Immatics NV【IMTX】株式ニュース

Start PLATTFORM LIFE SCIENCES Immatics is poised for its first breakthrough in 2026.
PLATTFORM LIFE SCIENCES
Immatics is poised for its first breakthrough in 2026.
The Tübingen-based biotech company is focusing on novel immunotherapies.

From Stefan Riedel- December 22, 2025
Symbolbild: 3d visualization of melanoma skin cancer cell. Copyright: Art_spiral - stock.adobe.com
Symbolbild: 3d visualization of melanoma skin cancer cell. Copyright: Art_spiral - stock.adobe.com
Table of contents
A killer duo against tumor cells
Strong clinical data
Many types of tumors are treatable
Why 2026 will be a key year
New capital measure
Positive analyst opinions
Conclusion
Author
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Image style: Art_spiral – stock.adobe.com , Immatics NV

Thanks to recent advances in its clinical pipeline, the stock of the cancer therapy-focused biotech company has more than doubled in value over the past three months. Currently, Immatics NV (NL0015285941), listed on the Nasdaq since summer 2020, is the fourth German biotech company, after BioNTech, Qiagen, and Evotec, to break the billion-euro mark in market capitalization. If Immatics delivers strong clinical data in a pivotal trial next year, the stock is poised for a revaluation. By Stefan Riedel

Although the major share price-boosting effects of positive clinical results presented at specialist conferences did not materialize for Immatics at the beginning of December 2025, the data presented at the ESMO Immuno-Oncology Congress in London from an ongoing Phase 1a dose-escalation study demonstrated the efficacy potential of the drug IMA203CD8.

IMA203CD8 is an advanced TCR-T cell therapy with improved pharmacology. TCR-Ts are genetically modified T cells with receptors that can bind to specific tumor antigens and represent a new form of cancer immunotherapy. While CAR-T cells target surface proteins, TCR-Ts can also identify tumor antigens present within the cells themselves.

A killer duo against tumor cells
Immatics is taking a completely new approach to targeting solid tumors, which are responsible for more than 80% of all cancers. The interplay between a peptide and a T-cell receptor is the crucial factor. These target molecules are presented on the cell surface via the HLA receptor, a human leukocyte antigen. In combination with a T-cell receptor (TCR), a lock-and-key mechanism is created to break down the cells of solid tumors. In addition to cell therapies, Immatics' clinical pipeline also includes bispecific T-cell receptors. In cancer medicine, Immatics sees itself as one of the few biotech companies developing clinical products with these two therapeutic approaches.

IMA203CD8 zielt darauf ab, das therapeutische Potenzial der PRAME-Targetierung über das Melanom hinaus auf weitere schwer behandelbare solide Tumoren auszuweiten. Ein besonderer Fokus liegt dabei auf gynäkologischen Tumoren wie dem Ovarialkarzinom. Das Zielmolekül PRAME kommt bei einer Vielzahl von Tumorarten vor. Harpreet Singh, der Vorstandsvorsitzende von Immatics, ist davon überzeugt, dass PRAME eine der aktuell vielversprechendsten Zielstrukturen für die Behandlung unterschiedlichster Tumorarten darstellt: „PRAME ist ein einzigartiges Zielmolekül, da es in sehr vielen verschiedenen Krebsarten wie Eierstockkrebs, Hautkrebs, uvealem Melanom, Brustkrebs, Synovialsarkom, Lungenkrebs und Gebärmutterkrebs vorkommt, in gesundem Gewebe aber nicht oder kaum zu finden ist.“

Starke klinische Daten
Die auf dem ESMO Immuno-Oncology Congress in London präsentierten klinischen Studienergebnisse bis zum Datenstichtag 27. Oktober 2025 umfassen insgesamt 78 stark vorbehandelte Patienten mit fortgeschrittenen oder metastasierten PRAME-positiven soliden Tumoren. Die Patienten hatten zuvor im Durchschnitt drei systemische Therapielinien erhalten und verfügten nur noch über begrenzte Behandlungsoptionen. IMA203CD8 zeigte dabei über alle Dosisstufen hinweg ein insgesamt gutes Sicherheitsprofil. Auf Basis dieses Sicherheitsprofils wird die Dosiseskalation fortgeführt. Die Bestimmung der empfohlenen Phase-2-Dosis ist für 2026 vorgesehen.

In der Phase-1a-Dosis-Eskalationsstudie lag die objektive Ansprechrate bei 46 %. Bei rund drei Viertel der behandelten Patienten wurde eine Tumorverkleinerung beobachtet, die Krankheitskontrollrate nach sechs Wochen betrug 84 %. Ein erheblicher Anteil der Responder zeigte eine Tumorreduktion von mindestens 50 %, einzelne komplette Remissionen hielten über mehrere Jahre an. Ein zentrales Ergebnis der vorgestellten Daten ist das dosisabhängige Wirksamkeitssignal beim Ovarialkarzinom. Alle ansprechenden Patientinnen waren zuvor gegen platinbasierte Chemotherapien resistent.

Viele Tumorarten behandelbar
Firmenchef Harpreet Singh skizziert die potenziellen Vorteile des Wirkprofils folgendermaßen: „Im Unterschied zu unserem am weitesten fortgeschrittenen klinischen Kandidaten anzu-cel nutzt IMA203CD8 zwei unterschiedliche Typen von Immunzellen. Es sind die sogenannten CD8- und CD4-T-Zellen, die sich in ihren Fähigkeiten ergänzen, um Krebszellen noch besser und langfristiger zu bekämpfen. Durch diese verbesserten pharmakologischen Eigenschaften sehen wir das Potenzial, mit IMA203CD8 auch schwer behandelbare PRAME-positive solide Tumoren außerhalb von Hautkrebs zu adressieren, zum Beispiel Eierstockkrebs.“

Warum 2026 ein Schlüsseljahr wird
Aus Investorensicht bleibt anzu-cel der größte Werttreiber des Unternehmens. „Unser erklärtes Ziel ist es, dieses Produkt 2027 als unsere erste PRAME-Therapie auf den Markt zu bringen“, erläutert Singh. Zur Vermarktungsstrategie sagt er: „Aktuell planen wir, anzu-cel ohne Partner zu entwickeln. Dafür sind wir gut aufgestellt und richten unsere Organisation gezielt auf diese nächsten Schritte Richtung Marktzulassung aus.“

Als wichtigen Datenpunkt mit potenziell kurstreibendem Effekt sieht Singh im Jahr 2026 die Zwischen- und finale Analyse der Phase-3-Studie „SUPRAME“. Bei positiven Ergebnissen plant Immatics im ersten Halbjahr 2027 die Einreichung des Zulassungsantrags für die USA. Grünes Licht von Seiten der US-Behörde vorausgesetzt, will Immatics noch in der zweiten Jahreshälfte 2027 mit der Markteinführung starten.

Neue Kapitalmaßnahme
Die positive Resonanz der Investoren auf die klinischen Fortschritte hat Immatics Anfang Dezember für eine weitere Kapitalerhöhung genutzt. Im Rahmen eines gezeichneten Angebots verkaufte das Unternehmen 12,5 Mio. Aktien zu einem Preis von jeweils 10 USD. Der entsprechende Bruttoerlös belief sich auf 125 Mio. USD. An der Börse hatte sich Immatics zuletzt vor rund einem Jahr 150 Mio. USD frisches Kapital beschafft. Zum Stichtag 30. September 2025 verfügte das Unternehmen über 505,8 Mio. USD an Cashreserven. Legt man den Barmittelverbrauch von rund 204 Mio. USD im Zeitraum Januar bis September 2025 zugrunde, wäre Immatics bis zum Frühjahr 2028 durchfinanziert.

Positive Analystenstimmen
Schwarze Zahlen sind bei Immatics in den kommenden Jahren nicht zu erwarten. Die Konsensschätzungen der neun Analysten, die das Unternehmen beobachten, gehen jedoch davon aus, dass sich der Konzernverlust nach 2025 schrittweise verringert – von 241,4 Mio. EUR auf 196,5 Mio. EUR im Jahr 2027. Alle neun Analysten empfehlen die Aktie zum Kauf, wobei die Kursziele mit einer Spanne von 11,00 USD bis 25,00 USD weit auseinanderliegen. Auf Basis des aktuellen Aktienkurses sieht das optimistische Szenario bei einer Kurssteigerung von 143 % die faire Bewertung erreicht. In der konservativsten Schätzung verbleiben dagegen nur noch rund sieben Prozent bis zum Erreichen des Kursziels.

Fazit
The stock is highly speculative. If Immatics succeeds in delivering excellent efficacy data with its clinical candidates next year, the stock should experience a surge into the double digits. In the field of TCR-T cell therapies, Immatics competes with numerous publicly traded and private biotech companies, including T-Knife GmbH from Berlin. If ancel receives approval, the product would have pioneering status in the solid tumor segment. The potential peak annual revenues are therefore currently difficult to quantify. For the already approved CAR-T therapies, which pursue a comparable technological approach for blood cancers, current industry studies assume that the commercial potential will almost quadruple from USD 4.4 billion in 2023 to over USD 16 billion in 2032.

Author

Stefan Riedel
Financial editor at the Office for Communication
Stefan Riedel is active in the international financial markets. For 20 years, this passionate stock market expert has written for the platforms and publications of GoingPublic Media, including GoingPublic and the Life Sciences platform.

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Keywordsshareshare priceShare saleBioNTech SEBiotech actionbiotechnologyStock exchangeIndustry studybreast cancerCAR-TDosiseskalationOvarian cancerEvotec SEfinancingUterine cancerHarpreet SinghHLAHochrisikoHighly speculativeImmatics NVImmuno-oncologyInnovationspipelineCapital increaseConsensus estimateDisease controlCancer immunotherapyCancer therapyCourse objectiveLung cancerMarket launchMarket capitalizationMarket approvalMelanomaNasdaqOvarian cancerpharmacologyPhase 3Phase-1aPhase-2Pioneer statusPipelinePRAMEQIAGEN N.V.RemissionKey yearSecurityStefan RiedelStudy resultsSynovial sarcomaT-Knife GmbHT-cell receptorTargetingTCR-TTumorTumorantigenTumor reductionSales potentialValue driverseffectivenessCell therapy

https://www.goingpublic.de/life-sciences/immatics-steht-2026-vor-dem-ersten-durchbruch/

Immatics Announces Updated Phase 1b Clinical Data on ACTengine® IMA203 TCR-T Targeting PRAME in Melanoma Patients and Provides Update on Upcoming SUPRAME Phase 3 Trial

Company to host conference call and webcast today, October 10, at 9:00 am EDT/3:00 pm CEST

Company announces updated Phase 1b clinical data on ACTengine® IMA203 targeting PRAME in 28 heavily pretreated metastatic melanoma patients with substantially enhanced maturity compared to the last data update in May 2024 and provides the first report on progression-free survival (PFS) and overall survival (OS)

Based on the Phase 1b data, the Company will proceed directly to a registration-enabling Phase 3 trial

Regulatory pathway and clinical trial design for IMA203 finalized following FDA Type D meetings and meeting with the Paul Ehrlich Institute (PEI); RP2D and CMC package confirmed

IMA203 continues to maintain a favorable tolerability profile in patients in Phase 1a and Phase 1b treated across all dose levels

IMA203 demonstrates a confirmed objective response rate of 54% with median duration of response of 12.1 months in Phase 1b

Median PFS is 6 months, comparing favorably to the IMA203 Phase 1a dose escalation median PFS of 2.6 months; patients with deep responses show median PFS of more than one year; median OS not reached

Phase 3 trial, “SUPRAME,” will enroll 360 patients with unresectable or metastatic melanoma post treatment with a checkpoint inhibitor (2L+) and will randomize patients 1:1 for treatment with IMA203 or investigator’s choice

Primary endpoint for full approval will be median PFS, which constitutes the fastest pathway to registration in this patient population

SUPRAME Phase 3 trial is on track to commence in December 2024; enrollment forecasted to be completed in 2026 with a pre-specified interim analysis planned for early 2026

Conference call and webcast can be accessed here

Houston, Texas and Tuebingen, Germany, October 10, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced updated Phase 1b clinical data on ACTengine® IMA203 TCR-T targeting PRAME in melanoma patients and provided an update on SUPRAME, the upcoming Phase 3 trial to evaluate IMA203 in metastatic melanoma patients.

The data from the ongoing Phase 1b trial will be presented on Friday, October 11, 2024, by Martin Wermke, M.D., during Plenary Session 1, Developmental Immunotherapy (Cellular Immunotherapy, Vaccines, & New Checkpoints) at the Society for Melanoma Research Congress 2024. The IMA203 data slides are accessible in the ‘Events & Presentations’ section of the Investor & Media section of the Company’s website. The conference presentation will include additional patient cases.

“Observing significant tumor shrinkage and durable responses combined with meaningful progression-free survival and overall survival outcomes after a single treatment with ACTengine® IMA203 in this patient population that have all exhausted multiple lines of systemic treatments illustrates the impact IMA203 can have on metastatic melanoma patients,” said Martin Wermke, M.D., Coordinating Investigator of the ACTengine® IMA203 TCR-T trial. “These results now affirm the therapeutic potential of IMA203 and provide a strong rationale for the expedited late-stage clinical development of this product candidate.”

“We are enthusiastic about the clinical data as they confirm our conviction in the durability and long-term efficacy of ACTengine® IMA203, demonstrated by the favorable median progression-free survival for patients in the dose expansion cohort. I would like to highlight that a subgroup of 12 out of 26 patients showed more than 50% reduction of tumor lesions and a median PFS of 13.4 months,” said Cedrik Britten, M.D., Chief Medical Officer at Immatics. “We believe the presentation of this data set in conjunction with our recent meeting with the FDA, which has resulted in a pivotal trial design with progression-free survival as the primary endpoint for full approval, positions us to advance the development of IMA203 in the second-line or later metastatic melanoma setting.”

Patient Population and Clinical Data Summary - ACTengine® IMA203 Monotherapy Phase 1b Trial

Patient population: Heavily pretreated metastatic melanoma patients
As of August 23, 2024, 28 heavily pretreated patients with metastatic melanoma were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells) with IMA203 during the Phase 1b dose expansion part of the clinical trial. The treated patient population is composed of patients with a median of 2 lines of prior systemic treatments, consisting of cutaneous melanoma patients (N=13), uveal melanoma patients (N=12), mucosal melanoma patients (N=2) and a patient with melanoma of unknown primary (N=1).

Safety: Favorable tolerability profile demonstrated across all dose levels in Phase 1a and Phase 1b
IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 adverse events in the safety population (N=701 Phase 1a and Phase 1b patients across all dose levels and all tumor types), even at doses up to ~10x109 TCR-T cells.

The most frequent adverse events were expected cytopenias (Grade 1 – 4) associated with lymphodepletion as well as mostly mild to moderate cytokine release syndrome (CRS). Some patients infrequently experienced ICANS (Grade 1: 6%, Grade 2: 4%, Grade 3: 4%).

The full IMA203 monotherapy tolerability profile is also generally consistent with that observed in the Phase 1b melanoma subset.

Anti-tumor activity and durability: Durable objective responses in melanoma patients at RP2D3
This data update adds substantial maturity to the most recent data update from May 2024 (data cut-off on April 25, 2024). The median follow-up for the median duration of response for this analysis was 9.3 months compared to 3.5 months in May 2024.

All melanoma patients in Phase 1b
(N=282,3)

Cutaneous melanoma patients in Phase 1b (N=133)

Confirmed Objective Response Rate

54% (14/26)

54% (7/13)

Objective Response Rate

62% (16/26)

62% (8/13)

Disease Control Rate

92% (24/26)

92% (12/13)

Tumor Shrinkage

88% (23/26)

85% (11/13)

Median Duration of Response

12.1 months

12.1 months

Median Progression-Free Survival

6.0 months

6.1 months

Median Overall Survival

Not reached

15.9 months

Progression-free survival (PFS) and overall survival (OS): Significant shift in PFS and OS between Phase 1a dose escalation to Phase 1b dose expansion in melanoma patients
Manufacturing improvements were implemented prior to the Phase 1b part of the trial to enhance key features of IMA203. As a result, all patients in dose expansion were treated with an updated version of IMA203 that includes a T cell enrichment process using monocyte depletion (negative selection) or CD8/CD4 positive selection.

The data presented today demonstrate a significant positive shift in median PFS and median OS between melanoma patients treated during Phase 1a and patients treated in Phase 1b.

Phase 1b dose expansion melanoma patients
(N=28)

Phase 1a dose escalation melanoma patients
(N=11)

Median Progression-Free Survival

6.0 months

2.6 months

Median Overall Survival

Not reached

6.3 months

In addition, approximately half of all patients in the Phase 1b trial have a deep response (>50% tumor reduction). This subgroup of patients was observed to have a median PFS of more than one year, while patients with <50% tumor reduction (including patients with tumor size increase) were still observed with a more than 2 times longer median PFS compared to patients treated in dose escalation with suboptimal doses.

Translational data: IMA203 T cell dose and T cell exposure are associated with clinical responses
Translational data from patients across Phase 1a and Phase 1b indicate that IMA203 T cells rapidly engrafted in all patients after a single dose and show a persistence of more than two years. Three associations/correlations were observed demonstrating high consistency of dose exposure, biological data and clinical outcome in all patients treated with IMA203 for which samples were available (N=65):

IMA203 T cell dose is significantly associated with confirmed clinical responses (p=0.02),
IMA203 T cell dose is correlated with T cell peak level (cmax, r=0.84, p=1.6x10-18),
IMA203 T cell peak level (cmax, p=0.05) and T cell exposure (AUC0-28d, p=0.05) are associated with confirmed clinical responses.

Development Path and Manufacturing for ACTengine® IMA203 Monotherapy

On September 24, 2024, Immatics completed a Type D meeting with the U.S. Food and Drug Administration (FDA) to confirm RP2D and the CMC package as well as discuss the trial design for SUPRAME, the planned registration-enabling Phase 3 randomized-controlled clinical trial for IMA203. Written post-meeting minutes from the FDA have been received.

The Phase 3 trial will evaluate IMA203 targeting PRAME in 360 HLA-A*02:01-positive patients with second-line or later (2L+) unresectable or metastatic melanoma who have received prior treatment with a checkpoint inhibitor. Patients will be randomized 1:1 for IMA203 or investigator’s choice of selected approved treatments in the 2L+ setting.

Based on the Company’s discussions with the FDA, the primary endpoint for full approval will be median PFS. Given the expected PFS of 2-3 months4 in this patient population, as well as the PFS of 6 months observed in the data from the IMA203 Phase 1b trial, the Company has determined that utilizing median PFS as the primary endpoint is the fastest pathway to seeking full approval and presents a more attractive commercial positioning as compared to objective response rate (ORR). Secondary endpoints for the trial will include ORR, safety, duration of response, no overall survival detriment and patient-reported outcomes. A pre-specified interim analysis is planned for early 2026.

The SUPRAME Phase 3 trial is planned to run globally with sites in the United States and Europe with the initial goal of seeking Biologics License Application (BLA) approval in the United States. On October 2, 2024, Immatics also completed a meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority, and determined the same trial design for conducting the clinical trial in Germany.

The Phase 3 trial is on track to commence in December 2024 and patient enrollment is forecasted to be completed in 2026. The Company aims to submit a BLA in early 2027 for full approval.

Immatics’ late-stage clinical cell therapy development is supported by its differentiated manufacturing related to timeline, capabilities and facilities. ACTengine® IMA203 cell therapy products are manufactured within 7 days, followed by a 7-day QC release testing at a success rate of >95% to reach the target dose. The Company has also completed construction of a ~100,000 square foot R&D and GMP manufacturing facility with a modular design for efficient and cost-effective scalability intended to serve early-stage and registration-enabling trials, as well as commercial supply. The new site is expected to start GMP manufacturing of cell therapy products in early 2025. Meanwhile, the existing GMP facility, which is run in collaboration with UT Health, will remain active until YE 2025.

Immatics Conference Call and Webcast
Immatics will host a conference call and webcast today, October 10, 2024, at 9:00 am EDT/ 3:00 pm CEST to discuss the clinical data.

A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Immatics website for at least 90 days.

About ACTengine® IMA203 and Target PRAME
ACTengine® IMA203 is Immatics’ most advanced TCR-based autologous cell therapy that is directed against an HLA-A*02-presented (human leukocyte antigen) peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers. PRAME is homogeneously and specifically expressed in tumor tissue and Immatics’ PRAME peptide is present at a high copy number per tumor cell. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for ACTengine® IMA203.
ACTengine® IMA203 TCR-T is currently being evaluated as a monotherapy in a Phase 1 clinical trial in patients with solid tumors expressing PRAME, such as cutaneous melanoma. An IMA203 registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” is planned to commence in December 2024.

ACTengine® IMA203 TCR-T is also currently being evaluated in Phase 1 IMA203CD8 (GEN2) monotherapy, where IMA203 engineered T cells are co-transduced with a CD8aß co-receptor.

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https://finance.yahoo.com/news/immatics-announces-updated-phase-1b-103000214.html