TACTIC-2 marks first in-human use of TAC-T cell therapy Phase 1/2 clinical trial will evaluate TAC01-HER2, Triumvira’s lead candidate, in patients with HER2-overexpressing solid tumors First patient dosed at MD Anderson Cancer Center in Houston, Texas AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics (“Triumvira”) today announced that the first patient has been dosed as part of the TACTIC-2 trial evaluating the company’s lead candidate, TAC01-HER2, an autologous T cell therapy for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors. Triumvira, a clinical-stage company, is developing novel, targeted autologous, and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid and liquid tumors. The company’s proprietary T cell Antigen Coupler (TAC) platform technology activates natural T cell functions differently from other cell therapies such as Chimeric Antigen Receptor T cell (CAR-T) and engineered T cell receptor therapies.
Category: Press Releases & News
Triumvira Appoints Teresa McRoberts as Chief Financial Officer and Announces Senior Level Promotions
AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics (“Triumvira” or the “Company”), a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, today announced the appointment of Teresa McRoberts as Chief Financial Officer. The Company also announced the promotion of Andreas Bader, Ph.D. to Chief Scientific Officer and Jon Irvin to Senior Vice President of Finance. “We are pleased to welcome Teresa to our management team as we continue to advance our platform of novel T cell therapies toward the clinic. Teresa brings strong expertise in financial strategy and capital markets across the healthcare sector which will be invaluable as we enter our next phase of growth,” said Paul Lammers, M.D., M.Sc., President and CEO of Triumvira. “Both Andy and Jon have been integral to the rapid growth of Triumvira and we are also excited to announce their promotions today. Andy has played an instrumental role in shaping our scientific strategy with a track record of taking research programs from the discovery stage into the clinic, and Jon has played a critical role in guiding our financial strategy to date as we’ve quickly scaled up our company.”
Top Life Sciences Startups to Watch in 2021
BioSpace is proud to present its NextGen Bio “Class of 2021,” a list of up-and-coming life sciences companies in North America that recently launched. To come up with this list, BioSpace looked at companies that recently launched over the past few years with Series A funding. They were then weighted by several different categories and ranked in a cumulative fashion, based on the points awarded for each category. These categories were: finance, collaborations, pipeline, growth potential, and innovation. The NextGen Bio Class of 2021 is a stellar group of companies that are already making an enormous impact on the industry now and will continue into the future. Congratulations to this group!
Bayer and Northpond Ventures Lead USD $55 Million Series A Financing Round for Triumvira Immunologics
LEVERKUSEN, Germany & AUSTIN, Texas–(BUSINESS WIRE)–Triumvira Immunologics Inc. (“Triumvira”), a privately-held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, successfully completed a USD $55 million Series A financing round. The financing was co-led by Leaps by Bayer, the impact investment unit of Bayer AG, and Northpond Ventures. Additional investors include Oceanpine Capital and Viva Biotech Holdings, and existing investors include Bloom Burton & Co. and the Centre for Commercialization of Cancer Immunotherapy (C3i). T-cells are a type of white blood cell that is critical in ridding the body from abnormal and cancerous cells in healthy individuals. In cancer patients, these T-cells frequently fail to either recognize or effectively engage cancer cells. Novel T-cell therapies have the potential to disrupt cancer care and potentially even provide cures. Triumvira is committed to developing novel T-cell therapies that are safer and more efficacious than current cell therapy cancer treatments, including chimeric antigen receptor (CAR) and engineered T-cell receptor (TCR) therapies. This financing will enable Triumvira to advance multiple autologous and allogeneic programs into the clinic for solid tumors and hematologic malignancies. Curing and preventing cancer is one of the main focus areas of Leaps by Bayer, as this disease still represents one of today’s most pressing health concerns, especially since there are limited curative or preventative therapies available.
Triumvira Announces Grant of T Cell Antigen Coupler (TAC) Technology Patent by U.S. Patent and Trademark Office
AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics (Triumvira), a privately-held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced the issuance of key claims in U.S. Patent No. 10640562 entitled “T cell-antigen coupler with various construct optimizations.” The newly allowed TAC-CD19 composition-of-matter claims build on other composition-of-matter claims previously granted by the US Patent and Trademark Office and expand the protection of the company’s TAC platform and therapeutic product candidates. “Expanding intellectual property protection of our TAC platform is key to developing a solid technology platform, and this issuance confirms that the TAC is a well-differentiated technology,” said Dr. Paul Lammers, Triumvira’s President and CEO. “Issuance of our composition-of-matter claims further strengthens our position as a company pioneering novel engineered T cell approaches as we are bringing this innovative treatment to patients.”
Triumvira Immunologics and Lonza Announce Collaboration to Develop Innovative Point-of-Care Manufacturing for TAC T-Cell Therapeutic Targeting Solid Tumors
AUSTIN, Texas & HAMILTON, Ontario & BASEL, Switzerland–(BUSINESS WIRE)–Triumvira Immunologics Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, and Lonza, a leading cell & gene therapy manufacturer, announced today that the companies have an agreement in place.
This collaboration, aimed at the development of Triumvira’s TAC01-HER2 T-cell therapy for treating solid tumors, will leverage Lonza’s expertise in process development and the usage of its proprietary Cocoon® Platform. This automated patient-scale cell therapy manufacturing platform offers flexibility to execute a wide variety of protocols within a single system that is enabled through a single-use, highly customizable cassette, and custom programming.
Immunotherapy, particularly T-cell products, belong to the most potent drugs that could overcome the complex barriers encountered in solid tumors. However, current T-cell approaches remain insufficiently effective. The TAC receptor represents a significant advancement, providing a novel mechanism of T-cell activation, leading to improved anti-tumor responses in solid tumor models.
Triumvira Immunologics Announces Fast Track Designation for Its First TAC T-Cell Therapeutic Product Candidate: TAC01-CD19
AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies. A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.
“FDA’s decision to grant Fast Track designation to TAC01-CD19 is an important recognition of both Triumvira’s differentiated cell therapy technology and the critical need to develop new therapies to address the unmet medical need in the treatment of B-cell lymphomas,” commented Paul Lammers, MD, MSc., President and CEO of Triumvira. “With our innovative TAC technology, we hope to significantly improve upon the limitations of existing cell therapies, including the risk of cytokine release syndrome (CRS) and neurotoxicity, which would allow us to expand the number of patients eligible to receive this type of treatment.”
Triumvira Announces Grant of T Cell Antigen Coupler (TAC) Technology Patent by U.S. Patent and Trademark Office
AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics Inc. (Triumvira), a privately-held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced the issuance of key claims in U.S. Patent No. 10435453 entitled “Trifunctional T cell-antigen coupler and methods and uses thereof.” The allowed composition-of-matter claims describe multiple structures used in TAC constructs providing broad protection of the company’s TAC platform.
Triumvira recently announced the clearance of it’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) by U.S. and Canadian Health Authorities for its novel T cell therapy product TAC01-CD19 in patients with CD19-positive B-cell malignancies. The Phase 1/2 study (TACTIC-19, NCT03880279) is expected to be initiated in late 2019.
“Obtaining intellectual property protection of our TAC platform is a key milestone and confirms that TAC is a well-differentiated technology,” said Dr. Paul Lammers, Triumvira’s President and CEO. “Issuance of our composition of matter claims further strengthens our position as a company pioneering novel engineered T cell approaches as we are bringing this innovative treatment to patients.”
Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19
Clinical trials of TAC01-CD19 expected to begin in third quarter 2019
AUSTIN, Texas & HAMILTON, Ontario & TORONTO–(BUSINESS WIRE)– Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, today announced that both the U.S. Food & Drug Administration (FDA) and Health Canada have cleared Triumvira’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) for its novel T cell therapy product TAC01-CD19 in patients with CD19-postive B-cell malignancies. The Phase 1/2 study (TACTIC-19) is expected to be initiated in the third quarter of 2019.
Paul Lammers, MD, MSc., President and CEO of Triumvira commented, “Obtaining FDA and Health Canada clearance of our first IND for this novel approach fulfills our goal to be a clinical stage biotechnology company and demonstrates our commitment to bringing this innovative treatment to patients. TAC01-CD19 will be tested at five leading lymphoma clinical study centers in the U.S. and Canada. Based on its preclinical profile, TAC01-CD19 has the potential to represent a significant advancement in T cell therapy.”
About TAC01-CD19
Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises patient-derived T cells that have been genetically engineered to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.
About CD19 and Diffuse Large B Cell Lymphoma (DLBCL)
CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma. DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs)and is expected to impact approximately 26,000 patients annually in the U.S. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes.
About Triumvira Immunologics
Triumvira Immunologics, Inc. (“Triumvira”) is a clinical stage immunotherapy company co-founded in 2015 by Dr. Jonathan Bramson at McMaster University and Bloom Burton & Co., with the vision of developing novel T cell therapies that are safer and more efficacious than current gene therapy cancer treatments, including chimeric antigen receptor (CAR) and engineered T cell receptor (TCR) therapies. Our proprietary T cell Antigen Coupler (TAC) technology recruits the entire natural T cell receptor and is independent of the Major Histocompatibility Complex (MHC), allowing for the development of better therapies for a broader range of patients with solid or liquid malignancies and with diseases other than cancer. With operations spanning North America, our corporate offices are in Austin, Texas, with our research facilities in Hamilton, Ontario. For more information, visit www.triumvira.com or send email inquiries to partners@triumvira.com
Contact
Triumvira Contact:
LaVoieHealthScience
Katie Gallagher
Phone: +1-617-374-8800, Ext. 109
kgallagher@lavoiehealthscience.com
Triumvira Submits Investigational New Drug (IND) Application to the FDA and Clinical Trial Application (CTA) to Health Canada to Evaluate TAC01-CD19, a T Cell Antigen Coupler Therapy, in Ph 1/2 TACTIC-19 Trial
AUSTIN, Texas & HAMILTON, Ontario & TORONTO – Triumvira Immunologics Inc. (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, has simultaneously submitted an IND to the U.S. Food and Drug Administration and a CTA to Health Canada to initiate a Phase 1/2, first-in-human trial of TAC01-CD19, a TAC-T cell therapy product engineered to target CD-19 in patients with Relapsed/Refractory Large B-Cell Lymphoma (TACTIC-19).
“TAC01-CD19 has the potential to be a next generation solution for cell therapy for patients with different types of cancer,” commented Paul Lammers, MD, MSc., President and CEO of Triumvira. “This filing is the result of an intensive preclinical development effort by the Triumvira team including the completion of the necessary IND-enabling studies as well as simultaneously preparing IND and CTA filings. We look forward to opening our first of five prominent clinical trial sites in the early summer of 2019.”
Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T and has the potential to be a next generation solution to these challenges. TAC technology is a novel way to genetically modify T cells and redirect these T cells to target cancer antigens by co-opting the natural T cell receptor (TCR) to eradicate the tumor cells. TAC01-CD19 is the lead program in Triumvira’s pipeline of several TAC programs for both solid tumors and hematological malignancies.
About TAC01-CD19
TAC-01CD19 is a novel genetically engineered T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises autologous T cells that have been genetically engineered via lentiviral transduction to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects.
About CD19 and DLBCL
CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL is expected to impact approximately 26,000 patients in the U.S. in 2018. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes (1).
About Triumvira Immunologics
Triumvira Immunologics, Inc. (Triumvira) is an immunotherapy company co-founded in 2015 by Dr. Jonathan Bramson at McMaster University and Bloom Burton & Co., with the vision of developing novel T cell therapies that are safer and more efficacious than current gene therapy cancer treatments, including chimeric antigen receptor (CAR) and engineered T cell receptor (TCR) therapies. Our proprietary T cell Antigen Coupler (TAC) technology recruits the entire natural T cell receptor and is independent of the Major Histocompatibility Complex (MHC), allowing for the development of better therapies for a broader range of patients with solid or liquid malignancies and with diseases other than cancer. With operations spanning North America, our corporate offices are in Austin, Texas, and our research facilities in Hamilton, Ontario. For more information, visit www.triumvira.com or send email inquiries to partners@triumvira.com
(1) Cancer. 2017 Sep 1;123(17):3326-3334
Contact
Triumvira Immunologics Inc.
LaVoieHealthScience
Katie Gallagher
Phone: +1-617-374-8800, Ext. 109
kgallagher@lavoiehealthscience.com
