On February 13, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population.

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This designation marks the first FDA Orphan Drug Designation for HanchorBio, representing a significant regulatory milestone for the company and further validating its strategy of advancing differentiated immunotherapies in areas of high unmet medical need.

HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care.

"Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101’s profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline."

Gastric cancer is a rare disease in the United States, with prevalence well below the FDA’s statutory threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes, particularly in the second-line setting, remain poor, with limited durability of response and substantial treatment-related toxicity.

HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer. Early clinical findings have demonstrated promising antitumor activity with a safety profile consistent with the molecule’s differentiated design.

Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The FDA’s decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101’s development. HCB101’s IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need."

Orphan Drug Designation provides certain development incentives, including eligibility for tax credits on qualified clinical trial expenses, exemption from FDA user fees, and the potential for seven years of market exclusivity upon approval in the United States.

HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications.

About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio’s FBDB platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies.

HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies.

Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies.

(Press release, Hanchor Bio, FEB 13, 2026, View Source [SID1234662652])

On February 12, 2026 Orion reported Full-Year 2025 Results.

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(Presentation, Orion, FEB 12, 2026, View Source [SID1234663023])

On February 12, 2026 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported the availability of PanTracer Pro, a new addition to the PanTracer Family, designed to help clinicians navigate increasingly complex molecular testing workflows to make informed decisions for patients with advanced-stage solid tumors.

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As precision oncology continues to evolve, clinicians face growing diagnostic complexity, increasing biomarker requirements, and mounting pressure to initiate treatment quickly, often before a complete molecular profile is available. Fragmented testing workflows, sequential ordering, and tissue limitations can delay care and introduce uncertainty at critical decision points. PanTracer Pro was developed to address these challenges more comprehensively and earlier in the diagnostic pathway.

"Every delay or unanswered question in the diagnostic process can affect how quickly patients begin treatment," said Tony Zook, chief executive officer at NeoGenomics. "PanTracer Pro is designed to help clinicians get the information they need earlier and more reliably, so care teams can plan next steps with greater clarity and confidence across the care journey."

PanTracer Pro integrates broad, comprehensive genomic profiling (CGP) with diagnosis-directed immunohistochemistry (IHC) and ancillary testing selected based on tumor type. By delivering comprehensive, guideline-aligned insights through a single coordinated order, PanTracer Pro enables physicians to ensure relevant biomarkers are assessed upfront rather than through multiple, sequential tests. Turnaround time for the test is 8–10 days, supporting timely real-world treatment decisions.

Beyond streamlining test selection, PanTracer Pro may help identify clinically relevant biomarkers that can be missed with incomplete testing. The ability of PanTracer Pro to combine broad DNA and RNA sequencing across more than 500 cancer-related genes with tumor-specific ancillary testing supports therapy selection, helps identify potential clinical trial options, and facilitates personalized treatment planning based on a patient’s unique tumor biology. When tissue samples are insufficient or unavailable, cases can automatically reflex to PanTracer LBx, NeoGenomics’ pan-solid tumor liquid biopsy assay, allowing clinicians to continue diagnostic workup without restarting the process.

(Press release, NeoGenomics Laboratories, FEB 12, 2026, View Source [SID1234662657])

On February 12, 2026 SURGE Therapeutics (SURGE), a clinical-stage oncology company pioneering intraoperative immunotherapy, reported the final patient has been dosed in its Phase 1 clinical trial of SRG-514, an investigational therapy for breast cancer patients undergoing surgery. The treatment was generally well tolerated in the Phase 1 dose-escalation study, and there were no treatment-related dose-limiting toxicities or treatment-related serious adverse events to date. Based on the data generated to date and discussions with the FDA, the company is preparing to advance SRG-514 directly into a registrational trial.

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SRG-514 is designed to deliver immunotherapy intraoperatively, directly into the resection cavity during the time of tumor removal. The therapy aims to reprogram the local inflammatory response from immunosuppressive to immunostimulatory, with the goal of generating a durable, systemic anti-tumor immune response when tumor burden is at its lowest.

"Intraoperative immunotherapy represents a fundamentally different approach to treating cancer," said Michael Goldberg, Ph.D., CEO & Founder, SURGE Therapeutics. "With SRG-514, we are targeting primary drivers of cancer mortality – post-surgical recurrence and metastasis – by improving how, when, and where immunotherapy is delivered. We are encouraged by the data generated to date and by the broader potential of our programs to serve as pipelines-in-a-product."

"One of the most persistent challenges in oncology is that microscopic disease can remain even after successful tumor removal and later drive cancer recurrence, both locally and distally," said Robert Langer, Sc.D., Institute Professor at MIT and Chair of SURGE’s Scientific Advisory Board. "Applying established principles of drug delivery in the intraoperative setting creates a powerful opportunity to influence immune responses where and when intervention may have the greatest impact."

SRG-514 is a novel thermosensitive formulation of ketorolac, a non-steroidal anti-inflammatory drug commonly used perioperatively. By intervening during surgery, the therapy is designed to provide extended, localized release directly at the tumor resection site and may counteract surgery-induced immune suppression, a biological process that can promote recurrence and metastasis.

Post-surgical recurrence remains one of the most significant unmet needs in oncology, as 90% of cancer-related deaths are driven by local recurrence and metastasis. Each year, approximately 9 million cancer patients worldwide undergo surgical tumor resection, yet an estimated 40% of patients experience disease recurrence within five years. While surgery triggers acute inflammation, standard post-operative therapies are typically not administered until several weeks after surgery, allowing residual cancer cells time to develop strategies to evade immune surveillance.

SURGE’s proprietary SURGERx platform uses an injectable, biodegradable hydrogel optimized for intraoperative administration to deliver a drug in a highly concentrated manner.

The company expects to initiate a registrational trial of SRG-514 in triple-negative breast cancer this year, with potential expansion into additional breast cancer and solid tumor indications. In parallel, the company is advancing two additional intraoperative immunotherapy programs – STM-416 and STM-416p, utilizing the TLR7/8 agonist resiquimod, in bladder cancer and prostate cancer, respectively. Both programs are expected to enter Phase 2 clinical trials this year.

These programs highlight SURGE’s mission to transform surgery from a purely physical intervention into a therapeutic modality to deliver localized immunotherapy to potentially improve patient outcomes.

(Press release, SURGE Therapeutics, FEB 12, 2026, View Source [SID1234662656])

On February 12, 2026 J INTS BIO, Inc. reported that research findings on its investigational fourth-generation EGFR tyrosine kinase inhibitor (TKI), JIN-A02, have been published in Clinical Cancer Research, a leading oncology journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper). According to the most recent Journal Citation Reports (2025), the journal has an Impact Factor of 10.2, reflecting its influence in translational and clinical cancer research.

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The study presents a therapeutic strategy designed to overcome EGFR C797S, a major resistance mutation that commonly emerges following treatment with the third-generation EGFR inhibitor Tagrisso. By integrating comprehensive preclinical findings with early clinical observations, the research outlines a potential new treatment approach for patients with EGFR-mutant non–small cell lung cancer (NSCLC) who have limited options after Tagrisso failure.

EGFR-mutant NSCLC is driven by aberrant activation of EGFR signaling, and while EGFR-targeted therapies have dramatically improved outcomes over the past decade, acquired resistance remains inevitable for most, if not all patients. In particular, the C797S mutation is known as a representative resistance mechanism that emerges, preventing existing third-generation EGFR targeted therapies from working effectively. Currently, there are no approved treatments targeting the C797S mutation. JIN-A02 was developed as an orally available, fourth-generation EGFR inhibitor engineered to selectively target resistance-associated EGFR mutations, including C797S and T790M, while minimizing activity against wild-type EGFR. In preclinical models derived from patients with EGFR E19del/T790M/C797S mutant NSCLC that are resistant to Tagrisso, JIN-A02 demonstrated marked antitumor activity, achieving a maximum tumor growth inhibition (TGI) of 168.2%, substantially exceeding the effects observed with Tagrisso under the same conditions and indicating tumor regression. This means that it was observed that administration of JIN-A02 could reduce tumor size beyond simple growth inhibition.

Tumor tissue analyses showed significant reductions in phosphorylated EGFR (p-EGFR) and the proliferation marker Ki-67 following JIN-A02 treatment, confirming effective inhibition of EGFR-driven signaling at the molecular level. In intracranial tumor models reflecting brain metastases, JIN-A02 produced rapid and sustained reductions in tumor burden, suggesting the ability to achieve therapeutically meaningful exposure across the blood–brain barrier (BBB).

The publication also reports early clinical observations from an ongoing Phase 1/2 trial (NCT05394831) in patients with EGFR-mutant NSCLC who progressed after prior EGFR-targeted therapies and chemotherapy. As of the data cutoff, 23 patients had been treated with JIN-A02, with partial responses and stable disease observed in multiple cases. Notably, one patient in the 300 mg dose cohort achieved a partial response, with a 39.7% reduction in lung lesion size observed at the start of the third treatment cycle. This response was sustained through the seventh cycle, reaching a maximum reduction of 44.9%. In addition, the patient’s brain metastatic lesions decreased by 25% at the fifth treatment cycle, with the response maintained throughout the seventh cycle.

In addition, blood-based circulating tumor DNA (ctDNA) analysis in this patient showed complete clearance of the EGFR C797S mutation and the exon 19 deletion, along with a reduction of more than 90% in the T790M mutation. These findings are interpreted as evidence that the molecular-level target inhibition achieved by JIN-A02 translated into a meaningful clinical response.

Professor Sun Min Lim of the Division of Medical Oncology at Severance Hospital, the corresponding author of the study, stated, "JIN-A02 has demonstrated meaningful preclinical activity and early clinical signals targeting C797S-mediated resistance, for which treatment options have been extremely limited following the failure of third-generation EGFR-targeted therapies. In particular, the observed activity in brain metastases, along with a reduction in EGFR mutations detected in plasma ctDNA, provides important support for its further clinical development."

J INTS BIO plans to further accelerate the clinical development of JIN-A02, focusing on dose optimization, expansion of clinical data in patients with brain metastases, and further validation of molecular response biomarkers, with the goal of establishing a new treatment option for patients with EGFR-mutant NSCLC who have exhausted current standard therapies.

(Press release, J INTS BIO, FEB 12, 2026, View Source [SID1234662655])