Nick Haining, Arsenal Bio

Sean Park­er-backed cell ther­a­py start­up Ar­se­nal­Bio plucks Mer­ck VP as new CSO

Mer­ck’s im­muno-on­col­o­gy su­per­star Nicholas Hain­ing has been ap­point­ed CSO at Ar­se­nal­Bio, which is work­ing on an ap­proach to pro­gram­ma­ble cell ther­a­pies.

The ad­di­tion of a high-pro­file ap­point­ment like Hain­ing, who co-found­ed the com­pa­ny but has been serv­ing as VP of dis­cov­ery on­col­o­gy and im­munol­o­gy at Mer­ck Re­search Lab­o­ra­to­ries and al­so did work on pe­di­atric hema­tol­ogy/on­col­o­gy at the famed Dana-Far­ber Can­cer In­sti­tute, comes as Ar­se­nal­Bio may set its sights on an IPO in the near fu­ture.

Hain­ing re­places Genen­tech vet Jane Gro­gan, who in April moved over to be Graphite Bio’s CSO af­ter serv­ing as Ar­se­nal’s CSO since the biotech’s launch in Oc­to­ber 2019.

“Ar­se­nal­Bio has laid out a vi­sion and a roadmap for en­gi­neer­ing the fate and func­tion of T cells to help cure can­cer,” Hain­ing said in a state­ment. “It will be a priv­i­lege to be part of the mis­sion of trans­form­ing the best sci­ence in­to ef­fec­tive ther­a­pies for pa­tients who need them most.”

The new se­nior lead­er­ship fits right in with Ar­se­nal’s re­cent­ly an­nounced col­lab­o­ra­tion with Bris­tol My­ers Squibb. Back in Jan­u­ary, Ar­se­nal teamed up with BMS to find, de­vel­op and com­mer­cial­ize tar­get­ed T cell ther­a­pies for sol­id tu­mors. Ar­se­nal will han­dle the ear­ly dis­cov­ery work in the deal while Bris­tol will pay $70 mil­lion up­front with an op­tion to li­cense pre­clin­i­cal can­di­dates and bring them to mar­ket.

Ar­se­nal has sharp­ened its fo­cus in the near­ly two years since its in­cep­tion, with new work on us­ing a “stack” of bi­ol­o­gy com­po­si­tions to cre­ate de­sign­er T cells that can be ad­min­is­tered at low­er dos­es, bet­ter tar­get sol­id tu­mors and pre­vent the se­ri­ous side ef­fects com­mon in oth­er im­munother­a­pies. The biotech says its can­di­dates may be eas­i­er to man­u­fac­ture too, giv­en the fact they’re not ad­min­is­tered through in­ac­ti­vat­ed virus­es.

Ken Drazan

Led by Ken Drazan, a J&J vet and for­mer pres­i­dent of Grail, the South San Fran­cis­co-based biotech has a for­mi­da­ble group of in­vestors, in­clud­ing the bil­lion­aire and for­mer Nap­ster head Sean Park­er, who sits on Ar­se­nal’s board of di­rec­tors, and his Park­er In­sti­tute for Can­cer Im­munother­a­py, along with oth­ers like West­lake Vil­lage BioPart­ners, Klein­er Perkins, the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co Foun­da­tion In­vest­ment Com­pa­ny, Eu­clid­ean Cap­i­tal, and Os­age Uni­ver­si­ty Part­ners.

“Ar­se­nal­Bio al­lows us to rewrite vast stretch­es of code to give T cells dra­mat­ic new func­tions — that means they can be made to be more ef­fec­tive at killing can­cer and a broad spec­trum of oth­er dis­eases,” Park­er said in a state­ment. “It’s al­so very re­ward­ing to see Ar­se­nal­Bio born from the deep col­lab­o­ra­tion of PI­CI in­ves­ti­ga­tors — who worked to­geth­er across re­search cen­ters, hos­pi­tals and uni­ver­si­ties on the sci­ence be­hind these tech­nolo­gies.”

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

(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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.