Karuna and In­cyte scrap pro­grams; More cash for the SPACs

Karuna Ther­a­peu­tics has built it­self in­to a $2 bil­lion com­pa­ny off the da­ta of an old Eli Lil­ly drug, when com­bined with tro­spi­um chlo­ride, showed in schiz­o­phre­nia. For a while, the com­pa­ny hoped that it might al­so prove ef­fec­tive as a non-opi­oid treat­ment for pain.

Now, how­ev­er, Karuna is aban­don­ing that ef­fort. Af­ter a Phase Ib tri­al of 24 healthy vol­un­teers did “not pro­vide con­clu­sive ev­i­dence of an anal­gesic ben­e­fit of KarXT,” the com­pa­ny said it would stop de­vel­op­ing it for that in­di­ca­tion. Karuna will con­tin­ue work­ing on the drug, an M1 and M4 ag­o­nist, for schiz­o­phre­nia. Pa­tients who re­ceived it in a Phase II tri­al last year showed a 24-point im­prove­ment on a com­mon clin­i­cal score.

A Phase III tri­al is sched­uled to be­gin lat­er this year, CEO Steve Paul said in a state­ment.

“Look­ing ahead, we re­main fo­cused on de­vel­op­ing KarXT for the treat­ment of se­vere neu­ropsy­chi­atric dis­or­ders, in­clud­ing schiz­o­phre­nia and de­men­tia-re­lat­ed psy­chosis, where ro­bust ev­i­dence from pre­vi­ous clin­i­cal tri­als sup­ports the po­ten­tial of KarXT to pro­vide a new, unique and mech­a­nis­ti­cal­ly dif­fer­en­ti­at­ed ther­a­peu­tic for the treat­ment of these dis­or­ders,” Paul said.

More cash for the SPACs

A week af­ter Tony Coles’ Cerev­el Ther­a­peu­tics nabbed $445 mil­lion as part of a merg­er with a Per­cep­tive Ad­vis­ers SPAC — a record for a life sci­ences “blank check” trans­ac­tion — an­oth­er firm has an­nounced a new life sci­ences SPAC, while RTW has priced their lat­est one.

The new SPAC, from High­Cape Cap­i­tal, has pen­ciled in $100 mil­lion in the ini­tial of­fer­ing, though it re­mains to be seen how much it will ul­ti­mate­ly try to fetch. The new RTW of­fer­ing, called RTW Health Sci­ences Ac­qui­si­tions 2, raised $139 mil­lion, sell­ing 13.9 mil­lion shares at $10 a piece.

SPACs have risen dra­mat­i­cal­ly in promi­nence in re­cent years, go­ing from 3% of the IPO mar­ket in 2014 to 35% to­day, ac­cord­ing to NAS­DAQ’s Jay Heller. In­vestors who pur­chase stock are es­sen­tial­ly bet­ting that the SPAC’s man­agers are savvy enough to, with­in 2 years, pick a good com­pa­ny to merge with. For com­pa­nies and in­vestors, it can al­so pro­vide a smoother path to pub­lic mar­kets than an IPO, help­ing skip over the lengthy and volatile process of set­ting a price. In ad­di­tion to Cerev­el, biotechs that have gone pub­lic via this route in the past year in­clude Im­muno­vant and Im­mat­ics.

G1 Ther­a­peu­tics gets up to $170M in Chi­na deal

Two weeks af­ter get­ting up to $310 mil­lion for a CDk4/6 drug from EQRx, G1 has sold com­mer­cial rights to an­oth­er one of its drugs.

G1 sold rights to tri­laci­clib, an ex­per­i­men­tal drug meant to mit­i­gate the side ef­fects of chemother­a­py, in Chi­na, Hong Kong, Macau and Tai­wan to Sim­cere Phar­ma­ceu­ti­cal Group for $14 mil­lion up­front and $156 mil­lion in mile­stones, plus roy­al­ties. The drug has re­ceived break­through sta­tus in the US and was re­cent­ly sub­mit­ted for ap­proval in small cell lung can­cer.

The drug works by pre­serv­ing bone mar­row func­tion that would oth­er­wise be se­vere­ly un­der­mined by chemother­a­py. It is now be­ing test­ed in oth­er can­cers. Sim­cere will be re­spon­si­ble for clin­i­cal de­vel­op­ment in Chi­na.

In­cyte aban­dons an ear­ly can­di­date

In­cyte an­nounced in its sec­ond quar­ter earn­ings that it re­tired one can­di­date from ear­ly de­vel­op­ment.

The ex­per­i­men­tal mol­e­cule, known as IN­CB59872, is an LSD-1 in­hibitor that was be­ing test­ed in ear­ly tri­als in sick­le cell dis­ease, sar­co­ma, and oth­er ma­lig­nan­cies. The sick­le cell dis­ease tri­al was ter­mi­nat­ed last year, ac­cord­ing to clin­i­cal­tri­als.gov. The can­cer tri­als were ter­mi­nat­ed in June, with In­cyte cit­ing a “strate­gic busi­ness de­ci­sion” for the can­cel­la­tion.

Once one of the more lu­cra­tive R&D en­gines in the in­dus­try — de­vel­op­ing the mol­e­cules that be­come the can­cer drug Tabrec­ta and the JAK in­hibitors Jakafi and Olu­mi­ant — the 29-year-old biotech has strug­gled in re­cent years to keep up the pace of de­vel­op­ment.

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.”

EU re­port­ed­ly eye­ing vac­cines deal for mon­key­pox out­break; Nas­daq tells Mereo to get stock price up or face delist­ing

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

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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