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])

On December 4, 2025 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported that the company has been awarded a $10.8 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the continued clinical investigation of IMGS-001 in patients with solid tumors. IMGS-001, the company’s lead program, is a cytotoxic immune checkpoint inhibitor targeting PD-L1 and PD-L2 and is being studied in a phase 1a/b dose-escalation and dose-expansion trial (NCT06014502). The focus of this grant, the company’s second from CPRIT, will be to support the phase 1b dose-expansion portion of the trial across multiple solid tumor cohorts.

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The phase 1b expansion focuses on demonstrating safety and initial clinical benefit in multiple solid tumor cohorts characterized by a high degree of immune exclusion where CD8 T cells—the immune system’s soldiers—are present but locked out of the tumor. IMGS-001 has been specifically engineered to drive clinical benefit in this patient population through its multifunctional mechanism of cell killing and PD-1 signal blockade.

"CPRIT has played a pivotal role in enabling ImmunoGenesis’ growth. The first award of $15.5 million in 2020 allowed us to establish our Texas headquarters, complete essential nonclinical studies, obtain IND clearance, and begin the phase 1a trial of IMGS-001," said James Barlow, CEO of ImmunoGenesis. "With this second award, we can build on the early signs of clinical activity and accelerate evaluation of IMGS-001 for immune-excluded tumor cohorts with high unmet need."

The award underscores CPRIT’s mission to support novel research. IMGS-001 is based on discoveries made by the laboratory of Dr. Michael A. Curran at The University of Texas MD Anderson Cancer Center and the Oncology Research for Biologics & Immunotherapy Translation (ORBIT) platform, part of MD Anderson’s Therapeutics Discovery division. Dr. Curran founded ImmunoGenesis and the technology was licensed to the company in 2019.

"ImmunoGenesis was previously awarded a CPRIT grant in 2020 to fund early development of IMGS-001," said CPRIT CEO Kristen Doyle. "The company successfully hit the goals and objectives of the original grant. Given this initial grant and the CPRIT funding provided to Dr. Curran in the early development work, CPRIT’s expert review panel that recommended funding saw this as an exciting opportunity for CPRIT to continue to support a novel molecule that has shown initial promise in early clinical testing."

ImmunoGenesis is headquartered in Houston, and the CPRIT award will enable the company to continue strengthening its leadership team and corporate infrastructure within the biotech community. Mr. Barlow added, "We are thrilled to contribute to, and grow within, the dynamic biotech ecosystem in Houston and across Texas."

(Press release, ImmunoGenesis, DEC 4, 2025, View Source;research-institute-of-texas-cprit-to-accelerate-the-clinical-development-of-imgs-001-for-patients-with-immune-excluded-tumors-with-high-unmet-need-302632467.html [SID1234661135])

On December 4, 2025 Immorta Bio reported the publication of a landmark preclinical study in the Journal of Translational Medicine demonstrating that its novel immunotherapy, SenoVax, dramatically reduces multiple types of solid tumors in murine models. Earlier this year, Immorta Bio filed IND #30745 with the FDA for a first-in-human trial in advanced lung cancer.

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The paper, titled "Reduction of Solid Tumors by Senescent Cell Immunization," was authored in collaboration with leading researchers from the University of Miami, Cedars-Sinai, UC San Diego, the Institute for Human Optimization, George Washington University, and Translational and Advanced Biosciences.

Full text: View Source In well-characterized mouse models of aggressive cancers, SenoVax, a personalized autologous immunotherapy that trains the immune system to attack senescent cells, achieved significant tumor shrinkage across lung, glioblastoma (brain), pancreatic, and breast cancers.

Senescent cells, which accumulate with age and chronic stress, are increasingly implicated in creating an immunosuppressive, pro-tumor microenvironment. By targeting antigens uniquely expressed on these cells, SenoVax appears to reprogram the tumor microenvironment, turning immunologically "cold" tumors "hot" by boosting CD8⁺ T-cell infiltration and reducing immune-suppressive cell populations. Key findings:

Statistically significant tumor growth inhibition and prolonged survival in both orthotopic and syngeneic models

Robust CD8⁺ T-cell infiltration and depletion of immunosuppressive cells in treated tumors

Strong activity as monotherapy and in combination with other treatments
"These data provide compelling proof-of-concept that immunizing against senescent cells represents an entirely new therapeutic modality in oncology," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio and lead author of the study. "We have already filed IND #30745 with the FDA for a first-in-human trial in advanced lung cancer and are completing the GMP manufacturing required to begin the study."

Dr. Gilberto Lopes, Chief of Thoracic Medical Oncology at the Sylvester Comprehensive Cancer Center (University of Miami) and study co-author, commented: "Many deadly solid tumors remain resistant to current immunotherapies because they are immunologically ‘cold.’ Converting the tumor microenvironment into a more inflamed, T-cell-friendly state by eliminating senescent cells could dramatically broaden the reach of checkpoint inhibitors and other immune therapies."

Dr. Boris Reznik, Chairman and CEO of Immorta Bio and senior author, added: "This publication lays a strong translational foundation for bringing senescent-cell-targeted therapies into the clinic, not only for cancer, but potentially for the many age-related diseases driven by pathologic cellular senescence."

The publication describes preclinical experiments in validated murine models demonstrating that immunization with SenoVax—a personalized, autologous immunotherapy designed to elicit immune responses against senescent cells—was associated with reduced tumor burden in lung, brain, pancreatic, and breast cancer settings. Senescent cells are increasingly recognized as contributors to tumor progression, immune evasion, and chronic inflammation. The work builds on prior evidence that removing senescent cells can modify the tumor microenvironment and may enhance antitumor immunity.

"These findings support further investigation of senescent-cell–targeted immunotherapy in oncology," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio and first author of the study. "Immorta Bio has submitted IND #30745 to the FDA for a planned first-in-human study in lung cancer and is completing the required GMP manufacturing run to enable initiation."

"Therapeutic resistance remains a major challenge, particularly in tumors with limited immune infiltration," said Dr. Gilberto Lopes, Chief of Medical Oncology at the University of Miami and second author of the publication. "These preclinical results raise the possibility that targeting senescent cells could improve immune responsiveness and complement existing treatment approaches."

Dr. Boris Reznik, Chairman and CEO of Immorta Bio and senior author, added: "This study provides foundational evidence for clinical development of senescent-cell–directed therapies in oncology, with potential future application to other aging-related biological processes."

(Press release, Immorta Bio, DEC 4, 2025, View Source [SID1234661134])