Lumen Bioscience co-founders Jim Roberts (left) and Brian Finrow

Lu­men lands an­oth­er DoD con­tract to treat Covid-re­lat­ed GI is­sues

The team at Lu­men Bio­science be­lieves that it can help pa­tients, in­clud­ing those in­fect­ed with Covid-19, through its plant-based drug LMN-301. Wednes­day, it an­nounced that the US Army is a be­liev­er too, hand­ing the com­pa­ny de­vel­op­ment fund­ing for its mon­o­clon­al an­ti­body cock­tail.

This deal builds on a pre­vi­ous grant from the US Army that helped fund pre­clin­i­cal de­vel­op­ment of the can­di­date to treat and pre­vent the gas­troin­testi­nal symp­toms of Covid-19, which of­ten takes a back seat to the con­cerns sur­round­ing res­pi­ra­to­ry is­sues. A study out of Wuhan found that GI symp­toms were found in 85% of se­vere­ly ill Covid-19 pa­tients, and 79% in sta­ble pa­tients.

LMN-301 is two an­ti­body-like fu­sion pro­teins, some­what sim­i­lar to the two-an­ti­body cock­tail from Re­gen­eron. Un­like Re­gen­eron, Lu­men’s cock­tail is de­liv­ered oral­ly. Oral de­liv­ery could po­ten­tial­ly block a pos­si­ble trans­mis­sion route.

Lu­men land­ed a new head­quar­ters out of an old Seat­tle bak­ery back in Ju­ly. The move was some­what fit­ting, as Lu­men’s spir­uli­na-based drugs are all plant de­rived. Spir­uli­na is a nu­tri­ent-packed di­etary sup­ple­ment that’s pop­u­lar on the West Coast, and CEO Bri­an Fin­row and his co­founder Jim Roberts be­lieve that it can be en­gi­neered in­to treat­ments for dis­eases like trav­el­er’s di­ar­rhea, norovirus and C. dif­fi­cile col­i­tis while cut­ting the cost.

“Long-du­ra­tion GI symp­toms are al­so com­mon among those suf­fer­ing from ‘long Covid,’ which we think of as a some­what dis­tinct set of is­sues,” Fin­row said in a blog post he penned on Medi­um.com. “In short, gas­troin­testi­nal symp­toms are a se­ri­ous but un­der­stud­ied com­pli­ca­tion of Covid-19. Lu­men Bio is pleased to do some­thing, fi­nal­ly, about this over­sight.”

This con­tract al­so ful­ly funds a Phase II clin­i­cal tri­al of the can­di­date, and part of the funds will be used to ex­pand Lu­men’s man­u­fac­tur­ing op­er­a­tions. The clin­i­cal tri­al will be car­ried out in Brazil in col­lab­o­ra­tion with the TO­GETH­ER Tri­al re­search con­sor­tium, es­tab­lished with fund­ing from the Bill & Melin­da Gates Foun­da­tion, among oth­ers. That will start in the late win­ter, so long as it is cleared by reg­u­la­tors, Lu­men said in a press re­lease.

“Like oth­er re­searchers, we have no­ticed a sig­nif­i­cant preva­lence of GI symp­toms in the thou­sands of Covid-19 pa­tient vol­un­teers that have pro­ceed­ed through the TO­GETH­ER um­brel­la clin­i­cal tri­al to date,” study leader Ed­ward Mills said in a press re­lease. “These symp­toms are se­vere in some pa­tients, and so we are ex­cit­ed to have this shot at mak­ing a dif­fer­ence in the pa­tients’ lives with LMN-301.”

Lu­men had a $16 mil­lion Se­ries B round of fundrais­ing in Sep­tem­ber 2020, and start­ed an R&D col­lab­o­ra­tion with No­vo Nordisk to study obe­si­ty and oth­er meta­bol­ic dis­or­ders. The com­pa­ny al­so has a can­di­date to treat Trav­el­er’s Di­ar­rhea in Phase II tri­als right now. All of its man­u­fac­tur­ing is on site, large­ly be­cause right now, there are no CD­MOs that are able to man­u­fac­ture its drugs.

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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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 are 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 are 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.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.