Adendra CEO Raj Mehta and scientific co-founder Caetano Reis e Sousa

Ap­ple Tree Part­ners leaps across the pond to launch a UK biotech look­ing to crack the se­crets of den­drit­ic cells

Once large­ly a mys­tery to re­searchers, the far-flung realm of cells in the im­mune sys­tem has emerged as a fruit­ful sand­box for drug de­vel­op­ers. A new UK biotech is lean­ing on re­search in­to the grow­ing role of den­drit­ic cells in spurring im­mune re­spons­es, and US ven­ture firm Ap­ple Tree Part­ners is bankrolling its ear­ly ef­forts.

Lon­don-based Aden­dra Ther­a­peu­tics launched Tues­day with $53 mil­lion from found­ing in­vestor ATP and re­search out of the Fran­cis Crick In­sti­tute look­ing to lever­age new in­sights in­to how den­drit­ic cells sic preda­to­ry T cells on­to tu­mors — and their role in dri­ving au­toim­mune dis­ease.

Lever­ag­ing re­search out of the lab of Cae­tano Reis e Sousa, Aden­dra starts life with cut­ting-edge re­search in­to den­drit­ic cells un­der its belt and a hefty pay­check to boot.

Reis e Sousa, who helped kick­start the com­pa­ny as sci­en­tif­ic co-founder, point­ed to den­drit­ic cells’ dual role in both tak­ing pieces of for­eign bod­ies and pre­sent­ing them to T cells for iden­ti­fi­ca­tion but al­so act­ing as T cells’ “on-off” switch. New­er re­search has al­so point­ed to those cells’ role in “goad­ing” pro­longed T cell ac­ti­va­tion, which means den­drit­ic cells not on­ly turn T cells on or off but al­so tell them how long to en­gage their tar­get.

“It’s not just about trig­ger­ing it but al­so about con­tin­u­ing to push the re­sponse for­ward,” he told End­points News. “That is im­por­tant par­tic­u­lar­ly in the con­text of au­toim­mu­ni­ty when you ac­tu­al­ly want to in­ter­rupt that cy­cle. You can think of it as a ther­a­peu­tic tar­get where you can ef­fec­tive­ly try and block these pos­i­tive sig­nals com­ing from the den­drit­ic cells, there­by break­ing the cy­cle that is lead­ing to con­tin­u­al ac­ti­va­tion of those T cells.”

With that po­ten­tial in mind, ATP and en­tre­pre­neur-in-res­i­dence Raj Mehta, now in­ter­im CEO, ap­proached Reis e Sousa about the po­ten­tial for a biotech start­up, with Mehta say­ing the wide-rang­ing po­ten­tial for the plat­form caught the ven­ture firm’s eye.

“We sat down to­geth­er about a year ago and said, this is an in­ter­est­ing area of bi­ol­o­gy, we want to learn more about how we can trans­late the re­search and work to­geth­er to set up the com­pa­ny,” Mehta said.

Aden­dra, of course, isn’t the on­ly biotech pur­su­ing break­throughs in den­drit­ic cell bi­ol­o­gy, a hot area for drug de­vel­op­ment giv­en those cells’ key reg­u­la­to­ry role in the im­mune sys­tem. BioN­Tech, for in­stance, is work­ing on us­ing mR­NA to help present tar­get­ed anti­gens in den­drit­ic cells — sim­i­lar to the way its Pfiz­er-part­nered Covid-19 vac­cine works.

Now emerged from stealth, Aden­dra is work­ing on build­ing out a pipeline with eyes on a range of ther­a­peu­tic modal­i­ties a pos­si­bil­i­ty, Mehta said. The one thing Mehta de­fin­i­tive­ly said Aden­dra would not pur­sue is cell ther­a­py.

In an un­usu­al work­ing arrange­ment, Aden­dra’s ac­tu­al cor­po­rate team will be a bare-bones op­er­a­tion in the short term, with re­search han­dled by sci­en­tists un­der Reis e Sousa at Fran­cis Crick. Mehta will look to bring on a full-time CEO to head the com­pa­ny’s next phase with­in the next two years as well as hire ex­pe­ri­enced ex­ec­u­tives to take the com­pa­ny for­ward.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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FDA slams door to piv­otal tri­al for bub­ble boy dis­ease gene ther­a­py as Mus­tang Bio runs in­to an­oth­er hold

Mustang Bio is in familiar territory, but that isn’t a place it necessarily wants to be.

The FDA has placed a hold on Mustang Bio’s pivitol trial for its gene therapy to treat patients with bubble boy disease, citing issues surrounding chemistry, manufacturing and controls clearance. It’s the second hold due to CMC issues the company has received in roughly 18 months.

An investigational new drug application was submitted in December 2021. If granted an IND, a Phase II study will then assess safety, tolerability and efficacy of MB-207. If approved by the FDA, the therapy would one day be eligible for a rare pediatric disease voucher.