CD22 x TLR9

-- TAC-001, Tallac’s lead immunostimulatory ADC program, potentiates cancer vaccine efficacy and rejuvenates immune responses in preclinical studies -- BURLINGAME, Calif.--(BUSINESS WIRE)-- Tallac Therapeutics, Inc., a privately held clinical stage biopharmaceutical company pioneering the discovery and development of novel antibody-oligonucleotide conjugates, today announced the presentation of preclinical data demonstrating TAC-001 potentiates cancer vaccine efficacy and rejuvenates vaccine responses. TAC-001 is an investigational, systemically delivered, Toll-like Receptor Agonist Antibody Conjugate (TRAAC) molecule, designed to selectively activate B cells to drive an anti-tumor immune response. The data will be presented today as part of the Vaccines, Antigens, and Antigen Presentation 2 session at the American Association for Cancer Research (AACR) 2024 Annual Meeting taking place in San Diego, April 5-10, 2024. The findings presented in the poster “A B cell targeted TLR9 Agonist Antibody Conjugate Potentiates Cancer Vaccine Efficacy and Rejuvenates Vaccine Responses in the Elderly” demonstrate that in combination with cancer vaccines, TAC-001 promotes robust and durable vaccine specific IgG titers, skews humoral response to Th1 phenotype, and rejuvenates vaccine responses. Moreover, TAC-001 enhances vaccine specific T cell activation and cytotoxic activity. As a result, anti-tumor vaccine efficacy is greatly improved by the combination with TAC-001. “The emerging data on TAC-001 in combination with cancer vaccines enhances our understanding of TAC-001 mechanisms in eliciting humoral and cellular anti-tumor immunity and provide a compelling rationale for combining TAC-001 with cancer vaccines in the clinic. This preclinical proof of concept expands the prospective therapeutic application of TAC-001 in oncology and other disease indications,” said Dr. Hong I. Wan, president, CEO, and co-founder of Tallac Therapeutics. AACR Poster Presentation Details: Title: “A B cell targeted TLR9 Agonist Antibody Conjugate Potentiates Cancer Vaccine Efficacy and Rejuvenates Vaccine Responses in the Elderly.” Session Type: Poster Session Session Category: Immunology Session Title: Vaccines, Antigens, and Antigen Presentation 2 Abstract Number: 6746 Section 4, April 10, 9:00AM-12:30PM About TAC-001 (CD22 TRAAC) TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent toll-like receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 lead to potent anti-tumor activity. TAC-001 is being developed for the treatment of solid tumors and is currently in a Phase 1/2 Study in cancer patients (NCT05399654). Emerging clinical data demonstrating tolerability, pharmacodynamic activity and preliminary clinical activity of single agent TAC-001 were observed (SITC 2023). About Tallac Therapeutics, Inc. Tallac Therapeutics is a privately held clinical stage biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer using next generation ADCs. Tallac’s pipeline of immunostimulatory ADC candidates is derived from the company’s novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform to deliver a potent Toll-like receptor (TLR9) agonist (T-CpG) for targeted immune activation via systemic administration. Several TRAAC molecules are in various stages of discovery and development. TAC-001, the company’s lead clinical candidate, is currently in an ongoing Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors. For more information, please visit .

Marks the First Clinical Data for a Systemically Administered TLR9 Agonist Antibody Conjugate (TRAAC) Activating B Cells to Drive a Clinical Response in Solid Tumors Preclinical Data From TAC-003, a Potentially Best-in-Class Nectin-4 TRAAC, Will Also be Featured BURLINGAME, CA, USA I November 03, 2023 I Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, today announced the first presentation of TAC-001 Phase 1 clinical safety and efficacy data in solid tumor patients. TAC-001 is an investigational, systemically delivered, TRAAC molecule comprised of a potent TLR9 Agonist conjugated to a CD22 antibody, designed to The findings presented in the TAC-001 poster “INCLINE-101: Preliminary Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAC-001 (TLR9 Agonist Conjugated to a CD22 mAb) in Patients With Advanced or Metastatic Solid Tumors” demonstrate that single-agent TAC-001 (0.1 to 3 mg/kg) given systemically every 2 weeks is well tolerated, demonstrates pharmacodynamic activity consistent with its proposed MOA and resulted in preliminary clinical activity with patients achieving durable stable disease (≥6 months) and partial response per RECIST v1.1. “These TAC-001 clinical data provide evidence that systemic administration of a TLR9 immune agonist targeting and activating B cells is generally well tolerated and induces immune activation consistent with preclinical studies. We also observed single-agent clinical benefit in late-stage metastatic cancer patients which supports the use of this novel agent for treating cancer,” said Kevin N. Heller, M.D., Chief Medical Officer at Tallac Therapeutics. “The pharmacodynamic biomarker data collected from these patients is highly encouraging. We look forward to continuing TAC-001 monotherapy dose escalation and further evaluating activity in selected patient populations. We would like to thank the participants and their families for their participation in our study.” Additionally, the Company presented preclinical data in the poster titled “TAC-003, a TLR9 Agonist Antibody Conjugate for Targeted Immunotherapy of Nectin-4 Expressing Tumors” that demonstrate TAC-003 induces robust immune cell activation, leading to innate and adaptive immunity against Nectin-4 positive cancers and potent single-agent anti-tumor activity. TAC-003 single agent treatment results in durable curative responses in models with a range of low to high Nectin-4 expression, including anti-PD-1 refractory tumors, with improved efficacy compared to enfortumab vedotin. TAC-003 has completed pre-clinical testing, including exploratory toxicological studies in cynomolgus monkeys, and has been selected as the Company’s third clinical candidate. “We are excited to see these initial clinical data with TAC-001, the first program from Tallac’s TRAAC platform,” said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics. “As we advance the TAC-001 program, we are also progressing our pipeline of immunotherapy candidates. TAC-003 represents a differentiated asset with potential to address unmet medical needs in multiple cancer types.” TLR9 agonists are a class of immunotherapy that generate both innate and adaptive immune response, which may produce more robust and durable anti-cancer immunity to help overcome resistance to standard-of-care oncology treatments. TLR9 agonists have demonstrated clinical activity in melanoma patients when administered intratumorally. Tallac Therapeutic’s TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration. About TAC-001 (CD22 TRAAC) TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent toll-like receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 lead to potent anti-tumor activity. TAC-001 is being developed for the treatment of solid tumors and is currently in a Phase 1/2 Study in cancer patients ( NCT05399654 ) About TAC-003 (Nectin-4 TRAAC) TAC-003 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a T-CpG conjugated to a novel Nectin-4-targeting antibody for systemic administration and TME delivery of a potent TLR9 agonist. Nectin-4 is a cancer associated antigen over-expressed in many solid tumor types with limited expression in normal tissues. Additionally, Nectin-4 over-expression correlates with poor prognosis. Preclinical data demonstrate that TAC-003 triggers TLR9 signaling, induces myeloid and dendritic cell activation, phagocytosis, cytokine production and lymphocyte activation, resulting in potent single-agent anti-tumor efficacy. About Tallac Therapeutics, Inc. Tallac Therapeutics is a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer. Tallac’s pipeline of immunotherapy candidates is derived from the company’s novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform to deliver a potent Toll-like receptor (TLR9) agonist (T-CpG) for targeted immune activation via systemic administration. Several TRAAC molecules are in various stages of discovery and development. TAC-001, the company’s lead clinical candidate, is the first to enter the clinic and is currently in an ongoing Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors. For more information, please visit www.tallactherapeutics.com . SOURCE: Tallac Therapeutics

FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego. They will join stakeholders across the immune-oncology field worldwide to advance the science, discover breakthroughs and enhance education on cancer immunotherapy, which uses the body's own immune system to find, target and fight many forms of the disease. Continue Reading FCS physician investigators will present research results for immunotherapy treatments during oral and poster abstract presentations at the annual SITC Conference. "Immunotherapy is one of the most promising and successful treatment areas for cancer, even at the most advanced stages, said Lucio N. Gordan, MD, FCS President & Managing Physician. "Through our robust and far-reaching clinical trials research program, FCS continues to contribute to cutting-edge research that is providing hope and improving outcomes for cancer patients worldwide." The following FCS physician investigators will present research results during oral and poster abstract presentations: Manish Patel, MD, FCS Director of Drug Development – COM701 + nivolumab demonstrates preliminary antitumor activity in patients with metastatic breast cancer; T-cell responses to individualized neoantigen therapy (INT) nRNA-4157 (V984) as monotherapy or in combination with pembrolizumab; Judy Wang, MD, FCS Associate Director of Drug Development - Characterization of the pharmacodynamic activity of CLN-619, an anti-MICA/B monoclonal antibody, in patients from an ongoing Phase 1 trial, COM701 + nivolumab demonstrates preliminary antitumor activity in patients with metastatic breast cancer; The combination of COM701 + nivolumab demonstrates preliminary antitumor activity in patients with metastatic breast cancer; TWT-101: A First-In-Clinic Study of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as Single Agent or Combined With Pembrolizumab in Subjects With Advanced Solid Malignancies; A first-in-human phase 1 clinical study evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the EDB+FN targeting ADC PYX-201 in participants with advanced solid tumors; A phase 1, first-in-human (FIH), open-label, dose-finding and expansion study of XmAb808, a B7H3 x CD28 bispecific antibody, in combination with pembrolizumab in patients with advanced solid tumors Cesar Perez, MD – a poster presentation as first author of INCLINE-101: Preliminary Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAC-001 (TLR9 Agonist Conjugated to a CD22 mAb) in Patients With Advanced or Metastatic Solid Tumors; as co-author of a Phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PRJ1-3024 in subjects with advanced solid tumor; as co-author of the abstract, T-cell responses to individualized neoantigen therapy (INT) nRNA-4157 (V984) as monotherapy or in combination with pembrolizumab. Dr. Manish Patel said, "As we increase our collective understanding of how the immune system interacts with cancer cells, we are able to continuously advance targeted treatment options as well as our ability to predict, with precision, which patients will respond best to this form of treatment. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Founded in 1984, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval For More Information, Contact: FCS Media Relations (239) 675-7201 Michelle Robey, Vice President of Marketing [email protected] Jen Bradley, Director of Corporate Communications [email protected] SOURCE Florida Cancer Specialists & Research Institute