HERVolution Therapeutics ApS, a biotechnology company focused on developing immunotherapies targeting the dark genome, has announced an $11.7 million Series A financing round. The funding, led by the Serum Institute of India (SII) with participation from the European Innovation Council (EIC) Fund and other investors, will support the advancement of its lead assets toward clinical evaluation.
The company's approach targets human endogenous retroviruses (HERVs), genetic remnants of ancient viral infections integrated into the human genome. These HERVs typically remain dormant until aging or disease causes them to reactivate, playing a role in diseases such as cancer, type 2 diabetes, and amyotrophic lateral sclerosis (ALS).
Novel HERV-Targeting Immunotherapies
HERVolution utilizes a proprietary engineering approach to unlock the therapeutic potential of HERVs. By breaking self-tolerance, the company aims to induce potent and durable anti-HERV immune responses. These re-designed HERVs can be expressed using adenoviral, virus-like particles, and mRNA vectors, offering opportunities to expand disease targets and dosing regimens.
"Leveraging decades of immunology and virology expertise, we have broken human immune tolerance to HERVs, enabling therapeutic targeting for the first time," said J. Robert Coleman, PhD, MBA, Chief Executive Officer of HERVolution. "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."
Lead Candidate: IPT-001
HERVolution'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. The company plans to enter the clinic with IPT-001 in 2025, in collaboration with SII.
IPT-002: mRNA Vector for Prime-Boost Strategy
The company is also developing IPT-002, an mRNA vector expressing its proprietary HERV antigen. This 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.
"This financing represents a significant milestone for the company and signals strong support of the potential of HERVs to tackle pressing challenges in cancer, metabolic disease and aging," said Peter Holst, MD, PhD, Founder and Chief Scientific Officer of HERVolution.
The proceeds from the Series A financing will support further validation of the HERV-targeting approach, cGMP manufacturing in collaboration with SII, initiation of Phase 1 studies for IPT-001, investigation of indication expansion opportunities, and expansion of company infrastructure to support clinical trials.
