Mark Manfredi, Ikena Oncology president & CEO

Ike­na On­col­o­gy drops an ear­ly-stage pro­gram as it looks to stretch its cash

An­oth­er biotech is lin­ing up to cut a piece of its pipeline to ex­tend its cash­flow. The Boston-based, can­cer-cen­tered biotech Ike­na On­col­o­gy is look­ing to make some changes to its pipeline, in­clud­ing a cull of one of its ear­ly-stage pro­grams.

Ike­na an­nounced this week that af­ter con­duct­ing a “port­fo­lio re­view,” it will dis­con­tin­ue the in­ter­nal clin­i­cal de­vel­op­ment of its can­di­date IK-007, an EP4 an­tag­o­nist, and that it is “ex­plor­ing strate­gic al­ter­na­tives” for the drug.

The biotech did state that clin­i­cal da­ta from IK-007 in mi­crosatel­lite sta­ble col­orec­tal can­cer will still be pre­sent­ed in a poster at the 2022 Eu­ro­pean So­ci­ety for Med­ical On­col­o­gy Im­muno-On­col­o­gy Con­gress.

Ac­cord­ing to clin­i­cal­tri­als.gov, the can­di­date was be­ing in­ves­ti­gat­ed in a Phase I com­bi­na­tion with Mer­ck’s an­ti-PD-1 drug Keytru­da in pa­tients with ad­vanced or pro­gres­sive mi­crosatel­lite sta­ble col­orec­tal can­cer, with the tri­al start­ing in 2018.

An Ike­na spokesper­son told End­points News in an email:

IK-007 is a lega­cy im­munol­o­gy pro­gram from our ear­ly days as a com­pa­ny. While it has and is de­vel­op­ing in­ter­est­ing re­sults, the de­ci­sion to de-pri­or­i­tize IK-007 was part of a port­fo­lio re­view to help stream­line our ac­tiv­i­ties and pri­or­i­tize our work in tar­get­ed on­col­o­gy. The repri­or­i­ti­za­tion al­so con­tributed to the ex­ten­sion of our run­way in­to 2025, ad­vanc­ing our tar­get­ed on­col­o­gy clin­i­cal and dis­cov­ery pro­grams to their next in­flec­tions, in­clud­ing our newest MEK-RAF com­plex de­vel­op­ment can­di­date, IK-595, through IND-en­abling stud­ies and IK-930, our nov­el TEAD in­hi­bi­tion pro­gram, through ini­tial clin­i­cal da­ta.

Though the move ex­tends Ike­na’s cash, it does not in­clude any po­ten­tial li­cens­ing rev­enue from the IK-175 pro­gram that is cur­rent­ly in de­vel­op­ment with Bris­tol My­ers Squibb, which is el­i­gi­ble for opt-in through ear­ly 2024.

In­stead, Ike­na will be turn­ing its fo­cus on­to an­oth­er one of its oral can­di­dates, IK-595, which will be its first pro­gram in the RAS path­way. Ike­na an­tic­i­pates that its can­di­date, which is still in ear­ly stages, may be el­i­gi­ble for an IND fil­ing at some point in the sec­ond half of next year, with “pre­clin­i­cal dif­fer­en­ti­a­tion da­ta” al­so planned to be pre­sent­ed in the first half of 2023, the com­pa­ny said in a re­lease.

Ike­na al­so plans to forge ahead with its TEAD in­hibitor, IK-930, which is cur­rent­ly in Phase I, and plans to un­veil more da­ta on the pro­gram next year. But Ike­na is not the on­ly biotech that has re­cent­ly had to make some ad­just­ments to its pipeline to stretch its cash.

Ear­li­er in No­vem­ber, Seat­tle-based Ne­oleukin stopped work on its can­di­date NL-201, a de no­vo IL-2/IL-15 ag­o­nist, af­ter Phase I da­ta did not show “sig­nif­i­cant im­muno­genic­i­ty” even af­ter “mul­ti­ple cy­cles of ther­a­py.”

Delaware-based on­col­o­gy biotech Pre­lude Ther­a­peu­tics al­so halt­ed the de­vel­op­ment of one of its as­sets, called PRMT5, and has de­cid­ed to fo­cus on its oth­er pro­grams as well.

These culls al­so come amid a wave of re­cent lay­offs among small­er biotechs.

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

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.