Major Milestone towards Clinical Trials
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
INVION ACHIEVES MAJOR MILESTONE TOWARDS CLINICAL TRIALS WITH SUCCESSFUL
MANUFACTURING OF INV043 UNDER GMP STANDARDS
Highlights:
Successful manufacturing of INV043, Invion’s lead candidate, at IDT Australia under
Good Manufacturing Practice (GMP) standards
GMP grade materials now available for upcoming Phase 1 clinical trials
IDT is a leading biopharmaceutical contract manufacturer in Australia with over 40
years’ experience developing drugs and active pharmaceutical ingredients for clinical
trials
MELBOURNE (AUSTRALIA) 21 November 2023: Invion Limited (ASX: IVX) (“Invion” or the
“Company”) is pleased to announce it has made a significant step towards commencing
clinical trials with the successful manufacturing of INV043 drug substance, used for the
treatment of cancers, under Good Manufacturing Practice (GMP) compliant manufacturing
process.
Invion collaborated with IDT Australia Limited (ASX: IDT), Australia’s leading end-to-end
biopharmaceutical contract development and manufacturing organisation with more than
four decades of experience producing high-containment and high-potency Active
Pharmaceutical Ingredients (API), to achieve this important milestone.
Invion’s Executive Chair and Chief Executive Officer, Thian Chew, said:
“We are excited to now have GMP-grade materials for INV043, which have been
developed with our Australian manufacturing partner, IDT. This is an important
achievement because it puts Invion ahead of the curve on the drug
manufacturing front. We are not only well placed for our upcoming Phase 1
clinical trials but for subsequent clinical trials as well.
“As a next generation photodynamic therapy (PDT), INV043 has the potential to
provide new therapeutic options for multiple cancers without significant off-target
issues.”
IDT Australia’s Chief Executive Officer, Paul McDonald, commented:
“We are pleased to have this opportunity to partner with Invion as it advances
towards its key clinical trial milestone. Our demonstration of high-potency
containment manufacturing capabilities to develop and produce GMP-certified
APIs, right through to finished dose forms, allows us to be a long-term partner of
Invion as it works towards the commercialisation of what could be a revolutionary
cancer treatment option.”
This announcement was approved for release by Invion’s Board of Directors.
____________________________________________
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
ASX ANNOUNCEMENT
Investor and Media enquiries:
Thian Chew (Chairman & CEO)
T: +61 3 9692 7222
E: investor@inviongroup.com
Brendon Lau (Investor & Media Relations)
M: +61 409 341 613
E: brendon.lau@inviongroup.com
About Invion
Invion is a life-science company that is leading the global research and development of the
PhotosoftTM technology for the treatment of a range of cancers, atherosclerosis and infectious
diseases. Invion holds the exclusive Australia and New Zealand license rights and exclusive
distribution rights to Asia Pacific excluding China (other than Hong Kong, which is included in
the Territory), Macau, Taiwan, Japan and South Korea to the PhotosoftTM technology for all
cancer indications. It also holds the exclusive rights to the technology in Asia Pacific (excluding
Greater China) for atherosclerosis and infectious diseases, and subsequently acquired the
rights to the United States for infectious diseases. Research and clinical cancer trials are funded
by the technology licensor, RMW Cho Group Limited, via an R&D services agreement with the
Company. Invion is listed on the ASX (ASX: IVX).
About Photodynamic Therapy (PDT)
Invion is developing PhotosoftTM technology as a novel next generation Photodynamic
Therapy (PDT). PDT uses non-toxic photosensitisers and light to selectively kill cancer cells and
promote an anti-cancer immune response. Less invasive than surgery and with minimal side
effects, PDT offers an alternative treatment option aimed at achieving complete tumour
regression and long-lasting remission.
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
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