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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.