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.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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