June Lee, Esker CEO

Vik Ba­ja­j's start­up in­cu­ba­tor at Fore­site un­cloaks an im­munol­o­gy play­er with a lead TYK2 in­hibitor in tow

Look­ing at a health­care sys­tem made more un­equal by Covid-19, Fore­site Cap­i­tal man­ag­ing di­rec­tor Vik Ba­jaj re­cent­ly kick­start­ed an ex­pan­sive plan to launch five in­no­v­a­tive star­tups to ad­dress un­met need. Just weeks af­ter the first of those biotechs emerged from stealth, a sec­ond has now un­cloaked, and it’s got im­munol­o­gy in its sights.

Es­ker Ther­a­peu­tics launched Wednes­day with a $70 mil­lion Se­ries A to pur­sue pre­ci­sion im­munol­o­gy tar­gets backed by Ba­jaj’s team at Fore­site, the biotech said. Fore­site foot­ed the en­tire round for Es­ker as it con­tin­ues to de­vel­op its pipeline and ad­vance its lead com­pound.

Un­der the lead­er­ship of founder and CEO June Lee, Es­ker is putting ESK-001, a TYK2 in­hibitor first fo­cused on pso­ri­a­sis, through its paces in a Phase I safe­ty and tol­er­a­bil­i­ty study in healthy pa­tients with a read­out ex­pect­ed by year’s end. Those re­sults will help pro­vide proof of con­cept for Es­ker’s dis­cov­ery plat­form, which the biotech hopes to lever­age to iden­ti­fy ge­net­ic tar­gets for pa­tients who have been left be­hind in the “come-one-come-all” im­munol­o­gy mar­ket, Lee told End­points News.

“I re­al­ly am ex­cit­ed by that vi­sion that we start­ed out with,” Lee said. “That we could do bet­ter in im­munol­o­gy than we have been do­ing. We’ve got to do what on­col­o­gy has been do­ing. There are a lot of pa­tients that haven’t been do­ing great, and I think that’s be­cause we fail to rec­og­nize the het­ero­gene­ity in these au­toim­mune con­di­tions.”

Vik Ba­jaj

Plat­form plays are noth­ing new in biotech, but Lee has rea­son to be­lieve in this one, pri­mar­i­ly be­cause of Ba­jaj’s lead­er­ship and mis­sion, she said. Lee al­so tout­ed her team’s pro­gram for TYK2, a sig­nal­ing path­way in the pan-JAK class, which is in the same chem­i­cal class, she said, as Bris­tol My­ers Squibb’s deu­cravac­i­tinib. That drug re­cent­ly won a head-to-head Phase III test against Am­gen’s Ote­zla in pso­ri­a­sis.

Pre­clin­i­cal da­ta have shown the Es­ker mol­e­cule’s promise as a tru­ly se­lec­tive mol­e­cule for TYK2, Lee said, a key as­ser­tion giv­en the on­go­ing safe­ty con­cerns about oth­er JAK in­hibitors, pri­mar­i­ly Pfiz­er’s Xel­janz. Lee knows there are a lot of play­ers out there tout­ing their own “tru­ly se­lec­tive” TYK2 com­pounds, but she thinks Es­ker’s mol­e­cule will even­tu­al­ly pull away from the pack.

“There’s a lot of peo­ple out there claim­ing to have the best com­pound, and it guess it de­pends on what you de­fine as best,” she said. “What I will say is we have a high­ly se­lec­tive TYK2 com­pound that is al­so high­ly de­risked.”

Lee, the for­mer chief de­vel­op­ment of­fi­cer at MyoKar­dia who joined the team in Feb­ru­ary, was one of a group of biotech lead­ers tapped as part of Ba­jaj’s ex­pan­sive plan to launch five star­tups uti­liz­ing his team’s en­gine to ad­dress un­met needs across the health­care spec­trum.

Es­ker joins Ses­ti­na Bio, a syn­thet­ic bi­ol­o­gy play­er aim­ing to cre­ate sus­tain­able sources for chem­i­cals and ma­te­ri­als, as the on­ly two of Fore­site Labs’ star­tups re­vealed to the pub­lic so far, but Ba­jaj told End­points last month that the oth­er com­pa­nies will fo­cus on pre­ci­sion med­i­cine in car­diometa­bol­ic dis­or­ders, map­ping the “pro­tein in­ter­ac­tome,” and col­lat­ing re­al-time, re­al-world da­ta.

“What we con­tin­ue to look for are en­tre­pre­neurs in res­i­dence who want to change this part of the world, change the health­care sys­tem and have the am­bi­tion to be on a plat­form like that,” Ba­jaj said. “That’s what’s re­al­ly go­ing to gate the num­ber of com­pa­nies that we cre­ate — it’s in find­ing those good re­la­tion­ships and peo­ple who re­al­ly want to adopt some­thing as their mis­sion or come to us with ideas that they think we can help with.”

Es­ker is cur­rent­ly work­ing with a full-time staff of four with plans to ex­pand as part of an “ag­gres­sive growth strat­e­gy” once the com­pa­ny locks in a lease in South San Fran­cis­co that is cur­rent­ly in the works, Lee said. Mean­while, Lee’s team is work­ing with about a dozen con­sul­tants at the start­up.

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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