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.”

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.