Fred Hutchinson Cancer Research Center

Planegg/Martinsried, October 2, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, will present a poster at the American Society of Gene & Cell Therapy (ASGCT) to be held October 16-17, 2024 in Philadelphia, PA in the US. In addition, the Company will host an R&D Event on Medigene’s optimal 3S (specific, sensitive, and safe) TCRs for TCR-guided precision immunotherapies on Thursday, October 10, 2024, at 4.30 pm CEST / 10:30 am ET. ASGCT 2024https://www.asgct.org/events/2024-advancing-gene-and-cell-therapies-for-cancerLocation: Wyndham Philadelphia Historic District, Philadelphia, PADate: October 16-17, 2024 The full abstract is now available on the ASGCT website: https://www.asgct.org/global/documents/abstracts/advancing-publication-v1.aspx Details of the poster presentations are as follows: Abstract and Title: “Seamless Integration of a Universal Epitope into Recombinant TCRs for Tagging and Tracking of TCR-T Cells Expressing 3S TCRs.” Authors: Dolores Schendel, Kanuj Mishra, Justyna Ogonek, Anne-Wiebe Mohr, Doris Brechtefeld, Kathrin Mutze, Barbara LöschProgramID: 31Date and time: Wednesday, October 16, Poster Hall 2, Betsy Ross Ballroom, poster session from 5:30 – 6:45 p.m, poster will be on display from 8 a.m. – 6:45 p.m The poster will showcase the Company's newly introduced technology, UniTope & TraCR, an innovative combination of universal TCR tagging and tracking. This system is designed to significantly enhance the precision and efficiency of T cell receptor identification and monitoring, offering remarkable capabilities for immunotherapy research and clinical applications. Invite to the Company’s R&D event on October 10, 2024Medigene will host an R&D Event on Thursday, October 10, 2024, at 4.30 p.m. CEST / 10:30 a.m. ET. A live Q&A session will follow the formal presentations and discussions. Management will discuss the advantages of the Company’s 3S TCRs across various modalities, including TCR-T, TCR-TCE, and TCR-NK therapies. Principal Investigator of the EPITOME1015-I trial, Dr. David B. Zhen, MD, Associate Professor at both the Fred Hutchinson Cancer Center and the University of Washington School of Medicine, will provide an overview of the lead program, MDG1015, highlighting its innovative approach to addressing unmet needs in solid tumor treatment. Additionally, Medigene’s proprietary End-to-End Platform and its modular approach to generating TCR-guided modalities will be presented, including the latest advancements. Registration details: Date: October 10, 2024 Time: 4.30 p.m. CEST / 10:30 a.m. ET Location: Virtual Webcast registration: Webcast registration here Following the call, an archived webcast will also be accessible on the Investors & Media section of the Medigene website https://www.medigene.com/investors-media/reports-presentations --- end of press release --- About Medigene AG Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene’s MDG1015 received IND approval in Q3 2024 and is filing for CTA in Q4 2024.For more information, please visit https://medigene.com/ This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Medigene AGPamela Keck Phone: +49 89 2000 3333 01 E-mail: investor@medigene.com In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.

J&J and Legend Biotech's Carvykti showed life extension benefit compared with two standard-of-care triplet combinations in earlier treatment of multiple myeloma. After putting on a strong performance in preventing disease progression in the earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti has once again mounted a major benefit—this time in prolonging patients’ lives.A single dose of the star BCMA CAR-T therapy significantly slashed the risk of death by 45% compared with two traditional combination treatments in myeloma patients who had received at least one prior line of therapy, according to an update of the phase 3 CARTITUDE-4 trial. Combinations of either Bristol Myers Squibb’s Pomalyst, Takeda’s Velcade and dexamethasone (PVd), or J&J’s Darzalex, Pomalyst and dexamethasone (DPd) served as the trial's comparators.Although neither arm reached its median overall survival time, 76.4% of patients in the Carvykti cohort were estimated to be alive at month 30, versus 63.8% for the control arm.The data were presented at the 2024 International Myeloma Society (IMS) annual meeting after investigators followed patients in CARTITUDE-4 for a median duration of 33.6 months. An earlier data cut from the study, linking Carvykti to a 59% lower risk of disease progression or death, enabled the med's second-line approval from the FDA in April.As the FDA has pointed out and warned in Carvykti’s label, treatment with the med may come with a higher risk of death early on. But there’s no question about Carvykti’s ability to extend patients’ life expectancy over the long term.The overall survival curves flipped in Carvykti’s favor at around month 12, and its advantage continued to widen after that, the data showed. In fact, the Carvykti curve roughly plateaued at about month 31, indicating that very few deaths happened afterward. The standard-of-care curve continued to experience notable declines every few months. Investigators also offered another look at patients’ quality of life from CARTITUDE-4. Despite starting with relative worse baseline performance on several health metrics such as physical and social functioning, plus pain and fatigue symptoms, patients in the Carvykti arm experienced improved overall health status over time. Their counterparts in the standard-of-care arm didn't experience the same improvements.Patient-reported outcomes from CARTITUDE-4 “remain as stunning as ever to support CAR-T in earlier lines” of myeloma treatment, Rahul Banerjee, M.D., from Fred Hutchinson Cancer Center tweeted Friday. He pointed to how patients’ pain scores were consistently better in the Carvykti arm and “how quickly and durably patient fatigue improves with CAR-T”  compared with the standard-of-care triplet group. An overall survival win further differentiates Carvykti from Bristol Myers Squibb and 2seventy bio’s rival CAR-T therapy Abecma, which wasn’t able to demonstrate that it could extend patients’ lives in the KarMMa-3 trial, which enrolled patients one treatment line later than those in CARTITUDE-4.But Abecma may still have a place in the myeloma market. Also at the IMS meeting, Doris Hansen, M.D. from Moffitt Cancer Center presented a multicenter retrospective study on behalf of the U.S. Multiple Myeloma Immunotherapy Consortium comparing Carvykti with Abecma in previously treated myeloma.The study examined results from 641 real-world patients, including 586 patients who actually received either one of the BCMA CAR-T products as intended. The patients were matched between the two arms based on multiple factors for comparison. Some patients didn’t get the CAR-T drugs mainly because of disease progression, death or manufacturing failures.The updated analysis linked Carvykti to better efficacy, including a 56% reduction in the risk of progression or death, versus Abecma in the entire intent-to-treat population, or 53% in those who were infused. Overall survival was similarly in favor of the J&J/Legend med.However, Carvytki also showed notably higher rates of some toxicities, including severe cytokine release syndrome (5.5 times as likely as Abecma) and delayed neurotoxicity (21 times as likely).“[T]his confirms what many of us have seen anecdotally,” Banerjee said Friday in another X post, pointing to the increased efficacy but certain adverse events with Carvykti.This analysis will help doctors select between the two products based on the patient characteristics. Carvykti, viewed as the more efficacious BCMA CAR-T therapy, has been pulling ahead of Abecma in market share. In another blow to Abecma, BMS and 2seventy last week decided to discontinue the phase 3 KarMMa-9 trial, which had been evaluating Abecma as a first-line maintenance treatment in patients with newly diagnosed multiple myeloma who had experienced a suboptimal response to a stem cell transplant. Carvykti's first-line studies are moving forward: CARTITUDE-5 has finished enrollment while CARTITUDE-6 is expected to be fully enrolled next year.

MIAMI, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the following upcoming October 2024 investor conferences: Lytham Partners Fall 2024 Investor Conference Date and Time: Tuesday, October 1, 2024 at 4:15 p.m. ETLocation: Virtual Format: Fireside Chat and 1x1 MeetingsRegistration link for the event: https://lythampartners.com/fall2024invreg 3rd Annual ROTH Healthcare Opportunities Conference Date: Wednesday, October 9, 2024Location: New YorkFormat: 1x1 Meetings A replay of the fireside chat at the Lytham Partners Fall 2024 Investor Conference will be available shortly after the conference on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Company Contact:Jaclyn JaffeFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com