Yingli Phar­ma brings small mol­e­cule re­search to the US in new pact with MD An­der­son; UCB's pso­ri­at­ic arthri­tis drug shows pos­i­tive PhI­II re­sults

Shang­hai biotech Yingli Phar­ma wants to bring its small mol­e­cule drug re­search glob­al — and a new pact with MD An­der­son will help it get there.

Yingli and MD An­der­son have inked a 5-year col­lab­o­ra­tion deal that will put its can­cer can­di­dates — some of which have al­ready gen­er­at­ed da­ta in Chi­na — in­to tri­als in the US. The lead pro­gram is lin­perlis­ib, a PI3Kδ in­hibitor that’s in a Phase III tri­al in fol­lic­u­lar lym­phoma, ac­cord­ing to Yingli’s web­site. In the US, MD An­der­son will work with Yingli to put the can­di­date in a Phase II tri­al for pe­riph­er­al T cell lym­phoma (PT­CL), an un­com­mon and ag­gres­sive type of non-Hodgkin’s lym­phoma.

About a year ago, Hen­grui Med­i­cine put down a $20 mil­lion eq­ui­ty in­vest­ment in re­turn for joint de­vel­op­ment and com­mer­cial­iza­tion rights to Yingli’s PI3kδ in­hibitor in Chi­na.

“This col­lab­o­ra­tion brings a po­ten­tial­ly ef­fec­tive treat­ment op­tion with a fa­vor­able safe­ty pro­file to the US to ad­dress an un­met need for pa­tients with this ag­gres­sive can­cer. I look for­ward to lead­ing this ex­cit­ing study,” prin­ci­pal in­ves­ti­ga­tor and MD An­der­son pro­fes­sor Swami­nathan Iy­er said in a news re­lease.

The duo will al­so launch a Phase I tri­al for a sec­ond pro­gram, a TGFβR1 in­hibitor dubbed YL-13027, in ad­vanced sol­id tu­mors.

In ad­di­tion to the ex­ist­ing pro­grams, Yingli and MD An­der­son will al­so progress Yingli’s dis­cov­ery pro­grams, with the goal of push­ing for­ward a steady stream of new can­cer can­di­dates.

The part­ners are keep­ing the fi­nan­cial terms of the deal un­der wraps for now. — Nicole De­Feud­is 

Pso­ri­at­ic arthri­tis drug shows pos­i­tive PhI­II re­sults

Bel­gian bio­phar­ma UCB has an­nounced that the Phase III BE COM­PLETE study for its pso­ri­at­ic arthri­tis drug has passed all of the pri­ma­ry and sec­ondary end­points, show­ing sig­nif­i­cant im­prove­ment over the place­bo.

Bimzelx is in­tend­ed to treat adults who did not re­spond to an­ti-TNF ther­a­pies. The drug achieved 50% or greater im­prove­ment in symp­toms from the base­line, and mea­sured a 90% im­prove­ment in skin clear­ance.

Pso­ri­at­ic arthri­tis is a chron­ic in­flam­ma­to­ry con­di­tion that af­fects a per­son’s joints and skin. The dis­ease can cause red patch­es of skin that are topped with sil­ver scales, and usu­al­ly fol­lows a pso­ri­a­sis di­ag­no­sis. It af­fects be­tween .05% and .25% of the world’s pop­u­la­tion, and be­tween 6% and 41% of those suf­fer­ing from pso­ri­a­sis. Those di­ag­nosed ex­pe­ri­ence joint pain and stiff­ness, swollen toes and fin­gers and in­flam­ma­tion.

“We be­lieve that these con­sis­tent and ro­bust re­sults have the po­ten­tial to el­e­vate the stan­dard of care for pa­tients,” said Em­manuel Caey­maex, the US head of UCB, in a state­ment. “Both pso­ri­at­ic arthri­tis stud­ies in the pro­gram used ACR50 as the pri­ma­ry out­come mea­sure. The pos­i­tive find­ings in both stud­ies high­light the clin­i­cal po­ten­tial of bimek­izum­ab in pso­ri­at­ic arthri­tis for both bi­o­log­ic naïve and an­ti-TNF ther­a­py ex­pe­ri­enced pa­tients.”

Bimzelx is cur­rent­ly be­ing re­viewed for ap­proval by the FDA. – Josh Sul­li­van

Mi­rati un­veils new PhII da­ta for ada­gra­sib in GI tu­mors 

While Mi­rati builds a case for its KRAS in­hibitor ada­gra­sib in non-small cell lung can­cer — where it would chal­lenge Am­gen’s Lumakras — the biotech is al­so un­veil­ing some new Phase II da­ta it says show promise in gas­troin­testi­nal tu­mors.

Of 27 evalu­able GI can­cer pa­tients in a co­hort of the KRYS­TAL-1 study (which is test­ing ada­gra­sib as a monother­a­py and in com­bi­na­tions across mul­ti­ple sol­id tu­mor types), 41% saw a re­sponse, Mi­rati an­nounced on Fri­day.

The co­hort en­rolled 30 pa­tients with GI can­cers har­bor­ing a KRAS G12C mu­ta­tion, who had re­ceived at least two lines of pri­or ther­a­py. That in­clud­ed pa­tients with pan­cre­at­ic duc­tal ade­no­car­ci­no­ma and oth­er GI tu­mors, in­clud­ing can­cers of the bil­iary tract, ap­pen­dix, small bow­el, gas­tro-esophageal junc­tion, and esoph­a­gus. They re­ceived ada­gra­sib monother­a­py, and had a me­di­an fol­low-up of about 6 months.

In 10 pa­tients with pan­cre­at­ic can­cer, the re­sponse rate was 50%, with a me­di­an du­ra­tion re­sponse of 7 months and a me­di­an fol­low-up of 8.1 months. Of the 17 pa­tients with oth­er GI tu­mors, 35% saw a re­sponse, and me­di­an du­ra­tion of re­sponse was 7.9 months.

The me­di­an pro­gres­sion-free sur­vival in pa­tients with pan­cre­at­ic can­cer was 6.6 months, com­pared to 7.9 months for pa­tients with oth­er tu­mors.

“We con­tin­ue to ag­gres­sive­ly eval­u­ate ada­gra­sib as a sin­gle agent and in com­bi­na­tion with oth­er can­cer med­i­cines in a broad de­vel­op­ment plan to help more peo­ple liv­ing with can­cer,” head of R&D Charles Baum said in a news re­lease. — Nicole De­Feud­is 

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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