New York biotech IRX Therapeutics just raised $31.6 million to finance later stage trials of its fast-tracked immunity-boosting cancer therapeutic, IRX-2.
The randomized head and neck cancer Phase 2B trial will study about 200 patients, with clinical trial centers in the U.S. and Western Europe.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
The company’s therapy ups the immune response of cancer patients, helping their innate defense systems better recognize and respond to tumors. In the process, this immunotherapy approach ostensibly helps patients immunize themselves against their own cancer, the spokesman said.
“Our approach can be categorized as a generic boost to the immune system,” an IRX spokesman said. “It’s not in the category of a targeted therapy; it’s not gene therapy; it potentially has broader applicability – so we’d pursue other indications if we had another dollar lying around.”
IRX’s therapies work to restore the body’s immune response by correcting both dendritic and T-cell defects. It’s developed a cell-derived biologic with multiple cytokines that “activate multiple arms of the immune system.”
Once this trial’s complete, IRX will look more closely at partnering out or selling the company, or even raising the money internally to conduct more costly Phase 3 trials. For this variety of trial, the spokesman said, it’d cost some $100 million to study IRX’s lead candidate in the required 600-800 patients.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
To date, IRX has raised more than $100 million since its 1994 launch, largely from high net worth individuals and family offices.
