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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.

Simba Gill, Evelo Biosciences CEO

Sim­ba Gill heads back to Flag­ship af­ter sev­en-year run as Evelo CEO

Evelo Biosciences is on the hunt for a new CEO, with its founding chief Simba Gill switching to the chairman post to free up time for his new gig at Evelo’s incubator, Flagship Pioneering.

Gill will trade in his former Flagship title of venture partner with the higher-up role of executive partner, after originally joining in 2015. He’ll serve as CEO of Evelo until his successor is chosen, and at Flagship his priorities will be counseling and supporting the venture firm’s portfolio companies.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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