Articles from Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (“ITI”), a privately held clinical-stage biotechnology company pioneering nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared ITI’s Investigational New Drug (IND) application for ITI-5000. This clearance allows ITI to initiate the first-in-human clinical trial evaluating ITI-5000, a UNITE®-based self-amplifying RNA vaccine, as monotherapy and in combination with pembrolizumab (Keytruda®), in patients with Stage II–III Triple-Negative Breast Cancer (TNBC).

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that it will present at SITC 39th Annual Meeting 2024 at the George R. Brown Convention Center in Houston, TX on November 8-10, 2024. Associate Director, Vaccine Discovery, Wei Shen, Ph.D., will present a poster entitled, “A UNITE®-based self-amplifying RNA vaccine advances anti-tumor immunity in a murine triple-negative breast cancer model” on Friday, November 8th & Saturday, November 9th, 2024.

Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.

Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that it will present at the Supply Chain and Logistics for Cell Therapy Summit, March 7-9 in Boston, MA. Senior Director of External Manufacturing and Supply Chain, Shah Ahmed, will present a talk entitled, “Seamless Cell Therapy Supply: Addressing Bottlenecks, Building Contingencies & the Lessons Learned from Global Launches,” at 4:55PM EDT on March 8, 2023.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, announced today that Dr. William Hearl, Chief Executive Officer, will give a presentation entitled, “Dynamic Activation of the Immune System Using UNITE® Technology, Nucleic Acid-Based Cell Therapies for Immuno-Oncology,” at Biotech Showcase 2023, being held January 9-11, 2023 in San Francisco. Dr. Hearl will discuss ITI’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (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.

Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the ITI-3000 program for the treatment of patients with Merkel cell carcinoma. The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV).

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that it will present at the Vaccines Summit 2022 at the Sheraton Reston Hotel in Reston, VA on October 11-13. Associate Director, Vaccine Discovery, Wei Shen, Ph.D., will present a talk entitled, “Nucleic Acid-Based UNITE® Vaccine Platform Provides Novel Treatment Options for Unmet Medical Needs in Oncology, Allergy and Infectious Diseases,” at 2:00PM EDT on October 13, 2022.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced the appointment of Frances Harrison as Senior Vice President, Regulatory Affairs. Ms. Harrison brings to the company more than 30 years of experience in global regulatory strategies and submissions, interactions, intelligence and advocacy. She succeeds Louise Peltier, Vice President of Regulatory Affairs, who retired on August 31, 2022.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company’s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy today announced the appointment of Brian Stamper to Vice President, Cell Therapy Operations. Brian joins the company with over 20 years of experience in cell therapy operations, pharmaceutical manufacturing, and process engineering.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that the company will be presenting at the World Vaccine Congress in Washington, DC being held April 18-21, 2022. CEO and Founder Bill Hearl, Ph.D., will present a talk titled, “Clinical Updates on Autologous Dendritic Cell Vaccines for Solid Tumors,” at 10:10AM EDT on April 21, 2022. Dr. Hearl’s presentation preempts emerging data from a Phase 2 clinical trial (ATTAC-II) for ITI-1000, an investigational dendritic cell vaccine therapy treatment for patients with Glioblastoma, a rare but aggressive form of brain cancer.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, announced today that the data from two posters are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 held in New Orleans, Louisiana, from April 8-13. These posters to be presented at the AACR Meeting focus on the investigational nucleic acid platform, UNITE™ (UNiversal Intracellular Targeted Expression) for two vaccines, ITI-3000 for Merkel cell carcinoma (targeting the large T antigen of the Merkel cell polyomavirus) and Her2/Neu-LAMP DNA vaccine, both of which fuse a tumor associated antigen with lysosomal associated membrane protein 1 (LAMP-1). This proprietary lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that the company will be presenting two posters at the American Association for Cancer Research (AACR) Annual Meeting 2022 being held in New Orleans, Louisiana, from April 8-13. The posters to be presented at AACR are developed from the investigational nucleic acid platform, UNITE™ (UNiversal Intracellular Targeted Expression) for two vaccines, ITI-3000 for Merkel cell carcinoma and Her2/Neu-LAMP DNA vaccine, both which fuse a tumor associated antigen with lysosomal associated membrane protein 1 (LAMP-1). This proprietary lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that the company will be presenting at the upcoming 2022 BIO CEO & Investor Conference being held at the Marriott Marquis in NYC on February 14-15 and virtually through the 17th.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy, today announced its first Phase 1 clinical study evaluating ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and will be led by Drs. Paul Nghiem, Song Park and David Koelle.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy announced today that the company will present at the 14th Annual Biotech Showcase Event, January 10-12 and January 17-19, virtually. Chief Business Officer at ITI, Bob Newman, will present a talk titled, “Pioneering the Next Generation of Immunotherapies.” Mr. Newman will discuss ITI’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (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.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, 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.

Immunomic Therapeutics, Inc., (“ITI”) a privately held clinical-stage biotechnology company focused on advancing its proprietary nucleic acid immunotherapy platform, announced today an exclusive option to license or acquire a series of innovative technologies in the immuno-oncology space from iOncologi, Inc., (“iOi”).

Immunomic Therapeutics, Inc. (‘ITI’), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced that Kristen Batich, MD, Ph.D. and a team from Duke University School of Medicine will present clinical data at the 2021 Society for Neurology (SNO) Annual Meeting being held in Boston, MA, November 18-21st, 2021.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it has appointed Steve Sang Young Park and Robert V. Ahlgren as new members to its Board of Directors, expanding the board to twelve members.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields. The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert”. Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it has appointed Robert Newman as Chief Business Officer. Mr. Newman brings to ITI over thirty years of global experience in the biopharmaceutical industry, including numerous executive roles with operational oversight of many key functions including corporate development, sales and marketing and drug development.

Immunomic Therapeutics, Inc. (ITI) announced today that it will participate at the World Vaccine Congress Washington being held virtually May 4-6, 2021. CEO and Co-Founder Bill Hearl, Ph.D., 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.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today a worldwide license and development collaboration agreement with Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions. The collaboration will generate a novel product candidate derived from Lineage’s investigational allogeneic VAC cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to an upfront payment of $2 million paid in the first year and development and commercial milestones totaling $67 million across multiple indications. Lineage also will be eligible to receive royalties up to 10% on future product sales.