Thierry Abribat, Amolyt CEO

En­docrine-fo­cused biotech gets new cash for its pep­tides, with dreams of launch­ing a fran­chise

On the hunt for a pipeline that keeps on giv­ing, a vet­er­an group of en­docri­nol­o­gists have earned new back­ers for a biotech it thinks can of­fer a tar­get-rich en­vi­ron­ment for pep­tide drugs.

Amolyt Phar­ma has put to­geth­er an $80 mil­lion Se­ries B, the French-Amer­i­can biotech an­nounced, aim­ing main­ly to push for­ward re­search in­to rare en­docrine dis­eases and its lead pro­gram for hy­poparathy­roidism. The round comes a lit­tle more than two years af­ter the com­pa­ny’s Se­ries A and about two weeks be­fore Amolyt un­veils new da­ta for that lead can­di­date.

CEO Thier­ry Abri­b­at told End­points News in an in­ter­view that Amolyt is the third biotech he’s found­ed, with the pre­vi­ous two be­ing ac­quired by Big Phar­ma com­pa­nies. But this time around, he and his team have more of a stretch goal in mind.

“We’re very fo­cused on the en­docrine field be­cause the long term vi­sion is this port­fo­lio could be­come a fran­chise,” Abri­b­at told End­points. “Be­cause we’re work­ing with en­docri­nol­o­gists, at some point when the first prod­uct reach­es ap­proval, we can com­mer­cial­ize it and have the fol­low-on prod­ucts be­ing com­mer­cial­ized by the same com­mer­cial Phase IV.”

In or­der to en­act what it hopes is a win­ning strat­e­gy, Amolyt is fo­cus­ing sole­ly on de­vel­op­ing pep­tides to treat the en­docrine dis­eases, Abri­b­at added. Many con­di­tions Amolyt wants to tar­get deal with hor­mone ex­cess­es or de­fi­cien­cies, and pep­tides are unique­ly equipped to treat such dis­eases.

The lead pro­gram, known as AZP-3601, is an ana­logue of the parathy­roid hor­mone. Pa­tients with hy­poparathy­roidism ex­pe­ri­ence low cal­ci­um lev­els in the blood, and AZP-3601 tar­gets a spe­cif­ic re­cep­tor to get cal­ci­um lev­els back to nor­mal.

Nor­mal­ly, those deal­ing with this dis­ease take sup­ple­ments through­out the day, a symp­to­matic treat­ment that may work for a short pe­ri­od but over time caus­es cal­ci­um lev­els to bounce around wild­ly, Abri­b­at said. Where Amolyt hopes to step in is by treat­ing the un­der­ly­ing process­es of the dis­ease and re­duc­ing pa­tients’ re­liance on cal­ci­um sup­ple­ments.

Some hy­poparathy­roidism pa­tients’ cal­ci­um lev­els are bad enough to where they de­vel­op kid­ney prob­lems — about 25%, Abri­b­at said — and ac­cu­mu­late too much cal­ci­um in urine. Oth­ers may suf­fer from low bone mass.

The da­ta Amolyt will re­veal in a few weeks come from a mul­ti­ple as­cend­ing dose study in healthy vol­un­teers, where the biotech hopes to show cal­ci­um lev­els in the serum can be sta­ble while tak­ing the ex­per­i­men­tal drug. Amolyt has al­ready start­ed en­rolling a tri­al in hy­poparathy­roidism pa­tients, with da­ta ex­pect­ed in mid-2022.

To fur­ther broad­en the pipeline, the biotech al­so pre­vi­ous­ly signed a col­lab­o­ra­tion with Japan­ese bio­phar­ma Pep­tidream, and ear­li­er this month ex­er­cised an op­tion to li­cense a va­ri­ety of macro­cyclic pep­tide growth hor­mone re­cep­tor an­tag­o­nists. One of the pro­grams com­ing out of this agree­ment will seek to treat acromegaly in com­bi­na­tion with so­mato­statin ana­logues.

All eyes are turn­ing to­ward the AZP-3601 da­ta re­lease, slat­ed for Oct. 1. Should the re­sults prove pos­i­tive, Abri­b­at hopes they can launch Amolyt to greater heights in the en­docrine field.

“We don’t re­al­ly have a tech­nol­o­gy plat­form in the com­pa­ny, the plat­form is the peo­ple who have been work­ing in en­docrinol­o­gy for a very long time,” Abri­b­at said.

Thurs­day’s fi­nanc­ing was co-led by Sec­toral As­set Man­age­ment and An­dera Part­ners, with par­tic­i­pa­tion from ATEM Cap­i­tal and all in­vestors from the com­pa­ny’s Ju­ly 2019 Se­ries A fi­nanc­ing. That group in­clud­ed LSP, No­vo Ven­tures, Kur­ma Part­ners, Mass Gen­er­al Brigham Ven­tures, In­no­bio 2, Or­biMed, Pon­tif­ax, Eu­razeo, Sham In­no­va­tion, San­té/Turenne Cap­i­tal and Cred­it Agri­cole Cre­ation.

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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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

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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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.

Neil Desai, Aadi Bioscience CEO (via YouTube)

Pre­ci­sion on­col­o­gy biotech agrees to $72M cash in­fu­sion as it seeks to in­crease rev­enue

Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going.

The oncology player announced Thursday that it has engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share, the biotech’s closing price at Nasdaq on Wednesday. The company is also selling off pre-funded warrants to purchase over 2.4 million more shares at $12.4999 per pre-funded warrant.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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