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 

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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