Jingwu Zang, I-Mab founder and chairman

#AS­CO21: Ab­b­Vie-part­nered Chi­nese biotech with first-in-class am­bi­tions show­cas­es ear­ly da­ta on CD73 an­ti­body

Weeks af­ter Gilead-part­nered Ar­cus whipped up some cheers from an­a­lysts around its small mol­e­cule CD73 in­hibitor — pre­sent­ing pre­lim­i­nary da­ta at AACR that “ex­ceed­ed ex­pec­ta­tions” — a Chi­nese biotech is un­veil­ing its own ear­ly re­sults us­ing an an­ti­body ap­proach that it says puts more weight be­hind the tar­get.

I-Mab tout­ed a 23% ob­jec­tive re­sponse rate in the US Phase I dose es­ca­la­tion study, among 13 evalu­able pa­tients with sev­er­al dif­fer­ent types of ad­vanced can­cers. All were giv­en a com­bi­na­tion of uliledlimab and Roche’s PD-L1, Tecen­triq.

While it’s still ear­ly, founder and chair­man Jing­wu Zang said the num­bers mark “a very in­ter­est­ing start­ing point for us to build on.”

CD73, he said, has been on top of I-Mab’s tar­get list as it hunts im­muno-on­col­o­gy agents that can help pa­tients who don’t re­spond to check­point in­hibitors. Oth­ers, in­clud­ing As­traZeneca and ORIC, are al­so pur­su­ing it. Be­cause it is part of the im­muno­sup­pres­sive adeno­sine path­way, block­ing it is the­o­rized to turn a cold tu­mor hot, there­by cre­at­ing a bet­ter mi­croen­vi­ron­ment for T cells to kill can­cer.

The com­pa­ny’s claim to fame lies in the crowd­ed CD47 field, where it boasts of a “dif­fer­en­ti­at­ed” an­ti­body that drew Ab­b­Vie in for a $3 bil­lion pact. CD73 is nowhere near­ly as pop­u­lar — Zang counts on­ly five an­ti­bod­ies around the world that’s reached clin­i­cal stage — but I-Mab sim­i­lar­ly be­lieves it has a unique drug on its hands.

In par­tic­u­lar, in­ves­ti­ga­tors re­port­ed no “hook ef­fect” in the Phase I tri­al, mean­ing the an­ti­body po­ten­cy seemed to in­crease pro­por­tion­ate with the dose rather than los­ing in­hi­bi­tion at a high­er dose, an is­sue ob­served with cer­tain oth­er drugs in the class.

“This is not com­plete­ly by de­sign,” Zang said, ex­plain­ing that they had on­ly in­tend­ed to avoid the epi­topes tar­get­ed by oth­ers.

The re­sult­ing an­ti­body ap­pears safe and pleas­ant­ly sur­prised him with the clin­i­cal ac­tiv­i­ty — both in PD-(L)1 treat­ment naïve and re­frac­to­ry cas­es. A pa­tient with ovar­i­an can­cer achieved a com­plete re­sponse, two oth­ers saw a par­tial re­sponse, while an­oth­er three had sta­ble dis­ease.

In­ter­est­ing­ly, in­ves­ti­ga­tors not­ed that the three re­spon­ders were al­so the on­ly ones whose tu­mors had high ex­pres­sion of both CD73 and PD-L1 — bio­mark­ers that I-Mab will like­ly start us­ing to screen and strat­i­fy pa­tients for fu­ture tri­als.

Zang not­ed that they will con­tin­ue mon­i­tor­ing pa­tients this tri­al (there are 20 in to­tal), while al­so test­ing uliledlimab in a Chi­nese Phase II tri­al to­geth­er with Jun­shi’s PD-1 Tuoyi, look­ing at non-small cell lung can­cer as well as oth­er metasta­t­ic can­cers. Oth­er com­bos are on the ta­ble.

Al­though he ac­knowl­edges that Ar­cus’ da­ta — with the first cut sug­gest­ing a 41% ORR — look promis­ing, Zang be­lieves an­ti­bod­ies are bet­ter at pro­vid­ing the per­sis­tent and com­plete in­hi­bi­tion need­ed to shut down a tar­get that’s ex­pressed abun­dant­ly as CD73. The an­swers ul­ti­mate­ly will have to come in fu­ture tri­als.

“We’re mov­ing for­ward with full speed,” he said.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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