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 Medi­ “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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.