Hop­ing to brake a slow crash, Aduro's Stephen Isaacs hits the re­set but­ton, ax­ing staff in re­or­ga­ni­za­tion

With in­vestor con­fi­dence steadi­ly bleed­ing out over the last year, Aduro $ADRO CEO Stephen Isaacs has hit the re­set but­ton in an at­tempt to get back on track. 

The biotech said this morn­ing that it is whack­ing 37% of the staff and cir­cling its wag­ons around lead pro­grams part­nered with 2 promi­nent big phar­mas — No­var­tis and Eli Lil­ly — fo­cused on STING. The biotech is al­so pur­su­ing an in-house an­ti-APRIL an­ti­body, in de­vel­op­ment in on­col­o­gy and IgA nephropa­thy.

How many staffers is that? We don’t know ex­act­ly, but when Aduro filed its 10-K for 2017 it had 162 full-time em­ploy­ees.

In­ter­est­ed in pick­ing up some shelved as­sets cheap? You should call Isaacs, who had this to say about the pro­grams be­ing pushed aside in the re­or­ga­ni­za­tion:

The strate­gic re­set will al­so al­low us to ex­plore new part­ner­ship op­por­tu­ni­ties for our de­pri­or­i­tized pro­grams, in­clud­ing pLADD, ADU-1604 (an­ti-CT­LA-4) and ADU-1805 (an­ti-SIR­Pα). While this was a dif­fi­cult de­ci­sion, I want to thank the em­ploy­ees who are leav­ing for their con­tri­bu­tions to Aduro.

Aduro biotech has seen its mar­ket cap shrink to less than its cash re­serves on a drum­beat of set­backs. 

The end­ed 2018 with $278 mil­lion in re­serves, then added a $12 mil­lion up­front in Jan­u­ary from Eli Lil­ly for their deal. The mar­ket cap, mean­while, was un­der $200 mil­lion be­fore the mar­ket open.

Aduro went pub­lic close to 4 years ago at $17 a share, tout­ing a pair of can­cer vac­cines and an on­col­o­gy pipeline, then saw the stock price to $40 soon af­ter. Af­ter that, things got rough — but very slow­ly.

A warmed up can­cer vac­cine — GVAX, one of the ini­tial wave — was a bust. Late in 2017 their oth­er can­cer vac­cine CRS-207, reengi­neered Lis­te­ria mono­cy­to­genes, hit the wall af­ter a long and trou­bled de­vel­op­ment pro­gram, forc­ing Isaacs to wash his hands of the ef­fort. 

Then J&J backed out of a promi­nent al­liance last fall. And Mer­ck didn’t make any­thing bet­ter when it ac­knowl­edged at ES­MO that its own STING ther­a­py didn’t ac­tu­al­ly work on its own.

Yes­ter­day Aduro’s stock closed at $2.47.


Im­age: Stephen Isaacs. BERKE­LEY via YOUTUBE

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

CDC’s Robert Redford, 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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

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.”

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.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.