Covid-19 roundup: Gates Foun­da­tion, Ex­sci­en­tia team up on pan­dem­ic an­tivi­ral dis­cov­ery pact; No­vavax opens tri­al for coro­n­avirus/flu com­bo vac­cine

UK-based AI dis­cov­ery out­fit Ex­sci­en­tia has signed its name to a $70 mil­lion col­lab­o­ra­tion with the Bill and Melin­da Gates Foun­da­tion to drum up five an­tivi­ral can­di­dates for use against coro­n­avirus­es and po­ten­tial pan­dem­ic virus­es, the part­ners said Wednes­day.

The part­ner­ship will pay Ex­sci­en­tia $35 mil­lion in eq­ui­ty through the Gates Foun­da­tion’s Strate­gic In­vest­ment Fund with the po­ten­tial for more grant fund­ing. Ex­sci­en­tia, mean­while, will front $35 mil­lion in match­ing funds to sup­port the dis­cov­ery work up to Phase I. The term of the pact is four years, and Ex­sci­en­tia will be tasked with find­ing “small mol­e­cule ther­a­peu­tics with less sus­cep­ti­bil­i­ty to vari­ants and greater pa­tient ac­cess than cur­rent ap­proach­es,” the com­pa­ny said in a re­lease.

The ini­tial fo­cus for the col­lab will be what the part­ners call “broad-spec­trum coro­n­avirus agents,” which in­cludes SARS-CoV-2 and its vari­ants as well as MERS. That first check­point will ac­cel­er­ate Ex­sci­en­tia’s ex­ist­ing Mpro pro­gram tar­get­ing the main pro­tease of the nov­el coro­n­avirus. Then, the part­ners will turn their fo­cus to ther­a­pies for in­fluen­za and the Ni­pah virus, with the po­ten­tial to add more tar­gets down the road.

“Small mol­e­cule ther­a­peu­tics could pro­vide a su­pe­ri­or ap­proach to guard glob­al health,” said Denise Bar­rault, Ex­sci­en­tia’s di­rec­tor of port­fo­lio man­age­ment, in a state­ment. “Cer­tain tar­gets are preva­lent across fam­i­lies of virus­es, mean­ing that po­tent ther­a­peu­tics could be broad­ly ef­fec­tive across mul­ti­ple virus fam­i­lies. Fur­ther, this col­lab­o­ra­tion will fo­cus on eval­u­at­ing pro­tein tar­gets that are evo­lu­tion­ar­i­ly con­served and are less like­ly to de­vel­op re­sis­tance.”

No­vavax opens ear­ly-stage tri­al for Covid-19/flu vac­cine com­bo

No­vavax has ini­ti­at­ed a Phase I/II tri­al com­bin­ing its re­com­bi­nant pro­tein-based NVX-CoV2373 for Covid-19 and NanoFlu with its pro­pri­etary Ma­trix-M ad­ju­vant in a sin­gle dose, the com­pa­ny said Wednes­day.

The tri­al will eval­u­ate the safe­ty, tol­er­a­bil­i­ty and im­mune re­sponse to the com­bo for­mu­la­tion in 640 healthy adults aged 50 to 70, ac­cord­ing to No­vavax. Health vol­un­teers will have been ei­ther pre­vi­ous­ly in­fect­ed with SARS-CoV-2 or vac­ci­nat­ed through an au­tho­rized vac­cine at least eight weeks pri­or to en­roll­ment, and ran­dom­ly as­signed to co­horts to eval­u­ate mul­ti­ple for­mu­la­tions and dosed on day 0 and again at Day 56.

The tri­al will be con­duct­ed in Aus­tralia at up to 12 study sites, with re­sults ex­pect­ed dur­ing the first half of 2022, No­vavax said.

Pas­cal So­ri­ot casts doubt on the need for im­me­di­ate boost­ers — re­port

As­traZeneca CEO Pas­cal So­ri­ot is down­play­ing the need for im­me­di­ate vac­cine boost­ers against Covid-19, ar­gu­ing that a third dose might not be need­ed and could put un­due pres­sure on the UK’s Na­tion­al Health Ser­vice, Reuters re­port­ed.

In com­ments first re­port­ed by the Tele­graph, So­ri­ot said he was wait­ing on more clin­i­cal da­ta from re­al-world stud­ies to de­ter­mine the need for boost­ers.

The fear here is that a wide­spread cam­paign to get boost­er shots in­to as many pa­tients’ hands as pos­si­ble could put a ma­jor bur­den on the NHS amid a win­ter sea­son that will like­ly see a wave of in­fluen­za pa­tients. As­traZeneca has ap­proval for its own Covid-19 vac­cine in the UK but not in the US.

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.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

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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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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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.