Hasselt University

ROTTERDAM, Netherlands and SAN DIEGO, Dec. 11, 2023 /PRNewswire/ -- SkylineDx, an innovative molecular diagnostics company, is thrilled to announce that a collaborative project for precision medicine, POINTILLISM 2.0, has been selected for funding as part of the prestigious VIB Grand Challenges Program1. This program aims to stimulate the development of socially impactful science. The significant milestone marks the first result of the company's strategic partnership2 with VIB, Flanders' leading life sciences institute, and potentially signifies an important step forward in the field of cancer immunotherapy for patients with advanced malignant melanoma (aMM) and triple-negative breast cancer (TNBC). POINTILLISM 2.0, officially titled "Validation of Multi-Parametric Predictive Biomarkers for Cancer Immunotherapy," is set to commence in December 2023 and will extend over a period of three years. This project is designed to independently validate several promising markers discovered in POINTILLISM 1.0. POINTILLISM 1.0 used innovative single-cell technologies to identify mechanisms of response to immune checkpoint blockade (ICB) in first-line treatment of aMM and neoadjuvant treatment of TNBNC. POINTILLISM 2.0 is a collaborative effort that reflects its interdisciplinary nature by bringing together research and tech transfer groups from VIB, KU Leuven and Skyline Dx, as well as oncologists, surgeons, pathologists from the University Hospital (UZ) Leuven, to work in synergy. The project benefits from the expertise of VIB-KU Leuven's Center for Cancer Biology (CCB), which is renowned for its work in studying the tumor microenvironment and the molecular and cellular mechanisms of cancer cells as well as the valorization expertise of the VIB Innovation & Business team. Unique aspects of this project include the collection of retrospectively and prospectively collected blood and tumor samples from cancer patients, the assessment of multiple markers of response, and the exploration of baseline and on-treatment predictive biomarkers in both tumor and liquid biopsies. Additionally, POINTILLISM 2.0 is designed to create lasting societal impact. ICB is effective for treatment of various cancers, but unfortunately only a subset of patients responds to these therapies. An important unmet clinical need is to identify biomarkers that predict which patients are likely to respond or develop resistance, sparing non-responders severe adverse events and mitigating unsustainable healthcare costs associated with these agents. Dharminder Chahal, SkylineDx CEO, said: "POINTILLISM 2.0 represents a crucial step toward personalizing cancer treatment and improving patient outcomes. We are proud to partner with VIB and esteemed researchers to bring this pioneering project to fruition. This exciting collaboration demonstrates the power of partnerships between industry and academia in driving innovation and advancing healthcare solutions." About SkylineDx SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit . About VIB VIB's core mission is to generate disruptive insights in the molecular underpinning of life and to translate these actively into impactful innovations for patients and society. VIB is an independent research institute where some 1,800 top scientists from Belgium and abroad conduct pioneering basic research. As such, they are pushing the boundaries of what we know about molecular mechanisms and how they rule living organisms such as human beings, animals, plants, and microorganisms. Based on a close partnership with five Flemish universities – Ghent University, KU Leuven, University of Antwerp, Vrije Universiteit Brussel, and Hasselt University – and supported by a solid funding program, VIB unites the expertise of all its collaborators and research groups in a single institute. VIB's technology transfer activities translate research results into concrete benefits for society such as new diagnostics and therapies and agricultural innovations. These applications are often developed by young start-ups from VIB or through collaborations with other companies. This also leads to additional employment and bridges the gap between scientific research and entrepreneurship. VIB also engages actively in the public debate on biotechnology by developing and disseminating a wide range of science-based information. More info can be found on . About the VIB Grand Challenges Program Science can make great contributions to societal progress and increased well-being. To further stimulate the development of socially impactful scientific advances, VIB has established the VIB Grand Challenges Program. Through the 'grand challenges strategy', VIB seeks to support and stimulate global, transdisciplinary, multi-institutional collaborative projects. In each of these projects, various VIB groups collaborate with several external partners from universities and university hospitals across Flanders and beyond. This form of cooperation ensures that new hypotheses can be tested starting from observations, issues and needs out of practice, leading to new insights that can concomitantly be validated in a clinical setting with the final aim to result in benefits for patients. More info can be found on About KU Leuven KU Leuven is Europe's most innovative university (Reuters) and ranks 45nd in the Times Higher Education World University rankings. As Belgium's largest university, KU Leuven welcomes 65,000 students from over 140 countries. Its 8,000 researchers are active in a comprehensive range of disciplines. KU Leuven is a founding member of the League of European Research Universities (LERU) and has a strong European and international orientation. University Hospitals Leuven, its network of research hospitals, provides high-quality healthcare and develops new therapeutic and diagnostic insights with an emphasis on translational research. About UZ Leuven UZ Leuven is a university hospital where patients can count on specialised care and innovative treatments, combined with humane attention and respect for every person. Every day, more than 10,000 passionate employees provide the best possible custom-made care. Future care providers and employees receive high-quality training in UZ Leuven, with a view lifelong learning and innovation. As a pioneer in clinical research, the hospital also contributes to future patient care. Footnotes: 1. 2. . SOURCE SkylineDx

Total Potential Development and Commercial Milestones of $32M plus Royalties Leuven, BELGIUM, Boston, MA, US – July 25, 2023 – 8:00 am CET – Oxurion NV (Euronext Brussels: OXUR) a biopharmaceutical company developing next-generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, announced today that it received approximately $400,000 in an upfront payment following the exercise of an option by a third party to license a preclinical oncology asset previously owned by its subsidiary, Oncurious, which had recently been transferred to VIB. Oxurion signed a profit-sharing agreement with VIB covering the asset in September 2022. The terms of this agreement included Oxurion receiving approximately 80% profit-sharing in any transaction for the asset, according to which Oxurion could receive more than $32 million in developmental, regulatory and commercial milestone payments, in addition to market conforming royalties on sales. Tom Graney, CEO of Oxurion, said, “We are delighted by the successful collaboration between VIB and its partner that will continue the development of what we view as a valuable preclinical asset addressing a key oncology target with an innovative scientific approach. The upfront payment will contribute to Oxurion’s investments in THR-149, being evaluated in a Phase 2 clinical trial as a potential treatment for of diabetic macular edema, which is expected to readout topline results by the end of this year.” Jérôme Van Biervliet, Managing Director VIB, said, “In the partnership with Oncurious, great progress was made based on scientific breakthroughs discovered at VIB. For the next phase of development, VIB and Oxurion are convinced that these innovative therapeutics deserve the most optimal setting for translation to the patient.” Oncurious is a wholly owned subsidiary of Oxurion that has been developing oncology therapies focused on antibody immunotherapy. About VIB VIB’s core mission is to generate disruptive insights in the molecular underpinning of life and to translate these actively into impactful innovations for patients and society. VIB is an independent research institute where some 1,800 top scientists from Belgium and abroad conduct pioneering basic research. As such, they are pushing the boundaries of what we know about molecular mechanisms and how they rule living organisms such as human beings, animals, plants, and microorganisms. Based on a close partnership with five Flemish universities – Ghent University, KU Leuven, University of Antwerp, Vrije Universiteit Brussel, and Hasselt University – and supported by a solid funding program, VIB unites the expertise of all its collaborators and research groups in a single institute. VIB’s technology transfer activities translate research results into concrete benefits for society such as new diagnostics and therapies and agricultural innovations. These applications are often developed by young start-ups from VIB or through collaborations with other companies. This also leads to additional employment and bridges the gap between scientific research and entrepreneurship. VIB also engages actively in the public debate on biotechnology by developing and disseminating a wide range of science-based information. More info can be found on www.vib.be. About Oxurion Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next-generation standard of care ophthalmic therapies, which are designed to improve and better preserve vision in patients with retinal disorders including diabetic macular edema (DME), the leading cause of vision loss in working-age people, as well as other conditions. Oxurion intends to play an important role in the treatment of retinal disorders, including the successful development of THR-149, its novel therapeutic for the treatment of DME. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the up to 50% of DME patients showing suboptimal response to anti-VEGF therapy. Oxurion is headquartered in Leuven, Belgium, with corporate operations in Boston, MA. More information is available at www.oxurion.com. Important information about forward-looking statements Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws. For further information please contact: Oxurion NVTom GraneyChief Executive OfficerTel: +32 16 75 13 10tom.graney@oxurion.com Michael DillenChief Business OfficerTel: +32 16 75 13 10michael.dillen@oxurion.com USConway CommunicationsMary T. Conwaymtconway@conwaycommsir.com Attachment EN

ExeVir Bio and VIB-UGent’s bioRxiv pre-print reports on S2-binding camelid single-domain antibody-based drug, XVR013, that targets the Achilles’ heel in the SARS-CoV-2 viral spikeFocus on protecting the millions of immuno-compromised patients, who are most vulnerable to COVID-19 GHENT, Belgium, March 13, 2023 (GLOBE NEWSWIRE) -- ExeVir Bio, a biotech company developing robust single domain antibody therapies for broad protection against infectious diseases, and its scientific founders at Belgium’s VIB, Flanders’ leading life sciences institute, today announced the publication of a pre-print paper by De Cae et al., entitled “Ultrapotent SARS coronavirus-neutralizing single-domain antibodies that bind a conserved membrane proximal epitope of the spike”. The pre-print paper is available here. Nearly all SARS-CoV-2 neutralizing antibodies that have been used in the clinic show substantial loss of potency against currently circulating variants. The bioRxiv pre-print details a novel, highly potent, anti-S2 camelid single-domain antibody, discovered at the VIB-UGent Center for Medical Biotechnology, and developed as a candidate drug molecule by ExeVir as XVR013. It targets a conserved region in the spike S2 subunit that is essential for viral entry. It neutralizes all previous and current variants of concern and the currently most frequently circulating variants, including XBB, XBB.1.5, BQ.1.1 and BF.7. These single-domain antibodies bypass the highly immunogenic spots on the S1 part of the COVID-19 virus, that were the targets of all first-generation anti-SARS-CoV-2 antibodies in the clinic. In addition, the anti-S2 single domain antibodies directly neutralize the virus without relying on the patient's own immune system, potentially providing protection for immunocompromised patients who typically do not, or only poorly, respond to COVID-19 vaccines. The S2 subunit of the SARS-CoV-2 spike mediates membrane fusion, an essential step during virus entry. XVR013 prevents this membrane fusion and potently protects against SARS-CoV-2 infection in vitro and in an in vivo model. ExeVir’s COVID-19 pipeline includes XVR012, which is a combination product of the S2-targeting single-domain antibody-based XVR013 reported in the pre-print paper, and XVR014, a bispecific single-domain-based antibody construct which targets two conserved epitopes in the S1 subunit, using an innovative design that will be reported in the future. XVR012 has demonstrated very high neutralization activity against all previous and current variants of concern and the currently most frequently circulating variants and is advancing towards clinical trials for COVID-19. Dr. Torsten Mummenbrauer, CEO of ExeVir, said: “The pandemic isn’t over; it is an ongoing challenge for immunocompromised patients, who total around 3%1 of the world population and remain at high risk of severe COVID-19 disease despite availability of current vaccines. We are therefore delighted to share our positive results in this pre-print paper with our VIB colleagues. It highlights XVR013’s unique and powerful mode of action targeted to a highly conserved epitope of the coronavirus spike protein. This is but one asset in our arsenal of multiple epitope binders which offer the potential of multi-specific binders to the spike protein in one molecule or as a cocktail. XVR013 is a super potent molecule with a single digit nanomolar IC50 against virtually all circulating known variants. It could add an additional layer of protection for the most vulnerable in our population who are unable to build an adequate immune response with current vaccines.” Dr. Bert Schepens of VIB, said: “As there is currently a strong need for antibodies that work against the newest omicron variants, we think it is useful to rapidly communicate to our scientific colleagues about the discovery that targeting this novel membrane-proximal S2 epitope can yield such strong neutralization of SARS-CoV-2. We will be submitting a comprehensive paper for peer review soon. As researchers, it is very motivating that ExeVir, who we have been working closely with, is finalizing the preclinical package to move into the clinic. Together we are enabling great strides towards bringing a long-lasting biologic to treat and protect immuno-compromised and elderly people. Our research, part of which is pre-printed today, has unveiled weak spots in the SARS-CoV-2 spike; a true Achilles’ heel that requires spears with a small tip to reach them well, in the form of our new single domain antibodies.” The new S2-binding camelid single domain antibodies described in the bioRxiv pre-print paper by Sieglinde De Cae were identified and characterized in the lab of Xavier Saelens by the team of Bert Schepens (VIB-UGent Center for Medical Biotechnology). A hybrid molecule based on these camelid single domain antibodies and a human antibody was designed and built in the lab of Nico Callewaert (also VIB-UGent Center for Medical Biotechnology). The interaction between these single domain antibodies and the S2 protein was characterized by Inge Van Molle in the lab of Han Remaut (VIB-VUB Center for Structural Biology). Together these labs form VIB's pandemic drug development response team, which was assembled by the Center for Medical Biotechnology in January 2020. The pharmacodynamic and safety properties of candidate drug molecules based on these S2-binding single domain antibodies were extensively evaluated in vitro and in vivo by ExeVir Bio. [1] Global, regional, and national estimates of the population at increased risk of severe COVID-19 due to underlying health conditions in 2020: a modelling study (thelancet.com) For more information contact: ExeVir BioVeronique Vandevoorde vvandevoorde@exevir.com Scius Communications (for media)Katja Stout+44 778 943 5990katja@sciuscommuications.com Daniel Gooch+44 774 787 5479daniel@sciuscommunications.com VIBJoran Lauwers +32 478 99 33 98joran.lauwers@vib.be About ExeVir Bio ExeVir Bio is a clinical stage biotechnology company developing single-domain antibody based therapeutics focusing on infectious diseases. The company is harnessing its llama-derived antibody (VHH) technology platform to generate multi-specific antibodies for prophylaxis and treatment of infectious diseases. ExeVir’s initial focus is on prevention of COVID-19 for the immunocompromised patient population, including active chemotherapy, immunosuppressive drugs, solid organ transplantation, hematological malignancies, and AIDS patients, where there remains a high unmet need due to the limitations of current vaccines and therapeutic approaches. ExeVir’s COVID-19 pipeline includes XVR012, a combination product of XVR013 and XVR014, a bi-specific single-domain-based antibody construct which targets two conserved epitopes in the S1 subunit. Together they target several S1 and S2 epitopes in one product. ExeVir has demonstrated it can progress its candidates from research to the clinic in under one year, execute on Phase 1a and Phase 1b studies and conduct scale-up manufacturing. Leveraging this extensive experience, its XVR012 asset is being developed for regulatory submission in 2023. ExeVir has also initiated research in dengue, a migrating disease becoming an increasing global health burden due to global warming and urbanization. VHHs are smaller in size than whole antibodies, giving them access to hidden epitopes that traditional monoclonal antibodies are unable to reach with potential for deeper tissue penetration and simpler, more cost-effective manufacturing. VHHs can be linked together like building blocks into a single molecule to tackle different epitopes or act through different mechanisms of actions at once, to address the “arms race” in more complex and co-evolving infectious diseases. ExeVir is a spin out of VIB, the leading Belgium-based life sciences research institute. It is backed by strong investors including Fund+, which led the series A of EUR 42 million, together with an international consortium including UCB Ventures, FPIM, V-Bio Ventures, VIB, SRIW, Noshaq, Vives IUF and SambrInvest. ExeVir has received support from VLAIO, the SPW-Recherche and the European Union, leading to a total of €16.5M in non-dilutive funding. In 2023, Exivir secured an option for EUR 25 million venture debt financing from the European Investment Bank. Find out more on ExeVir’s LinkedIn or on ExeVir’s website About VIB VIB’s core mission is to generate disruptive insights in the molecular underpinning of life and to translate these actively into impactful innovations for patients and society. VIB is an independent research institute where some 1,800 top scientists from Belgium and abroad conduct pioneering basic research. As such, they are pushing the boundaries of what we know about molecular mechanisms and how they rule living organisms such as human beings, animals, plants, and microorganisms. Based on a close partnership with five Flemish universities – Ghent University, KU Leuven, University of Antwerp, Vrije Universiteit Brussel, and Hasselt University – and supported by a solid funding program, VIB unites the expertise of all its collaborators and research groups in a single institute. VIB’s technology transfer activities translate research results into concrete benefits for society such as new diagnostics and therapies and agricultural innovations. These applications are often developed by young start-ups from VIB or through collaborations with other companies. This also leads to additional employment and bridges the gap between scientific research and entrepreneurship. VIB also engages actively in the public debate on biotechnology by developing and disseminating a wide range of science-based information. More info can be found on www.vib.be.