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.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.