Chris Martin, ADC Therapeutics CEO

ADC Ther­a­peu­tics nabs its first ap­proval as FDA of­fers a quick OK for its DL­B­CL can­cer treat­ment

The FDA won’t be wait­ing around for the PDU­FA date for its lat­est OK on the can­cer front.

Reg­u­la­tors came through with an ac­cel­er­at­ed ap­proval for ADC Ther­a­peu­tics’ lon­cas­tux­imab tesirine-lpyl as a third-line ther­a­py for dif­fuse large B-cell lym­phoma, which was ba­si­cal­ly a shoe-in look­ing for an OK in drug re­sis­tant pa­tients with a pri­or­i­ty re­view at­tached to the ap­pli­ca­tion.

This CD-19 an­ti­body drug con­ju­gate will now be sold as Zyn­lon­ta.

The ap­proval comes just un­der a year af­ter ADC went pub­lic, rais­ing a $233 mil­lion haul on its sec­ond try af­ter post­ing a 48% over­all re­sponse rate and a com­plete re­sponse rate of 24% for DL­B­CL. That’s what they took to reg­u­la­tors.

Fol­low­ing a PRV in No­vem­ber with a re­view date of May 21, Zy­lon­ta’s ac­cel­er­at­ed nod comes in about a month ahead of sched­ule. ADC will have to prove the drug’s clin­i­cal ben­e­fit in a con­fir­ma­to­ry study down the road to main­tain its mar­ket­ing ap­proval.

Pao­lo Cai­mi at Case West­ern Re­serve Uni­ver­si­ty said: “Sin­gle-agent Zyn­lon­ta demon­strat­ed clin­i­cal­ly im­por­tant out­comes in the piv­otal LO­TIS-2 study across sev­er­al dis­ease sub­types. No­tably, this in­clud­ed trans­plant el­i­gi­ble and in­el­i­gi­ble pa­tients and pa­tients who pre­vi­ous­ly re­ceived stem cell trans­plant or CAR-T cell ther­a­py.”

Pa­tients had a me­di­an time to re­sponse of 1.3 months and the me­di­an du­ra­tion of re­sponse for the 70 re­spon­ders was 10.3 months.

There’s no im­me­di­ate word on price here.

The ap­proval marks a big win for ADC CEO Chris Mar­tin, who helped launch the Eu­ro­pean com­pa­ny a decade ago and took the helm in 2015, two years af­ter sell­ing Spirogen to As­traZeneca. The biotech raised more than $200 mil­lion in a pub­lic of­fer­ing last fall as it prepped for an ap­proval.

Achiev­ing Dig­i­tal Trans­for­ma­tion: Un­lock­ing Cost Re­duc­tion, Clin­i­cal Ex­cel­lence & Pre­ci­sion Ther­a­peu­tics Man­u­fac­tur­ing

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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