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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.