ANDES-1537
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 cell cycle arrest and apoptosis of cancer cells.
The Company currently has other early stage drug candidates in its pipeline targeting different cancer and infectious disease indications.
PHASE I OVERVIEW
Andes Biotechnologies has an active IND for its Phase I clinical trial and it includes studies Phase Ia and Phase Ib.
Phase Ia (NCT02508441) – Completed in 2018
It was conducted from 2015 to 2018 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 was a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetic (PK) characteristics and efficacy of Andes-1537 for subcutaneous (SC) injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.
22 patients with heavily pretreated solid tumors were enrolled in 5 cohorts (100 mg, 200 mg, 400 mg, 600 mg and 800 mg, twice weekly). Results from the study indicated that Andes-1537 was a well-tolerated drug with a novel mechanism. The MTD was determined to be 600 mg SC twice weekly. Furthermore, preliminary efficacy signals were observed in hard-to-treat cancer: pancreatic cancer and cholangiocarcinoma.
Click here for additional information on the Phase I study results.
Phase Ib (NCT03985072) – Ongoing
It is a Phase 1 open-label 2-stage, safety and tolerability study to evaluate subcutaneous administration of Andes-1537 for patients with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.
The study is being conducted in collaboration with 4 different leading Clinical Research Centers in Chile and is assessing 6 cancer type-specific parallel cohorts: gallbladder and biliary tract carcinoma, cervical carcinoma, colorectal carcinoma, gastric carcinoma, pancreatic carcinoma, and renal cell carcinoma.
The study is expected to be completed in 2022.
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 or send us an email here.
