On December 16, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, together with Quantum Leap Healthcare Collaborative, reported the publication of new findings from the I-SPY 2 trial in Nature Communications.

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The study examined how Signatera can refine risk assessment in patients with early-stage breast cancer whose tumors resist neoadjuvant therapy (NAT). These cancers often leave behind substantial residual disease and carry a higher risk of metastasis, though only about 15–30% recur within three years1-3. Distinguishing which NAT-resistant tumors are more likely to recur could guide treatment decisions to potentially prevent or delay metastatic recurrence.

Researchers used Signatera to measure personalized circulating tumor DNA (ctDNA) in 723 women with high-risk, early-stage breast cancer receiving NAT at four time points: 1) before treatment; 2) after three weeks of paclitaxel with or without an investigational agent; 3) between paclitaxel- and anthracycline-based regimens; and 4) after completing neoadjuvant therapy. Key findings include:

Signatera ctDNA testing improved prognostic precision beyond residual cancer burden (RCB) alone in patients with high RCB (RCB-II/III) following neoadjuvant therapy (NAT).
Signatera-negative patients, at either pretreatment or post-NAT, had a much lower risk of metastasis:
RCB-II: Post-NAT, pre-surgery (T3) 3-year DRFS = 88% (ctDNA–) vs. 57% (ctDNA+), adj HR = 0.29, p = 0.001
RCB-III: Post-NAT, pre-surgery (T3) 3-year DRFS = 83% (ctDNA–) vs. 22% (ctDNA+), adj HR = 0.14, p < 0.001
Persistent Signatera positivity post-NAT (T3) was a strong independent predictor of metastatic recurrence (adj HR = 5.20, p < 0.001).
Early Signatera ctDNA clearance at week 3 (T1) was strongly associated with favorable response to NAT, including regimens containing immune checkpoint inhibitors and HER2-targeted therapies, supporting its potential as an early, dynamic biomarker of treatment sensitivity.
Personalized Signatera assay variants remained highly stable despite tumor evolution, with median conservation rates of 94–97% between pretreatment and post-NAT tumor samples.
"These findings show that ctDNA provided critical insight into which therapy-resistant tumors were most likely to recur and, importantly, which were not," said Laura Esserman, M.D., MBA, and Laura van ‘t Veer, Ph.D., professors at the UCSF and principal investigators of the I-SPY study. "That distinction is vital because it can help us identify who remains at higher risk for recurrence and who may not need more aggressive treatment. Our next step is to integrate these findings and examine how ctDNA, pathology and imaging can complement each other. The I-SPY trial provides a framework to optimize all of the information for the benefit of patients."

"The I-SPY 2 publication adds to a growing body of evidence supporting Signatera’s role in early breast cancer," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "Building on our previous studies, this work provides further validation that Signatera can improve risk assessment for therapy-resistant disease. We are grateful for our ongoing collaboration with the I-SPY investigators on research that brings us closer to more personalized and effective care for patients."

(Press release, Natera, DEC 16, 2025, View Source [SID1234661473])

On December 16, 2025 Iambic, a clinical-stage life sciences and technology company advancing novel medicines through its AI-driven discovery and development platform, reported that Tom Miller, Ph.D. (Co-Founder and Chief Executive Officer) and Fred Manby, Ph.D. (Co-Founder and Chief Technology Officer) will present at the 44th Annual J.P. Morgan Healthcare Conference. Iambic’s presentation will take place on Tuesday, January 13, 2026, at 4:30 p.m. PT at the Westin St. Francis Hotel in San Francisco.

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Iambic will highlight strategic progress over the past year, which has laid the groundwork for significant upcoming milestones. Highlights include:

Presentation of Phase 1/1b data for IAM1363, Iambic’s lead AI-designed drug candidate, demonstrating anti-tumor activity across HER2-wild-type and HER2-mutated cancers and a favorable safety profile
Research collaboration and drug supply agreement with Jazz Pharmaceuticals to evaluate IAM1363 in combination with zanidatamab in HER2-positive breast cancer
Presentation of IAM1363 pre-clinical NSCLC data at the World Conference on Lung Cancer showing potent anti-tumor activity and significant tumor regression across HER2-amplified and HER2-mutant NSCLC models, including greater anti-tumor activity compared to zongertinib
Technology-enablement collaboration with Revolution Medicines, leveraging Iambic’s NeuralPLexer protein-ligand prediction model to accelerate oncology target discovery
Continued development and validation of Enchant, Iambic’s multimodal model for predicting clinical and preclinical endpoints, with industry-leading performance benchmarks
Raising an oversubscribed financing exceeding $100 million to support clinical expansion and continued platform growth
The company will also preview key activities anticipated in the near-term, including:

Upcoming clinical data readouts, further defining IAM1363’s best-in-class potential and combination opportunities across HER2-driven cancers
Initiation of additional clinical trials for its potential first- and best-in-class programs, underscoring continued progress in advancing multiple pipeline candidates
Additional discovery and technology collaborations with biopharmaceutical partners, reflecting strong industry demand for Iambic’s platform capabilities
Advancement of new internal programs, broadening the company’s AI-driven discovery pipeline
Release of next-generation NeuralPLexer and Enchant models, featuring increased prediction breadth, expanded property coverage, and broader modality applicability
Iambic will also be at the conference to meet with investors and potential biopharmaceutical and technology partners.

(Press release, Iambic Therapeutics, DEC 16, 2025, View Source [SID1234661472])

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])