Peer Re­view: GSK re­cruits a star can­cer sci­en­tist to its board ahead of R&D re­or­ga­ni­za­tion

Lau­rie Glim­ch­er FRANCK FIFE/AFP/Get­ty

Glax­o­SmithK­line has just ap­point­ed Lau­rie Glim­ch­er — a pi­o­neer­ing sci­en­tist and a cham­pi­on for ad­vanc­ing women to se­nior po­si­tions in the bio­med­ical world — to its board. Up un­til just 7 days ago, she was al­so on the board of Bris­tol-My­ers Squibb, a trend­set­ter in the block­buster im­muno-on­col­o­gy world. And the move just may say some­thing about GSK CEO Em­ma Walm­s­ley’s ideas about the fu­ture of the com­pa­ny, which now re­port­ed­ly in­clude a plan to re­vamp the pipeline.

Glim­ch­er is the CEO of Dana-Far­ber, one of the most pres­ti­gious can­cer re­search cen­ters in the world. She is al­so a re­searcher who has de­vot­ed a con­sid­er­able amount of lab time to im­muno-on­col­o­gy, a sub­ject she helped cov­er dur­ing her 20 years on the board of Bris­tol-My­ers Squibb, a post which she abrupt­ly jumped out of a week ago with a note about her “re­tire­ment.”

GSK Chair­man Philip Hamp­ton spot­light­ed her “wealth of ex­per­tise in sci­en­tif­ic and med­ical in­no­va­tion” for her new board role as a sci­en­tif­ic and med­ical ex­pert.

GSK com­plet­ed a high-pro­file as­set swap with No­var­tis a few years ago, ex­chang­ing its ma­ture can­cer projects and com­mer­cial prod­ucts with No­var­tis in ex­change for vac­cines. Since then, it’s made lit­tle head­way in the late-stage pipeline out­side of vac­cines and HIV, through its ma­jor­i­ty-owned sub­sidiary Vi­iV. Af­ter the Phase III washout of a slate of ma­jor can­di­dates, GSK slashed its US R&D group in North Car­oli­na as it cut costs and re­grouped. Since then phar­ma R&D has be­come one of its least ex­cit­ing fields, with no big prod­ucts in the late-stage pipeline to ex­cite in­vestors.

Ac­cord­ing to a re­port from Reuters, Walm­s­ley is qui­et­ly plan­ning a re­vamp of the pipeline, look­ing to dump mar­gin­al projects and bring in new ones.

GSK, though, nev­er got out of on­col­o­gy. The phar­ma gi­ant re­tained a sig­nif­i­cant ear­ly-stage R&D group in can­cer, ex­e­cut­ing a part­ner­ship with the UK’s Adap­ti­m­mune. Any move to switch the spot­light back to on­col­o­gy would be a ma­jor change­up in the Big Phar­ma world. So you can ex­pect at least a few peo­ple to be pay­ing close at­ten­tion to this news.

David Meek­er

→ Ra­dius put out the word that it is mak­ing a change at the helm, with long­time CEO Bob Ward out and No­vo US pres­i­dent Jes­per Høi­land step­ping in to or­ches­trate the cam­paign for Ra­dius’ first mar­ket launch. The news ar­rived just af­ter Am­gen an­nounced that the FDA had for­mer­ly re­ject­ed its ri­val os­teo­poro­sis drug.

→ David Meek­er, the for­mer chief of Sanofi-Gen­zyme, has an­oth­er chair­man’s role to fill. This time he’s tak­ing the lead board chair at Tre­vi Ther­a­peu­tics, which just raised a $50 mil­lion C round.  Meek­er was named chair­man of Rhythm in April, fol­low­ing up with a board ap­point­ment at San Fran­cis­co-based MyoKar­dia.

→ My­ovant Sci­ences CEO Lynn Seely has been build­ing out her team. This week she named Matthew Lang as gen­er­al coun­sel and cor­po­rate sec­re­tary; Juan Cami­lo Ar­jona Fer­reira, has joined as chief med­ical of­fi­cer; Tere­sa Per­ney, PhD, has joined as se­nior vice pres­i­dent of reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance; and An­dria Lan­gen­berg, has joined as head of drug safe­ty and phar­ma­covig­i­lance.

→ Sin­ga­pore-based Tes­sa Ther­a­peu­tics, an on­col­o­gy-fo­cused biotech which re­cent­ly part­nered with the Park­er In­sti­tute, an­nounced the ap­point­ment of Jen­nifer But­ler as chief com­mer­cial of­fi­cer. She’s in charge of build­ing the com­pa­ny’s US op­er­a­tions.

→ Lon­don-based Au­to­lus has been adding to the T-cell team this week. Its new ex­ecs are Christo­pher Vann, chief op­er­at­ing of­fi­cer; Matthias Alder, chief busi­ness of­fi­cer; Muham­mad Al-Ha­jj, SVP of trans­la­tion­al sci­ence and Nush­mia Khokar, VP of clin­i­cal de­vel­op­ment.

→ Austin-based Ae­glea Bio­Ther­a­peu­tics $AGLE says that David Lowe re­signed as the com­pa­ny’s pres­i­dent, chief ex­ec­u­tive of­fi­cer and di­rec­tor, ef­fec­tive im­me­di­ate­ly. An­tho­ny Quinn, has been ap­point­ed to serve as in­ter­im chief ex­ec­u­tive of­fi­cer while the com­pa­ny con­ducts a com­pre­hen­sive search for a per­ma­nent chief ex­ec­u­tive of­fi­cer.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.