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 10, 2025 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported the latest clinical data at the annual European Society for Medical Oncology ("ESMO") Immuno-Oncology Congress, December 10-12, 2025, in London.

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The data from patients with PD-1 inhibitor-resistant metastatic melanoma treated with NUC-7738 in combination with pembrolizumab continue to demonstrate clinical activity and a favorable safety profile. All patients had progressive disease prior to starting treatment. Clinical activity includes two partial responses (one confirmed) and seven cases of stable disease, notably including one ongoing stable disease converting to a complete metabolic response with no detectable active disease. These results further reinforce the initial findings presented at the ESMO (Free ESMO Whitepaper) Congress 2024.

As of the most recent analysis, nine patients have been treated in the Expansion Cohort, which is part of the planned enrollment of up to 28 additional patients. Combined with the 12 patients previously treated in the Dose Confirmation Cohort, this will provide a total combination dataset comprising up to 40 patients. No new safety signals have been observed, and several patients remain on therapy with ongoing disease control, including one unconfirmed partial response and durable stable disease.

"We are very pleased to share the continued progress from this study," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "The clinical activity and favorable safety profile of NUC-7738 support its potential to offer meaningful benefit for patients with advanced melanoma who have exhausted current treatment options."

Mr. Griffith added: "These findings support continued enrollment and further clinical advancement as we move toward a potential registrational pathway."

One of the study participants, who achieved complete metabolic response, was recently featured in the UK Channel 4 documentary series Cancer Detectives: Finding the Cures, which also profiled Professor Sarah Blagden, the study’s lead investigator and Professor of Experimental Oncology at the University of Oxford.

Details of NuCana’s presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 are as follows:

Abstract Title: A Phase 2 expansion study of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant cutaneous melanoma (NuTide:701)

Poster Number: 321TiP

Date: Wednesday, December 10, 2025

Presenting Author: Dr Miranda J. Payne

All regular abstracts accepted for presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 have been published online via the ESMO (Free ESMO Whitepaper) website on Thursday, December 4 at 12:05 p.m. CET (Wednesday, December 3 at 6:05 p.m. ET). All accepted abstracts will be published online in the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Immuno-Oncology and Technology (IOTECH).

More information regarding the 2025 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress can be found at: View Source

(Press release, Nucana, DEC 10, 2025, View Source [SID1234661349])

On December 10, 2025 InduPro, Inc., a biotechnology company defining membrane protein spatial relationships to create novel therapeutics for the treatment of cancer and autoimmune diseases, reported a strategic equity investment and research collaboration with Sanofi. The agreement with Sanofi includes the right of first negotiation for InduPro’s bispecific PD-1 agonist program, which is currently in preclinical development for the treatment of autoimmune and inflammatory disorders.

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"We are thrilled to collaborate with Sanofi to advance toward the clinic our bispecific PD-1 agonist program. Sanofi’s know-how and global leadership position in autoimmune and inflammatory diseases make them the ideal partner to bring this exciting first-in-class molecule forward," said Prakash Raman, Ph.D., Chief Executive Officer of InduPro. "In addition, we welcome Sanofi’s strategic equity investment into InduPro, which further reinforces the strength of our collaboration."

Under the terms of the agreement, InduPro and Sanofi will collaborate on preclinical and IND-enabling research activities with funding from Sanofi, which will also make an undisclosed equity investment in InduPro.

InduPro therapeutically targets cell surface proteins in a variety of disease contexts by leveraging inherent or induced protein proximity. Through precise mapping of protein neighborhoods using its proprietary, high resolution proximity labeling technology, the Company is discovering novel co-target pairs that are highly selective for specific disease biology. Targeting these unique pairings via induced proximity provides a novel mechanism for influencing the cellular signaling pathways that are critical for impacting disease. InduPro’s approach relies on a unique discovery engine to generate potential first-in-class and best-in-class novel therapeutic candidates across multiple indications and modalities.

(Press release, InduPro, DEC 10, 2025, View Source [SID1234661365])

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])

On December 10, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported positive data from the Phase III lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (invasive disease-free survival [iDFS]) compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014). The lidERA results are being presented at the 2025 San Antonio Breast Cancer Symposium and are included in the official press program.

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"In early ER-positive breast cancer, challenges with disease recurrence and treatment adherence mean there is an urgent need for more effective, tolerable endocrine therapies," said Aditya Bardia, M.D., M.P.H., director, breast oncology program, professor of medicine at the David Geffen School of Medicine at University of California, Los Angeles (UCLA), director of translational research integration at the UCLA Health Jonsson Comprehensive Cancer Center, and lidERA principal investigator. "After almost 25 years, a new medicine – giredestrant – has demonstrated superiority over existing endocrine therapies in the curative setting, highlighting its potential as a new standard-of-care endocrine therapy for patients with breast cancer."

"The substantial efficacy observed with giredestrant in the lidERA trial underscores its potential to become a new standard-of-care endocrine therapy in ER-positive early-stage breast cancer, where the chance for cure is highest," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We look forward to sharing these results with health authorities around the world with the aim of bringing this new treatment option to patients as soon as possible."

At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm. The iDFS benefit was consistent across all clinically relevant subgroups. Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed. Follow-up for OS will continue to the next analysis. Giredestrant also demonstrated a 31% risk reduction of distant recurrence-free interval (HR=0.69, 95% CI 0.54-0.89) – another key secondary endpoint. Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

Giredestrant is the first and only oral selective estrogen receptor degrader (SERD) to show superior iDFS in the adjuvant setting and lidERA is the second positive Phase III readout for giredestrant following the evERA Breast Cancer results in the metastatic setting. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence supports the potential of giredestrant to meaningfully improve outcomes compared with standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

Genentech’s extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the lidERA Breast Cancer study
lidERA Breast Cancer [NCT04961996] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study.

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.

About giredestrant
Giredestrant is an investigational, oral, next-generation selective estrogen receptor degrader (SERD) and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

About estrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Genentech, DEC 10, 2025, View Source [SID1234661351])