Mark Timney, Blade Therapeutics chairman (Blade)

Small biotech chaired by ex-Pur­due CEO Mark Tim­ney jumps in­to the SPAC lane

The lat­est biotech SPAC has land­ed, and it’s one fea­tur­ing Pur­due Phar­ma’s for­mer CEO, Mark Tim­ney.

Blade Ther­a­peu­tics an­nounced its plans Mon­day to re­verse merge with the blunt­ly named Biotech Ac­qui­si­tion Com­pa­ny in a $254.3 mil­lion deal. Tim­ney, who cur­rent­ly serves as Blade’s ex­ec­u­tive chair­man, will re­tain the same role once the com­bined com­pa­ny com­pletes the merg­er in the first quar­ter of 2022.

Most of the funds — $230 mil­lion — come from the SPAC’s bank ac­count with the re­main­ing $24.3 mil­lion stem from a PIPE fi­nanc­ing that has a blue-chip slate of back­ers, in­clud­ing Deer­field, the VC arms of Pfiz­er and Bris­tol My­ers Squibb, MPM Cap­i­tal and Os­age Uni­ver­si­ty Part­ners.

As to what the SPAC cash will fund, Blade said in a press re­lease it ex­pects to push for­ward “clin­i­cal, man­u­fac­tur­ing and pre­clin­i­cal ac­tiv­i­ties” for its lead pro­grams with the new mon­ey.

Lit­tle ink has been spilled about Blade, but the South San Fran­cis­co-based biotech is aim­ing to bring oral small-mol­e­cule drugs to mar­ket. The lead pro­gram is known as cud­e­tax­e­s­tat, which Blade de­scribes as a “non-com­pet­i­tive, re­versible in­hibitor of au­to­tax­in.” It’s ex­pect­ed to en­ter a Phase II study in the first half of next year for id­io­path­ic pul­monary fi­bro­sis, Blade said.

Cud­e­tax­e­s­tat al­so re­cent­ly be­gan an­oth­er Phase I study last month to in­ves­ti­gate how it works in com­bi­na­tion with oth­er ap­proved ther­a­pies in IPF. It’s ex­pect­ed to wrap up be­fore April 2022.

The biotech al­so has three pre­clin­i­cal can­di­dates cur­rent­ly un­der de­vel­op­ment, each of which are cal­pain in­hibitors. Blade’s lead pre­clin­i­cal pro­gram is BLD-2184, which it’s de­vel­op­ing to treat a range of neu­rode­gen­er­a­tive dis­or­ders such as Hunt­ing­ton’s dis­ease, spin­ocere­bel­lar atax­ia type 3, Parkin­son’s dis­ease and Lewy body de­men­tia, among oth­ers.

Blade says it’s plan­ning a Phase I tri­al for BLD-2184 in the first half of 2022. The biotech’s oth­er two pre­clin­i­cal pro­grams are be­ing de­vel­oped for lung and liv­er fi­bro­sis, re­spec­tive­ly.

De­spite be­ing named in dozens of law­suits for his role in the opi­oid epi­dem­ic at Pur­due, Tim­ney has not found him­self lack­ing job op­por­tu­ni­ties. He pre­vi­ous­ly joined The Med­i­cines Com­pa­ny as CEO in De­cem­ber 2018, earn­ing an $84 mil­lion wind­fall in the biotech’s near­ly $10 bil­lion sale to No­var­tis the next year. And ear­li­er this year, Tim­ney joined At­tralus Ther­a­peu­tics as CEO in his next stop.

SPACs con­tin­ue chug­ging along fol­low­ing a mas­sive boom ear­li­er this year, lead­ing to more than $300 bil­lion across all mar­ket sec­tors by the end of the first quar­ter. Af­ter reg­u­la­tors asked fi­nan­cial in­sti­tu­tions to vol­un­tar­i­ly pro­vide doc­u­men­ta­tion on how they were in­ter­nal­ly polic­ing the blank-check com­pa­nies, ac­tiv­i­ty slowed, but it’s since picked back up as the year moved on.

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.

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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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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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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