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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.