Au­to­lus en­gi­neers a $100M-plus IPO for it­self as it blue­prints a new gen­er­a­tion of bet­ter, safer cell ther­a­pies

The Lon­don-based T cell en­gi­neers at Au­to­lus are steer­ing the com­pa­ny to a $100 mil­lion-plus IPO, hop­ing to bank on a so far in­sa­tiable ap­petite for a new gen­er­a­tion of cell ther­a­pies built to out­strip the pi­o­neers in the mar­ket.

Chris­t­ian Itin

Helmed by Mi­cromet vet Chris­t­ian Itin, Au­to­lus has been tout­ing its ear­ly-stage ap­proach to CD19 bind­ing with a quick dis­en­gage­ment strat­e­gy that they be­lieve will great­ly re­duce the risk of cy­tokine storms that fre­quent­ly af­flict pa­tients — a tox­i­c­i­ty that has lim­it­ed their ini­tial use.

Be­yond that, though, they al­so have built in mul­ti­ple bind­ing tech­nol­o­gy for BC­MA and TACI, to amp up ef­fec­tive­ness in mul­ti­ple myelo­ma. And there’s a CD22 binder that can latch on­to 5 dif­fer­ent do­mains. Like many in the field, Au­to­lus sees a big fu­ture for it­self in both blood can­cers and sol­id tu­mors, which have elud­ed the first gen drugs.

Mar­tin Pule

Au­to­lus was spun out of the lab of Mar­tin Pule at Uni­ver­si­ty Col­lege Lon­don. Years ago Pule — now CSO at Au­to­lus — got a chance to help with some of the pi­o­neer­ing re­search go­ing in­to reengi­neer­ing T cells in­to can­cer ther­a­pies at Mal­colm Bren­ner’s lab at Bay­lor Col­lege of Med­i­cine.

In the F-1 they filed, Au­to­lus ex­plains that it is look­ing to build its own man­u­fac­tur­ing op­er­a­tions and has some new tech in mind for its next round of safe­ty switch­es to use to defuse their cell ther­a­pies if they pose a threat to their pa­tient.

The next gen­er­a­tion of our safe­ty switch­es, which we plan to in­cor­po­rate in our sol­id tu­mor pro­grams, uti­lizes ra­pamycin ac­ti­vat­ed Cas­pase 9 (ra­paCasp9), a cell ther­a­py safe­ty switch that al­lows for se­lec­tive elim­i­na­tion of pro­grammed T cells us­ing a sin­gle ther­a­peu­tic dose of the com­mer­cial­ly avail­able prod­uct ra­pamycin, such as sirolimus or Ra­pa­mun

Au­to­lus had $129 mil­lion in cash on hand at the end of 2017.

Syn­cona is the big share­hold­er in the mix at Au­to­lus, with 40% of the eq­ui­ty. Neil Wood­ford’s groups are be­hind that, with 27% while Ar­ix has 9% and Itin him­self owns 3.6%.

I se­lect­ed Au­to­lus as one of our E11 biotechs ear­li­er this year.

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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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

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.