Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lu­men Bio­science an­nounced a $16 mil­lion Se­ries B to en­gi­neer spir­uli­na — a nu­tri­ent-packed su­per food — for dis­eases like trav­el­er’s di­ar­rhea, norovirus and C. dif­fi­cile col­i­tis. And now, the biotech has pulled in an­oth­er $4 mil­lion to do the same for Covid-19.

The ap­proach is quite sim­i­lar to oth­er gas­troin­testi­nal tar­gets the com­pa­ny is pur­su­ing, co-founders and Bri­an Fin­row and Jim Roberts said. The Seat­tle-based com­pa­ny is work­ing on a camelid an­ti­body cock­tail to com­bat GI in­fec­tion com­mon among Covid-19 pa­tients. In a study pub­lished in the Amer­i­can Jour­nal of Gas­troen­terol­o­gy, a ma­jor­i­ty of Covid-19 pa­tients showed GI and res­pi­ra­to­ry symp­toms, and 25% had on­ly GI symp­toms.

Fin­row and Roberts, CEO and CSO re­spec­tive­ly, told End­points News they saw a “big gap” here — while many drug de­vel­op­ers are fo­cused on res­pi­ra­to­ry ther­a­pies, few, if any, are honed in on GI symp­toms.

“The clin­i­cal con­se­quences of lung in­fec­tion are ob­vi­ous. And that’s why most or es­sen­tial­ly all ex­ist­ing ther­a­pies are tar­get­ed at lung in­fec­tion,” Roberts said.

“There’s just not re­al­ly good tools for go­ing af­ter dis­eases of the GI tract. And so the in­dus­try — and aca­d­e­m­ic re­searchers — for lack of tools haven’t done much. But … what we’ve got is a new tool that makes it ac­tu­al­ly quite straight­for­ward to do this,” Fin­row added lat­er.

The fi­nanc­ing comes from the US Army Med­ical Re­search and De­vel­op­ment Com­mand, op­er­at­ing through the Med­ical Tech­nol­o­gy En­ter­prise Con­sor­tium. It will fund de­vel­op­ment of the oral can­di­date through IND sub­mis­sion, and ini­tial en­gi­neer­ing for a new man­u­fac­tur­ing plant in Wash­ing­ton state, which will have the ca­pac­i­ty to pro­duce 1 bil­lion-plus dos­es per year.

The goal is to hit the clin­ic by late spring, ac­cord­ing to Roberts. The com­pa­ny is sift­ing through a pan­el of 10 to 20 an­ti­bod­ies to find the right com­bi­na­tion, which could be al­tered in the fu­ture if the virus mu­tates. “That’s an ad­van­tage of our plat­form, and it’s very easy for us to swap things in and out like that,” Roberts said.

Lu­men be­gan its Covid-19 pro­gram at the on­set of the pan­dem­ic. “This (Seat­tle) was ground ze­ro for the US … We start­ed think­ing about what we might be able to do to help the sit­u­a­tion,” Fin­row said.

The duo be­lieves they can de­vel­op the treat­ment on a large scale —  and do so in­ex­pen­sive­ly. Oth­er bi­o­log­ic drugs can cost be­tween $100 to $200 per gram to make, Fin­row told End­points ear­li­er this month. But spir­uli­na — which is so cheap to grow that peo­ple eat it — could “break this cost prob­lem,” he said. The man­u­fac­tur­ing sys­tem, he added, is as sim­ple as a fish tank with LED lights on the out­side.

So far, on­ly two treat­ments have been grant­ed emer­gency use au­tho­riza­tion to treat Covid-19 in the US: Gilead’s remde­sivir and con­va­les­cent plas­ma. The lat­ter has been the cen­ter of con­tro­ver­sy, with a pan­el of ex­perts con­vened by the NIH con­clud­ing ear­li­er this month that “there are cur­rent­ly no da­ta from well-con­trolled, ad­e­quate­ly pow­ered ran­dom­ized clin­i­cal tri­als that demon­strate the ef­fi­ca­cy and safe­ty of con­va­les­cent plas­ma for the treat­ment of COVID-19.” Gilead, on the oth­er hand, said back in June that it would charge US in­sur­ers $520 per vial, or $3,120 for a full course of remde­sivir.

“Our ther­a­peu­tics are so in­ex­pen­sive, that they cer­tain­ly could be tak­en as a pre­ven­ta­tive when you’re at risk, which is vir­tu­al­ly all peo­ple for the time be­ing,” Roberts said. “And if ei­ther route of ini­tial in­fec­tion is through the GI tract, which it seems to be in many cas­es, then this would be con­sid­ered a pre­ven­ta­tive.”

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

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.