IMC-nyeso(Immunocore Ltd.)

Adaptimmune Therapeutics plans to initiate a rolling FDA submission for its T-cell receptor (TCR) therapy letetresgene autoleucel (lete-cel) by the end of 2025, following positive Phase II data in rare sarcomas. "These data underscore lete-cel's potential to transform the lives of people with these cancers who have a poor prognosis and few treatment options," said Elliot Norry, chief medical officer.The announcement Wednesday comes just months after Roche terminated $3-billion cell therapy collaboration with the company on allogeneic αβ T-cell therapies (see – Vital Signs: Tracking the shrinking returns in I-O, and who has the most to lose).The pivotal IGNYTE-ESO trial met its primary endpoint with a 42% overall response rate across both synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) patients. Among 64 participants who received the therapy, there were six complete responses and 21 partial responses, with similar efficacy seen in both cancer types.Adaptimmune said the responses proved durable, with a median duration of 18.3 months in synovial sarcoma and 12.2 months in MRCLS. The median progression-free survival across both indications was 5.3 months.The engineered TCR T-cell therapy targets NY-ESO-1, a tumor antigen highly expressed in both cancer types. Safety findings aligned with previous data, with cytopenia, cytokine release syndrome, and rash being the most common adverse events.Adaptimmune noted that one-third of synovial sarcoma cases are diagnosed in people under 30. The five-year survival rate for metastatic disease is just 20%. Meanwhile, MRCLS makes up about 30% of all liposarcoma cases, and is more common in people aged 20 to 40 years old, the company added.

Planegg/Martinsried, October 24, 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, today reported financial results and provided a business update for the third quarter ended September 30, 2024. The Quarterly Statement Q3 2024 can be found on the website: https://medigene.com/investors-media/reports-presentations/. "During the third quarter of 2024, our focus remained on executing our strategic plan and creating additional value for both patients and our shareholders, beyond T cell receptor engineered T cell (TCR-T) therapies, by expanding our ability to apply our sensitive, specific and potentially safer (3S) TCRs into new modalities,” said Selwyn Ho, CEO at Medigene. “We are excited to have announced a three-year strategic partnership with WuXi Biologics to co-research TCR-guided T Cell Engagers (TCR-TCEs) for solid tumors, extending our pipeline. Our MDG3010 program will be a joint development with WuXi Biologics, aiming to create bispecific therapeutics that target cancer cells with precision while minimizing off-target effects. The target for this bispecific will be revealed later. As for our lead program MDG1015, we received FDA clearance for our investigational new drug application and are on track for the clinical trial application submission filing with the European Medicines Agency (EMA) in Q4 2024. In line with our guidance since 2023, and subject to additional financing, we anticipate initiating and generating an early data read-out for the EPITOME-1015-I trial by the end of 2025.” Financial and corporate development The financial performance in Q3 2024 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 1.4 million during the third quarter of 2024, derived primarily from the partnership with BioNTech. R&D expenses for the quarter amounted to EUR 2.7 million, reflecting our ongoing commitment to advancing our pipeline. As of September 30, 2024, the Company holds cash and cash equivalents in the amount of EUR 9.5 million. During the quarter, a 2:1 share capital reduction and consolidation of the shares was executed, as resolved by the AGM on June 24, 2024. This reduced the number of shares following the previous withdrawal of one share, from 29,475,188 to 14,737,594, with the newly converted shares trading under WKN A40ESG (ISIN: DE000A40ESG2) since August 29, 2024. The measure did not affect the company’s value or individual shareholders' ownership percentages and resulted in a reclassification from “subscribed capital” to “capital reserves” on Medigene AG’s balance sheet, aimed at raising the market value per share above the notional par value of one euro. Subsequent to the quarter, Medigene announced that the Company has secured a financing option through an equity commitment of up to EUR 15 million through a Standby Equity Purchase Agreement (SEPA) with a fund managed by Yorkville Advisors Global L.P. The SEPA enables Medigene to proceed the further development of the Company’s programs. This financing facility is designed to complement potential other sources of financing from both the capital markets and from non-dilutive sources from current and potential future partners and offers significant flexibility to deploy capital. As such, and unchanged from previous guidance, the Management Board therefore maintains its guidance and retains cash runway into July 2025 based on current plans. From a partnering perspective, Medigene entered a three-year, multi-target strategic partnership with WuXi Biologics to design and co-research TCR-guided T Cell Engagers (TCEs) for the treatment of solid tumors. The MDG3010 program aims to co-develop TCR-TCE constructs, jointly owned with WuXi Biologics, with Medigene retaining the option to further advance their development. These constructs will integrate Medigene’s highly specific 3S TCRs for precise target recognition with WuXi Biologics' anti-CD3 mAb, TCE platform, and proprietary bispecific antibody platform, WuXiBody™. Scientific and clinical development The company’s lead program, MDG1015, a first-in-class, third-generation NY-ESO-1 / LAGE-1a targeted TCR-T therapy combining a 3S TCR with the PD1-41BB costimulatory switch protein (CSP), has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application to initiate a phase 1 clinical trial (EPITOME1015-I) for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma. The submission of the clinical trial application (CTA) to the European Medicines Agency (EMA) remains on schedule for Q4 2024. During the quarter, Medigene presented at various scientific conferences. Latest pre-clinical data for MDG2021, the second TCR-T therapy within the KRAS library targeting KRAS G12D mutation with HLA-A*11, were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in September. In addition, the latest expansion of Company’s End-to-End Platform, UniTope & TraCR, an innovative combination of universal TCR tagging and tracking, was presented at the ESMO Congress 2024 in September as well as the American Society of Gene & Cell Therapy Annual Meeting in October. In Q3 2024, Medigene further advanced its intellectual property portfolio, which as of September 30, 2024, comprised 29 patent families with 104 issued patents and 124 pending applications. In July 2024, a patent was granted protecting TCR targeting NY-ESO-1 / LAGE 1a, which is the main component of the Company´s lead program MDG1015. In August 2024, the Company announced the receipt of a patent by the European Patent Office protecting the JOVI technology, a method allowing the enrichment of T cells using a specific anti-Cβ antibody. Also in August 2024, the Company announced a patent grant from the Hong Kong Patent Office for its inducible Medigene T cell receptor (iM-TCR) technology, enhancing control and safety of TCR-T therapies. This adds to previously granted patents by the Europe and Japan Patent Offices. --- 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 AG Pamela 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.