Sean Smith, ImmunOs Therapeutics CEO

A for­mer Mer­ck di­rec­tor's Pfiz­er-backed biotech will take on his old boss­es in nascent LIL­RB field

On­ly a hand­ful of biotechs are go­ing af­ter LIL­RBs, com­po­nents of the in­nate im­mune sys­tem. But af­ter an ini­tial crop of da­ta out of Mer­ck in au­tumn 2020, more in­ter­est sprung up in the area, and a for­mer Mer­ck fran­chise di­rec­tor has se­cured in­vestor back­ing to try to catch up to his for­mer em­ploy­er.

Zurich-area biotech Im­munOs Ther­a­peu­tics reeled in a $74 mil­lion Se­ries B to take that lead pro­gram in­to a Phase Ia study in Aus­tralia to­ward the end of this year, ex­ec­u­tives told End­points News. The drug, dubbed IOS-1002, is a mul­ti-agent based on hu­man leuko­cyte anti­gens (HLAs) that go af­ter two ver­sions of LIL­RB (1 and 2) and KIR3DL1.

Mer­ck’s an­ti­body tar­gets LIL­RB2, mean­while, and in a Phase I sol­id tu­mor study in 2020, the Big Phar­ma’s drug — when com­bined with Keytru­da — led to re­spons­es in eight out of 34 pa­tients. Known as MK-4830, the drug is now in Phase II for non-small cell lung, col­orec­tal, re­nal cell and small cell lung can­cer.

Char­lene Liao, CEO of LIL­RB com­peti­tor Im­mune-Onc, pre­vi­ous­ly de­scribed LIL­RBs as the PD-1 of T cells when her start­up raised near­ly the same amount last March.

While Im­munOs is well be­hind in clin­i­cal de­vel­op­ment, the 20-em­ploy­ee biotech thinks the transat­lantic fi­nanc­ing round and its aca­d­e­m­ic-found­ed sci­ence can beat out com­peti­tors.

“We ex­pect to be able to demon­strate su­pe­ri­or monother­a­py ef­fi­ca­cy rel­a­tive to what oth­ers are do­ing. We ex­pect to go in­to a broad­er in­di­ca­tion set be­cause we’re mul­ti­task­ing against mul­ti­ple im­mune check­points. And we al­so ex­pect to see a more durable re­sponse,” CEO Sean Smith, a for­mer fran­chise di­rec­tor for Mer­ck’s Eu­rope and Cana­da hos­pi­tal port­fo­lio, told End­points.

Jeff Abbey

Im­munOs will be­gin the Phase Ia tri­al in Aus­tralia and then ex­pand in­to oth­er re­gions, CBO and COO Jeff Abbey, the for­mer Ar­gos Ther­a­peu­tics CEO, said in the joint in­ter­view.

“We re­al­ly had our pick of in­vestors and, as Sean said, we want­ed an in­ter­na­tion­al syn­di­cate to re­al­ly pre­serve our op­tion­al­i­ty go­ing for­ward so that we’re well-fund­ed and can con­tin­ue to build out the com­pa­ny the way we want to build it out,” Abbey said.

The fresh funds will bankroll the Phase I study and get the drug in­to a Phase II tri­al as well, the ex­ec­u­tives not­ed. The fi­nanc­ing will al­so sup­port an­oth­er clin­i­cal en­try in on­col­o­gy and the biotech’s first hu­man study for­ay in the au­toim­mune field.

Steve Coats

Im­munOs is “re­verse-en­gi­neer­ing” its im­muno-on­col­o­gy pro­gram to get in­to the au­toim­mune space, ex­plained chief de­vel­op­ment of­fi­cer Steve Coats. The for­mer As­traZeneca R&D VP is build­ing out Im­munOs’ US op­er­a­tions in Gaithers­burg, MD, a Mid-At­lantic city he de­scribed as an “un­der­ap­pre­ci­at­ed tech­nol­o­gy cen­ter” that is close to uni­ver­si­ties, As­traZeneca ac­qui­si­tion Med­Im­mune, FDA and the NIH.

The Swiss biotech was spun out of the Uni­ver­si­ty of Basel and Uni­ver­si­ty of Zurich in 2017 and is based off the work of CMO Christoph Ren­ner and CSO Osiris Mar­ro­quin Be­laun­zaran.

Tues­day’s Se­ries B was led by new in­vestors Sam­sara Bio­Cap­i­tal, Light­speed Ven­ture Part­ners and Gimv. Mis­sion Bio­Cap­i­tal, GL Cap­i­tal, PEAK6 Strate­gic Cap­i­tal and Fis­cus Fi­nan­cial al­so joined for the first time, adding to the orig­i­nal 2019 back­ing from Pfiz­er Ven­tures, Bio­Med Part­ners and Schroder Ad­veq.

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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