Andrew Witty (Credit: Bloomberg)

Ex-GSK chief An­drew Wit­ty sum­moned back to the front­lines of vac­cine de­vel­op­ment at em­bat­tled WHO

Dur­ing his 10-year tenure at Glax­o­SmithK­line, An­drew Wit­ty made vac­cines one of his sig­na­ture ar­eas of fo­cus, lead­ing the phar­ma gi­ant to an ap­proval for an in­fluen­za vac­cine dur­ing the H1N1 pan­dem­ic and bag­ging No­var­tis’ vac­cine unit in an as­set swap be­fore he re­tired in 2017.

Now, two years in­to his new ca­reer man­ag­ing drug ben­e­fits, Wit­ty is back in the front­lines of the race against a dead­ly virus in­fil­trat­ing the world.

The WHO has asked Wit­ty to co-lead a glob­al ef­fort to “ac­cel­er­ate the de­vel­op­ment of a Covid-19 vac­cine,” ac­cord­ing to Op­tum. He will thus be tak­ing a leave of ab­sence from the phar­ma­cy ben­e­fits man­ag­er, where he is CEO.

Wit­ty, whose ap­point­ment will be ef­fec­tive April 20, is step­ping up at a tu­mul­tuous time.

Just hours ago, Pres­i­dent Trump pub­licly chas­tised the UN agency, ac­cus­ing it of “se­vere­ly mis­man­ag­ing and cov­er­ing up the spread of the coro­n­avirus,” and made the stun­ning an­nounce­ment that the US would sus­pend its con­tri­bu­tion to the WHO. Its $400 mil­lion con­tri­bu­tion in 2019 made up 15% of the or­ga­ni­za­tion’s bud­get last year.

That’s while the WHO is prepar­ing to launch an ap­peal for well over $1 bil­lion to fund op­er­a­tions against the coro­n­avirus world­wide.

It’s un­clear yet what Wit­ty’s ex­act role will be. But last week the WHO re­leased a draft blue­print for a pos­si­ble in­ter­na­tion­al tri­al to eval­u­ate mul­ti­ple vac­cines con­cur­rent­ly. Un­der that frame­work, in­ves­ti­ga­tors can ex­pect to know the ben­e­fits and risks with­in 3 to 6 months of the can­di­date en­ter­ing the tri­al, the out­line read.

Whether that time­line is re­al­is­tic will be up for de­bate, as crit­ics have cast doubt on Sanofi and GSK’s promise to make a vac­cine avail­able in a year. Con­sid­er­ing that some side ef­fects take 6 to 12 months to de­vel­op, an ap­proval may not come for two years — and even that would be con­sid­ered in­cred­i­bly fast, an ex­pert con­sult­ed by SVB Leerink said.

The blue­print sug­gest­ed a steer­ing com­mit­tee and a da­ta mon­i­tor­ing com­mit­tee to over­see the study, gov­ern­ing the adap­tive as­pects of the study. Op­tum de­clined to make Wit­ty avail­able for an in­ter­view.

Em­ma Walm­s­ley GSK

Em­ma Walm­s­ley, Wit­ty’s suc­ces­sor at GSK, has said that the world’s go­ing to need more than one vac­cine to meet the enor­mous de­mand.

Echo­ing that point, the WHO has brought to­geth­er a group of ex­perts to work on vac­cine de­vel­op­ment. In a pub­lic state­ment, the group pledged to “con­tin­ue ef­forts to strength­en the un­prece­dent­ed world­wide col­lab­o­ra­tion, co­op­er­a­tion and shar­ing of da­ta al­ready un­der­way.” Tal Zaks of Mod­er­na, Xue­feng Yu of CanSi­no Bi­o­log­ics, Kate Brod­er­ick of In­ovio — rep­re­sent­ing the first three groups to bring a vac­cine in­to hu­man test­ing — were in the group, which al­so fea­tured Sanofi’s John Shiv­er and of­fi­cials from the FDA and NIH.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Covid-19 roundup: In­dia to re­sume vac­cine ex­ports as its own cam­paign is un­der con­trol; Pfiz­er to file for vac­cine OK in chil­dren ages 5-11

After vaccine exports were halted to focus on providing its own people with enough doses, India will begin shipping its Covid-19 vaccines to the Covax program again, the health minister said Monday.

In April, the country halted shipments as it faced a brutal wave of the pandemic, which saw daily case numbers skyrocket from around 25,000 in mid-March to more than 400,000 a day by May. Since then, however, the vaccine output has more than doubled, and minister Mansukh Mandaviya said that it is set to quadruple to more than 300 million doses in October. Only the excess supply will be sent to Covax, he said.