On December 11, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported updated Phase 1a dose escalation data from its second-generation PRAME cell therapy, IMA203CD8, in heavily pre-treated patients with solid tumors. Based on the enhanced pharmacology of IMA203CD8 reported previously, IMA203CD8 provides the potential to address difficult-to-treat solid tumors expressing PRAME beyond melanoma, such as ovarian cancer.

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The data from the ongoing Phase 1a trial will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 during a Mini Oral Presentation by Prof. Dr. med. Antonia Busse, Charité, Berlin, Germany. The slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website.

"The patients enrolled in this trial were heavily pretreated and presented with various challenging cases of solid tumors expressing PRAME," said Antonia Busse, M.D. "It is encouraging to be able to offer these patients a one-time treatment that is tolerable with a durable clinical benefit, as shown in this dose escalation trial. These early results underscore the multi-indication targeting potential of IMA203CD8 in patients with PRAME-expressing solid tumors."

"IMA203CD8, our second-generation PRAME cell therapy, marks another wave of innovation in our PRAME franchise," said Cedrik Britten, M.D., Chief Medical Officer at Immatics. "Our vision is to leverage its tumor-agnostic potential and bring meaningful benefit to patients with advanced PRAME cancers beyond melanoma. The data from the ongoing dose escalation, including the initial proof-of-concept in patients with ovarian carcinoma, reinforce the promise of IMA203CD8 as a monotherapy for difficult-to-treat indications. We look forward to completing dose escalation for IMA203CD8 and upcoming clinical readouts of more patients treated at the two highest dose levels."

IMA203CD8 PRAME Cell Therapy (GEN2) Phase 1a Dose Escalation Data Summary

Patient Population: Heavily pre-treated patient population with limited treatment options

As of the data cutoff on October 27, 2025, 781 heavily pre-treated patients (median of three prior systemic treatments) with advanced and/or metastatic solid tumors expressing PRAME were enrolled in the ongoing Phase 1a dose escalation clinical trial (NCT03686124). The median total infused dose across seven escalating dose levels was 1.6×109 TCR T cells (range 0.4-12.5×109 TCR T cells). The efficacy-evaluable2 patient population included 69 patients: 42 with melanoma, 11 with ovarian carcinoma, 11 with synovial sarcoma and 5 with other tumor types3.

Safety: Treatment with IMA203CD8 showed manageable tolerability

IMA203CD8 showed manageable tolerability in the 78 patients enrolled. The most frequent treatment-emergent adverse events (AE) were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grade 1 to 2 and was consistent with the mechanism of action: Grade 1: 35%, Grade 2: 50%, Grade 3: 9%, Grade 4: 1%. Immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) were infrequently observed. No IMA203CD8-related Grade 5 events occurred.

Based on the manageable tolerability profile, dose escalation is ongoing at dose level 7 (range ~7.2-10×109 TCR T cells) and on track to determine the recommended Phase 2 dose (RP2D).

Anti-tumor Activity and Durability: Deep and durable objective responses in PRAME-positive advanced solid tumors during ongoing dose escalation

A one-time infusion of IMA203CD8 PRAME cell therapy showed promising initial anti-tumor activity during dose escalation across various PRAME-expressing indications at a low median dose of 1.6×109 total IMA203CD8 TCR T cells:

Confirmed Objective Response Rate (cORR): 36% (23/64)
Objective Response Rate (ORR): 46% (32/69)
Tumor reduction: 78% (54/69)
Disease Control Rate (DCR) at week 6: 84% (58/69)
Median Duration of Response (mDOR): 9.2 months at a median follow-up (mFU) of 14 months

Includes 3 patients without post-baseline scan not depicted in plot: n=2 deceased prior to first scan, n=1 with non-evaluable measurements of target lesions (all DL4a); b includes 2 patients without post-baseline scan not depicted in plot: n=2 deceased prior to first scan (1 DL4a, 1 DL5); patient DL4a-25 had a cPR prior to CR; BOR: best overall response; (c)CR: (confirmed) complete response; (c)PR: (confirmed) partial response; SD: stable disease; PD: progressive disease.

Deep and durable objective responses were observed for up to 3+ years. The data also showed three complete responses in addition to two confirmed partial responses with -100% reduction of target lesions across indications. 66% (21/32) of responders exhibited deep responses with tumor reduction of ≥ 50%, and seven responses remained ongoing for ≥ 1 year post infusion.

In patients with ovarian carcinoma (n=11, median dose of 2.3×109 TCR T cells), a promising, dose-dependent signal was observed, including deep, confirmed objective responses at higher dose levels. Among the five patients with ovarian carcinoma treated with IMA203CD8 at ≥DL5 (range 2.3-7.1×10⁹ TCR T cells), two confirmed partial responses (PRs) were observed, one of which is an ongoing metabolic complete response in the patient treated at the highest dose in the ovarian carcinoma efficacy population to date (7.1×10⁹ TCR T cells), and an additional unconfirmed PR. All responders were resistant to previous platinum-based chemotherapy. All responses were observed in patients who did not receive post-infusion low-dose IL-2. In addition, tolerability in ovarian carcinoma was generally consistent with the full IMA203CD8 tolerability profile.

Within Immatics’ PRAME franchise, its lead PRAME cell therapy, anzu-cel, showed a cORR of 19% during dose escalation (last reported cORR for anzu-cel in Phase 1b at RP2D in melanoma was 56%; anzu-cel is currently in Phase 3 development). With enhanced pharmacology, IMA203CD8 is designed to build on the potential of anzu-cel in additional tumor types across a broad spectrum of PRAME expression levels and characterized by a more complex tumor microenvironment than melanoma, such as ovarian carcinoma.

Next Steps for IMA203CD8 PRAME Cell Therapy
Immatics aims to position IMA203CD8 in the tumor-agnostic setting of advanced PRAME cancers beyond melanoma, starting with gynecologic cancers. In addition, the Phase 1 trial could support the positioning of IMA203CD8 without the requirement of post-infusion low-dose IL-2 in the future. The Company believes the early proof-of-concept data in ovarian carcinoma presented today support this strategy.

The Company is on track to complete Phase 1a dose escalation and determine RP2D in 2026, including data on the two highest dose levels, to unlock the full clinical potential of IMA203CD8.

About IMA203CD8 PRAME Cell Therapy (GEN2)
IMA203CD8 is Immatics’ second-generation PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. In addition, the co-transduction of CD8αβ alongside the PRAME TCR adds functional CD4+ T cells designed to boost anti-tumor activity. IMA203CD8 is currently being evaluated in a Phase 1a dose escalation clinical trial in solid tumors expressing PRAME.

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and two combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific as a monotherapy and in combination with an immune checkpoint inhibitor as well as anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.

(Press release, Immatics, DEC 11, 2025, View Source [SID1234661373])

On December 11, 2025 Purple Biotech Ltd. ("Purple Biotech" or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported positive new preclinical data from its CAPTN-3 tri-specific antibody platform presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO IO) Congress 2025. The data presented was generated in collaboration with the laboratory of Dr. Amir Horowitz of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.

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These new preclinical data successfully demonstrates that two CAPTN-3 tri-specific antibodies, IM1240 (capped-CD3×5T4×NKG2A) and IM1305 (capped-CD3×TROP2×NKG2A), each achieve strong anti-tumor activity across different tumor antigens. IM1240 has also shown anti-tumor activity in models resistant to prior PD1 therapy. These results indicate that the CAPTN-3 architecture can generate potent multi-arm activity beyond a single target, supporting the platform’s potential applicability across a range of solid tumors. The CAPTN-3 platform is designed to unite three functional mechanisms—T-cell engagement and activation, enhanced by NKG2A-mediated innate and adaptive immune activation, and tumor-antigen targeting—into a single tri-specific molecule intended to coordinate a synergistic immune response.

"Immune failure is one of the biggest obstacles in treating solid tumors, and CAPTN-3 was built to address that challenge," said Gil Efron, Chief Executive Officer of Purple Biotech. "The data we presented at ESMO (Free ESMO Whitepaper) IO shows that IM1240 can activate an immune response even in tumors that no longer respond to PD-1 therapy, and that each component of the molecule contributes to its overall effect. At the same time, the introduction of IM1305 demonstrates how CAPTN-3 can be adapted to different tumor targets, underscoring the versatility and scalability of the platform. These findings support our development roadmap as we prepare for anticipated key milestones in 2026 and advance CAPTN-3 toward IND-enabling studies."

"The NKG2A/HLA-E axis is emerging as a key post-treatment resistance mechanism, as previously shown by Dr. Horowitz of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai," said Dr. Hadas Reuveni, VP Research and Development at Purple Biotech. "The added value of the aNKG2A arm in IM1240 design, shown both in vivo and in vitro through reactivation of suppressed immune cell subsets, is now further supported by enhanced anti-tumor activity in PD-1–resistant patient-derived explants from non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). These findings underscore the potential importance of the NKG2A arm in advanced and treatment-resistant disease."

Key New Findings:

Lead Program IM1240: Anti-Tumor Activity in PD-1–Resistant Models

· The Company’s lead CAPTN-3 program, IM1240, demonstrated significant anti-tumor activity in three PD1–resistant ex-vivo models, including new results in HNSCC patient-derived biopsies. In these studies, IM1240 induced tumor cell apoptosis, with anti-tumor activity dependent on both CD3 and NKG2A arms.

· Similarly, IM1240’s immune-mediated anti-tumor activity in PD1-resistant NSCLC patient-derived explants was evidenced by a significant increase in IFNγ secretion.

· To discern IM1240’s selectivity, a transcriptomic analysis of ~11,000 TCGA (The Cancer Genome Atlas) human samples showed that NKG2A expression co-occurs with 5T4 in solid tissues, which provides rationale for inclusion of the αNKG2A arm unique to the CAPTN-3 platform.

Platform Versatility: New TROP2-Targeting Candidate IM1305

· The Company’s new TROP2-targeting candidate, IM1305, further validates the adaptability of the CAPTN-3 platform and demonstrated high-affinity binding to both TROP2 and NKG2A (EC₅₀ ~2 nM).

· Potent PBMC-mediated tumor cell killing was observed at low concentrations (EC₅₀ 1–5 pM) across multiple tumor types, including triple-negative breast, gastric, pancreatic, and head and neck cancers.

· Like IM1240, IM1305’s anti-cancer activity and CD3 binding were fully restored after cap cleavage, a critical component of CAPTN-3’s conditional activation design.

In humanized triple-negative breast cancer mouse models, IM1305 induced sustained tumor regression at low doses (p < 0.0001), reinforcing the platform’s broad application potential. The poster will be accessible under the Publications section of the Purple Biotech website following the congress, or using the following link: View Source

(Press release, Purple Biotech, DEC 11, 2025, View Source [SID1234661374])

On December 11, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported a new collaboration to evaluate TransCode’s lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform.

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The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and are ctDNA positive. The Phase 2a portion of the trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center.

This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the Minimal Residual Disease (MRD) setting, where the therapeutic intervention may have the greatest opportunity to improve long-term outcomes. The decision to test TTX-MC138 in patients who have demonstrated a pathological complete response following standard-of-care therapy but have evidence of circulating tumor DNA (ctDNA) is based on the high degree of recurrence in those patients and the lack of effective therapies in that setting. TTX-MC138 offers a therapeutic option in that setting because of the drug’s mechanism of action specifically targeting metastatic disease combined with an excellent safety profile.

"The safety and durable clinical benefit observed in TransCode’s Phase 1a trial with TTX-MC138 provide the basis for TransCode’s decision to proceed with Phase 2a clinical testing", noted Daniel Vlock, MD, TransCode’s Consulting Clinician. "The observed safety profile, coupled with the durability of TTX-MC138’s anti-tumor effects, is particularly encouraging. These findings are consistent with the drug’s mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions us to potentially intervene earlier in the patient’s disease, offering a new therapeutic option for patients at risk of developing metastatic disease."

"Detecting and treating micrometastatic disease before it becomes visible is one of the biggest unmet challenges in cancer," said Laura Esserman, M.D., co-founder of Quantum Leap, and Professor of Surgery and Radiology at the University of California, San Francisco. "The PRE-ISPY Trial is uniquely positioned to rapidly evaluate agents like TTX-MC138 that may eradicate minimal residual disease and prevent recurrence in colorectal and eventually other cancer. We are excited to collaborate with TransCode to accelerate this program, with the goal of advancing effective, less toxic precision therapies into Phase 2 and beyond—where the potential to truly cure patients exists."

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO (Free ESMO Whitepaper) 2025.

(Press release, TransCode Therapeutics, DEC 11, 2025, View Source [SID1234661375])

On December 10, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS ) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

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"We are very excited to see the robust and positive biomarker data, which may enable us to more confidently predict clinical responses in patients treated with the Bria-IMT regimen early in their treatment course," stated Kelly E. McCann, MD, PhD, breast medical oncologist at UCLA Health Jonsson Comprehensive Cancer Center, and lead investigator at UCLA for the Bria-ABC pivotal Phase 3 study. "These biomarkers could serve as highly valuable tools for clinicians, helping them inform treatment decisions for metastatic breast cancer, a complex disease in which many patients have limited or no remaining treatment options."

"BriaCell’s data shows the promise of the Bria-IMT regimen to address major unmet needs in the treatment of metastatic breast cancer, including in patients with CNS metastasis who have progressed on several lines of therapy – median 6 prior treatments," stated Chaitali S. Nangia, MD, Partner, Hoag Medical Group and first author of the poster.

"Our findings support further evaluation of cytokine and chemokine biomarkers as potential predictors of survival and clinical benefit with our Bria-IMT regimen, establishing a path towards more personalized therapeutic strategies in metastatic breast cancer patients with limited treatment options," commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

The details of the poster presentations are listed below.

Late-Breaking Abstract Number: 3688
Presentation Number: PS1-13-22
Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM CST

Summary
In BriaCell’s pivotal Phase 3 study in metastatic breast cancer, patients are randomized 1:1:1 to receive Bria-IMT plus an immune check point inhibitor (CPI), Bria-IMT monotherapy or Treatment of Physician’s Choice (TPC). A pooled interim analysis of 116 patients with available MHC subtyping and median 6 prior lines of therapy assessed safety, biomarker correlations and progression-free-survival (PFS) per imaging. All data remains blinded to date.

Key Findings

Favorable safety profile: The Bria-IMT regimen was well tolerated with no treatment-related discontinuations due to adverse events (AEs). The most common AEs were fatigue, anemia, and nausea and were predominantly low grade.
Early PFS signals by subtype: Median PFS values appeared highest in patients with HR+/HER2- disease (3.7 months) and HER2-Low disease (3.9 months).
Neutrophil-to-Lymphocyte Ratio (NLR) as a potential predictive biomarker: Consistent with findings from the Phase 2 study , the Neutrophil to Lymphocyte Ratio (NLR) continues to show potential as a biomarker of clinical benefit. Patients with favorable NLR of 0.7 – 2.3 demonstrated longer PFS with a median of 4.4 months vs 2.6 months in those with NLR <0.7 or >2.3.
Conclusion
Biomarkers previously associated with PFS and overall survival (OS) in BriaCell’s phase 2 study continue to show a direct relationship with PFS in this ongoing phase 3 study. Further analysis is planned as enrolment progresses, and as OS data mature.

Late-Breaking Abstract Number: 3713
Presentation Number: PS1-13-23
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM CST

The data analysis of Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer is presented below. Six patients had Central Nervous System (CNS) metastasis.

Summary
Positive Delayed Type Hypersensitivity (DTH) may be key predictor of clinical benefit as median overall survival (OS) was significantly (P=0.0001) higher in patients who were DTH+ (11.3 months) vs those who were DTH- (4.7 months).

In four evaluable patients with CNS metastasis, best clinical benefit Rate (CBR) including complete response (CR), partial response (PR), or stable disease (SD) in patients was 100% in HER2+ patients, 100% in HR+ patients, 50% in patients with TNBC, and 75% overall.

Conclusion
Maturing positive Phase 2 data continue to support the potentially meaningful clinical benefit of the Bria-IMT regimen and the ongoing pivotal Phase 3 study is further evaluating this immunotherapy and the role of biomarkers in predicting patient response.

Abstract Number: 1614
Presentation Number: PS2-09-03
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer.
Poster Presentation Date/Time: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM CST

Analysis of 35 different blood cytokines/chemokines from 30 patients enrolled in the Phase 1/2 studies of Bria-IMT alone or in combination with an immune checkpoint inhibitor (CPI).

Summary

Bria-IMT immunotherapy produced Th1 biased cytokine and chemokine changes consistent with immune activation suggesting their use as potential biomarkers to predict clinical responses of cancer patients to Bria-IMT regimen.
Patients with Stable Disease (SD) or PR (Partial Response) showed significantly higher levels of immune activating factors including IL-2, IL-15, IL-27, TNF-α, CXCL10, CCL2, CCL13, CCL26, and IL-17Apost-treatment, suggesting enhanced T-cell activation and pro-inflammatory signaling.
No induction of Th2- or regulatory-associated cytokines was observed suggesting that the Bria-IMT regimen did not suppress immune activation.
Elevated post-treatment levels of IL-1β, IL-6, IL-8, TNF-α, and MCP-4 were associated with better Overall Survival (OS).
Conclusion
BriaCell’s data suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer.

Copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, DEC 10, 2025, View Source [SID1234661342])

On December 10, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes. The company is targeting to begin a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026.

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"IDE574 is a promising potential first-in-class molecule that potently inhibits two tumor-promoting epigenetic modulators, KAT6 and KAT7, while sparing other structurally similar KAT family members. Preclinical studies demonstrate KAT6 and KAT7 collaboratively control lineage-specific tumorigenic transcription factor activity essential for tumor cell proliferation and survival. Dual KAT6/7 inhibition by IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast cancer xenograft models dependent upon lineage-specific transcription factor activity," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences.

IDE574 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies support the potential clinical evaluation of IDE574 monotherapy in patients with hormone receptor-positive breast cancer, lung adenocarcinoma as well as additional opportunities associated with lineage addiction. IDEAYA is targeting to share data from its preclinical work with IDE574 at a medical conference in the first half of 2026.

(Press release, Ideaya Biosciences, DEC 10, 2025, View Source [SID1234661358])