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.
Category: Press Releases & News
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
Triumvira Announces Addition of Veteran VP of Regulatory Affairs, Presentations at CellCAN and TRI-CON Conferences, and Attendance at Bio-Europe Partnering
AUSTIN, TX, and HAMILTON, ON, March 13, 2019 – Triumvira Immunologics, Inc., (Triumvira) a privately held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced the appointment of Cynthia Molina as Vice President of Regulatory Affairs. In this position, Cynthia will be responsible for global regulatory strategic development, oversight of regulatory submissions, and interactions with US and international governmental health authorities.
Before joining Triumvira, Ms. Molina was most recently VP of Global Regulatory Affairs at Cell Medica, Inc in Houston, TX, for 6 years and accumulated 30 years of experience in multiple facets of product development for pharmaceutical, biotechnology, biologic, and in vitro diagnostic products, with a primary focus on regulatory affairs. In addition to regulatory affairs, her experience includes clinical and preclinical strategic planning, quality assurance, process development and manufacturing for oncology and infectious disease products. Ms. Molina has experience leading preparation of a variety of global regulatory submissions, including INDs, NDAs, BLAs, MAAs, global CTAs, 510Ks, PMAs, orphan and Fast Track submissions, and clinical study reports. She has held management positions at both large and small corporations, including Abbott Laboratories.
Paul Lammers, MD, MSc., President and CEO of Triumvira commented, “We are very pleased to welcome Cynthia to our management team. Her background and experience in regulatory affairs will enhance our interactions with regulatory agencies supporting our plan to bring multiple TAC product candidates into clinical development alone, as well as in collaboration with our business partners.”
Additionally, several Triumvira executives are presenting at upcoming conferences. Triumvira Chief Technology Officer Donna Rill and Senior Vice President of R&D Dr. Andreas Bader will present at CellCAN’s Second Annual, Pan-Canadian Strategic Forum on Regenerative Medicine and Cell Therapy, to be held March 13-15, 2019, in Toronto, ON. Director of R&D and Head of Platform Development Dr. Christopher Helsen will present at the 26th International Molecular Med Tri-Conference on March 14, 2019, in San Francisco, CA. Topics of their presentations will be:
Characterizing products for GMP manufacturing: What, how and when? (Ms. D. Rill)
Optimizing cell and gene therapy manufacturing, Planning for Success – the path to commercialization (Ms. D. Rill)
TAC technology, its unique and novel MoA, preclinical data and considerations for biomarker analysis in our Phase I/II trial (Dr. A. Bader)
Development of a CD19-TAC therapy for a first in human phase I study (Dr. C. Helsen)
Triumvira also announces Joshua Carle, Vice President of Business Development, will attend the Bio-Europe Spring Partnering conference in Vienna, Austria from March 25–27, 2019. Mr. Carle and Triumvira are seeking to find out-licensing partners to accelerate our TAC pipeline development, collaborators with novel cancer cell surface antigens looking to expand into engineered T-cells, and to identify immuno-oncology assets that are complementary to our TAC T-cell platform.
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.
Contact
Triumvira Immunologics Inc.
LaVoieHealthScience
Katie Gallagher
Phone: +1-617-374-8800, Ext. 109
kgallagher@lavoiehealthscience.com
www.triumvira.com
partners@triumvira.com
Q&A with Dr. Paul Lammers, President and CEO of Triumvira Immunologics developing their T-Cell Antigen Coupler Technology to activate T-Cells in the treatment of Advanced Hematological Cancers and Solid Tumors
Dr. Paul Lammers
President & Chief Executive Officer
Triumvira Immunologics
www.triumvira.com
Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 4, 2019
CEOCFO: Dr. Lammers, you have been president and CEO for a little over a year now. What attracted you to Triumvira Immunologics, Inc?
Dr. Lammers: When I started to look at my next opportunity, I came across a number of companies and was really intrigued by the Triumvira technology. Given the fact that CAR-T therapy is about the hottest area in immune-oncology, and the TAC technology is very well differentiated from CAR-T cells and invented by a very reputable professor at McMaster University in Hamilton, Ontario. I thought, “Man, would it not be great to build a company around this technology and bring this technology into the clinic for patients.”
CEOCFO: What has happened over the last year at Triumvira? How are you leading the charge?
Dr. Lammers: When I joined on January 1st of 2018 there were two full-time Triumvira scientists up in Hamilton at Dr. Bramson’s lab. Right now, we have fourteen. The typical conundrum in biotech is that “you need a team to raise the money and you need money to raise the team”. Therefore, I told the board of directors, “If you want me build the team, then get ready, because I will build the team.” I then started to build the team and hired the best people in T-Cell therapy that I could find, no matter where they lived. We have an R&D group in Hamilton, Ontario that we moved out of the academic labs into a separate lab facility there. Then we opened a corporate headquarters here in Austin, Texas, where we have six people. Then we have a number of experienced professionals around the country, from Miami, to Seattle, to Houston. So far it is working very well, and a great deal of progress has been made! We had a great pre-IND meeting with FDA last December. We are moving our pipeline forward and aim to have our first IND submitted in March, which means that we could have our first patients treated with our technology in the middle of the year. Then we will move our second program forward into the IND-stage later this year. We also expanded our Board of Directors. We brought in two very strong independent directors with a lot of experience in oncology and cell therapy. Therefore, it has been a fantastic ride so far!
CEOCFO: What, if any, are the challenges of collaboration in science when you are working remotely? What have you learned over this year about how to do that successfully?
Dr. Lammers: I think the two critical components for any business are information and communication. I think that when you have a semi-virtual business model, it requires you to be more informative and communicate more often. Therefore, we have our weekly management team calls, and every other week we have a teleconference with the whole team. I want to make sure that the R&D group in Hamilton knows that there is a management team to support them, and so members of the management team try to spend two to three days a month up in Hamilton to make sure that we have presence and visibility. That is important, because for me, leadership is visibility to a large extent as well. I want to make sure that they realize that we come to work every day and we work hard to make things happen. So far it has been going really well.
Knight Therapeutics and Triumvira Immunologics Triumphantly Announce Secured Bridge Loan & License Agreement
MONTREAL and AUSTIN, Texas and HAMILTON, Ontario, Feb. 20, 2019 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a Canadian specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative pharmaceutical products, today announced it has entered into a secured loan and exclusive License Agreement with privately-held Triumvira Immunologics Inc. (“Triumvira”). The US$5 million secured loan has a term of 1 year and will enable Triumvira to accelerate activities to bring its innovative lead program into the clinic. In addition, Triumvira shall grant Knight an exclusive license to commercialize Triumvira’s future approved products for Canada, Israel, Mexico, Colombia and for TAC01-CD19 for Israel, Mexico, Brazil and Colombia.
“We are excited to help Triumvira accelerate development of their novel platform for engineering T cells to attack cancer,” said Jonathan Ross Goodman, Chief Executive Officer of Knight.
“We are thrilled both with this Knight solution to our short-term funding need and in having Knight as our proven successful Canadian, Israeli and South American distribution partner,” said Dr. Paul Lammers, President and Chief Executive Officer.
