TAVO412 / Tavotek - LARVOL DELTA

A trispecific antibody targeting EGFR/cMET/VEGF-A demonstrates multiple mechanisms of action to inhibit wild-type and mutant NSCLC animal models. (PubMed, Front Oncol) - "TAVO412 demonstrated more potent antitumor activity than amivantamab and cetuximab in NSCLC xenograft models using cell lines with varying levels of mutant and wild-type EGFR and cMET. Moreover, TAVO412 in combination with osimertinib, lazertinib, docetaxel, and radiotherapy, resulted in complete and durable regression of NSCLC xenograft tumors. These findings highlight TAVO412 as a promising therapeutic agent with multiple mechanisms of action and strong potential for synergistic combinations in NSCLC treatment."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Trispecific EGFR x cMET x VEGF antibody, TAVO412, has clinical responses in esophageal and lung cancers (AACR 2025) - P1 | "Stronger activities were also demonstrated when TAVO412 was in combination with docetaxel, TKIs, and with radiotherapy. The clinical study (TAVOTEK412-CN001) is a two-part, open-label, non-randomized, Phase I study to determine the safety and tolerability, to define the MTD/RP2D, and to assess the preliminary efficacy of TAVO412 in patients with advanced or metastatic solid tumors who progressed on prior standard-of-care therapies (Clinical trial NCT06761651). The Part 2 of the study is expected to start in Q4 2025. Keywords: trispecific antibody, EGFR, cMET, VEGF, gastrointestinal cancers, lung cancersEthics approval: "This study was approved by CRADL-Suzhou's Ethics Board; approval number P202302160002.NMPA IND Approval number 2023LP01660; Henan Cancer Hospital Ethics Board approval number 2023-314-003"

Clinical • Trispecific • Esophageal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Developing transcriptomic biomarkers for TAVO412 utilizing next generation sequencing analyses of preclinical tumor models. (PubMed, Front Immunol) - "The biomarker model was further validated in the PDX data set and resulted in comparable accuracy. In implementing precision medicine by leveraging preclinical model data, a predictive transcriptomic biomarker empowered by next-generation sequencing was identified that could optimize the selection of patients that may benefit most from TAVO412 treatment."

Biomarker • Journal • Next-generation sequencing • Preclinical • Lung Cancer • Oncology • Solid Tumor • EGFR • MET

A Study of TAVO412 in Patients with Cancer (TAVO412) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Tavotek Biotherapeutics

New P1 trial • Oncology • Solid Tumor

Triple inhibition of EGFR, c-Met and VEGF with TAVO412, as a promising strategy for patients with dysfunctional EGFR, cMET lung cancers, TNBC, and PDAC (SITC 2024) - "Our studies indicated that, through multiple mechanisms of action, TAVO412 has the potential to prevent or delay resistance when combined with SOCs in treating patients with NSCLC, Gastric cancer, TNBC, PDAC, making it a promising candidate for further clinical development. Ethics Approval This study was approved by CRADL-Suzhou's Ethics Board; Ethical number: P202302160002."

Clinical • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • EGFR • MET

A Study of TAVO412 in Patients with Cancer (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Tavotek Biotherapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Breaking the Solid Tumour Stromal Barriers Using Targeting Trispecific Agents (IO-SUMMIT EUROPE 2024) - "The presence of FAP and LRRC15 can be confirmed also in several solid tumours by immunohistochemistry. The combination of TAVO306 with CD3 redirection molecules or TAVO412 have strong tumour growth inhibition profiles."

Stroma • Trispecific • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • LRRC1

Breaking the Solid Tumour Stromal Barriers Using Targeting Trispecific Agents (IO-SUMMIT EUROPE 2024) - "The presence of FAP and LRRC15 can be confirmed also in several solid tumours by immunohistochemistry. The combination of TAVO306 with CD3 redirection molecules or TAVO412 have strong tumour growth inhibition profiles."

Stroma • Trispecific • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • LRRC1

A Study of TAVO412 in Patients With Cancer (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Tavotek Biotherapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Multi-specific cMet x EGFR x VEGF antibody for difficult to treat cancers (AACR 2023) - "The IND application was approved by the US FDA in October 2022. A first-in-human, 2-Part Phase 1 study to examine the preliminary efficacy, safety, tolerability, pharmacokinetic / pharmacodynamic parameters; maximum tolerated dose / recommended phase 2 dose of TAVO412 will be starting in the first quarter of 2023."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

A Study of TAVO412 in Patients With Cancer (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Tavotek Biotherapeutics | Initiation date: Jan 2023 ➔ Apr 2023 | Trial primary completion date: Jan 2024 ➔ Jun 2024

Metastases • Trial initiation date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

TAVO412 - A novel trispecific cMet x EGFR x VEGF antibody for triple negative breast cancer (SABCS 2022) - "There is also a synergistic tumor growth inhibition in the presence of a standard of care molecule such as doxorubicin (61% in HCC70 with TAVO412 + doxorubicin, 66% TGI in BT20 with TAVO412 + doxorubicin, 71% TGI in MDA-MB-231 with TAVO412 + doxorubicin). Tavo412 has the potential activity to be a superior multispecific antibody to treat patients with triple negative breast cancer. Phase 1 clinical testing in patients is anticipated in early 2023."

Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

A Study of TAVO412 in Patients With Cancer (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Tavotek Biotherapeutics

New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET