On March 25, 2026 TRIANA Biomedicines, Inc. (TRIANA), a leading biopharmaceutical company focused on advancing a target-first and proximity-first molecular glue discovery platform to address difficult to drug disease targets, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TRI-611, an investigational molecular glue degrader therapy for the treatment of anaplastic lymphoma kinase–positive (ALK+) non-small cell lung cancer (NSCLC).

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Fast Track designation is a U.S. Food and Drug Administration (FDA) program intended to accelerate the development and review of new drugs that have the potential to treat serious conditions and address urgent unmet medical needs.

"This Fast Track designation underscores the potential of TRI-611 to address the significant unmet need for patients with ALK+ NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors," said Dr. Patrick Trojer, President and CEO of TRIANA. "TRI-611 was designed as an innovative therapeutic approach to target ALK fusion proteins. We look forward to working closely with the FDA to potentially bring TRI-611 forward to the lung cancer patient community."

Earlier in March 2026, TRIANA announced that the first patient had been treated with TRI-611 in a Phase 1/2 clinical study. The Phase 1/2 trial is a global, first-in-human, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TRI-611 in patients with ALK+ NSCLC. The Phase 1 portion will consist of a dose escalation design, enrolling ALK+ NSCLC patients, who have been previously treated with standard of care ALK tyrosine kinase therapies. The Phase 2 portion will further evaluate and characterize the efficacy and safety of TRI-611 across different patient cohorts. For more information, visit ClinicalTrials.gov (NCT07491497).

About TRI-611

TRI-611 is a novel oral, small-molecule, investigational therapy designed to target and degrade ALK fusion proteins in patients with ALK+ NSCLC. TRI-611 is a potent, brain-penetrant molecular glue degrader that brings ALK fusion proteins and the E3 ligase enzyme cereblon together through a unique binding mechanism that works independently of the ALK kinase active site and harnesses the body’s innate protein-degradation machinery to selectively eliminate the ALK fusion protein. TRI-611 is designed to overcome the limitations observed with currently available ALK inhibitors.

(Press release, Triana Biomedicines, MAR 25, 2026, View Source [SID1234663919])

On March 25, 2026 Tempus AI, Inc., a leader in artificial intelligence and precision medicine, reported a strategic collaboration with Daiichi Sankyo (TSE: 4568) aimed at accelerating the clinical development and differentiation of an antibody drug conjugate (ADC) program in oncology.

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Through this collaboration, Daiichi Sankyo will leverage Tempus’ proprietary foundation models and AI expertise, including PRISM2, a state-of-the-art, multimodal foundation model that combines pathology images and clinical data to generate rich diagnostic and predictive insights. By combining clinical trial and preclinical research data from Daiichi Sankyo with Tempus’ comprehensive real-world data, the collaboration aims to unlock new opportunities for biomarker discovery and patient stratification.

Tempus and Daiichi Sankyo will develop proof-of-concept AI models to optimize patient selection and increase probability of success for a novel ADC. By deploying these models across Tempus’ expansive oncology database, the collaboration will generate detailed response maps, enabling precise patient stratification and supporting rigorous benchmarking of potential control arms for future clinical trials.

"Our collaboration with Daiichi Sankyo signals a new chapter in how multimodal AI and real-world data can be applied to advance the development of ADCs," said Ryan Fukushima, CEO of Data and Apps at Tempus. "Our multimodal foundation models seek to radically accelerate and improve our ability to uncover unmet patient needs and identify patients most likely to benefit from novel therapies. Applying AI in clinical development isn’t just about efficiency anymore, leading companies like Daiichi Sankyo are using these models to enhance the design of more targeted, impactful clinical trials."

(Press release, Tempus, MAR 25, 2026, https://www.businesswire.com/news/home/20260325439177/en/Tempus-Announces-Strategic-Collaboration-with-Daiichi-Sankyo-to-Advance-AI-Driven-Biomarker-Discovery-and-Clinical-Differentiation-Across-an-ADC-Clinical-Program [SID1234663918])

On March 25, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, reported its participation at the 23rd Annual Meeting of the Japanese Society of Medical Oncology (JSMO2026) from March 26–28, 2026, in Yokohama, Japan. The premier oncology conference brings together over 7,000 global experts to discuss the advancements in cancer research and clinical practice. The conference focuses on bridging the gap between cutting-edge evidence and practical patient value, highlighting oncology advances, cancer genome medicine, and the evolving role of AI in multidisciplinary care. BostonGene’s participation underscores its expanding work with global biopharmaceutical companies applying its platform to improve clinical trial outcomes and therapeutic development.

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BostonGene will present research demonstrating how its AI foundation model for tumor and immune biology enables disease-level modeling by integrating multimodal data from electronic medical records, genomics, transcriptomics, imaging, and immune profiling. Rather than focusing on individual biomarkers or isolated signals, the platform models the biological system to generate decision-grade insights. These insights are used to:

predict patient response, resistance, and toxicity
stratify patients for clinical trials
inform therapeutic strategies and combination approaches
This approach is already being applied in collaborations with leading biopharmaceutical companies, where engagements typically begin as focused pilots and expand into broader platform integration. The same modeling framework can be extended to other diseases through additional training, enabling efficient expansion beyond oncology without rebuilding the core architecture.

Details of BostonGene’s presentations are below.

Symposium Presentation
Title: The integration of genomic profiling with AI is transforming therapeutic decision-making in Oncology/Hematology
Date & Time: Thursday, March 26 | 16:05–18:05
Location: Room 4 (G5, 1F), Pacifico Yokohama North
Speaker: Alexander Bagaev, PhD, BostonGene

Poster Presentation
Poster Number: P014-2
Title: Validation of BostonGene Tumor Portrait Assay for Comprehensive Genomic and Transcriptomic Profiling in Diverse Cohorts
Date & Time: Thursday, March 26 | 13:05–13:50
Location: Poster Room | Exhibition Hall D, Pacifico Yokohama North
Presenter: Zlata Polyakova, PhD, BostonGene Japan

For more information or to schedule a meeting with BostonGene during the event, please contact Zlata Polyakova at [email protected].

(Press release, BostonGene, MAR 25, 2026, View Source [SID1234663916])

On March 25, 2026 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported positive top-line results from its ICESECRET clinical trial of ProSense for the treatment of small renal masses ("SRMs") in kidney cancer patients.

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A total of 114 patients were enrolled in the study, of whom 112 were evaluated at a median follow-up of four years (IQR 1.4–5.3). The study demonstrated that 83.9% of patients were recurrence-free at this median follow-up period. Among these patients, 12 underwent a second cryoablation procedure at a mean of 1.73±1.2 years. In a subgroup of patients with tumors ≤3 cm, no prior kidney cancer, and successful initial procedures, the recurrence-free rate reached 89.4%.

More detailed data from the study will be presented by Principal Investigator Prof. Halahmi Sarel at the European Conference on Interventional Oncology ("ECIO"), which will take place form April 26 to 30, 2026, in Basel, Switzerland.

ProSense is currently approved in the U.S., Europe and other key markets for the treatment of malignant and benign kidney tumors.

"We believe the positive top-line results from this study further reinforce cryoablation with ProSense as an effective and durable treatment option for patients with small renal masses," said Eyal Shamir, Chief Executive Officer of IceCure. "We believe these findings may help drive broader commercial adoption of ProSense in countries where it is already approved to treat kidney tumors, as physicians and healthcare systems continue to seek minimally invasive alternatives with strong long-term outcomes."

ICESECRET, a prospective, multicenter, single-arm clinical trial, was performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in Be’er Ya’akov, Israel and is led by Principal Investigator Prof. Halahmi Sarel. The trial included 114 patients (138 lesions) with localized SRMs of ≤5 cm ablated with ProSense cryoablation under CT guidance. Follow-up visits were performed at six weeks, six months, one year and then annually up to five years after the procedure using ProSense. During follow-up visits, data related to local recurrence, based on CT imaging, was collected. Safety was determined by monitoring procedure-related adverse events throughout the study.

SRMs are increasingly detected due to increased imaging and represent a growing clinical challenge, particularly among elderly patients and those with comorbidities who are not suitable candidates for surgery. Minimally invasive, nephron-sparing treatment options that preserve kidney function, while effectively controlling tumors, are critically needed. The incidence of kidney cancer is growing worldwide, with an estimated 400,000 new of kidney cancer cases globally, according to a 2024 study published in Nephrology Dialysis Transplantation. As of 2025, over 80,000 new cases of kidney cancer are diagnosed in the U.S. alone, according to the U.S. National Cancer Institute, highlighting a growing, unmet need.

About ProSense

The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website.

ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens the door to fast and convenient office-based procedures for breast tumors.

(Press release, IceCure Medical, MAR 25, 2026, View Source [SID1234663915])

On March 25, 2026 SciTech Development Inc., a clinical-stage oncology company advancing ST-001 nanoFenretinide, reported that early-stage clinical data from SciTech’s ongoing Phase 1a trial will be presented at the USCLC Annual Workshop 2026 in Denver, Colorado on March 26, 2026.

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Principal investigator, Auris Huen, MD, PharmD, associate professor of Dermatology at The University of Texas MD Anderson Cancer Center, will present "Clinical Benefit, High Systemic Exposure, and Manageable Toxicity in a First-in-Human Trial of ST-001 nanoFenretinide in Previously Treated Cutaneous T-Cell Lymphoma" which will highlight emerging data from SciTech’s clinical trial evaluating ST-001 in patients with Cutaneous T-Cell Lymphoma (CTCL), a subtype of T-cell non-Hodkin lymphoma.

The presentation will feature early clinical findings demonstrating meaningful anti-tumor activity, including complete and partial responses, alongside a favorable safety and tolerability profile. The data also underscores the ability of ST-001’s proprietary nanoparticle delivery platform to achieve enhanced systemic exposure—addressing a longstanding bioavailability limitation of fenretinide and supporting its therapeutic potential.

SciTech’s Phase 1a trial is fully enrolled and nearing completion, and data support the advancement of ST-001 into the next phase of clinical development.

The USCLC Annual Workshop convenes leaders in cutaneous lymphoma to discuss advances in diagnostics, therapeutics, and patient care. The 2026 theme, "Frontiers in Cutaneous Lymphoma: New Technologies, Therapeutics, and Future Directions," highlights the accelerating pace of innovation in the field.

"We are honored to have Dr. Huen present these important findings," said Earle Holsapple, CEO of SciTech Development. "Her medical expertise and leadership in CTCL, combined with the encouraging early data, continue to strengthen SciTech’s confidence in ST-001 as a potentially impactful therapy for patients with limited treatment options."

In addition to its CTCL program, SciTech recently received FDA clearance of its Investigational New Drug (IND) application to initiate a Small Cell Lung Cancer (SCLC) trial, further expanding the potential of its platform across multiple oncology indications.

(Press release, SciTech Development, MAR 25, 2026, View Source [SID1234663914])