Covid-19 roundup: South Ko­re­an vac­cine to go up against As­traZeneca shot in small Phase III; CD­C's ACIP af­firms full ap­proval for Pfiz­er/BioN­Tech vac­cine

SK Bio­science, a South Ko­re­an com­pa­ny, and Glax­o­SmithK­line will test their Covid-19 vac­cine can­di­date against As­traZeneca’s shot in about 4,000 peo­ple, the com­pa­nies said Tues­day.

Shots from Pfiz­er/BioN­Tech, Mod­er­na and As­traZeneca are ap­proved in South Ko­rea, and the SK shot is the coun­try’s first do­mes­tic can­di­date, po­ten­tial­ly help­ing not on­ly South Ko­rea, but the rest of Asia’s re­liance on shots from the West.

The GSK-SK jab would be­come avail­able through­out the world, through the WHO’s Co­v­ax vac­cine shar­ing pro­gram. Known as GBP510, it’s a self-as­sem­bled nanopar­ti­cle vac­cine can­di­date tar­get­ing the re­cep­tor bind­ing do­main of the spike pro­tein, com­bined with GSK’s pan­dem­ic ad­ju­vant. The anti­gen is be­ing de­vel­oped by SK in col­lab­o­ra­tion with the In­sti­tute for Pro­tein De­sign at the Uni­ver­si­ty of Wash­ing­ton.

Thomas Breuer, chief glob­al health of­fi­cer at GSK, said in a state­ment, “We are pleased to con­tribute with GSK’s pan­dem­ic ad­ju­vant and to be work­ing with SK to de­liv­er the vac­cine at scale via CO­V­AX if it is ap­proved.”

The vac­cine can­di­date ad­vanced to the Phase III tri­al fol­low­ing pos­i­tive in­ter­im Phase I/II da­ta which showed that all par­tic­i­pants who re­ceived the ad­ju­vant­ed vac­cine can­di­date de­vel­oped strong neu­tral­iz­ing an­ti­body re­spons­es. Neu­tral­iz­ing an­ti­body titers were be­tween five and a max­i­mum of eight times high­er com­pared to sera from peo­ple re­cov­ered from Covid-19, and no safe­ty con­cerns have been iden­ti­fied to date.

Re­sults from the Phase III study are ex­pect­ed in the first half of 2022.

CDC backs full ap­proval of Pfiz­er-BioN­Tech jab

A week af­ter the FDA cleared the Pfiz­er-BioN­Tech vac­cine for ap­proval, the Cen­ter for Dis­ease Con­trol and Pre­ven­tion’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices has unan­i­mous­ly vot­ed in fa­vor of the two-dose reg­i­men for those ages 16 and old­er.

The sign-off will hope­ful­ly al­low for the vac­cine to be more wide­ly ac­cept­ed, Bloomberg re­port­ed. CDC di­rec­tor Rochelle Walen­sky still needs to give the fi­nal ap­proval.

The vote comes as vac­ci­na­tion num­bers in the US have some­what ta­pered off in the last month, as the num­ber of ful­ly vac­ci­nat­ed Amer­i­cans has hov­ered around 50% since Ju­ly.

Com­pa­nies, schools and gov­ern­ments have put a vac­cine re­quire­ment in­to place al­ready as the vac­cine was ap­proved. Since gain­ing its emer­gency use au­tho­riza­tion in De­cem­ber, the Pfiz­er-BioN­Tech jab has been used the most, da­ta from the CDC said.

The pan­el did say that it could take a dif­fer­ent ap­proach to boost­er shots than what Pres­i­dent Joe Biden’s ad­min­is­tra­tion pro­posed. The pro­posed plan pri­or­i­tizes those who are high-risk, long-term care fa­cil­i­ty and health work­ers, rather than all el­i­gi­ble Amer­i­cans.

Biden’s ad­min­is­tra­tion has pre­vi­ous­ly said that boost­ers will be­come avail­able on Sep­tem­ber 20.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

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.