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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

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In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

David Coman, Science 37

Amid vir­tu­al tri­al craze, Sci­ence 37 earns uni­corn sta­tus and a trip to Nas­daq on the back of SPAC deal

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

As the Covid-19 pandemic made conventional trials impossible for some drugmakers, more and more companies moved to decentralize their clinical studies, accelerating business for tech developers like Science 37. Leveraging that boost, the company is on the verge of a SPAC merger, landing unicorn status and its very own stock ticker.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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