Ali Tehrani, Zymeworks CEO

Long­time Zymeworks CEO, co-founder Tehrani hits the ex­it in fa­vor of se­r­i­al biotech en­tre­pre­neur

Af­ter a down year, bio­phar­ma writ large is look­ing for a breath of fresh air — and now the winds of change have hit on­col­o­gy bis­pecifics play­er Zymeworks.

Ken Gal­braith

Ali Tehrani, a co-founder of Zymeworks who has been the biotech’s CEO since 2003, has re­signed from his po­si­tion and will be re­placed by Ken Gal­braith, a se­r­i­al biotech en­tre­pre­neur and for­mer board mem­ber, the com­pa­ny said Wednes­day.

Tehrani will take on an ad­vi­so­ry role with the com­pa­ny once his tenure for­mal­ly ends Feb. 1 to help aid in the tran­si­tion for Gal­braith’s lead­er­ship turn. Mean­while, board chair Lota Zoth will be moved in­to an in­de­pen­dent di­rec­tor role in con­junc­tion with the shake­up.

Shares in $ZYME were trad­ing down around 7% on the news ear­ly Thurs­day.

In both a press re­lease and con­cur­rent SEC fil­ing, Zymeworks re­leased no fur­ther de­tails on the rea­sons for Tehrani’s de­par­ture. He and his com­pa­ny came to terms on a sev­er­ance deal that will in­clude a $889,683 lump sum pay­ment as well as a re­main­ing an­nu­al bonus and ben­e­fits. His ad­vi­so­ry con­tract is set to end in Sep­tem­ber 2023.

Mean­while, Gal­braith will take the reins at a biotech that has been gung-ho in its ef­forts to rein in a suite of Big Phar­ma part­ners and re­cent­ly flashed some promis­ing da­ta for its bis­pe­cif­ic HER2-tar­get­ed an­ti­body, dubbed zanidatam­ab, at this year’s ES­MO.

Gal­braith has float­ed in and out of biotech lead­er­ship roles for years, most re­cent­ly serv­ing as ex­ec­u­tive-in-res­i­dence at Syn­cona since April and as a man­ag­ing part­ner at Five Cor­ners Cap­i­tal, which he co­found­ed back in 2013. Oth­er stops on his lengthy ré­sumé in­clude CEO of Lim­i­nal Bio­Sciences be­tween April 2019 and No­vem­ber 2020, CEO of Fairhaven Phar­ma­ceu­ti­cals from June 2017 to April 2019, and even as a Zymeworks board mem­ber from 2009 to 2013.

Gal­braith had this to say about his ap­point­ment:

I have long be­lieved in the po­ten­tial of in­no­v­a­tive tech­nol­o­gy plat­forms to gen­er­ate nov­el mul­ti­spe­cif­ic an­ti­bod­ies and an­ti­body-drug con­ju­gates and trans­form the treat­ment of can­cer. Zymeworks’ in­no­v­a­tive ap­proach, tech­nol­o­gy plat­forms and emerg­ing prod­uct pipeline rep­re­sent a tremen­dous op­por­tu­ni­ty, and I look for­ward to lead­ing the Com­pa­ny dur­ing this ex­cit­ing pe­ri­od of in­no­va­tion in can­cer ther­a­pies. This year, we ex­pect to progress our two on­go­ing piv­otal clin­i­cal stud­ies for zanidatam­ab, present im­por­tant new da­ta for zanidatam­ab and ZW49 to in­form ad­di­tion­al clin­i­cal de­vel­op­ment op­por­tu­ni­ties, fur­ther ad­vance our pre­clin­i­cal prod­uct pipeline and gain in­sights from our phar­ma­ceu­ti­cal part­ners’ pro­grams as they ad­vance in­to and through clin­i­cal de­vel­op­ment.

Gal­braith will be due a $600,000 an­nu­al salary plus stocks and op­tions, with the op­tion for an an­nu­al bonus worth up to 60% of that salary fig­ure.

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

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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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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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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.