On February 16, 2026 Delphi reported that new data presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) from the NRG/NSABP B-42 trial demonstrated that the Endocrine Activity Index (EAI) identifies postmenopausal women with hormone receptor–positive (HR+), HER2-negative breast cancer who may derive meaningful benefit from extended endocrine therapy. The findings were presented by Eleftherios P. Mamounas, MD, AdventHealth Cancer Institute, Orlando, FL, in a general session on behalf of the NRG Oncology/NSABP investigators, under the title: "Evaluation of the Sensitivity to Endocrine Therapy (SETER/PR) assay to predict benefit from extended endocrine therapy in the NRG/NSABP B-42 trial."

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Extended endocrine therapy beyond five years can reduce the risk of late breast cancer recurrence, but benefits must be weighed against cumulative side effects. Clinicians have limited options to identify which patients are most likely to benefit from prolonged treatment.

The NRG/NSABP B-42 trial evaluated extended letrozole therapy (ELT) versus placebo in postmenopausal women with HR+ breast cancer who had already completed five years of adjuvant endocrine therapy and demonstrated a small (3.3%) but significant benefit of ELT in this patient population. This new analysis examined whether the EAI test, a genomic signature that measures endocrine activity, could predict benefit from ELT.

Patients with high endocrine activity (EAI ≥ 1.50) experienced a statistically significant and clinically meaningful benefit from ELT, with a 10-year absolute BCFI benefit of 7.1%. Patients with lower EAI values (<1.50) did not experience a statistically significant benefit from extended therapy. This benefit was observed across nodal subgroups and was most pronounced in node-positive patients with high EAI scores, demonstrating a 10.5% absolute reduction in BCFI events compared to placebo. Treated as a continuous variable, higher EAI values were associated with a progressively greater relative benefit from ELT.

"EAI is the only test that can provide insight into how active the estrogen/progesterone pathway of a breast cancer tumor is," said Delphi Diagnostics Chief Medical Officer, Federico A. Monzon. "Data from the B-42 study supports the hypothesis that longer durations of endocrine therapy are most effective for patients whose cancers are highly endocrine-sensitive. This data continues to establish EAI as an important signature that can provide patient-specific insights to support treatment decisions for breast cancer patients."

About EAI
Delphi Diagnostics’ Endocrine Activity Index (EAI) test can provide actionable information for prognosis and prediction of dose-intense taxane-based chemotherapy benefit in stage II-III, HR+ HER2- breast cancer. The EAI measures endocrine activity in a breast tumor and for prognostic use, the Index Score is adjusted for baseline prognosis using molecular subtype genes (RNA4) and clinical factors such as tumor size and regional lymph node involvement. The EAI test has been shown in various studies to be a consistent prognostic indicator for long-term outcomes in stage II-III breast cancer patients, to be independent of other prognostic tests, as well as to be predictive for response to dose-dense chemotherapy.

(Press release, Delphi, FEB 16, 2026, View Source [SID1234662690])

On February 15, 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 release of an abstract on the Co-PSMA (NCT06907641)1 IIT, accepted for oral presentation at the upcoming EAU Congress 2026, Europe’s largest urological conference, to be held from 13 to 16 March 2026 in London, UK2. The abstract outlines key findings from the study.

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Co-PSMA ("Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy") was led by Prof Louise Emmett at St Vincent’s Hospital Sydney. This Phase II IIT evaluated the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 prostate cancer patients with BCR who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT within 3 weeks (at 1 h and 24 h post-injection, same-day and next-day imaging, respectively), on the same digital PET camera. A standard of truth (SOT) was used to determine accuracy of the PET findings and included biopsy, response to targeted treatment without androgen deprivation therapy [ADT] or corroborative imaging. The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number.

64Cu-SAR-bisPSMA PET/CT identified a statistically significant greater number of lesions per participant than 68Ga-PSMA-11 PET/CT, with a higher true positive rate also favouring 64Cu-SAR-bisPSMA. The mean per-patient lesion for 64Cu-SAR-bisPSMA was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 64Cu-SAR-bisPSMA next-day imaging detected 63 lesions. On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on the 64Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the 64Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable SOT, the true positive rate was 75% for 64Cu-SAR-bisPSMA (21/28) compared to 39% (11/28) for 68Ga-PSMA-11.

These results further build on the growing body of evidence showing that 64Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, with limited ability to detect cancer, especially in patients with low PSA levels3,4,5.

Further data outlining results from the Co-PSMA IIT will be announced in mid-March following their oral presentation at the EAU 2026.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The data from the Co-PSMA trial are nothing short of exceptional. We already knew of the significant benefits of the optimised bisPSMA molecule from the early days around 7 years ago, when it was purposely developed to overcome the many shortfalls of the current single-targeting SOC PSMA imaging agents. This innovative benchtop research of the dual-targeting bisPSMA agent quickly progressed to multiple clinical trials, including COBRA6, PROPELLER7 and SECuRE8, which enabled us to secure three Fast Track Designations from the United States (US) Food and Drug Administration (FDA) and advance to two registrational trials, AMPLIFY9 and CLARIFY10, both of which are nearing completion of recruitment.

"Importantly, in the COBRA trial, we also looked at the performance of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer following definitive therapy, but with participant selection criteria having no limitation on upper PSA levels (median 0.9 ng/mL, range 0.25 to 17.6). The Co-PSMA data we are seeing to date reinforces the COBRA trial findings where more lesions and patients with a positive scan were identified using 64Cu-SAR-bisPSMA compared to SOC PSMA PET products, including 68Ga-PSMA-11 and 18F-DCFPyL6. A subset of participants in the COBRA trial had a follow-up SOC PSMA PET. While 90% of these participants had a positive scan on the initial 64Cu-SAR-bisPSMA next-day imaging, only 60% were positive on SOC PSMA PET, despite median scan time from the first 64Cu-SAR-bisPSMA imaging to the follow-up scan being 73.5 days. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA on next-day imaging was >2.6 times higher than that detected by SOC PET agents (52.6 vs 20 lesions)6.

"What we are learning today from the head-to-head Co-PSMA study is a valuable insight into how 64Cu-SAR-bisPSMA directly compares against 68Ga-PSMA-11, further bolstering the data seen to date. Similar to COBRA, Co-PSMA demonstrated that our product was able to identify more than 2.5 times total number of lesions on the next-day imaging in comparison to the SOC. Furthermore, 4 out of every 5 participants had a positive scan for prostate cancer using 64Cu-SAR-bisPSMA, compared to only 2 in 5 participants using 68Ga-PSMA-11, therefore making 64Cu-SAR-bisPSMA far more reliable than 68Ga-PSMA-11 in detecting the presence of cancer in these patients. These findings, coupled with the much higher true positive rate of 64Cu-SAR-bisPSMA (75% vs. 39% for 68Ga-PSMA-11), will enable clinicians to treat prostate cancer more effectively and with a greater level of confidence based on the accurate detection of disease. These results speak for themselves, clearly illustrating that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence. Moreover, this sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management: almost half of the Co-PSMA and COBRA study participants had a change of their planned disease management as a result of the 64Cu-SAR-bisPSMA findings6, which could be absolutely game-changing for clinicians and their patients. This is the difference between allowing prostate cancer lesions to grow or having a clear diagnosis and an active and highly targeted treatment plan. Earlier intervention in BCR can prevent cancer growth and spread, avoid side effects from systemic therapies and considerably improve patient outcomes.

"The current market for PSMA PET imaging in the US alone is around US$2 billion per year, and this is expected to further grow to over US$3 billion by 2029. Unfortunately, this blockbuster market is dominated by 68Ga-PSMA-11 and 18F-DCFPyL, both of which have low sensitivity4,5. The development pipeline of new products, excluding 64Cu-SAR-bisPSMA, offers no significant differentiation from the existing agents, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. Time and time again we are seeing significant clinical and logistical benefits offered by 64Cu-SAR-bisPSMA through our trials. We strongly believe this product could not only become the new SOC in PSMA PET but also grow the market opportunity further by substantially improving the diagnosis of prostate cancer in many stages of the disease, from its early phases pre-definitive therapy, through to better identification of lesions in the BCR setting, including in patients with oligometastatic disease.

"While the AMPLIFY and CLARIFY trials are key to getting 64Cu-SAR-bisPSMA towards commercialisation, Co-PSMA provides further evidence of its benefits to clinicians and prostate cancer patients. This makes the paradigm shift towards improved diagnostics a no-brainer due to our relentless focus on rigorous clinical development and commitment to strong science to change the lives of people living with cancer. The acceptance of the Co-PSMA data by a world-leading urology conference as an oral presentation is a testament to the strength and quality of the data, generated by Prof Emmett, a global key opinion leader in the field."

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "While approved PSMA PET agents are highly specific, their low sensitivity at low PSA levels means that many patients with early rising PSA show no detectable disease, making treatment planning challenging. More sensitive diagnostics that remain highly specific are needed for effective early intervention in BCR. Our research demonstrates that 64Cu-SAR-bisPSMA PET/CT offers a significant advancement in the detection of recurrent prostate cancer. Compared to 68Ga-PSMA-11, the 24-hour 64Cu-SAR-bisPSMA images identified the site of disease recurrence in a higher proportion of patients, directly informing tailored treatment decisions for men in BCR. These findings highlight the potential for 64Cu-SAR-bisPSMA to improve patient outcomes."

(Press release, Clarity Pharmaceuticals, FEB 15, 2026, View Source [SID1234662682])

On February 15, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported that the U.S. FDA has cleared the IND application to initiate a Phase II clinical trial of its core asset, CS2009, in patients with advanced solid tumors.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "We are pleased to receive FDA clearance to proceed with the global Phase II clinical trial of CS2009. This milestone follows a productive interaction with the agency, during which they reviewed our comprehensive Phase I data—including safety and antitumor activity data collected during dose escalation and expansion—and provided alignment on key elements of the Phase II study design, including dose optimization and expansion strategies. We are now actively advancing CS2009 clinical program globally and look forward to sharing further updates as the study progresses."

About CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

CS2009, an innovative trispecific antibody designed and developed by CStone, with the potential to be first- or best-in-class. It combines three clinically validated targets—PD-1, VEGFA, and CTLA-4—and exerts multidimensional anti-tumor effects through synergistic actions. Specifically, anti-PD-1 activity reverses T cell exhaustion, anti-CTLA-4 activity promotes T cell activation and proliferation, while anti-VEGFA activity blocks tumor angiogenesis and improves the tumor micro-environment (TME). In the TME, anti-PD-1 and anti-CTLA-4 activities are significantly enhanced by crosslinking with VEGFA. Meanwhile, CS2009 preferentially blocks PD-1 and CTLA-4 on double-positive tumor-infiltrating T cells while minimizing interference with CTLA-4 regulation in peripheral T cells.

The ongoing global, multicenter Phase II clinical trial of CS2009 features a multi-cohort, parallel expansion design to evaluate the efficacy, safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of CS2009 as monotherapy and combination regimens. The study comprises 15 monotherapy and combination therapy cohorts across 9 solid tumor indications, including NSCLC, CRC, TNBC, ES-SCLC, PROC, cervical cancer (CC), hepatocellular carcinoma (HCC), gastric or gastroesophageal junction cancer (GC/GEJC), and esophageal squamous cell carcinoma (ESCC). The trial is actively enrolling patients in Australia and China and has received IND clearance in the U.S.

(Press release, CStone Pharmaceauticals, FEB 15, 2026, View Source [SID1234662683])

On February 13, 2026 Precision Biologics, Inc. CEO Philip M. Arlen, MD reported a Keynote presentation describing in vitro and in vivo efficacy of its novel tumor-specific antibody-drug-conjugate PB-223 ADC (PB-vcMMAE-5). Recent tumor killing data showing specific non-toxic anti-tumor activity in several human cancer types expressing truncated core 2 O-glycans will be reported in "PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors", at the 6th Ace Drug Discovery Summit, The Insurance Hall, London, UK, February 18-19, 2026.

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"The exquisite sensitivity and specificity of our recently developed mAb enables maximum anti-tumor response to our PB-223 ADC with minimal toxicity in the preclinical animal studies. The target is found on a broad variety of human solid tumors but not on healthy tissue, suggesting a strong rationale to move this drug into clinical trials."

"We’re excited to discuss PB-223 ADC with the scientific community, to share compelling preclinical data with several human tumor types, showing animal xenograph human tumor models resulting in complete tumor eradication with minimal toxicity observed in blood and tissue analysis," he went on to say. Although some preliminary data was shown on posters at SITC (Free SITC Whitepaper) (Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) and AACR (Free AACR Whitepaper)-Ovarian (American Association for Cancer Research, Ovarian Cancer) meetings, this is the first public talk presenting and explaining the full data in person.

Here are details of the presentation:

Title:

"PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors"

Date/Time:

Thursday, February 19, 12:00pm – 12:30pm – Day 2 – Presentation no. 15

Place:

6th ACE Drug Discovery Summit, The Insurance Hall, 20-21 Aldermanbury, London, UK

Keynote Speaker:

Philip Arlen, President & CEO, Precision Biologics, Inc.

(Press release, Precision Biologics, FEB 13, 2026, View Source [SID1234662676])

On February 13, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population.

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This designation marks the first FDA Orphan Drug Designation for HanchorBio, representing a significant regulatory milestone for the company and further validating its strategy of advancing differentiated immunotherapies in areas of high unmet medical need.

HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care.

"Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101’s profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline."

Gastric cancer is a rare disease in the United States, with prevalence well below the FDA’s statutory threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes, particularly in the second-line setting, remain poor, with limited durability of response and substantial treatment-related toxicity.

HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer. Early clinical findings have demonstrated promising antitumor activity with a safety profile consistent with the molecule’s differentiated design.

Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The FDA’s decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101’s development. HCB101’s IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need."

Orphan Drug Designation provides certain development incentives, including eligibility for tax credits on qualified clinical trial expenses, exemption from FDA user fees, and the potential for seven years of market exclusivity upon approval in the United States.

HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications.

About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio’s FBDB platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies.

HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies.

Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies.

(Press release, Hanchor Bio, FEB 13, 2026, View Source [SID1234662652])