Look­ing at a ground­break­ing ad­vance, My­ovant gets a pri­or­i­ty re­view at FDA; Agenus, G1 forge new Chi­na deals

→ Just weeks af­ter post­ing promis­ing piv­otal re­sults for re­l­u­golix in prostate can­cer, My­ovant has picked up a pri­or­i­ty re­view from the FDA, which isn’t plan­ning an ex­pert com­mit­tee re­view be­fore mak­ing its de­ci­sion. While much of the at­ten­tion in this class is fo­cused on uter­ine fi­broids, an OK here would make this the first GnRH re­cep­tor an­tag­o­nist treat­ment for men with ad­vanced prostate can­cer.

A cou­ple of new Chi­na deals ar­rived in to­day’s news feed. Agenus struck an agree­ment with Bet­ta Phar­ma­ceu­ti­cals for an ex­clu­sive col­lab­o­ra­tion and li­cense agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of bal­stil­imab and za­l­ifre­limab in Greater Chi­na. Agenus will re­ceive $35 mil­lion, which in­cludes $15 mil­lion in up­front cash and a $20 mil­lion eq­ui­ty in­vest­ment. The agree­ment al­so in­cludes $100 mil­lion in po­ten­tial mile­stones plus roy­al­ties on net sales. Al­so, G1 Ther­a­peu­tics and Genor Bio­phar­ma an­nounced an ex­clu­sive li­cense agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of le­ro­ci­clib in the Asia-Pa­cif­ic re­gion (ex­clud­ing Japan). G1 will re­ceive an up­front cash pay­ment of $6 mil­lion and be el­i­gi­ble to re­ceive up to an ad­di­tion­al $40 mil­lion in de­vel­op­ment and com­mer­cial mile­stone pay­ments.

→ Shang­hai’s STAR board has wel­comed its largest biotech, as Sinocell­Tech lands on the sci­ence and tech­nol­o­gy-fo­cused board with a $181 mil­lion raise in hand and sport­ing a $5 bil­lion mar­ket cap. Qim­ing Ven­ture Part­ners led its Se­ries A back in 2017, and many of its ex­per­i­men­tal prod­ucts — span­ning mon­o­clon­al an­ti­bod­ies, re­com­bi­nant pro­teins and vac­cines — have now en­tered Phase III.

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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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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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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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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Bench­Sci rais­es $70M Se­ries D for drug dis­cov­ery soft­ware; Zen­tal­is touts PhIb ovar­i­an can­cer da­ta

Canada’s BenchSci has raised $70 million in a Series D round designed to scale its AI drug discovery platform for scientists working in preclinical research.

The company boasts thousands of clients for its software, including 16 of the top 20 pharmaceutical companies. On the platform, researchers can get a digest of AI’s summary of medical, clinical and research data — helping them spot biological connections and choose among thousands of options with, say, a reagent or antibody.

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