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Positive guidance from the US FDA on Cu-64 SARTATE Phase III trial in patients with neuroendocrine tumours

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])

Jacobio Pharma Enters Global Exclusive License Agreement with AstraZeneca for Pan-KRAS Inhibitor JAB-23E73

On December 21, 2025 Jacobio Pharma (1167.HK,) reported that it has entered an agreement with AstraZeneca for its proprietary Pan-KRAS inhibitor JAB-23E73. AstraZeneca will receive exclusive development and commercialisation rights outside of China, while Jacobio and AstraZeneca will jointly develop and commercialise JAB-23E73 in China.

Under the terms of the agreement, Jacobio will receive an upfront payment of US$100 million, and is eligible for additional development and commercial milestone payments of up to US$1.915 billion, as well as tiered royalties on net sales achieved outside of China. AstraZeneca will be responsible for all clinical development, regulatory submissions, and commercialization activities for JAB-23E73 outside of China.

Yinxiang Wang Ph.D., Chairman and Co-CEO of Jacobio Pharma, commented: "We are delighted to partner with AstraZeneca. This collaboration marks a significant step forward as we bring our world-class programs to the global stage and maximize the value of our R&D innovation. We are committed to providing breakthrough treatments and improving survival for patients, including those with KRAS-mutated cancers, across the world."

Matt Hellmann, Senior Vice President, Early Oncology and Precision Medicine, Oncology R&D, AstraZeneca, said: "KRAS is one of the most important oncogenes in cancer, with KRAS-mutated tumours driving profound unmet need for patients with pancreatic, colorectal and lung cancers. By advancing KRAS inhibitors like JAB-23E73, and in combination with our diverse oncology portfolio, we aim to accelerate the development of new treatment regimens that have the potential to transform outcomes for patients."

JAB-23E73 is an innovative Pan-KRAS inhibitor developed using Jacobio’s induced allosteric drug discovery platform, designed to target multiple KRAS mutation subtypes. KRAS is the most frequently mutated oncogene in human cancers, present in approximately 23% of all patients. JAB-23E73 is being evaluated in Phase I trials in both China and the United States, where early signs of anti-tumor activity have been observed.

This agreement strengthens Jacobio’s financial position, accelerates the global development efforts, and expands our presence in the global oncology innovation ecosystem.

Jacobio will continue to delve into the KRAS pathway, advance tADCs with KRAS inhibitors as payloads, develop differentiated drugs targeting more KRAS mutation types, and drive forward its next immuno-oncology programs, including our STING-based iADC platform.

(Press release, Jacobio Pharmaceuticals, DEC 21, 2025, View Source [SID1234661569])

T-MAXIMUM Pharmaceutical’s Allogeneic CAR-T Therapy MT027 Receives FDA IND Clearance to Proceed to Phase II clinical Trial for Recurrent Glioblastoma

On December 21, 2025 T-MAXIMUM Pharmaceutical reported that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial for the treatment of recurrent glioblastoma (rGBM). This milestone marks a significant breakthrough in addressing one of the most formidable challenges in oncology: developing effective allogeneic CAR-T therapies for solid tumors.

"The FDA’s clearance of the IND for MT027 represents a strong validation of our strategic commitment to tackling the most challenging solid tumors," said Dr. Xiaoyun Shang, Founder and CEO of T-MAXIMUM Pharmaceutical. "This milestone is not only a small step for T-MAXIMUM, but a significant leap forward for the entire cell therapy field as we push into the ‘uncharted territory’ of solid tumor treatment. The successful development and advancement of MT027 is grounded in our deep understanding of immunology and our decisive investment in allogeneic cell-editing technologies. As a technology-driven company, T-MAXIMUM Pharmaceutical will continue to uphold a rigorous and pragmatic scientific approach, steadily advancing the clinical development of MT027. We remain committed to breaking new ground in the unexplored landscape of solid tumor cell therapy and using the power of science to win more time for patients."

About MT027

MT027 is an "off-the-shelf" allogeneic CAR-T product sourced from healthy donors and designed to target B7-H3 for the treatment of recurrent glioblastoma. As an allogeneic therapy, MT027 enables large-scale manufacturing and cryopreservation, allowing patients to receive treatment rapidly without the delays associated with autologous cell production—an advantage that can be critical for individuals facing fast-progressing and life-threatening diseases.

Unlike many industry peers relying on lentiviral or retroviral vectors, T-MAXIMUM Pharmaceutical has achieved a major advancement during the product’s transition to registration-oriented clinical development—establishing a fully non-viral gene-editing platform. This innovation enhances product safety while improving manufacturing precision and controllability, representing the next generation of cell therapy engineering.

CAR-T therapies have revolutionized treatment for hematologic malignancies; however, progress in solid tumors has been notably slower—particularly in glioblastoma, where the blood-brain barrier, intratumoral heterogeneity, and immunosuppressive microenvironment pose unique challenges. FDA IND clearance enabling MT027 to enter Phase II clinical evaluation represents a milestone step in advancing allogeneic CAR-T technology toward one of the most difficult solid tumor indications.

Leveraging its mature allogeneic technology platform, T-MAXIMUM Pharmaceutical is concurrently developing additional clinical programs targeting brain metastases and other solid tumors, further expanding its therapeutic pipeline.

About Glioblastoma

Glioblastoma (GBM) is among the most aggressive and lethal cancers of the central nervous system, often referred to as the "Mount Everest" of neurosurgery. Despite widespread adoption of the standard Stupp regimen, median overall survival remains only 14–16 months, with a five-year survival rate below 5%. For patients with recurrent glioblastoma, treatment options are even more limited, with median survival typically less than 6–9 months. There remains a profound unmet medical need in this area.

Since its founding, T-MAXIMUM Pharmaceutical has focused its research and development strategy on addressing these unmet needs, deliberately steering away from highly competitive hematologic indications to confront the formidable challenge of glioblastoma. This regulatory achievement validates the feasibility and potential of the company’s platform.

(Press release, T-MAXIMUM Pharmaceutical, DEC 21, 2025, View Source [SID1234661568])

Wasatch BioLabs Announces Co-Marketing Agreement With Agilent to Advance Native-Read Targeted Sequencing

On December 19, 2025 Wasatch BioLabs (WBL), a leader in native, long-read sequencing and epigenomic analysis, reported a co-marketing agreement with Agilent Technologies to support the adoption of its Direct Targeted Methylation Sequencing (dTMS) platform. The collaboration brings together Agilent’s enrichment chemistries—SureSelect for genomic DNA and Avida for cell-free DNA—and WBL’s proprietary Oxford Nanopore-based native-read workflow, expanding access to scalable targeted multi-omic analysis for RUO and clinical research studies.

The SureSelect and Avida capabilities both fill a critical gap in native-read sequencing by enabling precise, custom targeting up to 1 Mb, while preserving native DNA features such as methylation and structural variants. By eliminating off-target sequencing, DNA damage of traditional bisulfite-based methods, and biases introduced by PCR amplification, researchers can capture true biology across large and short, customized genomic regions. This opens new doors for liquid biopsy and targeted genomic applications with cost-efficient, scalable, and highly precise approaches suitable for a broad-array of research and screening applications.

"Multi-omic biology is essential for understanding disease, but for broad adoption it has to be delivered in a way that scales," said Dean Lilley, Senior Director of Product Development at Wasatch BioLabs. "Our alignment with Agilent ensures that native-read targeted sequencing delivers integrated genetic and epigenetic insight, while establishing the consistency, reproducibility, and operational reliability required for high-throughput research and potential future clinical translation.

Early adopters in oncology, neurology, rare disease, and prenatal research are already applying dTMS to resolve structural variation, allelic context, repeat expansions, and methylation patterns in a unified assay. These programs demonstrate how native-read targeted sequencing can support more comprehensive, mechanism-informed profiling across research areas such as liquid biopsy and large cohort studies.

"Partnering with Wasatch BioLabs allows Agilent to deliver a next-generation experience for customers who need both innovation and operational flexibility," said Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division. "By integrating SureSelect and Avida enrichment with Wasatch’s novel sequencing technology and robust send-out service model, we are enabling customers to access high-quality NGS data without workflow barriers. This collaboration accelerates adoption, improves turnaround times, and provides a powerful, innovation-led path to achieving high-confidence genomic insights at any scale."

Under the agreement, WBL and Agilent will jointly deliver scientific content, educational programming, and technology demonstrations through 2027. The organizations anticipate the collaboration will scale adoption of native-read targeted sequencing and accelerate the development of cost-efficient, relevant native-read assays.

WBL welcomes additional partners interested in integrating the targeted sequencing assay into their research or development programs. The service will remain in early access through Q1 2026. Early adopters will have the opportunity to shape future enhancements and gain first access to new capabilities.

(Press release, Agilent, DEC 19, 2025, View Source [SID1234661565])

Tolmar Announces Expanded Indication for Rubraca® (rucaparib) First and Only PARP Inhibitor to Outperform Docetaxel in a Head-to-Head Phase 3 Trial

On December 19, 2025 Tolmar, Inc. (Tolmar) reported that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Rubraca (rucaparib), enabling its use prior to chemotherapy for eligible patients with metastatic castration-resistant prostate cancer (mCRPC). The approval is supported by the pivotal TRITON3 Phase 3 trial, which demonstrated that Rubraca is the first and only PARP inhibitor to exceed the efficacy of docetaxel in a direct, head-to-head comparison, marking a significant evolution in treatment sequencing for patients with DNA damage repair (DDR)-deficient tumors.

"This approval reflects a breakthrough moment for patients and for precision oncology," said Anil D’Souza, Chief Executive Officer of Tolmar. "For years, oncologists have relied on docetaxel as an important therapy in this setting. Now, TRITON3 has shown that Rubraca can not only move ahead of chemotherapy but outperform it—supported by clear genomic rationale and superior progression-free survival. Bringing Rubraca earlier in the treatment journey offers physicians a more targeted approach for patients with BRCA mutated prostate cancer."

The TRITON3 study is a Phase 3, multicenter, open-label, randomized trial of rucaparib in chemotherapy-naïve mCRPC patients who had been previously treated with an androgen receptor directed therapy. The study enrolled 405 patients with a mutation in BRCA or ATM who were randomized to rucaparib or the control group, which consisted of physician’s choice of docetaxel, abiraterone acetate, or enzalutamide. Approximately 55% of the patients in the control arm received docetaxel. The primary endpoint was radiographic progression-free survival (rPFS) by independent radiology review (IRR), in patients with mutations in BRCA1, BRCA2 or ATM. TRITON3 was designed as a Phase 3 trial to confirm and expand the efficacy data from TRITON2 in an earlier treatment setting in mCRPC against a relevant control arm. Patients were selected for therapy based on an FDA-approved companion diagnostic for rucaparib.

Key findings include:

Superiority in Radiographic Progression-Free Survival (rPFS):
Rubraca achieved a statistically significant improvement in rPFS vs. the control arm, delivering a median rPFS of 11.2 months vs. 6.4 months , HR 0.50
In a sub-analysis of Rubraca vs Docetaxel, the rPFS was 11.2 months vs. 8.3 months with docetaxel in the BRCA subgroup
Compelling Genomically Driven Benefit:
Patients with BRCA mutations demonstrated the strongest response, showing a ~50% reduction in risk of progression or death vs. docetaxel
Rubraca Tolerability Profile:
The safety profile of Rubraca observed in TRITON3 was consistent with previous studies. In TRITON3, the discontinuation rate for TEAEs was 14.8% for Rubraca-treated patients and 21.5% for the control arm
Prostate cancer is the most diagnosed cancer in U.S. men, with an estimated 313,780 new cases diagnosed in 2025.2 Approximately 10 to 20 percent of patients progress to castration-resistant prostate cancer, an incurable disease, within five years of diagnosis.3 The vast majority have metastases at diagnosis or develop metastases within two years.3 Of these, an estimated 13% have BRCA-mutated mCRPC,4 a disease characteristic associated with a poor prognosis.5 Men with mCRPC and the presence of a germline BRCA2 mutation, a prognostic marker, have more aggressive disease and poorer survival.6 While less common in prostate cancer, germline mutations in BRCA1 are also associated with more aggressive disease6. mCRPC generally responds to initial androgen deprivation therapy.7 However, most patients will inevitably develop treatment resistance.7

Rubraca (rucaparib) U.S. Prostate Cancer FDA-Approved Indication

INDICATION

RUBRACA (rucaparib) is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 2141 treated patients with ovarian and prostate cancer, MDS/AML occurred in 34 patients (1.6%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.7%).
The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In ARIEL3, of patients with ovarian cancer associated with a germline and/or somatic BRCA mutation who were treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

In TRITON3, MDS/AML occurred in 2 out of 201 patients (1%) with a BRCA mutation treated with RUBRACA. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years.

Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue RUBRACA.

Based on findings from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. Advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of RUBRACA. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of RUBRACA.

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥10%, Grade 1-4) were fatigue/asthenia (61%), musculoskeletal pain (53%), nausea (51%), decreased appetite (34%), diarrhea (31%), constipation (31%), vomiting (25%), dyspnea (19%), dysgeusia (18%), edema (18%), abdominal pain (17%), dizziness (16%), weight decreased (16%), rash (13%), headache (12%), peripheral neuropathy (12%), photosensitivity reaction (12%), and urinary tract infection (10%).

Most common select laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥ 25%, Grade 1-4) were increased ALT (68%), decreased neutrophils (67%), decreased phosphate (64%), decreased hemoglobin (60%), increased AST (59%), increased creatinine (56%), increased glucose (45%), decreased lymphocytes (43%), decreased sodium (35%), decreased platelets (34%), and increased calcium (29%).

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), decreased appetite (28%), rash (27%), constipation (27%), vomiting (22%), and diarrhea (20%).
Most common laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 35%; Grade 1-4) were increased ALT (69%), decreased leukocytes (69%), decreased phosphate (68%), decreased absolute neutrophil count (62%), decreased hemoglobin (59%), increased alkaline phosphatase (44%), increased creatinine (43%), decreased lymphocytes (42%), increased triglycerides (42%), decreased platelets (40%), and decreased sodium (38%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

(Press release, Tolmar Pharmaceuticals, DEC 19, 2025, View Source [SID1234661564])