umitrelimorgene autodencel (ITI-1000) / HLB Bio Group - LARVOL DELTA

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients. (clinicaltrials.gov) - P1 | N=6 | Terminated | Sponsor: University of Florida | N=10 ➔ 6 | Trial completion date: May 2025 ➔ Sep 2023 | Active, not recruiting ➔ Terminated; Terminated by mutual agreement by sponsor and institution.

Enrollment change • Trial completion date • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients. (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: University of Florida

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

ATTAC II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=175 | Completed | Sponsor: University of Florida | Active, not recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Nov 2023 | Trial primary completion date: Sep 2024 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus

ATTAC II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: University of Florida | Trial completion date: Sep 2024 ➔ Sep 2026

Trial completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus • IL2

ATTAC II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: Immunomic Therapeutics, Inc. | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus • IL2

Historical Performance Trends In Winter Ultra-Endurance Events (ACSM 2023) - "For the ITI 1000, finish times for bike (433±90 hrs) were faster than those for foot (642±123 hrs) (p<0.001) and bike speed was greater than foot speed (p<0.001)... In the last two decades, bicycling has consistently yielded the fastest times and greatest speeds in self-supported winter ultra-endurance events ranging from 80-1000 miles. Results indicate that bicycling offers the superior mode of transport when time is the objective and suggest that it has a lower metabolic cost of transport compared to foot and ski. Finally, finish times for all four events have decreased over time independent of locomotive mode suggesting general improvements in training and/or technology."

ATTAC II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: Immunomic Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus • IL2

ITI-1020, a novel PDE type 1 inhibitor, reduces tumor growth in triple negative breast cancer (TNBC) mouse models (AACR 2023) - "Furthermore, scRNAseq analysis of tumors from mice treated with ITI-1020 in monotherapy showed altered expression of genes involved in inflammatory processes and cell proliferation within the tumor microenvironment and in the cancer cells.These results suggest that ITI-1020 promotes antitumor immunity by a novel mechanism (PDE1 inhibition), leading to tumor growth inhibition in E0771 and 4T1 tumor models. Translating these findings to the clinic may provide a new hope for the treatment of refractory or resistant TNBC tumors."

IO biomarker • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ATTAC: Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Gary Archer Ph.D. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2022

Lymphopenia • Trial completion • Trial completion date • Brain Cancer • CNS Tumor • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients. (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: University of Florida | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2023 ➔ Dec 2023

Enrollment closed • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

ATTAC: Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Gary Archer Ph.D. | Trial completion date: Jul 2022 ➔ Dec 2022

Lymphopenia • Trial completion date • Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor

ATTAC: Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Gary Archer Ph.D. | Trial completion date: Jan 2022 ➔ Jul 2022

Lymphopenia • Trial completion date • Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients. (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University of Florida | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

ATTAC-II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2; N=175; Recruiting; Sponsor: Immunomic Therapeutics, Inc.; N=120 ➔ 175

Clinical • Enrollment change • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus • IL2 • MRI

Immunomic Therapeutics Announces Open Enrollment for RENEW Clinical Study of CMV RNA-Pulsed Dendritic Cell Vaccine for the Treatment of Newly-Diagnosed Glioblastoma Patients (Businesswire) - "Immunomic Therapeutics...announced the opening of a new clinical study in collaboration with Dr. Duane Mitchell at the University of Florida. RENEW (NCT04963413) is designed to evaluate the ability to generate pp65 Lysosomal Associated Mediated Protein (LAMP) RNA-pulsed dendritic cells in patients who have completed standard external beam radiation and concomitant temozolomide and who are receiving adjuvant temozolomide chemotherapy at the time of enrollment....The RENEW pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care surgery and chemoradiation and who are currently receiving adjuvant temozolomide chemotherapy."

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology

Immunomic Therapeutics Presents Clinical Data From ATTAC Studies in GBM at the 2021 Society for Neurology (SNO) Annual Meeting (Businesswire) - "The data to be presented at the SNO meeting are from three sequential clinical trials utilizing Cytomegalovirus (CMV)–specific dendritic cell vaccines that encode the chimeric CMV protein LAMP-pp65 in patients with primary Glioblastoma....The Phase II ATTAC study (NCT00639639) led to an expanded cohort trial (ATTAC-GM: NCT00693639) resulting in positive immunologic and clinical response. The larger confirmatory trial, ELEVATE (NCT02366728), revealed significantly longer overall survival (OS) in patients randomized to LAMP pp65 RNA loaded DC vaccines combined with tetanus-diphtheria booster. The results demonstrate that a CMV pp65-LAMP RNA-pulsed dendritic cell vaccination was associated with positive immunologic and clinical response in patients with glioblastoma (GBM)."

P1 data • P2 data • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients. (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: University of Florida; Trial completion date: Aug 2023 ➔ May 2025

Clinical • Trial completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

RENEW: Pilot Study of Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: University of Florida

Clinical • New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Immunomic Therapeutics to Participate at World Vaccine Congress Washington 2021 (Businesswire) - “Immunomic Therapeutics…announced today that it will participate at the World Vaccine Congress Washington being held virtually May 4-6, 2021…will present a talk titled, ‘Adaptive T-cell immunotherapy for newly diagnosed glioblastoma: Using targeted antigen presentation to enhance immune responses,’ at 15:00 on May 4, 2021."

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology

ATTAC-P: Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma (clinicaltrials.gov) - P1; N=11; Completed; Sponsor: Gary Archer Ph.D.; Active, not recruiting ➔ Completed; Trial completion date: Aug 2022 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Glioma • Infectious Disease • Medulloblastoma • Oncology • Pediatrics • Solid Tumor • Tetanus

Immunomic Therapeutics’ CEO to present at the 13th Annual Biotech Showcase Digital Event (Businesswire) - "Immunomic Therapeutics, Inc...announced...that the company will present at the 13th Annual Biotech Showcase Digital Event, January 11-15, 2021. Chief Executive Officer at ITI, Dr. Bill Hearl, will present a talk titled, 'ITI-1000-A Novel Immunotherapy for GBM.'....ITI’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy."

Clinical • Glioblastoma • Oncology

ATTAC-II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2; N=120; Active, not recruiting; Sponsor: Immunomic Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus

ATTAC-II: Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Immunomic Therapeutics, Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Infectious Disease • Oncology • Solid Tumor • Tetanus

Immunomic Therapeutics and CoImmune Therapeutics Enter into Partnership to Manufacture ITI-1020, a Novel Experimental Cell Therapy for Glioblastoma (Businesswire) - "Immunomic Therapeutics...and CoImmune...announced today that the companies have entered into a license agreement for ITI to use CoImmune’s proprietary dendritic cell process for certain ITI cell therapy vaccine programs...Under the terms of the license agreement that supports this partnership, ITI will employ CoImmune’s process for manufacturing and cGMP work for the advancement of ITI-1020, ITI’s autologous dendritic cell (DC) investigational vaccine loading with mRNA encoding LAMP: pp65 for the treatment of newly diagnosed glioblastoma (GBM)."

Licensing / partnership • Glioblastoma • Oncology

Immunomic Therapeutics Announces Publication of Results from 3 ATTAC Studies of CMV-Specific Dendritic Cell Vaccines for the Treatment of GBM (Businesswire) - P1, N=42; ATTAC (NCT00639639); P2, N=100; ELEVATE (NCT02366728); P2, N=120; ATTAC-II (NCT02465268); Sponsor: Immunomic Therapeutics, Inc; "The three small studies (total n = 26; NCT#s 00639639, 2366728) revealed that overall 5-year survival increased from a historical low of 5% to 25%. However, in two of the studies, vaccination site pre-conditioning with either Td or GM-CSF: Enhanced the immune response by increasing migration of DCs to regional lymph nodes to "present" the pp65 CMV antigen to immune cells. Increased the percentage of long-term, 5-year survivors to nearly 35% in that subset of treated patients who received vaccination site pre-conditioning with either Td or GM-CSF."

P1 data • P2 data • Brain Cancer • Glioblastoma • Oncology