On June 29, 2026 AB Science SA (Euronext – FR0010557264 – AB) reported an update on the Phase 1 study of the molecule AB8939 and the completion of Step 3, evaluating the combination of AB8939 + venetoclax in patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

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Step 3 evaluated the combination of AB8939 plus venetoclax administered over a 14-day cycle. A total of six patients were treated across two dose levels of AB8939 (16 mg/m² and 21.3 mg/m²), each in combination with venetoclax. The combination was well-tolerated, with no dose-limiting toxicity (DLT) and no hematological toxicity observed at either dose level, allowing selection of the recommended Phase 2 dose (RP2D).

Encouraging preliminary signs of efficacy were observed. Of the six patients treated, four achieved an objective response (one complete remission with incomplete hematologic recovery and three partial responses), corresponding to a 67% overall response rate (ORR). The two remaining patients achieved stable disease, resulting in a 100% disease control rate (CDR). These responses were achieved after a single cycle of treatment (14 days) in heavily pre-treated patients receiving second- to fourth-line therapy. Notably, two of the responding patients had previously progressed on venetoclax in combination with other chemotherapies.

The patients treated all have very difficult to treat cytogenetic profiles, including complex karyotype, TP53 mutation, NRAS mutation, monosomy 5 and 7 and MECOM-rearrangement, that typically have a poor prognosis due to their aggressive disease course and treatment resistance

This is a high response rate in a population where standard-of-care therapies achieve ORR of 10–30% in adverse-risk, multiply pre-treated AML (Gill H, et al. Cancer Med. 2020;9(10):3371-3382).

Response after the first 14 days cycle in the six patients treated in Step 3 (AB8939 + venetoclax)

Patient AB8939 dose Line of therapy Key adverse genetics Best response
Patient 1 16 mg/m² 2nd RUNX1 and NRAS mutations CRi
Patient 2 16 mg/m² 2nd MECOM-rearrangement, complex karyotype, monosomy 5 and 7 PR
Patient 3 16 mg/m² 4th TP53 mutation, complex karyotype, monosomy 5 and 7 PR
Patient 4 21.3 mg/m² 3rd TP53 mutation, complex karyotype, monosomy 5 and 7 PR
Patient 5 21.3 mg/m² 2nd TP53 mutation SD
Patient 6 21.3 mg/m² 2nd TP53 mutation (very high-risk MDS) SD
Complete remission (CRc) is defined as CRc = CR + CRh + CRi + CRp

CR=Bone marrow blasts <5%; of circulating blasts; low level (<5%); extramedullary disease; ANC ≥1.0 x 109/L (1000/μL); platelet count ≥100 x 109/L (100 000/μL).
CRh =ANC ≥ 0.5 × 109/L (500/μL) and platelet count ≥ 50 × 109/L (50 000/μL), otherwise all other CR criteria met
CRi =All CR criteria except for residual neutropenia (<1.0 x 109/L [1000/μL]) or thrombocytopenia (<100 x 109/L [100 000/μL]).
CRp =All CR criteria except platelet count < 100 × 109/L (100 000/μL)
Partial remission (PR) requires bone marrow response of at least 50% with a residual % between 5% and 25%.
Progressive disease (PD): > 50% increase in marrow blasts over baseline (a minimum 15% increase is required in cases <30% blasts at baseline).

This diversity of responsive patients appears to corroborate the mechanism of action of AB8939, which is capable of destabilizing microtubules while evading multi-drug resistance and also targeting cancer stem cells without eliminating non tumoral stem cells

These results corroborate the positioning of AB8939 in patients with adverse genetics, complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement, which represents the highest unmet medical need.

Nicholas J. Short, MD, Associate Professor and Co-Lead of the Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, "This new data is very encouraging, particularly considering the very adverse risk profile of this patient’s leukemia. These early efficacy and safety data suggest that AB8939 can be combined with venetoclax and could have significant activity in the highest-risk subtypes of AML. There is a strong interest in continuing the development of this combination in patients whose AML has high-risk features that are expected to lead to resistance to venetoclax + azacitidine."

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France, said, "There is a strong rationale to combine AB8939 and venetoclax as both molecules have low hematologic toxicity and complementary mode of actions. These first results are supportive of this rationale."

With Step 3 completed, the next step is Step 4, evaluating the triple combination of AB8939 + venetoclax + azacitidine.

About AB8939

AB8939 is a drug candidate that targets (i) cancer cells by destabilizing microtubules (essential for cell division) and (ii) cancer stem cells by inhibiting ALDH1A1 and ALDH2 (enzymes essential for maintaining their physiological state and survival).

AB8939 has shown in vitro activity in Ara-C (cytarabine, which is one of the standards of care) resistant patient cell lines, including adverse genetic MECOM and TP53 mutations.
Analysis of cell lines responsive to AB8939 showed that AB8939 is effective in cell lines with TP53 mutations, MECOM, and complex karyotypes, whereas ARAC and azacitidine are not effective.
AB8939 increased survival and had an additive effect in combination with venetoclax (another standard of care) in vivo in a MECOM-grafted PDX mouse model.
AB8939 increased survival and had an additive effect in combination with Vidaza (azacitidine, another standard of care) in vivo in the MECOM PDX#C1005 mouse model of leukemia.
AB8939 eradicated Leukemia Cancer Stem Cells in vivo in a human PDX AML mouse model, which is compatible with targeting stem cells via ALDH.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first three steps. The first two steps determined the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy. In both cases, the MTD was 21.3 mg/m².

The third step, now completed, evaluated the combination of AB8939 and venetoclax. Six patients were treated across two dose levels (AB8939 14 days at a dose of 16 mg/m² + venetoclax 14 days, then AB8939 14 days at a dose of 21.3 mg/m² + venetoclax 14 days), with no dose-limiting toxicity observed, supporting selection of the recommended Phase 2 dose. The next step (Step 4) will evaluate the triple combination of AB8939 + venetoclax + azacitidine.

Medical need in AML and AB8939 mechanism of action

Although several drugs have been registered for AML, 70% of patients still relapse and die, creating a persistent unmet medical need for effective treatments. Acute myeloid leukemia remains the most lethal form of leukemia in humans.

AML is a heterogeneous disease, and its outcome is highly dependent on genetic factors. TP53 mutation has a very poor prognosis, with a median overall survival (OS) of 5.5 months. NRAS and KRAS mutants have a poor prognosis, with a median OS of 12.1 months. MECOM also has a very poor prognosis in AML, with a median OS of 5.5 months in relapsed or refractory settings.

The challenge in AML is the recurrence of tumors due to a combination of two factors: the resistance of cancer cells to chemotherapy and relapse due to the persistence of cancer stem cells. This challenge may be overcome by AB8939’s dual mechanism of action.

First, AB8939 blocks the proliferation of leukemia cells through microtubule disruption. It is not subject to multi-drug resistance as it does not bind to PgP, which is responsible for efflux outside the cells, and is not degraded by myeloperoxidase.
Second, AB8939 targets leukemia cancer stem cells by inhibiting ALDH and promotes bone marrow repopulation of normal progenitors.
AB8939 + venetoclax combination

There is a strong rationale to combine AB8939 with venetoclax

Both molecules exhibit low hematologic toxicity. This combination is expected to be less toxic than azacitidine + venetoclax as first-line treatment for AML
These molecules have different and complementary targets in cancer cells. There is an additive, even synergistic, efficacy potential for the combination, with three mechanisms of action in a single treatment.
Venetoclax’s mechanism of action inhibits the BCL2 pathway, a protein that prevents apoptosis (programmed cell death) in cancer cells. BCL2 is a key factor in AML resistance, as it allows cancer cells to survive despite treatment
AB8939 is pro-apoptotic, destabilizing microtubules, and would benefit from BCL2 inhibition to optimize apoptosis
In addition, AB8939 specifically targets cancer stem cells by inhibiting ALDH, reducing resistance to treatment and limiting the risk of relapse

Next steps

Following completion of Step 3, the next step is to initiate Step 4, evaluating the triple combination of AB8939 + venetoclax + azacitidine, and to launch an expansion study in approximately 15 AML patients eligible for AB8939 + venetoclax at the appropriate dose. The expansion phase is expected to generate robust preliminary evidence of efficacy in the AML label, sufficient to support the clinical development plan and a beneficial partnership agreement.

AB Science has started to discuss three possibilities for registration studies, which are not mutually exclusive, with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA):

AB8939 + venetoclax as first-line treatment, with aged patients and/or patients with adverse genetics (complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement)
AB8939 + venetoclax as a second- or third-line treatment, in all patients or patients with adverse genetics
AB8939 as a single agent in MECOM as a second or third-line treatment.

Addressable market with AB8939 in relapsed/refractory AML

Treatments for relapsed or refractory AML represent an estimated market size potential of greater than EUR 2 billion per annum.

Region Incidence Case
(1) % Relapse or Refractory (2,3) % Insured Patients (4) Drug Price (€) Market Size
(per in Mio EUR)
USA / CANADA 23,700 50%

90% 100,000(5) 1 000 000
EUROPE 27,600 90% 60,000 770 000
APAC 27,800 30% 60,000 250 000
INDIA 11,000 30% 60,000 100,000
LATAM 7,200 30% 60,000 65 000
MENA 3,900 30% 60,000 35 000
TOTAL 90,200 2 200 000
EUROPE = EU27 + Norway + United Kingdom + Switzerland ; APAC = Australia, People’s Republic of China , Japan, New Zealand, Singapore, Taiwan ; LATAM = Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico ; MENA = Algeria, Bahrain, Egypt, Israel, Kuwait, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates
(1) Zhou, Y et al. Global, regional, and national burden of acute myeloid leukemia, 1990–2021: a systematic analysis for the global burden of disease study 2021. Biomark Res 12, 101 (2024).
(2) Ravandi F. Relapsed acute myeloid leukemia: Why is there no standard of care Best Pract Res Clin Haematol. 2013;26(3):253-9
(3) Walter RB et al. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia (2015) 29:312–20. .
(4) Estimated
(5) Choi M. et al. Costs per patient achieving remission with venetoclax-based combinations in newly diagnosed patients with acute myeloid leukemia ineligible for intensive induction chemotherapy. Journal of Managed Care & Specialty Pharmacy Volume 28, Number 9. View Source

Intellectual property

AB8939 intellectual property rights in AML are secured until 2036 through a ‘composition of matter’ patent and potentially until 2041 with a 5 years extension. Two additional ‘second medical use’ patent applications have been filed to protect the use of AB8939 in the treatment of AML with specific chromosomal abnormalities. If these applications are accepted, the protection for AB8939 will be extended until 2044 and 2046 for these AML subpopulations.

AB8939 has also received orphan drug designation for AML by both the EMA and FDA. This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

AB Science is the sole proprietary holder of AB8939 and its family of compounds.

(Press release, AB Science, JUN 29, 2026, View Source [SID1234668988])

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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])