Gilead throws its weight — and $50M cash — be­hind Tan­go's I/O dis­cov­ery en­gine

Gilead is in for the long game in im­muno-on­col­o­gy. And that has spelled a big break for a small Third Rock start­up boast­ing a CRISPR-pow­ered dis­cov­ery en­gine.

Tan­go Ther­a­peu­tics has scored a “sig­nif­i­cant” col­lab­o­ra­tion with the big biotech that starts with $50 mil­lion up­front and dons a string of fees and mile­stones that could add up to $1.7 bil­lion.

No­tably, though, Tan­go is hold­ing on­to an op­tion to co-de­vel­op and co-com­mer­cial­ize two of the five pro­grams that could emerge from the pact. That’s in line with its vi­sion to even­tu­al­ly be­come a ful­ly in­te­grat­ed biotech — not a CRO — even though its lead pro­grams are still in very pre­lim­i­nary stages of pre­clin­i­cal de­vel­op­ment, CEO Bar­bara We­ber tells me.

“Noth­ing’s im­pos­si­ble, but it’s un­like­ly that you’ll see an­oth­er big deal from us any time in the next year or so,” she tells me.

Rather, in that near fu­ture, We­ber plans to steer Tan­go’s most ad­vanced pro­grams in­to lead op­ti­miza­tion, beef­ing up the team to 50 or 60 pre­clin­i­cal ex­perts be­fore se­ri­ous­ly be­gin­ning to build up a clin­i­cal or­ga­ni­za­tion to­ward the end of 2019.

Those are pro­grams fo­cused on turn­ing on tu­mor sup­pres­sor genes and find­ing un­marked onco­genes, two of what We­ber de­scribes as “three dif­fer­ent ver­sions of how you might think about syn­thet­ic lethal­i­ty,” the idea that per­turb­ing spe­cif­ic com­bi­na­tions of genes could kill their func­tions where­as just tin­ker­ing with one of them wouldn’t.

Gilead, how­ev­er, is more in­ter­est­ed in nov­el im­mune eva­sion tar­gets Tan­go might iden­ti­fy — the third piece of the puz­zle — and the po­ten­tial to cre­ate drugs that in­hibits tu­mors’ abil­i­ty to hide from the im­mune sys­tem.

The part­ner­ship will work as a “true col­lab­o­ra­tion,” We­ber says, with a small team of se­nior sci­en­tists from both com­pa­nies iden­ti­fy­ing and de­sign­ing ex­per­i­ments to­geth­er. Gilead staffers will be on the ground ad­vis­ing Tan­go’s tar­get val­i­da­tion process — and the role will flip when Gilead takes over the de­vel­op­ment phase, which will like­ly be fur­ther down the road.

We­ber, who built the com­pa­ny at Third Rock and ini­tial­ly signed on as the in­ter­im CEO, will stay on to see that through af­ter she re­al­ized she “couldn’t bear the thought” of re­plac­ing her­self.

“This is a space I’ve been think­ing about for a long time,” We­ber says, since she was a re­searcher at Penn. But what was tech­ni­cal­ly im­pos­si­ble back then is now doable thanks to ad­vances in CRISPR gene edit­ing, which she con­sid­ers a valu­able tool.

“This ap­proach, as we’ve start­ed to see, is re­al­ly iden­ti­fy­ing more tar­gets than Tan­go alone could pros­e­cute,” she adds. “So be­ing able to get those tar­gets in­to the hands of a part­ner that can bring them to pa­tients as well is re­al­ly huge. It al­lows us to fo­cus on what we’re do­ing with some ad­di­tion­al re­sources and not have the lim­i­ta­tions of the num­ber of tar­gets that we would’ve had with­out them as a part­ner.”

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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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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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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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.

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.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.