There ap­pears to be no short­age of cash for those in the hunt for a bet­ter IL-2. On Thurs­day, Swiss-based Anaveon raked in an­oth­er $119 mil­lion to see its own can­di­date in­to a se­ries of Phase II tri­als — and a new Big Phar­ma in­vestor is get­ting on board.

Im­munother­a­pies tar­get­ing IL-2 — which stim­u­lates T-cells to mul­ti­ply and at­tack tu­mors — have proven to be quite pow­er­ful against can­cer over the last cou­ple decades, but are in­fa­mous for their tox­ic side ef­fects. While Pro­leukin, ap­proved in 1992, helped es­tab­lish the po­ten­cy of IL-2, safe­ty is­sues and a mod­est half-life thwart­ed its po­ten­tial.

Now a broad range of com­pa­nies are rac­ing to see if they can cre­ate a next-gen­er­a­tion IL-2 ther­a­py sans the dan­ger­ous side ef­fects. Anaveon’s can­di­date, ANV419, is de­signed to pref­er­en­tial­ly sig­nal through the be­ta/gam­ma re­cep­tor of IL2, ex­clud­ing the al­pha re­cep­tor, in the hopes of achiev­ing high­er se­lec­tiv­i­ty.

“It helps the safe­ty be­cause the al­pha/be­ta/gam­ma is re­spon­si­ble for some of the safe­ty is­sues,” CEO and co-founder An­dreas Katopodis told End­points News. “It does not pro­lif­er­ate reg­u­la­to­ry cells, which are pro­tect­ing the can­cer, and pro­lif­er­ates on­ly so-called ef­fec­tor cells, which are an­ti-can­cer in this case.”

The ap­proach traces back to re­search done by the Uni­ver­si­ty of Zurich’s Onur Boy­man. The No­var­tis In­sti­tutes of Bio­med­ical Re­search (where Katopodis was di­rec­tor) had been part­ner­ing with the uni­ver­si­ty on the project, be­fore No­var­tis de­cid­ed to pull out. Boy­man and Katopodis launched Anaveon to con­tin­ue the work in 2017.

The com­pa­ny se­cured a rough­ly $35 mil­lion Se­ries A round two years lat­er, with the No­var­tis Ven­ture Fund chip­ping in. This time around, Pfiz­er’s ven­ture arm is al­so hop­ping on board for the Se­ries B. The round was led by For­bion, with a help­ing hand from Syn­cona, the No­var­tis Ven­ture Fund, Cowen Health­care In­vest­ments, Pfiz­er Ven­tures and Pon­tif­ax.

ANV419 is cur­rent­ly in a Phase I/II tri­al in pa­tients with sol­id tu­mors, which is ex­pect­ed to read out re­sults at AACR in April. Next up will be a se­ries of Phase II stud­ies in mul­ti­ple in­di­ca­tions, which Katopodis de­clined to re­veal at this time.

“We are tak­ing the road of try­ing to do many tri­als in par­al­lel, and ei­ther give a green sig­nal to our mol­e­cule ear­ly or a red sig­nal, (which) hope­ful­ly will nev­er hap­pen,” the chief ex­ec­u­tive said. “We don’t want to de­lay the de­ci­sion-mak­ing.”

Anaveon isn’t the on­ly IL-2-fo­cused com­pa­ny to swing a megaround in the last year or so.

Ash­er Bio­ther­a­peu­tics closed a $108 mil­lion Se­ries B just a cou­ple months ago to ad­vance its lead can­di­date, an en­gi­neered IL-2 tar­get­ing CD8+ ef­fec­tor T cells, through a proof-of-con­cept hu­man study. That came just a few months af­ter the com­pa­ny hooked a $55 mil­lion Se­ries A. And back in June, Bright Peak Ther­a­peu­tics nabbed a $107 mil­lion B round to launch its IL-2 pro­gram in­to the clin­ic in 2022.

“I can­not tell you we’re bet­ter than they are, be­cause we don’t know all their da­ta … nor do I know ex­act­ly what they’re do­ing,” Katopodis said of the com­pe­ti­tion. “In the end, of course, it will be a mat­ter of who shows ef­fi­ca­cy and in what in­di­ca­tion.”

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.”

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.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.