HERVolution Therapeutics, a Copenhagen-based biotechnology company focused on targeting human endogenous retroviruses (HERVs) from the “dark genome,” has secured $11.7 million in Series A funding. The round was led by the Serum Institute of India (SII) with participation from the European Innovation Council (EIC) Fund. The funds will support key activities, including manufacturing and advancing the clinical development of the company’s lead immunotherapy candidate, IPT-001, with Phase 1 trials expected to begin in 2025. HERVolution’s approach aims to address diseases like cancer and metabolic disorders by breaking immune tolerance to HERV antigens, which are reactivated during aging or disease, offering potential new avenues for treatment.
HERVs are genetic remnants of ancient viral infections that have integrated into the human genome. As they typically lie dormant until aging or disease cause them to reactivate, these targets are often considered part of the “dark genome.” 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. Despite this, successful HERV targeting has remained elusive because the immune system views them as “self” antigens.
HERVolution utilizes a proprietary engineering approach to unlock the therapeutic potential of HERVs. By breaking “self” tolerance, the company can deliver a new class of therapies with a demonstrated ability to induce potent and durable anti-HERV immune responses. These re-designed HERVs can be expressed using adenoviral, virus-like particles, and mRNA vectors, providing opportunities to expand disease targets and dosing regimens. The company’s pipeline of HERV-targeted immunotherapies offers off-the-shelf applications in an array of diseases and the potential to improve outcomes for the world’s increasingly aging population.
“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. 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.”
Supported by robust preclinical data, the company’s lead candidate, IPT-001, is a dual adenoviral (Ad) vector immune therapy with 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 currently in development in collaboration with SII, with plans to enter the clinic in 2025. HERVolution is also developing IPT-002, an mRNA vector expressing its proprietary HERV antigen, which 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.
HERVolution Therapeutics (formerly InProTher Aps) is a dark genome-focused biotechnology company based in Copenhagen, Denmark, and the U.S., pioneering novel human endogenous retrovirus (HERV)-targeted immunotherapies to address diseases of aging. With its proprietary engineering approaches, HERVolution has rationally redesigned HERV-antigens to yield a new class of highly immunogenic antigens to address cancer, metabolic, and other aging-related diseases. The company’s world-class scientific team has advanced a strong product development pipeline, with lead program, IPT-001, anticipated to enter the clinic in 2025.
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