Product pipeline
AlethiaBio’s pipeline places great emphasis on the development of monoclonal antibodies generated against its disease-specific targets. AlethiaBio is developing an inhibitor of the epithelial-to-mesenchymal transition (EMT), a key process in cancer metastasis. The inhibitor, sotevtamab, is a humanized IgG2 monoclonal antibody that targets tumor-associated secreted clusterin (sCLU), a potent inducer of EMT. Preclinical studies have shown that sotevtamab potently inhibits EMT, leading to decreased tumor invasion and enhanced response to chemotherapy in animal models of cancer. Early clinical trials in patients with metastatic carcinoma refractory to conventional therapies have demonstrated good tolerability, safety, and clinical benefit for many patients, confirming the inhibition of EMT. Building on these promising results, Alethia has successfully completed a Phase II clinical study in patients with metastatic lung cancer. It was an open-label, single-arm, multi-center Phase II trial of sotevtamab in combination with docetaxel in previously treated subjects with metastatic non-small cell lung cancer who have experienced disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody (NCT04364620).
AlethiaBio has recently initiated another Phase II study in colorectal cancer patients with liver-dominant metastases. It is a proof-of-concept Phase II trial of sotevtamab in combination with FOLFOX-based preoperative neoadjuvant systemic chemotherapy in participants with resectable liver-dominant metastases and candidate to neoadjuvant FOLFOX followed by partial hepatectomy (NCT06225843).
Addressing Urgent Medical Needs through Functional Genomics
AlethiaBio is tackling pressing medical challenges by leveraging functional genomics to identify novel therapeutic targets. The company’s approach is centered around a proprietary subtractive cloning technology called STAR (Sensitive Transcription-based Amplification and Representation), which is one of the most sensitive transcription-based platforms available. AlethiaBio’s pipeline places great emphasis on the development of monoclonal antibodies generated against its disease-specific targets.
The STAR platform allows AlethiaBio to generate comprehensive expression profiles of diseased conditions by conserving the relative abundance of each mRNA. This sensitivity enables the discovery of differentially expressed transcripts, including both high and low abundance ones, that are normally not detected using other methods.
By harnessing the power of STAR, AlethiaBio is able to uncover candidate genes that have the potential to serve as novel therapeutic targets. This approach allows the company to address urgent medical needs by exploring previously unexplored avenues for drug development, ultimately leading to the discovery of innovative treatments.