Eli Lil­ly's on­col­o­gy R&D spree con­tin­ues with $576M deal to buy a start­up and reel back Au­ro­ra A drug

Eli Lil­ly’s on­col­o­gy deal spree is con­tin­u­ing this morn­ing with a $576 mil­lion deal to buy out a Mon­tre­al-based start­up and reel back in an ear­ly-stage can­cer drug for its pipeline.

Levi Gar­raway

Lil­ly, which has been beef­ing up its can­cer R&D group in an­tic­i­pa­tion of a burst of new projects in the field, is pay­ing $111 mil­lion up front to buy Mon­tre­al-based Au­r­Ka Phar­ma with an­oth­er $465 mil­lion in mile­stones on the ta­ble.

The deal comes just four days af­ter Lil­ly $LLY an­nounced it had ac­quired Ar­mo Bio­Sciences $AR­MO for $1.6 bil­lion in cash. Ar­mo is one of the dar­lings in im­muno-on­col­o­gy which has a strat­e­gy in­volv­ing cy­tokine im­muno-stim­u­la­to­ry ther­a­pies, like Loxo.

In this new deal, Lil­ly wants to re­trieve an Au­ro­ra ki­nase A in­hibitor dubbed AK-01 that’s been demon­strat­ing some ear­ly-stage promise in Phase I stud­ies. TVM (Au­r­Ka’s par­ent com­pa­ny) bagged the drug back in 2016, when Lil­ly was shed­ding as­sets that didn’t fit its pri­or­i­ty list.

The big idea here is that the Au­ro­ra A ki­nase — a mas­ter reg­u­la­tor of mi­tot­ic pro­gres­sion — is need­ed for ge­nom­ic sta­bil­i­ty and dis­rupt­ing it can play a role in pre­vent­ing tu­mor pro­gres­sion along a cou­ple of dif­fer­ent path­ways. As such it now fits Lil­ly’s sweet spot and the can­cer team wants it back in their pipeline.

Lil­ly’s on­col­o­gy group has been hir­ing in top tal­ent in an­tic­i­pa­tion of gear­ing up in can­cer drug de­vel­op­ment. The phar­ma gi­ant has scored some sig­nif­i­cant ap­provals in re­cent years, but has a rep in the in­dus­try as a lag­gard that tends to come in last place among more ag­gres­sive ri­vals.

The new lead­er­ship at Lil­ly says they plan to cor­rect past be­hav­iors in a late bid to catch up with the lead­ers in on­col­o­gy R&D. And they’ve laid out plans for do 4 or 5 of these ear­ly-stage deals every year — steer­ing clear of big M&A.

“The ac­qui­si­tion of Au­r­Ka Phar­ma ex­pands our pipeline with a promis­ing on­col­o­gy com­pound tar­get­ing a dis­tinct cell cy­cle path­way,” says Levi Gar­raway, se­nior vice pres­i­dent, glob­al de­vel­op­ment and med­ical af­fairs, Lil­ly On­col­o­gy. “The work done by Au­r­Ka will al­low Lil­ly to lever­age emerg­ing da­ta about can­cers in which this mol­e­cule might be ef­fec­tive, and de­ter­mine if it can be ben­e­fi­cial to peo­ple liv­ing with var­i­ous forms of can­cer.”

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

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

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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New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

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.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”