sotevtamab (AB-16B5) / Alethia BioTherap - LARVOL DELTA

ResQ108B-PANC: Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P1 trial • Oncology • Pancreatic Cancer • Solid Tumor

A phase II trial to evaluate the epithelial-to-mesenchymal (EMT) inhibitor sotevtamab combined with docetaxel in patients with metastatic non-small cell lung cancer following failure of primary chemoimmunotherapy. (ASCO 2024) - P2 | "This phase II study showed promising response and overall tumor control. Duration of response was particularly encouraging and relevant to further exploration. The sotevtamab and docetaxel combination may enhance immune-mediated anti-tumor response through induction of TLS."

Clinical • Metastases • P2 data • Anemia • Fatigue • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CLU

EGIA-003: Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis (clinicaltrials.gov) - P2 | N=17 | Recruiting | Sponsor: Alethia Biotherapeutics | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatology • Oncology • Solid Tumor

EGIA-003: Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis (clinicaltrials.gov) - P2 | N=17 | Recruiting | Sponsor: Alethia Biotherapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

EGIA-003: Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis (clinicaltrials.gov) - P2 | N=17 | Not yet recruiting | Sponsor: Alethia Biotherapeutics

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (clinicaltrials.gov) - P2 | N=35 | Completed | Sponsor: Alethia Biotherapeutics | Active, not recruiting ➔ Completed

Metastases • Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Alethia Biotherapeutics | Trial primary completion date: Mar 2023 ➔ Dec 2023

Metastases • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Alethia Biotherapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: May 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Enrollment closed • Trial completion date • Trial primary completion date • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Alethia Biotherapeutics | Trial completion date: Jul 2022 ➔ May 2023 | Trial primary completion date: Feb 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Alethia Biotherapeutics; Not yet recruiting ➔ Recruiting

Enrollment open • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Alethia Biotherapeutics announces receipt of FDA authorization to begin phase 2 development for its EMT inhibitor, AB-16B5 (GlobeNewswire) - "Alethia Biotherapeutics announced today that the U.S. Food and Drug Administration has cleared its Phase 2 Investigational new drug (IND) application for AB-16B5, a potent inhibitor of the epithelial to mesenchymal transition (EMT). This allows the Company to initiate a multi-center trial of AB-16B5 in combination with docetaxel in previously treated subjects with metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody."

IND • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology

"#AlethiaBiotherapeutics Announces Receipt of #FDA Authorization to Begin Phase 2 Development for its #EMTInhibitor, #AB16B5 https://t.co/LLF9eooQ4o" (@1stOncology)

AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Alethia Biotherapeutics

Clinical • New P2 trial • Immune Modulation • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer