UK biotech hands off mid-stage C. dif­fi­cile drug in up to $570M deal

A biotech in the UK has out-li­censed a C. dif­fi­cile can­di­date to a US biotech for fur­ther clin­i­cal and com­mer­cial­iza­tion ef­forts.

UK-based Des­tiny Phar­ma an­nounced Fri­day that it is hand­ing NTCD-M3 to Se­bela Phar­ma­ceu­ti­cals. The deal in­cludes an ini­tial $1 mil­lion up­front, $19 mil­lion in de­vel­op­ment mile­stones, and an ad­di­tion­al $550 mil­lion in sales mile­stones — on top of roy­al­ties.

The deal al­lows Se­bela to lead and fi­nance clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion of the drug in North Amer­i­ca, while Des­tiny re­tains the ma­jor­i­ty of rights in Eu­rope and the rest of the world. Des­tiny added in a state­ment that Se­bela “has a mi­nor­i­ty in­ter­est in any in­come gen­er­at­ed in these non-North Amer­i­can ter­ri­to­ries based on the clin­i­cal stud­ies it is fund­ing.”

NTCD-M3, test­ed to pre­vent re­cur­rence of C. dif­fi­cile in­fec­tions, was orig­i­nal­ly in-li­censed from its de­vel­op­er Dale Gerd­ing, a pro­fes­sor of med­i­cine at Loy­ola Uni­ver­si­ty Chica­go. The ther­a­py is a non-tox­ic strain of C. dif­fi­cile that was found to po­ten­tial­ly out­com­pete tox­ic strains of the dis­ease, Des­tiny Phar­ma CEO Neil Clark tells End­points News.

Af­ter the can­di­date was de­vel­oped, it was then out-li­censed to Vi­roPhar­ma, which took it through a Phase I study be­fore the com­pa­ny was ac­quired by Shire in 2014 for more than $4 bil­lion. Clark said that Shire then hand­ed the ther­a­py back to Gerd­ing, and then made its way to Des­tiny in 2020.

Clark said that the deal with Se­bela came about through “good old-fash­ioned busi­ness de­vel­op­ment.” As he elab­o­rat­ed,

we knew we had a very good as­set in the GI space. So we, as you can imag­ine, be­gan to try and tar­get GI play­ers as well as in­fec­tious dis­ease com­pa­nies. And we ob­vi­ous­ly had quite a few dis­cus­sions fo­cused to­wards the end of last year, ob­vi­ous­ly with Se­bela, and man­aged to strike a deal with them, which we’re hap­py about.

Clark said that with Des­tiny as a Lon­don-list­ed biotech, “we can’t raise the funds to car­ry out Phase III stud­ies on our own,” ad­di­tion­al­ly not­ing that find­ing part­ners to join up with on Phase III de­vel­op­ment is a long­stand­ing strat­e­gy for the com­pa­ny.

The chief ex­ec­u­tive said that the com­pa­ny want­ed a part­ner that could bring in ex­per­tise in late-stage clin­i­cal de­vel­op­ment, along with the “abil­i­ty to think through to the re­quire­ments for hope­ful­ly prod­uct ap­proval — and then of course com­mer­cial­iza­tion.”

With this deal now set, Des­tiny is go­ing to fin­ish man­u­fac­tur­ing every­thing that’s need­ed for Se­bela to take the drug through Phase III, which Des­tiny ex­pects will start some­time next year.

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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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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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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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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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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