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.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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