Kartik Krishnan, departed Arcus Biosciences CMO

UP­DAT­ED: Scoop: Ar­cus CMO Kar­tik Kr­ish­nan left for new op­por­tu­ni­ty ahead of big TIG­IT read­out

Ar­cus Bio­sciences chief med­ical of­fi­cer Kar­tik Kr­ish­nan re­cent­ly left the biotech to take an­oth­er op­por­tu­ni­ty else­where, a com­pa­ny spokesper­son con­firmed to End­points News.

The com­pa­ny has be­gun a search process for his re­place­ment. Kr­ish­nan told End­points he left the start­up last month af­ter see­ing the clin­i­cal de­vel­op­ment team grow from three MDs to about 150 peo­ple hop­ping on clin­i­cal op­er­a­tions group meet­ings.

“I had put peo­ple in place in lead­er­ship roles, in­clud­ing in the de­vel­op­ment func­tion, that I felt the shop would be well tak­en care of if there were no me there,” he said. He starts his next job, an­oth­er CMO role at a small­er on­col­o­gy-fo­cused biotech, next month. “I’ve nev­er tak­en a month off,” he added.

The move comes less than a year af­ter Kr­ish­nan was el­e­vat­ed to the head of the biotech’s clin­i­cal de­vel­op­ment op­er­a­tions, which in­cludes a mul­ti-tri­al TIG­IT as­set, a drug that is like­ly to come un­der in­creased pres­sure and scru­ti­nized eyes af­ter Roche’s prized TIG­IT failed a clin­i­cal tri­al ear­li­er this week.

His job move­ment “didn’t have any­thing to do with the da­ta,” Kr­ish­nan said, not­ing he was “sur­prised” by the Roche da­ta and hadn’t seen it un­til every­body else did.

Kr­ish­nan as­sumed the post in Ju­ly 2021 from Bill Gross­man, who left to be­come Gilead’s SVP of on­col­o­gy clin­i­cal re­search. The two worked to­geth­er close­ly fol­low­ing the tran­si­tion, giv­en their em­ploy­ers’ part­ner­ship on the TIG­IT as­set, which is in mul­ti­ple clin­i­cal tri­als.

“How­ev­er, giv­en the strongest sig­nal of clin­i­cal ac­tiv­i­ty was from [Roche’s] tiragolum­ab (Fc-com­pe­tent TIG­IT), we need to see sup­port­ive clin­i­cal da­ta be­fore as­sum­ing any oth­er com­pa­ny has a bet­ter mol­e­cule or strat­e­gy than Roche. We ex­pect the first such da­ta will be the 2H22 read­out of ARC-7 from Ar­cus / Gilead,” SVB Se­cu­ri­ties an­a­lysts wrote in a note this week af­ter Roche’s TIG­IT as­set failed a Phase III study in pa­tients with non-small cell lung can­cer.

Ar­cus’ ARC-7 study is al­so a tri­al in NSCLC. The biotech’s stock $RCUS slid about $7 on Wednes­day af­ter Roche re­leased its TIG­IT da­ta ear­ly that morn­ing.

Kr­ish­nan joined Hay­ward, CA-based Ar­cus in 2019 as SVP of clin­i­cal de­vel­op­ment. Pri­or to Ar­cus, he was in var­i­ous med­ical di­rec­tor roles at Aster Phar­ma­ceu­ti­cals, Genen­tech, FivePrime Ther­a­peu­tics, Bio­Marin Phar­ma­ceu­ti­cal and Am­gen over the past decade.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

Four days ago, Moderna CEO Stéphane Bancel was made a Chevalier — basically knighted — in his home country of France. And now the billionaire CEO said he will exercise and donate about  $355 million in stock options.

Bancel announced early Tuesday via a blog post that he and his wife Brenda will be donating the after-tax proceeds of his original stock options to charity — the stock options Bancel was granted back in 2013 after he became CEO, two years after he first joined the mRNA specialist outfit.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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David Sinclair, Genocea Biosciences co-founder (Alpha Wave Global)

Geno­cea reach­es end of road, delist­ing from Nas­daq and let­ting go of re­main­ing staff

A pivot into neoantigen immunotherapies was not enough to save Genocea Biosciences after all.

The 16-year-old biotech said it would be closing down and laying off all remaining employees “except those deemed necessary to complete an orderly wind down” of operations. It has also delivered a formal notice to Nasdaq, notifying the stock exchange of its intent to delist voluntarily.

The move comes a month after Genocea laid off 75% of its workforce and revealed it’s looking for strategic alternatives, such as a sale, merger or reverse merger. At the end of 2021, it had 74 employees.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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