UPDATED: Immunomedics Ignored, HGS Adored as Annual Rheumatology Confab Kicks Off

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The American College of Rheumatology’s annual confab kicks off this weekend, and one item not on the menu is detailed Phase IIb data for Immunomedics and partner UCB’s lupus drug epratuzumab.

Back in August, Immunomedics issued a hype-y press release claiming “positive” and “clinically meaningful” data that could provide a “new hope” for lupus patients…but they failed to provide any details or even say whether or not the trial had met its endpoints. Analysts said there was a benefit only in one of five dose groups and that it wasn’t significant, but the stock popped 60 percent anyway, conveniently supporting a financing. (Update: A new press release from Immunomedics states that all doses tested were “numerically superior” to placebo; p-values weren’t provided but the company reminded folks that the trial was not powered for statistical significance.)

Investors expected detailed data to be unveiled at ACR, but epratuzumab is not on the ACR’s list of late-breaker abstracts. Avik Roy, analyst with Monness Crespi Hardt & Co., said the ACR’s decision “implies that they did not find the epratuzumab data compelling.”

Headlining the late-breaker abstracts, however, is another lupus drug: Human Genome Sciences’ Benlysta (belimumab). Top-line data announced in July represented the first real Phase III success in lupus and sent HGS’ stock up 277 percent.

The details of that Phase III trial will be presented Tuesday afternoon, and the abstract shows that both dose groups met the primary endpoint and at least one of the two dose groups hit statistical significance on each secondary endpoint, with no safety issues. Analysts will no doubt be sifting through the details provided during the presentation, and at an analyst event later that evening, for any predictors of success or failure in HGS’ second Phase III Benlysta trial, data from which are due in December.

Tags: Analyst, Endpoint, Investment, Financial Accounting, Finance, Trista Morrison

Trista Morrison is a staff writer at BioWorld Today, a daily newspaper that's been covering the biotech industry about as long as there's been a biotech industry to cover.

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1

idahoranch

10/16/09 | Report as spam

RE: Immunomedics Ignored, HGS Adored as Annual Rheumatology Confab Kicks Off

Immunomedics would love to be able to release the data from UCB's phase llb dosing trial, but therein lies the problem, it is UCB's data and they indicate they want to present the data at a medical conference, and yes, their submission for the late breaker to ACR was not one of the 6 accepted.

In a previous column you state "no mention that the treatment advantage was seen in just one of five dose groups, according to analyst reports" in your effort to diminish both the release and Immunomedics. In your column today you don't address the fact that you are now informed by Immunomedics release that all 5 dose arms beat the placebo arm. Where is the fairness and objectivity in your reporting?

You also don't mention that under the trial protocol the placebo arm patient had a 21% response rate and the best dose of 600mg had a 46% response rate. Isn't it obvious to you that a trial designed in such a way to get a 43% response rate in the placebo group is suspect?

HGSI managed to get FDA to go along with a trial design that gets their drug to barely squeak by the placebo group and you sing its praises. They will probably get approval, but if the main objective of the research is to really help SLE patients, Epratuzumab is showing evidence it does that much better, even without all the data, and that is coming.

I think you are missing the boat on this one.
2

Trista Morrison

10/18/09 | Report as spam

RE: Immunomedics Ignored, HGS Adored as Annual Rheumatology Confab Kicks Off

Idahoranch - thank you for pointing out that Immunomedics had issued a press release with a few more trial details; I had not seen that but have now updated the article accordingly.

Also, I appreciate that their hands may be tied by UCB, I'm just not a fan of unsubstantiated "a new hope for patients" claims in press releases. The lupus field has seen too many hopes fizzle in Phase III. Even if the epratuzumab Phase IIb data are the most stellar ever (which seems unlikely given the ACR late-breaker rejection, but who knows), they've still got Phase III to contend with. I hope they make it, but it's a long road. - Trista
3

idahoranch

10/19/09 | Report as spam

RE: Immunomedics Ignored, HGS Adored as Annual Rheumatology Confab Kicks Off

Trista, Epratuzumab has had a rocky road, but not because it lacked efficacy. It has shown efficacy in every autoimmune trial it's been tried it (SLE in 4 trials, including at least two double blinded and a small Sjogren's syndrome trial). This isn't a compound that is just coming out of a typical phase ll trial. UCB has a lot of data now, and most of it from placebo controlled, blinded, multi-center trials. All trials have used the BILAG scoring system, a more rigid standard than the SLENA or SLEDAI.

UCB chose to halt two phase lll trials that Immunomedics had started and were running when UCB licensed E-mab. They used a "bottle capping" issue as the reason, but there is little doubt they wanted to see what the phase lll data looked like at that point. After seeing that data, they decided to look at a range of doses rather than taking the 360mg/m2 dose that was used in NHL indications, and that is where the dosing trial came into play and where this latest data was generated, the data we only have a glimpse of.
Phase lll trials will likely begin after the first of the year. E-mab, a CD22 antibody, downregulates B cells and slows down their hyperactivity, so it should work in a host of autoimmune diseases.
Questioning why UCB's abstract didn't get accepted by the ACR is valid, maybe the abstract was poorly written, I really don't know.

The biotech story of 2010 is going to be hPAM4 in pancreatic cancer, an Immunomedics compound. Data on about 30 patients will be presented at ASCO-GI in Jaunary.