Andreas Katopodis, Anaveon CEO

The next-gen IL-2 race heats up as Anaveon se­cures a megaround with its sights set on mid-stage tests

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.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

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.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

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.”

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

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.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

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.