On December 16, 2025 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that European Urology Oncology published results of a clinical study demonstrating the implications of implementing Bladder EpiCheck in conjunction with standard-of-care (SoC) white light cystoscopy (WLC) for non-muscle invasive bladder cancer (NMIBC) surveillance in high-grade recurrence. The article was published online in European Urology Oncology.

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The results demonstrated superior Bladder EpiCheck sensitivity in detecting high-grade recurrences, specifically in patients with stage 0is (cases with carcinoma in situ [CIS] without papillary tumors [Tis]), versus current SoC WLC. Bladder EpiCheck outperformed WLC across all measures of sensitivity. The analysis included 231 high-grade NMIBC patients followed up for a median of 16 months with 316 surveillance visits of both WLC and Bladder EpiCheck. Two events of progression to muscle invasive bladder cancer (MIBC), 28 high-grade NMIBC recurrences and seven low-grade NMIBC recurrences occurred within 6 months of a surveillance visit. Bladder EpiCheck detected 92% of these events, including 90% of high-grade NMIBC/MIBC cases and 100% of low-grade NMIBC cases versus 62%, 63%, and 57%, respectively, detected by WLC. Importantly, Bladder EpiCheck detected 92% of Tis cases, where WLC detected 38%. These results underscore the ability of Bladder EpiCheck to detect high-grade recurrences that were missed by WLC by identifying NMIBC patients with a negative surveillance cystoscopy who should undergo biopsy.

"CIS is one of the more aggressive forms of bladder cancer, with up to a 60% risk of progressing to muscle-invasive disease (stage II) if left untreated," said Professor Param Mariappan, Consultant Urological Surgeon at Western General Hospital, Edinburgh (NHS Lothian), who led this project and is a member of the European NMIBC and MIBC Guidelines Committees. "If CIS recurrence at stage 0 (Tis) is missed and the tumor is detected only after it has progressed to stage I or stage II, removal of the bladder by cystectomy is usually the recommended treatment and patients’ five-year survival rates might significantly decrease. The findings from this study are significant because they demonstrated that Bladder EpiCheck can open a vital window of tumor detection at an earlier disease stage allowing for earlier intervention, potentially avoiding bladder removal, and better outcomes."

"We are excited to see the results from this impressive study and believe that Bladder EpiCheck is poised to significantly improve care management for NMIBC patients," said Chris Hibberd, Chief Executive Officer of Nucleix.

Earlier data from this study was presented at the 46th Annual European Association of Urology (EAU) Congress and the American Urological Association’s (AUA) 2025 Annual Meeting.

About Bladder EpiCheck

Bladder EpiCheck provides physicians and their patients with a simple, objective urine test for recurrent bladder cancer. The PCR test analyzes subtle disease-specific changes in DNA methylation markers, with high sensitivity and specificity. Bladder EpiCheck is intended for use as a non-invasive method for detection of NMIBC recurrence in conjunction with standard of care methods. Bladder EpiCheck is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. It is commercially available in Europe and in the United States.

(Press release, Nucleix, DEC 16, 2025, View Source [SID1234661471])

On December 16, 2025 Affibody AB ("Affibody") reported that the Trial Review Committee (TRC) has recommended to advance the Phase I clinical study with the Radioligand Therapy (RLT) candidate ABY-271 in HER2-positive metastatic breast cancer to its second part, where higher radioactivity levels will be evaluated.

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The TRC has based its positive recommendation on safety, tolerability, dosimetry and biodistribution data from the first enrolled cohort of patients, demonstrating tumor targeting and a favorable safety profile with low uptake in kidneys and other critical organs.

"The initial data from the ABY-271 study are very promising. We observed a favorable safety profile and encouraging biodistribution data, supporting progression of the study to the next stage," said assistant professor Oscar Wiklander at the Karolinska University Hospital, coordinating investigator in the study. "These results offer important insight into how the therapy behaves in patients, and we are eager to advance the study to deepen our understanding of its clinical potential."

"I am thrilled that these early clinical results with ABY-271 mirror the preclinical findings and dosimetry predictions remarkably well. I am especially excited about the low kidney uptake," said David Bejker, CEO of Affibody. "The positive outcome not only marks an important milestone for this program but also for the Affibody platform as a powerful technology for developing next-generation targeted radiotherapeutics."

ABY-271 is an Affibody molecule that targets HER2-expressing tumors and is labeled with the radioisotope lutetium-177, which emits cytotoxic beta radiation exerting irreversible damage to the tumor cells. Affibody is evaluating ABY-271 in a first-in-human, open-label, two-stage, randomized Phase 1 clinical study to assess the safety, tolerability, and biodistribution of ABY-271 in tumors and critical organs in subjects with HER2-positive metastatic breast cancer. The study is conducted at sites specialized in breast cancer and nuclear medicine in Sweden and Germany.

The TRC, including principal investigators, medical monitor, dosimetry and nuclear medicine specialists, has reviewed safety, tolerability, dosimetry and biodistribution data from a pre-specified number of enrolled patients. The TRC confirmed favorable safety and biodistribution, with low uptake in kidneys and other critical organs. The TRC recommends advancing the study to part B, which will evaluate higher radioactivity levels and additional protein mass doses. In line with this recommendation, Affibody will submit a protocol amendment to the European Medicines Agency (EMA) to accelerate the transition to the second part, which is expected to start in H1 2026 with the first results anticipated in H2 2026.

About the Phase 1 clinical study

The clinical study is a Phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of ABY-271 in tumors and critical organs in subjects with HER2-positive metastatic breast cancer.

The trial consists of two parts, part A in which the uptake of ABY-271 in tumors and critical organs will be evaluated in up to six sequentially enrolled patients, and part B in which higher radioactivity levels and additional protein mass doses for subsequent clinical trials will be evaluated in a total of 15 randomized patients. Patients will receive a single intravenous infusion of ABY-271 in both part A and part B. Dr Oscar Wiklander at Karolinska University Hospital is the coordinating investigator in Sweden. More information about the study can be found on clinicaltrials.gov under NCT07081555.

(Press release, Affibody, DEC 16, 2025, View Source [SID1234661470])

On December 16, 2025 Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code: 2563.HK), reported that the first patient has been dosed for one of its key oversea clinical studies: the U.S. pivotal clinical study (NCT06764940) of Utidelone Injection(UTD1) combined with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM).

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The study adopts a two-stage design and plans to enroll approximately 120 subjects. The primary endpoint is the central nervous system objective response rate (CNS-ORR). Nearly 20 top tier clinical institutes across the United States are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte, Robert H. Lurie Comprehensive Cancer Center at Northwestern University, University of Colorado Hospital, Augusta University, and University of California Los Angeles.

Utidelone’s unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux enable it to cross the blood-brain barrier (BBB) and prevent or treat brain metastases of solid tumors, setting it apart from taxanes, which are also microtubule stabilizers. A Phase II clinical study of utidelone combined with bevacizumab and chemotherapy for HER2-negative BCBM, which enrolled 34 subjects, was presented orally at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting [1]. The results showed a CNS-ORR of 67.6%, a central nervous system clinical benefit rate (CNS-CBR) of 88.2%, and a median central nervous system progression-free survival (CNS-PFS) of 15 months. The results of another Phase II clinical study of utidelone combined with bevacizumab for HER2-negative BCBM were published in JAMA Oncology in 2025 [2]. 47 subjects were recruited in the study, with a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months. In both studies, most treatment-related adverse events (TRAEs) were Grade 1-2, controllable, and reversible. The U.S. FDA has also granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases.

Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]. Due to the presence of the BBB, many breast cancer treatments were unable to achieve effective concentrations intracranially, leading to generally poor prognoses for BCBM patients, particularly those with HER2-negative BCBM, whose median progression-free survival is only 2-6 months. However, there is currently no clearly effective drug therapy for HER2-negative BCBM, and no drugs worldwide have been approved for this indication, highlighting a significant and urgent unmet medical need. Utidelone has the potential to change this landscape, offering a new treatment option and hope for survival to these patients.

(Press release, Beijing Biostar Technologies, DEC 16, 2025, View Source [SID1234661469])

On December 16, 2025 METiS TechBio ("METiS") reported that two of its oncology pipeline candidates, MTS-105 and MTS-107, have been published in leading international peer-reviewed journals, Nature Communications and the Journal for ImmunoTherapy of Cancer (JITC), representing two major breakthroughs in mRNA-based cancer therapeutics.

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Both studies leverage METiS’s proprietary AI-powered NanoForge platform, which introduces a precision-guided rocket-and-payload delivery analogy. By combining liver- and spleen-targeted lipid nanoparticle (LNP) delivery systems with programmable mRNA engineering, METiS has developed a new generation of immunotherapy strategies capable of efficiently activating antitumor immunity in specific organs in vivo.

MTS-105 is a first-in-class mRNA-encoded T cell engager (TCE) therapy candidate for hepatocellular carcinoma (HCC), delivered via METiS’s proprietary liver-targeted LNP system. Study results demonstrate that, once delivered to and taken up within the liver, the mRNA is translated in situ and secreted locally as high level of bispecific antibodies, which rapidly penetrate HCC tissues. Employing this "Trojan Horse" strategy, MTS-105 efficiently activates T cells within the tumor to induce tumor cell killing, achieving complete tumor clearance and long-term T cell immune memory in mouse models.

MTS-105 provides a breakthrough solution to the long-standing limitations of protein-based TCEs in solid tumors, positioned as the world’s first mRNA-encoded TCE therapy for solid tumors. The program has now entered clinical development.

MTS-107 is an innovative mRNA therapeutic vaccine targeting HPV16/18-positive cervical and head and neck cancers, with potential to achieve breakthrough treatment for HPV-associated cancers. Using spleen-targeted LNPs, METiS’s team designed a construct combining dual E6/E7 antigens with a novel immune-activating adjuvant. In mouse models, MTS-107 demonstrated synergistic antitumor activity with PD-1 checkpoint inhibitors, resulting in robust expansion of HPV-specific CD8⁺T cells. MTS-107 will continue into original clinical exploration.

Chris LAI, Co-founder and CEO, said:

"This is an important milestone demonstrating the power of METiS’s AI-driven NanoForge platform in therapeutic development. In conventional cancer therapy, most ‘soldiers’ remain outside the tumor, unable to infiltrate solid tumors for precise, effective killing. Our ‘rocket-and-satellite’ precision delivery paradigm has been strongly validated in these studies. We look forward to advancing global clinical development with our partners, bringing targeted therapies to patients and offering hope for survival or even cure."

Dr. Wei XU, Chief Scientific Officer and corresponding author of two studies, added:

"mRNA therapeutics have long been constrained by delivery challenges, and innovation in LNP technology is essential for unlocking their full potential. MTS-105 is the first to show that an Fc-free bispecific T cell engager can activate T cells without driving exhaustion, while MTS-107 introduces a new antigen design and built-in adjuvant that markedly enhance antitumor immunity.

A recent Nature study reported that patients treated with PD-1 inhibitors nearly doubled their three-year survival if they had also received an mRNA COVID-19 vaccine—a finding that strongly aligns with our observations for MTS-107. These results highlight how mRNA platforms can synergize with PD-1 blockade and signal a new chapter for immuno-oncology"

Dr. Andong LIU, Vice President and Head of Platform Technologies, and co-corresponding author of the Nature Communications study, stated:

"Our NanoForge engine significantly accelerates LNP and mRNA design cycles, boosting delivery efficiency and safety for liver- and spleen-targeted therapeutics. LNP nanodelivery is critical for precise tissue targeting and effective antitumor therapy. These studies open broad new avenues for innovative mRNA therapeutics."

MTS-105: Preclinical Breakthrough in Nature Communications

On December 15, Nature Communications (IF 15.7, 2024) published METiS’s preclinical study titled:
"Organ-Specific Delivery of an mRNA-Encoded Bispecific T Cell Engager Targeting Glypican-3 in Hepatocellular Carcinoma."

Key highlights:

Organ-Specific Delivery: MTS-105 achieves highly efficient liver-targeted delivery with minimal systemic exposure. Studies in mice, rats, and cynomolgus monkeys show superior hepatic enrichment compared to antibody-based TCEs.

Controlled Release and Safety: Reduced C max and systemic exposure lower toxicity risks. In cynomolgus monkeys, linear pharmacokinetics were observed with excellent tolerability, supporting potential weekly dosing.

Potent Antitumor Efficacy: Data from mouse models showed a marked increase in intratumoral exposure, enabling 100% complete responses—with full tumor clearance—at doses as low as 0.15 μg. In contrast, the protein-based TCE control achieved only ~50% tumor growth inhibition even at 1 mg/kg (approximately 20 μg).

Durable T Cell Memory: Cured mice remained tumor-free upon rechallenge, indicating long-term immune memory and prevention of recurrence.
MTS-105 sets a new paradigm for translating TCE therapy into solid tumors, paving the way for first-in-class mRNA-encoded TCE therapy.

MTS-107: Breakthrough HPV Vaccine Published in JITC

On September 17, JITC published: "mRNA-encoded mutant HPV16/18 vaccines promote specific T-cell responses and synergize with anti-PD-1 checkpoint blockade in mediating therapeutic tumor regression in mice."

Key findings:

Complete Tumor Regression: In advanced HPV18⁺MC38 tumor models, MTS-107 combined with PD-1 blockade achieved 100% complete response (CR).

Spleen-Targeted LNP Delivery: Enhances antigen presentation and T cell activation.

Dual-Subtype Antigen Design: Encodes mutated HPV16/18 E6/E7 antigens; optimized mRNA sequences improve translation and stability.

Built-in Adjuvant: Co-expresses GM-CSF to promote dendritic cell maturation and HPV-specific CD8⁺T cell activation.

Synergy with PD-1 Blockade: While monotherapy expands tumor-infiltrating HPV-specific T cells; combination with PD-1 blockade relieves immune suppression for complete tumor regression.
This work demonstrates the transformative potential of AI-powered mRNA vaccines in HPV-associated cancers and establishes METiS’s innovation at the intersection of AI-driven nanodelivery and tumor immunotherapy, providing a strong foundation for clinical translation.

(Press release, METiS Pharma, DEC 16, 2025, View Source [SID1234661468])

On December 16, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported that its therapeutic research arm, Caris Discovery, has entered into a multi-year collaboration and license agreement with Genentech, a member of the Roche Group. In this collaboration, Caris will work to identify and validate novel oncology targets in solid tumor tissue.

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Under the terms of the agreement, Caris is eligible to receive upfront and near-term payments of $25 million and is also eligible for up to $1.1 billion of potential research, development, commercial and net sales milestone payments, as well as potential tiered royalties on net sales of collaboration therapies.

"At Caris, we are committed to making precision medicine a reality for all patients. This innovative collaboration with Genentech is specifically designed to identify and validate novel targets in solid tumors. By combining Caris’ unparalleled multimodal data and tissue-based discovery engine with Genentech’s deep expertise in therapeutics development, we hope to enable the development of first-in-class medicines for cancer patients," said Milan Radovich, PhD, Senior Vice President and Chief Scientific Officer at Caris.

"Roche and Genentech are driven by a profound vision – a future where cancer can be cured," said Boris L. Zaïtra, Head of Roche Corporate Business Development. "We have successfully led many fundamental scientific advances in oncology. As we continue to bring forth transformative medicines, collaborations with partners such as Caris allow us to pursue future innovation for patients with unmet needs."

Caris is able to leverage insights from its extensive repository of nearly 500,000 solid tumor samples, along with matched comprehensive molecular and clinical data, to offer sophisticated and flexible target discovery capabilities leveraging both tissue-based and data-centric techniques to biopharma partners. Caris Discovery scientists use an integrated bioinformatics and wet-lab workflow, which combines interrogation of solid tissue and cell-based systems with multimodal data to validate prioritized targets and help advance the development of next generation therapies.

(Press release, Caris Life Sciences, DEC 16, 2025, View Source [SID1234661467])