Out: NIH bud­get cuts. In: Alzheimer’s R&D as law­mak­ers boost pro­posed ’19 spend­ing to $2.3B

The US Sen­ate is feel­ing gen­er­ous to­ward med­ical re­searchers, and that may soon trans­late in­to a big hike in spend­ing on Alzheimer’s re­search — the most frus­trat­ing field in R&D to­day.

Law­mak­ers passed a 2019 bud­get pro­pos­al on Thurs­day that gives the NIH a 5% bump in its bud­get, with an ex­tra $425 mil­lion di­rect­ed specif­i­cal­ly at Alzheimer’s. That would give the agency $2.3 bil­lion for Alzheimer’s, which the AP notes is four times as much as what the NIH spent on the mem­o­ry wast­ing dis­ease four years ago.

The added Alzheimer’s spend­ing rep­re­sents a big chunk of the $2 bil­lion sen­a­tors want to add to the NIH bud­get for fis­cal 2019. Al­to­geth­er they vot­ed 85 to 7 in sup­port of the bud­get bill.

The in­creased fed­er­al spend­ing is be­ing dri­ven by two sim­ple re­al­i­ties: The grow­ing cost of the dis­ease that af­flicts mil­lions and the ap­par­ent help­less­ness by most de­vel­op­ers to bend the course of Alzheimer’s. The steady drum­beat of clin­i­cal fail­ures over a decade-plus leaves pa­tients with no ef­fec­tive ther­a­pies while the on­ly claimed suc­cess by Bio­gen and Ei­sai has been swamped by con­tro­ver­sy and a grow­ing dis­en­chant­ment with the amy­loid be­ta the­o­ry.

Now re­searchers are go­ing ever ear­li­er in try­ing to slow or stop dis­ease pro­gres­sion, while adding new tar­gets like tau and look­ing to at­tack Alzheimer’s with com­bi­na­tion ther­a­pies. This new NIH mon­ey could pro­vide a ma­jor boost to the new think­ing in the field.

It’s not a done deal, with Sen­ate and House rep­re­sen­ta­tives slat­ed to hash out all the de­tails in up­com­ing ne­go­ti­a­tions. But it un­der­scores an im­mense amount of sup­port in con­gress for added re­search spend­ing.

“Alzheimer’s is the most ex­pen­sive dis­ease in Amer­i­ca and, with­out a break­through, by 2050 we’ll spend $1.1 tril­lion treat­ing peo­ple with Alzheimer’s each year — twice as much as the an­nu­al de­fense bud­get,” said Mis­souri Sen­a­tor Roy Blunt in a state­ment. “This bill not on­ly meets, but sur­pass­es the $2 bil­lion re­search goal of the Na­tion­al Plan to Ad­dress Alzheimer’s Dis­ease.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

Roche ditch­es fi­nal PhI­II for can­cer hope­ful, re­ports set­back for key drug in $1.4B buy­out

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials.

Now, the last piece of the program is gone.

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Simba Gill, Evelo Biosciences CEO

Sim­ba Gill stay­ing on at Evelo to weath­er lay­offs and a PhII fail

Simba Gill will be staying put as CEO of Evelo Biosciences for now.

Gill announced last year that he would be leaving the head position at Evelo to take on the role of executive partner at Flagship Pioneering. He was aiming to stay on until a successor was selected, but there’s a new course of action in the wake of a Phase II miss and a reduced headcount.

“I want to emphasize that I remain personally committed to Evelo and staying on to lead the organization. I continue to believe that Evelo is a remarkable opportunity in terms of the science, the platform, the type of products that we’re able to produce, and most importantly, the potential of millions of patients suffering from all stages of inflammatory disease,” Gill said on a conference call.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.