On June 29, 2026 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, reported the acceptance of data on 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for presentation at the European Association of Nuclear Medicine (EANM) Annual Congress 2026, to be held on October 17-21 in Vienna, Austria. These include:

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Top Rated Oral Presentation of data from the Co-PSMA investigator-initiated trial (IIT) with 64Cu-SAR-bisPSMA, led by Prof Louise Emmett at St Vincent’s Hospital, Sydney.
Three-patient case report on detection of prostate cancer recurrence using 64Cu-SAR-bisPSMA following negative standard-of-care (SOC) prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan on Siemens Biograph Vision Quadra.
Case reports from the theranostic Phase I/IIa SECuRE trial1 on two participants with metastatic castration-resistant prostate cancer (mCRPC) who achieved undetectable disease following 67Cu-SAR-bisPSMA treatment as reported this year.
EANM 2026 Annual Congress is one of the world’s leading nuclear medicine conferences and the acceptance of these abstracts is testament to the strength of the data generated by Clarity’s products and the promising prospects for SAR-bisPSMA to change the paradigm in the diagnosis and treatment of prostate cancer.

64Cu-SAR-bisPSMA

Prof Emmett’s Co-PSMA trial compared 64Cu-SAR-bisPSMA head-to-head with the current SOC 68Ga-PSMA-11 PET/computed tomography (CT) in patients in biochemical recurrence (BCR) of prostate cancer with low PSA, following radical prostatectomy. The study demonstrated improved diagnostic performance of 64Cu-SAR-bisPSMA next-day imaging vs. 68Ga-PSMA-11 across all key parameters assessed, including mean number of lesions per participant (1.26 vs. 0.48, p<0.0001), total number of lesions (63 vs. 24), true positive rate (71% vs. 29%) and proportion of participants with a positive scan (78% vs. 36%, respectively)2.

In addition to the Co-PSMA presentation, 64Cu-SAR-bisPSMA is also being highlighted through real-world case profiles. The case study abstract reports on three patients with BCR of prostate cancer who were negative on SOC PSMA PET/CT (68Ga-PSMA-11 and/or 18F-DCFPyL) using Siemens Biograph Vision Quadra, but positive with subsequent 64Cu-SAR-bisPSMA PET/CT in all three cases. Baseline prostate-specific antigen (PSA) in the 3 patients ranged from 1.4–21.0 ng/mL. Next-day imaging (24 hours post-injection) detected a 2.25-fold increase in lesions (nine versus four) compared with same-day (1 hour post-injection) imaging, with additional lesions identified in the prostate bed and lymph nodes. For the lesions visible at both 64Cu-SAR-bisPSMA imaging timepoints, mean maximum standardised uptake value (SUVmax) increased from 3.5 to 6.1, a 1.8-fold increase in tracer uptake.

Importantly, 64Cu-SAR-bisPSMA imaging changed planned clinical management in all three patients. In one patient this enabled targeted radiotherapy to 64Cu-SAR-bisPSMA-positive lesions and allowed androgen deprivation therapy (ADT) to be deferred over a 3-year period while achieving PSA responses, a patient-centric relevant outcome given the side-effect burden of ADT2.

The patient described above, Steve Hunter, who received 64Cu-SAR-bisPSMA under compassionate use, commented, "I was diagnosed with prostate cancer in 2016 and initially had the usual treatment of a prostatectomy and radiation therapy. Although initially quite successful, in 2023 my blood PSA indicated that my cancer was returning, doubling every six months. With SOC PSMA imaging currently available, no lesions were detectable. I was informed by more than one doctor that what I had was a micro-metastatic version of prostate cancer; that is, I had a large number of cancers too small to be detected, and worse, my only option was ADT and the significant side effects I would suffer.

"My recent career has been dedicated to the area of advanced medical imaging utilising PET, single-photon emission computed tomography (SPECT) and magnetic resonance imaging (MRI). I have also worked in the past in oncology research. My experiences led me to believe that what I really had were a small number of tumours that were undetectable by the current SOC PSMA PET/CT imaging even on a state-of-the-art PET/CT system. I contacted Dr Alan Taylor in 2023 and asked if there was any possibility of being tested using their next-day imaging, knowing that this would significantly enhance the chance of finding these tumours. The results were beyond my expectations. Three tumours were found and I underwent targeted external beam radiation. Since then, I have repeated this process with Clarity and Alan’s support a few times to scan, find and subsequently treat the ensuant small number of tumours that arise, with stereotactic radiation therapy.

"I am so grateful to Clarity in making these scans available. This approach has proven to be highly successful by allowing me to obtain clear information about my disease and defer requiring ADT therapy and all the associated side effects with this treatment. I am currently symptom-free and hope to remain like this for a long time. It certainly demonstrates the importance of this agent for patients like me."

67Cu-SAR-bisPSMA

The therapeutic potential of 67Cu-SAR-bisPSMA is also being showcased at the EANM 2026 Annual Congress through a case study of the two participants from Clarity’s Phase I/IIa SECuRE trial1, a theranostic study in mCRPC that Clarity reported earlier this year. Both participants had Stage IV mCRPC at study entry. Participant A (64 years old, baseline PSA: 6.06 ng/mL with metastatic bone disease) received prior definitive radiotherapy and ADT, docetaxel for metastatic hormone-sensitive disease and enzalutamide for mCRPC with additional palliative stereotactic body radiotherapy. He went on to receive four cycles of 67Cu-SAR-bisPSMA across 5 months. His PSA declined by 95.7% to 0.26 ng/mL within 4 weeks of first cycle and became undetectable (limit of detection 0.02 ng/mL) after the third cycle, remaining undetectable at 33 weeks (last follow-up). No metastatic disease was detected on follow-up bone scan and 64Cu-SAR-bisPSMA PET/CT following treatment with 67Cu-SAR-bisPSMA.

Patient A: Lesion uptake of 64Cu-SAR-bisPSMA PET at baseline (left), following two cycles of 67Cu-SAR-bisPSMA (8 GBq each; centre) and following four cycles of 67Cu-SAR-bisPSMA (right). Coloured arrows indicate metastatic bone lesions within each region: red – skull; blue – ribs and sternum; orange – spine; green – pelvis.​ No detectable disease was observed on the post-treatment PET. Images are shown as maximum intensity projections. SUV: standardised uptake value.

Participant B (76 years old, baseline PSA: 3.25 ng/mL with nodal metastases) had undergone salvage prostate fossa radiotherapy with ADT and later progressed to mCRPC treated with abiraterone and ongoing ADT. He received two cycles of 67Cu-SAR-bisPSMA across 2 months, with concomitant enzalutamide. His PSA declined by 94.2% to 0.19 ng/mL within 4 weeks of first cycle and was undetectable at 8 weeks, remaining undetectable at 16 weeks (last follow-up), with a complete response per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) and undetectable disease on 64Cu-SAR-bisPSMA PET/CT after two cycles of treatment.

Patient B: Lesion uptake of 64Cu-SAR-bisPSMA PET at baseline (left images) and following two cycles of 67Cu-SAR-bisPSMA (8 GBq each; right images). PET images on the right were acquired 1 month after the second cycle and show no lesion uptake of 64Cu-SAR-bisPSMA compared to baseline. Red arrows indicate metastatic nodal lesions. Top images: maximum intensity projections. Bottom images: coronal sections of the corresponding insets. SUV: standardised uptake value.

Both participants experienced mostly mild and transient 67Cu-SAR-bisPSMA-related adverse events, with Participant A reporting Grade 1 nausea, vomiting, flu-like symptoms (all resolved) and Participant B having Grade 1 altered taste, dry eyes, eye pain, fatigue, salivary gland soreness (all resolved) as well as Grade 2 anaemia (ongoing at the last assessment).

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "The EANM Annual Congress is a conference focused specifically in our area of nuclear medicine, and we are very pleased to see Professor Louise Emmett and her team receive yet another Top Rated Oral Presentation for her excellent work on the Co-PSMA trial, which corroborated previously reported improvement in diagnostic performance of 64Cu-SAR bisPSMA over SOC PSMA imaging in BCR patients3. The Co-PSMA data has already been published in a high impact factor journal, European Urology2, and presented at the European Association of Urology 2026 conference. This additional recognition from EANM is testament to the high quality and clinical relevance of this head-to-head trial.

"Data from trials with 64Cu-SAR-bisPSMA to date2,3,4 provide an early view of what is expected to be the largest single body of work ever undertaken on PSMA imaging agents comparing same-day and next-day imaging in the pre-prostatectomy and BCR spaces, supporting our two ongoing registrational Phase III clinical trials5,6. Furthermore, we have now generated head-to-head data in a range of clinical trials where 64Cu-SAR-bisPSMA has always outperformed SOC imaging under multiple conditions. As part of this commitment to the highest standard of clinical validation and rigor, we have also continued to generate data under the Special Access Scheme (SAS) in Australia and Expanded Access Program (EAP) in the US, building a growing body of real-world evidence that complements and confirms the findings of clinical trial data generated to date, which we will continue to release to the market in preparation for commercialisation. This body of knowledge is now in the range of 700-800 patients dosed with 64Cu-SAR-bisPSMA and imaged on a wide range of different cameras, spanning multiple geographies and numerous clinical settings. Beyond the data, what drives our team in the development of this product is the effect it can have on patients’ lives and the positive feedback we continue to receive from clinicians and patients. The ability to detect lesions where other products cannot and have a real, positive impact on a cancer journey of men and their families battling this disease is what unites and motivates our team and collaborators to persevere and work harder towards our mutual goal.

"We recognise that there is significant interest in this product, which is expected, given its potential to change the diagnostic field and reshape treatment pathways in prostate cancer management. This is why we continue to design and support robust clinical trials with rigorous methodologies and work directly with clinicians through SAS and EAP programs, including head-to-head studies against SOC imaging and investigating same-day versus next-day imaging. We will continue to release these data, all in preparation to enter the large and growing market of PSMA PET imaging with our continued audacious goal of taking a product from the Australian benchtop to blockbuster status. In the entire history of Australian life sciences, this has only been achieved by a number of pharmaceutical products you can count on one hand, the most widely recocognised of which is Gardasil. At Clarity, with clinical trials on track and our regulatory, manufacturing, medical, clinical and commercial teams in place, we are entirely committed to this goal, especially for our fellow teammates, our shareholders and the patients we serve. This is a truly Australian story, with the potential to deliver meaningful impact for patients around the world.

"At Clarity, this does not stop at diagnostic products, and our core mission continues to be to improve treatment outcomes for patients with cancer. 67Cu-SAR-bisPSMA represents a key asset within our therapeutic portfolio for achieving this goal. The continued encouraging results from the SECuRE trial, together with the two most recently announced cases where participants achieved undetectable disease, further build on a growing body of evidence supporting the clinical potential of 67Cu-SAR-bisPSMA to make a difference in the lives of prostate cancer patients. In the two mCRPC patients, 67Cu-SAR-bisPSMA demonstrated marked anti-tumour activity with only three or fewer cycles, leading to undetectable disease by PSA and imaging, with most adverse events being mild and transient. These findings reinforce the potential role of 67Cu-SAR-bisPSMA in addressing a significant unmet need in mCRPC treatment."

Product Abstract Title
64Cu-SAR-bisPSMA Top Rated Oral Presentation: #1803
Prospective Comparison of 64Copper[64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial)Session Date: Monday, October 19 2026
Session Time: 8:00AM – 9:30AM
64Cu-SAR-bisPSMA E-Poster: #296
Real-world Detection of Prostate Cancer Recurrence With 64Cu-SAR-bisPSMA Imaging Following Negative Standard-Of-Care PSMA PET: A Three-Patient Case Report
67Cu-SAR-bisPSMA E-Poster: #1786
67Cu-SAR-bisPSMA leads to Undetectable Disease in Metastatic Castration-Resistant Prostate Cancer Patients: Two Case Reports From The Phase I/IIa SECuRE Trial

Presentations will be available on Clarity’s official website after the EANM 2026 Congress: claritypharmaceuticals.com/pipeline/scientific_presentations

(Press release, Clarity Pharmaceuticals, JUN 29, 2026, View Source [SID1234668987])

On June 29, 2026 Daiichi Sankyo and Astrazeneca reported that Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options.

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Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across three phase 2 trials, including DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.

In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate (ORR) of 52.3% (95% confidence interval [CI]: 42.6-61.8) and median duration of response (DOR) of 21.1 months (95% CI: 10.6-25.0) in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors. In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% (95% CI: 27.8-77.0) and median DOR of 6.9 months (95% CI: 4.0-9.8) in a subgroup of previously treated patients (n=17) with centrally confirmed HER2 positive non-small cell lung cancer (NSCLC). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) and median DOR of 5.5 months (95% CI: 4.2-8.1) in a subgroup of previously treated patients (n=64) with centrally confirmed HER2 positive colorectal cancer.

"HER2 overexpression occurs across multiple tumor types and is associated with aggressive disease and a poor prognosis. Until now, HER2 directed therapies were only available for specific tumor types," said Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany. "The approval of trastuzumab deruxtecan as a tumor agnostic therapy opens a new treatment option for patients with HER2 positive cancers regardless of where the tumor originated."

In DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, the safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. Grade 3 or grade 4 adverse reactions from a pooled safety analysis of patients treated with Enhertu (5.4 mg/kg) across multiple tumor types in clinical studies included neutropenia (18.5%), anemia (9.9%), fatigue (8.2%), leukopenia (5.8%), thrombocytopenia (5.2%), nausea (4.8%), lymphopenia (4.2%), hypokalemia (3.6%), increased transaminases (3.6%), diarrhea (2.5%), vomiting (2.4%), decreased appetite (1.6%), pneumonia (1.4%) and decreased ejection fraction (1.0%). Grade 5 adverse reactions occurred in 1.1% of patients, including interstitial lung disease/pneumonitis (1.0%).

"This approval of Enhertu marks a significant milestone in the EU for patients with HER2 positive metastatic solid tumors and establishes the first tumor agnostic indication for a HER2 directed therapy and antibody drug conjugate in the region," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "Enhertu is now approved for six indications in the EU, which demonstrates our commitment to advancing innovative medicines in areas of high unmet need to patients with cancer."

"Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "Enhertu is already approved in breast, gastric and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2 positive status across multiple additional tumor types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2 positive disease are considered for targeted treatment."

Enhertu (5.4 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials.

Additional regulatory submissions for Enhertu also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from the DESTINY-Breast09 trial and for patients with HER2 positive breast cancer with residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial.

Financial Considerations

Following this approval in the EU, an amount of $25 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2 positive metastatic solid tumor indication. Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

About DESTINY-PanTumor02

DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors.

The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology.

DESTINY-PanTumor02 enrolled 267 patients, including 111 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America, South America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-Lung01

DESTINY-Lung01 is a global, open-label, two-cohort, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg or 6.4 mg/kg) in patients with HER2 mutant (Cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (Cohort 1 and 1a, n=90) unresectable or metastatic NSCLC who had progressed after one or more systemic therapies.

The primary endpoint of DESTINY-Lung01 is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology.

DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-CRC02

DESTINY-CRC02 is a global, randomized, two arm, parallel, multicenter, phase 2 trial evaluating the efficacy and safety of two doses (5.4 mg/kg or 6.4 mg/kg) of Enhertu in patients with locally advanced, unresectable or metastatic HER2 positive colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumor types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomized 1:1 to receive either 5.4 mg/kg or 6.4 mg/kg of Enhertu. In the second stage, additional patients (n=42) were enrolled in the 5.4 mg/kg arm.

The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology.

DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Expression in Solid Tumors

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.1 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in some cancers.2 HER2 overexpression occurs in a range of solid tumors with the prevalence varying by tumor type.3

HER2 directed therapies have been used to treat HER2 overexpression in breast, gastric and biliary tract cancers in the EU.1,4,5,6 Although HER2 is overexpressed in additional solid tumor types including biliary tract, lung, bladder, cervical, colorectal, endometrial, ovarian, salivary gland and pancreatic cancers, HER2 testing is not routinely performed in these additional tumor types and prior to this approval there were no HER2 directed treatments approved in the EU to treat a broad range of solid tumors.2,7,8

About Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) is approved in the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4 mg/kg) followed by THP is approved in China and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in Brazil, India, Israel, Saudi Arabia, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4 mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the Enhertu Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, JUN 29, 2026, View Source [SID1234668982])

On June 27, 2026 PDX Pharma reported it has secured intellectual property protection in Japan for the AIRISE (Augmenting Immune Response and Inhibiting Immune Suppressive Environment) family, marking an important milestone in our continued innovation and global IP strategy. This achievement strengthens the AIRISE platform and supports the advancement of in situ cancer vaccination approaches based on our Pdx-NP platform, designed for the co-delivery of anticancer agents and nucleic acid adjuvants.

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This news follows our recent success in securing an additional US patent for the ARAC (Antigen Release Agent and Checkpoint inhibitor) family last month (US12,582,658). This patent includes broad claims covering Pdx-NP-based co-delivery of a wide range of anticancer agents and immune checkpoint inhibitors. Both AIRISE and ARAC developments have been funded by the National Cancer Institute.

(Press release, PDX Pharmaceuticals, JUN 27, 2026, View Source [SID1234668967])

On June 26, 2026 Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for cancer, reported that the California Institute for Regenerative Medicine (CIRM) has awarded the Company an $8M non-dilutive CLIN2 grant to support the clinical development of SRN-101, Siren’s lead investigational AAV immuno-gene therapy for high-grade glioma brain cancers.

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The award follows the U.S. Food and Drug Administration’s (FDA) clearance of Siren’s first Investigational New Drug (IND) application earlier this year, which advanced the Company to clinical stage and enabled a Phase 1/2 trial in adult patients with recurrent high-grade glioma. CIRM’s transformative CLIN2 funding will support the conduct of that trial and the activities required to evaluate SRN-101 in patients.

SRN-101 is built on Siren’s Universal AAV Immuno-Gene Therapy platform, designed to enable localized, durable delivery of immune-modulating payloads directly within tumors. The program has received Fast Track, Orphan Drug and Rare Pediatric Disease designations from the FDA. CIRM previously supported the program at the translational stage with a $4M non-dilutive TRAN1 grant, and today’s award extends that support into the clinic.

We are profoundly grateful to CIRM, who backed this science at its earliest stage and is now standing with us as we enter the clinic," said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. "High-grade gliomas remain among the hardest cancers to treat, and the patients who live with them cannot wait. This funding propels SRN-101 toward the patients who need it, made possible by the vision of the people of California."

This research is supported by the California Institute for Regenerative Medicine (CIRM), a State of California agency that funds regenerative medicine, stem cell, and gene therapy research (Grant numbers: CLIN2-19526 and TRAN1-15325).

About High-Grade Glioma
High-grade gliomas, including glioblastoma, are among the most aggressive and lethal primary brain tumors. Current treatments include surgery, radiation, and chemotherapy, all of which offer limited benefit. Novel therapeutic approaches are urgently needed.

(Press release, Siren Biotechnology, JUN 26, 2026, View Source [SID1234668979])

On June 26, 2026 Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

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Advancing complementary immunotherapies to improve patient outcomes
Teclistamab and daratumumab work in a mechanistically complementary manner by engaging multiple tumour and immune directed pathways.1,2 When combined, daratumumab modulates the immune system to create a more favourable immune microenvironment and enhances T-cell fitness and activation, amplifying teclistamab-mediated killing of myeloma cells.1,2 This combination improves patient outcomes by using immunotherapies earlier in the treatment journey when patients’ immune systems are more robust.1,2

Expert and company perspectives support the earlier use of teclistamab combination in multiple myeloma care
"Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control." said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "This CHMP opinion marks an important step towards establishing the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma."

"At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care."

Teclistamab plus daratumumab SC achieves meaningful and sustained improvements in patient outcomes
The CHMP recommendation is supported by data from the Phase 3 MajesTEC-3 study (NCT05083169), evaluating the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received 1–3 prior lines of therapy.3

At nearly three years of follow-up, results show an 83.4% reduction in the risk of disease progression or death in patients treated with teclistamab plus daratumumab SC, compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p<0.0001).1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, demonstrating sustained disease control over time.1 Overall survival (OS) favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p<0.0001), with treatment benefit observed across all prespecified subgroups.1,2 At three years, OS rates were 83.3% for the combination and 65.0% for standard of care.1 Both progression-free survival and OS benefits were clinically meaningful and statistically significant.1

Manageable safety profile observed with teclistamab combination
Teclistamab plus daratumumab SC demonstrated a safety profile consistent with the well-known profiles of the individual therapies.1,3,4 All cases of cytokine release syndrome were Grade 1/2, did not lead to treatment discontinuation, and were manageable and resolved.1 Rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable to standard of care regimens (95.1% vs. 96.6%) with cytopenia and infection most commonly observed.1 Grade ≥3 infections decreased over time with the use of immunoglobulin supplementation and infection prophylaxis, along with a switch to monthly dosing.2 Discontinuations due to TEAEs were low and similar between study arms (4.6% vs. 5.5%).1

About the MajesTEC-3 Study
MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.5 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.5 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.5

About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.3,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.1,3 Teclistamab is currently being evaluated in several combination studies.5,9,10,11

To date, more than 26,000 patients have been treated worldwide with teclistamab.12

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.

About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide.13 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.5,14 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.5,15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.5,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.5 Daratumumab may also have an effect on normal cells.5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.17,18,19,20,21,22,23,24,25,26

For further information on daratumumab, please see the Summary of Product Characteristics at: View Source

About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.27,28 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.29,30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.32,33,34 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, JUN 26, 2026, View Source [SID1234668978])