Radiopharm Theranostics Announces Positive Data from the Phase 1 Imaging Trial of RAD301 in Patients with Pancreatic Ductal Adenocarcinoma

Early Phase 1 imaging data suggest RAD301 may offer more tumor-specific detection of pancreatic cancer and support its advancement to Phase 2.

Rhea-AI Summary

Radiopharm Theranostics (RADX) reported positive Phase 1 imaging data for its radiopharmaceutical candidate RAD301 in healthy volunteers and patients with pancreatic ductal adenocarcinoma (PDAC).

The trial, designed to assess safety, biodistribution and dosimetry, showed a favorable safety profile in all evaluable participants. RAD301, a Ga‑68–labeled peptide targeting αvβ6‑integrin, demonstrated favorable biodistribution and significant, selective tumor uptake in pancreatic cancer metastases in all evaluable PDAC patients. Low background uptake in liver, lung and bowel, common metastatic sites, supports the potential of RAD301 to distinguish metastatic lesions from normal tissue. The company said these results support continued clinical development, including a future Phase 2 imaging trial, and reinforce αvβ6‑integrin as a potential diagnostic, therapeutic and theranostic target. RAD301 has previously received FDA Orphan Drug Designation.

Positive

• Favorable safety profile reported for RAD301 in all evaluable Phase 1 participants
• Significant and selective tumor uptake seen in all evaluable PDAC metastases imaged with RAD301
• Low background uptake in liver, lung and bowel supports clearer visualization of metastatic lesions
• Data support progression of RAD301 into a future Phase 2 imaging trial
• FDA Orphan Drug Designation previously granted to RAD301 for pancreatic cancer

Negative

• RAD301 remains in early clinical development with data only from a Phase 1 imaging trial and no efficacy outcomes reported

Market Context

RADX closed at $2.12 before the Phase 1 imaging update, while peer movements were mixed; the pre-hea...

Analysis

RADX closed at $2.12 before the Phase 1 imaging update, while peer movements were mixed; the pre-headline market context did not show a coordinated biotechnology-sector move.

Key Terms

biodistribution, dosimetry, αvβ6-integrin, orphan drug designation, +1 more

5 terms

biodistribution medical

"Positive safety and favourable biodistribution seen in all subjects dosed"

Biodistribution is the map of where a drug, vaccine, or diagnostic agent travels and accumulates inside the body after administration. Investors care because where a product ends up affects how well it works, what side effects it may cause, and whether regulators will approve it—similar to tracking dye in a plumbing system to find leaks or blockages; unexpected destinations can raise safety, cost, and market-adoption risks.

dosimetry medical

"evaluate the safety, biodistribution and dosimetry of RAD 301"

Dosimetry is the measurement and calculation of how much ionizing radiation is absorbed by people, tissues, or devices, similar to a thermostat tracking temperature in different rooms to know where and how much heat is present. Investors should care because accurate dosimetry underpins safety, treatment effectiveness, regulatory approval, and liability for products and services that use radiation—affecting market access, costs, and commercial risk.

αvβ6-integrin medical

"RAD301 is a peptide-based molecule bound to Gallium-68 (Ga-68) that targets αvβ6-integrin"

A cell-surface receptor made of two protein subunits, alpha-v and beta-6, that helps cells stick to their surroundings and send signals; think of it as a specific lock on some cells’ surfaces. It matters to investors because αvβ6-integrin is often increased in certain cancers and fibrotic diseases, so drugs or diagnostics that target it can be the basis for clinical trials, patents, partnerships, and potential commercial products.

orphan drug designation regulatory

"RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fdg pet medical

"conventional approaches such as FDG PET are limited by variable tumor biology"

A FDG PET is a medical imaging scan that uses a radioactive sugar tracer (fluorodeoxyglucose, FDG) and a positron emission tomography (PET) camera to show areas of increased metabolic activity in the body. Think of it as a heat map for cells: regions that take up more sugar light up, which helps detect cancer, inflammation, or active brain tissue. Investors care because FDG PET use affects demand for imaging equipment, radiotracers, clinical trial results, and reimbursement decisions in healthcare markets.

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            Positive safety and favourable biodistribution seen in all subjects dosed

Imaging data in all evaluable pancreatic cancer patients demonstrated significant tumor uptake

Data support the targeting potential of RAD301 and continuation of its clinical development

SYDNEY, Australia, Sept. 09, 2026 (GLOBE NEWSWIRE) -- 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 positive data from the Phase 1 imaging trial designed to evaluate the safety, biodistribution and dosimetry of RAD 301 in healthy volunteers and subjects with Pancreatic Ductal Adenocarcinoma (PDAC).

RAD301 is a peptide-based molecule bound to Gallium-68 (Ga-68) that targets αvβ6-integrin, a cellular marker for tumor invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas. The αvβ6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target. RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA.

"These data are an important step forward for patients suffering from advanced pancreatic cancer, as RAD301 has demonstrated significant and selective tumor uptake in metastatic lesions," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Given the limited imaging and treatment options available for patients with PDAC, these findings highlight the potential role of RAD301 in improving disease detection, patient selection, and future theranostic applications. Pancreatic cancer remains a challenging disease to image, and conventional approaches such as FDG PET are limited by variable tumor biology and non-specific uptake. The results from this Phase 1 study support the potential of αvβ6-integrin-targeted imaging to provide a more tumor-specific approach to detecting pancreatic cancer, further supporting the advancement of RAD 301 into Phase 2 development.”

Data from the Phase 1 trial of RAD301 demonstrated a favorable safety profile in all evaluable participants. Additionally, RAD301 had favorable biodistribution along with significant tumor uptake in pancreatic cancer metastases, consistent with initial results from the first five patients evaluated. The results showed significant and selective tumor uptake in pancreatic cancer metastases, which supports the potential of αvβ6-integrin as a target for future therapeutic development and potentially as a theranostic pair. Importantly, the low background uptake observed in liver, lung and bowel — the sites where pancreatic cancer most often spreads — supports the potential of RAD301 to distinguish metastatic lesions from surrounding normal tissue. The unmet medical need in the earlier stages of disease and the high mortality of the disease provide a rationale for a future Phase 2 imaging trial of RAD301.

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 five Phase 1 trials in a variety of solid tumor cancers including lung, breast, prostate and brain. Learn more at radiopharmtheranostics.com.

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/

FAQ

What is RAD301 and how does it work in pancreatic cancer?

RAD301 is a peptide-based molecule labeled with Gallium‑68 (Ga‑68) that targets αvβ6‑integrin, a cellular marker associated with tumor invasion and metastatic growth. The αvβ6‑integrin receptor is present at high density on most pancreatic carcinoma cells, which makes it an attractive diagnostic and therapeutic target for imaging and potential theranostic applications.

What was the main objective of the Phase 1 trial of RAD301?

The Phase 1 imaging trial was designed to evaluate the safety, biodistribution and dosimetry of RAD301 in healthy volunteers and in subjects with pancreatic ductal adenocarcinoma (PDAC). The results showed a favorable safety profile and biodistribution, along with significant tumor uptake in pancreatic cancer metastases.

Why is low background uptake in liver, lung and bowel important for RAD301?

Pancreatic cancer often spreads to the liver, lung and bowel. The low background uptake of RAD301 in these organs supports its potential to distinguish metastatic lesions from surrounding normal tissue, which may improve the imaging of metastatic disease compared with less specific approaches.

How could RAD301 compare with conventional FDG PET imaging in PDAC, based on these data?

The company stated that pancreatic cancer is challenging to image and that conventional approaches such as FDG PET are limited by variable tumor biology and non-specific uptake. In this Phase 1 study, αvβ6‑integrin–targeted imaging with RAD301 showed significant and selective tumor uptake, which the company said supports a more tumor-specific approach to detecting pancreatic cancer.

What are the planned next steps for the clinical development of RAD301?

The results from the Phase 1 trial, including favorable safety, biodistribution and tumor uptake data, provide a rationale for a future Phase 2 imaging trial of RAD301 in pancreatic cancer. The company indicated that these findings support the continuation of RAD301’s clinical development and its potential future theranostic applications.

What is the current clinical pipeline of Radiopharm Theranostics beyond RAD301?

Radiopharm Theranostics is a clinical-stage radiotherapeutics company with a pipeline of peptides, small molecules and monoclonal antibodies for cancer. Its clinical program includes one Phase 2 and five Phase 1 trials across several solid tumors, including lung, breast, prostate and brain cancers.