LUND, SWEDEN, April 1, 2020 /PRNewswire/ --
Immunovia AB (publ) ("Immunovia") today provides
an update on the actions that the company is taking to support
patients, employees, and public health initiatives in response to
the coronavirus (COVID-19) pandemic. Despite these extraordinary
times, Immunovia remains focused on the Q3 2020 sales start for the
first test for early diagnosis of pancreatic cancer, IMMray™
PanCan-d.
The company will continue to monitor the global development of
the COVID-19 epidemic closely and enact strategies that adhere to
authorities' guidelines in each of the countries where we are
active in order to protect the health of our employees and the
greater community to slow down and minimize the spread of the
virus. In line with these critical efforts, Immunovia is taking
proactive steps to protect and limit the exposure of our personnel.
Furthermore, inventories of critical consumables have been secured
to enable the uninterrupted continuation of our commercialization
start.
In conjunction, Immunovia will host a live call today at
16:30 CET with Mats Grahn, CEO, to further discuss COVID-19 and
IMMray™ PanCan-d launch in Q3 2020.
Response to COVID-19 Pandemic:
- Protecting employees and others. Immunovia has
taken the necessary steps to minimize the exposure of COVID-19
based on the recommendations/orders from governments and health
agencies in each geographic region where Immunovia has employees,
including suspending field-based, face-to-face interactions.
- Travel restrictions to/from the USA, and greater EU, has been mitigated,
as previously announced, and has no to minimal effect on the
commercial launch of IMMray™ PanCan-d.
- Effective March
16th, employees who can work from home have
been asked to do so, minimizing the staff in Company offices only
to those who are essentially needed for activities that need to be
done at site, for example to perform laboratory-critical work. At
this time, Immunovia reports no confirmed COVID-19 cases amongst
employees.
- Stocked reagents, chemicals and other consumables at
Immunovia. The company has obtained and stocked all the
resources and technology required for the preparations of the
launch of IMMray™ PanCan-d.
- Maintaining our Swedish R&D, laboratory, and production
capabilities. Immunovia's R&D laboratories and
clinical laboratory, in Lund, as
well as the production facilities remain operational at this time.
Business continuity plans are in place at all sites to help sustain
operations as far as possible during this unprecedented time.
- Marlborough, MA laboratory
is well prepared for the commercial phase with detailed plans for
activities leading up to accreditation and sales start.
However, the state of Massachusetts announced a mandatory state-wide
quarantine from March 25th
until April 7th. All
residents are to stay at home during this time, this will prevent
certain aspects of the commercial preparation that require any
laboratory work to be performed. If the duration of the state-wide
quarantine is extended to the end of April or even further, there
may be addition impacts on the completion of these plans. Immunovia
is actively monitoring this situation as it evolves and will update
our plans accordingly.
Update on The Remaining Steps Towards Commercialization of
IMMray™ PanCan-d:
- All blood samples for the Verification study are in the
laboratory in Lund, Sweden.
Immunovia has more than enough samples in the freezers to conduct
the Verification study, one of the two remaining steps to market
for IMMray™ PanCan-d. The surplus of samples obtained for the
Verification study are being allocated to the Validation Study. The
Verification Study remains on track for Q2 2020 completion.
- Validation Study remains on track as Immunovia secures the
necessary blood samples. Immunovia's successful collection of
blood samples for the Verification Study supplied the company with
a surplus of blood samples. The surplus blood samples are now being
reallocated for the Validation Study; a decision that will help
mitigate any potential shortfalls in deliveries from hospitals as a
result of COVID-19. As of today, the Validation Study remains on
track for Q3 2020 completion that is essential to launch the sales
start.
- Immunovia continues to prioritize the launch of IMMray™
PanCan-d. The production facility is ready with ample capacity
for the launch. Additionally, the company's well-established
infrastructure is fully prepared for the final accreditations.
Immunovia will do its utmost to adjust to any further unforeseen
circumstances and will continue our commercialization efforts to
ensure a successful launch of IMMray™ PanCan-d. Immunovia is
targeting an initial addressable market of USD 4.4 billion in the US and Europe, and we look forward to working with
healthcare providers around the world to improve the situation of
this affected patient group.
Update on Prospective studies:
- Prospective studies impacted by COVID-19. A top
priority for Immunovia is the health and safety of all study
participants. All sites involved in the three ongoing prospective
pancreatic cancer studies are following their respective national
recommendations and regulations for health and safety and, thus,
many have therefore in general stopped clinical trial activities,
including blood sample collection. These studies, as previously
announced, are focusing on the main risk groups: PanFAM
-1 for Familiar/hereditary pancreatic cancer risk
group, PanDIA-1 for New onset diabetes type
II associated pancreatic cancer; and PanSYM-1 for risk
groups with symptom profiles associated to pancreatic
cancer.
- The interim analysis of PanFAM-1 may be postponed to
Q1/Q2 2021, depending on the development of the
COVID-19 pandemic situation. PanDIA-1 interim analysis will not be
affected as sample collection is well advanced already at this
stage and we are confident that we also will be able to enter the
interventional phase of PanSYM as planned in early 2021, to show
clinical utility of differential diagnosis of pancreatic cancer
versus symptomatic non-PDAC patients.
Update on Commercial Launch Preparation Activities:
- Pre-launch activities have been refocused to online meetings
and presentations as clinical conferences and patient
organization meetings have been cancelled or postponed due to the
COVID-19 related restrictions on larger meetings. We
have been increasing our digital plans and activities for these
target groups as well as continuing planning for our presence in
later conferences and patient organization meetings.
- Immunovia's commercial team have concentrated their
efforts on maintaining a high level of launch and sales
preparation activities during these times to achieve our goal to
start sales Q3 2020.
Live Call Details:
Wednesday, April 1, 2020 at
16:30 CET. To attend, please
dial-in at one of the numbers below and provide the conference code
Immunovia to the operator:
Conference Numbers:
Sweden: +46 (0) 8 50 520
424
Austria: +43 (0) 12530807
Germany: +49 (0) 30 3001 90612
Denmark: +45 3271 4573
Switzerland: +41 (0) 22 592
7103
Spain: +34 91 787 0777
Netherlands: +31 (0) 20 794
8426
United States: +1 212 999 6659
Norway: +47 2156 3318
France: +33 (0) 1 7037 7166
United Kingdom (standard
international access): +44 (0) 20 3003 2666
Conference Code: (to provide to the operator)
Immunovia
Immunovia Webcast:
https://channel.royalcast.com/webcast/immunovia/20200401_1/
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 16:00 CET on
April 1, 2020.
About Immunovia
Immunovia AB is a diagnostic company that is developing and
commercializing highly accurate blood tests for the early detection
of cancer and autoimmune diseases based on Immunovia's
proprietary test platform called IMMray™. Tests are based on
antibody biomarker microarray analysis using advanced
machine-learning and bioinformatics to single-out a set of relevant
biomarkers that indicate a certain disease. Thus, forming a unique
"disease biomarker signature".
The company was founded in 2007, based on cancer studies and
ground-breaking research in the Department of Immuntechnology at
Lund University and CREATE Health
Cancer Center, Sweden.
The first product, IMMray™ PanCan-d, is undergoing clinical
evaluation in some of the world's largest clinical studies for
pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is
currently entering the final validation for sales start Q3
2020. When validated, IMMray™ PanCan-d will be the first
blood-based test for early diagnosis of pancreatic cancer on the
market, with a potential to significantly improve patient survival
and outcome.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
For more information, please contact:
Julie Silber
Director of Investor Relations
Email: julie.silber@immunovia.com
Tel: +46-7-93-486-277
This information was brought to you by Cision
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https://news.cision.com/immunovia-ab/r/immunovia-takes-action-during-covid-19-pandemic-and-remains-focused-on-launch-of-immray--pancan-d,c3079118
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