Clinical Trials & Pipeline

Andes-1537, a proprietary antisense oligonucleotide designed by Andes Biotechnology, is the Company’s most advanced investigational drug candidate and the first to enter a human clinical study. It targets a novel non-coding mitochondrial RNA (ncmtRNA) and has demonstrated antineoplastic activity in preclinical studies. Upon administration, Andes-1537 binds to a specific ncmtRNA, inducing apoptosis of cancer cells.

The Company currently has 17 investigational drug candidates in its pipeline targeting various solid tumor cancer indications.

PHASE I OVERVIEW

Andes Biotechnologies has an active IND for its Phase I clinical study, which is being conducted at the Cancer Center of the Mount Zion Hospital of the University of California at San Francisco under the direction of Dr. Pamela Munster, Professor of Medicine and Director of Early Phase Clinical Program.

This trial is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Part 1 of the clinical trial is a dose-escalation study to establish the maximum tolerated dose based on dose-limiting toxicities and to evaluate the safety and tolerability of multiple doses of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Part 2 is an open-label, dose-expansion study to determine the safety, tolerability, and preliminary efficacy of Andes-1537 for Injection in patients with advanced solid tumors.  In part 2, patients will be enrolled and receive the recommended Phase 2 dose established in part 1 based on the safety, tolerability, pharmacokinetics, and preliminary efficacy data.

The Phase I trial started in December 2015 and is currently on going. Including Part 2, the estimated study completion date is December 2018.

For additional information on the Phase I study, please visit https://clinicaltrials.gov/ct2/show/NCT02508441.

 

For additional information on the Phase I study, please visit https://clinicaltrials.gov/ct2/show/NCT02508441.

Partnerships

Andes Biotechnologies is open to innovative alliances that can drive our business forward while enabling our partners to develop and commercialize oligonucleotides therapeutics worldwide. We place a high value on relationships that will provide us the opportunity to expand our internal research and development programs through access to new technologies and therapeutic programs. The company is interested in establishing commercial relationships for the clinical development of our products.

Andes’ management team has many years of experience structuring pharmaceutical partnerships, and has the flexibility and creativity to structure deals that provide unique value creation opportunities. For more information, please contact Cristián Hernández, Chief Operating Officer, at +56 2 2367 2000.