HERVolution Therapeutics ApS - a dark genome-focused biotechnology company developing immunotherapies for addressing aging-related diseases - announced a $11.7 million Series A financing to advance its lead assets toward clinical evaluation. This funding round was led by the Serum Institute of India (SII) with participation from the European Innovation Council (EIC) Fund and other investors.
The proceeds will support key activities, including further validating and demonstrating the value of its human endogenous retroviruses (HERV)-targeting approach, cGMP manufacturing in collaboration with SII, initiating Phase 1 studies of its lead asset, investigating indication expansion opportunities, and expanding company infrastructure to support clinical trials.
HERVs are genetic remnants of ancient viral infections integrated into the human genome. As they typically lie dormant until aging or disease causes them to reactivate, these targets are often considered part of the dark genome. And HERVs have been clinically observed to play a key role in causing numerous diseases like cancer, type 2 diabetes, and amyotrophic lateral sclerosis (ALS), and early research signals roles in the aging process.
HERVolution utilizes a proprietary engineering approach to unlock the therapeutic potential of HERVs. The company can deliver a new class of therapies that can induce potent and durable anti-HERV immune responses by breaking self-tolerance. And these re-designed HERVs can be expressed using adenoviral, virus-like particles, and mRNA vectors, offering opportunities to expand disease targets and dosing regimens. The company's pipeline of HERV-targeted immunotherapies offers off-the-shelf applications in various diseases and the potential to improve outcomes for the world's increasingly aging population.
With robust preclinical data, the company's lead candidate, IPT-001, is a dual adenoviral (Ad) vector immune therapy with the potential to address a range of diseases as monotherapy or in combination with other agents. IPT-001 utilizes two unique, proprietary Ad-vectors with low pre-existing immunity and excellent antigen expression to enable simultaneous induction of potent HERV-specific T and B cell responses. IPT-001 is developing in collaboration with SII, with plans to enter the clinic in 2025.
HERVolution also develops IPT-002, an mRNA vector expressing its proprietary HERV antigen. It may enable repeat dosing in humans and maintenance and amplification of anti-HERV immune responses when administered in a prime-boost treatment strategy with IPT-001.
KEY QUOTES:
"Leveraging decades of immunology and virology expertise, we have broken human immune tolerance to HERVs, enabling therapeutic targeting for the first time. We are revolutionizing the treatment of complex age-related diseases with proprietary engineering approaches that allow us to make these once-invisible antigens visible to the immune system. With the financial and manufacturing support of our investors, we are well resourced to accelerate our pipeline and expedite bringing breakthrough treatments within reach for patients worldwide."