- May 21, 2020
Alethia Biotherapeutics Announces Receipt of FDA Authorization to Begin Phase 2 Development for its EMT Inhibitor, AB-16B5
MONTREAL, May 21, 2020 – 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.
“We are extremely pleased to have achieved this important milestone in the development of AB-16B5 and to continue to advance the clinical development of this promising antibody” commented Yves Cornellier, President and CEO of Alethia. “EMT is a central enabler for solid tumor progression because it triggers metastatic invasion, resistance to several classes of anti-cancer drugs and contributes to immune evasion. There is also increasing evidence that EMT contributes to resistance to immune checkpoint inhibitors. AB-16B5 may play an important role in overcoming these problems”, added Dr. Mario Filion, Chief Scientific Officer.
This multicenter, open-label, Phase 2 study of AB-16B5 in combination with docetaxel (NCT04364620) will enroll approximately 40 subjects with advanced NSCLC who have previously been treated with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, a patient population with very limited options. The primary objectives are to assess the anti-tumor efficacy of AB-16B5 in combination with docetaxel as measured by objective response rate and to determine the safety and tolerability of the combined drugs. Secondary objectives of the study include clinical benefit rate, percentage of subjects with complete response or partial response, duration of stable disease, progression-free survival and overall survival.
AB-16B5 is a humanized IgG2 monoclonal antibody that selectively binds and inhibits tumor-associated secreted clusterin, a protein expressed in many cancers. Tumor-associated secreted clusterin is induced early in the EMT cascade and its inhibition with AB-16B5 stops and reverts EMT in animal models. A Phase 1 study in subjects with advanced carcinomas demonstrated that AB-16B5 was safe and well tolerated and provided clinical benefit to several subjects. Stable disease was observed in several patients for up to one year. There was also evidence of EMT inhibition in tumor biopsies.
About Alethia Biotherapeutics
Alethia is a privately held clinical stage biotechnology company located in Montreal. Alethia develops immunotherapeutics for the treatment of cancer.
- June 4, 2019
BioMed Propulsion Program: Québec grants $ 4 million loan to Alethia Biotherapeutics
Through the BioMed Propulsion program, administered by Investissement Québec, the MEI is providing a $ 4 million loan to Alethia Biotherapeutics to support the completion of a project valued at $ 17 million. The BioMed Propulsion program improves access to financing for companies in the life sciences sector.
Alethia will conduct a phase II clinical trial of AB-16B5, a therapeutic antibody for the treatment of metastatic non-small cell lung cancer (NSCLC). The funding will also support research on another biological product of the company.
Québec intends to position itself in the promising sector of biological products, as confirmed in the Quebec Strategy for Life Sciences. Support to Alethia helps strengthen this growing sector.
- May 21, 2015
MONTREAL, May 21, 2015 – Alethia Biotherapeutics Inc. announced today the commencement of patient dosing in a Phase 1 clinical trial with AB-16B5, a fully humanized monoclonal antibody that inhibits epithelial to mesenchymal transition (EMT), in patients with advanced solid tumors.
- February 17, 2015
Alethia Biotherapeutics Submits a Clinical Trial Application (CTA) for a Phase I Study with AB-16B5, an Inhibitor of EMT in Patients with Advanced Cancers
- January 20, 2015
Alethia Biotherapeutics announces the issuance of U.S. Patent No. 8,937,163 entitled “Antibodies against kidney associated antigen 1 and antigen binding fragments thereof” by the United States Patent and Trademark Office (“USPTO”)
- December 2, 2014
Alethia Biotherapeutics announces the issuance of U.S. Patent No. 8,900,579 entitled “Siglec-15 antibodies in treating bone loss-related diseases” by the United States Patent and Trademark Office (“USPTO”)
- August 12, 2014
Alethia Biotherapeutics announces the issuance of U.S. Patent No. 8,802,826 entitled “Anti-clusterin antibodies and antigen binding fragments and their use to reduce tumor volume” by the United States Patent and Trademark Office (“USPTO”)
- August 1, 2014
Alethia Biotherapeutics announces the issuance of patent JP5589149 entitled “Polynucleotides and polypeptide sequences involved in cancer ” by the Japan Patent Office
- June 20, 2014
Alethia Biotherapeutics announces the issuance of patent JP5564249 entitled “Polynucleotides and polypeptide sequences involved in cancer ” by the Japan Patent Office
- June 3, 2014
Alethia Biotherapeutics announces the issuance of U.S. Patent No. 8,741,289 entitled “Siglec-15 antibodies in treating bone loss-related diseases” by the United States Patent and Trademark Office (“USPTO”)