Kally­ope lands $112 mil­lion Se­ries C to ride the gut-brain ax­is for an­oth­er 3 years

Five years af­ter their launch, Kally­ope and the gut-brain ax­is are head­ed to the clin­ic — and they’re get­ting a new fire hose of cash to do so.

The biotech an­nounced a $112 mil­lion in Se­ries C fund­ing that will help bring their lead weight loss drug in­to the clin­ic lat­er this year and a drug for in­flam­ma­to­ry bow­el dis­ease not long af­ter. The syn­di­cate con­tains a long list of back­ers, most of whom had pre­vi­ous­ly in­vest­ed, in­clud­ing The Col­umn Group, Lux Cap­i­tal, Po­laris Part­ners, Eu­clid­ean Cap­i­tal, Two Sig­ma Ven­tures, Il­lu­mi­na Ven­tures, Alexan­dria Ven­ture In­vest­ments and Bill Gates. Four new in­vestors joined: Cas­din, Green­spring and two un­named in­sti­tu­tion­al in­vestors.

“This lead pro­gram tar­gets cells in the gut to re­lease hor­mones tied to sati­ety,” CEO Nan­cy Thorn­ber­ry told End­points News. It’s “his­tor­i­cal­ly a chal­leng­ing area for the phar­ma­ceu­ti­cal in­dus­try but we are able to over­come a lot of the pre­vi­ous chal­lenges.”

The coro­n­avirus pan­dem­ic could de­lay that time­line, though, Thorn­ber­ry ac­knowl­edged. With New York on all-but lock­down, the com­pa­ny is staffing on­ly es­sen­tial per­son­nel and have sent every­one else home, where they are re­view­ing the da­ta amassed over the last four years. Much of their chem­istry and some in vi­vo phar­ma­col­o­gy work is con­tract­ed out and is con­tin­u­ing, Thorn­ber­ry said.

“We are on track with our pre­clin­i­cal study, how­ev­er ob­vi­ous­ly the en­vi­ron­ment is evolv­ing quick­ly and much of that re­mains out of our con­trol,” she said. “We’re build­ing con­tin­gency plans.”

Nan­cy Thorn­ber­ry, Kally­ope

Thorn­ber­ry knows a thing or two about the gut. At Mer­ck, She led the de­vel­op­ment of Janu­via, the first drug to tar­get the gut hor­mone GLP-1 to help di­a­bet­ics man­age their blood sug­ar. Then, in 2015, she was re­cruit­ed to lead a biotech with an in­ter­est­ing ap­proach to those hor­mones and some of the dis­eases Thorn­ber­ry had been work­ing on.

Peo­ple have known for cen­turies that the brain and the gut com­mu­ni­cate in unique, two-di­rec­tion­al ways: Drug­ging cer­tain neu­rons can pro­voke sud­den shifts in blood sug­ar; changes to cer­tain cells and sig­nals in the gut may con­tribute to dis­eases like Parkin­son’s. Around 2015, there was an ex­plo­sion in the in­ter­est in this so-called gut-brain ax­is as new tech­nolo­gies al­lowed re­searchers to study — and po­ten­tial­ly drug — this in­ter­nal, two-lane high­way. No­vo Nordisk dipped their feet. Rhythm Meta­bol­ic and Ax­i­al Bio­ther­a­peu­tics launched. So did Kally­ope, land­ing a $44 mil­lion Se­ries A and re­cruit­ing Thorn­ber­ry as CEO.

The com­pa­ny has spent the last four years us­ing sin­gle-cell se­quenc­ing and oth­er tech­niques to map out the cir­cuits that con­nect the spheres. Some are hor­mon­al — and some of those are fa­mil­iar: GLP-1, CCK, etc. The oth­ers are neur­al, op­er­at­ing through the va­gus nerve.

“We can look at hor­mones re­leased in the gut and we can look at where the re­cep­tors are on dif­fer­ent neu­rons in the va­gus,” Thorn­ber­ry said. “Then we can use some oth­er el­e­ments of our tech­nol­o­gy to un­der­stand the func­tion of those va­gal neu­rons.”

The re­sults, at times, have been sur­pris­ing. Re­searchers had once be­lieved there were about 6 spe­cial­ized hor­mone-se­cret­ing cells in the gut. Now they have tracked over 20. “We just have a much broad­er, much more com­pre­hen­sive un­der­stand­ing of what the sys­tem looks like,” Thorn­ber­ry said.

Kally­ope has been cir­cum­spect on the pre­cise mech­a­nism be­hind their lead pro­gram, but the broad stroke looks like this: Take hor­mones long un­der­stood to reg­u­late hunger and sati­ety — GLP-1, neu­rotensin, CCK — and find ways of con­trol­ling the re­lease of those hor­mones through cells di­rect­ly in the gut, as op­posed to with small mol­e­cules that will dif­fuse through­out the body.

“One way to think about it as a safe way to the brain,”  Thorn­ber­ry said.

The sec­ond pro­gram, not far be­hind, will try to tack­le in­flam­ma­to­ry bow­el dis­ease through a phe­nom­e­non called bar­ri­er func­tion. The idea is that ep­ithe­lial cells that line and in­su­late the gut are com­pro­mised, al­low­ing metabo­lites and tox­ins to trick­le to the rest of the body and cause sev­er­al dis­eases, in­clud­ing al­ler­gy and autism.

Even if Covid-19 de­lays that time­line, the Se­ries C should give them plen­ty of wig­gle room. They will now have 3 years of cash run­way.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Stephan Christgau, Amanda Hayward, Andreas Segerros and Magnus Persson (Eir Ventures)

A new ven­ture fund amid a pan­dem­ic? In the Nordics? Eir Ven­tures brings it on with €76M first close

From Pharmacia and Lundbeck to Novo Nordisk and AstraZeneca, the Nordic countries have been the birthplace for some legacy pharma companies. But for all that history and reputation, Stephan Christgau counts only five specialized life science investors backing biotechs today.

That leaves plenty of room for Eir Ventures, a brand new venture fund Christgau — one of the founders of Novo Seeds — is launching with three other veteran VCs.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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An­oth­er four biotechs scratch out the first num­ber and ask for more as IPO boom con­tin­ues

Four more biotechs are raising their offers in an already record year for biotech IPOs.

Softbank-backed Relay Therapeutics scratched out its original $200 million filing and proposed a $250 million raise that would make them a $1.5 billion company. CAR-T developer Poseida Therapeutics bumped itself up $74 million to $224 million. Off-the-shelf cell therapy startup Nkarta upped from $150 million to $215 million — and then priced even higher, at $252 million. France’s Inventiva did its own modest reset, raising its bar from $102 million to $108 million.