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.

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Noubar Afeyan, Flagship

Step­ping out along­side ARCH's record raise, Flag­ship adds a $1.1B mon­ster fund of its own

ARCH’s unveiling this morning of 2 new funds bulging with $1.5 billion in cash for biotech startups was just the first round of today’s venture news.

Right on its heels we have another monster fund debuting at Flagship Pioneering, another big venture group known for making huge bets on cutting-edge tech — the kind it brews up in its labs.

And this one weighs in at $1.1 billion, which will operate in tandem with the $1.1 billion in funds Flagship rolled out last year.

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Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Mer­ck scores new ad­vance on tu­mor-ag­nos­tic front as Keytru­da beat chemo-based reg­i­mens in a type of col­orec­tal can­cer

Back in 2017, before the term “tumor agnostic” really took hold among cancer drug developers, Merck became the first to secure such an approval for Keytruda as a second-line treatment for patients characterized by a biomarker — rather than where the cancer started in the body. Now it’s looking to break fresh ground with a new slate of data suggesting the drug’s utility in the frontline setting for colorectal cancer.