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Archive for the ‘CDX-110’ Category

Apr
20

Readers’ picks, responses to Fierce’s ‘Top 10′ cancer drugs report

Posted under BiovaxID, Blog, Cancer Drugs, cancer vaccine, CDX-110, Companies, Diagnostics, Endocyte, Funding, Medical Devices, Medical Supply, Merck, multikine, Pharmaceuticals, Pipeline, rindopepimut, Startups, Universities, Videos, vintafolide by rmcbride

Our readers have really strong feelings about experimental treatments for cancer, and that is one of the reasons that FierceBiotech has encouraged readers to send their feedback on our annual report, Top 10 Late-Stage Cancer Drugs, now in its second year (find last year's report here).

Now find out about several programs that didn't make the cut, much to the dismay of some of our readers.

Below I've tried to capture some of the most interesting responses we've gotten over the past few days since we published our 2012 report. To be clear, we're standing by our top 10 picks and only highlight some of the responses to share with our broader readership the pulse of fervent cancer drug development around the world.

Therapeutic vaccine and immunotherapy fans seem to feel like their favorite programs were overlooked.

We included Amgen's ($AMGN) immunotherapy talimogene laherparepvec (also known as OncoVex), which is in late-stage trials for patients with advanced melanoma. This drug has been a high-flier in cancer vaccine development, in part because Amgen acquired the program in a $1 billion buyout deal with BioVex last year.

Of course, the entire field of therapeutic cancer vaccines has come into question because of the market challenges that Dendreon ($DNDN) has faced with the biotech's pioneering product Provenge. But here are some of the lesser-known cancer immunotherapies that readers asked me to consider for the next report:

-- Rindopepimut, Celldex Therapeutics' ($CLDX) brain cancer vaccine, which is code-named CDX-110. This is the program that Pfizer ($PFE) dumped from its roster of partnerships back in 2010. Still, a reader notes that the EGFRvIII-targeted treatment has advanced into Phase III for primary brain cancer after some promising mid-stage trial data. Read more here.

-- BiovaxID, Biovest International's malignant B cell-targeting therapeutic vaccine. The company recently said it aims to seek approval of the personalized therapy in Canada for treating non-Hodgkin lymphoma. Get more about the plans here.

-- Multikine, Cel-Sci's ($CVM) immunotherapy in late-stage development for treating head and neck cancer. One advantage of the program that a reader noted is that, unlike Dendreon's Provenge, Multikine can be used off-the-shelf and doesn't require cancer patients' cells to be harvested to make the therapy. We'll see how the company's Phase III data look.

Here's an experimental drug that just barely missed the cut for the top 10:

-- Vintafolide, or EC145, Endocyte's ($ECYT) late-stage candidate that combines a chemotherapy drug with a conjugate to home in on cancer cells. Merck ($MRK), of course, just laid down $120 million and committed up to $880 million more in potential payments to gain rights to the program, which has the lead indication of platinum-resistant ovarian cancer.

The "Top 10 Late-Stage Cancer Drugs - 2012" report has only been out for a few days, so I expect we'll get more feedback in the days and weeks to come. I'll plan to tweet some of feedback. -- Ryan McBride (Twitter | email)

Nov
21

Celldex shares rally (briefly) on positive PhII brain cancer data

Posted under Blog, CDX-110, Celldex Therapeutics, Companies, Dendreon, Diagnostics, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Provenge, Startups, Universities, Videos by John Carroll

Celldex Therapeutics ($CLDX) reports that a small, single-arm study of its experimental brain cancer vaccine scored a significantly higher overall survival rate than the historical numbers on file. Investigators for the biotech say patients taking rindopepimut (CDX-110) demonstrated a median OS rate of 24.6 months from diagnosis, significantly better than the 15.2 month historical average cited by the biotech.

Investigators selected patients for the study who expressed the EGFRvIII oncogene, which is linked to a particularly poor prognosis. CDX-110 had earned some significant interest from Pfizer ($PFE), which paid $50 million in upfront fees and an equity stake in 2008, with promises of $390 million more, to partner on the program. That pact ended last year, though, when Pfizer said its changing pipeline interests forced it to dump the program.

Celldex's shares have also been subject to the cancer vaccine blight triggered by soft sales of Dendreon's ($DNDN) Provenge. Its shares briefly spiked this morning but were trading up only 2% by mid-morning.

"The consistency of data from three separate studies, including a large multicenter trial, is very encouraging and clearly supports our plan to advance clinical development of rindopepimut with ACT IV, a pivotal, randomized, blinded international Phase III study," said Dr. Thomas Davis, CMO of Celldex Therapeutics.

- here's the press release

Related Articles:
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Celldex touts promise of PhII brain cancer vaccine data
Celldex stock hit hard, but cancer vaccine shows promise