- Combined 25 GMP(2) Phages Portfolio to cover by end 2025
five of the most critical pathogens (S. aureus, P. aeruginosa, E.
coli, K. pneumoniae, A. baumannii) and expansion by end 2026 to
35-45 GMP Phages and two additional pathogens
- Opportunity to provide physicians with access to a
comprehensive GMP phage portfolio and a diagnostic solution
enabling the implementation of Individualized Phages Therapies
(IPT)
- Collaboration on the GMP Phages manufacturing and
Phages-Susceptibility-Testing (PST) capabilities
development
- Concurrently both parties continue to independently develop
their traditional clinical Phages Therapy Medicinal Product (PTMP)
pathway
Regulatory News:
PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a
biopharmaceutical company (“PHAXIAM” or “the
Company”) developing innovative treatments for severe and
resistant bacterial infections and Technophage SA
(“Technophage”), a Portuguese company specializing in GMP
phage development, today announces a strategic collaboration. This
strategic partnership aims to provide physicians across Europe with
access to a comprehensive GMP phages portfolio, enabling the
implementation of IPT through shared capabilities.
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.
Expanding the GMP Phage Portfolio to Advance Individualized
Phages Therapies (IPT)
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.
Shared manufacturing and phagogram capabilities
PHAXIAM and Technophage will collaborate on GMP phages
manufacturing and supply through the following arrangements:
- PHAXIAM will produce and supply Technophage with commercial
batches of PHAXIAM’s GMP phages.
- Technophage will produce and supply PHAXIAM with commercial
batches of Technophage’s GMP phages.
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:
- Commercial success in IPT will help finance PTMP programs and
facilitate rapid uptake of future approved medicinal products,
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20250130421816/en/
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
PHAXIAM Therapeutics (EU:PHXM)
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