January 2021 was a banner month for CEL-SCI Corp. (CVM), with the stock price having more than doubled.
CEL-SCI is a clinical-stage biotechnology company developing immunotherapy technologies to treat cancer, autoimmune, and infectious diseases.
The company's lead product candidate is Multikine, an investigational immunotherapy being developed for neoadjuvant treatment of advanced primary (previously untreated) head and neck cancer (squamous cell carcinoma), as well as cervical dysplasia in human immunodeficiency virus (HIV) and human papillomavirus (HPV).
A global pivotal phase III trial of Multikine for patients with advanced primary head and neck cancer, dubbed IT-MATTERS, is underway. The phase III trial was started in late 2010 and the last patient was enrolled in the study in September 2016. With 928 patients having been enrolled, this study is said to be the largest ever in head and neck cancer.
In a letter to shareholders last month, Geert Kersten, the company's CEO, said that the database for the study was locked late last year (meaning it was ready to be analyzed) and experts are now analyzing the data according to a statistical analysis plan that was agreed to and finalized before database lock.
Multikine has also completed a phase I trial in cervical dysplasia in HIV/HPV co-infected patients.
In addition to Multikine, the company is also developing products based on LEAPS (Ligand Epitope Antigen Presentation System), an immunotherapy vaccine technology platform.
There are 3 product candidates based on the LEAPS technology platform - potential therapeutic vaccines for rheumatoid arthritis namely CEL-2000 and CEL-4000, which are under IND-enabling studies, and a potential therapeutic vaccine for COVID-19, which is under preclinical testing.
CVM has traded in a range of $6.35 to $40.91 in the last 1 year. The stock closed Friday's (Jan.29, 2021) trading at $24.95, up 28.61%.
As the company continues to wait for the Multikine data from its head & neck cancer trial, it would be worth keeping an eye on this stock. If approved, the addressable market opportunity for Multikine in the U.S. alone is over $2 billion.
Will the company's head and neck cancer trial succeed or will it disappoint? After all, "IT-MATTERS" the most to investors.
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