In­tel­liphar­ma­ceu­tics shares crushed as FDA ex­perts snub pain drug; Mon­cef Slaoui joins Mod­er­na board

→ Af­ter get­ting chas­tised by reg­u­la­tors in an in­ter­nal FDA re­view of Toron­to-based In­tel­liphar­ma­ceu­tics$IP­CI new pain drug Rex­ista, a pan­el of out­side ex­perts joined in, vot­ing to rec­om­mend a re­jec­tion of the ther­a­py. Billed as a new ver­sion of oxy with new fea­tures which the biotech claimed would de­ter abuse, the pan­elists vot­ed 22 to 1 against an OK. And all of them agreed that the com­pa­ny nev­er of­fered the da­ta that would be need­ed to gain an abuse-de­ter­rent note on the la­bel, if it were to be ap­proved. The com­pa­ny’s shares cratered, drop­ping 45%.

→ Rad­nor, PA-based Com­plexa has raised a big $62 mil­lion round de­signed to fu­el a pair of mid-stage tri­als for its lead ther­a­py, CXA-10. The drug will be test­ed in fo­cal seg­men­tal glomeru­loscle­ro­sis (FS­GS), an or­phan dis­ease af­fect­ing the kid­ney, and pul­monary ar­te­r­i­al hy­per­ten­sion (PAH), a rare pul­monary dis­ease. New En­ter­prise As­so­ciates and Pfiz­er Ven­ture In­vest­ments led the round with help from Ed­mond de Roth­schild In­vest­ment Part­ners, HBM Health­care In­vest­ments and ex­ist­ing in­vestors in­clud­ing JAF­CO, which led the Com­pa­ny’s Se­ries B fi­nanc­ing in 2014.

→ Fre­mont, CA-based Quark Phar­ma­ceu­ti­cals is re­port­ing that their Phase II study for the siR­NA drug QPI-1002 came through with pos­i­tive da­ta for re­duc­ing the rate of acute kid­ney in­jury fol­low­ing car­diac surgery. The study en­rolled 341 sub­jects. “Quark is de­vel­op­ing QPI-1002 in a va­ri­ety of in­di­ca­tions as­so­ci­at­ed with is­chemia-reper­fu­sion re­nal in­jury,” stat­ed Shai Er­lich, CMO and pres­i­dent of Quark’s US op­er­a­tions. “We are ex­cit­ed about the QRK-209 study re­sults which re­in­force the pos­i­tive ef­fect of QPI-1002 as pre­vi­ous­ly re­port­ed in a ran­dom­ized, dou­ble-blind, place­bo-con­trolled mul­ti­cen­ter Phase 2 study (QRK-006b; NCT00802347) where QPI-1002 was shown to re­duce the in­ci­dence and sever­i­ty of de­layed graft func­tion (DGF) in pa­tients un­der­go­ing re­nal trans­plan­ta­tion.”

→ Mon­cef Slaoui, the for­mer R&D and vac­cines chief at Glax­o­SmithK­line, is join­ing the board at the mR­NA com­pa­ny Mod­er­na. Slaoui is an en­thu­si­as­tic cham­pi­on of pi­o­neer­ing drug R&D. And he says he’s look­ing “for­ward to work­ing with the team to nav­i­gate this un­chart­ed ter­ri­to­ry, and sup­port the strate­gic plan­ning al­ready un­der­way as Mod­er­na works to de­liv­er mR­NA med­i­cines and vac­cines to ad­dress se­ri­ous un­met med­ical needs in the U.S. and glob­al­ly.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

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Keytru­da be­fore and af­ter lung can­cer surgery cuts re­lapse risk by 42%, but doesn’t im­prove sur­vival: #AS­CO23

CHICAGO — Merck has found partial success with its latest effort to more aggressively treat earlier stages of lung cancer.

On Saturday the pharma giant announced results from a large trial in which patients received Merck’s immunotherapy Keytruda plus chemotherapy before surgeons removed their tumors, followed by another course of Keytruda afterward.

The Phase III study, called KEYNOTE-671, enrolled 800 people with the early stages of the most common kind of lung cancer: non-small cell lung cancer, or NSCLC. Everyone got chemo before surgery, and half also got Keytruda before and after. At two years, 62.4% of those who got Keytruda kept their cancer at bay, compared to 40.6% who got a placebo.

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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