Covid-19 roundup: UK pulls out of bil­lion-dol­lar vac­cine sup­ply deal as na­tion em­braces mix-and-match boost­er ap­proach

A vac­cine agree­ment be­tween the UK and French biotech Val­ne­va worth $1.65 bil­lion has been aban­doned af­ter the coun­try says terms of the deal were not met.

Val­ne­va’s vac­cine can­di­date us­es an in­ac­ti­vat­ed virus to in­voke an im­mune re­sponse. While that may pro­vide greater cov­er­age against the virus, it can al­so cause a longer man­u­fac­tur­ing timetable. The com­pa­ny an­nounced that Phase III re­sults for VLA2001 were ex­pect­ed in ear­ly Q4 2021, and will be a part of the can­di­date’s sub­mis­sion to the MHRA for ap­proval.

The UK has al­leged that Val­ne­va hasn’t held up its end of the bar­gain, while the com­pa­ny has de­nied the claims. The Fi­nan­cial Times said that it’s not clear what pushed the gov­ern­ment to kill the deal, though the slow­er time­line means the deal would prob­a­bly have lit­tle im­pact on the coun­try’s boost­er shot roll­out.

A press re­lease from Dy­navax, who has a sup­ply agree­ment with Val­ne­va for VLA2001, said that Val­ne­va hasn’t yet can­celed any pur­chase or­ders for the CpG 1018 ad­ju­vant, which is used to make the jab. Val­ne­va is not the on­ly com­pa­ny us­ing the ad­ju­vant in its de­vel­op­ment of a vac­cine, CEO Ryan Spencer said in a press re­lease.

“Dy­navax in­tends to con­tin­ue to mon­i­tor the sit­u­a­tion but can make no as­sur­ances re­gard­ing the out­stand­ing or­ders,” the press re­lease said. “If Val­ne­va’s ex­ist­ing pur­chase or­ders are can­celed, Dy­navax will work to re­al­lo­cate CpG 1018 in­ven­to­ry to its oth­er COVID-19 col­lab­o­ra­tors.”

Mix-and-match cam­paign to lead UK boost­er ef­forts

As com­pa­nies around the world give the mix-and-match vac­cine strat­e­gy a try, the UK is set to be­come the first coun­try to use the method for its boost­er pro­gram, gov­ern­ment of­fi­cials told the Fi­nan­cial Times. 

A third dose will like­ly be a dif­fer­ent ver­sion from the first two af­ter stud­ies from Ox­ford Uni­ver­si­ty found that pro­tec­tion against symp­to­matic in­fec­tion be­gan to lose pow­er four months af­ter the ini­tial in­oc­u­la­tion. Many in the UK have been vac­ci­nat­ed with the As­traZeneca jab, which is less ef­fec­tive against the Delta vari­ant that is caus­ing a ma­jor­i­ty of break­through cas­es.

In Ju­ly, South Ko­rea be­gan of­fer­ing Pfiz­er’s shot as a sec­ond dose for 760,000 peo­ple who first re­ceived As­traZeneca’s jab, as it await­ed a ship­ment of 835,000 dos­es of As­traZeneca’s vac­cine that were months be­hind sched­ule. In Cana­da, the pub­lic health agency rec­om­mend­ed a sec­ond dose of an mR­NA shot as op­posed to an AAV vac­cine. In France, health reg­u­la­tor Haute Au­torité de San­té rec­om­mend­ed As­traZeneca re­cip­i­ents un­der the age of 55 switched to an mR­NA dose as well.

In May, re­sults from a Span­ish study showed that it was safe and ef­fec­tive to mix and match the Pfiz­er/BioN­Tech jab and As­traZeneca, though that could lead to more se­vere side ef­fects. The an­nounce­ment from the UK is the first time a plan has been in place for mix-and-match boost­er shots, how­ev­er. Re­searchers no­ticed an in­crease in cas­es of fever, chills, fa­tigue, headache, joint pain, malaise, and mus­cle ache in the mixed sched­ule groups. No one was hos­pi­tal­ized due to the symp­toms, most of which oc­curred in the 48 hours af­ter vac­ci­na­tion

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.

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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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.

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.

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.

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.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.