Rick Klausner (Aspen Institute via YouTube)

Rick Klaus­ner's crew of T cell spe­cial­ists wraps $425M IPO, hit­ting Nas­daq along­side Verve, Mol­e­c­u­lar Part­ners

It’s har­vest day for a pair of biotech star­tups with lofty goals to break new ground in can­cer and coro­nary heart dis­ease — and their high-pro­file founders.

Rick Klaus­ner’s Lyell Im­munophar­ma and Sek Kathire­san’s Verve Ther­a­peu­tics have both priced their IPOs, rais­ing $425 mil­lion and $266.7 mil­lion, re­spec­tive­ly. Nei­ther are in the clin­ic yet, but if their new­ly gained val­u­a­tions are any in­di­ca­tion, there is plen­ty of ap­petite for the kind of an­i­mal da­ta and bold ap­proach­es they of­fer.

Al­so round­ing out the first half of the year is Mol­e­c­u­lar Part­ners, the Swiss com­pa­ny that’s raised $63.8 mil­lion for its sec­ondary list­ing in the US based on an Am­gen- and No­var­tis-part­nered plat­form.

As many as 70 biotech com­pa­nies have filed or al­ready priced an IPO so far in 2021, ac­cord­ing to End­points News’ IPO track­er.

Rick Klaus­ner’s crew of T cell spe­cial­ists hits Nas­daq with $425M raise

Ex-NCI chief Klaus­ner set out three years ago to build a top play­er in the field of cell ther­a­py 2.0, re­cruit­ing some of the top ex­perts and al­ly­ing him­self with Glax­o­SmithK­line’s Hal Bar­ron along the way.

The stat­ed aim is noth­ing short of cur­ing sol­id tu­mors. With two tech­nol­o­gy plat­forms to re­tool T cells — one to over­come loss of func­tion due to ex­haus­tion, and the oth­er to cre­ate durable T cell pop­u­la­tions — the biotech isn’t mar­ried to any par­tic­u­lar ap­proach. Al­though they are start­ing with a CAR-T against ROR-1 as the lead can­di­date, the pipeline spans TIL and TCR ther­a­pies.

That big-pic­ture ap­proach to drug hunt­ing at­tract­ed Bob Nelsen’s ARCH, as well as the Park­er In­sti­tute for Can­cer Im­munother­a­py. GSK stands to gain as an in­vestor on top of be­ing a part­ner on two NYE­SO-di­rect­ed TCR pro­grams.

Lyell is gun­ning for four IND sub­mis­sions by the end of 2022. Out of the IPO pro­ceeds, $260 mil­lion are re­served for the Phase I tri­als of the two in-house can­di­dates, while the tech plat­form R&D and man­u­fac­tur­ing teams will get $100 mil­lion each. The com­pa­ny priced its 25 mil­lion shares at $17, the mid­point of its range, giv­ing it a $4.4 bil­lion val­u­a­tion ac­cord­ing to Re­nais­sance Cap­i­tal.

As a foot­note you may re­mem­ber that Lyell had pen­ciled in a $150 mil­lion goal in its S-1 — an­oth­er il­lus­tra­tion that these fig­ures are of­ten place­hold­ers these days.

Eye­ing one-and-done heart ther­a­py, Sek Kathire­san grabs $266.7M on the way to the clin­ic

CRISPR base edit­ing isn’t ex­act­ly new, and nei­ther is PC­SK9 as a tar­get for car­dio­vas­cu­lar drugs. But Verve’s pitch to com­bine the two is clear­ly strik­ing a nerve.

The Boston-based biotech went above its range by pric­ing at $19, with 14,035,789 shares on of­fer in its Nas­daq de­but.

Sek Kathire­san

The idea be­hind Verve stems from Sek Kathire­san’s years of re­search on the ge­net­ics of car­dio­vas­cu­lar dis­ease. If the fun­da­men­tal cause is cu­mu­la­tive ex­po­sure to lipids, the think­ing goes, can’t you do some­thing to try to pre­vent that — es­pe­cial­ly when sci­en­tists have un­cov­ered ge­net­ic mu­ta­tions that seem pro­tec­tive against coro­nary heart dis­ease?

It helped that tools al­so be­came avail­able to make a one-and-done ther­a­py pos­si­ble. Verve li­censed its base ed­i­tors from Beam Ther­a­peu­tics; the first pro­gram in­volves chang­ing a sin­gle let­ter in the PC­SK9 gene, there­by in­ac­ti­vat­ing it.

With promis­ing mon­key da­ta in hand, Verve’s plan is to sub­mit an IND in 2022. Af­ter test­ing the ap­proach in a small group of pa­tients with a rare con­di­tion that puts them at the high­est risk, Kathire­san ex­pects to even­tu­al­ly ex­tend the reach to a mass mar­ket.

Be­hind it comes a base ed­i­tor that tar­gets ANGPTL3, which will claim the chunk of the IPO pro­ceeds, and there’s a set of oth­er genes Verve reck­ons will be rel­e­vant here.

GV is a big be­liev­er, re­tain­ing 24.6% of shares af­ter the of­fer­ing. Oth­er in­vestors in­clude ARCH Ven­ture, Bio­mat­ics Cap­i­tal, Cas­din Cap­i­tal and Welling­ton, while Kathire­san keeps 1.8% for him­self.

Un­de­terred by CRL, in­vestors buy in­to Swiss biotech’s tech with mod­est IPO

Mol­e­c­u­lar Part­ners is all about DARPins, a nov­el class of mol­e­cules that it says can per­form the same func­tions as an­ti­bod­ies but are just a tenth of the size and de­signed to be more spe­cif­ic.

Most re­cent­ly, the tech­nol­o­gy has been ap­plied to cre­ate a “trispe­cif­ic” an­tivi­ral against Covid-19, a drug it’s teamed up with No­var­tis on. Dubbed enso­vibep, it’s al­so part of the NIH’s mas­ter pro­to­col for hos­pi­tal­ized mild-to-mod­er­ate pa­tients.

The in­fec­tious dis­ease branch is a new fo­cus rel­a­tive to on­col­o­gy and oph­thal­mol­o­gy, where Mol­e­c­u­lar Part­ners’ tech­nol­o­gy has in­spired dis­cov­ery pacts with both Am­gen and Ab­b­Vie.

But it’s not all been smooth sail­ing.

The eye drug it is de­vel­op­ing with Ab­b­Vie (via Al­ler­gan) was re­ject­ed by the FDA last year, as reg­u­la­tors took is­sue with “the rate of in­traoc­u­lar in­flam­ma­tion” ob­served af­ter ad­min­is­tra­tion of the an­ti-VEGF in­jec­tion and the risk that en­tails. It’s still un­clear what will hap­pen to the mol­e­cule, abic­i­par, which has been test­ed for both wet age-re­lat­ed mac­u­lar de­gen­er­a­tion and di­a­bet­ic mac­u­lar ede­ma.

For the IPO, though, the com­pa­ny fo­cused on the bright side, with plans to take a FAP/CD40 bis­pe­cif­ic through Phase I, ex­pand­ing in­fec­tious dis­ease R&D, and do­ing more with the CD3 plat­form.

It sold 3 mil­lion shares at $21.25 each, sim­i­lar to what it was trad­ing at on the Swiss ex­change — where it’s been list­ed since 2014.

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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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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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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