On December 22, 2025 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 it will be commencing a pivotal Phase III registrational trial of its 64Cu-SARTATE diagnostic agent in patients with neuroendocrine tumours (NETs). This follows a successful End of Phase meeting with the United States (US) Food and Drug Administration (FDA), in which all key components of the proposed trial design were agreed upon with the Agency. Recruitment into the trial is expected to commence in 2026.

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The trial will be a multi-centre, single arm, non-randomised, open-label Phase III diagnostic clinical trial of 64Cu-SARTATE Positron Emission Tomography (PET) in approximately 70 participants. As a pivotal trial, the final study results are intended to support an application to the US FDA for approval of 64Cu-SARTATE as a new diagnostic imaging agent in NETs.

The aim of this registrational trial is to investigate the ability of 64Cu-SARTATE PET/computed tomography (CT) to detect NETs, building on compelling preclinical and clinical trial data generated to date, including the first-in-human CL01 trial1 and the Phase II DISCO trial (NCT04438304)2-3. The DISCO trial findings were recently accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, which will be held January 8-10, 2026 (San Francisco, CA)4.

In the DISCO trial, 64Cu-SARTATE was found to be safe and well tolerated with lesion detection substantially higher than that of the current standard-of-care (SOC), 68Ga-DOTATATE. 64Cu-SARTATE also showed enhanced lesion detection in the liver, the most common metastatic site for patients with gastroenteropancreatic (GEP)-NETs. Hepatic metastatic burden is clinically important as it is strongly associated with patient outcomes and significantly influences clinical management of the disease5. The enhanced diagnostic capabilities of 64Cu-SARTATE offer significant potential to transform and advance both the detection and management of patients with NETs, paving the way for improved patient outcomes and more effective treatment pathways.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to progress to a Phase III trial in the NETs indication and are thankful for the time and valuable guidance the FDA has provided on our 64Cu-SARTATE agent during the End of Phase meeting. This will be our third registrational trial, highlighting Clarity’s strong commitment to advancing our pipeline in areas of high unmet medical need with our next-generation Targeted Copper Theranostic products.

"Our team and collaborators are determined to progress 64Cu-SARTATE through this registrational trial and towards commercialisation as we continue building on excellent preclinical and clinical data clearly illustrating the advantages of this product over SOC agents. Time and time again we have shown our commitment to the highest standards of scientific and clinical research, putting ourselves head-to-head against the current SOC to clearly emphasise the benefits and enhanced diagnostic performance of our products, something that very few radiopharmaceutical companies do.

"We would like to thank everyone who contributed to progressing 64Cu-SARTATE to this exciting stage, from our patients who participate in our clinical trials and their families, to our incredible team, investigators and collaborators who work tirelessly towards our mutual goal of improving treatment outcomes for people with cancer. We also thank the FDA for their collaborative approach to our interactions, which we have now experienced for many years. We believe that better diagnostic tools will help clinicians determine the best course of treatment for their patients. With 64Cu-SARTATE we are getting closer to achieving this goal, and we look forward to commencing recruitment into this pivotal trial next year."

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE).

Disclaimer
64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration. There is no guarantee that this product will become commercially available.

About NETs
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system6. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin7. NETs can either be benign or malignant, as well as non-functional and functional8. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon9.

Overall, it is estimated that approximately 200,000 people are living with NETs in the US10-11. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years12. As such, about 30-75% of NETs patients have distant metastases at the time of diagnosis13. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%.

(Press release, Clarity Pharmaceuticals, DEC 22, 2025, View Source [SID1234661567])

On December 22, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference:

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J.P. Morgan Healthcare Conference on Monday, January 12, 2026 beginning at 11:15 a.m. Pacific Time
The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation.

(Press release, Gilead Sciences, DEC 22, 2025, View Source [SID1234661589])

On December 22, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported updates on zugocaptagene geleucel (zugo-cel), formerly known as CTX112, its investigational allogeneic CAR T targeting CD19, in development for autoimmune disease and hematologic malignancies.

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"Preliminary data from zugo-cel in patients with rheumatologic autoimmune diseases have been encouraging, and the therapy has been well tolerated to date. We have also initiated an additional Phase 1 basket study in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA), two autoimmune hematologic diseases," said Naimish Patel, M.D., Chief Medical Officer of CRISPR Therapeutics. "In hematologic malignancies, clinical experience to date supports continued advancement of the program. Together with our recently established collaboration with Lilly to evaluate zugo-cel with pirtobrutinib in aggressive B-cell lymphomas, these developments reflect the breadth of opportunity for zugo-cel. We look forward to sharing additional data at future scientific meetings."

Autoimmune Disease

Zugo-cel, targeting CD19, is in an ongoing Phase 1 basket trial in autoimmune rheumatologic diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis. Patients in the study may have active SLE (with or without renal involvement), SSc, or idiopathic inflammatory myopathy (IIM) despite the use of standard therapies.

Preliminary clinical data from the Phase 1 study has been encouraging, and zugo-cel has been well tolerated to date.

As of the data cut-off on December 17, 2025, four patients (2 SLE and 2 immune-mediated necrotizing myopathy (IMNM) with interstitial lung disease) have been treated at a dose of 100 million cells and followed for at least 28 days post-infusion:

Zugo-cel cell expansion is comparable to that observed at the same dose in patients in the ongoing B-cell lymphomas trial.
Rapid and deep B-cell depletion in the periphery was observed within the first 1-2 days and maintained over the first month of treatment, with repopulating B-cells demonstrating a shift toward an unswitched, naïve repertoire.
All patients demonstrated significant clinical improvement at the Day 28 assessment.
The first patient with SLE, refractory to 9 prior therapies with a baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 8, has maintained drug-free DORIS clinical remission through Month 6 following CAR T therapy.
Treatment has been well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune-effector cell-associated neurotoxicity syndrome (ICANS) observed.
Clinical trials in autoimmune disease remain ongoing across indications. The Company expects to provide additional updates in the second half of 2026. In addition, a Phase 1 clinical trial for zugo-cel has been initiated in ITP and wAIHA.

Immuno-Oncology

Positive clinical data generated to date support the advancement of zugo-cel into the Phase 2 portion of the ongoing Phase 1/2 trial in patients with (R/R) CD19-positive B-cell malignancies. Eligible disease subtypes include large B-cell lymphoma (LBCL), follicular lymphoma (FL) grade 1-3a, marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).

Zugo-cel was administered after a standard course of lymphodepletion with fludarabine and cyclophosphamide. A total of 39 patients have been treated across all 4 dose levels. The recommended Phase 2 dose (RP2D) was recently endorsed at the 600 million cell dose for the large B-cell lymphoma (LBCL) cohort.

As of the data cut-off of November 20, 2025, 10 patients with R/R LBCL have been treated at the RP2D of 600 million cell dose and have had at least one month of follow-up, with the following observations:

An overall response rate (ORR) of 90% (9/10) and a complete response rate (CRR) of 70% (7/10) were observed, including a complete response (CR) in a patient who relapsed following autologous CAR T cell therapy.
Among patients who have completed 12-months of follow-up, 67% (2/3) remained in CR at the 12-month evaluation.
Peak mean CAR T cell expansion of approximately 1,700 cells/µL was observed at the RP2D, representing approximately a four-fold higher expansion compared with patients receiving 300 million cells.
Rates of Grade 3 CRS, ICANS and serious infections were 17%, 17%, and 8%, respectively, among all LBCL patients treated at the RP2D (n=12).
No Grade 3 ICANS or CRS has been observed at the 100 million cell dose, which is the dose currently being studied in the autoimmune basket trials.
The Phase 1/2 clinical trial in R/R B-cell malignancies is ongoing. The Company expects to provide additional updates in the second half of 2026. CRISPR Therapeutics has also established a new collaboration and clinical supply agreement with Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, further expanding the program’s development in oncology.

About Zugocaptagene Geleucel (zugo-cel; formerly CTX112)
Zugocaptagene geleucel (zugo-cel) is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. Zugo-cel is an off-the-shelf allogeneic CAR T that utilizes CRISPR Cas9 for targeted gene knockout and CAR insertion for immune evasion and enhanced T effector cell potency. Zugo-cel is given following a standard lymphodepletion regimen without the need for HLA matching. Zugo-cel is being investigated in ongoing clinical trials in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis and in adult patients with relapsed or refractory B-cell malignancies.

(Press release, CRISPR Therapeutics, DEC 22, 2025, View Source [SID1234661577])

On December 22, 2025 Ginkgo Bioworks (NYSE: DNA) reported its partnership with Carnegie-Mellon University (CMU) for an award by the Advanced Research Projects Agency for Health (ARPA-H) for its POSEIDON program (Platform Optimizing SynBio for Early Intervention and Detection in Oncology). With Ginkgo Bioworks serving as the Commercial Partner, the project will also be led by Rebecca Taylor (principal investigator), professor of mechanical engineering at Carnegie Mellon University.

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Combining recent advancements in synthetic biology with cutting-edge detection technology, the team expects to develop both a highly innovative orally administered pill containing specially engineered, tumor-targeting sensors and a user-friendly cancer screening device designed for at-home testing. As part of this team, Ginkgo plans to apply its cell and enzyme engineering expertise to support development of these new diagnostic tools.

Using a combination of synthetic biology and nucleic acid nanotechnology, the pill’s specially engineered, tumor-targeting sensors aim to detect tumor-specific conditions, such as low oxygen, acidity, and lactate—hallmarks of cancer. The sensors will then release reporters to indicate the presence of a tumor and its specific tissue of origin. Synthetic reporters will then be excreted into urine to collect the results.

"Our dual-function approach is designed to provide an unprecedented level of precision, effectively illuminating hidden tumors from within the body, which then signals the presence of disease through a simple urine test," explained Taylor. "This is a scientific leap forward that we believe will profoundly change how we approach early cancer diagnostics."

"We are truly excited to get to support this effort," said Jesse Dill, Government BD Lead at Ginkgo Bioworks. "This type of interdisciplinary teaming, and ambitious vision, are essential for bringing transformative new diagnostics to the market. We hope that patients and doctors will be empowered to make well-informed decisions, to the benefit of all."

In addition to Carnegie Mellon researchers, the multidisciplinary project team includes academic experts from the University of Pittsburgh, the University of Massachusetts Amherst, and KU Leuven, as well as corporate partners at Ginkgo Bioworks, Velentium Medical, Clinical Research Strategies, and Platypus Bio.

(Press release, Ginkgo Bioworks, DEC 22, 2025, View Source [SID1234661593])

On December 22, 2025 Alphamab Oncology (stock code: 9966.HK) reported that that the clinical trial application for the independently developed TROP2/HER3 bispecific antibody-drug conjugate (ADC) JSKN016, in combination with InventisBio’s oral selective estrogen receptor degrader (SERD) D-0502, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The trial (Study Number: JSKN016-204) is for the treatment of locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer.

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Breast cancer is the most prevalent malignancy among Chinese women, with the HR+/HER2- subtype accounting for approximately 70% of all breast cancer cases. The current first-line standard of care involves endocrine therapy combined with CDK4/6 inhibitors. However, primary or acquired resistance often leads to disease progression, resulting in a significant unmet clinical need in later-line treatment. Therefore, it is crucial to explore novel-mechanism drugs and combination therapies.

JSKN016 is a novel bispecific ADC that simultaneously targets TROP2 and HER3 on the surface of tumor cells. It blocks the corresponding signaling pathways while enhancing cellular endocytosis and release of topoisomerase I inhibitors, enabling precise tumor killing. Early phase clinical studies have shown promising antitumor activity and a favorable safety profile in various solid tumors, including breast cancer. D-0502 is a novel, oral SERD independently developed by InventisBio. Early phase clinical studies have demonstrated its antitumor activity and good tolerability as monotherapy. The combination of both drugs is expected to achieve multiple synergistic effects, which may lead to prolonged disease control and improved survival outcomes for patients.

JSKN016-204 is a multicenter, open-label, randomized controlled phase Ib/II clinical study. It aims to evaluate the safety, tolerability, dose-limiting toxicity (DLT), preliminary antitumor activity, and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN016 in combination with D-0502 in patients with locally advanced or metastatic HR+/HER2- breast cancer who have been previously treated with CDK4/6 inhibitor in combination with endocrine therapy.

Ms. Yang Liu, Chief Operating Officer of Alphamab Oncology, stated: "Oral SERDs, including InventisBio’s D-0502, have recently demonstrated superior efficacy in HR+ breast cancer. Currently, there are no global precedents for combining an ADC with an oral SERD. Our JSKN016 has shown excellent efficacy and safety in later-line HR+ breast cancer. By combining with D-0502, we hope to further extend the progression-free survival for HR+ breast cancer patients after front-line therapy resistance and translate it into high-quality, long-term survival benefits. We greatly look forward to this collaboration."

Dr. Ling Zhang, Chief Medical Officer of InventisBio, stated: "We are very pleased that the clinical trial application for the combination therapy of D-0502 and JSKN016 has been approved. Drug resistance in HR+/HER2- breast cancer remains a major clinical challenge, with limited treatment options in later lines. D-0502, an oral SERD with a favorable safety profile and high bioavailability, in combination with the ADC JSKN016, is expected to synergistically inhibit tumor growth through a dual mechanism of action, offering new hope for patients with refractory disease."

About JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. Upon binding to TROP2 and/or HER3 on the tumor cell surface, JSKN016 blocks the corresponding signaling pathways and enhances cellular endocytosis to release topoisomerase I inhibitors, thereby exerting anti-tumor effects.

JSKN016 has demonstrated promising antitumor activity and a favorable safety profile across multiple solid tumors. Dose optimization and dose confirmation have been completed, and it is poised to advance into Phase III clinical studies.

About D-0502 (Taragarestrant)

D-0502 is a novel, oral selective estrogen receptor degrader (SERD) independently developed by InventisBio, intended for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Compared to existing injectable SERDs, its oral administration offers greater convenience for patients. D-0502 has demonstrated favorable antitumor activity and a promising safety profile in both preclinical studies and clinical trials. In October 2021, the Center for Drug Evaluation (CDE) granted approval to initiate a registrational Phase III clinical trial in China for D-0502. This trial is designed as a head-to-head comparison against standard of care in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. The first patient was successfully enrolled in this registrational Phase III trial in September 2022, and the trial is currently proceeding as planned.

(Press release, Alphamab, DEC 22, 2025, View Source [SID1234662085]).