Terry Connolly, K36 Therapeutics CEO

At­las, F-Prime launch K36 Ther­a­peu­tics to ad­vance on­col­o­gy mol­e­cule for elu­sive epi­ge­net­ic tar­get

Af­ter be­ing in stealth for near­ly 11 months, a new biotech has made it­self known, com­plete with an in­flux of cash from some big-name in­vestors.

K36 Ther­a­peu­tics, an on­col­o­gy biotech out of Cam­bridge, MA, emerged from stealth this morn­ing — an­nounc­ing a long-fin­ished $30M Se­ries A co-led by F-Prime Cap­i­tal, At­las Ven­ture and glob­al in­vest­ment firm Eight Roads Ven­tures.

K36 CEO Ter­ry Con­nol­ly told End­points News that the se­ries was ac­tu­al­ly closed back in Feb­ru­ary — and is now just be­ing an­nounced. Con­nol­ly said that he ex­pects the fund­ing to get K36 through proof-of-con­cept stud­ies and hope­ful­ly push the can­di­date to the IND phase, which the biotech plans to file by the end of June next year.

If more fund­ing is need­ed, K36 will have those dis­cus­sions at that time — but in the mean­time, $30 mil­lion is enough, ac­cord­ing to Con­nol­ly.

With on­ly 5 em­ploy­ees, K36 on­ly has one drug it’s fo­cus­ing on: KTX-1001, which the com­pa­ny in-li­censed from No­var­tis. That drug tar­gets the hi­s­tone methyl­trans­ferase (HMT) MM­SET, look­ing at pa­tients with mul­ti­ple myelo­ma.

Con­nol­ly told End­points that he was em­ploy­ee No. 1 in mid-Feb­ru­ary.

He said what drew him to K36 was the tar­get. Con­nol­ly knew MM­SET from his time at Cel­gene, where he spent eight years be­fore mov­ing on to Drag­on­fly Ther­a­peu­tics and then to K36. Cel­gene was known for its mul­ti­ple myelo­ma drugs Rem­i­cade and Po­m­a­lyst, and al­so worked close­ly with the biotech Epizyme on a se­ries of methyl­trans­ferase in­hibitors.

“And it’s re­al­ly just one of those holy grail tar­gets for mul­ti­ple myelo­ma, where peo­ple have been try­ing to drug it for a cou­ple of decades and no one has been suc­cess­ful,” Con­nol­ly said in an in­ter­view. “So when I learned that there was a mol­e­cule that was avail­able for li­cens­ing, and this com­pa­ny was go­ing to in-li­cense the mol­e­cule and be the first to take a se­lect MM­SET in­hibitor in­to the clin­ic, I want­ed to be a part of that.”

The com­pa­ny’s cur­rent end goal is get­ting an IND sub­mit­ted. Af­ter that point, K36 will start look­ing at oth­er pro­grams, but not be­fore, Con­nol­ly said.

Along­side leav­ing stealth and an­nounc­ing its raise, K36 al­so an­nounced a new ad­di­tion to its board: Lori Kunkel, a for­mer act­ing CMO at Loxo On­col­o­gy and cur­rent­ly a mem­ber of the board of di­rec­tors at Nurix.

The drug is the newest can­di­date in a long line of drugs with epi­ge­net­ic tar­gets — and while some have worked, many of the drugs have not had as much ef­fi­ca­cy as hoped. It is in the same class of drugs as Epizyme’s tazeme­to­stat, a methyl­trans­ferase in­hibitor which got ap­proved for its sec­ond in­di­ca­tion last year in fol­lic­u­lar lym­phoma.

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.

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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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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Dan O'Day (Getty Images)

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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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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