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.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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