TGI-2 / TG ImmunoPharma - LARVOL DELTA

198Au-labeled gold nanoparticle depot effectively inhibited the growth of both locally irradiated and distant non-irradiated subcutaneous MDA-MB-231 breast cancer tumors in humanized NCG mice (SNMMI 2024) - "Our aim was to study the therapeutic and abscopal effects of 198AuNPD alone or in combination with clinically used anti-PD-L1 antibody atezolizumab (Atez) on human MDA-MB-231 breast cancer (BC) tumors engrafted in humanized NCG (hNCG) mice that more closely model the treatment of patients with 198AuNPD...Mean TGI-2 increased in 198AuNPD or 198AuNPD + Atez treated mice (no significant difference; p=0... 198AuNPD and 198AuNPD + Atez were effective for treatment of s. c. MDA-MB-231 tumors in hNCG mice and caused an abscopal effect on distant, non-irradiated tumors. Eradication of local and distant tumors was achieved for some mice treated with 198AuNPD. Treatment with 198AuNPD improved survival vs."

IO biomarker • Preclinical • Breast Cancer • Oncology • Solid Tumor • PTPRC

Characterization of the correlation between BTK degradation and tumor growth inhibition of the BTK target protein degraders using PK/PD modeling (AACR 2024) - "The PK/PD model was then linked with a mathematical model describing TGI2...The efficacy of BGB-16673 was predicted using the model and it agreed with the observed value. The current model deepened our understanding of the PK/PD relationship of CDACs... The current model deepened our understanding of the PK/PD relationship of CDACs. The approach can be used to simulate different scenarios, e.g. different BTK turnover, potency or PK exposure. It can also be used in compound selection and optimization to predict repeated dose PD and efficacy from a single dose PK/PD data.1."

PK/PD data • Oncology

A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Hefei TG ImmunoPharma Co., Ltd. | Withdrawn ➔ Recruiting | Trial completion date: Jun 2023 ➔ Sep 2027 | Trial primary completion date: Jun 2023 ➔ Sep 2027

Combination therapy • Enrollment open • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Hefei TG ImmunoPharma Co., Ltd. | N=38 ➔ 0 | Trial completion date: Sep 2026 ➔ Jun 2023 | Recruiting ➔ Withdrawn | Trial primary completion date: May 2026 ➔ Jun 2023

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial withdrawal • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Hefei TG ImmunoPharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

Tiangang Yinuo’s TGI-2 clinical trial application has been approved by China’s NMPA [Google translation] (eBiotrade.com) - "On April 18, 2023, the anti-PVRIG monoclonal antibody injection (project code TGI-2/NM1F) for the treatment of solid tumors (IND) has been approved by the National Medical Products Administration (NMPA) of China, and Phase I clinical research will be carried out in China in the near future."

New P1 trial • Oncology • Solid Tumor

A First-in-human, Phase I, Open-label, Multicenter Study of NM1F Administered as Monotherapy and in Combination With Pembrolizumab to Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=38 | Not yet recruiting | Sponsor: Hefei TG ImmunoPharma Co., Ltd.

Combination therapy • Metastases • Monotherapy • New P1 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

TG ImmunoPharma (TGI) announces FDA clearance of IND application for TGI-2, a novel anti-PVRIG therapeutic antibody (PRNewswire) - "TG ImmunoPharma...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody used in patients with advanced solid tumors. Currently, no drugs targeting PVRIG have been approved globally. TGI-2/NM1F is a humanized IgG1 monoclonal antibody targeting PVRIG for the treatment of malignant cancers....'We are excited to initiate a phase 1 clinical trial in multiple centers in the U.S. for patients with advanced solid tumors....In addition, IND in China is expected to be submitted soon'."

IND • New P1 trial • Oncology • Solid Tumor