CEO Fabrice Chouraqui (Cellarity)

Flag­ship up­start Cel­lar­i­ty gath­ers $123M to fi­nance its ex­plo­ration of cell be­hav­ior, blaz­ing a new path to build­ing a broad pipeline

Right from the start, the dis­cov­ery plan at Flag­ship-spawned Cel­lar­i­ty was to take their cues from cell bi­ol­o­gy and fol­low them to new drugs. Rather than start with a tar­get and de­vel­op a drug to hit it, they’d use new tech­nol­o­gy to dig­i­tal­ly map cell be­hav­ior and then de­vel­op new drugs from what they learned.

“Over the past decades it has al­ways been about find­ing a tar­get, about re­duc­ing a dis­ease to a sin­gle mol­e­c­u­lar tar­get,” says Fab­rice Chouraqui, the No­var­tis vet who was re­cruit­ed to run the op­er­a­tion about 9 months ago. “And that ap­proach has pro­duced thou­sands of life-sav­ing med­i­cines. Yet, this ap­proach has lim­i­ta­tions. A mol­e­c­u­lar tar­get ap­proach is fine when you talk about a sim­ple dis­ease, but for very com­plex dis­eases like neu­rode­gen­er­a­tion, like meta­bol­ic dis­ease, like can­cer, you hope to re­al­ly har­ness the com­plex­i­ty of hu­man bi­ol­o­gy.

“We de­vel­oped a drug dis­cov­ery plat­form to de­sign med­i­cines at the lev­el of the cell, which as we both know is the fun­da­men­tal of life,” says the CEO.

Net­work bi­ol­o­gy, high res­o­lu­tion da­ta and the right ma­chine learn­ing tools give them bet­ter in­sights in­to un­der­stand­ing “how a cell moves from a state of health to a state of dis­ease.”

For the staff at Cel­lar­i­ty, that ap­proach has helped cre­ate a va­ri­ety of pre­clin­i­cal dis­cov­ery projects. And now there’s $123 mil­lion more to fi­nance the next leg of the ex­plo­ration as they con­tin­ue the pipeline work, with maybe 1 or 2 more years to go be­fore they reach the clin­ic.

“We’ve been able to re­al­ly progress our pipeline,” says Chouraqui. “To­day we have 7 drug dis­cov­ery pro­grams in 4 dif­fer­ent dis­ease ar­eas and I think those 4 dis­ease ar­eas re­al­ly show­case the breadth and the depth of our plat­form; they range from meta­bol­ic dis­ease to im­muno-on­col­o­gy. I think we are get­ting clos­er to move in­to the clin­ic. The goal is not to rush in­to the clin­ic with one pro­gram, we have a plat­form which can be vir­tu­al­ly ap­plied to any dis­ease area.”

And now they have the mon­ey to work up a stream of new drug pro­grams. But that’s about as de­tailed as the pub­lic sto­ry gets at this stage of the jour­ney. Like most star­tups, it’s best to get to the late pre­clin­i­cal stage be­fore you start open­ing up about how the lead ther­a­pies work.

The in­sid­er sto­ry, though, was good enough to bring in an ex­pand­ed syn­di­cate for the rich round. Black­Rock, The Bau­post Group, Banque Pictet and 8 oth­er un­named in­vestors have jumped in to grab a front row seat in the lab. And Chouraqui plans to do some ac­tive re­cruit­ing to dou­ble the size of the staff 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.