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])

On December 11, 2025 CASI Pharmaceuticals, Inc. (NASDAQ:CASI, the "Company"), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, reported that the Company has entered into a convertible note purchase agreement (the "Purchase Agreement") with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He (the "Purchaser"), pursuant to which the Company will issue and sell convertible notes in an aggregate principal amount of US $20 million to the Purchaser through a private placement. This investment is planned to provide runway to fund the Company through a Phase 1 study in China in renal allograft anti-body-mediated rejection (AMR) as well as development toward a stable, high concentration protein solution for subcutaneous formulation.

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The sale of the convertible notes will be in tranches and subject to multiple closings with certain closing conditions, including Purchaser being satisfied with the business results and financials status of the Company and the use of proceeds upon each closing.

Each convertible note issued pursuant to the Purchase Agreement will mature in 36 months, bearing interest of 12% per annum from the issuance date. Upon maturity, each note may, at the Company’s option, be convertible into ordinary shares of the Company, par value US $0.0001 per share (the "Shares"), at a conversion price of the volume weighted average closing price of the Company’s Shares during the five consecutive trading days immediately preceding the maturity date. The Purchaser also has the right to convert each note into Shares at any time from and including the 91st day after the issuance thereof to and including the maturity date at a conversion price of the volume weighted average closing price of the Company’s Shares during the five consecutive trading days immediately preceding the date of conversion notice by the Purchaser. In no event shall the conversion price be higher than US $2 per ordinary Share or lower than US $1 per Share.

(Press release, CASI Pharmaceuticals, DEC 11, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=8482484705256594&symbol=CASI [SID1234669171])

On December 10, 2025 Privo Technologies, Inc., reported that the first patient has been dosed in its first-in-human clinical trial evaluating PRV131, a nanoengineered intratumoral cisplatin injectable for the treatment of T1–T3 oral squamous cell carcinoma (OSCC).

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The Phase 1/2 Dose Escalation and Dose Optimization Run-In Study (Arm 3 of CLN-004) is designed to refine dosing by evaluating safety, preliminary efficacy, tolerability, and pharmacokinetics of PRV131 across selected dose levels as a neoadjuvant therapy. With the intention of debulking tumors prior to surgery, the goal of PRV131 is to improve surgical outcomes, preserve oral tissue, and reduce the morbidity associated with traditional surgical approaches.

The trial has now opened at the first clinical site, where the inaugural patient received treatment with PRV131, marking a key milestone in the development of novel locoregional therapies for head and neck cancer.

About PRV131

Built on Privo’s proprietary PRV Platform technology, PRV131 is a nanoengineered intratumoral injectable suspension designed to deliver high-concentration cisplatin directly into solid tumors while minimizing systemic exposure. This inaugural dosing represents an important expansion of the PRV program beyond topical and intraoperative patches (e.g., PRV111 and PRV211) toward intratumoral delivery of cisplatin for patients with oral cavity malignancies. PRV131 is engineered to address significant unmet needs in oral cavity cancer by:

Shrinking or debulking tumors prior to surgery to improve functional and cosmetic outcomes
Delivering high intratumoral drug concentration while limiting off-target toxicity
Potentially preserving form and function of the oral cavity, which can be severely impacted by standard surgical interventions
Preclinical studies have demonstrated that PRV131 can shrink or eliminate several solid tumor types, including squamous cell carcinomas, while generating durable responses. In companion animal studies conducted in dogs with large, naturally occurring tumors, PRV131 reduced tumor volumes by over 80% with no observed systemic toxicity.

"We are incredibly pleased to begin dosing patients with PRV131 in this first-in-human study," said Dr. Manijeh Goldberg, PhD, Founder and CEO of Privo Technologies. "Patients with oral cavity cancer often face invasive surgeries that can dramatically affect their ability to speak, eat, and live comfortably. PRV131 is designed to shrink tumors directly at the site, helping preserve critical oral structures and maintain function, offering the potential for meaningful improvements in quality of life. This milestone represents an important step in our mission to transform local cancer treatment with precise, targeted, nanoengineered chemotherapy."

(Press release, Privo Technologies, DEC 10, 2025, View Source [SID1234661350])