On December 11, 2025 NanOlogy, LLC, a private clinical-stage oncology company, reported its drug development program aimed at transforming the treatment of diffuse intrinsic pontine glioma (DIPG), an aggressive highly lethal pediatric brainstem tumor. The company is developing Large Surface Area Microparticle (LSAM) Cisplatin for stereotactic intratumoral (IT) administration in this initial indication.

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Plans for Pediatric Clinical Trials

NanOlogy is completing Investigational New Drug (IND) enabling studies required by the U.S. Food and Drug Administration (FDA). Upon completion of these studies, the company plans to submit an IND application for LSAM-Cisplatin to treat malignant neoplasms of the brain including DIPG. Subject to FDA allowance to proceed, NanOlogy aims to initiate a clinical trial in late 2026 to evaluate the safety and response of stereotactic IT administration of LSAM-Cisplatin in children diagnosed with DIPG. According to DIPG.org, DIPG afflicts 150 – 300 children annually in the United States, with median survival of less than one year. Current treatments, like radiation therapy, may delay progression but almost always fail to deliver long term survival. NanOlogy is also assessing future opportunities to extend the use of LSAM-Cisplatin to treat other brain and solid tumors.

The Promise of LSAM-Cisplatin in DIPG

In laboratory research studies, cisplatin has been shown to kill DIPG tumors by binding to DNA and disrupting cell replication, leading to cell death. Unfortunately, current systemically administered cisplatin formulations are associated with numerous severe side effects throughout the body. In addition, cisplatin does not cross the blood brain barrier well, limiting its efficacy in brain tumors, making systemically administered cisplatin a suboptimal treatment for DIPG.

"We believe NanOlogy’s innovative LSAM-Cisplatin investigational drug designed for intratumoral administration can overcome the limitations of current treatment options with highly targeted delivery of drug into the tumor, continuous drug release, and minimal systemic toxicity," said H. Paul Dorman, founder and chairman of NanOlogy. "Advancements in minimally invasive surgical procedures and imaging now allow local delivery of LSAMs to solid tumors virtually anywhere in the body, including the brain. We are excited to advance IT LSAM-Cisplatin for DIPG and explore the promise it may hold for children and families facing this devastating disease."

(Press release, NanOlogy, DEC 11, 2025, View Source [SID1234661381])

On December 11, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that new clinical data from its flagship macrophage-checkpoint program, HCB101, has been selected for a mini oral presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 in London, United Kingdom. Only 26 abstracts were chosen for mini-oral presentation this year, marking a major milestone for HanchorBio as it delivers its first-ever oral presentation of clinical data at an international oncology congress, following its prior preclinical oral presentation of HCB101 at CSCO 2022.

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The ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress is Europe’s premier meeting dedicated exclusively to immuno-oncology science, distinct from the broader ESMO (Free ESMO Whitepaper) Annual Congress. While the annual ESMO (Free ESMO Whitepaper) meeting spans all oncology disciplines, ESMO (Free ESMO Whitepaper)-IO focuses on immune mechanisms, translational innovation, and next-generation therapeutic strategies across innate and adaptive immunity.

Presentation Details:

Abstract ID: 242MO
Title: HCB101, a Differentiated SIRPα Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity Across Solid Tumors and Lymphoma
First Author: Dr. Fangling Ning, Affiliated Hospital of Binzhou Medical University
Date / Time: 11 December 2025 / 11:45 – 12:45 GMT
Location: Whittle Room, Queen Elizabeth II Centre, London
Presenter: Alvin Luk, PhD, MBA, CCRA – President & CMO (Group) and CEO (U.S.A.), TIME100 Health 2025 Honoree

"For nearly a decade, CD47 therapies were held back not by flawed biology but by flawed molecules, which struggled to balance safety and efficacy at the same time, especially in immunologically cold tumors," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "HCB101 was engineered from the ground up to solve that problem. Using AI-guided structural modeling, we identified three core mutations that reshape SIRPα’s interaction with CD47, allowing us to combine the strengths of first- and second-generation approaches into a single, differentiated molecule. Being selected as one of only 26 mini-oral presentations at ESMO (Free ESMO Whitepaper) Immuno-Oncology reinforces the field’s recognition of this effort and redefines the CD47 therapies. With its clean safety profile, strong target engagement, and early activity in cold tumors, HCB101 is emerging as a true macrophage-checkpoint backbone – much like the transformative PD-1/PD-L1 therapies that were based on T-cell checkpoint inhibition."

Key Findings Highlighted in the Mini-Oral

Monotherapy (HCB101-101; NCT05892718)

Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW
No bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2
Linear PK (T1/2 ~3 days) with receptor occupancy (RO) >99% at ≥8 mg/kg
Durable antitumor activity, including confirmed PRs in:
HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks)
MZL – Marginal zone lymphoma (~89% tumor regression, ≥16 weeks)
Stable disease ≥4-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma
Combination Therapy (HCB101-201; NCT06771622)
Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC
No new safety signals across all evaluated combinations
Cytopenias fully attributable to chemotherapy, not HCB101
2L GC:
58.3% ORR (7/12) for all cohorts evaluated, 77.8% ORR (7/9) for mid-dose cohorts, and 100% DCR
Tumor shrinkage up to -78.2%
1L HER2+ GC: 33% ORR (1/3)
1L TNBC: 50% ORR (3/6) and 100% DCR
Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The early efficacy signals from HCB101 are unusually compelling for this stage of development. In second-line GC, where standard therapy achieves an ORR of about 27%, HCB101 combinations exceed 78% ORR, achieve 100% disease control, and result in tumor reduction approaching -78%. These results are not incremental; they meaningfully exceed expectations and reflect robust macrophage checkpoint engagement. With clean safety and sustained receptor occupancy, the data give us confidence to anchor development in second-line disease and expand into first-line and perioperative settings where depth and durability of response matter most."

About HCB101: A Next-Generation SIRPα Fc-Fusion Protein

HCB101 is a 3.5th-generation engineered SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s FBDB platform to selectively target tumor CD47 while minimizing binding to red blood cells. This design avoids the anemia and thrombocytopenia that limited early anti-CD47 programs, while preserving potent macrophage activation and downstream T-cell engagement. Key differentiators include:

Cytopenia-sparing safety up to 30-36 mg/kg
Receptor occupancy (RO) >99% at clinically active exposures
Strong macrophage and downstream T-cell activation
Broad antitumor activity across >80 PDX/CDX models and multiple clinical tumor types
Robust early combination efficacy in tumors that historically respond poorly to immunotherapy
Unlike earlier approaches, HCB101’s safety, target selectivity, and RO profile support its use as a macrophage-checkpoint backbone – analogous to how PD-1/PD-L1 inhibitors function as foundational T-cell backbones in oncology. HCB101 is designed for broad combinability across established and emerging treatment modalities, including:

Chemotherapy
Antibody-drug conjugates (ADCs)
Anti-PD-1/anti-PD-L1 checkpoint inhibitors
Anti-VEGF inhibitors
Anti-EGFR therapies
Anti-HER2 regimens
This versatility positions HCB101 as a modular, next-generational immuno-oncology component capable of enhancing the efficacy of multiple therapeutic backbones across solid tumors and hematologic malignancies.

(Press release, Hanchor Bio, DEC 11, 2025, View Source [SID1234661382])

On December 11, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported updates across the company’s portfolio of assets, including a summary from its mini symposium held on December 5, 2025 focused on targeting VISTA in AML, the scientific rational and clinical applications in NPM1 mutated r/r AML in combination with a menin inhibitor. The company’s recently announced financing transaction, which provides for $15.6 million in gross proceeds, is expected to provide the cash runway to accomplish multiple key milestones across all three development programs.

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"2025 was a transformational year for us, having initiated our accelerated approval Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda in front-line MCC, having completed the merger with Kineta bringing a Phase 2 ready VISTA inhibiting antibody to our pipeline and having presented data positioning the DOR as a promising new target in overcoming resistance to checkpoint inhibitors. We were pleased to raise $15 million in our June 2025 PIPE financing and warrant exercise earlier this year and the recently announced $15.6 million equity financing transaction providing us with a cash runway to accomplish multiple key milestones across all three development programs" said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.

"We look forward in 2026 to the expected completion of enrollment for our Phase 3 study of IFx-2.0 in MCC, and anticipate receiving FDA clearance to initiate our randomized Phase 2 trial of physician’s choice of menin inhibitor vs a menin inhibitor+TBS-2025, our VISTA inhibiting antibody, in NPM1 mutated r/r AML. We also expect to present preliminary data from our IFx-2.0 basket trial; data on inhibiting DOR on MDSCs, TAMs and T regs at a scientific conference in 2Q; and proof-of-concept data in animal models for our lead ADC at a scientific conference in Q4 2026."

"In an encouraging development in our VISTA inhibiting antibody (TBS-2025) clinical program, at a mini symposium on December 5, 2025 prior to the ASH (Free ASH Whitepaper) meeting, several key opinion leaders, provided valuable insights and recommendations on our Phase 2 clinical trial plans for TBS-2025, in AML. There was clear enthusiasm for the potential of combining TBS-2025 with a menin inhibitor both in NPM1 r/r/ AML, in high-risk AML and in patients with AML who are unfit for intensive therapies. The KOLs noted that while menin inhibitors have become standard of care in NPM1 mutated AML, there still exists a significant unmet medical need, citing the relatively low CR rate and short duration of response as the two obstacles to improving clinical benefit in these patients."

Dr. Bianco continued, "The VISTA gene is the only checkpoint upregulated in patients with AML, notably among high-risk AML. It has been shown that VISTA expression on leukemic blasts is the primary culprit in the low response rate and short duration of response in AML. Targeting VISTA represents the first potential for immunotherapy to improve the treatment outcomes in AML, not just NPM1 mutated AML was the consensus opinion from the group," concluded Dr. Bianco.

Participants at the mini symposium included: Geoffrey Uy, MD, Co-chair of the Leukemia Committee for the ALLIANCE for Clinical Trials in Oncology, and Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation at Washington University School of Medicine in St. Louis; Kevin Lin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program at the Washington University in St. Louis; and Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology at Vanderbilt University Medical Center.

Highlights from the Company’s mini-symposium on TBS-2025. The Company’s studies and data have shown the following:

VISTA was shown to be the only checkpoint highly upregulated in patients with AML with the highest expression in poor-risk subtypes. Its expression is seen in AML with or without common mutations like DNMT3A, NPM1, FLT-3.

VISTA expression on AML contributes to low response rate and short duration of response among patients with NPM1 mutated AML treated with menin inhibitors.

TBS-2025 provided survival advantage comparable to standard front line combination chemotherapy while significantly improving survival when used in combination with front line chemotherapy in murine model of VISTA expressing AML

Inhibition of VISTA, either through gene silencing or an inhibiting antibody, and inhibition of menin signaling pathway significantly improves survival in murine models of AML
Speaker Bios:
Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center. Dr. Kim investigates mechanisms of immune evasion in leukemia and develops new immunotherapeutic strategies. Trained under Dr. Lieping Chen, a pioneer in immuno-oncology, his work explores emerging co-inhibitory pathways and approaches to selectively prevent graft-versus-host disease while preserving graft-versus-leukemia activity. Selected Honors received by Dr. Kim include: American Society of Hematology (ASH) (Free ASH Whitepaper) Scholar Award; American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Career Development Award; Evans MDS Young Investigator Award; American Cancer Society Clinician Scientist Development Grant; Forbeck Scholar Award.

Geoffrey L. Uy, MD, Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, Research Member, Siteman Cancer Center. Dr. Uy is a hematopoietic stem cell transplant specialist and serves as Medical Director for Clinical Research in the Division of Oncology. His research centers on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with a focus on improving outcomes for patients with high-risk myeloid malignancies.

Kevin Yin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program Washington University in St. Louis. Dr. Yin studies how initiating mutations in AML shape immune escape mechanisms and contribute to leukemia progression. His work aims to define AML–immune interactions to support the development of next-generation immunotherapies. Dr. Yin’s research is being conducted under Timothy J. Ley, MD, group who serves as his PhD advisor. Dr Ley’s research group focuses on the genetics and genomics of acute myeloid leukemia (AML). His lab studies the development of normal and leukemic blood cells. His work is focused on identifying the mutations and epigenetic events that are responsible for the initiation and progression of AML. Dr. Ley led the team that sequenced the first cancer genome from an AML patient. He has gone on to develop projects that will use whole genome sequencing to help diagnose and treat patients with AML

Conference Call Information
Management will host a conference call and webcast today, December 11, 2025, at 8:30 am Eastern Time, to discuss the corporate update and recent financing. Call details and dial-in information are as follows:

Thursday, December 11th @ 8:30 am ET
Toll Free: 1-800-225-9448
Alternate: 1-203-518-9708

(Press release, TuHURA Biosciences, DEC 11, 2025, View Source [SID1234661383])

On December 11, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company’s investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer’s crizotinib, an oral c-MET inhibitor, in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM). IDEAYA expects to report median progression-free survival (PFS) data from this trial in the first quarter 2026 to support a potential accelerated approval filing in the United States. Median overall survival (mOS) data from OptimUM-02, once available, will be used to support a potential full approval filing. Metastatic uveal melanoma is a rare, aggressive form of ocular cancer with limited treatment options and historically poor survival outcomes.

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"We are very pleased to announce that we have achieved the target enrollment to enable potential full approval filing in our Phase 2/3 registration-enabling trial of darovasertib in combination with crizotinib in first-line HLA*A2-negative metastatic uveal melanoma. This milestone reflects both the clear unmet need in metastatic uveal melanoma, as well as the strong clinical interest in our darovasertib program. Moreover, the promising overall survival data and broader clinical efficacy demonstrated in the recently reported median overall survival results from the Phase 1/2 clinical trial (OptimUM-01) of this combination in metastatic uveal melanoma are indicative of the clinical potential of darovasertib to meaningfully impact patients with this devastating disease. With target full enrollment now complete, we look forward to the availability of median PFS data we project from OptimUM-02 in the first quarter of next year, and, if approved, making darovasertib in combination with crizotinib available to patients with HLA*A2-negative metastatic uveal melanoma as a first-line treatment as expeditiously as possible," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

OptimUM-02 is a multi-arm, multi-stage, open-label Phase 2/3 trial with patients randomized to receive either the darovasertib and crizotinib combination or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine). The primary endpoints are median PFS and median OS, which will be used to support a potential accelerated approval and full approval in the United States, respectively. In October 2025, IDEAYA presented data from its single-arm, Phase 2 trial (OptimUM-01) of the darovasertib and crizotinib combination at the Society for Melanoma Research (SMR) Congress that demonstrated a 21.1 month median OS and 7.0 months median PFS in 1L mUM, including both HLA*A2-negative and HLA*A2-positive patients.

Darovasertib has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary uveal melanoma (UM) and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in metastatic UM. IDEAYA is currently enrolling patients in a pivotal Phase 3 trial of single-agent darovasertib in the neoadjuvant setting of primary UM (OptimUM-10).

(Press release, Ideaya Biosciences, DEC 11, 2025, View Source [SID1234661384])

On December 11, 2025 ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV (Intravenously Deliverable Oncolytic Virus) platform, reported the initiation of a first-in-human clinical trial evaluating IDOV-Immune, its investigational oncolytic vaccinia virus therapy, in patients with advanced solid tumors (NCT06910657). Additional trial sites across the United States are expected to begin enrolling in 2026, pending clearance of the U.S. IND. The first patient was dosed at The Alfred Hospital in Melbourne, Victoria, Australia.

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"Launching this first-in-human trial marks an important milestone for ViroMissile and our mission to reshape cancer immunotherapy with selective viruses that target tumors while sparing healthy tissue," said Nanhai George Chen, PhD, CEO and founder of ViroMissile. "IDOV-Immune was engineered to penetrate the tumor, destroy cancer cells directly, and activate a coordinated immune response against the disease in a convenient systemic dose. We are excited to begin evaluating this therapy in patients who have exhausted standard options and to advance a new class of immunotherapies that may meaningfully improve outcomes."

The Phase I, open-label, multi-center trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of a single intravenous (IV) infusion of IDOV-Immune. The study plans to enroll up to 78 adult participants at study sites across the United States and Australia, including leading cancer centers. The primary objective is to determine the safety and tolerability of IDOV-Immune, including characterization of treatment-emergent adverse events (TEAEs) through Day 90 and dose-limiting toxicities (DLTs) during the first 28 days, and to determine the maximum tolerated dose and recommended dose for Phase 2 studies. Secondary objectives include evaluating the PK and PD profile of IDOV-Immune, characterizing immunologic responses and the development of neutralizing antibodies, and assessing preliminary signs of antitumor activity, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR) over a 12-month follow-up period.

Shah Rahimian, MD, chief medical officer at ViroMissile, added, "As we enroll patients into this first-in-human study, we are particularly encouraged by the opportunity to evaluate IDOV-Immune as a systemically administered oncolytic therapy. Delivering a single intravenous dose that can reach tumors throughout the body, while also activating both innate and adaptive immunity, represents an important evolution in the field. This trial will help us understand the safety profile, viral kinetics, and early biological activity of IDOV-Immune, and we are deeply grateful to the patients who make this work possible."

(Press release, ViroMissile, DEC 11, 2025, View Source [SID1234661462])