SQZ play: Roche dou­bles down on a $1.37B-plus deal for a new ap­proach to im­muno-on­col­o­gy out of Bob Langer's lab

Ar­mon Sharei

What­ev­er Roche $ROG learned about SQZ over the last 33 months clear­ly on­ly whet­ted their ap­petite for much, much more.

This morn­ing SQZ is un­veil­ing a re­vise-re­place-and-ex­pand de­vel­op­ment pact with the Wa­ter­town, MA-based biotech, one of many to emerge from the lab of MIT’s Bob Langer. 

In this new deal Roche is putting up $125 mil­lion for an up­front and near-term mile­stones in a col­lab­o­ra­tion deal em­bed­ded with $1 bil­lion in de­vel­op­ment goal mon­ey. An­oth­er $250 mil­lion is on the line for each new ther­a­py that man­ages to make it all the way to an ap­proval.

“It’s a huge step for us,” CEO Ar­mon Sharei told me over the week­end in an ad­vance re­view of the news that ar­rived Mon­day morn­ing. 

An per­haps it’s an even big­ger step than he may be will­ing to al­low right now.

Amy Schul­man

Sharei popped up over the sum­mer with a $72 mil­lion round to back his com­pa­ny, which start­ed 5 years ago on a shoe­string bud­get to es­sen­tial­ly work on an in­ter­est­ing de­vel­op­ment tool. Now the com­pa­ny has 76 staffers — head­ed to 100 — with a gi­ant part­ner al­lied on a clin­i­cal de­vel­op­ment pro­gram set to be­gin next year.

Add in a Big Phar­ma vet, Po­laris part­ner Amy Schul­man, as ex­ec­u­tive chair­man, and you have the per­fect pro­file for an IPO.

Sharei and Schul­man veered away from that top­ic in our dis­cus­sion, pre­fer­ring to talk about a ma­tur­ing de­vel­op­ment strat­e­gy to build a pipeline around their plat­form cell tech­nol­o­gy.

Bob Langer

What Sharei had worked on in Langer’s lab was a de­vice that squeezed a cell, cre­at­ing open­ings for reengi­neer­ing the cell in­to some­thing new. In this case, they’re adding anti­gens that are in­tend­ed to pro­voke a storm of CD8 killer cells that can be di­rect­ed against can­cer, the kind of im­muno-on­col­o­gy play that’s at­trac­tive on Wall Street. And they’re promis­ing that their drugs can be man­u­fac­tured rel­a­tive­ly eas­i­ly, giv­ing them a clear com­mer­cial path to fol­low.

This new deal is with Basel-based pRED, as op­posed to Genen­tech’s gRED side of the R&D op­er­a­tion at Roche. 

That’s the kind of com­pa­ny you want to keep in a lead-up to an IPO, es­pe­cial­ly when the VC mon­ey has piled up.

We’ll like­ly see how the SQZ play works on Wall Street.

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 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.

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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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.

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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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.