Ali­gos cuts an­oth­er 10% of its work­force in repri­or­i­ti­za­tion for NASH and Covid pipelines

NASH and Covid-fo­cused Ali­gos Ther­a­peu­tics an­nounced that it is re­or­ga­niz­ing its pipeline and cut­ting around 10% of its staff to ex­tend its cash re­sources through the end of 2024.

In all, there’s been a 25% re­duc­tion in the over­all work­force at Ali­gos since the be­gin­ning of 2022, ac­cord­ing to the com­pa­ny. As of Sept. 30, 2022, Ali­gos had 89 full-time em­ploy­ees, in­clud­ing 72 em­ploy­ees in re­search and de­vel­op­ment, ac­cord­ing to SEC fil­ings.

Now the fo­cus will be on Ali­gos’ pri­or­i­tized pipeline: the NASH can­di­date ALG-055009, an oligonu­cleotide re­search col­lab­o­ra­tion with Mer­ck al­so for NASH, ALG-097558 for Covid-19 and two he­pati­tis B pro­grams.

A small­er work­force al­so means the com­pa­ny is con­sol­i­dat­ing two South San Fran­cis­co lo­ca­tions in­to its head­quar­ters. Sites in Bel­gium and Chi­na are “ex­pect­ed to re­main in op­er­a­tion.”

Lawrence Blatt

“With such a di­verse clin­i­cal port­fo­lio, in­clud­ing four drug can­di­dates in or near the clin­ic, as well as main­tain­ing a strong dis­cov­ery en­gine, where we con­tin­ue to sup­port mul­ti­ple re­search col­lab­o­ra­tions, we de­ter­mined that Ali­gos would be best po­si­tioned to achieve its busi­ness ob­jec­tives by tak­ing ac­tion now to stream­line op­er­a­tions, repri­or­i­tize its port­fo­lio, and im­ple­ment cer­tain cost-sav­ing mea­sures, in­clud­ing a re­duc­tion in force,” Ali­gos CEO and board chair­man Lawrence Blatt said in a state­ment.

Ali­gos plans to com­plete two Phase I tri­als this year: for ALG-055009, the THR-β ag­o­nist in NASH; and ALG-097558, a pan-coro­n­avirus pro­tease in­hibitor that does not re­quire ri­ton­avir boost­ing. Ri­ton­avir is an an­ti­retro­vi­ral med­ica­tion typ­i­cal­ly used in HIV/AIDS.

For ALG-055009, Ali­gos is prepar­ing for a Phase II fil­ing by the end of 2023. The biotech is al­so plan­ning to start a Phase II study for the Covid can­di­date by the end of the year.

The pipeline for chron­ic he­pati­tis B is a lit­tle more un­cer­tain. The two can­di­dates are in Phase I tri­als and the com­pa­ny plans to “re­view next steps” based on the da­ta that come out.

Ear­ly last year, Ali­gos had to axe two lead pro­grams with­in three months for chron­ic he­pati­tis B af­ter dis­ap­point­ing Phase I da­ta in one and a safe­ty is­sue in an­oth­er.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

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Keytru­da be­fore and af­ter lung can­cer surgery cuts re­lapse risk by 42%, but doesn’t im­prove sur­vival: #AS­CO23

CHICAGO — Merck has found partial success with its latest effort to more aggressively treat earlier stages of lung cancer.

On Saturday the pharma giant announced results from a large trial in which patients received Merck’s immunotherapy Keytruda plus chemotherapy before surgeons removed their tumors, followed by another course of Keytruda afterward.

The Phase III study, called KEYNOTE-671, enrolled 800 people with the early stages of the most common kind of lung cancer: non-small cell lung cancer, or NSCLC. Everyone got chemo before surgery, and half also got Keytruda before and after. At two years, 62.4% of those who got Keytruda kept their cancer at bay, compared to 40.6% who got a placebo.

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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