Japan­ese bil­lion­aire Mik­i­tani takes full con­trol of Rakuten As­pyr­i­an; HOX Ther­a­peu­tics taps Karl Kee­gan as CEO

→ Hav­ing in­fused $150 mil­lion in­to Rakuten As­pyr­i­an weeks ago, Hi­roshi “Mick­ey” Mik­i­tani is step­ping up his con­trol on the biotech he’s been chair­ing since 2016. The Japan­ese bil­lion­aire, known for build­ing a leg­endary e-tail­er from scratch, is tak­ing over the CEO role so that Miguel Gar­cia-Guz­man can con­tin­ue to build the pho­toim­munother­a­py pipeline as CSO and vice chair­man. As the San Diego-based com­pa­ny turns the cor­ner on a Phase III study, it’s al­so ap­point­ed Takashi Toraishi, who was man­ag­ing its Japan of­fices, as COO to over­see clin­i­cal tri­als and com­mer­cial­iza­tion.

→ With Jack­ie Fouse gone to take the reins of Agios, Der­ma­vant Sci­ences — a der­ma­tol­ogy fo­cused unit of Vivek Ra­maswamy’s Roivant Sci­ences — has hired in­dus­try vet­er­an Todd Za­vod­nick as its CEO, as the com­pa­ny pre­pares to be­gin a late-stage tri­al of its lead ex­per­i­men­tal drug, tap­inarof. Za­vod­nick comes with over two decades of ex­pe­ri­ence, hav­ing worked at ZEL­TIQ Aes­thet­ics be­fore it was ac­quired by Al­ler­gan $AGN as well as Gal­der­ma, among oth­er firms.

→ Can­cer biotech HOX Ther­a­peu­tics has ap­point­ed new CEO Karl Kee­gan to lead its en­try in­to the clin­ic. In a ca­reer span­ning prod­uct de­vel­op­ment at SmithK­line Beecham, in­vest­ment an­a­lyst in Lon­don and CFO/cor­po­rate de­vel­op­ment roles at Pharm­ing, Vec­tura and Shield Ther­a­peu­tics, the com­pa­ny notes, he’s amassed sig­nif­i­cant ex­pe­ri­ence in fi­nanc­ing com­pa­nies, busi­ness de­vel­op­ment and cor­po­rate M&A. He is now ex­pect­ed to bring it all to the ta­ble at Guild­ford, UK-based HOX, which is fo­cused on a type of “con­trol” genes cen­tral to em­bryo­ge­n­e­sis called HOX.

→ Se­r­i­al en­tre­pre­neur Pe­ter Suz­dak is out at Rex­ahn Phar­ma­ceu­ti­cals, pass­ing the pres­i­dent and CEO ba­ton to Dou­glas Swirsky. Swirsky, who joined the can­cer drug de­vel­op­er at the be­gin­ning of the year, will car­ry on be­ing CFO. A for­mer in­vest­ment banker, Swirsky was chief ex­ec­u­tive at Gen­Vec for four years un­til it was sold to In­trex­on.

→ Af­ter a decade with Thomas Van­Cott at the helm, ABL is turn­ing a new leaf by pro­mot­ing chief com­mer­cial of­fi­cer Jar­lath Keat­ing to pres­i­dent and CEO. While Keat­ing is a re­cent hire, he’s a vet­er­an of the con­tract re­search and man­u­fac­tur­ing ser­vice in­dus­try, hav­ing held com­mer­cial roles at Mil­li­pore­Sig­ma and tech­ni­cal roles at Lon­za Bi­o­log­ics. His ap­point­ment, the com­pa­ny says, is a “clear re­flec­tion of ABL’s com­mit­ment to a long-term glob­al ex­pan­sion strat­e­gy.”

→ Four new ex­ecs are com­ing on board Flag­ship-seed­ed Sig­ilon Ther­a­peu­tics’ pur­suit of the Holy Grail in di­a­betes: get­ting stem cells to trans­form in­to in­sulin pro­duc­ing pan­cre­at­ic be­ta cells with­out trig­ger­ing a se­vere im­mune re­ac­tion. Deya Cor­zo has joined as CMO af­ter work­ing up her clin­i­cal tri­al mus­cles at So­journix, uniQure, Cel­gene, Take­da and Sanofi/Gen­zyme; Vi­a­Cyte vet Olivia Kel­ly is named VP of islet cell ther­a­py re­search; Martha Rook is jump­ing from Mil­li­pore­Sig­ma to be­come head of man­u­fac­tur­ing; and Vanya Sagar, for­mer­ly of Bio­gen, will be VP of HR.  

Agenus’ $AGEN in-house mid-stage check­points and can­cer vac­cines may still have a long path to com­mer­cial­iza­tion, but the Lex­ing­ton, MA-based biotech wants to be sure it’s ready for it. Jen­nifer Buell is now chief op­er­at­ing of­fi­cer, a role that com­bines all three po­si­tions she’s held in her five years at the com­pa­ny: She has a broad man­date cov­er­ing re­search, clin­i­cal de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial op­er­a­tions. Al­li­son Jeynes-El­lis, bio­phar­ma vet and Avil­lion CEO, has been ap­point­ed as a board di­rec­tor.  

El­liot Ehrich

Kevin For­rest has brought in a new part­ner from 5AM Ven­tures — where he used to be a prin­ci­pal — to his team at Ex­pan­sion Ther­a­peu­tics. El­liot Ehrich, the new­ly mint­ed CMO, had re­cent­ly joined the ven­ture firm af­ter a 17-year run at Alk­er­mes that cul­mi­nat­ed in the top R&D and med­ical role. His ex­pe­ri­ence in dri­ving drug as­sets from ear­ly re­search through ap­proval will be “in­stru­men­tal” for Ex­pan­sion, CEO For­rest says, which is still in dis­cov­ery stage with its RNA-tar­get­ing small mol­e­cule med­i­cines de­signed to treat a set of ge­net­ic dis­eases called ex­pan­sion re­peat dis­or­ders.

→ As Asha Das makes an abrupt de­par­ture from Toca­gen to tend to “un­fore­seen and im­me­di­ate per­son­al mat­ters,” it’s tapped a board mem­ber to fill in as the act­ing CMO. Lori Kunkel, who has three CMO stints from Loxo On­col­o­gy, Phar­ma­cyclics and Pro­te­olix un­der her belt, will take charge of ad­vanc­ing Toca­gen’s Phase III high grade glioma pro­gram and the rest of its pipeline un­til the San Diego-based biotech finds a per­ma­nent hire.

→ Now that As­cle­tis has some­what stead­ied its po­si­tion on the Hong Kong Stock Ex­change — al­beit not an en­vi­able one, cur­rent­ly trad­ing around half of its de­but price — it’s ready to move on with a new CFO on the team. Lin­di Tan brings 15 years of as a health­care an­a­lyst, with stints at SeaTown Hold­ings and Temasek.  

Mer­ck vet Joel Lebowitz has joined Schrödinger as CFO at a time the com­pu­ta­tion­al drug dis­cov­ery shop is dou­bling down on big bio­phar­ma part­ner­ships, marked by a joint ven­ture with WuXi AppTec launched days ago. Lebowitz, who spent much of his time at the phar­ma gi­ant eval­u­at­ing the port­fo­lio and do­ing pipeline val­u­a­tion, will al­so play a key role in busi­ness de­vel­op­ment.

→ Af­ter a decade at now trou­bled Idera, Louis Ar­cu­di is mov­ing on to his next CFO role. The sea­soned ex­ec will be en­ter­ing Mil­len­do Ther­a­peu­tics with Michael Yeh, an alum­ni of So­bi and Bio­gen who’s just been ap­point­ed VP of med­ical af­fairs.

→ Ox­nard, CA-based CURE Phar­ma has tapped ven­ture cap­i­tal­ist Alex Katz to over­see its fi­nan­cial func­tions as CFO. Katz, a for­mer man­ag­ing part­ner for ff Ven­ture Cap­i­tal and Dif­fer­en­tial Ven­ture Part­ners, has been work­ing with the drug de­liv­ery in­no­va­tor as an ad­vis­er.

→ On the heels of a much an­tic­i­pat­ed up­date that keeps the con­tro­ver­sy burn­ing over NK­TR-214/Op­di­vo, Nek­tar $NK­TR an­nounced it has re­cruit­ed Genen­tech vet Wei Lin to spear­head its on­col­o­gy pro­grams. As SVP of clin­i­cal de­vel­op­ment, Lin will have over­sight not just on NK­TR-214 com­bo tri­als but al­so the rest of the I/O pipeline.

→ We fi­nal­ly know where Lisa Suen­nen is head­ed af­ter a sur­pris­ing ex­it from GE Ven­tures.  Man­att Phelps & Phillips, a lead­ing law and con­sult­ing firm with a health-fo­cused branch, an­nounced Suen­nan will head up its dig­i­tal and tech­nol­o­gy busi­ness­es and as well as the firm’s ven­ture cap­i­tal fund from its San Fran­cis­co of­fice.

De­nali CMO Ca­r­ole Ho has tak­en a board seat at Beam Ther­a­peu­tics, the base edit­ing biotech found­ed by CRISPR trail­blaz­ers Feng Zhang, David Liu and J Kei­th Joung.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.