Af­ter dig­ging through dis­cards, biotech start­up is mak­ing a $45M bet it can fix a failed can­cer ther­a­py

The re­sults were clear: Nap­tu­momab estafe­na­tox failed to pro­long over­all sur­vival for re­nal cell car­ci­no­ma pa­tients in a large tri­al, de­fin­i­tive­ly enough that Ac­tive Biotech ef­fec­tive­ly shelved it in 2013.

But three years lat­er NeoTX, a scav­enger start­up that had been dig­ging through drugs that failed in hopes of find­ing a sub­pop­u­la­tion with a bio­mark­er that the orig­i­nal de­vel­op­er had missed, stum­bled up­on the da­ta and saw the un­ex­pect­ed gem they were look­ing for.

Ash­er Nathan

“Their Phase I da­ta was stel­lar, great Phase I, and then they had this Phase II that failed pri­mar­i­ly be­cause they added the wrong drug,” Ash­er Nathan, CEO and co-founder of NeoTX, told End­points News as he un­veils $45 mil­lion in new fi­nanc­ing.

In­ter­fer­on al­pha was “ab­solute­ly the wrong drug” to com­bine with nap­tu­momab estafe­na­tox as it negat­ed cer­tain qual­i­ties of the ex­per­i­men­tal fu­sion pro­tein, Nathan said. More im­por­tant­ly, Ac­tive Biotech didn’t re­al­ly know just the kind of po­ten­tial they had in a plat­form tech that binds to the tu­mor and coat it with a bac­te­r­i­al “su­per­anti­gen” that at­tracts an im­mune at­tack.

“This is a nat­ur­al im­mune re­sponse as op­posed to if you look at oth­er tech­nolo­gies like bis­pecifics, where they gauge CD3 mol­e­cules, that’s some­thing you’ll nev­er find in na­ture,” Nathan said.

So the Is­raeli biotech li­censed the drug from Ac­tive for $250,000 up­front, and has been col­lab­o­rat­ing to start a Phase I that tests a com­bo of nap and As­traZeneca’s check­point drug, Imfinzi (dur­val­um­ab).

Roger Ko­rn­berg

Roger Ko­rn­berg, a No­bel lau­re­ate, Stan­ford can­cer re­searcher and long­time friend of Nathan’s, helped guide the com­pa­ny’s piv­ot to fo­cus on this ap­proach, which they call se­lec­tive T cell redi­rec­tion or STR. And long­time Bris­tol-My­ers Squibb ex­ec Mar­cel Rozencweig is on­board as CMO, lead­ing a small of­fice in Prince­ton, New Jer­sey in prepa­ra­tion for a tri­al ex­pan­sion to the US.

They are en­rolling pa­tients with a wide range of sol­id tu­mors to the Phase Ib dose es­ca­la­tion tri­al — from pan­cre­at­ic ade­no­car­ci­no­ma and ovar­i­an can­cer to prostate can­cer and triple neg­a­tive breast can­cer — as nap­tu­momab tar­gets the on­cofe­tal anti­gen 5T4.

Oth­er drug­mak­ers have mount­ed ef­forts to hone in on 5T4, rang­ing from Sanofi and Ox­ford Bio­med­ica’s Phase III can­cer vac­cine to Pfiz­er’s ear­ly-stage an­ti­body-drug con­ju­gate to Gen­mab’s pre­clin­i­cal CD3/5T4 bis­pe­cif­ic.

Mar­cel Rozencweig

NeoTX is al­so work­ing on a sec­ond can­di­date hit­ting a dif­fer­ent tar­get specif­i­cal­ly tai­lored to glioblas­toma. They’ve brought David Rear­don of Dana Far­ber on for that pro­gram, which al­so uti­lizes the bac­te­r­i­al com­po­nent.

The team of around 20 has some pow­er­ful — if un­con­ven­tion­al — back­ers. For the Se­ries C, they en­ticed “one of the top 10 rich­est peo­ple in the world,” for­mer Black­stone vice chair­man Tomil­son Hill, Amer­i­can busi­ness­man Paul Marinel­li as well as Ko­re­an in­vestor An­drew Kim.

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.”

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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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.

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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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.”

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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