Mendus AB

The US Food and Drug Administration (FDA) approved the trial protocol for the registrational Phase III trial for OSE’s Tedopi in January. Image Credit: Lubo Ivanko / Shutterstock. OSE Immunotherapeutics has received €8.4m ($9m) in non-dilutive funding from the ‘France 2030’ plan funded by the French Government. The public funds will finance the registrational Phase III trial evaluating OSE’s cancer vaccine, Tedopi, as a second-line treatment for patients with HLA-A2 positive non-small cell lung cancer (NSCLC). The funds were dispersed by Bpifrance on behalf of the government as part of a research and development (R&D) innovation loan programme. The US Food and Drug Administration (FDA) approved the registrational Phase III trial protocol in January 2024. The company also concurrently filed for FDA approval for the companion diagnostic test for Tedopi , developed by Genome Diagnostics. OSE plans to initiate the registrational Phase III trial in the US in Q2 this year, following the approval from ethics committees. The company also plans to file for trial protocol approval with the European Medicines Agency (EMA). It will begin trial initiation across European sites, including France, following trial protocol approval. Tedopi is a neoepitope-based immunotherapy activating tumour-specific T-cell cancer vaccine. Apart from the planned Phase III trial, OSE also evaluated the cancer vaccine as a third-line therapy in advanced NSCLC patients in another Phase III Atalante-1 trial (NCT02654587). The study found that Tedopi led to a 41% reduction in risk of death compared to chemotherapy in patients with secondary resistance to immune checkpoint inhibitors. See Also: Eagle Pharmaceuticals gets grant for long-term stable bendamustine-containing composition in sterile vial BeyondSpring gets grant for treating cancer expressing mutant ras protein with plinabulin OSE is also conducting three Phase II trials evaluating Tedopi as a combination therapy in solid tumours such as pancreatic, ovarian and lung cancers. Data from the Phase II trials (NCT04713514 and NCT04884282) for Tedopi in combination with MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab), respectively, is expected in 2025. Multiple companies are developing cancer vaccines for different cancers. US-based Diakonos Oncology is developing a dendritic cell vaccine, DOC1021, for malignant glioma. Earlier this year, the vaccine was awarded an orphan drug designation by the FDA. Sweden-based Mendus is developing its cancer vaccine, vividencel, for treating acute myeloid leukaemia. The vaccine was granted a fast track designation by the FDA in September 2023.

The global market for AML therapies is expected to be worth $6.62bn in 2031, according to a GlobalData report. Image Credit: LALAKA / Shutterstock. Massachusetts-based company Edgewood Oncology has raised $20m in Series A to advance the clinical development of its lead cancer therapy BTX-A51. The Series A funding round was led by US-based venture fund Alta Partners. Edgewood Oncology expects the funds to finance multiple clinical trials into 2026. BTX-A51 is a multi-kinase inhibitor of casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9). Edgewood acquired the rights to the therapy from the Hebrew University of Jerusalem in 2023. Edgewood is evaluating BTX-A51 in an open-label Phase I/II trial (NCT04243785) as a monotherapy and in combination with a chemotherapeutic, azacitidine, in patients with relapsed/refractory acute myeloid leukaemia (r/r AML). In Phase Ia, the BTX-A51 monotherapy showed a favourable safety profile along with encouraging antileukemic activity. The combination cohort started enrolment in December 2023. The cohort is expected to enrol up to 30 participants. The cohort aims to evaluate the response rate, safety, toxicity, and pharmacokinetics of the combination therapy of BTX-A51 and azacytidine in patients with r/r AML. See Also: Oncology in 2024: The clinical trial trends reshaping the role of CROs Avenzo Therapeutics secures $150m to progress oncology pipeline The global market for AML therapies is expected to be worth $6.62bn in 2031, according to a GlobalData report . The AML therapy pipeline consists of more than 200 drugs in early development, with the majority of drugs in development being enzyme inhibitors, according to GlobalData Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology . Edgewood is also investigating BTX-A51 as a treatment for solid tumours and non-Hodgkin lymphoma, open-label Phase I trial (NCT04872166). The study expects to enrol up to 116 participants and is estimated to be completed in May 2027. The company also plans to initiate a Phase II trial evaluating BTX-A51 in breast cancer patients with a genetically defined profile in Q2 2024. Advances in AML therapies include Daiichi Sankyo ’s Vanflyta (quizartinib). In November 2023, the European Commission (EC) approved Vanflyta as an add-on therapy for newly diagnosed fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive AML in adults. In September 2023, Mendus’s cancer vaccine, vividencel, received fast-track designation from the US Food and Drug Administration (FDA). A month later, Sellas Life Sciences Group’s CDK9 inhibitor, SLS009, received an orphan drug designation from the FDA. AML therapies in early development include Aptose Biosciences ’ tuspetinib. The company started the Phase I/II APTIVATE trial evaluating the drug’s pharmacodynamics, tolerability, safety, and pharmacokinetics in r/r AML patients in January. In September 2023, Foghorn Therapeutics dosed the first patient in the Phase I trial evaluating the combination therapy of FHD-286 and chemotherapy in patients with r/r AML.

Press Release Stockholm, Sweden, March 19, 2024 Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces that it will present the progress of its NK cell program at the 9th Annual Innate Killer Cell Summit, a leading conference for NK cell-based therapies. Mendus Director of Research Satwinder Kaur Singh, PhD will be expert speaker at the 9th Annual Innate Killer Summit held March 18-20 in San Diego, CA, USA. The Innate Killer Summit is a leading global conference dedicated to advancing NK cell therapies to clinic. This year’s theme of the conference is “Improve Functionality & Streamlining Manufacture to Realise the Potential of NK Therapies.” Dr Singh will present research data demonstrating the use of Mendus’ DCOne platform to expand so-called memory NK cells, their phenotypic and functional characterization and the steps taken by Mendus to develop a manufacturing process suitable for therapeutic purposes. The presentation will be part of the CMC and Process Development Track held today, March 19. “Following our initial discovery that the DCOne platform can be used to expand memory NK cells, we have made significant progress in the preclinical validation of the method, including tumor cell killing experiments. We have made the expansion protocol more robust and successfully performed the first in-house experiments with manufacturing systems suitable for the production of therapeutic quantities of memory NK cells,” says Alex Karlsson-Parra, Chief Scientific Officer of Mendus. “We are therefore excited to present our NK cell program at the Innate Killer Summit.” Natural Killer (NK) cells are part of the innate immune system and form a first line of defense against infections and tumor cells. Unlike T cells, NK cells are not restricted to individual antigens and therefore may offer broader therapeutic applications. Key challenges to develop NK cell therapies are a better understanding of NK cell biology and manufacturing. Memory NK cells have superior persistence and tumor cell killing capacity and the presence of memory NK cells is associated with improved survival in blood-borne tumors. Memory NK cells therefore hold great therapeutic promise, but their therapeutic application is dependent on the development of reliable expansion methods. Mendus has developed a novel method to expand memory NK cells derived from healthy donors based on the company’s proprietary DCOne platform, which provides for an off-the-shelf source of cells that combine cancer cell and dendritic cell biology. The presence of activating ligands on the cell surface of DCOne-derived mature dendritic cells provide a mechanistic rationale for the observed expansion of memory NK cells with well-characterized molecular signatures. For more information, please contact:Erik Manting, CEOE-mail: ir@mendus.com About Mendus AB (publ)Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ Attachment 240319_Mendus_Innate Killer Summit 2024_ENG