Aankondiging • Jun 02

+ 2 more updates

Immatics Presents Clinical Activity and Response Dynamics of Anzu-Cel Prame Cell Therapy At 2026 Asco Annual Meeting

Immatics N.V. announced extended data from the ongoing Phase 1b clinical trial evaluating anzu-cel (anzutresgene autoleucel, IMA203) PRAME TCR T-cell therapy in heavily pretreated patients with advanced melanoma in an oral presentation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago, USA. The dataset is focused on patients treated with anzu-cel at the recommended Phase 2 dose (RP2D), including longer follow-up and further characterization of the durability and systemic nature of the observed clinical responses. One-time infusion of anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy induced rapid, deep and durable systemic anti-tumor activity in metastatic PD-1 relapsed cutaneous melanoma and metastatic uveal melanoma. Anzu-cel showed a 56% confirmed ORR, 14.6 months mDOR, 6.1 months mPFS and 16.2 months mOS at longer follow-up alongside a predictable and manageable tolerability profile in metastatic melanoma. Exploratory response analysis suggests continued control of baseline disease and anti-tumor activity across multiple metastatic disease sites with many lesions remaining controlled, some even after progression. Findings reinforce the continued effectiveness of anzu-cel to treat advanced melanoma; Phase 3 SUPRAME trial remains on track as it advances toward BLA submission in First Half 2027. As of September 24, 2025, 33 heavily pretreated patients with metastatic (stage IV) melanoma received a one-time infusion of anzu-cel at the recommended Phase 2 dose (RP2D, 1 - 10x10^9 TCR T cells) in the Phase 1b dose expansion. The treated patient population consisted of cutaneous melanoma (n=14), uveal melanoma (n=16), mucosal melanoma (n=2) and melanoma of unknown primary (n=1). All patients with cutaneous melanoma, mucosal melanoma and melanoma of unknown primary had metastatic stage IV disease including lesions in liver, brain and/or lung. All patients with uveal melanoma had metastatic stage IV disease with liver and/or extrahepatic metastases. Patients had a median of two prior lines of systemic treatment. The subgroup of patients with cutaneous melanoma (n=14) had a median of 2.5 lines of prior systemic treatments, including a median of two prior lines of immune checkpoint inhibitors. Of these, 64% (9/14) received a combination of ipilimumab and nivolumab and 29% (4/14) received a combination of nivolumab and relatlimab prior to anzu-cel infusion. Anzu-cel has maintained a manageable tolerability profile, which was consistent across patients with different melanoma subtypes. The most frequent treatment-emergent adverse events were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grades 1 and 2, which is consistent with the mechanism of action. No patients experienced long-term CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred infrequently, was manageable and mostly mild (Grades 1 and 2). Rapid, deep and durable anti-tumor activity of anzu-cel PRAME cell therapy, including durable responses up to greater than 3 years. cORR: 56% (18/32) for all melanoma, 50% (7/14) for cutaneous melanoma, 67% (10/15) for uveal melanoma. ORR: 64% (21/33) for all melanoma, 57% (8/14) for cutaneous melanoma, 69% (11/16) for uveal melanoma. DCR: 91% (30/33) for all melanoma, 93% (13/14) for cutaneous melanoma, 88% (14/16) for uveal melanoma. mDOR (range) /mFU [mo]: 14.6 (4.2, 38.2+) /18.7 for all melanoma, 17.9 (4.2, 38.2+) /18.7 for cutaneous melanoma, 11.0 (4.4, 31.6) /Not defined for uveal melanoma. mPFS (range) /mFU [mo]: 6.1 (1.4, 39.6+) /20.0 for all melanoma, 6.0 (1.4, 39.6+) /20.0 for cutaneous melanoma, 8.5 (1.4, 32.9) /10.4 for uveal melanoma. mOS (range) /mFU [mo]: 16.2 (2.4, 39.6+) /17.3 for all melanoma, 13.9 (2.4, 39.6+) /20.0 for cutaneous melanoma, Not reached (4.5, 34.2) /14.3 for uveal melanoma. The PFS rate was 55% at six months and 37% at 12 months. The overall survival rate was 70% at 12 months and 46% at 24 months. 42% (14/33) of patients experienced a deep response (greater than or equal to 50% tumor reduction). In these patients, mPFS was 15.9 months at 39.6 months mFU. Anzu-cel induced systemic anti-tumor activity across multiple metastatic sites, including difficult-to-treat metastases, such as liver, lung, lymph node, abdomen/peritoneum, skin and others. Even patients who had a best overall response of progressive disease (PD) according to RECIST 1.1 (n=3) experienced shrinkage of individual lesions. Progressive disease was frequently the result of new lesions, progression of non-target lesions, or selective outgrowths of individual lesions, while many target lesions remained controlled, indicating continued control of baseline disease. Responses occurred rapidly (median time to BOR: 1.4 months) and were durable across multiple metastatic sites, including target and non-target lesions. These findings support the continued development of anzu-cel in advanced melanoma. Immatics’ ongoing Phase 3 clinical trial, SUPRAME, is evaluating the efficacy, safety and tolerability of anzu-cel PRAME TCR T-cell therapy as a monotherapy vs. investigator's choice in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a PD-1 immune checkpoint inhibitor. In parallel, a Phase 2 cohort in metastatic uveal melanoma is ongoing and intended to support a potential label expansion for anzu-cel following expected initial approval in cutaneous melanoma. PRAME is a target expressed in more than 50 cancers. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and three combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy, IMA402 PRAME bispecific as monotherapy, in combination with immune checkpoint inhibitors, in combination with IMA401 MAGEA4/8 bispecific as well as anzu-cel in combination with Moderna’s PRAME mRNA designed to enhance cell therapy. Anzu-cel (anzutresgene autoleucel; IMA203) is a 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. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1/2 clinical trial is ongoing with a focus on uveal melanoma.

Aankondiging • Nov 09

Immatics N.V. Reports Interim Clinical Data from ACTengine IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRame in an Ongoing Phase 1 Trial

Immatics N.V. announced interim data from the ongoing Phase 1 trial with ACTengine®? IMA203 in patients with recurrent and/or refractory solid cancers. The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2. Treatment with IMA203 GEN1 monotherapy in Phase 1a and Phase 1b Cohort A at RP2D demonstrated durable objective responses in melanoma patients with one patient exceeding 12 months and two patients exceeding 15 months post infusion and a 50% (6/12) confirmed objective response rate (cORR). In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused. In addition, the first data on the company’s second-generation product candidate IMA203CD8 demonstrated 56% (5/9) cORR with enhanced pharmacology and a differentiated response pattern compared to IMA203 GEN1. The company plans to develop IMA203 GEN1 in melanoma and to pursue development of IMA203 in ovarian cancer, uterine cancer, NSCLC, triple-negative breast cancer and other tumor types preferentially with IMA203CD8 GEN2. The melanoma-focused data on IMA203 GEN1 will be presented by Martin Wermke, MD, Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine® IMA203 TCR-T trial, at the 20th International Congress of the Society for Melanoma Research in Philadelphia, PA, taking place November 6th-9th, 2023. IMA203 GEN1 in melanoma patients treated at RP2D: IMA203 GEN1 demonstrates a high rate of objective responses with ongoing durability of more than 15 months after treatment: At data cut-off on September 30, 2023, a total of 16 PRAME-positive patients with cutaneous, uveal or melanoma of unknown primary origin were infused with IMA203 GEN1 at the recommended Phase 2 dose (RP2D, 1-10x109 total TCR-T cells) across Phase 1a or Phase 1b Cohort A. IMA203 GEN1 monotherapy continues to be well tolerated. All 16 patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. Patients had mostly mild-moderate cytokine release syndrome (CRS), of which 10 patients (63%) had Grade 1, and 5 patients (31%) Grade 2 and 1 patient (6%) Grade 3 CRS. One non-serious, mild (Grade 1) immune effector cell associated neurotoxicity syndrome (ICANS) was observed. No dose-dependent increase of CRS, no dose-limiting toxicities (DLTs) and no IMA203-related death was observed. The safety profile for non-melanoma patients treated with IMA203 GEN1 was generally consistent with safety in the melanoma subset and is provided in the appendix of the presentation. 13 out of 16 infused patients were evaluable for efficacy analysis based on at least one tumor response assessment being available post treatment. These patients received a median total infused dose of 1.73x109 IMA203 TCR-T cells (range 1.07-5.12x109 TCR-T cells). Most patients were heavily pre-treated with a median of 4 lines of systemic therapies, thereof a median of 2 lines of checkpoint inhibitors; all 8 cutaneous melanoma patients were checkpoint inhibitor-refractory and 5 of 8 were BRAF inhibitor-pretreated. 50% (6/12) confirmed objective response rate (cORR) and 62% (8/13) initial ORR (RECIST 1.1). Durability of responses ongoing beyond 12 months in one patient and 15 months in two patients after treatment. Median duration of response (mDOR) was not reached (min 2.2+ months, max 14.7+ months) at a median follow-up (mFU) of 14.4 months. RP2D has been defined at 1-10x109 total TCR-T cells. Cell product manufacturing: 7-day manufacturing process plus 7-day release testing. Manufacturing success rate: >95% to reach RP2D. Immatics has recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for IMA203 GEN1 in multiple PRAME-expressing cancers, including cutaneous and uveal melanoma, and is now targeting a registration-enabling Phase 2 trial in cutaneous melanoma potentially bundled with uveal melanoma in 2024. Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing. IMA203CD8 GEN2 in Cohort C: First clinical data set on IMA203CD8 shows an enhanced pharmacology profile with a differentiated response pattern compared to IMA203 GEN1 At data cut-off on September 30, 2023, a total of 12 PRAME-positive patients were infused with IMA203CD8 GEN2 across DL3 (0.2-0.48x109 TCR-T cells/m2 BSA), DL4a (0.481-0.8x109 TCR-T cells/m2 BSA) and DL4b (0.801-1.2x109 TCR-T cells/m2) in Cohort C with a median total infused dose of 1.17x109 IMA203CD8 TCR-T cells (range 0.64-2.05x109 TCR-T cells). All patients were heavily pre-treated with a median of 3 lines of systemic therapies. All patients experienced cytopenia (Grade 1-4) associated with lymphodepletion as expected. 11 out of 12 patients (92%) experienced a cytokine release syndrome (CRS), of which 8 patients (67%) had Grade 1 or 2 CRS, 2 patients (17%) had Grade 3 CRS and 1 patient (8%) had a Grade 4 CRS. The latter patient also had a reported Grade 4 neurotoxicity. No ICANS or neurotoxicity was reported for the other patients. No IMA203CD8-related deaths were observed. Dose-limiting toxicities (DLTs) were reported for 2 of 4 patients treated at DL4b. No DLT was reported for all 4 patients treated at DL3, or all 4 patients treated at DL4a. DL4a dose cohort is ongoing. Initial clinical activity was observed with a cORR of 56% (5/9) and initial ORR of 58% (7/12) (RECIST 1.1). 6 of 7 responses (including two unconfirmed responses with no subsequent scan available at data cut-off) were ongoing at data cut-off with longest response at >12 months after infusion. mDOR was not reached (min 2.0+ months, max 11.5+ months) at a mFU of 4.8 months. Reduction of tumor size was observed in 11 out of 12 patients, with a deepening of response from initially stable disease (SD) to partial response (PR) observed in two patients. Translational data showed enhanced pharmacology of IMA203CD8 GEN2: trend towards responses at lower T cell dose and higher tumor burden compared to IMA203 GEN1; IMA203CD8 GEN2 achieved higher peak expansion (Cmax) when normalized to infused dose and T cells showed higher initial activation levels without exhaustion over time.

Biotechs winstgroei	29.0%
Inkomstengroei	50.8%
Toekomstig rendement op eigen vermogen	n/a
Dekking van analisten	Good
Laatst bijgewerkt	25 Aug 2026

Datum	Inkomsten	Inkomsten	Vrije kasstroom	Geldmiddelen uit operationele activiteiten	Gem. Aantal analisten
12/31/2028	98	-244	-264	-253	7
12/31/2027	34	-265	-265	-260	8
12/31/2026	40	-246	-170	-223	8
6/30/2026	42	-207	-210	-206	N/A
3/31/2026	37	-214	-189	-184	N/A
12/31/2025	48	-196	-183	-177	N/A
9/30/2025	85	-120	-184	-176	N/A
6/30/2025	130	-74	-175	-165	N/A
3/31/2025	144	-22	-170	-160	N/A
12/31/2024	156	15	-175	-158	N/A
9/30/2024	116	-49	-45	-20	N/A
6/30/2024	71	-74	-45	-17	N/A
3/31/2024	74	-77	-26	9	N/A
12/31/2023	54	-95	-13	18	N/A
9/30/2023	76	-84	-117	-92	N/A
6/30/2023	85	-79	-113	-94	N/A
3/31/2023	80	-68	-40	-31	N/A
12/31/2022	173	28	94	100	N/A
9/30/2022	151	34	97	102	N/A
6/30/2022	142	28	113	119	N/A
3/31/2022	130	15	38	44	N/A
12/31/2021	35	-93	-90	-85	N/A
9/30/2021	28	-95	-86	-81	N/A
6/30/2021	30	-231	-133	-127	N/A
3/31/2021	32	-226	-97	-91	N/A
12/31/2020	31	-211	-88	-81	N/A
9/30/2020	26	-208	-38	-31	N/A
6/30/2020	23	-49	75	81	N/A
3/31/2020	22	-34	N/A	60	N/A
12/31/2019	18	-32	N/A	71	N/A
12/31/2018	4	-31	N/A	21	N/A

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/09/14 20:48
Aandelenkoers aan het einde van de dag	2026/09/11 00:00
Inkomsten	2026/06/30
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Alec Stranahan	BofA Global Research
Eric Schmidt	Cantor Fitzgerald & Co.
Yevgeniya Livshits	Chardan Capital Markets, LLC

Immatics Toekomstige groei

Future criteriumcontroles 2/6

Belangrijke informatie

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