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.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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Novartis headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

No­var­tis’ Kisqali pre­vents breast can­cer from com­ing back for longer — but can it best Eli Lil­ly’s Verzenio? #AS­CO23

CHICAGO — Novartis’ CDK4/6 inhibitor Kisqali helped early breast cancer patients stay cancer-free for longer after surgery, according to interim study results presented at ASCO.

In a Phase III study, Kisqali was added on top of endocrine therapy — the current standard treatment for early breast cancer patients. Kisqali reduced the risk of disease relapse by 25% compared with endocrine therapy alone in patients with Stage II or III HR-positive, HER2-negative breast cancer.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

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