This collaboration seeks to deliver a faster and more effective response to the growing challenge of antimicrobial-resistant infections. By combining PHAXIAM’s GMP phages portfolio and advanced diagnostic capabilities, including its phagogram-based approach, with Technophage’s complementary GMP phages portfolio and GMP manufacturing expertise, the partnership aims to drive innovation and accelerate access to IPT in Europe.
The combined GMP phage portfolios will significantly enhance the number and diversity of GMP phages available for IPT. The partnership aims to achieve a collection of 25 GMP phages by the end of 2025 and 35-45 GMP phages by the end of 2026. This expanded portfolio will target at least 7 of the most critical pathogens: S. aureus, P. aeruginosa, E. coli, K. pneumoniae, A. baumannii, in addition to two other key pathogens. Together, these seven pathogens account for approximately 70%(1) of the most prevalent and difficult-to-treat antimicrobial-resistant infections.
PHAXIAM and Technophage will collaborate on GMP phages manufacturing and supply through the following arrangements:
The phagogram platform - a critical in-vitro Phages-Susceptibility-Testing (PST) solution for evaluating GMP phages against patient bacterial strains - forms a cornerstone of this collaboration. PHAXIAM will develop and expand its Phages-Susceptibility-Testing (PST) capabilities by integrating new GMP phages provided by Technophage. These enhanced capabilities will then be transferred to Technophage’s territory under undisclosed terms.
Individualized Phages Therapies (IPT) to Drive Revenue Growth in Major European Markets
Each party will manage the commercialization of the joint GMP phage portfolio within territories to be defined, leveraging their strengths. The objective is to capitalize on respective assets of both companies, considering (1) the level of interactions with regulatory authorities, (2) the potential commercial reach due to (a) the clinical deployment in any country through ongoing clinical trials, (b) the opening of clinical sites, and (c) distance from patients. The optimal commercial organization and the respective responsibilities of both companies will be defined according to the principles outlined earlier.
As part of PHAXIAM’s strategy presented in November 2024, this collaboration strengthens its position in IPT and supports its objective of marketing GMP phages in around 30-40 European hospitals in 2027.
Both parties will pursue their respective clinical pathways for their own Phage Therapy Medicinal Products (PTMP)
PHAXIAM will conduct GLORIA Phase II study, the 1st global, multicenter, randomized, placebo-controlled proof-of-concept phage therapy study in Prosthetic Joint Infection (PJI), conducted in Europe and the United States.
Technophage will pursue the completion of REVERSE 2 (Phase 2b) and initiate REVERSE 3 (Phase 3) in 2025, focusing on confirming the efficacy and safety of the Fast Track Designated TP-102 bacteriophage cocktail for the treatment of infections in Diabetic Foot Ulcers. Additionally, the company will launch the Phase 1/2a clinical trial of TP-122A (RECOVER) to evaluate the safety and tolerability of this phage cocktail in the context of Ventilator-Associated Pneumonia (VAP).
PTMP and IPT market channels form together a self-reinforcing virtuous cycle for Phages Therapy:
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Commercial success in IPT will help finance PTMP programs and facilitate rapid uptake of future approved medicinal products,
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Clinical success in PTMP will help broaden clinical and market acceptance of IPT in clinical indications not yet addressable by PTMP.
Thibaut du Fayet, Chief Executive Officer of PHAXIAM, stated: "This strategic collaboration represents a major advancement in the fight against severe resistant infections. By combining our respective areas of expertise and capabilities, we are presenting a compelling value proposition designed to deliver more effective, individualized GMP Phages therapies to patients. This partnership further supports our IPT model while accelerating our strategic development and strengthening our leadership position in the rapidly growing phages therapy market".
Miguel Garcia, Chief Executive Officer of Technophage, added: "Technophage has long been dedicated to advancing phage therapy as a revolutionary approach to treating bacterial infections. Our partnership with PHAXIAM enables us to combine our strengths and expedite patient access to high-quality individualized phage-based treatments. This collaboration represents a vital step in establishing phage therapy as a key therapeutic option, while aligning with our long-term goal of introducing innovative phage-based products to the biopharmaceutical market."
About Technophage
Technophage's mission is to develop innovative biologics to address the therapeutic needs of unmet medical conditions in infection, neurosciences, and ophthalmology. The company believes that its role in bringing safe and effective therapeutics to the market will significantly contribute to helping patients across the globe who are unable to find solutions in existing medicines.
The company's vision is to become a worldwide reference by providing unique and innovative solutions for unmet medical needs, leveraging its proximity to local healthcare systems. Technophage believes that its purpose of discovering alternative therapeutic solutions for unmet needs through the development of unique and innovative biologics can only be achieved by working every day to establish itself as a global partner. As the world faces increasing challenges in healthcare, the company's commitment is to be part of the solution.
For more information, please visit www.technophage.pt
About PHAXIAM Therapeutics
PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.
PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
For more information, please visit www.phaxiam.com
Forward-looking information
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM's control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.
1 Antimicrobial Resistance Collaborators, Lancet 2022; 399: 629–55 ; ESKAPEE pathogens responsible for 70 % of deaths attributable to AMR: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli pathogens
2 GMP: Good Manufacturing Practice
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Contacts
PHAXIAM
Thibaut du Fayet
CEO
+33 4 78 74 44 38
investors@phaxiam.com
NewCap
Mathilde Bohin / Dušan Orešanský
Investor Relations
Arthur Rouillé
Media Relations
+33 1 44 71 94 94
phaxiam@newcap.eu