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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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