Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum hits the re­set but­ton, slic­ing away 30% of its work­force in piv­ot around 2 lead as­sets

Covid-19 has been a rough go for many drug­mak­ers, but few more so than Spec­trum Phar­ma­ceu­ti­cals, which has seen in­spec­tion de­lays and un­want­ed CRLs haunt its chance at a first ap­proval. Feel­ing the sting, Spec­trum will now down­size to keep the lights on through the year.

Spec­trum will cut 30% of its work­force and piv­ot its R&D ef­forts around its two fur­thest-along drugs as part of a re­struc­tur­ing ef­fort that will pave the com­pa­ny’s cash run­way out in­to next year, it an­nounced Wednes­day.

In Au­gust 2021, the FDA hand­ed Spec­trum a CRL for a neu­trope­nia drug set to be mar­ket­ed as Rolon­tis, cit­ing man­u­fac­tur­ing is­sues in the drug’s ap­pli­ca­tion. The FDA or­dered a re-in­spec­tion at the drug’s man­u­fac­tur­ing site in South Ko­rea — this af­ter Covid-19 re­lat­ed trav­el re­stric­tions for FDA in­spec­tors pushed off Rolon­tis’ ear­ly re­view date by the agency.

Spec­trum said it would pri­or­i­tize its R&D ef­forts around get­ting Rolon­tis across the fin­ish line as well as dri­ving ahead on pozi­o­tinib, a TKI in­hibitor can­di­date for HER2 ex­on 20-mu­tant non-small cell lung can­cer.

Spec­trum CEO Tom Riga had this to say in a state­ment:

The de­ci­sion to re­struc­ture the or­ga­ni­za­tion is nec­es­sary to fo­cus on our ad­vanced clin­i­cal pro­grams that will dri­ve our fu­ture growth. I would like to ex­press my ap­pre­ci­a­tion to our col­leagues who are af­fect­ed by this de­ci­sion and are leav­ing Spec­trum. We are grate­ful for their ded­i­ca­tion and their con­tri­bu­tions to ad­vanc­ing our mis­sion. The changes we are im­ple­ment­ing are ex­pect­ed to re­sult in a re­duc­tion in op­er­at­ing ex­pens­es and the ex­ten­sion of the com­pa­ny’s cash run­way in­to 2023.

As Rolon­tis and pozi­o­tinib get the up­vote, Spec­trum said it will “de­pri­or­i­tize” de­vel­op­ment of its ear­ly-stage pipeline, which in­cludes its FIT Pro­gram (IGN 002) and IL-12. Mean­while, the com­pa­ny plans to “sig­nif­i­cant­ly re­duce” its foot­print at se­lect­ed fa­cil­i­ties this year amid the cost-cut­ting ef­forts.

In all, the cuts will re­duce Spec­trum’s burn rate by about 20-25%, which the com­pa­ny ex­pects will save enough cash to get it in­to 2023.

Shares in $SP­PI, al­ready well in pen­ny stock ter­ri­to­ry, were trad­ing down around 4% on the news Wednes­day.

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.

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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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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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.

John Roberts, exiting Vyant Bio CEO

Neu­rode­gen­er­a­tive biotech Vyant warns of po­ten­tial wind-down

The CEO and chief scientific officer of Vyant Bio are out the door as the little-known but publicly-listed neurodegenerative biotech searches for an exit or, if all else fails, a wind-down.

The soul-searching bookends a winding journey for the biotech, which rebranded and transitioned from diagnostics company Cancer Genetics in 2021 after a merger with StemoniX. That came after a failed merger attempt with NovellusDx (now Fore Biotherapeutics) in 2018. In the last few years, units have been sold off and the stock price $VYNT has plummeted from the $30 range to penny stock territory.

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