Brenus Pharma Raises $25 Million to Accelerate Clinical Trials of Its Precision Cancer Vaccines.

On September 18, 2024 Brenus Pharma, a biotech company specializing in the development of cancer vaccines, reported the completion of a $25 million Series A financing round (Press release, Brenus Pharma, SEP 18, 2024, View Source [SID1234646715]).

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The round is led by Angelor, an investment fund bringing together a cluster of investors from the Auvergne-Rhône-Alpes (AURA) region, including UI Investissement for the Fonds régional Avenir industrie Auvergne-Rhône-Alpes, Crédit Agricole Centre-France and Crédit Agricole Centre-Est, with 2 family offices. Belgian funds Noshaq and Investsud complete this significant deal. Together, they join co-founder and lead investor Jacques Gardette (BIOJAG) and long-time investor Stéphane Legastelois (33 CALIFORNIE). In addition, Brenus Pharma has received non-dilutive funding from the French government and Bpifrance, as beneficiary of the France 2030 call for projects.

Jacques GARDETTE, BIOJAG Chairman commented: "Brenus Pharma has taken a major step forward. The arrival of investment professionals in our young company confirms the interest we are arousing. After the creation and sale of Biocorp to Novo Nordisk in 2023, Brenus Pharma now has our full attention to help the company achieve its ambitious goals. I’m convinced that the constant commitment and innovation of the Brenus team have built a solid foundation for tackling one of the world’s most complex therapeutic challenges. During it’s rapid development, Brenus has demonstrated boldness, achievement and resilience in the biotech field."

The proceeds will be used to fully fund the STC-1010 cancer vaccine’s first-in-human proof-of-concept, in first line settings for metastatical colorectal cancer patients. STC-1010 is the first vaccine candidate based on the STC ‘Stimulated-Tumor-(ghost)-Cells’ technology platform developed by Brenus Pharma. Adaptive and innovative, this platform uses an in-depth understanding of the complexity of cancer to offer a new type of precision treatment, enabling Brenus Pharma to give patients’ immune systems a head-start by anticipating the progression of their disease.

Marie CHAMBODUT, Partner, and Investment Director at Angelor, added: "We are proud to lead this strategic transaction for Brenus Pharma to support the clinical development of their cancer vaccines, including STC-1010, the first and most advanced program to emerge from the platform. We look forward to joining Paul and his exceptional team in transforming Brenus into a global player in precision immuno-oncology, bringing solutions to millions of patients experiencing treatment failure, and contributing to the development of the French biotherapeutics industry."

Hélène SABATEL, Investment Manager at Noshaq, said: "Together with our colleagues at InvestSud, we are delighted to support the Brenus Pharma team in the development of this cutting-edge technological platform, as we are convinced of its future impact for patients currently without concrete therapeutic solutions. We are also enthusiastic about the prospect of welcoming a Brenus R&D branch to the Liège region soon, and we hope that this new Franco-Belgian collaboration between two biotech ecosystems will provide the company with optimal support for its development."

The funds raised will enable the STC platform to be deployed in humans from the end of the year, starting with STC-1010, which will be administered as a first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC) resistant to immunotherapies (pMMR/MSS and dMMR/MSI-H). At the same time, STC-1010 will be extended to other types of gastric tumors, such as those of the pancreas and liver. Finally, Brenus Pharma intends to accelerate the development of its portfolio in other solid tumor indications, notably with STC-1020, our second candidate in development.

Paul BRAVETTI, Chief Executive Officer of Brenus Pharma, added: "We are delighted to welcome top-tier investors who have been part of recent French success stories (Mablink, Amolyt Pharma). This is an important milestone for Brenus Pharma, confirming the potential of the STC platform, and of STC-1010, which has already demonstrated solid proof of efficacy in various preclinical models. I would like to thank all our team for their motivation and their passionate work to rapidly bring a new therapeutic solution to patients. Our shared ambition is to position our platform at the forefront of the national and international scene, and to become a leader in next-generation cancer immunotherapies."

A PRESSING NEED FOR SOLUTION

This cutting-edge technology is based on proteomics-guided anti-cancer vaccines, and sparked from the ambition to produce, in France, an innovative biotherapy on an industrial scale capable of responding to a significant public health challenge: 90% of patients treated for solid tumors will suffer a relapse, while by 2022, 10 million of them will have reached a therapeutic dead-end leading to their death. This figure is set to rise by 70% by 2045 (Source: Cancer Tomorrow | IARC – View Source).

The technology developed by Brenus Pharma not only treats the immediate threat, but also defends the immune system against tumors that may appear later, thereby reducing the risk of relapse. To achieve this, STC reproduces in the laboratory the resistance and escape mechanisms of tumor cells, to educate the patient’s immune system to detect and destroy them, thanks to the widest panel of therapeutic targets currently available (over 200 tumor antigens).

With proven expertise in CMC and a standardized, ready-to-use production process, it ensures rapid availability to patients in need, with controlled costs and supply chain, outpacing personalized approaches and autologous vaccines in development.

THE "BREAK-CRC" STUDY IS DESIGNED TO CONFIRM THE THERAPEUTIC POTENTIAL OF STC-1010

STC-1010’s phase I/IIA "BreAK-CRC" study is currently under review by the European regulatory authorities and will be conducted with the participation of expert clinicians in early-phase immuno-oncology units in Europe, and subsequently in the United States. It is based on very positive preclinical studies obtained in vitro, in ovo and ex vivo, showing extremely encouraging safety and efficacy results, validated by a committee of international immuno-oncology experts.

Phase I will evaluate the tolerability of different dose levels of STC-1010, combined with low-dose immunostimulants and standard chemotherapy. Subsequently, the Phase IIA study will further evaluate treatment efficacy, with a particular focus on progression-free survival at 12 months. Innovative exploratory assays will evaluate the immune response and the dynamics of circulating tumor DNA (ctDNA). The ambition is to make STC platform products a permanent part of precision medicine by anticipating patient responses, thanks to a set of analyses unprecedented at this level of development.