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)

Merck snags rights to Endocyte’s ovarian cancer drug in $1B deal

Posted under Blog, Companies, companion diagnostics, Diagnostics, EC145, Endocyte, Funding, Medical Devices, Medical Supply, Merck, ovarian cancer, Partnering, personalized medicine, Pharmaceuticals, Startups, Universities, Videos by john

Merck has scooped up worldwide rights to Endocyte's ($ECYT) late-stage ovarian cancer drug in a billion-dollar deal, paying $120 million upfront and committing up to $880 million in milestones. And West Lafayette, IN-based Endocyte will also get co-promotion rights and a split of U.S. profits while earning double-digit royalties in the rest of the world.

Investors liked the sound of big round numbers, bidding up Endocyte shares by 111% once the news hit.

Merck ($MRK) says the drug--Vintafolide, or EC145--matches the profile of what it's looking for in a cancer drug, highlighting Endocyte's development of a companion diagnostic to identify patients most likely to respond to the treatment. And Endocyte says it's only months away from filing for U.S. approval. The treatment has been given orphan drug status in Europe.

Endocyte's strategy is to use an imaging agent, EC20, to identify patients whose tumors express folate receptors. Those patients who test positive are treated with EC145, which combines a chemotherapy with a conjugate that includes vitamin folate, targeting specific cancer cells. That approach has produced positive results in mid-stage studies, with folate receptor-positive patients achieving a median 5.5 month PFS rate compared to a control arm's 1.5 months.

"Vintafolide is a promising and innovative late-stage cancer drug candidate. In addition to pursuing the lead indication of platinum-resistant ovarian cancer, Merck plans to further evaluate its potential for treatment of multiple other cancer types," said Peter S. Kim, executive vice president and president at Merck Research Laboratories. "This agreement underscores our strategy of building a portfolio of oncology therapeutics that employ a companion diagnostic to facilitate selection of those patients most likely to respond to treatment."

- here's the press release

Special Report: Endocyte - Fierce's 5 Drug Delivery Companies to Watch

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Endocyte shares spike on plan to seek early approval for lead cancer drug

Endocyte – Biotech IPOs of 2011

Posted under Biotech IPO, Blog, Companies, Diagnostics, Endocyte, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by Maureen Martino

Company: Endocyte ($ECYT)
Based: Indianapolis
Raised: $75M (12.5M shares at $6)
Target range: $13 to $15
Current price: $3.59 

Scoop: Endocyte is the kind of IPO that's a tough sell to investors. The developer, which was founded in 1996, has no marketed products but boasts a pipeline of cancer and inflammatory disease drug candidates with companion diagnostics. Six of the company's programs are in human trials.

Endocyte first announced its intentions to go public in August 2010, but it took 6 months--and a heavy discount--to reach the markets. The Indianapolis-based developer debuted at just $6 per share, far below the low end of its targeted $13 to $15 range.

Endocyte's lead drug is EC145. It targets a receptor that's often overexpressed in many solid tumors, including ovarian, non-small cell lung, breast, colorectal, kidney, endometrial and other cancers, according to the company. A companion imaging agent is used to identify which patients will benefit the most from treatment with EC145. Not long after its February debut, the company's shares spiked on positive Phase II data for its ovarian cancer drug and news that it would file for accelerated approval in Europe. 

Things were looking good for Endocyte until the company announced in December that overall survival results from a Phase II trial of EC145 for ovarian cancer were inconclusive. The company's stock dropped 60%, and continues to hover around the $3.50 mark.