J&J clears PhII for rare blood dis­or­der with drug from $6.5B Mo­men­ta buy­out

The lead drug from John­son & John­son’s $6.5 bil­lion buy­out of Mo­men­ta, now be­ing test­ed in near­ly 10 in­di­ca­tions, has cleared a Phase II in a rare blood dis­or­der.

J&J’s ther­a­peu­tics unit Janssen was sparse on de­tails but said the drug, nipocal­imab, met the pri­ma­ry end­point in the UNI­TY study. The ma­jor­i­ty of preg­nant pa­tients in the tri­al ex­pe­ri­enced a live birth at or af­ter 32 weeks with­out re­quir­ing in­trauter­ine trans­fu­sion, or IUT, the Big Phar­ma said on Mon­day.

Janssen touts nipocal­imab as the on­ly ther­a­peu­tic be­ing in­ves­ti­gat­ed in the clin­ic for treat­ing al­loim­mu­nized preg­nant adults at risk of se­vere he­molyt­ic dis­ease of the fe­tus and new­born, or HDFN, in which an­ti­bod­ies from the preg­nant per­son at­tack fe­tal red blood cells, which leads to ane­mia in the fe­tus.

The dis­ease oc­curs in about 80 out of every 100,000 preg­nan­cies in the US, Janssen said, not­ing no ap­proved drugs ex­ist to­day. The in­va­sive IUT surgery, some­times done re­peat­ed­ly, is the stan­dard pro­ce­dure. In the 14-per­son study, peo­ple in the US, Cana­da, Aus­tralia and Eu­rope re­ceived the drug in­tra­venous­ly once a week.

The drug­mak­er is shap­ing up plans for a piv­otal Phase III and will present more de­tails of the mid-stage UNI­TY tri­al at a sci­en­tif­ic med­ical meet­ing, Janssen said. The safe­ty pro­file dur­ing the 20-week treat­ment pe­ri­od “sup­ports fur­ther de­vel­op­ment,” per the com­pa­ny’s press re­lease.

Katie Abouzahr

“These ear­ly re­sults rep­re­sent an im­por­tant step to­wards de­liv­er­ing a po­ten­tial med­ica­tion for ex­pec­tant moth­ers at high risk of se­vere HDFN, and we are en­cour­aged by what this treat­ment could mean for fam­i­lies af­fect­ed by this po­ten­tial­ly dev­as­tat­ing dis­ease,” Katie Abouzahr, Janssen’s VP of au­toan­ti­body de­vel­op­ment, said in a state­ment.

For HDFN, Janssen’s drug has fast track and or­phan drug tags in the US and an or­phan des­ig­na­tion in the EU.

Janssen is al­so test­ing the drug in more than half a dozen neu­ro­science and im­munol­o­gy in­di­ca­tions, in­clud­ing rheuma­toid arthri­tis, for which a Phase II read­out is ex­pect­ed this year. All told, the phar­ma gi­ant thinks the drug can top $5 bil­lion in even­tu­al an­nu­al sales.

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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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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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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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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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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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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