GSK vets Wit­ty and Slaoui find new roles in biotech as the great mi­gra­tion con­tin­ues

An­drew Wit­ty has signed on as a part­ner at Durham, NC-based Hat­teras. “An­drew Wit­ty we be­lieve brings the high­est lev­el of un­der­stand­ing about the phar­ma in­dus­try as a whole,” Hat­teras gen­er­al part­ner Bob In­gram tells End­points News, count­ing off Wit­ty’s lead­ing roles in the glob­al com­mer­cial as well as R&D side of the busi­ness. In­gram says Wit­ty — like­ly the on­ly knight­ed mem­ber of the biotech ven­ture com­mu­ni­ty — is ex­pect­ed to help ad­vise the firm and its biotech com­pa­nies, lend­ing some of his ster­ling Big Phar­ma rep to the or­ga­ni­za­tion as it grows up new com­pa­nies. And, you can add one more new biotech role for ex-GSK CEO. The for­mer phar­ma chief has joined the ad­vi­so­ry board at Syn­thego, a genome en­gi­neer­ing out­fit based in Red­wood City, CA.

⇨ Mon­cef Slaoui has joined the Eu­ro­pean biotech ven­ture cap­i­tal team at Medicxi. Slaoui was the long­time R&D chief at GSK be­fore he moved to chair the big vac­cines side of the busi­ness ahead of his re­tire­ment last June. Not long af­ter leav­ing GSK, the en­thu­si­as­tic and out­go­ing Slaoui start­ed join­ing biotech boards, with wel­comes at SutroVax, mR­NA play­er Mod­er­na as well as the pub­lic out­fit In­tel­lia $NT­LA, one of a hand­ful of CRISPR/Ca9 gene edit­ing star­tups dom­i­nat­ing the field. Then, a lit­tle over a month ago, he dropped off the In­tel­lia crew, cit­ing a con­flict but not ex­plain­ing it. In a state­ment, Slaoui said he was look­ing for­ward to start­ing, “with funds avail­able to in­vest not on­ly in ear­ly stage as­sets but al­so to build­ing in­no­v­a­tive com­pa­nies through clin­i­cal de­vel­op­ment and mar­ket en­try. I am look­ing for­ward to mak­ing an ac­tive con­tri­bu­tion to se­lect­ing and lead­ing in­vest­ments, and to sup­port­ing am­bi­tious en­tre­pre­neurs to de­vel­op med­i­cines that ul­ti­mate­ly make a dif­fer­ence to pa­tients.”

Roivant Sci­ences has added an­oth­er sea­soned biotech ex­ec to its sta­ble of CEOs. The um­brel­la group an­nounced this morn­ing that Kei­th Katkin, the long­time CEO at Avanir up to its sale to Ot­su­ka, is tak­ing the CEO’s job at Urovant. The start­up vant is fo­cused on uro­log­i­cal con­di­tions.

⇨ An­oth­er se­nior As­traZeneca R&D ex­ec has jumped ship. San­jay Jari­wala is mov­ing on to Bio­gen, where he will be the new se­nior vice pres­i­dent, world­wide med­ical, re­port­ing to Al San­drock. “San­jay’s depth of ex­pe­ri­ence and track record of strate­gic in­te­gra­tion of glob­al ther­a­peu­tic op­er­a­tions, clin­i­cal de­vel­op­ment, com­mer­cial, and state of the art med­ical lead­er­ship across large or­ga­ni­za­tions is im­pres­sive,” said San­drock.

Paul Hast­ings

⇨ The long­time biotech ex­ec and On­coMed $OMED CEO Paul Hast­ings is go­ing on med­ical leave. There’s no im­me­di­ate word about what ails him, but the biotech says that Hast­ings will keep his ti­tles as he re­mains on med­ical leave at the biotech, which is fo­cused on new can­cer ther­a­pies. In the mean­time, the com­pa­ny will be led by a se­nior man­age­ment team with an “Of­fice of the Pres­i­dent” con­sist­ing of R&D chief John Lewic­ki and CFO Sunil Pa­tel.  In ad­di­tion, On­coMed’s board has ap­point­ed a spe­cial com­mit­tee con­sist­ing of Jack Laser­sohn, the lead di­rec­tor, with Per­ry Karsen, Deepa Pakianathan and Rick Win­ning­ham to work close­ly with Lewic­ki and Pa­tel dur­ing Hast­ings’ leave.

⇨ Bob Goeltz is join­ing San Fran­cis­co-based UNI­TY Biotech­nol­o­gy as the new CFO. Join­ing as gen­er­al coun­sel is Tam­my Tomp­kins. Join­ing as se­nior vice pres­i­dent of op­er­a­tions is Doug Rich.

⇨ So­raya Bekkali is the new CEO at Gy­ro­scope Ther­a­peu­tics. Bekkali had a stint at Lyso­gene and served as glob­al head of the oph­thal­mol­o­gy busi­ness unit at Sanofi be­fore join­ing the reti­nal dis­ease com­pa­ny.

⇨ Matthew Ottmer has joined Voy­ager Ther­a­peu­tics as their CFO.  Voy­ager’s CEO Steven Paul not­ed that “in ad­di­tion to lead­ing strat­e­gy, pro­gram and al­liance man­age­ment, Matt will over­see the com­mer­cial de­vel­op­ment plans of our lead and pipeline pro­grams, in­clud­ing new prod­uct plan­ning for our Parkin­son’s dis­ease pro­gram, which are crit­i­cal, val­ue-dri­ving ar­eas for the com­pa­ny.”

⇨ Achao­gen’s got a new chief busi­ness of­fi­cer. Liz Bhatt’s pri­or gigs in­clude VP of cor­po­rate de­vel­op­ment at Gilead and cor­po­rate de­vel­op­ment and strat­e­gy roles at Eli Lil­ly and Maxy­gen.

⇨ Ka­ma­da Deputy CEO and CFO Gil Efron plans to leave the com­pa­ny at the end of the year.

⇨ Aerie Phar­ma­ceu­ti­cals named Tori Arens as VP of drug prod­uct man­u­fac­tur­ing and Er­ic Carl­son as vice pres­i­dent of re­search and de­vel­op­ment.


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.