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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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