APIM Therapeutics AS
A Novel Intervention Point in Cancer Therapy
APIM Therapeutics AS is a venture capital financed biotechnology company developing first-in-class peptide drugs for multiple cancer indications. Specifically targeting a natural stress defense mechanism controlled by PCNA (Proliferating Cell Nuclear Antigen; a master protein regulator involved in diverse cellular processes highly relevant for cancer escape such as DNA replication and repair, cell cycle control, signal transduction etc), the company’s current drug candidate, ATX-101, offers a novel combination treatment rationale applicable to >15 different chemotherapeutic and targeted agents [Gilljam et al, 2009, J Cell Biol 186, 645-654, Müller et al, 2013, PLoS One. 2013 Jul 31;8(7), Gederaas et al, Transl Oncol. 2014 Dec;7(6):812-23].
APIM’s technology, originally developed by Prof. M. Otterlei and co-workers at the Dpt. of Cancer and Molecular Medicine at the Norwegian University of Science and Technology (NTNU), is broadly applicable to several cancer indications. Specifically, ATX-101 has shown proof-of-concept in several preclinical in vivo and ex vivo cancer models of solid tumors and blood cancer (e.g. bladder, prostate, multiple myeloma, leukemia) in combination with >5 clinical drugs. Other in vitro experiments suggest additional development opportunities in more than 25 different indications. These properties support the company’s platform potential i.e. the possibility to develop new ATX-101-based combination treatments in a wide range of oncology indications.
Pipeline and platform development potential of ATX-101-based treatments.
Currently concluding the preclinical development phase, the company aims to submit two Clinical Trial Applications (CTAs) to regulatory authorities in late 2015. Our subsequent clinical plans include execution of the following two trials in 2016:
– A phase I/IIa clinical trial of intravesical ATX-101 co-administered with Mitomycin-C (MMC) in patients suffering from non-muscle invasive bladder cancer (5th most prevalent cancer indication globally, 1st in terms of lifetime costs per patient). Aiming to prove the high safety potential of ATX-101, this pivotal study may also provide early insights to the therapeutic potential of the ATX-101/MMC combination as based on the assessment of efficacy of the combination on the marker lesion (i.e. tumor present in the bladder during dose escalation).
– A Phase I/IIa clinical trial of single agent, intravenous ATX-101 in advanced cancer patients. This study will provide key safety information and constitutes the gateway for all subsequent systemic trials in combination with different agents. Among different cancer indications to be pursued, advanced bladder cancer, multiple myeloma, prostate cancer and a few other indications show strong development potential. Of note, the company is currently working on expanding its current preclinical validation by performing additional animal experiments in relevant disease models of breast cancer and glioblastoma.
Based on this program, APIM Therapeutics will seek to raise additional venture capital in late 2015 – early 2016. Partnerships and collaboration opportunities will also be sought upon completion of the first two clinical trials in late 2016 – early 2017.