Mathai Mammen, Janssen global head of R&D (Rob Tannenbaum, Endpoints News)

Covid-19 roundup: J&J of­fers new da­ta to sup­port boost­ers — but some ex­perts are not im­pressed; Thai­land uni­ver­si­ty's ro­bot­ic arm max­i­mizes vac­cine vials

Amidst all the boost­er shot talk with Pfiz­er and Mod­er­na, J&J on Wednes­day of­fered new da­ta that may lead to its own sin­gle-shot boost­er.

New in­ter­im da­ta from Phase I/IIa tri­als showed that J&J’s boost­er gen­er­at­ed a lev­el of spike-bind­ing an­ti­bod­ies that was 9-fold high­er than 28 days af­ter the first sin­gle-dose shot.

“We have es­tab­lished that a sin­gle shot of our COVID-19 vac­cine gen­er­ates strong and ro­bust im­mune re­spons­es that are durable and per­sis­tent through eight months. With these new da­ta, we al­so see that a boost­er dose of the John­son & John­son COVID-19 vac­cine fur­ther in­creas­es an­ti­body re­spons­es among study par­tic­i­pants who had pre­vi­ous­ly re­ceived our vac­cine,” glob­al head of R&D Math­ai Mam­men said in a state­ment.

The study, how­ev­er, on­ly fea­tured 20 pa­tients, three of which end­ed up be­ing ex­clud­ed from the da­ta. Those three re­cip­i­ents had a sharp in­crease in an­ti­body re­spons­es dur­ing study, with one re­cip­i­ent hav­ing break­through in­fec­tion with mi­nor symp­toms and 2 who had re­ceived an mR­NA vac­cine. An­ti­bod­ies changed just a lit­tle, which led Er­ic Topol, the di­rec­tor of the Scripps Re­search In­sti­tute, to crit­i­cize the press re­lease from J&J on Twit­ter.

“Where are the re­sults from their 2-dose tri­al?” he tweet­ed.

Thai­land uni­ver­si­ty’s ro­bot­ic arm max­i­mizes vac­cine vials

In hopes of bat­ting down its worse Covid-19 out­break yet, Thai­land will in­tro­duce a ro­bot­ic arm called the “Au­to­Vacc” to help draw more ef­fi­cient dos­es of vac­cines and max­i­mize the coun­try’s low sup­ply.

The arm comes from Chu­la­longko­rn Uni­ver­si­ty, and sci­en­tists say that it can draw 12 dos­es of the vac­cine in four min­utes from a vial, an im­prove­ment from the 10 dos­es drawn man­u­al­ly. It’s been used at the uni­ver­si­ty’s vac­ci­na­tion cen­ter since Mon­day, and sole­ly deals with As­traZeneca vials, ac­cord­ing to Reuters, which says on the la­bel that it con­tains be­tween 10 and 11 dos­es. The pro­to­type cost $76,243, and the team plans to make sim­i­lar ma­chines to use with the Pfiz­er-BioN­Tech and Mod­er­na vac­cines as well.

Pre­vi­ous­ly, health work­ers used a cer­tain type of sy­ringe called a low dead space sy­ringe to re­duce the waste, but those re­quire skilled man­pow­er, some­thing that lead re­searcher Juthamas Ratanavara­porn says could drain en­er­gy, as they’d be at it for months.

Just about 9% of the Thai­land pop­u­la­tion has been ful­ly vac­ci­nat­ed, while 28% has re­ceived at least one dose.

British study finds wan­ing vac­cine pro­tec­tion

A study out of Eng­land has found that the pro­tec­tion of­fered by the Pfiz­er-BioN­Tech and the Ox­ford-As­traZeneca vac­cines fades with­in six months, re­it­er­at­ing the need for boost­er shots.

The ef­fi­ca­cy of the Pfiz­er-BioN­Tech jab fell from 88% to 74% af­ter five to six months, and As­traZeneca’s fell from 77% to 67% af­ter four to five months, Reuters re­ports. That study used da­ta from 1.2 mil­lion test re­sults.

Pro­tec­tion for the el­der­ly and health­care work­ers could drop by 50% by this win­ter, the study’s prin­ci­pal in­ves­ti­ga­tor Tim Spec­tor said. Britain has be­gun plans for a boost­er cam­paign lat­er this year, while in the US, Pres­i­dent Joe Biden’s ad­min­is­tra­tion an­nounced that boost­ers were rec­om­mend­ed for Amer­i­cans eight months af­ter their ini­tial vac­ci­na­tion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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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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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.

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.

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.