Maze in­ter­im chief Charles Hom­cy pass­es ba­ton to Ja­son Colo­ma; William Col­lier tapped as CEO of Ar­bu­tus

Ja­son Colo­ma Third Rock

→ Four months in­to Maze Ther­a­peu­tics’ launch, Charles Hom­cy is pass­ing the start­up’s reins to an­oth­er Third Rock col­league. Ja­son Colo­ma, the cur­rent COO, is leav­ing his role at the VC firm to be­come full-time CEO on a mis­sion to trans­late ge­net­ic in­sights in­to new med­i­cines. Equipped with a whop­ping $191 mil­lion with sup­port from Arch, Maze’s big idea is to find and tar­get ge­net­ic mod­i­fiers that play a role in Mendelian dis­eases caused by an­oth­er gene. Colo­ma, a Roche/Genen­tech vet sea­soned in busi­ness de­vel­op­ment, was CBO at Corvus Phar­ma­ceu­ti­cals be­fore join­ing Third Rock in 2017.

Ar­bu­tus Bio­phar­ma has scooped William Col­lier from Vi­iV Health­care to suc­ceed Mark Mur­ray, who says it’s an op­por­tune time for him to re­tire con­sid­er­ing “the ef­fec­tive con­sol­i­da­tion of Ar­bu­tus’s op­er­a­tions and sci­en­tif­ic team in Warmin­ster, Penn­syl­va­nia, a pipeline fo­cused on a com­bi­na­tion ther­a­peu­tic reg­i­men to cure HBV, and a clear strate­gic busi­ness plan in place.” A Glax­o­SmithK­line vet, Col­lier spent the past nine years man­ag­ing Vi­iV’s North Amer­i­can op­er­a­tions, with launch­es for HIV, her­pes and bac­te­r­i­al in­fec­tions treat­ments un­der his belt.

Michael Stein Va­lo

Michael Stein has tran­si­tioned to the full-time CEO role at Va­lo Ther­a­peu­tics, which is look­ing to com­bine two ap­proach­es in can­cer im­munother­a­py: On­colyt­ic virus­es coat­ed with tu­mor-spe­cif­ic pep­tides. Stein has been serv­ing as Va­lo’s part-time co-chair­man since the biotech was spun out of the Uni­ver­si­ty of Helsin­ki in Jan­u­ary 2017. One of his most no­table achieve­ments was break­ing the UK record for a seed round as CEO of Ox­ford spin­out OxStem, a re­gen­er­a­tive med­i­cine com­pa­ny. His oth­er stints in­clude co-found­ing soft­ware start­up Map of Med­i­cine; it was lat­er sold to In­for­ma and then Hearst, where he land­ed an EVP role.

Robert For­rester Ve­rastem

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture. The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO. The com­pa­ny says it will search for a new chief with sub­stan­tial com­mer­cial ex­pe­ri­ence.

→ As N8 Med­ical moves its an­ti-in­fec­tive drug/de­vice in­to the clin­ic, it’s tapped Biocodex vet Marc Rohman as CEO. Laud­ed for his track record in launch­ing car­dio­vas­cu­lar med­i­cine and in­ter­ven­tion­al de­vices, Rohman is now tasked with plan­ning the com­mer­cial­iza­tion of N8’s plat­forms, which are de­signed to pre­vent com­pli­ca­tions caused by oth­er med­ical de­vices such as ven­ti­la­tors by de­liv­er­ing a class of syn­thet­ic mol­e­cules dubbed cer­a­genins.

Dar­lene Dep­tu­la-Hicks Linkedin

→ While mov­ing in­to an of­fice in Cam­bridge, Mass­a­chu­setts will grow their fi­nan­cial, clin­i­cal and reg­u­la­to­ry pres­ence in the US, the an­ti­body de­sign ex­perts at the UK’s F-star Ther­a­peu­tics have added Dar­lene Dep­tu­la-Hicks to their team. As CFO, Dep­tu­la-Hicks will lead a tran­si­tion in­to the clin­i­cal stage — the biotech re­cent­ly be­gan test­ing its lead bis­pe­cif­ic in can­cer pa­tients — and po­ten­tial­ly the pub­lic mar­ket, if chief Eliot Forster gets his way turn­ing the biotech in­to a heavy­weight play­er. Jump­ing from North­ern Bi­o­log­ics, she suc­ceeds Tol­ga Has­san, who will tran­si­tion to a COO po­si­tion.

→ In a sign of just how se­ri­ous it is about in­ter­nal drug de­vel­op­ment, Schrödinger has wooed ex­pe­ri­enced ex­ecs from Mer­ck and Ei­sai to its pre­clin­i­cal and trans­la­tion­al re­search team. Dun­can Hamish Wright is join­ing as VP of trans­la­tion­al sci­ence, while George Lai will lead trans­la­tion­al PK/PD and drug me­tab­o­lism with a se­nior di­rec­tor ti­tle. While the com­pa­ny has his­tor­i­cal­ly been known for the drug dis­cov­ery and de­sign ser­vices it pro­vides to bio­phar­ma clients — us­ing a physics-based mol­e­c­u­lar mod­el­ing plat­form — chief bio­med­ical sci­en­tist Karen Akin­sanya is now spear­head­ing an ef­fort to build a whol­ly-owned pipeline, be­gin­ning with on­col­o­gy.

Sharath Hegde Busi­ness Wire

Re­cur­sion wel­comed Ther­a­vance vet Sharath Hegde to its team as CSO. At Ther­a­vance, Hegde served as its SVP and head of re­search. Dur­ing his 15-year stint at Ther­a­vance, Hegde par­tic­i­pat­ed in the dis­cov­ery of sev­er­al NCEs — in­clud­ing Yu­pel­ri and Vi­ba­tiv. Hegde had a pre­vi­ous stint at Syn­tex.

Nov­aBay Phar­ma­ceu­ti­cals — fo­cus­ing on com­mer­cial­iz­ing Aven­o­va for the do­mes­tic eye care mar­ket — has tapped Justin Hall as pres­i­dent and CEO and brought on Ja­son Raleigh as its CFO — both have served in in­ter­im po­si­tions since March 2019. Hall has been with the com­pa­ny for six years and Raleigh for more than three.

→ CMO Phar­is Mo­hideen is part­ing ways with Mil­len­do Ther­a­peu­tics  — de­vel­op­ing treat­ments for or­phan en­docrine dis­eases — to be clos­er to his fam­i­ly in New Jer­sey. A search for a new CMO is un­der­way and in the mean­time, SVP of de­vel­op­ment, Ryan Zei­dan, will help over­see the med­ical func­tion dur­ing the in­ter­im pe­ri­od as well as con­tin­u­ing with his own func­tions.

Teri Hei­land Im­mu­nom­ic

Teri Hei­land is mov­ing up the ranks at Im­mu­nom­ic Ther­a­peu­tics. She has been pro­mot­ed to the role of CSO at the com­pa­ny. Hei­land — a co-founder of the com­pa­ny — has ex­per­tise in DNA vac­cine de­sign. Pri­or to join­ing Im­mu­nom­ic, Hei­land was one of the founders at Mary­land-based bio­mark­er and drug dis­cov­ery com­pa­ny, Cap­i­tal Genomix, where she served as VP of re­search and de­vel­op­ment. She al­so served as a prin­ci­pal in­ves­ti­ga­tor on over $2M in grants from the De­part­ment of De­fense and NI­AID.

Abzena — spe­cial­iz­ing in ADC drug de­vel­op­ment ser­vices — has made two new ad­di­tions to its lead­er­ship team: An­drew Kraus as Chief Tech­nol­o­gy Of­fi­cer and Philip Payne as CMO.

Kraus “will im­ple­ment ad­vanced tech­nol­o­gy so­lu­tions to fur­ther en­hance da­ta in­tegri­ty con­trols, reg­u­la­to­ry com­pli­ance and ef­fec­tive elec­tron­ic da­ta shar­ing. He will al­so over­see a range of plat­forms to sup­port glob­al op­er­a­tions in­clud­ing Elec­tron­ic Lab­o­ra­to­ry Note­book and En­ter­prise Re­source Plan­ning sys­tems.” His pre­vi­ous stints in­clude serv­ing at Bio­Clin­i­ca, ICON Clin­i­cal Re­search and the Car­dio­vas­cu­lar Re­search Foun­da­tion. Payne “will lead glob­al busi­ness de­vel­op­ment with a par­tic­u­lar fo­cus on grow­ing the com­pa­ny’s busi­ness in the Eu­ro­pean and UK re­gions.” He joins the com­pa­ny from stints at Con­cept Life Sci­ences, Ap­tu­it and Catal­ent Phar­ma So­lu­tions.

Nkechi Azie Linkedin

SCYNEX­IS tapped Nkechi Azie as vice pres­i­dent of clin­i­cal de­vel­op­ment. In his new role, Azie will lead clin­i­cal de­vel­op­ment ac­tiv­i­ties and strength­en med­ical af­fairs ef­forts in an­tic­i­pa­tion of ibrex­a­fungerp’s — an an­ti­fun­gal agent in Phase III clin­i­cal and pre­clin­i­cal de­vel­op­ment for the treat­ment of in­va­sive fun­gal in­fec­tions caused by Can­di­da, As­pergillus and Pneu­mo­cys­tis species po­ten­tial ap­proval and com­mer­cial launch.

Pri­or to join­ing SCYNEX­IS, Azie served as SVP of med­ical af­fairs at The Med­i­cines Com­pa­ny. Her oth­er stints in­clude serv­ing as se­nior di­rec­tor of med­ical af­fairs at Astel­las Phar­ma — where she was re­spon­si­ble for the an­ti­fun­gal fran­chise in­clud­ing mi­ca­fun­gin and isavu­cona­zole — and di­rec­tor of an­ti-in­fec­tive clin­i­cal de­vel­op­ment for Pfiz­er.

→ CRO George Clin­i­cal brought on Meel­ian Hoh on to its ex­ec­u­tive team as CFO. Hoh joins from Mi­tel, where she served as fi­nance di­rec­tor for the Asia-Pa­cif­ic re­gion. Some of her pre­vi­ous stints in­clude gen­er­al man­ag­er – fi­nance at Kin­care, CFO for Pe­lion Group, and oth­er se­nior-lev­el po­si­tions at Bell­wether Phar­ma, No­var­tis and Pfiz­er/Phar­ma­cia.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.