CC:3-32 extp'ltes to max time to reach 4of3 phenotypes by~30 enrolled by Dec 22-xxx | NAVB Message Board Posts

Navidea Biopharmaceuticals, Inc.

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Msg  38257 of 38624  at  9/30/2022 12:58:22 AM  by


The following message was updated on 11/25/2022 2:05:16 PM.

CC:3-32 extp'ltes to max time to reach 4of3 phenotypes by~30 enrolled by Dec 22-xxx

-Using 12 to 13 enrolled as of Sept 8 CC
-Two phenotypes at 4 or more (fibroid and  diffuse myeloid interpolated at 4 or more, leaving lympho-myeloid at 3)
-or 1 lympho-myeloid average every 4.0 months elapsed or 1 every 7.5 to 8.0 enrolled)
-Earliest to reach 4 lympho type would be in Dec 2022 based on months elapsed rate or in June or July 2023 based on enrolled elapsed rate
In NAV3-32, our comparison study of tilmanocept imaging to joint biopsy, this trial remains in active recruitment. As we've announced and discussed previously, the preliminary results of this trial are promising. Our aim is to recruit patients with each of the 3 pathotypes of RA to obtain comparative imaging and pathology results. And the trial is designed so that we enroll a minimum of 4 subjects in each of these 3 pathotypes of RA, fibroid, diffuse myeloid and lympho-myeloid. So overall trial size has been expected to range between 12 to 24.

To date, we have achieved the minimum or more in 2 out of 3 of the pathotype buckets, with patients having had both their imaging and joint biopsies completed. The primary objective of this study is to assess the relationship between joint-specific tilmanocept uptake values and the pathobiology of RA-involved joint tissue. Knowledge of an individual RA patient's pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond.

There is a growing body of literature suggesting that those patients with the fibroid type of RA are much less responsive to the anti-TNF alpha drugs. And so a means of determining whether or not a patient has this particular pathotype is seen as extremely important to a number of key opinion leaders in rheumatology.

As of this time, there is no reliable way of assessing a patient's pathotype of RA other than by doing an invasive biopsy. And we have hypothesized that tilmanocept could provide this information. We previously discussed those preliminary results that I mentioned on the first 11 patients. These results indicated that tilmanocept uptake in RA inflamed joints is able to discretely differentiate patients with the fibroid pathotype, i.e., those with low macrophage involvement from those having either the diffuse myeloid or the lympho-myeloid pathotypes of RA, i.e., those with high macrophage involvement.

7 of the subjects had relatively low levels of tilmanocept uptake. All 7 of these subjects were found to have the fibroid pathotype. Of the remaining 4 subjects, 3 have the diffuse myeloid pathotype and 1 had the lympho-myeloid. Furthermore, those subjects with either one of these 2 pathotypes had, on average, more than 3x the tilmanocept uptake as the average subject with the fibroid pathotype. So we have been able to clearly classify patients as either fibroid or non-fibroid based on our imaging results taken before the biopsy in those 11 cases.

These data also provides support for one of our indications in the Phase III trial, the ability to predict from a baseline scan alone whether a patient is likely to receive a meaningful clinical benefit from an anti-TNF alpha therapy, since, as I mentioned, there's increasing evidence that if a patient has a fibroid pathotypes of RA, they are less likely to receive significant clinical benefit from anti-TNF alpha therapy.






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