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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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