The Park­er In­sti­tute aims to speed up can­cer R&D, carv­ing out du­pli­cate IRBs at top cen­ters

The Park­er In­sti­tute for Can­cer Im­munother­a­py has brought its 6 top cen­ters to­geth­er to sup­port a sim­ple ini­tia­tive de­signed to shave months off the clin­i­cal tri­al process. In­stead of each field­ing their own IRB — in­sti­tu­tion­al re­view board — they’ve agreed to des­ig­nate one that will work for the en­tire net­work for mul­ti-cen­ter stud­ies.

IRBs are tasked with keep­ing a sharp eye on tri­als to pre­serve pa­tient safe­ty, over­see over­all con­duct and main­tain da­ta in­tegri­ty. But they can al­so slow down the work, par­tic­u­lar­ly when each of these groups field their own re­view boards for each study. A col­lec­tive agree­ment to des­ig­nate one IRB as the re­view board of record could save a con­sid­er­able amount of time, these sci­en­tists agreed.

The big 6 have played a big role in can­cer re­search, and they can be ex­tra­or­di­nar­i­ly in­flu­en­tial in aca­d­e­m­ic cir­cles. They are: Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, Stan­ford Med­i­cine, the Uni­ver­si­ty of Cal­i­for­nia, Los An­ge­les, the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, the Uni­ver­si­ty of Penn­syl­va­nia and The Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter.

Forbes’ Matt Her­p­er with Sean Park­er and Dr. Carl June

The Park­er In­sti­tute, bankrolled by on­line tech mogul Sean Park­er, flagged the ef­fort as the first of many aimed at sim­pli­fy­ing re­search work, with an eye to elim­i­nat­ing bar­ri­ers to progress. Their sci­en­tists in­clude UCSF’s Jef­frey Blue­stone, Jim Al­li­son at MD An­der­son and An­toni Ribas at UCLA.

“This type of col­lab­o­ra­tive part­ner­ship is an im­por­tant first step that we are tak­ing to ac­cel­er­ate im­munother­a­py re­search,” said Ramy Ibrahim, M.D., vice pres­i­dent of clin­i­cal de­vel­op­ment at the Park­er In­sti­tute for Can­cer Im­munother­a­py. “By min­i­miz­ing ob­sta­cles that sci­en­tists rou­tine­ly face in clin­i­cal tri­als, we save time. And every day we save ini­ti­at­ing a clin­i­cal tri­al brings us a day clos­er to de­liv­er­ing promis­ing treat­ments to can­cer pa­tients.”

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

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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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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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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Novartis headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

No­var­tis’ Kisqali pre­vents breast can­cer from com­ing back for longer — but can it best Eli Lil­ly’s Verzenio? #AS­CO23

CHICAGO — Novartis’ CDK4/6 inhibitor Kisqali helped early breast cancer patients stay cancer-free for longer after surgery, according to interim study results presented at ASCO.

In a Phase III study, Kisqali was added on top of endocrine therapy — the current standard treatment for early breast cancer patients. Kisqali reduced the risk of disease relapse by 25% compared with endocrine therapy alone in patients with Stage II or III HR-positive, HER2-negative breast cancer.

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On­corus lays off most of its re­main­ing team, warns of wind-down as it takes one last shot at deal­mak­ing

Despite cutting its headcount, pipeline and lease late last year, Oncorus is still struggling to stay afloat and is now on the brink of bankruptcy or dissolution, the company revealed late Thursday.

The Andover, MA-based biotech is letting “substantially all of Oncorus’ workforce” go, after the board of directors approved the layoffs. CEO Ted Ashburn, COO/chief of staff Stephen Harbin and CMO John Goldberg are among the 55 to depart.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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