Locally Advanced Hepatocellular Carcinoma

Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, has previously announced that detailed and mature data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima® (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 16, 2024. The abstract, titled “Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a study.” will be presented by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea. After the presentation Medivir will also host a webcast where Dr Chon and Dr Pia Baumann, Chief Medical Officer at Medivir, will present the data and answer questions. The webcast will take place on September 16, at 13.45 CET, and will be streamed via a link on the website: www.medivir.com/investors/presentations. In addition to the presentation of phase 1b/2a data, Dr Chon with his experience of treating liver cancer patients, will provide additional context to the data by comparing with what can be expected with current clinical practice in second-line. The poster and the presentation from the webcast will be available on Medivir’s website after the webcast. For additional information, please contact; Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100. E-mail: magnus.christensen@medivir.com About fostrox Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile. About primary liver cancer Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1,2. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a drug candidate designed to selectively treat cancer cells in the liver and to minimize side effects. Collaborations and partnerships are important parts of Medivir’s business model, and the drug development is conducted either by Medivir or in partnership. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list. www.medivir.com. 1)Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118. 2)Yang, J.D., Hainaut, P., Gores, G.J. et al. A global view of hepatocellular carcinoma: trends, risk, prevention and management. Nat Rev Gastroenterol Hepatol 16, 589–604 (2019).

STOCKHOLM , July 18, 2024 /PRNewswire/ -- Medivir AB (NASDAQ: MVIR) (STOCKHOLM: MVIR) , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, is pleased to announce that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima® (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 13-17, 2024. The abstract, titled "Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a study." will be presented by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea. Updated clinical data from the ongoing phase 1b/2a study with fostrox in combination with Lenvima. will be presented. As patients are able to stay on treatment long-term, it enables a detailed update on the safety and tolerability profile and how it evolves over time. The presentation will also include additional updates on efficacy endpoints. The poster will be available on Medivir's website after the presentation. For additional information, please contact: Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100. E-mail: [email protected] About fostrox Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile. About primary liver cancer Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1,2. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. . 1) Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118. 2) Yang, J.D., Hainaut, P., Gores, G.J. et al. A global view of hepatocellular carcinoma: trends, risk, prevention and management. Nat Rev Gastroenterol Hepatol 16, 589–604 (2019). This information was brought to you by Cision The following files are available for download: SOURCE Medivir

WOBURN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced multiple presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 31-June 4, 2024. The Company has two abstracts selected for oral presentation, including an updated presentation of investigator-assessed 12-month data from the IGNYTE clinical trial of RP1 (vusolimogene oderparepvec) plus nivolumab in anti-PD-1 failed melanoma, and another presentation showcasing data from the Phase 1 trial of RP2 combined with nivolumab in advanced uveal melanoma. In addition, RP1 and RP2 are also featured in three trial-in-progress posters. Details for the presentations are as follows: Oral data presentations Abstract Title: Efficacy and safety of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma from the IGNYTE clinical trial. Data included in the presentation will be 12-month investigator-assessed data with a cutoff date of March 8, 2024, as compared to the abstract which includes 6-month investigator-assessed data. As previously disclosed, the topline 12-month primary analysis results by independent central review are expected later in Q2 2024. Session Title: Melanoma/Skin CancersDate: June 3, 2024; 10:57-11:03 AM CDTLocation: S406Abstract: 9517 Abstract Title: Safety, efficacy, and biomarker results from an open-label, multicenter, phase 1 study of RP2 alone or combined with nivolumab in a cohort of patients with uveal melanoma. Session Title: Melanoma/Skin CancersDate: June 3, 2024; 9:57-10:03 AM CDTLocation: S406Abstract: 9511 Trial-in-progress poster presentations Abstract Title: A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec (VO) combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti-PD-1 and anti-CTLA-4 therapy (IGNYTE-3). Poster Session Title: Melanoma/Skin CancersDate: June 1, 2024, 1:30 PM-4:30 PM CDTLocation: Hall A, Poster Board 385bAbstract: TPS9604 Abstract Title: An open-label, multicenter study investigating RP2 oncolytic immunotherapy in combination with second-line systemic atezolizumab combined with bevacizumab in patients with locally advanced unresectable or metastatic hepatocellular carcinoma Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and HepatobiliaryDate: June 1, 2024, 1:30 PM-4:30 PM CDTLocation: Hall A, Poster Board 165bAbstract: TPS4191 Abstract Title: IST: Trial in progress: A phase 1/2 study of Vusolimogene oderparepvec in primary melanoma (mel) to reduce the risk of sentinel lymph node (SLN) metastasis. Poster Session Title: Melanoma/Skin CancersDate: June 1, 2024, 1:30 PM-4:30 PM CDTLocation: Hall A, Poster Board 390bAbstract: TPS9614 About RP1RP1 is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP-R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. About RP2RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP-R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. Forward Looking StatementsThis press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris BrinzeyWestwicke, an ICR Company339.970.2843chris.brinzey@westwicke.com Media InquiriesArleen Goldenberg Replimune917.548.1582media@replimune.com