Manfred Rüdiger, Ariceum Therapeutics CEO (Presseportal)

Ger­man start­up jumps in­to the hot ra­dio­phar­ma space with a for­mer Ipsen com­pound as lead pro­gram

Ra­dio­phar­ma­ceu­ti­cals are con­tin­u­ing to be­come a hot top­ic in bio­phar­ma, with com­pa­nies such as Se­quoia, No­var­tis and Bris­tol My­ers Squibb look­ing to get in on the ac­tion. A new start­up launched Wednes­day is look­ing to catch the wave, start­ing with a team and as­sets from Ipsen.

Berlin-based Ariceum Ther­a­peu­tics has se­cured a €25 mil­lion ($26.7 mil­lion) Se­ries A to fur­ther de­vel­op its lead as­set and pro­pri­etary pep­tide de­riv­a­tive. Found­ed last year (and co-found­ed by EQT Life Sci­ences), Ariceum is head­ed by Man­fred Rüdi­ger, a vet­er­an of over 25 years in the bio­phar­ma world.

The com­pa­ny was formed around of a sale of as­sets from Ipsen, tak­ing along the ra­dio­phar­ma­ceu­ti­cal can­di­date as well as a team of re­searchers, in­clud­ing the Ariceum’s new CMO, ac­cord­ing to Rüdi­ger.

The as­set in ques­tion, dubbed satoreotide, is a ra­dio­phar­ma­ceu­ti­cal drug and an an­tag­o­nist of the so­mato­statin type 2 (SST2) re­cep­tor, which is over­ex­pressed in many can­cers, Rüdi­ger says. This in­cludes cer­tain dis­eases such as small cell lung can­cer, high-grade neu­roen­docrine tu­mors (NETs) and neu­rob­las­toma. Satoreotide will be used as a “ther­a­nos­tic” for both the di­ag­no­sis and treat­ment of tu­mors ex­press­ing the SST2 re­cep­tor.

“The rea­son why the share­hold­ers de­cid­ed to en­ter in­to the ra­dio­phar­ma­ceu­ti­cal busi­ness is that this has be­come a very hot and very com­pet­i­tive area with some re­cent big suc­cess­es,” Rüdi­ger said. “Every­body now re­al­izes that small com­pounds, which you can ad­min­is­ter by in­tra­venous in­fu­sion, will find the tu­mor and al­so the metas­tases and the can­cer cells through­out the body and kill them due to the ra­dioac­tive pay­load.”

For the Se­ries A round, three in­vestors par­tic­i­pat­ed, in­clud­ing EQT, Swe­den-based Health­Cap and Swiss firm Pure­os Bioven­tures. All three in­vestors will con­tribute to Ariceum’s board.

Ariceum will use the funds for sev­er­al dif­fer­ent pur­pos­es, such as build­ing up the head­count and gen­er­al op­er­a­tions, with the goal of hav­ing three clin­i­cal tri­als run­ning by next year. Rüdi­ger said the round’s run­way is very short, and the com­pa­ny is an­tic­i­pat­ing pur­su­ing an­oth­er round of fund­ing in the sec­ond half of 2022.

The com­pa­ny is po­si­tioned dif­fer­ent­ly than oth­ers in this space, Rüdi­ger notes, in that ex­ecs are start­ing with a Phase II clin­i­cal as­set, where safe­ty in pa­tients has al­ready been de­ter­mined. Satoreotide, while it’s in ear­ly clin­i­cal de­vel­op­ment, has been ad­min­is­tered to more than 100 pa­tients in ear­li­er stud­ies al­ready.

He al­so said Ariceum has more of a head start be­cause they are launch­ing with an ex­pe­ri­enced team and in­vestors fa­mil­iar with the space. Ac­cord­ing to Rüdi­ger, these fac­tors help the com­pa­ny apart from oth­er star­tups in the field.

How­ev­er, the com­pa­ny wants to carve its own path for­ward and not nec­es­sar­i­ly try to dom­i­nate every­one else.

“You have to find your sweet spot. Again, like in the car in­dus­try, you don’t on­ly have BMW and Porsche. There are many, many oth­ers and they’re all suc­cess­ful,” he said. “So we have a plat­form tech­nol­o­gy on which we will build screen­ing and de­vel­op­ing new com­pounds. And I think we have some very good ideas on how to do this more ef­fi­cient­ly than oth­ers.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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