­quadt said.

The Se­ries B was led by Sur­vey­or Cap­i­tal and Viking Glob­al In­vestors. Black­stone chipped in again this round, as well as Lon­gi­tude Cap­i­tal and Qim­ing Ven­ture Part­ners USA. Oth­er new in­vestors in­clude Cor­morant As­set Man­age­ment, In­vus, funds and ac­counts man­aged by Black­Rock, Even­tide As­set Man­age­ment, Lo­gos Cap­i­tal, Ais­ling Cap­i­tal and Pamo­ja Cap­i­tal.

“Im­muno­sup­pres­sive agents are tox­ic to the kid­ney, and as a re­sult you typ­i­cal­ly need to have kid­ney trans­plant every 15 years or so. And if we’re able to dis­con­tin­ue the drugs that are tox­ic to the kid­ney, you know, the po­ten­tial is that peo­ple would ben­e­fit from a sin­gle trans­plant for much longer pe­ri­ods of time,” Re­quadt said. “Maybe even one kid­ney for life.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.