ELC-401 / Elicera Therap - LARVOL DELTA

Elicera Therapeutics AB…announced that it has received a Notice of Allowance from the USPTO (United States Patent and Trademark Office) regarding its patent application for the CAR T-cell candidate ELC-401 (Elicera Press Release) - "The patent application protects Elicera's special antibodies that recognize and bind to the protein IL-13Ra2...as well as uses thereof in cancer treatment, such as CAR-T cell therapies. The patent gives Elicera exclusive rights in U.S. to develop and sell treatments based on these anti-IL-13Ra2 antibodies and related technologies for cancer treatment. This strengthens the company's protection for ELC-401 (its CAR-T cell candidate against glioblastoma) and other future products based on the same principle."

Patent • Glioblastoma

Elicera Therapeutics AB…announces that the company held a scientific advice meeting with the Swedish Medical Products Agency (MPA) regarding the planned first-in-human clinical study of ELC-401, the company’s iTANK-armed CAR T-cell candidate targeting IL13Ra2 in grade IV glioma (Elicera Press Release) - "During the meeting, Elicera presented its proposed trial design and received supportive and constructive regulatory guidance from the MPA regarding the clinical protocol, dose-escalation strategy, and product manufacturing specifications. The agency confirmed that the submitted preclinical data package is considered sufficient to support the initiation of clinical development."

First-in-human • New trial • Glioma

Elicera Therapeutics receives Notice of Allowance for Japanease patent protecting the ELC-401 CAR T-cell candidate (Elicera Press Release) - "Once the patent has been granted, it can be maintained in force until 2041. The patent protects Elicera's special antibodies that recognize and bind to the protein IL-13Ra2 (which is often present in large quantities on cancer cells, particularly brain tumors), as well as uses thereof in cancer treatment, such as CAR-T cell therapies."

Patent • Brain Cancer • CNS Tumor

Elicera Therapeutics provides update on preclinical CAR T-cell program ELC-401 for glioblastoma… (Elicera Press Release) - "Preclinical development of ELC-401 has been successfully concluded. Through preclinical studies, the company has determined that local administration of CAR-T cells represents the optimal route of delivery to overcome the blood-brain barrier (BBB) and ensure effective CAR T-cell trafficking to tumors in the brain. Elicera has advanced toward clinical development with a planned phase I/Ib dose-escalation/expansion trial. The proposed study design includes: Enrollment of 12 patients across four arms (three patients per arm), phase Ia....The proposed study design will be discussed with the Swedish Medical Products Agency (MPA) during a scientific advice meeting scheduled for mid-June 2026....The clinical trial could potentially commence during the second half of 2027."

New P1 trial • Preclinical • Glioblastoma

Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2024 (Cision) - "The final preparations are under way ahead of the start of CARMA...The final preparations for enrolling the first patients in the autumn are presently under way, and we believe that we will be able to report interim data from the first dosage group in early 2025. The results from the dose-escalation study will then be expected in the second half of 2025, depending on how patient recruitment progresses. The results from the second part of the study will be expected 6 to 12 months later, also depending on how quickly we can include patients in the study...We recently announced that our head of research, Magnus Essand, had been awarded a research grant of approximately SEK 4 million to conduct further preclinical studies with ELC-401....Given that the last patient in the AdVince-study still has to be identified, we aim to report the final study results in second half of 2025."

Financing • P1/2 data • Trial status • Hematological Malignancies • Lymphoma • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Elicera Therapeutics’ co-founder Magnus Essand invited to present the company's CAR T-cell projects at the world's largest cancer immunotherapy conference, CICON (Elicera Press Release) - "Elicera Therapeutics AB...today announced that the company's Chief Scientific Officer and co-founder, Professor Magnus Essand, has received a prestigious speaking invitation from the Eighth International Cancer Immunotherapy Conference (CICON)...CICON is the world's largest recurring conference in the field of cancer immunotherapy and is being held this year in Washington, DC, between September 8 and 11....In his presentation, Magnus Essand will focus on the company's CAR T-cell programs ELC-301 and ELC-401, which are being developed for the treatment of diffuse large B-cell lymphoma and glioblastoma, respectively. Both programs use Elicera's unique iTANK technology platform to strengthen and broaden the effect of the treatments and reduce the risk of disease recurrence."

Clinical • Brain Cancer • CNS Tumor • Diffuse Large B Cell Lymphoma • Glioblastoma • Glioma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Elicera Therapeutics participates in a collaborative project for the development of improved CAR T-cell production that has been awarded research support of SEK 850 thousand (Elicera Press Release) - "Elicera Therapeutics AB...announced that a collaborative project with Vecura at Karolinska University Hospital and Uppsala University has been awarded SEK 850,000 from the Center for Advanced Medical Products (CAMP). The purpose of the project is to develop an automated production process of CAR T-cells (ELC-401) for use in clinical studies...The production process will be developed in a research lab at Uppsala University, and tech-transferred to Vecura – a GMP manufacturing unit for advanced therapy medicinal products at Karolinska University Hospital. Elicera contributes by providing the research grade and GMP grade vector necessary for implementation. The goal is to generate better quality of ELC-401 drug product, and reduce the lead time between extraction of T-cells and treatment with the finished CAR T-cells....The project will be run within the framework of the development of the company's CAR T-cell therapy ELC-401 against glioblastoma. The project..."

Licensing / partnership • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Elicera Therapeutics' co-founder receives a grant totalling 4.8 MSEK from the Swedish Childhood Cancer Fund to support CAR T-cell research (Elicera Press Release) - "Elicera Therapeutics AB (publ)...today announced that that its co-founder, Professor Magnus Essand, has received a total of 4.8 MSEK in funding from the Swedish Childhood Cancer Fund. The research project, which spans over three years, will be conducted by professor Magnus Essand's research group at Uppsala University and aims to investigate the ability of CAR T-cells to induce immunity in brain tumors in children....The research grant from the Swedish Childhood Cancer Fund is awarded to Uppsala University, and the results generated in the project will contribute to the understanding of whether Elicera's cell therapy candidate ELC-401 could also be used in the future to treat brain tumors in children."

Financing • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2023 (Elicera Press Release) - "The objective for both ELC-201 and ELC-401 during the year is to produce clinical development plans, including trial design and costs for the forthcoming Phase I/II trials, and thereafter to decide how the programs should best be advanced and financed – by Elicera alone or potentially together with a partner."

Clinical protocol • Commercial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Elicera Therapeutics publishes a scientific article in Nature Communications about the CAR T construct in the ELC-401 program (Market Screener) - "Elicera Therapeutics AB...today announced the publication of a scientific article in the prestigious journal, Nature Communications, describing the CAR T construct in the ELC-401 program...The publication...describes the chimeric antigen receptor (CAR), that ELC-401 uses to bind to the target IL13Ra2 and which Elicera plans on using to treat the brain tumor form glioblastoma....Furthermore, the article shows the importance of thoroughly screening the CAR molecules that are produced in order to be able to manufacture functional CAR T-cells with the ability to persist and kill tumor cells over longer periods of time. This is of utmost importance to prevent relapse after CAR T-treatment."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor