STOCKHOLM, June 27, 2022 /PRNewswire/ -- Immunovia today
announced results from the PanFAM-1 study. The PanFAM-1 study is a
prospective, multi-center, investigational study, designed to
assess the performance of the IMMray™ PanCan-d test in early
detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk
populations. The IMMray™ PanCan-d test met its primary endpoint of
test specificity comparable to imaging in the study. Sensitivity,
however, could not be evaluated due to the low number of PDACs
among study participants.
"We aimed for more tangible results of the PanFAM-1 study, which
are partly inconclusive due to a variety of factors related to the
execution of the clinical trial compared with original study
design. The PanFAM-1 clinical study was also impacted by the COVID
pandemic, when many hospitals were closed for the routine
surveillance or screening of patients, as many others in the
industry have experienced", said Philipp
Mathieu, CEO and President of Immunovia AB.
Analysis of the sensitivity of IMMray™ PanCan-d in the PanFAM-1
study was confounded by the unexpectedly low 0.2% prevalence of
PDAC in the PanFAM-1 cohort, which was lower than the c.1%
prevalence in this risk group observed in other studies1,
2 and was lower than the prevalence assumed in the study
design. In addition, the execution of the study was compromised by
the following factors:
- The COVID pandemic significantly impacted the recruitment and
monitoring of patients
- Insufficient number of serial blood draws and/or imaging for
each patient
- Failure to provide a quality/accuracy assessment of imaging
results
Philipp Mathieu, CEO and
President of Immunovia AB, continues: "We are very grateful to the
patients, clinicians and hospitals who participated in this study.
In close collaboration with key opinion leaders and participating
study sites we are currently analyzing the important learnings from
PanFAM-1 which together with our ongoing discussions with payers
will inform the way forward in establishing further clinical
validation in this risk group."
Analysts, investors and media are invited to a webcast and
teleconference, today Monday, June
27, at 13:00 pm CET for a
presentation of the outcome and learnings from the PanFAM-1 study.
For details, see the end of the press release.
PanFAM-1, background and details
PanFAM-1 was the first prospective, multi-center trial
initiated by Immunovia in 2016, with the goal of evaluating the
performance (sensitivity and specificity) of the
IMMray™ PanCan-d test in individuals at high risk for
developing familial or hereditary pancreatic ductal adenocarcinoma
(PDAC) in comparison to conventional imaging.
Individuals enrolled in PDAC surveillance programs were planned
to receive imaging and clinical evaluation at least once per year
consistent with the study center's protocol (MRI, EUS or CT) and
had a blood draw every 6 months. As an observational study, blood
samples were frozen and stored until the IMMray™ PanCan-d test
was clinically validated.
Samples were collected at 23 sites in the US (14) and
Europe (9), with 3,457 blood
samples collected from 1,255 participants between January 2016 and November
2021. Sites in the U.S. contributed over 2,300 blood samples
from two third of the study participants, with a median observation
period of 1-2 years. The IMMray™ PanCan-d results for US
participants were in line with those reported for the US PanFAM-1
subjects in the blind validation (88.8% negative, 9.5% borderline,
and 1.7% positive) [Clinical and Translational Gastroenterology,
2022; doi.10.14309/ctg.0000000000000468].
Statistical comparison of specific imaging findings and IMMray™
PanCan-d results is ongoing to examine trends in IMMray™ PanCan-d
results relative to specific germline mutations, family histories,
and imaging findings at the direction of the Principal
Investigators in this study. Independent analysis of the PanFAM-1
results was conducted by Biostatisticians at the Biostatistical and
Epidemiological Data Analysis Center (BEDAC) at Boston University School of Public Health.
1 Overbeek KA, Levink IJ, Koopmann BDM et al.
Long-term yield of pancreatic cancer surveillance in high-risk
individuals. Gut. 2022;71:1152-1160.
2 Overbeek KA, Goggins MG, Dbouk M et al. Timeline
of development of pancreatic cancer and implications for successful
early detection in high-risk individuals. Gastroenterol.
2022;162:772-785.
Details for webcast and teleconference
Analysts, investors and media are invited to a webcast and
teleconference today, Monday June 27
at 13:00 pm CET. The presentation
slides will be available at www.immunovia.com.
The presentation will be held in English and be followed by a
Q&A session. You are welcome to join via webcast or phone, see
details below.
Telephone numbers and webcast
Ring any of the numbers below to participate via telephone.
Please dial in a few minutes before the presentation starts.
Sweden: +46850510031
United Kingdom: +442071070613
United States: +16315705613
Link to the
webcast: https://creo-live.creomediamanager.com/806a27cb-a49a-4fa9-b7e7-3ac9fd7a4795
To ask questions, it is necessary to dial in. A recording of the
presentation will be available on Immunovia's website.
For more information, please contact:
Philipp Mathieu
CEO and President
philipp.mathieu@immunovia.com
Tobias Bülow
Senior Director Investor Relations and Corporate
Communications
tobias.bulow@immunovia.com
+4673663574
This is information that Immunovia is obliged to make public
pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person
set out above, at 08:30 CET
June 27, 2022.
About Immunovia
Immunovia AB is a diagnostic company with the vision to
revolutionize blood-based diagnostics and increase survival rates
for patients with cancer.
Our first product, IMMray™ PanCan-d is the only blood test
currently available specifically for the early detection of
pancreatic cancer. The test has unmatched clinical performance.
Commercialization of IMMray™ PanCan-d started in August 2021 in the USA and IMMray™ PanCan-d is offered as a
laboratory developed test (LDT) exclusively through Immunovia, Inc.
For more information see: www.immunoviainc.com
Immunovia collaborates and engages with healthcare providers,
leading experts and patient advocacy groups globally to make this
test available to all high-risk pancreatic cancer groups.
The USA, the first market in
which IMMray™ PanCan-d is commercially available, is the world's
largest market for the detection of pancreatic cancer with an
estimated value of more than USD 4
billion annually.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit: www.immunovia.com.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/immunovia-ab/r/panfam-1-results-partly-inconclusive,c3591702
The following files are available for download:
https://mb.cision.com/Main/13121/3591702/1597357.pdf
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