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Global AR Leader XREAL Showcases Revolutionary New Experiences in Collaboration with Industry Titans
LAS VEGAS, Jan. 7, 2025 /PRNewswire/ -- XREAL, the worldwide leader in augmented reality (AR), is announcing a series of groundbreaking collaborations and a new distributor agreement at the annual Consumer Electronics Show 2025 trade show (CES). These collaborations highlight XREAL's continued commitment to transforming how the world interacts with AR technology and deliver unparalleled immersive experiences, while amplifying sector leaders' unique contributions in the exciting space.
XREAL is today's AR market leader. The brand has held the consumer augmented and extended reality market leadership position in terms of shipments since it began shipping AR glasses in 2021, reaching more than half-a-million shipments life-to-date. According to IDC, XREAL maintained the industry leading market share for the global AR and optical see-thru (OST) industry throughout the first three quarters of 2024*. Also in 2024, XREAL was the only augmented and extended reality company to rank among the top five global companies by market share for the broader ARVR industry. XREAL has been in the top five ARVR companies for market share by shipments for six consecutive quarters, and has remained the only augmented and extended reality (non-VR) company to break into the top five.*
This week at CES, XREAL will showcase its latest innovations, including its brand new XREAL One Series AR glasses and its Beam Pro handheld spatial compute device. In addition, the company is proud to unveil new and renewed collaborations with world-renowned industry leaders such as BMW Group, Google, Qualcomm Technologies, Inc., Bose, T-Mobile, Mawari and more. Also this week, the XR Sports Alliance (XRSA) has announced its first cohort of members, including XREAL.
"We are proud to be leading from the front for AR technology and excited to welcome our new collaborators who are all leaders in their respective fields," said Chi Xu, CEO and Co-founder, XREAL. "Together, we're discovering new boundaries for what's possible in AR. From luxury automobiles to the most advanced mobile networks, and from next-gen chips to immersive sound, this partner ecosystem will change the way people interact with everything around them through AR glasses."
CEO Xu continued, "At CES 2025, we're not just showcasing products—we're unveiling the future of AR. With the XREAL One, XREAL One Pro, and Beam Pro, we're offering a suite of devices that deliver powerful, transformative experiences, whether for entertainment, communication, transportation or mobility."
Collaborations:
- BMW Group: A leader in automotive innovation, a brand-new BMW X3 M50 will be a spotlight feature inside the XREAL booth at CES. At CES2024, XREAL and BMW Group showed driver and co-driver experiences in moving vehicles. This time, XREAL and BMW will demo 3D entertainment for passengers. Two laps of BMW's M Mixed Reality race will be showcased with XREAL's AR technology to provide a glimpse into the future of in-car entertainment. CES attendees can enjoy the new XREAL One Series for big screen, action-packed entertainment in ultimate style inside the BMW X3 M50.
- Google: When paired with an XREAL Beam Pro Android mobile device XREAL glasses have access to Google Play apps and experiences – which are featured throughout XREAL's CES booth. In addition, more information about the exciting Android XR platform and collaboration with Qualcomm Technologies and XREAL will be shared later in 2025.
- Qualcomm: Renowned for its world-class Snapdragon® chips, Qualcomm Technologies, Inc. provides the powerful processing power behind the XREAL Beam Pro handheld Android mobile device. The Snapdragon processor provides AI capabilities, high performance and reliability for people taking their XREAL AR glasses to the spatial level with Beam Pro.
- Bose: XREAL One and XREAL One Pro incorporate customized Sound by Bose, delivering audio for the XREAL One Series that provides significantly enhanced listening experiences when compared to similar head worn or mobile devices. Bose meticulously fine-tuned the audio performance of XREAL One and XREAL One Pro to provide optimal audio quality for the wearer. Superior mid-to-high frequencies enrich subtle details, while the glasses form factor allows for a more natural soundscape.
- T-Mobile and Mawari: Known for its industry-leading 5G network, T-Mobile is teaming up with Mawari to showcase a realistic, immersive 3D call experience using XREAL glasses inside the XREAL booth. By combining T-Mobile's ultra-fast 5G network with Mawari's real-time immersive content streaming technology, CES attendees can interact with Mawari's virtual avatar as if they were physically present, but visible only through the XREAL glasses.
- AT&T: XREAL has formed a distributor relationship with AT&T to bring XREAL One Series glasses to customers in the US through AT&T's future-forward online store at newtech.att.com. The New Tech storefront features an AT&T-curated selection of sophisticated, experiential products that are leading the way in new technologies. The relationship is a major advancement for XREAL's online retail presence. The new XREAL One AR glasses are expected to become available this month at newtech.att.com, with plans for XREAL One Pro to be available soon.
"T-Mobile's 5G network was designed to usher in a new era of connected devices," said John Saw, Executive Vice President and Chief Technology Officer at T-Mobile. "AR has immense potential to transform the way we live, work, and play. With ultra-low latency, faster speeds, and greater reliability than 4G LTE or public Wi-Fi, 5G is essential to delivering a seamless and truly mobile AR experience."
"Mawari's vision is to bring immersive experiences to everyone, and we're excited to partner with T-Mobile and XREAL to showcase what cutting-edge 3D streaming technology can deliver," Luis Ramirez, Mawari CEO said. "We built our spatial streaming stack to enable the most lifelike, real-time interactions with digital humans and this application is a brilliant demonstration of where the future is heading."
"The Sound by Bose program allows us to bring our renowned audio capability to new categories and markets where sound matters," said Nick Smith, Senior Vice President of Strategy and Business Development at Bose. "Our audio tuning expertise creates a powerful and distinguished sound experience for the XREAL One Series. Content is more vibrant and lifelike, and we know consumers will hear the difference."
XREAL's cutting-edge AR glasses, known for their unmatched visual fidelity, portability and lightweight comfort, are further enhanced by these collaborations, which provide seamless integration of hardware, software, services, and experiences. Together, these relationships set a new standard for immersive AR scenarios across various industries, from automotive to mobile technology to entertainment.
CES attendees can learn more about XREAL, its products and its partners by visiting the XREAL booth inside the Las Vegas Convention Center central hall, booth number 14056.
About XREAL
XREAL is the global leader in the design and manufacture of consumer AR glasses. XREAL has pioneered several core innovations that are transforming the AR industry, including its proprietary optical technologies, and its uniquely consumer focused products. XREAL was first to popularize the concept of connecting AR glasses with existing computing devices.
Contact: ralph.jodice@xreal.com
Snapdragon is a trademark or registered trademark of Qualcomm Incorporated. Snapdragon is a product of Qualcomm Technologies, Inc. and/or its subsidiaries.
*According to IDC Worldwide Quarterly ARVR Tracker, 2024Q3. Q4 2024 data not yet reported.
Global AR Leader XREAL Showcases Revolutionary New Experiences in Collaboration with Industry Titans
LAS VEGAS, Jan. 7, 2025 /PRNewswire/ -- XREAL, the worldwide leader in augmented reality (AR), is announcing a series of groundbreaking collaborations and a new distributor agreement at the annual Consumer Electronics Show 2025 trade show (CES). These collaborations highlight XREAL's continued commitment to transforming how the world interacts with AR technology and deliver unparalleled immersive experiences, while amplifying sector leaders' unique contributions in the exciting space.
XREAL is today's AR market leader. The brand has held the consumer augmented and extended reality market leadership position in terms of shipments since it began shipping AR glasses in 2021, reaching more than half-a-million shipments life-to-date. According to IDC, XREAL maintained the industry leading market share for the global AR and optical see-thru (OST) industry throughout the first three quarters of 2024*. Also in 2024, XREAL was the only augmented and extended reality company to rank among the top five global companies by market share for the broader ARVR industry. XREAL has been in the top five ARVR companies for market share by shipments for six consecutive quarters, and has remained the only augmented and extended reality (non-VR) company to break into the top five.*
This week at CES, XREAL will showcase its latest innovations, including its brand new XREAL One Series AR glasses and its Beam Pro handheld spatial compute device. In addition, the company is proud to unveil new and renewed collaborations with world-renowned industry leaders such as BMW Group, Google, Qualcomm Technologies, Inc., Bose, T-Mobile, Mawari and more. Also this week, the XR Sports Alliance (XRSA) has announced its first cohort of members, including XREAL.
"We are proud to be leading from the front for AR technology and excited to welcome our new collaborators who are all leaders in their respective fields," said Chi Xu, CEO and Co-founder, XREAL. "Together, we're discovering new boundaries for what's possible in AR. From luxury automobiles to the most advanced mobile networks, and from next-gen chips to immersive sound, this partner ecosystem will change the way people interact with everything around them through AR glasses."
CEO Xu continued, "At CES 2025, we're not just showcasing products—we're unveiling the future of AR. With the XREAL One, XREAL One Pro, and Beam Pro, we're offering a suite of devices that deliver powerful, transformative experiences, whether for entertainment, communication, transportation or mobility."
Collaborations:
- BMW Group: A leader in automotive innovation, a brand-new BMW X3 M50 will be a spotlight feature inside the XREAL booth at CES. At CES2024, XREAL and BMW Group showed driver and co-driver experiences in moving vehicles. This time, XREAL and BMW will demo 3D entertainment for passengers. Two laps of BMW's M Mixed Reality race will be showcased with XREAL's AR technology to provide a glimpse into the future of in-car entertainment. CES attendees can enjoy the new XREAL One Series for big screen, action-packed entertainment in ultimate style inside the BMW X3 M50.
- Google: When paired with an XREAL Beam Pro Android mobile device XREAL glasses have access to Google Play apps and experiences – which are featured throughout XREAL's CES booth. In addition, more information about the exciting Android XR platform and collaboration with Qualcomm Technologies and XREAL will be shared later in 2025.
- Qualcomm: Renowned for its world-class Snapdragon® chips, Qualcomm Technologies, Inc. provides the powerful processing power behind the XREAL Beam Pro handheld Android mobile device. The Snapdragon processor provides AI capabilities, high performance and reliability for people taking their XREAL AR glasses to the spatial level with Beam Pro.
- Bose: XREAL One and XREAL One Pro incorporate customized Sound by Bose, delivering audio for the XREAL One Series that provides significantly enhanced listening experiences when compared to similar head worn or mobile devices. Bose meticulously fine-tuned the audio performance of XREAL One and XREAL One Pro to provide optimal audio quality for the wearer. Superior mid-to-high frequencies enrich subtle details, while the glasses form factor allows for a more natural soundscape.
- T-Mobile and Mawari: Known for its industry-leading 5G network, T-Mobile is teaming up with Mawari to showcase a realistic, immersive 3D call experience using XREAL glasses inside the XREAL booth. By combining T-Mobile's ultra-fast 5G network with Mawari's real-time immersive content streaming technology, CES attendees can interact with Mawari's virtual avatar as if they were physically present, but visible only through the XREAL glasses.
- AT&T: XREAL has formed a distributor relationship with AT&T to bring XREAL One Series glasses to customers in the US through AT&T's future-forward online store at newtech.att.com. The New Tech storefront features an AT&T-curated selection of sophisticated, experiential products that are leading the way in new technologies. The relationship is a major advancement for XREAL's online retail presence. The new XREAL One AR glasses are expected to become available this month at newtech.att.com, with plans for XREAL One Pro to be available soon.
"T-Mobile's 5G network was designed to usher in a new era of connected devices," said John Saw, Executive Vice President and Chief Technology Officer at T-Mobile. "AR has immense potential to transform the way we live, work, and play. With ultra-low latency, faster speeds, and greater reliability than 4G LTE or public Wi-Fi, 5G is essential to delivering a seamless and truly mobile AR experience."
"Mawari's vision is to bring immersive experiences to everyone, and we're excited to partner with T-Mobile and XREAL to showcase what cutting-edge 3D streaming technology can deliver," Luis Ramirez, Mawari CEO said. "We built our spatial streaming stack to enable the most lifelike, real-time interactions with digital humans and this application is a brilliant demonstration of where the future is heading."
"The Sound by Bose program allows us to bring our renowned audio capability to new categories and markets where sound matters," said Nick Smith, Senior Vice President of Strategy and Business Development at Bose. "Our audio tuning expertise creates a powerful and distinguished sound experience for the XREAL One Series. Content is more vibrant and lifelike, and we know consumers will hear the difference."
XREAL's cutting-edge AR glasses, known for their unmatched visual fidelity, portability and lightweight comfort, are further enhanced by these collaborations, which provide seamless integration of hardware, software, services, and experiences. Together, these relationships set a new standard for immersive AR scenarios across various industries, from automotive to mobile technology to entertainment.
CES attendees can learn more about XREAL, its products and its partners by visiting the XREAL booth inside the Las Vegas Convention Center central hall, booth number 14056.
About XREAL
XREAL is the global leader in the design and manufacture of consumer AR glasses. XREAL has pioneered several core innovations that are transforming the AR industry, including its proprietary optical technologies, and its uniquely consumer focused products. XREAL was first to popularize the concept of connecting AR glasses with existing computing devices.
Contact: ralph.jodice@xreal.com
Snapdragon is a trademark or registered trademark of Qualcomm Incorporated. Snapdragon is a product of Qualcomm Technologies, Inc. and/or its subsidiaries.
*According to IDC Worldwide Quarterly ARVR Tracker, 2024Q3. Q4 2024 data not yet reported.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
XREAL Announces Groundbreaking Collaborations at CES 2025
XREAL Announces Groundbreaking Collaborations at CES 2025
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HIGHLIGHTS
- Following an interim data review of the Cohort Expansion Phase (Phase II) of the SECuRE trial, the Safety Review Committee (SRC) confirms the trial will continue with no modifications to the protocol.
Patient population
- With the SECuRE trial continuing to recruit, a total of nine participants who had evaluable data by the 25th of November 2025 were included in the interim assessment by the SRC, with the majority of participants receiving at least two cycles of 8 GBq of 67Cu-SAR-bisPSMA each by the data cut-off date.
- Seven participants received 67Cu-SAR-bisPSMA and two participants were treated with a combination of 67Cu-SAR-bisPSMA with enzalutamide.
- Most participants were heavily pre-treated (with 55.6% having received more than 5 previous anti-cancer regimens) and had bone metastasis (66.7%).
Safety
- The safety profile of 67Cu-SAR-bisPSMA remains favourable with most related adverse events (AEs) in the Cohort Expansion to date being Grade 1 or 2. The most common AEs were nausea and lymphopenia (observed in 33.3% of participants, for each AE).
Efficacy
- Six participants had at least two prostate specific antigen (PSA) results following 67Cu-SAR-bisPSMA administration, with all showing a decrease in PSA. Of those, four participants (66.7%) thus far had a reduction of more than 50% in PSA (PSA50) and two participants (33.3%) had a reduction of more than 80% (PSA80).
- One participant who presented with bone metastasis at enrolment achieved undetectable PSA with no prostate cancer detected by computed tomography (CT) or bone scan following 67Cu-SAR-bisPSMA treatment. The participant reported having excellent quality of life following the treatment.
Next Steps
- The SECuRE trial will continue enrolment into the Cohort Expansion Phase with planned completion of recruitment in 2026. Phase III registrational trial planning ongoing based on data generated to date.
SYDNEY, Jan. 15, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to share a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25th of November 2025 and continue to show promising efficacy and a favourable safety profile of 67Cu-SAR-bisPSMA.
The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to 67Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of 67Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.
Of the nine participants included in this SRC analysis, six had at least two PSA results following their 67Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).
The safety profile of 67Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to 67Cu-SAR-bisPSMA have been observed to date.
Trial participant with no detectable disease after 3 cycles of 67Cu-SAR-bisPSMA
One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of 67Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of 67Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.
The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial[1] and supports the continuation of the trial with the aim to progress to a registrational Phase III study.
Clarity's Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer 'bis' structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.
"We have already seen a glimpse of the effects of 67Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of 67Cu-SAR-bisPSMA.
"All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following 67Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.
"Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease."
About the SECuRE trial
The SECuRE trial (NCT04868604)[2] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.
The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)[3].
Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)[1]. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants[1]. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.
Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial[4] and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company's Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.
About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[5]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[6].
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR Technology Platform for the treatment of cancers.
www.claritypharmaceuticals.com
For more information, please contact:
References
- Clarity Pharmaceuticals. SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences. https://www.claritypharmaceuticals.com/news/secure-update/
- ClinicalTrials.gov Identifier: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604
- Clarity Pharmaceuticals. SECuRE trial update: First patient treated in the Phase II Cohort Expansion. https://www.claritypharmaceuticals.com/news/secure-fp-phase2/
- Emmett L et al. ENZA-p Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Overall survival and quality of life with [177Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):291-299. doi: 10.1016/S1470-2045(25)00009-9.
- Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
- American Cancer Society: Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
This announcement has been authorised for release by the Executive Chairperson.
HIGHLIGHTS
- Following an interim data review of the Cohort Expansion Phase (Phase II) of the SECuRE trial, the Safety Review Committee (SRC) confirms the trial will continue with no modifications to the protocol.
Patient population
- With the SECuRE trial continuing to recruit, a total of nine participants who had evaluable data by the 25th of November 2025 were included in the interim assessment by the SRC, with the majority of participants receiving at least two cycles of 8 GBq of 67Cu-SAR-bisPSMA each by the data cut-off date.
- Seven participants received 67Cu-SAR-bisPSMA and two participants were treated with a combination of 67Cu-SAR-bisPSMA with enzalutamide.
- Most participants were heavily pre-treated (with 55.6% having received more than 5 previous anti-cancer regimens) and had bone metastasis (66.7%).
Safety
- The safety profile of 67Cu-SAR-bisPSMA remains favourable with most related adverse events (AEs) in the Cohort Expansion to date being Grade 1 or 2. The most common AEs were nausea and lymphopenia (observed in 33.3% of participants, for each AE).
Efficacy
- Six participants had at least two prostate specific antigen (PSA) results following 67Cu-SAR-bisPSMA administration, with all showing a decrease in PSA. Of those, four participants (66.7%) thus far had a reduction of more than 50% in PSA (PSA50) and two participants (33.3%) had a reduction of more than 80% (PSA80).
- One participant who presented with bone metastasis at enrolment achieved undetectable PSA with no prostate cancer detected by computed tomography (CT) or bone scan following 67Cu-SAR-bisPSMA treatment. The participant reported having excellent quality of life following the treatment.
Next Steps
- The SECuRE trial will continue enrolment into the Cohort Expansion Phase with planned completion of recruitment in 2026. Phase III registrational trial planning ongoing based on data generated to date.
SYDNEY, Jan. 15, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to share a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25th of November 2025 and continue to show promising efficacy and a favourable safety profile of 67Cu-SAR-bisPSMA.
The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to 67Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of 67Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.
Of the nine participants included in this SRC analysis, six had at least two PSA results following their 67Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).
The safety profile of 67Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to 67Cu-SAR-bisPSMA have been observed to date.
Trial participant with no detectable disease after 3 cycles of 67Cu-SAR-bisPSMA
One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of 67Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of 67Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.
The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial[1] and supports the continuation of the trial with the aim to progress to a registrational Phase III study.
Clarity's Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer 'bis' structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.
"We have already seen a glimpse of the effects of 67Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of 67Cu-SAR-bisPSMA.
"All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following 67Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.
"Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease."
About the SECuRE trial
The SECuRE trial (NCT04868604)[2] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.
The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)[3].
Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)[1]. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants[1]. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.
Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial[4] and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company's Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.
About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[5]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[6].
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR Technology Platform for the treatment of cancers.
www.claritypharmaceuticals.com
For more information, please contact:
Clarity Pharmaceuticals
Dr Alan Taylor
Lisa Sadetskaya
Executive Chairperson
Director, Corporate Communications
ataylor@claritypharm.com
lisa@claritypharm.com
References
This announcement has been authorised for release by the Executive Chairperson.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
SECuRE trial to continue with no modifications to protocol following Safety Review Committee meeting
