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.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Mer­ck scraps their $425M Covid-19 drug in lat­est pan­dem­ic set­back

Seven months after paying $425 million cash to acquire it, Merck is scrapping a Covid-19 drug they hoped could provide one of the only treatments for severe hospitalized patients.

Merck’s decision comes after they faced significant and unexpected regulatory delays in getting the drug, known as MK-7110 or CD24Fc, across the finish line. The Big Pharma licensed the drug under the belief that it had already shown sufficient benefit in severe patients and they could help scale it up far faster than OncoImmune, its former owner, could. But in February, the company reported that the FDA insisted Merck run a new trial before seeking authorization.

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Alise Reicin (L) and Tim Springer

Har­vard bil­lion­aire Tim Springer has lined up his lat­est biotech launch. And he's re­cruit­ed a star R&D ex­ec to man­age their break­through game plan

Tectonic Therapeutic isn’t your average biotech startup story. For all sorts of reasons.

There’s your billionaire Harvard scientist and philanthropist who’s personally bankrolling much of the operation. The CEO is one of the most prominent women involved in the global drug hunting business. And they have enough collective cachet between them to command virtually as much cash as they might dream of, at a time that biotech dreams are running beyond the fantastic.

But this story isn’t about them right now, so much as it is about a scientist who’s never quite been center stage in the floodlights of biostardom. There’s a whole group of prominent players, though, who believe that’s about to change. Players perfectly happy to gamble some significant coin to give that hope every chance possible of becoming a reality.

Andrew Kruse may not be an immediately recognizable name to you. But to his Harvard colleague Tim Springer, he’s a rock star. They co-founded the Institute for Protein Innovation together, a non-profit that the internationally renowned Springer has been funding with a fortune earned from a remarkable run of successful startups, from his first $100 million out of Millennium to the gusher of wealth that followed his decision to back Stéphane Bancel and the crew at mRNA pioneer Moderna.

Kruse has specialized in work revolving around GPCRs, or G protein-coupled receptors, that make up about a third of all — while still only scratching the surface of potential targets. He was a student of Brian Kobilka at Stanford, who won the Nobel Prize in 2012 for his contribution on the work on GPCRs. And Kruse has published extensively on his lab’s structural analysis of GPCRs, which Springer believes will open the door to a whole new field of drug R&D that can crack open a slew of currently “undruggable” targets to biologics — covering a gamut of both agonists and antagonists.

“We just have unparalleled experience in the biochemistry and biophysics of GPCRs,” says Springer about this new venture of his. “Andrew Kruse is a real star. He went from being a PhD student at Stanford to an assistant professor at Harvard Medical School — he had many papers out of his PhD — and he’s gone on to full professor at Harvard Medical School in 7 years. That is a record at least in modern times. The guy is just amazing. And he’s a nice guy.”

Springer is so convinced by the potential of Kruse’s research that he put up the first $5 million to seed the company 18 months ago. Terry McGuire — the co-founder at Polaris who goes back a long way with Springer — chipped in a million.

Which brings us to the nut of today’s news story.

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Joe Biden (Carolyn Kaster, AP Images)

Covid-19 roundup: Biden in­vests $1.7B to ad­dress Covid vari­ants; EU puts faith in Pfiz­er with new vac­cine deals

The Biden administration said Friday that it’ll pump $1.7 billion into various programs to address Covid-19 variants as the original strain of Covid-19 makes up only about half of all US cases today.

Most of those new funds, $1 billion in total, will go to expand genomic sequencing so the CDC, states and other jurisdictions can improve their capacity to identify Covid mutations and monitor the circulation of variants. Back in February, US labs were only sequencing about 8,000 Covid-19 strains per week, although the rate of sequencing has increased substantially since then, the administration said.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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