When the FDA first ap­proved Alex­ion’s Soliris — then eculizum­ab — in 2007, ex­perts cel­e­brat­ed how the first-of-its-kind drug trans­formed the way physi­cians could treat a rare dis­ease called parox­ys­mal noc­tur­nal he­mo­glo­bin­uria.

As Soliris racked up more land­mark OKs, the C5 in­hibitor al­so be­came a wild­ly suc­cess­ful fran­chise for the com­pa­ny, spurring block­buster sales that led to a fol­low-on drug and a $39 bil­lion buy­out by As­traZeneca while in­spir­ing new play­ers to jump in­to the com­ple­ment space.

Di­anthus Ther­a­peu­tics be­lieves it can make an even big­ger leap than what’s been pro­posed to date — and the start­up is tak­ing the wraps off a $100 mil­lion Se­ries A as it ex­plains the mis­sion.

“This field is ripe for pa­tient cen­tric in­no­va­tion and im­prove­ments,” CEO Mari­no Gar­cia told End­points News.

Sim­rat Rand­hawa

With ba­sic un­der­stand­ing of how dys­reg­u­la­tion of the com­ple­ment path­way trig­gered the com­ple­ment cas­cade and au­toim­mune dis­or­ders, the first-gen­er­a­tion prod­ucts “hit where they could,” CMO Sim­rat Rand­hawa said. The orig­i­nal C5 in­hibitors proved high­ly ef­fec­tive in tam­ing down the prob­lem­at­ic im­mune re­ac­tion, but they al­so shut down a lot else, in­clud­ing the im­mune re­ac­tions one needs to fend off for­eign at­tacks. As a re­sult, the drug la­bels came with boxed warn­ings about life-threat­en­ing bac­te­r­i­al in­fec­tions.

As the sci­ence evolves — and it’s still evolv­ing — sci­en­tists have un­earthed new ways of ap­proach­ing this part of the in­nate im­mune sys­tem.

For in­stance, Di­anthus’s lead com­pound is de­signed to se­lec­tive­ly hit the ac­tive forms of C1s in or­der to on­ly tar­get the clas­si­cal com­ple­ment path­way — one of three path­ways that trig­ger the com­ple­ment cas­cade.

“What we’re try­ing to pro­vide is pret­ty much the most tar­get­ed ap­proach to a com­ple­ment in­hibitor that is avail­able,” Rand­hawa said.

Oth­er than po­ten­tial­ly be­ing safer, the biotech hopes that the se­lec­tiv­i­ty will al­so mean that it will need to de­liv­er a lot less an­ti­body than the first-gen­er­a­tion com­ple­ment in­hibitors, lend­ing it­self to sub­cu­ta­neous self-ad­min­is­tra­tion.

Gar­cia not­ed that Di­anthus worked with a part­ner to ex­plore half-life ex­ten­sion tech­nolo­gies that made the an­ti­bod­ies last even longer.

With the team of 15 scat­tered across the US — the in­com­ing head of qual­i­ty will be work­ing out of Ohio, while the head of clin­i­cal op­er­a­tions re­sides in Seat­tle and the head of tech ops re­ports from the Philadel­phia area — the com­pa­ny hopes to be in the clin­ic by the end of the year.

Lon­nie Moul­der’s Tel­lus BioVen­tures pro­vid­ed the ini­tial fund­ing along­side Fair­mount, while Ven­rock helped with the seed. 5AM Ven­tures, Avid­i­ty Part­ners and Fi­deli­ty led the round, with par­tic­i­pa­tion from Wed­bush Health­care Part­ners.

Al­though Di­anthus has no wet labs, it hopes to lever­age its net­work of tech­ni­cal ex­perts in be­com­ing a next-gen leader in com­ple­ment ther­a­pies — an am­bi­tion hint­ed in its name, which com­bines the Greek words for god (“dios”) and flower (“an­thus”).

“The whole idea was that the an­thus flower was cre­at­ed by Zeus to sort of sur­pass the beau­ty and the scent of the lily,” Gar­cia said. “And I mean, it’s a great sym­bol for the com­pa­ny, be­cause es­sen­tial­ly, that’s what we’re try­ing to do.”

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

It’s not just American startups that are tuning into the rising interest in radiopharmaceuticals.

Sequoia China is leading a $37 million Series A into Full-Life Technologies, a biotech headquartered in Shanghai with offices in Brussels, Belgium, to develop a pipeline of radioactive cancer therapies.

The idea isn’t new: As clinicians started routinely deploying radiation to kill cancer cells, scientists and drugmakers have long been exploring ways to limit that powerful effect only to cancer cells while sparing healthy cells. But recent progress in the production of radioisotopes — coupled with big investments from Big Pharma, most notably Novartis and Bayer — has inspired a new wave of startups.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.