Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When In­fin­i­ty put up du­velis­ib for a no-mon­ey-down in­stant deal, the biotech was look­ing for a quick ex­it from a clin­i­cal dis­as­ter. Ab­b­Vie had walked away from their al­liance af­ter look­ing at how the da­ta stacked up in a crowd­ed field.

And while it was ap­prov­able, it wasn’t look­ing pret­ty to any­one who thought in com­mer­cial terms.

One Big Phar­ma’s trash, though, was seen as a biotech trea­sure as a deeply trou­bled Ve­rastem stepped up to grab the PI3K-delta/gam­ma — promis­ing to run it across the goal lines at the FDA. And they did just that, on­ly with lit­tle to show for it.

Now, af­ter rack­ing up just $12 mil­lion in prod­uct sales last year, it’s Ve­rastem’s turn to walk away — on­ly they get $70 mil­lion in cash for the un­der­per­form­ing can­cer ther­a­peu­tic, with a chance to add $200 mil­lion-plus if the new own­er can make a suc­cess of it.

Se­cu­ra Bio now counts it­self as the own­er of the drug, sold as Copik­tra. And Se­cu­ra will add up to $45 mil­lion in mile­stones if the drug is ap­proved in the US and Eu­rope for pe­riph­er­al T-cell lym­phoma. There’s $50 mil­lion if Se­cu­ra can push sales over the $100 mil­lion an­nu­al sales lev­el, which al­so comes with low dou­ble-dig­it roy­al­ties over that $100 mil­lion mark.

Ve­rastem now wants to cre­ate a string of cat­a­lysts to whet in­vestors’ in­ter­est in its RAF/MEK in­hibitor VS-6766 for low grade ovar­i­an can­cer and a FAK in­hibitor — de­fac­tinib — pro­gram in KRAS mu­tant tu­mors. In­ves­ti­ga­tors are fo­cused on KRAS G12V, part of a busy field af­ter Am­gen opened up things with pos­i­tive da­ta for NSCLC. “Reg­is­tra­tion-di­rect­ed” Phase II tri­als get un­der­way be­fore the end of this year.

Ve­rastem lost about $149 mil­lion last year, as it took its to­tal burn past the half-bil­lion dol­lar mark. Bri­an Stug­lik, an Eli Lil­ly vet, jumped on as CEO a year ago, re­plac­ing Robert For­rester. Now Stug­lik’s team is bet­ting that this time they’re go­ing to get it right. Or at least as good as it gets.

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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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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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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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

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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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.

Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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