Solarfuture
4月前
Immatics N.V. (IMTX) Investor Outlook: Exploring an 88% Upside Potential in Biotech
Immatics N.V. (NASDAQ: IMTX) is capturing the attention of individual investors with its focus on pioneering therapies in the biotechnology sector. Headquartered in Tübingen, Germany, this clinical-stage biopharmaceutical company is dedicated to developing T cell redirecting immunotherapies for cancer treatment, particularly targeting solid tumors. Despite a challenging financial backdrop, Immatics stands out with a promising pipeline and strong analyst support, offering significant potential upside.
**Current Market Landscape and Price Performance**
Immatics is currently trading at $10.15 per share, with a modest price change of 0.17 (0.02%). The stock has experienced significant volatility, moving within a 52-week range of $3.50 to $11.87. This fluctuation reflects the broader challenges and opportunities within the biotech industry, particularly for companies at a clinical-stage development phase.
**Valuation and Performance Metrics**
The valuation metrics for Immatics indicate a complex financial picture. With a Forward P/E of -5.53 and a negative EPS of -1.09, the company is not yet generating profits, which is common for biotechnology firms in the R&D phase. Notably, revenue growth has contracted by 89.70%, highlighting the financial strains of ongoing research and development activities. The company’s Return on Equity (ROE) is also negative at -30.03%, and free cash flow is reported at -$140 million, underscoring the capital-intensive nature of their pioneering work.
Growth Potential and Analyst Ratings**
Despite these challenges, Immatics holds potential for significant growth. Analysts have given the company nine buy ratings, with no hold or sell ratings, reflecting confidence in Immatics’ strategic direction and clinical pipeline. The target price range for the stock is $11.00 to $25.00, with an average target of $19.13, suggesting an impressive potential upside of 88.42% from its current price. This optimism is driven by the company’s innovative approach to immunotherapy and strategic collaborations with major institutions like MD Anderson Cancer Center, Celgene Corporation, and Genmab A/S.
**Technical Indicators**
From a technical standpoint, the stock’s 50-day moving average stands at $10.07, while the 200-day moving average is $7.34, indicating a recent upward trend. However, the Relative Strength Index (RSI) of 38.43 suggests that the stock is approaching oversold territory, potentially offering an attractive entry point for investors. The MACD and Signal Line, both negative, highlight the potential for a bullish turnaround if the company’s clinical advancements continue to progress positively.
Pipeline and Strategic Collaborations**
Immatics’ pipeline is robust, with several promising candidates in various stages of development. Products like IMA203 and IMA203CD8 are in Phase 1b clinical trials, targeting solid tumors. Meanwhile, IMA204 and IMA30x are in preclinical stages, focusing on tumor stroma and allogenic cellular therapy, respectively. Additionally, TCR Bispecifics products such as IMA401 and IMA402 are progressing through early clinical trials, offering the potential for breakthrough treatments in oncology.
Strategic partnerships bolster the company’s research capabilities, providing access to cutting-edge technology and resources. Collaborations with MD Anderson Cancer Center, Celgene, and Genmab A/S are pivotal, enhancing Immatics’ capacity to innovate and accelerate the development of its therapeutic candidates.
For investors seeking exposure to the transformative potential of biotechnology in cancer treatment, Immatics N.V. presents a compelling opportunity. While the financials reflect the high-risk nature of early-stage biotech investments, the company’s strategic positioning and analyst confidence offer a promising outlook for those willing to navigate the inherent volatility of the sector.
https://www.directorstalkinterviews.com/immatics-n-v-imtx-investor-outlook-exploring-an-88-upside-potential-in-biotech/4121236332
Solarfuture
5月前
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
Related articles:
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/
Solarfuture
2年前
https://finance.yahoo.com/news/why-immatics-n-v-imtx-180757431.html
Why Is Immatics N.V. (IMTX) Among the Best Small-Cap Biotech Stocks With Massive Potential According to Hedge Funds?
Laiba Immad
Wed, December 4, 2024 at 7:07 PM GMT+1 6 min
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We recently compiled a list of the 10 Best Small-Cap Biotech Stocks with Massive Potential According to Hedge Funds. In this article, we are going to take a look at where Immatics N.V. (NASDAQ:IMTX) stands against the other small-cap biotech stocks.
Revolutionizing Healthcare and Economy: The Rapid Growth of Biotechnology
The biotechnology sector is expanding quickly due to rising demand for novel therapies, technological advances, and government assistance. Advances in fields like gene editing, sequencing, personalized medicine, and artificial intelligence are making new techniques possible, while the aging population and growing healthcare demands are driving a robust market for new treatments. According to a report by McKinsey & Company, venture capital firms made approximately $52 billion in global investments in therapeutic-focused biotech companies between 2019 and 2021. Two-thirds of this sum was given to platform-tech start-up companies.
Despite its growth, many biotech companies have faced challenges in turbulent markets, taking drastic measures such as cutting programs and implementing significant layoffs to conserve cash. While recent rate cuts could encourage the revival of scientific projects, analysts like Jared Holz note the difficulty of gauging their impact. Holz also highlighted a shift in market dynamics, observing that biotech's performance increasingly correlates with small-cap equities. If small-cap stocks trade well, biotech is likely to follow, though stagnation could occur if momentum fades. Notably, the idea of interest rates predicting biotech success is relatively new, emerging only after the pandemic, which reshaped the industry by driving substantial investment into therapeutic-focused companies.
With innovative treatments, biotech businesses are revolutionizing healthcare by tackling important unmet medical needs. Establishing the National Bioeconomy Board as a component of Biden's Investing in America agenda is a significant breakthrough. It seeks to maximize biotechnology's economic potential in the United States.
Furthermore, policy suggestions to expedite the approval process for biotechnology goods are being developed by the National Security Commission on Emerging Biotechnology. More academics will be able to use biotechnology for agricultural purposes if entry obstacles are reduced, which will benefit American farmers and increase food security. It is anticipated that these initiatives will open up new markets.
Pharmaceuticals as Defensive Investments and the 2024 Healthcare Market Outlook
This year (2024) started strongly for the biotechnology sector due to a rise in mergers and acquisitions as well as anticipations of falling interest rates. Therefore, estimates suggest that the worldwide biotechnology market might increase at a compound annual growth rate (CAGR) of around 14% from 2024 to 2033, reaching an astonishing $5.7 trillion. The market for agricultural biotechnology is also expected to develop at a 7.9% compound annual growth rate (CAGR) and reach $232 billion by 2032.
But even with the market's potential, investing in biotech companies still carries a number of serious dangers. Bankruptcy may result from failing to satisfy clinical trial endpoints or obtain adequate finance before a product launch. In the biotech industry, where drug development usually takes more than ten years and has an estimated failure rate of about 90%, the danger of failure is very substantial. Hence, biotech stocks are often considered “high-risk, high-reward” investments due to their upside potential coupled with significant risks
Our Methodology
In our methodology, we identified the top small-cap biotech stocks with significant growth potential, ranked according to their total hedge fund holdings as of Q2 2024. Our selection process began by filtering companies with a small market capitalization. Next, we reviewed analyst recommendations, focusing on stocks with strong bullish sentiment and high institutional ownership. Finally, we ranked these companies based on the number of hedge funds holding their shares as of Q2 2024.
Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 275% since May 2014, beating its benchmark by 150 percentage points (see more details here).
A close-up of test tubes and laboratory equipment, showing the complexity of biopharmaceutical research.
Immatics N.V. (NASDAQ:IMTX)
Number of Hedge Fund Holders: 32
Immatics N.V. (NASDAQ:IMTX) is a clinical-stage biopharmaceutical company focused on developing innovative cancer immunotherapies. At its core, the company specializes in discovering and developing novel T-cell receptor (TCR)-based therapies for cancer treatment.
Immatics N.V. (NASDAQ:IMTX) is advancing two types of therapies: Engineered Adoptive Cell Therapies (ACTengine) and antibody-like TCR Bispecifics (TCER), aimed at different stages of solid tumors. Its lead candidate, IMA203, has demonstrated promising clinical results, with a 55% overall response rate and a median response duration exceeding 13 months, indicating the potential for breakthrough treatments in melanoma and other solid cancers.
Immatics N.V. (NASDAQ:IMTX), one of the best small-cap biotech stocks with massive potential according to hedge funds, reported a significant increase in total revenue, which rose to $56.7 million in Q3 2024, up from $6.6 million in the same quarter last year. This surge was primarily driven by a one-time revenue from the IMA401 partnership termination by Bristol Myers Squibb YoY.
The total value of cash and cash equivalents, as well as other financial assets, increased from $476.8 million in the same quarter last year to $549.2 million in Q3 2024. The increase, which was primarily brought on by the January 2024 public offering, was somewhat mitigated by ongoing research and development activities. Following its $150 million initial public offering (IPO) in October 2024, Immatics N.V. (NASDAQ:IMTX) currently projects a financial runway until the second half of 2027.
As of Q3 2024, 32 hedge funds held stakes in the company as tracked by the Insider Monkey database. The largest stakeholder in the company was Perceptive Advisors with holdings worth $92.2 million. Street analysts hold a consensus Strong Buy rating on the stock, with an average target of $18.00. The high forecast is $19.00, and the low is $16.00, representing a 90.48% increase from the current price of $9.45.
Solarfuture
2年前
https://transkript.de/artikel/2024/gute-datenlage-immatics-kann-direkt-in-phase-iii-gehen/
Good data situation: immatics can go directly into Phase III
Tübingen-based Immatics NV published updated Phase Ib clinical data on ACTengine® IMA203, which allow for a more in-depth analysis compared to the last data update in May 2024. The data on progression-free survival (PFS) and overall survival (OS) are so convincing that the company can proceed directly with an approval-ready Phase III study on this basis. And Immatics is using the tailwind to place new shares for $150 million.
The data from the ongoing Phase 1b study have been eagerly awaited and will only be presented tomorrow by Dr. Martin Wermke at the Society for Melanoma Research Congress 2024. However, the Tübingen-based company Immatics NV is making it public earlier. The observation of significant tumor shrinkage and a lasting response in combination with meaningful results on progression-free survival and overall survival after a single treatment with ACTengine® IMA203, which Dr. Martin Wermke, coordinating investigator of the TCR-T study, will present there, are simply too impressive to keep quiet any longer.
"These results now confirm the therapeutic potential of IMA203 in this patient population, all of whom have exhausted multiple lines of systemic treatment. They demonstrate the impact IMA203 can have in patients with metastatic melanoma and provide a strong rationale for accelerating late-stage clinical development of this product candidate," said Wermke.
And that is the second important part of the advance announcement before the congress presentation: With the complete study data from Phase I, Immatics can go straight into a phase III study that is relevant for approval after consultation with the FDA. Recruitment will start soon, but the company expects that it will take around a year until enough study participants have been found, and then another year until the crucial data packages can be viewed in an interim analysis.
The Type D meeting with the US Food and Drug Administration (FDA) took place at the end of September. The study design for SUPRAME (Phase III) was discussed, in which IMA203, which targets PRAME, will be investigated in 360 HLA-A*02:01-positive patients with inoperable or metastatic melanoma in the second line or later (2L+) who were previously treated with a checkpoint inhibitor.
"We are excited about the clinical data as they confirm our belief in the durability and long-term efficacy of ACTengine® IMA203, as demonstrated by the favorable median progression-free survival of patients in the dose expansion cohort. I would like to highlight that a subset of 12 of the 26 patients had a reduction in tumor lesion size of more than 50% and a median PFS of 13.4 months," said Dr. Cedrik Britten, Chief Medical Officer at Immatics. "We believe that the presentation of this data set, coupled with our recent meeting with the FDA, which resulted in a pivotal study design with progression-free survival as the primary endpoint for full approval, positions us to significantly advance the development of IMA203."
The Tübingen-based cell therapy company is taking advantage of the tailwind and today announced the start of a subscribed public offering for its common shares. The volume is planned to reach 150 million US dollars, but this also depends a little on the current stock market situation. However, the data could also lead to increased interest.
© |transkript.de
Georg Kääb
October 10, 2024
FACT-MASTER
2年前
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
Solarfuture
2年前
Immatics () has received a new Buy rating, initiated by Piper Sandler analyst, .
Joseph Catanzaro has given his Buy rating due to a combination of factors surrounding Immatics’ potential in the biotechnology sector. He identifies the company’s PRAME-targeting portfolio as having extensive utility across various solid tumors. Catanzaro is particularly impressed by Immatics’ lead program, IMA203, which he believes could offer superior cell therapy for post-PD-1 melanoma based on scenario modeling that indicates competitive durability and potential for registrational development. Furthermore, he sees substantial opportunity for Immatics’ cell therapy portfolio beyond melanoma, particularly with IMA203CD8, which could show meaningful clinical activity in ovarian, endometrial, and lung cancers. Catanzaro’s outlook suggests that Immatics’ pipeline could lead to blockbuster therapies, with data expected in the next 6-18 months that could further reduce investment risks.
The positive rating also stems from validation of Immatics’ proprietary platforms, XPRESIDENT and XCEPTOR, which are starting to show clinical validation in their abilities to identify relevant peptide targets and generate highly active TCRs. These platforms have positioned Immatics to build a pipeline capable of developing first-in-class or best-in-class therapies for solid tumor indications. The report also highlights the competitive profile of the IMA203 program in post-PD-1 melanoma, noting its potential for best-in-indication response rates, competitive durability, and favorable safety profile. Lastly, Catanzaro emphasizes the potential of Immatics’ PRAME-targeting portfolio outside of melanoma, supported by strong evidence from clinical datasets and the enhanced efficacy observed with the incorporation of the CD8 co-receptor. Despite the inherent risks in clinical, regulatory, and commercial areas, Catanzaro’s analysis suggests a strong Buy recommendation for Immatics.
https://www.tipranks.com/news/blurbs/immatics-promising-pipeline-and-buy-recommendation-a-comprehensive-analysis-by-joseph-catanzaro?mod=mw_quote_news
Solarfuture
2年前
That's fine!
Yes, think we have good chance to see some nice weeks coming up...
Interesting article:
At the European Cancer Congress ESMO in Barcelona, Tübingen-based immatics NV did not present any new data on advanced T-cell therapy developments, but rather early data on the bispecific approach of a T-cell receptor against MAGEA4/8. The fact that the partner Bristol Myers Squibb is backing out of this previously collaborative development is only reported as a side note.
The many good news reports on advances in the treatment of cancer at the ESMO Congress in Barcelona in mid-September have given some companies like BioNTech a real boost, with their share prices soaring in just a few days. Tübingen-based immatics NV, on the other hand, did not choose the more advanced development of the so-called ACT engine, which is currently being evaluated in phase Ib either on its own or in combination with a CD8 binding site, as its presentation topic. This study is to continue with an increased dosage and will then be presented at another conference a little later in the year.
In contrast, Immatics' previous, preclinical approach to a bispecific T cell engaging receptor (TCER®) candidate, IMA401, was presented at the current conference. This is derived from a technology for the production of next-generation bispecific TCR molecules with an extended half-life. The molecules were developed to "maximize efficacy while minimizing toxicities," according to the company. The proprietary format, consisting of a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter that binds to the T cell, offers a more convenient dosing regimen for the patient than if such molecular capabilities had to be administered as individual active ingredients in combination.
Dr. Martin Wermke from the University Hospital Dresden presented the first clinical data of IMA401 (directed against the tumor antigen MAGEA4/8), which provided information on the safety, pharmacokinetics and antitumor activity of TCER IMA401 from the phase I dose escalation. These data show initial anti-tumor activity and a manageable tolerability profile for TCER® IMA401 monotherapy. The patient population includes 35 heavily pretreated patients with a total of 16 different solid tumor types; the dose escalation is now ongoing.
Only 29% was considered to be an objective response rate (ORR), or even 25% in the confirmed ORR (cORR). Nevertheless, a disease control rate (DCR) of 53% and a tumor shrinkage rate of 53% were shown in the "efficacy population" (i.e. those who responded). In addition, a "sustained partial response" of up to 13+ months and a deeper response (with tumor shrinkage of ≥50%) were shown in very different tumors, which is now being used as a justification for continuing and further increasing the dosage.
It was announced in passing that the previous development partner Bristol Myers Squibb is withdrawing from this sub-project of a broader development partnership (which was reported in the news a few months ago when it was converted into a shareholder ) and that immatics is giving back all rights. The stock market remained quiet, probably because immatics is currently extremely well financed with a good 530 million euros in the bank to take the next development steps on its own. The presentations from the adoptive, modified cell therapy development track will now receive much more attention, because the next approval-relevant studies are due to be carried out there after good data. Things remain exciting in Tübingen.
© |transkript.de
Georg Käab
17. September 2024
https://transkript.de/artikel/2024/hoch-und-tief-bei-immatics/
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