On December 4, 2025 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST.

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This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment.

The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib’s tolerability and anti-tumor response across a number of solid and hematologic malignancies.

"Based on non-clinical data being presented at ASH (Free ASH Whitepaper), we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura.

Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH (Free ASH Whitepaper) on Monday, December 8, 2025 at 6pm EST.

These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial.

Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib’s intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease."

In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH (Free ASH Whitepaper).

iOnctura poster presentations at the 67th ASH (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, USA:

1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)

2. M Balliu et al.: Monday, December 8, 06:00 PM – 08:00 PM EST

Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis

3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas

4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)

About myelofibrosis (MF)

MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3].

JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6].

About the HEMA-MED clinical trial

The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib.

(Press release, iOnctura, DEC 4, 2025, View Source [SID1234661140])

On December 4, 2025 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment.

The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib’s tolerability and anti-tumor response across a number of solid and hematologic malignancies.

"Based on non-clinical data being presented at ASH (Free ASH Whitepaper), we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura.

Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH (Free ASH Whitepaper) on Monday, December 8, 2025 at 6pm EST.

These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial.

Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib’s intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease."

In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH (Free ASH Whitepaper).

iOnctura poster presentations at the 67th ASH (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, USA:

1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)

2. M Balliu et al.: Monday, December 8, 06:00 PM – 08:00 PM EST

Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis

3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas

4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)

About myelofibrosis (MF)

MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3].

JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6].

About the HEMA-MED clinical trial

The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib.

(Press release, iOnctura, DEC 4, 2025, View Source [SID1234661140])

On December 4, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, reported the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. During the meeting, the FDA provided the Company feedback on potential expedited regulatory pathways and development options across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.

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The meeting focused on clinical development design, endpoint strategy, and pathways that could support a streamlined registrational approach. Atossa believes the FDA interaction meaningfully clarified potential routes to accelerate clinical development and regulatory review for (Z)-endoxifen, helping to position the Company to pursue a faster and more focused development strategy across multiple breast cancer indications.

"This meeting was a meaningful development milestone for our programs," said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. "We used this discussion to incorporate FDA feedback into our development planning that could meaningfully shorten our regulatory timeline. We continue to aggressively execute the advancement of (Z)-endoxifen across the breast cancer continuum and toward potential registration pathways."

This includes multiple high-value clinical settings, including:

Metastatic breast cancer (mBC): A dose-ranging study is in preparation as part of the Company’s strategy to support registrational development.
Neoadjuvant ER+/HER2- breast cancer: Enrollment and data generation continue in the Phase 2 EVANGELINE trial.
Breast cancer risk-reduction: Development includes a low-dose strategy targeting mammographic breast density and overall breast cancer risk.
In support of its metastatic breast cancer program, Atossa recently submitted an Investigational New Drug application ("IND") to the FDA and is awaiting feedback. The Company also anticipates additional IND submissions in 2026 to advance combination strategies and explore opportunities beyond monotherapy and breast cancer.

"Our clinical program is now structured around decisive value-creating milestones," said Janet Rea, MSPH, Senior Vice President of Research and Development. "We have completed multiple clinical trials involving nearly 800 participants, and are optimistic that this foundation, combined with anticipated upcoming data, and FDA input supports an active push towards multiple regulatory endpoints."

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated ability to inhibit and potentially degrade estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), at clinically achievable blood and tumor levels. (Z)-endoxifen also seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise partially convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In nearly 800 adults (healthy volunteers and breast cancer patients) receiving doses up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, supporting continued dose-range exploration.

Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including four recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, DEC 4, 2025, View Source [SID1234661139])

On December 4, 2025 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer therapies, reported the initiation of dosing in a Phase 1 study evaluating A9-3408, a novel Actinium-225-based radiotherapeutic targeting melanocortin 1 receptor (MC1R) for the treatment of patients with melanoma. The Phase 1 study is a multi-center, open-label trial designed to evaluate the safety, dosimetry, and dose escalation of A9-3408 in patients with MC1R-positive melanoma, who have progressed on standard-of-care therapies.

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This milestone advances Alpha-9’s melanoma program, which first entered the clinic last year with A9-3202, a Gallium-68-based imaging agent used to assess MC1R expression and identify patients for the A9-3408 therapeutic study.

"Dosing the first patient with our MC1R radiotherapeutic marks an important milestone for the company and validates our internal R&D platform," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "We are excited to have initiated trials for our first therapeutic program and look forward to advancing additional best-in-class assets into the clinic as we aim to bring novel, life-improving treatments to people living with cancer."

"MC1R is an ideal target due to its high expression in melanoma and limited presence in healthy tissue," said Robert Meehan, M.D., Chief Medical Officer at Alpha-9. "Despite advances in immunotherapy, significant unmet needs remain for patients who progress on current standard of care. In our A9-3202 imaging study, 92% of patients had strong MC1R expression after progression on immunotherapy, demonstrating the potential for this program to provide a new modality for patients."

Dr. Meehan recently joined Alpha-9 as Chief Medical Officer, bringing progressive leadership experience in biopharma and biotechnology, specializing in the creation of complex, novel development programs. Dr. Meehan is a board-certified physician trained in hematology and oncology, with expertise in all phases of drug development across multiple modalities. Prior to Alpha-9, Dr. Meehan was the Senior Vice President, Clinical Development at Dragonfly Therapeutics, held multiple senior clinical leadership roles at Moderna, and was a staff clinician in the Developmental Therapeutics Clinic at the National Cancer Institute.

Alpha-9’s platform is built on a systematic approach to molecule design, optimizing binders, linkers, and chelators to create radiotherapeutics with superior uptake and retention in tumors while minimizing off-target effects. The advancement of the MC1R program highlights the company’s capability to develop best-in-class molecules and deliver on the promise of precision oncology.

(Press release, Alpha9 Oncology, DEC 4, 2025, View Source [SID1234661138])

On December 4, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators from leading cancer centers, including those within the Caris Precision Oncology Alliance (Caris POA), will collectively present 19 studies across a range of breast cancer types at the San Antonio Breast Cancer Symposium (SABCS) from December 9-12, 2025.

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The studies investigated seven distinct breast cancer subtypes, including HR+/HER2–, HER2-positive, HER2-low/ultralow/null, triple-negative, invasive lobular carcinoma, male and metastatic. The range of studies demonstrates how multi-omics-driven profiling, subtyping and biomarker discovery accelerate precision oncology and improve patient outcomes. The studies represent 40+ collaborating institutions, including leading NCI-designated cancer centers.

"SABCS is the premier global stage for advancing breast cancer research, and we are excited to share how Caris’ multi-omic tumor profiling is helping define molecularly distinct patient groups," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer. "By integrating whole exome and whole transcriptome sequencing with IHC profiling and AI-driven signatures, we are uncovering new insights into therapeutic resistance and real-world outcomes that bring us closer to truly personalized cancer care."

"The selection of two studies we collaborated on for oral and rapid oral presentations underscores Caris’ leadership in multimodal AI for recurrence prediction and risk stratification in early and late breast cancer," said Caris President David Spetzler, MS, PhD, MBA.

Oral Presentation:

Multimodal Artificial Intelligence (AI) Models Integrating Image, Clinical, and Molecular Data for Predicting Early and Late Breast Cancer Recurrence in TAILORx. Oral #GS1-09
General Session 1. December 10, 2025. 11:30 AM-11:45 AM CST
Rapid Oral Presentation:

A Multimodal-Multitask Deep Learning Model Trained in NSABP B-42 and Validated in TAILORx for Late Distant Recurrence Risk in HR+ Early Breast Cancer. Rapid Oral #RF3-07
Rapid Fire 3. December 10, 2025. 5:18-5:26 PM CST
Spotlight Posters Include:

Personalized Acquired CDK4/6i Resistance: Associations with Baseline Characteristics Like Obesity in Real-World (RW) Clinical-Multiomics Data. #PD3-02
Poster Spotlight 3. December 10, 2025. 7:33-7:36 AM CST
Overcoming ADC Resistance: Payload Diversification as a Strategy for Sequential Therapy.
#PD3-11
Poster Spotlight 3. December 10, 2025. 8:12-8:15 AM CST
The Genomic, Transcriptomic, and Immune characterization of Metastatic Lobular Breast Cancer. #PD9-07
Poster Spotlight 9. December 11, 2025. 8:00-8:03 AM CST
Differential Benefit to Elacestrant in a Large Cohort of ER+ Breast Cancer: Impact of ESR1 mutants and prior therapy. #PD10-11
Poster Spotlight 10. December 12, 2025. 8:12-8:15 AM CST
Posters Include:

Outcomes in patients with PIK3CA-mutated breast cancer treated with metformin. #PS1-11-11
Poster Session 1. December 10, 2025. 12:30-2:00 PM CST
Evaluation of steroid hormone receptor expression and clinical outcomes in ER-positive breast cancer bone metastases. #PS1-11-27
Poster Session 1. December 10, 2025. 12:30-2:00 PM CST
Comprehensive Characterization of PTEN loss by IHC and PTEN alteration by NGS in Metastatic HR-Positive, HER2-Negative Breast Cancer– An Exploratory Analysis of Biomarker Concordance and Co-Occurrence. #PS2-08-02
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Site specific Genomic and Immune Landscapes Underpinning in metastatic Male Breast Cancer. #PS2-08-04
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Chemokine signatures improve PD-L1-based prediction of pembrolizumab response in triple-negative breast cancer. #PS2-08-14
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Tertiary lymphoid structure (TLS)-related gene expression and outcomes in HER2-Positive (HER2+) breast cancer (BC) in the Real-World Database. #PS2-09-08
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
TONSL, an immortalizing oncogene on Chr.8q24.3 amplicon, confers intrinsic resistance to CDK4/6 inhibitors in breast cancer. #PS2-09-19
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Combined T and B Cell Signatures as Prognostic Biomarkers in Triple-Negative Breast Cancer (TNBC). #PS2-10-25
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Metabolic and Immune Reprogramming via SCD1 Inhibition Enhances Chemo-Immunotherapy Response in TNBC. #PS2-12-07
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Immune microenvironment and survival differences among Hispanic and African American breast cancer cases by biopsy site. #PS3-12-06
Poster Session 3. December 11, 2025. 12:30-2:00 PM CST
Comparative efficacy of antibody drug conjugates (ADCs) in male versus female breast cancer across the spectrum of HER2 expression. #PS4-01-13
Poster Session 4. December 11, 2025. 5:00 – 6:30 PM CST
Evaluation of Metabolic Dysregulation, Endocrine Therapy Outcomes, and Tumor Biology in HER2-/HR+ Breast Cancer using a Multi-Omic, Real-World Analysis. #PS4-01-14
Poster Session 4. December 11, 2025. 5:00 – 6:30 PM CST
EGFR amplification and PI3K pathway mutations identify a subset of breast cancers that synergistically respond to EGFR and PI3K inhibition. #PS4-05-05
Poster Session 4. December 11, 2025. 5:00 – 6:30 PM CST
Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth #209. The full abstracts will be available on the Caris website following the presentations.

The Caris Precision Oncology Alliance consists of 98 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, all collaborating to advance precision oncology and biomarker-driven research. Caris and Caris POA members collaborate to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers, aiming to improve clinical outcomes for cancer patients.

(Press release, Caris Life Sciences, DEC 4, 2025, View Source [SID1234661136])