Oncology Conference Countdown: What Will Pharma and Biotech Companies Report?

This is gonna be a crazy couple of days. At 9 pm last night the American Society of Clinical Oncology put nearly 5,000 studies on its website all at once.

Although ASCO says it's all about the science and protecting the "scientific integrity" of its upcoming conference, this is, frankly, an attempt to level the playing field for Wall Street.

In years' past ASCO has sent out a big, heavy book with all the data to around 25,000 of its member doctors and a bunch of reporters. But then investors would try to game the system and get some of those oncologists to hand over the book or tell them what's in it. Those alleged leaks manifested themselves in trading activity in the shares of certain biopharmas in the cancer space. For example, ImClone (IMCL) had a wild move up ahead of "embargoed" data being presented at least year's meeting.

So, pressure mounted on ASCO to find a better way. We'll see if it works. An ASCO spokesman says the group has upgraded its servers to handle all the traffic it expects tonight, but I haven't gotten a reply yet to a follow-up question about whether they've been tested to handle the surge.

My inbox is full of analyst research reports guiding clients about what to look for. Companies to watch, they say, include Genentech (DNA), Celgene (CELG), Ariad (ARIA), Cougar (CGRB), Medivation (MDVN), Onyx (ONXX), OSI Pharmaceuticals (OSIP), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Novartis (NVS) just to name a handful. For laypeople, the study results which are called "abstracts" can be all Greek.

So, analysts and doctors spent the night combing through the data--many of them pulling college-style all-nighters--to interpret the numbers and make calls on them before the opening bell Friday morning. And buyer beware. These data were submitted for publication in January and many companies say they will be presenting new, updated and possibly different results at the ASCO conference itself at the end of the month.

And, a reminder that not all of the stuff came out last night. ASCO is not giving up some of the marquee studies so it'll still get some big media-play in Chicago. The expected headliner is ImClone/Bristol with survival data on their drug Erbitux in lung cancer.

And the fun doesn't stop there. The very next week is the American Diabetes Association meeting where Lilly, Amylin Pharmaceutials (AMLN), and Novo Nordisk (NVO) will be presenting major study results on their late-stage experimental drugs.

Comments

[R J Steffens]

Hi Mike, great article and idea for investors of biotech and pharma oncology stocks. We know big pharma has been looking at small biotechs with promising cancer vaccines. Looks like this one of a Phase I study I found from ASCO 2008 is not only safe (no grade 3 toxicity cases), but is the first peptide vaccine to exhibit such positive immuno responses even WITHOUT an adjuvant:

Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER2/neu peptide (AE37) vaccine: United States Military Cancer Institute Clinical Trials Group Study I-03.
Sub-category: Vaccines
Category: Developmental Therapeutics: Immunotherapy
Meeting: 2008 ASCO Annual Meeting

"Results: All 15 patients completed the trial with no grade 3-5 local or systemic toxicities. Dose reductions occurred in 47% of patients for local reactions >100mm or grade 2 systemic toxicities. The second group (peptide=500mcg, GM-CSF=250mcg) all required dose reductions prompting peptide-only inoculations in the third group (peptide=1,000mcg, GM-CSF=0mcg). AE37, with and without GM-CSF, elicited dose-dependent immunologic responses in vitro and in vivo to both AE37 and AE36 albeit AE37 responses were more robust. Assessing both toxicities and immunologic responses, the hypothesized optimal biologic dose was determined as peptide=500mcg, GM-CSF=62.5mcg, in 6 monthly injections. Conclusions: The hybrid AE37 vaccine appears safe and well tolerated with minimal local or systemic toxicity if properly dosed. AE37 is capable of eliciting HER2/neu-specific immune responses, even without the use of an adjuvant.

This trial represents the first human experience with the Ii-Key modification, and to our knowledge, AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant."

www.abstract.asco.org/...

AE37 vaccine is from Antigen Express- a wholly owned subsidary of (GNBT) Generex. This is now in a large Phase II with the USMCI. What do you think?

[NormanLepoff, M.D.]

Very interesting. Thanks for the info.

[User 227706]

Dear Dr. Norman Lepoff,

I am a retired Principal Biochemist and recognized expert in carbohydrate chemistry with 5 US Patents. I have worked out a novel anti-cancer therapy that I would like to discuss with you in private rather than in a public forum. Can you send me your private contact information for a confidential yet thorough discussion? I think that you will be impressed. I ultimately hope to obtain from you the names of contact individuals in oncological research, preferably at the big pharmaceutical houses.

Thank you,
Robert J. Mizerak
(Oconomowoc, WI)