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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.