Pop­u­lar ke­to di­et set to be test­ed in hu­mans to see if it can amp up ef­fect of weak PI3K drugs

Could a pop­u­lar di­et be put on the menu of treat­ment op­tions for some can­cer pa­tients? A new mouse study sug­gests that the an­swer might be yes — and a mar­quee sci­en­tist in the field is set to test it in hu­mans.

Com­bin­ing a ke­to­genic di­et with PI3K in­hibitors like Zy­delig (Gilead) and Aliqopa (from Bay­er) ap­pears to be an ef­fec­tive way to com­bat the in­ter­fer­ence of an in­sulin re­sponse mech­a­nism trig­gered when the drug in­ter­rupts in­sulin pro­duc­tion and then sets off an al­ter­na­tive spike in in­sulin pro­duc­tion which may well be re­spon­si­ble for ei­ther re­duc­ing or elim­i­nat­ing its ef­fi­ca­cy.

Feed­ing mice a ke­to­genic di­et — with high fat, ad­e­quate pro­tein and ex­treme­ly low carbs — was able to low­er blood glu­cose, over­com­ing the treat­ment loop, ac­cord­ing to the study pub­lished in Na­ture. An SGLT2 drug that blocked ab­sorp­tion of glu­cose in the kid­neys al­so had the same ef­fect.

Sid­dhartha Mukher­jee

Now on­col­o­gist Sid­dhartha Mukher­jee — of The Em­per­or of all Mal­adies fame — is set­ting up a 40-pa­tient study with Bay­er to see how this works in hu­mans.

“If you com­bine them with a di­et which [keeps in­sulin low], all of a sud­den these drugs be­come ef­fec­tive,” Mukher­jee told The Guardian. “The di­et re­al­ly works like a drug.”

A new ap­proach to boost the ef­fi­ca­cy of PI3K could have a pos­i­tive im­pact here. Re­searchers have seen poor or weak sur­vival ad­van­tages with these drugs, which spurred Roche to dump taselis­ib a few weeks ago at the end of Phase III.

Gilead’s pi­o­neer­ing Zy­delig got slapped with a black box warn­ing on side ef­fects, forc­ing an end to its quest to com­plete front­line tri­als. Bay­er’s Aliqopa (co­pan­lis­ib) was ap­proved last fall for fol­lic­u­lar lym­phoma pa­tients on the ba­sis of some promis­ing re­sults, crowd­ing a field that Ve­rastem hopes to join with du­velis­ib, a PI3K dropped by In­fin­i­ty Phar­ma­ceu­ti­cals af­ter Ab­b­Vie walked away af­ter get­ting a glimpse of unim­pres­sive — but still ap­prov­able — re­sults.

The ke­to­genic di­et is sim­ple enough. You slash your carbs to a lim­it of 20 grams a day, forc­ing the body to switch to the fat you’re pump­ing in as an al­ter­na­tive en­er­gy source. It’s a proven method for fast weight loss, with most pros in the di­et are­na warn­ing that few adults can sus­tain it. Can­cer re­searchers have al­so stud­ied ke­to to see if starv­ing tu­mors — such as glioblas­toma — of carbs can shut off a key en­er­gy source.

So here come the caveats.

First, mice aren’t hu­mans. 

The re­searchers here al­so aren’t claim­ing that can­cer pa­tients should drop­kick carbs in re­sponse to what they’ve found. For one thing, there still is pre­cious lit­tle hard ev­i­dence that a ke­to di­et alone could sig­nif­i­cant­ly help can­cer pa­tients. And in some cas­es clin­i­cians sus­pect the ap­proach could be counter pro­duc­tive.

Pro­fes­sor Karen Vous­den, Can­cer Re­search UK’s chief sci­en­tist, had this cau­tion­ary note to add to The Guardian about di­et and can­cer: “There’s a lot of black mag­ic and old wives’ tales. None of it is re­al­ly based on any ev­i­dence.”

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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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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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

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