Todd Harris (L) and Daniel Bensen (Tyra)

RA Cap­i­tal aims to take pre­clin­i­cal biotech to Nas­daq as Tyra files S-1 dur­ing sum­mer lull

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The sum­mer has brought a rel­a­tive breather to the IPO mar­ket af­ter sev­er­al months of boom­ing funds, but the biotech sec­tor saw a new fil­ing last Fri­day in Tyra Bio­sciences.

Based out of Carls­bad, CA, Tyra pen­ciled in a $100 mil­lion ask ahead of the week­end, com­ing less than five months af­ter it com­plet­ed a $106 mil­lion Se­ries B. Tyra’s ul­ti­mate raise may prove greater than the ini­tial es­ti­mate as it’s raised near­ly $160 mil­lion over­all, but the biotech has yet to get any of its ex­per­i­men­tal drugs in­to hu­man test­ing, with the lead pro­gram for blad­der can­cer ex­pect­ed to see an IND fil­ing in mid-2022.

RA Cap­i­tal Man­age­ment and Box­er Cap­i­tal have been there every step of the way for Tyra, and each will take home a nice IPO prize by virtue of own­ing a near­ly 20% stake pre-of­fer­ing. Al­ta Part­ners and Canaan have al­so con­tributed re­peat­ed­ly, lead­ing to 13% and 14.6% stakes, re­spec­tive­ly.

Tyra’s stat­ed goals all deal with en­sur­ing can­cer pa­tients can con­tin­ue tar­get­ed treat­ment should their tu­mors mu­tate or see their ther­a­pies stop work­ing. The biotech has de­vel­oped a plat­form it calls SNAP, which in­volves shoot­ing X-ray beams to dis­cov­er the three-di­men­sion­al struc­ture of a par­tic­u­lar pro­tein.

It’s not a new ap­proach, but Tyra is hop­ing to dif­fer­en­ti­ate it­self with a team that re­peat­ed­ly looks over the mod­els sev­er­al times per week, get­ting as close to an atom-by-atom per­spec­tive of its can­di­dates’ bind­ing process as it can. The pipeline as a whole will be tar­get­ed at the fi­brob­last growth fac­tor re­cep­tor, or FGFR, fam­i­ly, with the lead pro­gram start­ing off at FGFR3.

Known as TYRA-300, the can­di­date is be­ing stud­ied in mus­cle in­va­sive blad­der can­cer and sol­id tu­mors. The MIBC field has on­ly seen one FDA-ap­proved FGFR3 in­hibitor, and Tyra is aim­ing to po­si­tion it­self as a sec­ond-gen­er­a­tion play­er by de­sign­ing TYRA-300 to avoid the phe­nom­e­non of “gate­keep­er mu­ta­tions” that it says have lim­it­ed the ef­fi­ca­cy of that drug, J&J’s Balver­sa.

Funds from the IPO will go to­ward launch­ing a Phase I/II clin­i­cal tri­al for this pro­gram and tak­ing it through the Phase I por­tion, though it’s un­clear when the study will be­gin — and how much Tyra will spend — giv­en the IND is like­ly about a year away. The biotech al­so out­lined fund­ing plans for two oth­er pro­grams in the S-1: an FGFR2 in­hibitor and a sep­a­rate FGFR3 pro­gram for achon­dropla­sia.

Two founders and mem­bers of Tyra’s C-suite will be adding to their per­son­al bank ac­counts as well. CEO Todd Har­ris gets a 7.2% stake ahead of the IPO, while COO Daniel Bensen has a 2.7% piece of the pie.

Though the groundswell of biotech IPOs has slowed down in Au­gust, 2021 is still on pace to eclipse 2020’s record year. More than 80 com­pa­nies have com­bined to raise near­ly $13 bil­lion, in the first sev­en and a half months of the year, per the End­points News’ tal­ly. Last year, 91 biotechs raised $16.5 bil­lion in IPOs, ac­cord­ing to Nas­daq fig­ures.

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.