ELC-301 / Elicera Therap - LARVOL DELTA

Promising preliminary results for Elicera Therapeutics’ CAR T-cell study (BioStock) - P1/2a | N=18 | CARMA-01 (NCT06002659) | "Preliminary results from the first patient cohort in Elicera Therapeutics’ ongoing phase I/IIa CARMA study with the drug candidate ELC-301 was presented at the 7th Swedish Cancer Research Meeting in Malmö yesterday....The first patient in Elicera Therapeutics’ phase I/IIa study was disease-free already at the one-month follow-up, an effect that persisted after six months. The second patient showed possible disease progression after three months, which is now being further investigated. The third patient, who, like patient two, had previously been treated with CD19 CAR T-cell therapy, was also disease-free after one month."

P1/2 data • B Cell Lymphoma • Lymphoma

Elicera Therapeutics AB (publ) Interim 1 January - 31 March 2025 (Elicera Press Release) - "Elicera Therapeutics’ clinical Phase I/IIa study with ELC-301 is making significant progress and is planning to report preliminary data during the coming year."

P1/2 data • Non-Hodgkin’s Lymphoma

Elicera Therapeutics continues the Phase I/IIa CARMA study with its CAR T-cell therapy as planned following the safety committee’s assessment of cohort 1 (Elicera Press Release) - "Elicera Therapeutics AB...announced that the Data Safety and Monitoring Board (DSMB) has completed its first assessment of the ongoing Phase I/IIa CARMA clinical trial with the CAR T-cell therapy ELC-301 for the treatment of B-cell lymphoma. The DMSB recommended that the study continue as planned....Elicera intends to report preliminary results from the study as each dosing cohort is completed. Preliminary efficacy data from the first cohort is expected to be presented at the 7th Swedish Cancer Research Meeting in Malmö on May 22."

DSMB • P1/2 data • B Cell Non-Hodgkin Lymphoma

Elicera Therapeutics Receives Notification of Partial Payment of EUR 500,000 from the European Innovation Council Accelerator Programme (Elicera Press Release) - "Elicera Therapeutics AB (publ)...announces today that the company has received notification of a partial payment of EUR 500,000 from the European Innovation Council (EIC) under the framework of its Accelerator Programme. This represents the third payment in a four-part funding program....EIC awarded Elicera Therapeutics the grant to support the clinical development of its innovative cell therapy, ELC-301. The current EUR 500,000 disbursement has been granted following the company’s reported progress in the ongoing Phase I/IIa clinical study CARMA. The fourth and final payment of EUR 375,000 is expected in 2026."

Financing • Non-Hodgkin’s Lymphoma

Elicera Therapeutics Presents Initial Clinical Data from the CARMA Study at ISCT 2025 in New Orleans (Elicera Press Release) - "Elicera Therapeutics AB (publ)...announces today that the company will participate in the scientific conference International Society for Cell & Gene Therapy (ISCT) Meeting 2025 in New Orleans, USA, taking place from May 7 to May 10. At the conference, the company will present initial data from the ongoing clinical Phase I/IIa CARMA study, which show complete tumor remission in the first patient one month after treatment."

P1/2 data • Non-Hodgkin’s Lymphoma

Elicera Therapeutics presents first clinical results from iTANK-armed CAR T-cell therapy at scientific conference (Elicera Press Release) - "Elicera Therapeutics...announces today that the first patient in the CAR T-cell study CARMA, which evaluates the efficacy of ELC-301 against B-cell lymphoma, has been successfully treated. The one-month follow-up after treatment shows that the patient achieved a complete response with only very mild side effects. The treatment outcome will now be presented at the Cancer Crosslinks conference in Oslo on January 23.....Two more patients will be treated with the lowest dose level in the first dosing group (cohort 1). Elicera intends to report structured and consolidated results from the study as each cohort is completed. These data are expected to be presented at scientific conferences in 2025 and 2026."

P1/2 data • Trial status • Non-Hodgkin’s Lymphoma

Elicera Therapeutics includes the first patient in the Phase I/II clinical study CARMA targeting B-cell lymphoma (Elicera Press Release) - "Elicera Therapeutics AB (publ)...announced today that the first patient has been enrolled in the company's Phase I/II clinical study, CARMA. The study aims to evaluate the iTANK-armed CAR T-cell therapy, ELC-301, in patients with hard-to-treat B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma who have not responded to standard treatment or have experienced a relapse of the disease...According to the company’s preliminary timeline, the dose escalation study, including 12 patients in total, is expected to be completed and reported in the second half of 2025. Data from the first dose group of three patients is expected to be reported in first quarter of 2025."

P1/2 data • Trial status • Hematological Malignancies • Lymphoma • Oncology

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 AB (publ) Interim Report 1 January - 31 March 2024 (Elicera Press Release) - "CARMA, our first clinical CAR T-cell study, is expected to start soon and will generate vital findings for both our CAR T-cell therapy ELC-301 and our iTANK gene technology method....According to the current timetable, we expect to be able to treat the first patients after summer and thus present interim data from the first dosage group with three patients at the turn of the year 2024/2025. Provided we reach that milestone on schedule, it should be possible to complete and present a full report on the dose-escalation study in the second half of 2025. The preliminary findings from the second part of the study will be expected approximately 6 to 12 months later. After the treatment phase, a monitoring period of at least two years will follow, which means that CARMA is planned to be completed and reported on in full in 2028."

P1/2 data • Trial status • Non-Hodgkin’s Lymphoma

CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study) (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Uppsala University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Elicera Therapeutics announces outcome in rights issue (Elicera Press Release) - "Elicera Therapeutics AB...has completed the rights issue of units consisting of shares and warrants of series TO2 which the board of directors resolved on January 18, 2024, and was approved at the extraordinary general meeting on February 20, 2024...Through the Rights Issue, the Company will receive approximately SEK 27.6 million before issue costs....'With the new capital we are adding, we will be able to recruit and treat all planned 18 patients in our CAR T-cell study CARMA and be able to reach important value adding clinical milestones. We will also be able to continue the work on commercializing our platform technology, iTANK. I would like to extend a big thank you to our shareholders for your participation and support through this rights issue.'"

Financing • Trial status • Hematological Malignancies • Lymphoma • Oncology

Issue to take Elicera's ELC-301 through clinical study [Google translation] (BioStock) - "Cell and gene therapy specialist Elicera Therapeutics is about to take its second project through phase I/II clinical trials. With ELC-301, the aim is to establish itself as a prominent player in CAR T-cell therapies. The company is currently in the process of a preferential issue of units where the initial aim is to raise SEK 64 million...data is needed that shows that ELC-301 works as intended, which is why they are now preparing for the first clinical step with the candidate, the phase I/II study CARMA....The company hopes to report partial results at the end of 2024 and then have complete data ready in the second half of 2025....The issue is for an initial amount of SEK 64 million, where subscription bonds and guarantee commitments of approximately 43 percent of the amount have been received, which is deemed to be sufficient to treat all 18 planned patients in the CARMA study and last through the second half of 2026."

Financing • P1/2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Elicera Therapeutics publishes prospectus in connection with rights issue of units (Elicera Press Release) - "Elicera Therapeutics AB...has prepared an EU growth prospectus...for the forthcoming issue of units consisting of shares and warrants with preferential rights for existing shareholders...which the board of directors resolved on January 18, 2024 and was approved at the extraordinary general meeting on February 20, 2024. The Prospectus was approved by the Swedish Financial Supervisory Authority today February 21, 2024...'To continue the development of our breakthrough therapies, we are now conducting a rights issue that will primarily fund the clinical trial of our most advanced CAR T-cell therapy ELC-301 against B-cell lymphoma.'....'By carrying out the issue already now, we ensure that the company continues to have a strong financial position during the implementation of our phase I/IIa study with ELC-301.'"

Financing • Hematological Malignancies • Lymphoma • Oncology

Elicera Therapeutics receives approval to initiate clinical Phase I/II-study CARMA with CAR T-cell therapy ELC-301 in B-Cell lymphoma (Elicera Press Release) - "Elicera Therapeutics AB...announced that the company has received approval from the Swedish Medical Products Agency to start the clinical phase I/II study CARMA in patients with B-cell lymphoma that no longer respond to standard treatment or have relapsed....It is carried out on patients diagnosed with difficult-to-treat CD20-positive B-cell lymphoma, mantle cell lymphoma or indolent lymphoma, or who have relapsed in the disease....According to the company's preliminary timetable, the dose escalation study is expected to be completed and reported in the second half of 2025, and phase 2 is expected to be completed and reported approximately 6-12 months later. The full CARMA-study is expected to be completed and reported in 2027, after a follow-up period of at least two years."

P1/2 data • Trial status • Diffuse Large B Cell Lymphoma • Indolent Lymphoma • Mantle Cell Lymphoma

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 submits GMP validation data to the Swedish Medical Products Agency for the CARMA study to supplement the conditionally approved clinical trial application (Elicera Press Release) - "Elicera Therapeutics AB...today announced that it has submitted complementary data to the Swedish Medical Product Agency (MPA) that validates the GMP-level production standard of the CAR T-cell therapy ELC-301. The data package is submitted to meet the MPA’s request for additional information which was queried in its conditional approval of Elicera Therapeutic’s clinical Phase I/IIa study CARMA...The MPA will now review the data, for a period of maximum 14 weeks, and subsequently inform the company whether it can initiate the Phase I/IIa study CARMA or if additional data is needed....'Next, we look forward to the MPA’s hopefully speedy review of our full clinical trial application and aim to be able to initiate the CARMA study in the first part of 2024.'"

New P1/2 trial • Hematological Malignancies • Oncology

Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2023 (Elicera Press Release) - "The clinical trial, which we also call the CARMA study, is intended to evaluate the safety and efficacy of a dose of CD20-targeted CAR T-cells...The approval is conditional on Elicera conducting certain further validations of its GMP process, which was previously was expected to be completed and given final approval during the third quarter of the year but which we now, after additional dialogue with the Agency, is instead expected to be completed in the fourth quarter of the year. First patient is expected to be treated in the beginning of 2024....We have made progress in our ongoing clinical phase I/IIa study with our oncolytic virus, ELC-100, in the treatment of neuroendocrine tumors and will shortly treat patient number 11. Thus, we only have one patient left to treat in the dose escalation phase, which we expect to be able to do by the turn of the year."

New P1/2 trial • Trial status • Hematological Malignancies • Lymphoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Elicera Therapeutics receives conditional approval from the Medical Products Agency on its CAR T-cell Clinical Trial Application to test ELC-301 (CARMA-study) (Market Screener) - "Elicera Therapeutics AB...announced that it has received approval from the Swedish Medical Products Agency (MPA) on its Clinical Trial Application (CTA) to evaluate its CAR T-cell therapy, ELC-301, in treatment of patients with B-cell lymphoma (CARMA-study), conditional on certain further validations of its GMP-process. Elicera is acting co-sponsor together with Uppsala university.... The MPA grants the application for a clinical trial on the condition that Elicera carries out certain further validations of the GMP-process, which is estimated to be completed and finally approved during Q3 this year."

New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology

Elicera Therapeutics submits Clinical Trial Application to evaluate its CAR T-cell therapy in B-cell lymphoma (Market Screener) - "Elicera Therapeutics AB...announced that it has submitted a Clinical Trial Application (CTA) to the Swedish Medical Products Agency and the Ethics Committee' to evaluate its CAR T-cell therapy, ELC-301, in treatment of B-cell lymphoma. The study aims to evaluate the safety and efficacy of one dose of CD20 directed CAR T-cells, armed with bystander immune activating properties, using the iTANK-platform, in patients with relapsed and/or refractory B-cell malignancies, by studying tolerance, toxicity, biological effects, and anti-tumor responses."

New trial • Hematological Malignancies • Lymphoma • Oncology