Laura Shawver, Silverback

Sil­ver­back files to go pub­lic, po­ten­tial­ly adding to this year's record-high biotech IPO raise

The signs were there: A cou­ple of months ago, Sil­ver­back Ther­a­peu­tics quick­ly pulled in $163 mil­lion in two back-to-back rounds for what CEO Lau­ra Shawver called “an im­por­tant growth phase.” As ex­pect­ed, the Seat­tle-based biotech turned in its S-1 on Tues­day seek­ing a $100 mil­lion IPO.

Sil­ver­back could be one of more than 72 biotech and bio­phar­ma com­pa­nies to hit Wall Street this year, con­tribut­ing to a record raise of over $13 bil­lion. Many up­sized their of­fers, and if Sil­ver­back fol­lows suit, it could stand to raise much more than its $100 mil­lion bid. A cou­ple of weeks ago, Nas­daq head of health­care list­ings Jor­dan Saxe pegged a “fair es­ti­mate” of 75 de­buts and just un­der $14 bil­lion in pro­ceeds to round out the year.

A chunk of Sil­ver­back’s pro­ceeds will be used to de­vel­op its own twist on an­ti­body-drug con­ju­gates, which are mak­ing a come­back. While oth­er AD­Cs de­liv­er can­cer-killing tox­ins, Sil­ver­back’s three can­di­dates re­ly on a TLR8 ag­o­nist with a can­cer-di­rect­ed an­ti­body. The lead drug, SBT6050, de­liv­ers a TLR8 ag­o­nist to HER2-ex­press­ing tu­mors in the hopes of ac­ti­vat­ing and re­pro­gram­ming myeloid cells to dri­ve an im­mune re­sponse. It’s cur­rent­ly in Phase I/Ib test­ing, with an in­ter­im da­ta read­out from dose-es­ca­la­tion co­horts ex­pect­ed in the first half of next year.

The biotech’s two oth­er can­di­dates have yet to reach the clin­ic, though one is rel­a­tive­ly close, ac­cord­ing to Sil­ver­back. SBT6290 is a “TLR8 link­er-pay­load con­ju­gat­ed to a mon­o­clon­al an­ti­body that tar­gets Nectin4, which is ex­pressed in cer­tain blad­der, triple neg­a­tive breast, head and neck, and non-small cell lung can­cers,” the S-1 states. Sil­ver­back plans on fil­ing an IND in the Q4 of 2021. Its third TLR8 can­di­date fea­tures an AS­GR1 mon­o­clon­al an­ti­body, which could po­ten­tial­ly treat chron­ic he­pati­tis B virus in­fec­tion (cHBV).

“TLR8 is the in­nate im­mune re­cep­tor ex­pressed in hu­man myeloid cells, and the abil­i­ty then to sys­tem­i­cal­ly de­liv­er an agent, whose ac­tiv­i­ty is lo­cal­ized to the site of the tu­mor and on­ly ac­ti­vates myeloid cells in the tu­mor is a very ex­cit­ing ther­a­peu­tic,” CSO Va­lerie Ode­gard told End­points News back in March.

Since its found­ing in 2016, Sil­ver­back has burned through $83.6 mil­lion. Or­biMed, which led the com­pa­ny’s $47.5 mil­lion Se­ries A in 2018, holds 35% of shares, while US Ven­ture Part­ners, which led the $78 mil­lion Se­ries B, holds 10.1%. Co-founder and Or­biMed part­ner Pe­ter Thomp­son al­so has 35% of the stock, and Shawver 3.6%.

It’ll list un­der the tick­er $SBTX.

Oth­er AD­Cs in the can­cer space in­clude Im­munomedics’ Trodelvy, which was re­cent­ly ap­proved for metasta­t­ic triple-neg­a­tive breast can­cer. The biotech was ac­quired by Gilead for $21 bil­lion last month. New da­ta in urothe­lial can­cer sets the drug up to com­pete with Seat­tle Ge­net­ics’ ADC Pad­cev.

Ear­li­er this year, Dai­ichi Sankyo and As­traZeneca’s En­her­tu was ap­proved for breast can­cer months ahead of sched­ule. And Roche’s Kad­cy­la, ap­proved for HER-2 pos­i­tive breast can­cer, scored huge sales last year.

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.