Jeffrey Goldberg

Tout­ing CD161 as a test case for sin­gle-cell tech, Long­wood-backed Im­mu­ni­tas bags $58M for next-gen I/O work

Back when Long­wood un­veiled its lat­est im­munother­a­py start­up, Im­mu­ni­tas, the VC’s co-founder Lea Hachi­gian talked at length about how its sin­gle-cell ge­nomics analy­sis plat­form could en­able re­searchers to “ask ques­tions of the im­mune sys­tem we weren’t able to ask be­fore,” un­der­stand hu­man bi­ol­o­gy on a much deep­er lev­el and iden­ti­fy tar­gets that no­body else was work­ing on. They just couldn’t dis­close the pre­cise tar­get for the lead pro­gram.

Kai Wucherpfen­nig

This Feb­ru­ary, Im­mu­ni­tas fi­nal­ly did — pub­lish­ing a pa­per in Cell that ze­roes in on CD161 as a re­cep­tor on T and NK cells that sup­press­es their abil­i­ty to kill glioma cells.

Months lat­er, the start­up is back with $58 mil­lion in fresh cash to steer a CD161-block­ing an­ti­body to­ward the clin­ic while fu­el­ing a slate of oth­er pro­grams be­hind it. The goal, Im­mu­ni­tas CEO Jef­frey Gold­berg told End­points News, is to keep ex­pand­ing the pipeline at a rate of about one pro­gram per year.

Kai Wucherpfen­nig, chair of Dana-Far­ber Can­cer In­sti­tute’s de­part­ment of can­cer im­munol­o­gy and vi­rol­o­gy, co-found­ed Im­mu­ni­tas with Aviv Regev (be­fore Roche’s Genen­tech re­cruit­ed her to run R&D), Dane Wit­trup of MIT and Mass Gen­er­al’s Mario Su­và.

For Wucherpfen­nig, the dis­cov­ery of CD161 was a tes­ta­ment to the key ad­van­tages of the sin­gle-cell plat­form he helped in­vent, which start­ed out an­a­lyz­ing hun­dreds of cells but can now work with hun­dreds of thou­sands at a time, at high res­o­lu­tion. Through iso­lat­ing T cells from pa­tients’ tu­mor sam­ples (sep­a­rate from, say, stro­mal cells, tu­mor cells, and so on), clus­ter­ing them by gene ex­pres­sion and then ex­am­in­ing dif­fer­ent pop­u­la­tions, his team es­sen­tial­ly came up with an at­las of im­mune cells in glioma — all based on hu­man sam­ples.

“We’ve been asked mul­ti­ple times, why do oth­er peo­ple not pick it up? And the rea­son ac­tu­al­ly is that the bi­ol­o­gy is very dif­fer­ent be­tween mice and hu­mans,” he said. “Most peo­ple start with mouse mod­els, and then in mice there are ac­tu­al­ly mul­ti­ple genes that en­code CD161 like mol­e­cules. Some of them are in­hibito­ry, some just are ac­ti­vat­ing re­cep­tors, and the bi­ol­o­gy is very con­fus­ing. And in hu­mans it’s ac­tu­al­ly more straight­for­ward. There’s a sin­gle gene that en­codes an in­hibito­ry re­cep­tor, OK. And so most peo­ple have looked at this — I know some peo­ple have looked at this and said, nev­er mind. And they nev­er re­al­ly looked at the hu­man bi­ol­o­gy.”

As Im­mu­ni­tas — now grown to 20-plus staffers — car­ried on the work, once again re­ly­ing on the sin­gle-cell se­quenc­ing and an­a­lyt­ics tech, they found out that the re­cep­tor is not just as­so­ci­at­ed with glioma. CD161 ap­pears to be in play in T and NK cell in­ter­ac­tions with mul­ti­ple can­cer types span­ning sol­id and liq­uid tu­mors, giv­ing the biotech mul­ti­ple op­tions to ex­plore in the first hu­man tri­als, with an IND slat­ed for the first half of next year.

Specif­i­cal­ly, Im­mu­ni­tas’ IMT-009 is de­signed to bind to CD161 on T and NK cells and pre­vent it from in­ter­act­ing with CLEC2D on tu­mor cells, there­by restor­ing the im­mune cells’ can­cer-killing pow­er.

Wucherpfen­nig and Gold­berg fig­ure there are many more im­muno-on­col­o­gy tar­gets out there sim­i­lar­ly lurk­ing in cor­ners tra­di­tion­al dis­cov­ery meth­ods can’t un­cov­er.

The promise has drawn a siz­able syn­di­cate. Agent Cap­i­tal led the round, which fea­tured Med­ical Ex­cel­lence Cap­i­tal, 120 Cap­i­tal, So­las­ta Ven­tures, Mi­rae As­set, Ono Ven­ture In­vest­ment, The Mark Foun­da­tion for Can­cer Re­search, NS In­vest­ment, Bright­Edge (Amer­i­can Can­cer So­ci­ety) and the Leukemia & Lym­phoma So­ci­ety Ther­a­py Ac­cel­er­a­tion Pro­gram. Ex­ist­ing back­ers al­so re­turned: They are Alexan­dria Ven­ture In­vest­ments, Evotec, Leaps by Bay­er, M Ven­tures, No­var­tis Ven­ture Fund and, of course, found­ing in­vestor Long­wood.

Be­yond that, the sci­en­tist al­so sees the up­com­ing work as part of a big­ger ex­per­i­ment to test the un­der­ly­ing plat­form as a com­pre­hen­sive tool to close the loop on trans­la­tion.

“We’re al­so think­ing about how we can use sin­gle cell tech­nolo­gies to ac­tu­al­ly un­der­stand what the drug does in pa­tients — you know, once we start a clin­i­cal tri­al,” he said. “There ob­vi­ous­ly are some lo­gis­ti­cal chal­lenges with sam­ple pro­cure­ment, et cetera, but it could ac­tu­al­ly be an ex­cit­ing op­por­tu­ni­ty. So we — we use sin­gle cell tech­nolo­gies to dis­cov­er it, we use sin­gle cell tech­nolo­gies to de­fine in­di­ca­tions, and then al­so study mech­a­nism of ac­tion in peo­ple.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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