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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Glax­o­SmithK­line moves malar­ia vac­cine pro­duc­tion to In­dia; Nevakar bags Eu­ro­pean part­ner and nine-fig­ure deal

GSK is shifting production of its malaria vaccine to a Covid-19 vaccine developer in India.

Wednesday’s move to Bharat Biotech was made as part of efforts to battle the deadly fever, as GSK’s vaccine is the first to prove effective in combating the disease. Bharat will take over manufacturing of the protein part of the vaccine while GSK continues developing the adjuvant portion of the shot.

The vaccine is currently being piloted in regions of Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Program. More than 500,000 children have received the first dose since the pilots were initiated by the three countries in 2019.

Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.