The company engineers novel immunotherapies that empower the immune system to target HERV antigens from the dark genome to treat cancer, metabolic disease, and other aging-related diseases

Funds to fuel pipeline of off-the-shelf assets through several key milestones, including initiating clinical evaluation for its lead program in 2025

COPENHAGEN, Denmark and NEW YORK, December 19, 2024 – HERVolution Therapeutics ApS ('HERVolution'), a dark genome-focused biotechnology company developing immunotherapies to address aging-related diseases, today announced a $11.7 million Series A financing to advance its lead assets toward clinical evaluation. The funding round was led by Serum Institute of India (SII) with participation from the European Innovation Council (EIC) Fund and other investors. 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 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.

About HERVolution Therapeutics

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. For more information, please visit: HERVolutionTx.com.

About the Serum Institute of India (SII)

Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SII's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.

Founded in 1966, SII's primary mission is to produce lifesaving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosil,' the world's most affordable PCV, and 'Cervavac' the first indigenous qHPV vaccine in India. Moreover, SII has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.

To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com

Media Contact

Lia Dangelico
Deerfield Group
lia.dangelico@deerfieldgroup.com