Jim Roberts and Brian Finrow (Lumen Bioscience)

Lu­men Bio­science reels in $16M Se­ries B to 'de­moc­ra­tize' bi­o­log­ics

It all start­ed with spir­uli­na — a nu­tri­ent-packed su­per­food pop­u­lar on the West Coast.

The pho­to­syn­thet­ic mi­croal­gae has been com­mer­cial­ly farmed since the 1970s. But Lu­men Bio­science co-founders Bri­an Fin­row and Jim Roberts aren’t look­ing to sup­ple­ment their di­ets. They be­lieve spir­uli­na can be en­gi­neered to de­liv­er ther­a­peu­tic pro­teins and treat dis­eases like trav­el­er’s di­ar­rhea, norovirus and C. dif­fi­cile col­i­tis. And Lu­men just reeled in a $16 mil­lion Se­ries B to prove it.

The most re­cent round builds on the $11.2 mil­lion Se­ries A the Seat­tle-based com­pa­ny land­ed in 2017.

Most mod­ern bi­o­log­ic drugs are “ob­scene­ly ex­pen­sive” to man­u­fac­ture with tra­di­tion­al tech­nol­o­gy, said Fin­row, who is al­so the com­pa­ny’s CEO. Some cost be­tween $100 and $200 per gram to make.

“That’s all af­ford­able, ac­tu­al­ly bare­ly, if you’re mak­ing a drug for rich-world dis­eases like, you know, arthri­tis or can­cer. Be­cause, you know, our health­care sys­tem can af­ford that. But there are all kinds of dis­eases where that’s just way too ex­pen­sive to go af­ter them,” he said. “So that was the ba­sic in­tu­ition… That this mi­croor­gan­ism spir­uli­na, which is so cheap to grow that you can just eat it as a food, if you can en­gi­neer it, it would be a way to break this cost prob­lem.”

The CEO said his com­pa­ny hopes to “de­moc­ra­tize” bi­o­log­ic drug tech­nol­o­gy by cut­ting man­u­fac­tur­ing costs.

“Now that we can man­u­fac­ture it cheap­ly enough, we can make it avail­able for the mass mar­ket,” he said.

The idea isn’t new. “A lot of peo­ple have tried to en­gi­neer spir­uli­na be­fore and failed” due to tech­ni­cal is­sues, Fin­row said. But Roberts and a col­lab­o­ra­tor have demon­strat­ed their at­tempt works as billed, and they’re now ad­vanc­ing drugs in the clin­ic.

Fin­row and Roberts found­ed the biotech in 2017 with 8 em­ploy­ees. In 2018, they patent­ed their tech­nol­o­gy plat­form. And now, they have 50 em­ploy­ees, one can­di­date en­ter­ing Phase II for trav­el­er’s di­ar­rhea, and two oth­er pro­grams head­ing for clin­i­cal tri­al. The com­pa­ny al­so com­mis­sioned its cGMP man­u­fac­tur­ing plant, which pro­duces about 3 kg of drug ma­te­r­i­al per week to sup­port its pro­grams. The busi­ness is grow­ing “like gang­busters,” Fin­row said.

The com­pa­ny will use Se­ries B fund­ing to push its norovirus en­teri­tis and C. diff col­i­tis pro­grams in­to the clin­ic. Fin­row ex­pects the pro­grams to en­ter the clin­ic by next year.

Lu­men’s lead pro­gram for trav­el­er’s di­ar­rhea is part­ly fund­ed by the Bill & Melin­da Gates Foun­da­tion. LMN-101, a cock­tail of “mon­o­clon­al an­ti­body-like pro­tein bi­o­log­ics,” is de­signed to neu­tral­ize the bac­te­r­i­al pathogens Campy­lobac­ter je­ju­ni and en­tero­tox­i­genic E. coli. The pathogens are al­so be­hind in­fant mor­tal­i­ty and mor­bid­i­ty in the de­vel­op­ing world. Lu­men’s po­ten­tial so­lu­tion has com­plet­ed Phase I, and should en­ter Phase II in ear­ly 2021.

“Our man­u­fac­tur­ing sys­tem is dead sim­ple,” Fin­row said. Pic­ture a fish tank, with LED lights on the out­side. “That sim­plic­i­ty means that the cost of mak­ing the prod­uct is a small frac­tion of the $100 to $200 per gram of an­ti­body” us­ing tra­di­tion­al tech, he said.

“So that’s why we can make both the vol­umes you need to go af­ter these glob­al dis­eases, these huge­ly preva­lent dis­eases,” he added lat­er.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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