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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.