mozistobart zoratolimod (TAC-001) / Tallac Therap - LARVOL DELTA

INCLINE-101: A Phase 1/2 Trial of TAC-001 (TLR9 agonist-CD22 mAb) in Advanced or Metastatic Solid Tumors (AACR 2025) - "Abstract is embargoed at this time."

Metastases • P1/2 data • Oncology • Solid Tumor • CD22

INCLINE-101: A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=72 | Active, not recruiting | Sponsor: Tallac Therapeutics | Recruiting ➔ Active, not recruiting | N=200 ➔ 72

Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor

A B-cell targeted TLR9 agonist antibody conjugate potentiates cancer vaccine efficacy and rejuvenates vaccine responses in the elderly (AACR 2024) - P1/2 | "In all studies, mCD22 TRAAC led to the most potent vaccine recall response, with high antigen specific IgG titers skewing towards a Th1 phenotype, as shown by elevated levels of effector function antibodies of IgG2a subclass and increased IFNγ production. These findings provide a strong rationale for combining TAC-001 with cancer vaccines."

Clinical • Oncology • Solid Tumor • CD22 • GZMB • HER-2 • IFNG • IL17A • NECTIN4 • TLR4

Tallac Therapeutics Presents New Preclinical Data on TAC-001 in Combination with Cancer Vaccines at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) (Businesswire) - "Tallac Therapeutics...announced the presentation of preclinical data demonstrating TAC-001 potentiates cancer vaccine efficacy and rejuvenates vaccine responses....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....The findings presented in the poster...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."

Preclinical • Oncology

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 (SITC 2023) - "Two of eight response evaluable pts have stable disease and remain on study (range 5+ to 10+ months). Conclusions TAC-001 appears well tolerated with dose dependent PK and PD activity consistent with the proposed proof of mechanism - evaluation & enrollment is ongoing."

Clinical • IO biomarker • Metastases • PK/PD data • Oncology • Solid Tumor • CD22

Tallac Presents First Clinical Data for TAC-001 at SITC 2023 (Businesswire) - P1/2 | N=200 | INCLINE-101 (NCT05399654) | Sponsor: "Tallac Therapeutics, Inc...today announced the first presentation of TAC-001 Phase 1 clinical safety and efficacy data in solid tumor patients...The findings presented in the TAC-001 poster....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....'We look forward to continuing TAC-001 monotherapy dose escalation and further evaluating activity in selected patient populations.'"

P1/2 data • Trial status • Oncology • Solid Tumor

Tallac Therapeutics Announces Two Abstracts Accepted for Presentation at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting (Businesswire) - "Tallac Therapeutics...announced the acceptance of two abstracts (related to TAC-001 and TAC-003) at the SITC 38th Annual Meeting in San Diego, CA, from November 3-5, 2023....Both abstracts will be available for viewing on October 31, 2023 at 9:00 am EDT on the Journal for Immunotherapy of Cancer (JITC) website."

P1/2 data • Preclinical • Solid Tumor

INCLINE-101, A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 (a TLR9 agonist conjugated to a CD22 antibody) in Patients with Select Advanced or Metastatic Solid Tumors (SITC 2022) - P1/2 | "INCLINE-101 is enrolling in the USA and Australia. Trial Registration NCT05399654"

Clinical • IO biomarker • P1/2 data • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • CD22

Tallac Therapeutics Presents Data for Two, First-in-Class Toll-like Receptor 9 Agonist Antibody Conjugates at the Society for Immunotherapy of Cancer 37th Annual Meeting (Businesswire) - "A trial in progress poster for TAC-001...highlights the study design, dosing regimen, and study protocol for the Company's ongoing Phase 1/2 clinical trial....The Company expects to report initial clinical data from the trial, which is currently enrolling patients in the USA and Australia, at medical conferences in 2023....Additionally, the Company presented preclinical data demonstrating that its Nectin-4 targeted TLR9 agonist antibody conjugate triggers TLR9 signaling, induces myeloid and dendritic cell activation, phagocytosis, cytokine production and lymphocyte activation, resulting in potent anti-tumor efficacy."

Clinical protocol • P1/2 data • Preclinical • Oncology • Solid Tumor

INCLINE-101: A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Tallac Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Tallac Therapeutics Announces First Patient Dosed with TAC-001, a First-in-Class Toll-like Receptor 9 Agonist Antibody Conjugate, in a Phase 1/2 Study for Patients with Advanced Solid Tumors (Businesswire) - "Tallac Therapeutics, Inc...announced that the first patient has been dosed with TAC-001 in a Phase 1/2 clinical trial for patients with advanced or metastatic solid tumors. TAC-001 is the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform and the first to enter the clinic...'As this study advances, we are also progressing additional assets in our pipeline and plan to file an investigational new drug application (IND) in the beginning of next year for our Phase 1 study in partnership with ALX Oncology Holdings Inc...for ALTA-002.'....The Phase 1/2 trial, known as INCLINE-101 (NCT05399654), is an open label, multicenter, dose escalation and expansion study of TAC-001 in patients with select advanced or metastatic solid tumors. "

IND • New P1 trial • Trial status • Oncology • Solid Tumor

INCLINE-101: A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Tallac Therapeutics

New P1/2 trial • Oncology • Solid Tumor

Tallac Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for TAC-001, a First-in-Class Toll-like Receptor 9 (TLR9) Agonist Antibody Conjugate for Patients with Advanced Solid Tumors (Businesswire) - "Tallac Therapeutics, Inc...today announced the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) Application to study TAC-001 in a Phase 1/2 clinical trial for patients with advanced or metastatic solid tumors...Tallac Plans to Initiate a Phase 1/2 Clinical Study of Systemically Administered TAC-001 for Patients with Advanced Solid Tumors in the Second Half of 2022."

IND • New P1/2 trial • Oncology • Solid Tumor

[VIRTUAL] TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells, promotes anti-tumor immunity and favorable safety profile following systemic administration in preclinical models (AACR 2021) - "These results demonstrate the unique properties of TAC-001 which integrates TLR9 activation and B cells to employ both innate and adaptive immune responses to promote anti-tumor activity. These data support the development of TAC-001 for a broad range of solid tumor malignancies."

IO biomarker • Preclinical • Melanoma • Oncology • Solid Tumor • IL10 • PD-1

Tallac Therapeutics Presents New Data on Toll-like Receptor Agonist Antibody Conjugate, TAC-001, at the 2021 Virtual Annual Meeting of the American Association for Cancer Research (AACR) (Businesswire) - “Tallac Therapeutics…announced the first presentation of preclinical data demonstrating potent single-agent anti-tumor activity in preclinical cancer models with systemically administered TAC-001, the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform…investigators present data providing evidence that in vitro targeted delivery of TAC-001 leads to superior TLR9 activation in B cells, increased expression of co-stimulatory molecules and cross-presentation leading to T cell proliferation. In vivo, TAC-001 demonstrated robust, curative and durable single agent anti-tumor activity in checkpoint inhibitor resistant and refractory tumor models.”

Preclinical • Oncology • Solid Tumor