On December 10, 2021 APIM Therapeutics (APIM), a clinical stage biotech company focusing on the development of novel peptide therapeutics targeting PCNA (Proliferating Cell Nuclear Antigen), reported that a Phase II Investigator Initiated Study (IIS) of ATX-101 will begin enrolling patients with sarcoma at Columbia University Irving Medical Center (Press release, APIM Therapeutics, DEC 10, 2021, View Source,c3468947 [SID1234605479]).
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The clinical study (ClinicalTrials.gov Identifier: NCT05116683) will investigate ATX-101, the lead compound of APIM’s development program, as single agent therapy for patients with leiomyosarcoma and liposarcoma who have received at least one prior treatment. An IND has been granted by the FDA and the local IRB approved the study.
Sarcoma is a rare malignant tumor that originates from connective tissue. Lipo- and leiomyosarcoma are the most frequently observed soft tissue sarcomas. About 12,750 new cases of soft tissue sarcoma are diagnosed in the US every year. Late-stage disease has a poor prognosis with a 5-year survival rate below 20%.
"Sarcoma is a disease with a very high medical need, and new treatments are needed to fight this cancer," said Matthew Ingham, MD, assistant professor of medicine in Hematology & Oncology at Columbia and Principal Investigator of the study. "We are interested in exploring the potential of inhibiting PCNA activity in cancer cells as a potential new therapy for sarcoma patients."
Columbia’s Division of Hematology & Oncology, led by Gary Schwartz, MD, professor of oncology at Columbia, is a leader in translational and clinical research on sarcoma. "ATX-101 has shown encouraging pre-clinical data published in peer reviewed journals," said Dr. Schwartz. "We have been able to confirm these data in our lab. Our study will help us determine if this therapeutic approach has clinical benefit for sarcoma patients."
APIM supports the study financially and provides the investigational drug ATX-101. "APIM is happy to support this IIS. Data from our Phase I study indicate a favorable safety profile of ATX-101, including anticancer activity. This sarcoma study is a valuable complement to our own clinical development program investigating ATX-101 in combination with chemotherapy for patients with ovarian cancer," explained Dr. Jens-Peter Marschner, CMO of APIM.
"Our work with distinguished sarcoma specialists at Columbia University Irving Medical Center is an important step for APIM Therapeutics and indicates that our first in class approach is of academic interest," said Dr. Kostas Alevizopoulos, CEO of APIM. "With this IIS and its translational investigations, additional data will be collected that advance our understanding of complex PCNA-dependent activities in cancer and their inhibition by ATX-101."
About ATX-101
ATX-101 is a first-in-class, cell penetrating peptide featuring a novel PCNA-interacting motif (AlkB homolog 2 PCNA Interacting Motif or APIM). In preclinical experiments, it was shown that APIM-containing proteins bind to PCNA and mediate processes of escape mechanisms and survival of cancer cells. ATX-101 competitively inhibits interaction of PCNA with APIM-containing protein complexes resulting in cancer cell death and altered cellular signaling. These properties translate in anticancer effects of ATX-101 as demonstrated in several preclinical models in vitro and in vivo.