APIM Therapeutics AS is a venture-capital financed biotech spin-off from the Norwegian University of Science and Technology (NTNU, Trondheim).
Based on an original discovery by Prof. Marit Otterlei and co-inventors, the company targets a novel therapeutic intervention point shown to be critical in the regulation of cellular responses to stress and in tumor evasion from therapy.
Briefly, APIM Therapeutics is using a series of proprietary Protein Protein Interaction (PPI) blocking peptides targeting complexes formed between PCNA (Proliferating Cell Nuclear Antigen) and proteins bearing a novel PCNA-interacting Peptide Motif called APIM (AlkB homolog 2 PCNA Interacting Motif). A series of preclinical and other experiments have revealed the functional importance of PCNA/APIM-protein interactions in the regulation of cancer cell growth and apoptosis during stress (e.g. DNA Damage Response) induced by anti-cancer treatment. Furthermore, it was shown that cell penetrating peptides containing the APIM-motif abrogate PCNA-APIM protein interactions and are capable of potentiating the action of several classes of anti-cancer drugs across multiple indications.
APIM’s lead therapeutic candidate ATX-101, is a first-in class compound targeting this therapeutic intervention point. In preclinical experiments, ATX-101 has shown single agent activity in certain cancers and combinatorial activity with more than 25 different anti-cancer drugs in different tumor indications. Developed as a new therapeutic option in oncology, ATX-101 has recently concluded a first-in-human, phase I clinical study. Conducted by APIM’s Australian subsidiary Therapim Pty Ltd, the study demonstrated a favorable safety profile of the compound. Furthermore, promising disease stabilization was observed in patients with advanced, progressive tumors lacking standard treatment options. The results of the phase I study have been published in Oncogene, see Publications for more details.
Following conclusion of the phase I study, two additional studies have been initiated:
1. A phase Ib study in platinum-sensitive ovarian cancer, testing ATX-101 in combination with platinum-based chemotherapy. The study has recently been concluded and preliminary results have shown that the tested combination had a favorable safety profile and a high response rate. Based on these results, further clinical testing in this indication is warranted.
2. A phase II study in sarcoma (lipo-, and leiomyosarcoma) conducted as an Investigator Initiated Study by the Columbia University Irving Medical Center, evaluating ATX-101 as monotherapy. Preliminary data obtained in a small number of patients confirmed the therapeutic potential of ATX-101. This data, together with additional preclinical results obtained with an ATX-101 combination, support further phase II testing of the combination in lipo-, and leiomyosarcoma patients.
The company is also working on 2nd generation ATX molecules with improved properties; a few leads are currently being tested. A lead candidate is expected to be selected within 2025 and will subsequently enter preclinical development.
For more information on our technology, please see Intervention Point, ATX-101 and Publications.