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RAD 402 preclinical data package complete; demonstrates safety and promising biodistribution profile
Ethics approval and Phase 1 clinical trial start in prostate cancer anticipated in 2H 2025
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Invion Limited
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With a strong IP portfolio, deep clinical-stage pipeline, global collaborations and an experienced leadership team, Invion is poised for transformative value creation as it enters the next phase of clinical and commercial growth.
Overview
Invion Limited (ASX:IVX) is a clinical-stage Australian life sciences company focused on transforming photodynamic therapy (PDT) into a next-generation solution for treating cancer and infectious diseases. The company’s core value lies not just in preclinical promise, but in real-world clinical validation.
At the heart of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively target diseased cells and, upon light activation, induce a precise oxidative stress response to destroy them. Unlike conventional PDTs that suffer from toxicity and off-target effects, Photosoft compounds are engineered for enhanced safety, specificity, immune activation, and theragnostic utility. INV043, Invion’s lead cancer drug candidate, has demonstrated up to 80 percent tumor control in combination with immune checkpoint inhibitors, and is now in human trials.The company is actively progressing a broad pipeline across multiple indications, including:
- A Phase I/II trial in non-melanoma skin cancer (NMSC), now dosing in Australia
- An anogenital cancer trial in collaboration with Peter MacCallum Cancer Centre, scheduled to begin in 2025
- A completed investigator-led Phase II prostate cancer trial, showing a 40 to 44 percent response rate with a strong safety profile
These trials signal a critical shift for Invion from preclinical research to meaningful clinical validation, spanning both systemic and topical formulations. The safety data from the NMSC trial is expected to support accelerated development of the anogenital cancer program, given both use the same topical compound.
The clinical results so far have been consistent with the findings from the preclinical studies – showing INV043 to be very safe with promising efficacy signals. The next set of trials aim to further solidify the potential for the technology, where the one drug can treat multiple cancers, improve patient outcomes when using checkpoint inhibitors in combination with INV043 and demonstrate its diagnostic and theragnostic potential.
Beyond internally funded trials, Invion is strategically expanding its clinical and commercial footprint through non-dilutive, global partnerships. In South Korea, Hanlim Pharm is funding the preclinical development of Photosoft for glioblastoma multiforme — a highly aggressive brain cancer — and oesophageal cancer, both of which present major unmet needs. These programs are fully financed by Hanlim, with Invion retaining all intellectual property
Similarly, Dr. I&B Co. (Dr.inB), another South Korean group, is backing the development of Photosoft for human papillomavirus (HPV) in a new proof-of-concept trial. This collaboration not only funds a novel therapeutic area outside of oncology but underscores the versatility of Photosoft as a multi-indication, platform technology. Invion bears none of the clinical trial costs and maintains all rights to future commercialization.
In parallel, Invion is expanding the Photosoft platform into infectious diseases, where preclinical studies have demonstrated broad-spectrum antimicrobial activity. The compound has proven effective in vitro against:
- Antibiotic-resistant “superbugs”
- Fungal and bacterial infections
- SARS-CoV-2 (Omicron)
- Oral and periodontal conditions such as peri-implant mucositis
These results reflect Invion’s long-term vision of developing a scalable, accessible and affordable therapy platform that addresses both high-burden cancers and the growing global threat of antimicrobial resistance. With Photosoft, the company is building a foundation not just for treating disease — but for reshaping therapeutic accessibility and patient outcomes worldwide.
Company Highlights
- Clinical-stage Pipeline in Multiple Indications: Successfully completed Phase II prostate cancer trial, ongoing Phase I/II skin cancer trial, and anogenital cancer trial initiating in 2025. Multiple cancer and infectious disease programs underway.
- Photosoft Platform Technology: Combines cancer selectivity, immune system activation, and minimal toxicity. Preclinical studies show INV043 can regress multiple cancers, deliver superior safety and efficacy and improve tumour control to 80 percent in combination therapy studies with blockbuster ICIs (vs 12 percent with ICIs alone).
- Renowned Partners & Global Pharma-funded Collaborations: Working with distinguished research institutions like Peter MacCallum Cancer Centre and Hudson Institute of Medical Research. Further, Hanlim Pharm (GBM, oesophageal cancer) and Dr.inB (HPV) are funding multiple programs without requiring Invion to contribute capital or give up IP.
- Theragnostic Capability: Photosoft compounds enable both treatment and imaging, allowing for highly precise cancer targeting and enhanced surgical decision-making.
- Strong Clinical and IP Foundation: GMP-grade INV043 manufactured and patented in Australia, with global IP protection extending to at least 2041.
- Compelling Upside: Following a share consolidation and reduced overhangs, IVX offers significant re-rating potential with multiple clinical readouts expected over the next six to 12 months.
Key Programs
Non-melanoma Skin Cancer
Invion’s leading active trial is a Phase I/II adaptive clinical study targeting non-melanoma skin cancer — a condition that represents 98 percent of all skin cancers and constitutes a substantial public health burden in Australia. Using a topical formulation of INV043, the trial is designed with a 3+3 structure allowing real-time protocol optimization for safety and efficacy. The formulation offers significant cosmetic and pain-reduction benefits over existing approved PDT treatments like Metvix (by Galderma S.A.) and excisional surgery, both of which have limitations related to scarring and pain. Dosing of the first patient commenced in December 2024, with ongoing recruitment and interim data expected in the second half 2025 or early 2026. The skin cancer program not only represents a potentially fast path to market but also supports downstream programs, such as the anogenital cancer study, through shared formulation and safety data.
Anogenital Cancers (Peter Mac Collaboration)
The anogenital cancer program is a major upcoming milestone for Invion, developed in collaboration with the prestigious Peter MacCallum Cancer Centre in Melbourne, Australia, one of the leading oncology research centres in the world. Utilizing the same topical INV043 formulation as the non-melanoma skin cancer trial, this Phase I/II study will leverage safety data from the trial to accelerate approval timelines. The anogenital trial targets high-risk lesions and cancers with limited therapeutic options, and benefits from the scientific and operational expertise of Peter Mac. Preclinical data showed exceptional synergy when INV043 was used in combination with immune checkpoint inhibitors (anti-PD-1), achieving up to 80 percent tumor-free responses in models of anal squamous cell carcinoma, compared with a circa 12 percent response rate with aniti-PD-1 alone. This program exemplifies Invion’s theragnostic strength, where the compound also enables fluorescent visualization of tumor margins to aid surgical decision-making.
Prostate Cancer (Phase II Completed)
INV043 has completed a Phase II investigator-led clinical trial in prostate cancer, funded by the RMW Cho Group. The trial involved sublingual systemic administration of the compound followed by targeted light therapy. Following COVID-related disruptions, a second cohort of 16 patients was successfully treated and evaluated using PSMA-PET scans and RECIST criteria. Results were compelling: 44 percent of patients showed no detectable cancer via PSMA-PET scan three months post-treatment, while 40 percent demonstrated partial or stable response by MRI. The therapy was extremely well-tolerated, with no serious adverse events and only mild treatment-emergent side effects. These findings serve as clinical proof-of-concept for systemic delivery of INV043, highlighting its potential for deeper-seated cancers and reinforcing its safety and scalability.
Glioblastoma and Oesophageal Cancer (Hanlim Pharma Collaboration)
Through a strategic partnership with South Korean pharmaceutical company Hanlim Pharma, Invion is advancing preclinical programs for two highly aggressive and deadly cancers: glioblastoma multiforme and oesophageal cancer. Hanlim is funding both programs entirely, allowing Invion to retain all IP and avoid capital outlay. These programs are exploring INV043’s efficacy in some of the most treatment-resistant solid tumors, with early-stage studies underway and updates expected in 2025. If successful, this collaboration could lead to regional licensing or joint ventures in Asia, significantly expanding Invion’s global footprint.
HPV and Infectious Diseases (Dr.inB Collaboration)
Dr.inB, a leading PDT innovator in South Korea, is partnering with Invion to develop Photosoft-based treatments for HPV-related conditions, including genital warts and potentially HPV-linked cancers. The program, which includes proof-of-concept human trials, is entirely funded by Dr.inB, and Invion retains all IP and commercialization rights. Beyond HPV, Photosoft has demonstrated broad-spectrum antimicrobial potential against antibiotic-resistant bacteria, fungi and viruses, including SARS-CoV-2. This opens the door to applications in periodontal disease, peri-implant mucositis, and other infectious conditions. PDT’s unique mechanism of action — using light to generate oxidative stress — renders it immune to resistance development, making it an ideal candidate for combatting antimicrobial resistance, one of the top 10 threats to humanity identified by the World Health Organization.
Management Team
Thian Chew – Executive Chairman & CEO
Thian Chew brings over two decades of executive and advisory experience in healthcare and finance. He is the co-founder of Chronic Airway Therapeutics and a board advisor at Stanford Medicine’s Center for Asian Health Research and Education (CARE). Formerly an executive director at Goldman Sachs and director at KPMG Consulting, Chew combines strategic vision with operational rigor. He is an adjunct professor at the University College London and associate professor at HKUST, holding dual an MBA from Wharton School (Palmer Scholar) and an MA from the Lauder Institute, University of Pennsylvania.
Robert Ramsay – Scientific Advisor
A world-renowned expert in immunotherapy and translational cancer biology, Robert Ramsay is a senior scientist at Peter MacCallum Cancer Centre and has over 30 years of oncology research experience. He was instrumental in demonstrating the synergy between INV043 and checkpoint inhibitors, leading to his appointment as a key advisor. Ramsay also served as president of the Australian Society for Medical Research.
Scott Carpenter – Program Director
Scott Carpenter brings cross-functional expertise in regulatory affairs, business development and stakeholder engagement. He previously held leadership roles at Starpharma, AusBiotech and Bayer CropScience and holds an MBA from Melbourne Business School.
Sebastian Marcuccio – Medicinal Chemistry Lead
The co-inventor of Invion’s PDT patents, Sebastian Marcuccio is the founder of Advanced Molecular Technologies and has a deep background in pharmaceutical R&D, including with CSIRO. He is currently adjunct professor at La Trobe University and holds a PhD in organic chemistry.
Kim Steel – Clinical Trial Director
With more than 18 years of experience managing global Phase I-IV drug and device trials across 14 countries, Kim Steel has worked with Novotech and Pacific Clinical Research. She is managing director of SAPRO Consulting, leading operational delivery for Invion’s ongoing trials.
Alexander Bennett – Technical Advisor, Light Devices
A veteran of scientific instrumentation development, Alexander Bennett brings 35+ years of experience designing medical and forensic light systems. He led PDT light source trials at Peter MacCallum Cancer Centre and ensures the clinical precision of INV043’s light activation protocol.
Revolutionizing Photodynamic Therapy (PDT) for cancer and infectious diseases
Radiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for ¹?¹Tb-KLK3-mAb Phase I Clinical Trial in Australia
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the signing of a supply agreement with Cyclotek to radiolabel RAD 402 with Terbium-161 ( 161 Tb) in Australia, which supports the initiation of a Phase 1 clinical trial. RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic labelled with the radionuclide 161 Tb for treatment of prostate cancer.
"This agreement is an important milestone for the development of RAD 402 and is the last step needed to submit for ethics approval and begin our Phase 1 clinical trial in prostate cancer," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We are very appreciative of the entire team at Cyclotek for their support as we work together to bring an innovative new treatment option to patients battling prostate cancer."
RAD 402 has been designed to target KLK3, which is highly expressed in the prostate, with very limited/no expression in other tissues and organs. Compared to 177 Lu, 161 Tb emits additional Auger and conversion electrons alongside its β-radiation, which can lead to potentially improved antitumoral therapeutic efficacy. 161 Tb-RAD 402 is the first company-sponsored Phase I trial in prostate cancer using 161 Tb.
Under the agreement, Cyclotek will produce and provide doses of 161 Tb-labeled RAD 402 to support Radiopharm's upcoming Phase 1 clinical trial in prostate cancer in Australia. The Phase 1 trial is anticipated to start in the second half of 2025.
"We are pleased to partner with Radiopharm to facilitate the development of their innovative radiotherapeutic, RAD 402, for the treatment of prostate cancer," stated Greg Santamaria, CEO of Cyclotek. "Our mission at Cyclotek is to improve the accessibility of radiopharmaceuticals to enhance patient outcomes. As we support the Radiopharm Theranostics team, we look forward to RAD402 advancing toward market approval while demonstrating the value radiotherapeutics can bring to patients."
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com .
About Cyclotek
Cyclotek is the leading radiopharmaceutical manufacturer in Australia and New Zealand. We manufacture diagnostic and therapeutic radiopharmaceuticals for supply into clinical trials and for clinical use.
At Cyclotek, we are committed to improving patient outcomes by making diagnostic and therapeutic radiopharmaceuticals accessible. PET tracers provide patient specific insights into their disease state, leading to earlier diagnosis, more accurate assessment of disease extent, and improved treatment planning and monitoring. Paired with radionuclide therapies, these products offer a comprehensive, non-invasive disease management option.
Our dedication to innovation drives our continuous development of new radiopharmaceuticals.
This helps provide our customers a growing range of tools that enhance the understanding of each patient's health, contributing to more cost-effective healthcare solutions.
At Cyclotek, we are not just a manufacturer, we are a hub of innovation. Our commitment to quality, safety, supply and customer service ensures that healthcare providers have the best tools available for precise diagnostics and therapies, fostering improved patient care.
Through our unwavering focus on excellence, we aim to make a lasting, positive impact on healthcare.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
News Provided by GlobeNewswire via QuoteMedia
Inside the ASX Biotech Boom: What’s Fuelling the Next Wave
On a global scale, the biotechnology market size was pegged at US$1.55 trillion in 2023, with growth projections reaching US$3.88 trillion by 2030, according to a report from Grand View Research.
While much global biotech attention is focused on the NASDAQ, the ASX has carved out a niche as a launchpad for early stage innovation, offering investment exposure before major clinical or regulatory milestones are reached.
Investors’ approach to biotech stocks
Evaluating a biotech investment requires a unique set of variables that may be different from traditional valuation metrics, like earnings and revenue.
“Biotech doesn’t fit neatly into traditional valuation frameworks. Revenue might not exist yet. Profits could be years away. And the outcome of a single clinical trial can send valuations soaring or crashing overnight,” wrote Lior Ronen, founder and CEO of Finro Financial Consulting.
In this sector, every stage — from preclinical to Phase III — serves as a potential value inflection point. Investors also prioritise pipeline diversity. A single therapy focus can be riskier than a platform addressing multiple indications or mechanisms, which inherently balances failure risk.
Robust IP is essential. Comprehensive IP protection enhances both commercial potential and the opportunity for strategic partnerships. Capital discipline is another key consideration. With no immediate revenue stream, biotech firms need to manage cash efficiently. Companies that combine non-dilutive funding, such as grants, with lean operations can extend their runway and reduce dilution for existing shareholders.
External validation through partnerships with research institutions or global pharmaceutical companies further strengthens investor confidence.
Together, these factors compose a robust framework for evaluating biotech investments. Investors who monitor upcoming catalysts like clinical data releases or regulatory meetings stand a strong chance of making timely and informed decisions.
Clinical milestones as catalysts
Timing is often the most critical variable in biotech investing. With less than 10 percent of drug candidates making it from clinical trials to approval, securing positions before significant catalysts is crucial.
Each phase of clinical trials — Phase I (safety), Phase II (efficacy) and Phase III (confirmatory efficacy and large-scale safety) — represents a de-risking stage. Success at any point can trigger partnerships, licensing discussions or stock run ups. For example, Neuren Pharmaceuticals (ASX:NEU) surged after receiving US Food and Drug Administration approval for a Phase III trial of its NNZ-2591 to treat a rare condition called Phelan-McDermid syndrome.
Understanding both where a company sits in this sequence, and whether it’s sufficiently funded to reach its next milestone, are essential for well-timed entry and exit strategies.
Over the years, Australia has produced several beacon biotech stories:
CSL (ASX:CSL) grew from a government vaccine lab to a global biotech powerhouse worth over AU$140 billion. Its journey blends scientific innovation, strategic acquisitions and sustained global expansion.
Mesoblast (ASX:MSB) has navigated multiple clinical programs and regulatory reviews, demonstrating how IP-protected assets and global licensing deals can foster long-term growth despite inevitable setbacks.
These cases demonstrate that scalable platforms, a global mindset, clinical progress and IP robustness are the legs on which biotech success stands.
Emerging biotech platforms
Australia’s next wave of biotech leaders is emerging in areas such as immunotherapy, RNA platforms, regenerative medicine and non-invasive cancer therapies. Investor-favoured trends include:
- Non-toxic cancer treatments
- Theragnostics (integrated diagnostics and therapy)
- RNA-based therapeutics
- Platform technologies with cross-disease applications
These innovations benefit from Australia’s strong R&D ecosystem, leading universities and a regulatory structure capable of early phase clinical trials.
Case in focus: Invion Limited
Invion Limited (ASX:IVX) is emerging as a standout in the ASX biotech landscape, advancing a novel, IP-protected photodynamic therapy (PDT) platform with strong early clinical momentum.
Invion has a portfolio of over 300 unique compounds protected by over 10 patent families. Its lead cancer compound, INV043, is designed to selectively destroy cancer cells using light-activated photosensitisers, while leaving healthy tissue unharmed — a promising non-toxic, non-invasive alternative to chemotherapy, radiation or surgery.
The therapy’s dual mechanism of targeted cell death and immune activation positions it within the growing field of theragnostics, combining diagnostic and therapeutic utility. INV043 has demonstrated tumour fluorescence under violet light and therapeutic efficacy under red light, offering potential value not only as a treatment but also as a tool for visualising and monitoring cancer in real time.
The theragnostic potential of Invion's INV043.
Image via Invion Limited.
Invion recently reported positive Phase II results in prostate cancer, showing a 44 percent tumour response rate (PSMA-PET scans) and no serious adverse events across six treatment cycles.
A separate Phase I/II trial in non-melanoma skin cancer also reported no treatment-related pain or adverse events and early indications of lesion reduction. This trial will support the company’s upcoming anogenital cancer study in partnership with Peter MacCallum Cancer Centre.
The potential for a drug to be effective against more than one cancer target is unusual, to say the least. What makes the technology even more unique is its potential ability to stimulate the body’s immune system to continue to fight cancers. This was demonstrated in preclinical animal studies carried out by Invion’s research partners, the Peter MacCallum Cancer Centre and Hudson Institute of Medical Research on various cancers, including ovarian, colorectal, kidney, lung, triple negative breast and T-cell lymphoma.
Additionally, Invion has partnered with two South Korean pharmaceutical groups, Hanlim Pharm Co., Ltd. and Dr. I&B Co., Ltd. These parties are providing non-dilutive funding for studies using Invion’s Photosoft™ technology platform on glioblastoma (a deadly brain cancer), esophageal cancer and the human papillomavirus (HPV).
Beyond oncology, Invion is applying its Photosoft platform to infectious diseases, where resistance to antibiotics is escalating globally. Preclinical data show broad-spectrum antimicrobial activity, including against antibiotic-resistant pathogens and even SARS-CoV-2, without promoting resistance. This expands the company’s addressable market while reinforcing the flexibility of its core platform technology.
In a market where combination therapies are becoming standard, INV043’s ability to enhance immunotherapy responses may significantly increase its licensing or partnering potential.
With a capital-efficient structure, validated early data, world-renowned partners and a growing portfolio of trials across multiple cancers and infectious diseases, Invion is positioned as a platform biotech that is scalable, defensible and aligned with global healthcare trends favouring safety, precision and accessibility.
Strategic criteria for identifying the next breakout
A report by Jeremiah Grant, economic damages and business valuation expert at Arrowfish Consulting, outlines the following attributes to help investors evaluate biotech companies:
- A platform technology with multiple therapeutic or diagnostic uses
- Strong IP protection, preferably with international reach
- Active clinical relevance and small-scale data or early trial feedback
- Clear, upcoming regulatory or clinical milestones
- A capital-efficient model, supported by non-dilutive finance
- Strategic validation through partnerships or collaborations
- A confident commercial or licensing roadmap
Companies meeting these criteria are prime candidates for exponential gains with risk-managed entry points.
Investor takeaway
The ASX healthcare and biotech sector offers a distinctive opportunity for investors who understand its unique valuation drivers. While inherently high risk, the sector can deliver high-reward outcomes when approached with informed timing, strategic insight and rigorous scientific evaluation.
Innovators like Invion, which combine strong IP, scalable platforms, disciplined funding and impending clinical inflection, represent the kind of high-upside opportunities that savvy investors seek. By marrying financial discipline with scientific foresight, investors can access what may be one of the most transformative sectors of the next decade.
This INNSpired article is sponsored by Invion Limited (ASX:IVX). This INNSpired article provides information which was sourced by the Investing News Network (INN) and approved by Invion Limited in order to help investors learn more about the company. Invion Limited is a client of INN. The company’s campaign fees pay for INN to create and update this INNSpired article.
This INNSpired article was written according to INN editorial standards to educate investors.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Invion Limited and seek advice from a qualified investment advisor.
Radiopharm Theranostics Granted U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain Metastases
Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.
RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastases.
"The FDA's Fast Track Designation for RAD101 highlights the seriousness of recurrent brain metastases as a condition and the unmet medical need for innovative products that can differentiate between tumor recurrence and radiation necrosis or pseudprogression," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "RAD101 represents a promising advancement in improving diagnostic precision for brain metastases, offering hope for more effective clinical decision-making in the over 300,000 patients diagnosed annually in the U.S. We are excited to advance our Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025."
The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. A Sponsor that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. A Sponsor's drug receiving Fast Track designation also may be eligible for Priority Review if relevant criteria are met.
About the Phase 2 Clinical Trial of RAD101
The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases.
About RAD101
RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com .
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (Formerly Stern IR)
E: annemarie.fields@precisionaq.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
News Provided by GlobeNewswire via QuoteMedia
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