On­coMed shares crushed as Cel­gene-part­nered lead drug flops and Bay­er takes a pass on op­tions

On­coMed CEO Paul J. Hast­ings

It’s a black day at On­coMed $OMED. A lit­tle more than a year af­ter its num­ber two drug foundered in a Phase II fail­ure, its top drug dem­cizum­ab — part­nered with Cel­gene in a multi­bil­lion-dol­lar deal — has flopped in a Phase II as well. And the biotech fol­lowed up with the news that Bay­er is by­pass­ing a tie-up on two oth­er key pro­grams, com­plet­ing a one-two punch.

The mid-stage study of dem­cizum­ab was an em­bar­rass­ing fail­ure for the pri­ma­ry as well as the key sec­ondary end­point in the study of metasta­t­ic pan­cre­at­ic can­cer — a tough field in can­cer R&D. Com­bin­ing dem­cizum­ab with Abrax­ane and gem­c­itabine in un­treat­ed pa­tients es­sen­tial­ly mir­rored the PFS re­sults for the com­par­a­tive triple that re­placed On­coMed’s drug with a place­bo.

The me­di­an over­all sur­vival rate in the dem­cizum­ab arm, mean­while, hit 13.2 months, while the place­bo group hasn’t yet reached a me­di­an OS rate. The over­all re­sponse rate was 33.1% in the drug triple, com­pared to 41.2% in the com­para­tor arm.

“Based on the lack of ben­e­fit over stan­dard-of-care, which per­formed re­mark­ably well, we will be dis­con­tin­u­ing this tri­al. We will con­duct ad­di­tion­al analy­ses, to­geth­er with our part­ner, Cel­gene, to un­der­stand these out­comes.  We will al­so dis­con­tin­ue any ad­di­tion­al en­roll­ment in our oth­er on­go­ing dem­cizum­ab tri­als and con­duct analy­ses of the da­ta from those tri­als as planned,” said On­coMed CEO Paul J. Hast­ings.

Cel­gene paid $177 mil­lion up front and promised more than $3 bil­lion in mile­stones to gain co-mar­ket­ing rights to dem­cizum­ab in 2013. That deal helped es­tab­lish On­coMed as a biotech to watch, with a spot­light on their lead can­cer stem cell ther­a­py.

Robert Stagg, On­coMed

Bay­er Phar­ma added in­jury to in­sult to­day, no­ti­fy­ing On­coMed that it de­cid­ed not to ex­er­cise its op­tion on the biotech’s Wnt path­way in­hibitors van­tic­tum­ab (an­ti-Fzd, OMP-18R5) and ipafri­cept (Fzd8-Fc, OMP-54F28) for “strate­gic rea­sons.”

The Red­wood City, CA-based biotech’s near term hopes now rest on two oth­er Phase II stud­ies, PIN­NA­CLE and DE­NALI, that are due to read out lat­er in this quar­ter.

“Pan­cre­at­ic can­cer has proven to be a unique­ly chal­leng­ing dis­ease, and these da­ta ap­pear to re­flect some of those dis­ease and treat­ment com­plex­i­ties.  The safe­ty da­ta seen in the YOSEMITE tri­al were gen­er­al­ly con­sis­tent and in line with our ex­pec­ta­tions.  We con­tin­ue to an­a­lyze these da­ta, and look for­ward to pre­sent­ing the full study find­ings at a fu­ture sci­en­tif­ic con­gress,” said Robert Stagg, Se­nior Vice Pres­i­dent of Clin­i­cal Re­search and De­vel­op­ment.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.