Topics Alert

Genitope's MyVax Disappoints

Date: December 20, 2024

In a previous Topics Alert (#258, November 12, 2024) we reviewed the less-than-encouraging interim results from the Genitope MyVax clinical trial for CLL patients. This vaccine approach to controlling CLL was hugely interesting to our members, and we gave this clinical trial high visibility on our website. You can look up the earlier articles describing the technology by searching for the keyword “Genitope” in the custom search boxes provided on every page of this website.

Today, the other shoe dropped – big time. Genitope’s phase-3 clinical trial of MyVax in NHL patients has been going on for much longer, and today the results of the final analysis of the data became public. The news is not good. In this crucial trial, MyVax failed to prove that the vaccine increased progression free survival of patients who got the vaccine, compared to those that did not. There was not even a trend that MyVax patients had better disease control, longer progression free survival. The stock plunged by about 50% after the news.

Obviously, the company is trying to find a silver lining to this very large and dark cloud, but the future looks bleak for this company and the MyVax technology. With their lead trial in NHL patients failing to achieve its target, it is anyone’s guess whether the company can / will continue monitoring the MyVax trial for CLL patients.

I have to admit I had better hopes for this technology and was keeping my fingers crossed for its success. This feels like getting a lump of coal in our collective Christmas stocking! But we have no choice but to stay optimistic and keep hoping for new options and better technology to become available in the years ahead.

Below is a link to a report on Bloomberg.com, followed by an article which appeared in thestreet.com..

Be well,

Chaya
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Press Reports

I. Bloomberg.com

News report dated December 21, 2024

Genitope Shares Fall as MyVax Fails to Slow Lymphoma
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II. TheStreet.com Article

Genitope's MyVax Vaccine Falls Short

By Adam Feuerstein
Senior Writer
Article Link

Genitope (GTOP) said Thursday that its non-Hodgkin's lymphoma vaccine MyVax failed to meet the primary endpoint in a pivotal phase III study.

The negative outome of the MyVax study is a significant setback for Genitope, which has hitched its entire future on developing MyVax as a new treatment for non-Hodgkin's lymphoma, a cancer that targets B cells, a part of the immune system. Genitope issued a press release earlier Thursday annoucing its upcoming MyVax conference call, driving shares down nearly 40% to close at $2.59. Following the news, Genitope fell another 79 cents in recent after-hours trading to $1.75.

In the primary analysis of the study, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax compared to patients receiving a control substance, Genitope said.

In a phone interview conducted earlier Thursday, Genitope CEO Dan Denny acknowledged that MyVax patients didn't even show a trend toward prolonged PFS compared to the control patients.

But Denny remains optimistic about MyVax's future because of a secondary analysis from the study showing a subgroup of MyVax patients who did get a significant clinical benefit from the vaccine.

Genitope plans to discuss these positive data with the Food and Drug Administration, said Denny, hinting that the company will more than likely file for approval based on the subgroup analysis.

This secondary analysis of the phase III study examined MyVax patients who mounted an immune response to the cancer vaccine (responders) compared to MyVax patients who did not have an immune response (non-responders) When the two groups were compared, MyVax responders were shown to have a statistically significant prolongation in PFS compared to non-responders.
Denny says this responder analysis proves that there is a subset of non-Hodgkin's lymphoma patients who can be put into prolonged or even life-long remission from their disease by an immunotherapy.

While not as positive if the study has reported positive results for all MyVax patients, it still represents a breakthrough in non-Hodgkin's lymphoma treatment because for some patients, MyVax will outperform current treatments like Genentech's (DNA) Rituxan, Denny added.

The FDA will be the ultimate arbiter of MyVax, but history and precedent are clearly running against Genitope. The phase III study failed, which tends to work against drugs being reviewed by the FDA. The agency also generally doesn't take well to subgroup analysis as the basis for approval, even if the analysis was pre-specified in the study's statistical plan, as it was in this case.
There is no way to determine in advance which non-Hodgkin's lymphoma patients will respond to MyVax. And while Genitope claims that response to the vaccine is correlated directly with longer remissions, there could be other factors responsible. For instance, MyVax responders might simply be healthier or have cancer that is progressing more slowly compared to non responders.

Genitope's desire to find a silver lining in the failed MyVax study might just be a natural defense mechanism given the fact that the company is running out of cash. With about 50 cents a share in cash, Genitope probably has nothing to lose by seeking FDA approval on so-so MyVax data.
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