HEPHAISTOS-Pharma, a biopharmaceutical company developing next-generation innate immunotherapies for cancer, today announced the appointment of Stephan Braun as Chief Medical Officer.

A seasoned oncology drug development leader, Stephan Braun brings extensive experience in translational and clinical development, with a strong track record in advancing innovative immuno-oncology programs from early development into clinical execution. He joins HEPHAISTOS-Pharma at a pivotal stage, as the company prepares the clinical development of its lead candidate, HEPHA440, a 3rd generation TLR4 agonist small molecule designed for effective & safe cancer therapy.

The appointment reflects growing recognition of HEPHAISTOS-Pharma’s scientific and therapeutic approach targeting Myeloid cells against solid tumors by a senior industry leader who recently contributed to the development success of ImCheck Therapeutics, one of Europe’s most visible immuno-oncology biotech companies.

“I am very pleased to join HEPHAISTOS-Pharma at such an important moment in its development,” said Stephan Braun, Chief Medical Officer of HEPHAISTOS-Pharma. “The company’s science is highly compelling, and its approach to innate immune activation has the potential to address a major unmet need in oncology. I look forward to working with the team to build a strong clinical development strategy and bring HEPHA440 closer to patients.”

Stephan Braun’s appointment further strengthens a development organization recently reinforced with the addition of Frédérique Brune as Chief Development Officer and Delphine Brégeon as Head of CMC Operations. Together, the team brings complementary expertise across medical strategy, development execution, CMC, regulatory preparation and clinical readiness, positioning HEPHAISTOS-Pharma to advance HEPHA440 toward first-in-human studies.

“We are very pleased to welcome Stephan in our team. Stephan’s appointment is a major milestone for HEPHAISTOS-Pharma,” said Frédéric Caroff, Chief Executive Officer of HEPHAISTOS-Pharma. “As we move closer to clinical development, we are strengthening the company with the expertise required to translate our science into a rigorous, patient-focused clinical strategy. Stephan brings exactly the combination of oncology experience, translational insight and clinical execution that we need at this stage.”

As illustrated by the recent progress of companies such as ImCheck Therapeutics, immunomodulation is emerging as a key lever unlock the full potential of cancer immunotherapies. HEPHAISTOS-Pharma is pursuing this ambition by targeting Myeloid cells within the tumor microenvironment. HEPHA440 is specifically designed to activate the innate immune system while maintaining a high therapeutic index.

As Chief Medical Officer, Stephan Braun will lead HEPHAISTOS-Pharma’s clinical development strategy, including the preparation of first-in-human studies, clinical trial design, translational development and medical strategy as the company advances toward clinical-stage execution.

HEPHAISTOS-Pharma secures a €2 million seed round with xista science ventures, Foundation Fournier-Majoie and Noshaq

• 1st institutional round for HEPHAISTOS-Pharma, getting on track to bring its lead product ONCO-Boost to the clinic.
• ONCO-Boost is a novel class of TLR4 immunostimulants that turn cold tumors into hot ones, increasing the efficacy of other therapies, notably immune-checkpoint inhibitors.

Orsay, France, January 23rd, 2024. HEPHAISTOS-Pharma, a biotechnology company developing next generation immunotherapies against cancer, today announced that it has raised a €2 million seed round to finance GMP transfer and advance its lead candidate towards the clinic. The round was co-led by xista science ventures and the Foundation Fournier-Majoie, with the participation of Noshaq.

« The Foundation is very pleased to be part of HEPHAISTOS-Pharma thanks to this financing round. The valuable and dedicated team developed a promising TLR4 compound that will be used systemically which will bring to the oncologists a best-in-class product for their cancer patients. We are eager to help the company bring to the clinic this innovative program. » said Jerome Majoie, CEO and Chairman at Fournier- Majoie Foundation.

“We are very proud to be joined by institutional investors” said Frederic CAROFF, CEO, and co-founder of HEPHAISTOS-Pharma. “They bring the necessary funds to match our non-dilutive financing, but also the expertise and network that will help structure the company. They will play a critical role in the success of HEPHAISTOS as we move our platform to the clinic. We are also thankful to our historical investors and new business angels from Angels Santé, who joined the round.”

The proceeds from this financing round will enable HEPHAISTOS to industrialize its manufacturing process and prepare for the clinical phases, with the goal of advancing its lead candidate, ONCO-Boost, into clinical development for the treatment of solid tumors with high unmet medical needs, in particular sarcoma. Ingrid Kelly, Partner at xista science ventures, commented that « HEPHAISTOS has an impressive set of preclinical data, showing the high potential of their TLR4 agonist ONCO-Boost to tackle solid tumors, particularly in combination with immunotherapies such as checkpoint inhibitors.

The proceeds will also be used to open a new subsidiary in Liège, Wallonia. The objective will be to leverage local state-of -the-art facilities and expertise to explore additional applications and strengthen HEPHAISTOS’ pipeline. “We are delighted to attract HEPHAISTOS to develop part of its activities in our vibrant local ecosystem. In the midst of a challenging market landscape, Noshaq remains a magnet for innovative companies with a disruptive approach and high-level management” said Eric Brandt, Investment Manager at NOSHAQ.

About HEPHAISTOS-Pharma

HEPHAISTOS-Pharma is a preclinical biotech company developing the next generation of immunostimulants against cancer, revolutionizing immune stimulation targeting innate immunity with a unique technology for intravenous administration, opening the way to metastatic and hard-to-treat indications. HEPHAISTOS-Pharma is the laureate of prestigious grants such as Bpifrance i-Nov and the EIC accelerator in Europe. The company is also involved in the SyStInn consortium headed by academic partners that received an additional 9.8M€ grant from the French National Research Agency RHU program, which will part-fund clinical trials evaluating ONCO-Boost.

HEPHAISTOS-Pharma is one of the few innovative companies to be selected for its disruptive potential and supported by the Paris Saclay Cancer Cluster.

HEPHAISTOS-Pharma is headquartered in France, with a subsidiary in Liège, Belgium. Learn morewww.hephaistos-pharma.com

About ONCO-Boost

ONCO-Boost is the first product from HEPHAISTOS-Pharma’s platform. It stimulates the patients’ own immune system, strengthening both innate and adaptive immune systems, to increase their responses against cold tumors. ONCO-Boost can work both as a single agent and in combination with established immunotherapies that do not work against cold tumors, boosting their efficacy to breakthrough levels. Thanks to its intravenous administration, ONCO-Boost is the first immunostimulant to demonstrate simultaneous efficacy against both primary tumors and metastases.

About ELAIA

Elaia Partners is a European top-tier Venture Capital firm with a strong technology DNA. We invest in technology disruptors with global ambition from early stage to growth development. For the past 20 years, our commitment has been to deliver high performance with values.

We are proud to have been an active partner in over 100 startups including success stories such as Criteo (Nasdaq), Orchestra Networks (acquired by Tibco), Volterra (acquired by F5), Mirakl (valued $3.5B in Series E), Shift Technology (valued $1B+ in Series D), Mablink Bioscience (acquired by Eli Lilly), Aqemia and Alice&Bob.

Learn more www.Elaia.com • @Elaia_Partners

About xista sciences ventures

xista science ventures is an Austria-based venture fund investing in early-stage life science and deeptech startups across Europe. With a deep understanding of both scientific and investor perspectives, xista is an active partner to its portfolio companies, providing support for founders in realizing deep-tech ideas and scaling enterprises. The fund’s diverse portfolio spans the full breadth of science, in fields such as biotechnology, medtech, materials science and software. xista is embedded in the innovation system around the Institute of Science and Technology Austria (ISTA).

Learn more www.xista.vc.

About the Fondation Fournier-Majoie

Fondation Fournier-Majoie is a Belgium venture philanthropy organization dedicated to innovation against cancer. Foundation’s mission is to identify, fund and support the most promising early-stage oncology European companies and their Founders as of pre-seed/seed development stage.

Learn more www.fournier-majoie.org

About Noshaq

Noshaq is an investment fund and project developer with a portfolio of more than 450 companies in different sectors. Noshaq is the reference financial partner for the creation and development of SMEs in the region of Liège, Belgium. Noshaq places a significant emphasis on the life science sector, aiming to actively support promising companies in this field.

Learn more www.noshaq.be

We are pleased to announce that HEPHAISTOS-Pharma has been awarded a Sanofi’s Golden Ticket 2023, winning a year’s free lab space at BioLabs @Hôtel-Dieu (France) to explore the application of their technology in developing new effective adjuvantation for mRNA vaccines. As a sponsor of BioLabs @Hôtel-Dieu, SANOFI is very committed to support game changing start-up emerging from the biotech ecosystem and to further accelerate patient access to these disruptive innovations.

Paris, December 12th 2023

Lien : https://www.sanofi.com/fr/partenariat/golden-ticket-competition

We are very proud to announce that we are winners of the #EIC_Accelerator grant from the European Innovation Council

October 30th 2023. Winners of the EIC accelerator grant have been announced. 47 winning innovative projects have been awarded all over Europe among them 12 are french companies. The EIC accelerator aims at supporting innovative SME with technologies that will have high impact over Europe.

Winner of the #health theme, our project consists in the development of a new immunotherapy platform against incurable cancer like sarcomas and able to treat metastatic patients. This platform can be used alone or in combination with therapeutic antibodies. 

HEPHAISTOS-Pharma is a biotechnology company developing the next generation of cancer treatments based on stimulating patients’ immune systems. ONCO-Boost, the flagship product of HEPHAISTOS-Pharma’s platform, can treat cancers with no treatment option and increase the efficacy of current immunotherapies which are not working against cold tumors. Thanks to its intravenous injection, ONCO-Boost is the first immunostimulant to have demonstrated efficacy against both primary tumors and metastases.

HEPHAISTOS-Pharma has developed its technology up to the preclinical regulatory phases by validating the feasibility of its industrialisation as well as its improved safety and efficacy. ONCO-Boost has obtained unprecedented preclinical results in various tumour models (osteosarcoma, colorectal, lymphoma, breast cancer). The EIC accelerator grant aims to support HEPHAISTOS up to clinical phases. Our objective is to create a European champion backed by a network of scientific and industrial excellence in the field, and create many jobs in Europe against American and Asian competitors.

HEPHAISTOS-Pharma is in the process of preparing Seed round to finance its development and is currently seeking investors to complete the ongoing syndication and close the round. 

➕ More information about the other laureates 

https://eic.ec.europa.eu/system/files/2023-10/EIC%20Accelerator-June%2021%202023%20Cut%20Off.pdf

🏆 Nous sommes très fiers d’annoncer que nous sommes lauréats de la bourse #EIC_Accelerator du Conseil européen de l’innovation. 💪       🇫🇷

30 octobre 2023. Les lauréats du concours EIC accelerator ont été annoncés. 47 projets innovants ont été récompensés dans toute l’Europe, dont 12 entreprises françaises. L’accélérateur EIC a pour objectif de soutenir les PME innovantes dont les technologies auront un fort impact en Europe.

Lauréat de la thématique #santé, notre projet consiste à développer une nouvelle plateforme d’immunothérapie contre les cancers incurables comme les sarcomes et capable de traiter les patients métastatiques. Cette plateforme peut être utilisée seule ou en combinaison avec des anticorps thérapeutiques.

HEPHAISTOS-Pharma est une société de biotechnologie qui développe la prochaine génération de traitements contre le cancer basés sur une stimulation du système immunitaire des patients. ONCO-Boost, le produit phare de la plateforme d’HEPHAISTOS-Pharma, permet de traiter les cancers sans option thérapeutique et d’augmenter l’efficacité des immunothérapies actuelles qui ne sont pas efficaces contre les tumeurs solides. Grâce à son injection en intraveineuse, ONCO-Boost est le premier immunostimulant à avoir démontré une efficacité contre les tumeurs difficiles d’accès mais aussi contre les métastases ouvrant la voie à un traitement des patients sans solution thérapeutique.

HEPHAISTOS-Pharma a développé sa plateforme d’immunothérapie jusqu’aux phases réglementaires précliniques en validant la faisabilité de son industrialisation ainsi que la meilleure efficacité et innocuité par rapport aux concurrents. ONCO-Boost a obtenu des résultats sans précédent en préclinique sur des modèles variés de tumeurs (Ostéosarcome, colorectal, lymphome, cancer du sein). La subvention de l’accélérateur EIC vise à soutenir HEPHAISTOS jusqu’aux phases cliniques. Notre objectif est de créer un champion européen soutenu par un réseau d’excellence scientifique et industrielle dans le domaine, et de créer de nombreux emplois en Europe face aux concurrents américains et asiatiques.

HEPHAISTOS-Pharma est en train de préparer un tour de table pour financer son développement et recherche actuellement des investisseurs pour compléter la syndication en cours et clôturer le tour de table.

➕ Plus d’information sur les lauréats

https://eic.ec.europa.eu/system/files/2023-10/EIC%20Accelerator-June%2021%202023%20Cut%20Off.pdf

We are very proud to announce that we are winners of the #iNov France2030 Innovation Competitions

For this 9th edition, 53 winning innovative projects will be supported by the State via #France2030 for a total amount of €56.3M. The i-Nov innovation competition aims to select projects with particularly strong potential for the French economy, which can claim to be global in scope!

Winner of the #health theme, our project consists in the development of a new immunotherapy platform against incurable cancer like sarcomas or metastatic patients. This platform can be used alone or in combination with therapeutic antibodies. 

HEPHAISTOS-Pharma is a biotechnology company developing the next generation of cancer treatments based on stimulating patients’ immune systems. ONCO-Boost, the flagship product of HEPHAISTOS-Pharma’s platform, can treat cancers with no treatment option and increase the efficacy of current immunotherapies which are not working against cold tumors. Thanks to its intravenous injection, ONCO-Boost is the first immunostimulant to have demonstrated efficacy against both primary tumors and metastases.

HEPHAISTOS-Pharma has developed its technology up to the preclinical regulatory phases by validating the feasibility of its industrialisation as well as its improved safety and efficacy. ONCO-Boost has obtained unprecedented preclinical results in various tumour models (osteosarcoma, colorectal, lymphoma, breast cancer). The i-Nov project aims to support HEPHAISTOS in the next phases of industrialisation and regulatory validation. It will enable this innovative technology, which is capable of improving patient survival, to be taken into clinical trials. It will also demonstrate the relevance of a unique and clean industrial process, position France at the forefront of immunostimulants by creating a new European champion backed by a network of scientific and industrial excellence in the field, and create many jobs in Europe.

HEPHAISTOS-Pharma is in the process of preparing Seed/Series A round to finance its development up to clinical phase I and is currently seeking investors to complete the ongoing syndication and close the round. 

➕ More information about the other laureates 

👉https://www.gouvernement.fr/sites/default/files/contenu/piece-jointe/2023/01/recueil_des_laureats_i-nov_vague_9_vf.pdf

🏆 Nous sommes très fiers d’annoncer que nous sommes lauréats du volet iNov des Concours d’innovation de l’Etat 💪             🇫🇷

A l’occasion de cette 9^ème édition, ce sont 53 projets innovants lauréats qui seront soutenus par l’Etat via #France2030 pour un montant total d’aides de 56,3 M€. Le concours d’innovation i-Nov a pour vocation de sélectionner des projets au potentiel particulièrement fort pour l’économie française, pouvant prétendre à une envergure mondiale ! 

Lauréat de la thématique #sante, notre projet consiste au développement d’une nouvelle plateforme d’immunothérapie contre les cancers incurables comme les sarcomes ou les patients métastatiques, pouvant être utilisée seule ou en combinaison avec les anticorps thérapeutiques. 

HEPHAISTOS-Pharma est une société de biotechnologie qui développe la prochaine génération de traitements contre le cancer basés sur une stimulation du système immunitaire des patients. ONCO-Boost, le produit phare de la plateforme d’HEPHAISTOS-Pharma, permet de traiter les cancers sans option thérapeutique et d’augmenter l’efficacité des immunothérapies actuelles qui ne sont pas efficaces contre les tumeurs solides. Grâce à son injection en intraveineuse, ONCO-Boost est le premier immunostimulant à avoir démontré une efficacité contre les tumeurs difficiles d’accès mais aussi contre les métastases ouvrant la voie à un traitement des patients sans solution thérapeutique.

HEPHAISTOS-Pharma a développé sa plateforme d’immunothérapie jusqu’aux phases réglementaires précliniques en validant la faisabilité de son industrialisation ainsi que la meilleure efficacité et innocuité par rapport aux concurrents. ONCO-Boost a obtenu des résultats sans précédent en préclinique sur des modèles variés de tumeurs (Ostéosarcome, colorectal, lymphome, cancer du sein). Le projet i-Nov a pour objectif d’accompagner HEPHAISTOS dans les prochaines phases d’industrialisation et de validation réglementaire. Il permettra d’amener en études cliniques cette technologie innovante capable d’améliorer la survie des patients. Il permettra également de démontrer la pertinence d’un procédé industriel unique et propre, de positionner la France à la pointe des immunostimulants en créant un nouveau champion national adossé à un réseau d’excellence scientifique et industriel dans le domaine, et créant de nombreux emplois en France.

HEPHAISTOS-Pharma est en préparation d’une levée de fonds privés en Seed / Série A pour financer son développement jusqu’en phase I clinique et cherche actuellement des investisseurs pour compléter la syndication en cours et boucler le tour. 

➕ Découvrez le détail de tous les projets lauréats ici  👉https://www.gouvernement.fr/sites/default/files/contenu/piece-jointe/2023/01/recueil_des_laureats_i-nov_vague_9_vf.pdf

➕ Découvrez la technologie de HEPHAISTOS-Pharma ici 

👉 https://hephaistos-pharma.fr/

The European Medicines Agency (EMA) has granted Orphan Drug Designation to ONCO-Boost (HEPHAISTOS-Pharma) as treatment for osteosarcoma.

Paris, France, September 1st, 2022, 7:00 pm CET.

HEPHAISTOS-Pharma a French Biotech company developing a new class of immunotherapies to address hard-to-treat and metastatic cancers, today announced that the European Commission granted Orphan Drug designation (ODD) to ONCO-Boost for the treatment of osteosarcoma.

“This designation is an important milestone in the development of ONCO-Boost and demonstrate its potential clinical benefits for sarcoma patients who have an urgent need for effective, tolerable, and convenient treatment options” said Frédéric Caroff, CEO and co-founder of HEPHAISTOS-Pharma. “This key milestone was reached thanks to the collaboration of HEPHAISTOS-Pharma with the academic teams from Pr. Charles Dumontet at the Centre de Recherche contre le Cancer de Lyon (CRCL), and Pr. Jean-Yves Blay at the Centre Léon Bérard (CLB). These collaborations have demonstrated the potential clinical benefit of ONCO-Boost against sarcomas such as osteosarcoma and chondrosarcoma, but also against Lymphoma, colorectal and breast cancers. The company is now heading toward regulatory validation and expects a first clinical study by 2023.”

In a recent interview on B-SMART TV, Dr. Aurélie Dutour from the CLB estimates that “ONCO-Boost is a great opportunity for patients as there was no therapeutic progress against osteosarcoma for 40 years and even the latest antibodies used in Immunotherapy failed and did not show any efficacy. The results that we obtained with ONCO-Boost were impressive and really encouraging”.

In the European Union (EU), Orphan drug designation is granted by the European Commission, based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products, to investigational therapies addressing rare medical diseases or conditions that affect fewer than five in 10,000 persons in the EU, and having sufficient non-clinical or clinical data demonstrating its potential clinical benefit in the indication. Orphan drug status provides benefits to drug developers, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.

About Osteosarcoma

Osteosarcoma (OSa) is the most common primary malignancy of bone in children and young adults, but it’s a rare disease with 35.000 cases diagnosed each year in the world. Despite multimodal treatments including mainly surgery and chemotherapies, the 5-year survival rate of OSa patients has not been improved in the last four decades with a rate around 60 % for patients with no clinically detectable metastasis and 30 % for patients with metastatic foci detectable at the time of diagnosis. There is therefore an urgent need to rapidly develop new treatment options for this very aggressive cancer causing the premature death of children.

About ONCO-Boost

ONCO-Boost is the first-in-class natural immunostimulant targeting the Toll Like Receptor 4 (TLR4) compatible with systemic administration enabling to address hard-to-treat and disseminated tumors but also metastatic cancers. ONCO-Boost development has reached preclinical regulatory phases by validating its industrialization, its safety but also its efficacy in various tumor models both as monotherapy and in combination with different therapeutic monoclonal antibodies (mAbs). As monotherapy, ONCO-Boost notably showed impressive anti-tumor efficacy on a relevant orthotopic Osteosarcoma model leading to complete regression of primary tumor and pulmonary metastasis in 78% and 40% of the animals respectively. Unprecedented results were also obtained in combination with a mAb like Rituximab on a Human B lymphoma model (Raise of complete response rates from 17% to 67-100%), and immune checkpoint inhibitors (ICI) on a mouse model of colorectal cancer (Raise of efficacity from 0% to 80%). ONCO-Boost was also found to generate anti-tumor memory immune responses for long-term protections against relapses but also to efficiently address at the same time primary tumors and related metastasis which is unique in this competitive field. The antitumor activity of ONCO-Boost was associated with its capacity to modulate the tumor microenvironment (TME) from a “cold” (immunologically suppressed) to a “hot” (immunologically active) environment.

HEPHAISTOS-Pharma is currently rising private funds to prepare industrialisation of the drug manufacturing and regulatory validation to go to clinical phases. Private investors or Business Angels can contact Frederic CAROFF, the CEO if they wish to participate to our next fundraising.

For more information , visit hephaistos-pharma.fr

Press & Investors Contacts  :

HEPHAISTOS-Pharma

Frederic CAROFF, MSc. MBA
CEO and co-founder
T. : +33 (0)6.67.89.30.47

Simon PICO, PhD. MBA
Business Developer
T. : +33 (0)6.38.87.79.80