Tom Wiggans, Pardes Biosciences CEO

Biotech launched dur­ing Covid — for Covid — looks for strate­gic al­ter­na­tives af­ter an­tivi­ral fails PhII tri­al

A next-gen Covid-19 an­tivi­ral has flunked a Phase II test, forc­ing its de­vel­op­er to go in­to some se­ri­ous soul search­ing.

The mid-stage read­out was cru­cial for Pardes Bio­sciences, which em­bod­ied some of the hottest top­ics be­tween 2020 and 2021: It launched at the height of the pan­dem­ic on the promise of de­liv­er­ing a pill to treat Covid-19, and lat­er went pub­lic via a SPAC merg­er. Fore­site, Gilead, RA Cap­i­tal Man­age­ment and Fra­zier Life Sci­ences helped bankroll the SPAC deal, which gave Pardes $250 mil­lion to work with.

But de­spite what it con­sid­ered pos­i­tive ear­ly da­ta, Pardes’ po­motrelvir failed the pri­ma­ry end­point in Phase II, as mea­sured by the pro­por­tion of Covid-pos­i­tive par­tic­i­pants — all vac­ci­nat­ed and oth­er­wise healthy — who go be­low the lim­it of de­tec­tion for in­fec­tious SARS-CoV-2 on day 3 of treat­ment.

Chair­man and CEO Tom Wig­gans called the re­sults “un­ex­pect­ed,” forc­ing the “dif­fi­cult de­ci­sion” to sus­pend de­vel­op­ment of po­motrelvir and search for strate­gic al­ter­na­tives.

“We con­tin­ue to be­lieve in the need for new oral an­tivi­rals for COVID-19, and the im­por­tance of con­tin­ued in­vest­ment in next gen­er­a­tion ther­a­peu­tics that will be need­ed to help pre­vent the next pan­dem­ic,” he said.

Pardes shares trad­ed up 7% to $1.4 Mon­day morn­ing, but it’s still a frac­tion of the $10 stock price it in­her­it­ed from Fore­site’s blank check com­pa­ny when it first start­ed trad­ing.

Ini­tial­ly dubbed PBI-0451, po­motrelvir blocks the main pro­tease of the coro­n­avirus. It was po­si­tioned as an ini­tial treat­ment for in­fect­ed peo­ple, keep­ing them out of hos­pi­tals.

While the drug didn’t work as hoped, Pardes said the find­ings from the tri­al could in­form fu­ture de­vel­op­ment of Covid-19 ther­a­peu­tics at this stage of the pan­dem­ic, where high­er pop­u­la­tion im­mu­ni­ty may mean “a more mod­est vi­ral bur­den and acute symp­toms.”

Pardes end­ed 2022 with 57 em­ploy­ees and, as of March, has cash, cash equiv­a­lents and short-term in­vest­ments of $172.4 mil­lion.

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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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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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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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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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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