| | LUND, SWEDEN, April 1, 2020 /PRNewswire/ -- Immunovia (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
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