On December 11, 2025 Biohaven Ltd. (NYSE: BHVN) reported that it presented clinical safety and efficacy data for BHV-1510 at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress, taking place from December 10-12, 2025, in London, United Kingdom. The presentation highlights Biohaven’s novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, in combination with Regeneron’s anti-PD-1 cemiplimab demonstrating efficacy and manageable safety across several tumors.

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At the BHV-1510 dose of 2.5 mg/kg Q3W in combination with cemiplimab, confirmed ORR was 72.7%. Confirmed responses were observed in 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, which included a complete response, and 1/2 (50%) in urothelial cancer (Fig.1). In all 23 efficacy evaluable participants treated with BHV-1510 in combination with cemiplimab across dose levels, as of the clinical cutoff date (October 10, 2025) the confirmed objective response rate (ORR) was 52.2%, with confirmed objective responses in 6/14 (42.9%) in NSCLC, 4/6 (66.7%) in endometrial cancer, and 1/2 (50%) in urothelial cancer (Fig. 2). A confirmed response was reported in the participant with triple negative breast cancer. The majority of participants had tumor reduction on their first scan, with a median time to response of 11.1 weeks. Participants remain on study at 6 months and beyond, 18 participants continue on the study treatment at time of the clinical cutoff date (Fig.3).

Ida Micaily, M.D., M.S., Principal Investigator and Assistant Professor at Sidney Kimmel Comprehensive Cancer Center at Jefferson stated, "We are excited by this emerging data and the potential synergy of BHV-1510 with cemiplimab. The early responses we are observing in these difficult-to-treat tumors—despite patients having received prior therapies, including other PD-1/PD-L1 agents—are particularly encouraging. We also have patients remaining on therapy beyond six months, suggesting the potential for durable disease control."

In the population studied, the median prior lines of therapy for advanced/metastatic disease were two and the majority (87.1%) had prior PD-(L)1 exposure with 16 participants (51.6%) receiving a PD-(L)1 as the most recent treatment prior to receiving study treatment. The maximum tolerated dose was not reached and only one participant had a dose limiting toxicity of stomatitis (Grade 3) at the 2.75 mg/kg Q3W dose. As of the clinical cutoff date, a total of 31 participants were treated with the combination of BHV-1510 and cemiplimab, with BHV-1510 doses ranging from 2-2.75 mg/kg Q3W and 1.25-1.5 mg/kg D1D8Q3W. Cemiplimab was given at 350 mg Q3W.

Across all doses BHV-1510, was generally well tolerated with a safety profile differentiated from other Trop-2 ADCs. The rate of neutrophil count decrease was low and manageable; all Grade (Grade ≥3), 12.9% (6.5%). Similarly, the rates of treatment emergent diarrhea and alopecia were low; all Grade (Grade ≥3), 6.5% (0) and 9.7% respectively. The most frequent toxicity observed was oral mucositis/stomatitis all Grade (Grade ≥3), 59.1% (22.7%) in the Q3W regimen and all Grade (Grade ≥3), 33.3% (11.1%) in the D1D8Q3W regimen. This is a well-known class effect which is manageable. Importantly, there were no cases of interstitial lung disease, and no participants discontinued treatment due to an adverse event. Treatment emergent SAEs were reported in 4 participants, none of which were related to the study treatment. The pharmacokinetic profile for BHV-1510 was favorable, the unconjugated payload concentration was low with a payload-to-ADC molar ratio < 1%, indicating that ADC was highly stable in the circulation.

Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "Continued preliminary clinical data with BHV-1510 in patients who have received and progressed on standard-of-care treatment, including prior anti-PD1/PDL1 therapy, are highly encouraging. These findings—together with the early promising efficacy, differentiated safety profile, lack of payload-related toxicity, enabled by our novel TopoIx payload and stable linker technology—underscores the potential for BHV-1510 to move into earlier lines of therapy, in particular with checkpoint inhibitor combinations, for these challenging tumor types."

Poster Presentation Information:

Poster 252P: Phase 1 clinical trial of BHV-1510, a next generation Trop2 ADC, in combination with the PD-1 monoclonal antibody, cemiplimab in patients with advanced solid tumors.
Date/Time: Wednesday, December 10, 2025, 5:15-6:30 pm GMT

The poster will be available on the Posters and Presentations page after the conference at www.biohaven.com.

(Press release, Biohaven Pharmaceutical, DEC 11, 2025, View Source [SID1234661378])

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 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 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 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported a strategic restructuring plan intended to position the Company for long-term value creation for patients and shareholders and improve its financial discipline.

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"After my first four months at Geron, the leadership team and I have assessed the business with the goal of streamlining our organizational structure to advance our strategy and create long-term value. We are implementing these changes from a position of strength and in the spirit of prudent fiscal management," said Harout Semerjian, President and Chief Executive Officer of Geron. "Our key objectives remain unchanged. We are focused on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance our Phase 3 IMpactMF trial. We expect this restructuring will have a meaningful impact on our 2026 operating expenses and position Geron to meet the needs of patients. I want to express my gratitude to the employees that will be impacted in this restructuring. Your contributions over the years have made a positive difference in the lives of the people we endeavor each day to assist."

The Company’s strategic restructuring plan is expected to result in an approximately one-third reduction in Geron’s current workforce of approximately 260 employees. As a result of the restructuring plan, which is expected to be substantially complete in the first quarter of 2026, initial projected full year 2026 operating expenses are expected to be less than the Company’s projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026. Geron will incur restructuring charges consisting primarily of cash-based expenses in connection with the restructuring plan, with additional information to be provided in a Current Report on Form 8-K to be filed with the Securities and Exchange Commission. Geron thanks all employees who will be impacted by today’s announcement for their contributions to the Company.

(Press release, Geron, DEC 11, 2025, View Source [SID1234661372])