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.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.