Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aard­vark Ther­a­peu­tics CEO Tien Lee start­ed his work on the biotech’s lead can­di­date, ap­petite sup­pres­sion was the goal for the small mol­e­cule.  Soon af­ter, his team start­ed to see added ben­e­fits with low­er blood glu­cose lev­els and an­ti-in­flam­ma­to­ry ac­tiv­i­ty. On the tail end of that, the com­pa­ny has emerged from stealth mode and an­nounced to­day that they’ve raised enough cash in the B round to cov­er mid-stage de­vel­op­ment work.

San Diego-based Aard­vark has se­cured $29 mil­lion in Se­ries B fi­nanc­ing. The mon­ey will be used to com­plete three Phase II tri­als of its lead com­pound ARD-101, a small mol­e­cule bit­ter taste re­cep­tor pan-ag­o­nist.  The funds will al­so be used to ad­vance ad­di­tion­al for­mu­la­tions for the can­di­date.

The fundrais­ing was led by Sor­ren­to Ther­a­peu­tics and fea­tured par­tic­i­pa­tion from Vick­ers Ven­ture Part­ners, Pre­mier Part­ners, BNH In­vest­ment, and Ko­rea Omega. The Foun­da­tion for Prad­er-Willi Re­search par­tic­i­pat­ed as well, which is key be­cause a Phase II tri­al in pa­tients with Prad­er-Willi Syn­drome is set to kick off lat­er this year. PWS is a ge­net­ic dis­or­der that leads pa­tients to be­come con­stant­ly hun­gry. That can of­ten lead to obe­si­ty and type 2 di­a­betes.

“I think we’re re­al­ly on to some­thing,” Lee said in a call with End­points News Wednes­day. “There are a few com­pa­nies that have looked in­to this space be­fore but no one has re­al­ly delved in and tried to ex­ploit this gut-brain path­way us­ing bit­ter taste re­cep­tors.”

ARD-101 has shown pos­i­tive ef­fects against obe­si­ty, hy­per­pha­gia, di­a­betes, hy­per­lipi­demia and in­flam­ma­tion in an­i­mal mod­els so far.

The drug uti­lizes bit­ter taste re­cep­tors, which Lee says are not on­ly in the mouth, but all over the body, and act as na­ture’s way of pro­tect­ing you against tox­ins. Over 99% of the drug is re­tained in the gut, which nor­mal­ly could be a bad thing for small mol­e­cules, but in this case, it ac­ti­vates en­teroen­docrine cells in the gut. When giv­en through an IV, the can­di­date doesn’t work the same, Lee said.

Aard­vark raised $10 mil­lion dur­ing its Se­ries A fundrais­ing two years ago, and that mon­ey was used to bring the can­di­date to in-hu­man tri­als. While the $29 mil­lion will more than cov­er the com­ple­tion of three Phase II tri­al, there is a lot more op­por­tu­ni­ty on the hori­zon, Lee said. The in­tent is to de­vel­op be­yond PWS in the long term, but for now it’s fo­cused on tak­ing a shot at an ac­cel­er­at­ed ap­proval for the ge­net­ic dis­ease — a goal that has elud­ed oth­ers.

“The main qual­i­ty of life im­pair­ment for Prad­er-Willi Syn­drome is an un­abat­ed ap­petite, says the CEO. “These kids, if giv­en un­re­strict­ed food ac­cess, they eat to the point of stom­ach rup­ture some­times. We have a lot of di­a­betes and obe­si­ty re­lat­ed com­pli­ca­tions in young adult­hood, and the fact that we’re hit­ting a va­ri­ety of hor­mones, we think we’re able to shut down ap­petite in a very unique way. We’ll see. Bi­ol­o­gy is hard and we’re not mak­ing any promis­es, but we’re def­i­nite­ly very hope­ful that we can see a dif­fer­ence for these kids.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

The following Q&A has been edited for length and clarity.

John Carroll:

We’ve had a chance to talk a little bit before here about some of the things that you’ve done. Just really remarkably, a lot of the things that you’ve done early in your career puts you in the path with some amazing science that has had an absolutely huge impact in terms of what we’re seeing now on drug development and some of the new technologies that are coming out here, and not only the new technologies, but also some of the most remarkable people ever.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.