Biotech vet Paul Bren­nan takes helm at re­gen­er­a­tive med biotech; Ax­cel­la names CFO

Paul Bren­nan

→ Re­gen­er­a­tive med­i­cine com­pa­ny, Nerv­Gen Phar­ma — fo­cused on the treat­ment of nerve dam­age — has tapped Paul Bren­nan to head the helm of the com­pa­ny as CEO and pres­i­dent. Bren­nan is the suc­ces­sor to Ernest Wong, who will con­tin­ue to serve as a con­sul­tant to the com­pa­ny. In ad­di­tion, the com­pa­ny has en­list­ed Lloyd Macken­zie in the new­ly cre­at­ed po­si­tion of COO. Bren­nan’s pre­vi­ous stints in­clude roles at Eu­prax­ia Phar­ma­ceu­ti­cals, Aquinox Phar­ma­ceu­ti­cals, Ar­bu­tus Bio­phar­ma (for­mer­ly Tek­mi­ra Phar­ma­ceu­ti­cals) and AnorMED among oth­ers. Bren­nan played roles in han­dling the sale of As­pre­va to Vi­for Phar­ma for $915 mil­lion, the sale of AnorMED to Gen­zyme for $580 mil­lion and the merg­er of Tek­mi­ra and On­Core Bio­phar­ma to form Ar­bu­tus Bio­phar­ma, val­ued at over $1 bil­lion on the day of the trans­ac­tion. Macken­zie hails from his re­cent role as chief de­vel­op­ment of­fi­cer at No­table Labs and pri­or to that was the COO at Aquinox Phar­ma­ceu­ti­cals.

Lau­rent Chardon­net

Bill Hen­shaw-led Ax­cel­la Health — which closed its IPO ear­li­er in May, bag­ging $71.4 mil­lion — has ap­point­ed Lau­rent Chardon­net as CFO and pro­mot­ed VP of le­gal, Hei­dy King-Jones, to gen­er­al coun­sel. Chardon­net joins the com­pa­ny af­ter a 15-year stint at In­cyte, where he helped build the com­pa­ny from a $500 mil­lion de­vel­op­ment-stage or­ga­ni­za­tion in­to a com­mer­cial bio­phar­ma com­pa­ny. Pri­or to In­cyte, Chardon­net served as con­troller, VP of fi­nance and act­ing CFO at Dru­gAbuse Sci­ences. King-Jones joined Ax­cel­la in Jan­u­ary 2018 and pri­or to her time with the com­pa­ny, man­aged the cor­po­rate law de­part­ment and was lead com­mer­cial coun­sel at Sarep­ta Ther­a­peu­tics.

MiMedx — which yes­ter­day had the feds add fraud charges to the pil­ing ac­cu­sa­tions made against the com­pa­ny’s for­mer ex­ecshas wel­comed William Butch Hulse as its new gen­er­al coun­sel and sec­re­tary. Most re­cent­ly, Hulse served as a mem­ber of na­tion­al law firm Dyke­ma. Pri­or to that he served as chief com­pli­ance of­fi­cer and SVP of qual­i­ty, reg­u­la­to­ry and en­ter­prise risk man­age­ment at Aceli­ty LP.

Hei­dy King-Jones Ax­cel­la

In­ter­sect ENT — fo­cused on the treat­ment of ear, nose and throat con­di­tions — has ap­point­ed Richard (Randy) Meier as EVP and CFO. Meier pre­vi­ous­ly served in the same role as CFO, along with oth­er ex­ec po­si­tions, of Owens & Mi­nor. Pri­or to that, he was the EVP and CFO of Tele­flex and COO of Ad­vanced Med­ical Op­tics.

→ Acor­da Ther­a­peu­tics — where CEO Ron Co­hen re­struc­tured the com­pa­ny af­ter re­port­ing mea­ger sales from its new drug — has elect­ed for­mer Tenax Ther­a­peu­tics CEO John Kel­ley to serve as non-ex­ec­u­tive board chair. Kel­ley has been a mem­ber of the board since 2008.

→ IVER­IC bio —fo­cused on the treat­ment of reti­nal dis­eases — has wel­comed the cur­rent pres­i­dent of the Amer­i­can So­ci­ety of Gene and Cell Ther­a­py (AS­GCT), Guang­ping Gao — a pi­o­neer in AAV gene de­liv­ery tech­nol­o­gy — as chief strate­gist, gene ther­a­py. Gao will help shape the com­pa­ny’s strat­e­gy mov­ing for­ward in his new role. In ad­di­tion, Gao is the co-di­rec­tor, Li Wei­bo In­sti­tute for Rare Dis­eases Re­search and di­rec­tor, Ho­rae Gene Ther­a­py Cen­ter and Vi­ral Vec­tor Core.

Guang­ping Gao Gao Lab

No­vo Seeds, the ear­ly-stage in­vest­ment arm of No­vo Hold­ings, has an­nounced that sev­er­al en­tre­pre­neurs will be join­ing its ad­vi­so­ry unit, BiO­ri­gin. For­mer ex­ecs Mar­tin Bonde of Vac­ci­body, John Hau­rum of F-star and An­ders Hins­by of Or­p­hazyme have all hopped aboard as en­tre­pre­neurs-in-res­i­dence. In ad­di­tion, the com­pa­ny has en­list­ed co-founder and for­mer CEO of Plexxikon Pe­ter Hirth and for­mer Lund­beck ex­ec An­ders Gersel Ped­er­sen as ad­vi­sors.

→ As Re­zo­lute gears up to start Phase IIb tri­als for its an­ti­body, RZ358, for the ul­tra-or­phan in­di­ca­tion of con­gen­i­tal hy­per­in­sulin­ism, the com­pa­ny has wel­comed Nek­tar Ther­a­peu­tics COO and CFO Gil Labrucherie to its board of di­rec­tors as chair­man of the au­dit com­mit­tee.

George Tid­marsh

La Jol­la Phar­ma­ceu­ti­cal has to re­con­sid­er its fu­ture with­out CEO George Tid­marsh. He hit the ex­it af­ter a 7-year stint at the com­pa­ny to pur­sue oth­er op­por­tu­ni­ties, fol­low­ing a key tri­al fail­ure. The com­pa­ny’s board di­rec­tors Kevin Tang and Craig John­son will step in to over­see the man­age­ment team, along with be­ing tasked with max­i­miz­ing sales of Gi­apreza — a vaso­con­stric­tor ap­proved to in­crease blood pres­sure in adults with sep­tic or oth­er dis­trib­u­tive shock in the US, and to treat re­frac­to­ry hy­poten­sion for the same pop­u­la­tion in Eu­rope — and seek an FDA green light for the malar­ia ther­a­py LJPC-0118. La Jol­la has re­cent­ly filed an NDA for the drug.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado to fo­cus on CSO job at Rain Ther­a­peu­tics

→ A Big Pharma vet has joined Cambridge, MA upstart Vedanta Biosciences to help develop and expand on its microbiome-derived bacteria portfolio.

Jeffrey Silber signed on as CMO of Vedanta after 4 years at EMD Serono as their SVP, global clinical development. Silber worked his way through the ranks at Merck in the late 1990s, eventually becoming their VP and therapeutic area head, vaccine clinical research. And after 16 years at the pharma giant, Silber moved on to AbbVie to be their VP, strategic portfolio development.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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