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.”

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.