Ab­b­Vie calls off PhI tri­al for I-Mab’s CD47 days af­ter Zai Lab shelves its own pro­gram

The CD47 field ran in­to an­oth­er hur­dle Tues­day as I-Mab qui­et­ly dis­closed in an SEC fil­ing that Ab­b­Vie is say­ing good­bye to a Phase I study of the biotech’s drug.

Weeks af­ter end­ing an ex­plorato­ry tri­al of I-Mab’s CD47 an­ti­body, Ab­b­Vie has now called it quits on an­oth­er ear­ly-stage tri­al. The Phase I was test­ing the drug, lem­zopar­limab, in com­bi­na­tion with azac­i­ti­dine and vene­to­clax in pa­tients with acute myeloid leukemia and myelodys­plas­tic syn­drome.

“This de­ci­sion was not based on any spe­cif­ic or un­ex­pect­ed safe­ty con­cerns,” I-Mab dis­closed in the pa­per­work filed with the SEC.

The study arose from the pact Ab­b­Vie and I-Mab inked in au­tumn 2020 with $200 mil­lion up­front and more than a bil­lion dol­lars in back-end pay­ments.

The part­ner­ship will con­tin­ue with “cer­tain new an­ti-CD47 an­ti­bod­ies” or “oth­er li­censed prod­ucts,” I-Mab dis­closed. I-Mab stands to re­ceive up to $1.295 bil­lion in pay­ments and tiered roy­al­ties un­der the amend­ed deal, the com­pa­ny said.

The move comes days af­ter Zai Lab shelved a Phase I pro­gram of its CD47 in­hibitor ZL-1201 af­ter scop­ing out the com­pet­i­tive land­scape.

Mul­ti­ple set­backs have oc­curred to the CD47 space since Gilead’s ma­grolimab, for­mer­ly of the biotech Forty Sev­en and one of the lead pro­grams in the in­dus­try, was placed on par­tial clin­i­cal holds last year. All study paus­es have since been lift­ed, and the Cal­i­for­nia bio­phar­ma has re­it­er­at­ed its “un­wa­ver­ing” con­fi­dence in the pro­gram, which aims to block the “don’t eat me” sig­nal loved by some can­cer cells.

I-Mab once tout­ed lem­zopar­limab as one of the “glob­al front-run­ners af­ter ma­grolimab,” the drug that Gilead picked up in its $4.9 bil­lion Forty Sev­en ac­qui­si­tion two years ago.

But the Chi­na-Mary­land biotech is al­so aware of the dif­fi­cul­ties with CD47.

“As one of the most promis­ing drug class­es in im­muno-on­col­o­gy, the de­vel­op­ment of CD47 an­ti­bod­ies is pri­mar­i­ly ham­pered by their on-tar­get bind­ing to red blood cells (RBCs). There­fore, var­i­ous CD47 an­ti­bod­ies in their clin­i­cal de­vel­op­ment are found to be sus­cep­ti­ble to se­vere ane­mia and oth­er hema­to­log­ic side ef­fects. As a re­sult, many CD47 an­ti­body pro­grams have been ei­ther ter­mi­nat­ed in ear­ly clin­i­cal tri­als or faced drug safe­ty chal­lenges in clin­i­cal tri­als,” I-Mab dis­closed in an SEC fil­ing ear­li­er this year.

I-Mab is al­so test­ing the drug’s po­ten­tial at treat­ing MDS, oth­er hema­to­log­i­cal ma­lig­nan­cies and var­i­ous sol­id tu­mors.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.