A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors.
Primary objectives:
* To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I)
* To characterize the safety and tolerability of IMA402 (Phase I/II)
* To evaluate anti-tumor activity of IMA402 (Phase II)
Secondary objectives:
* To evaluate the initial anti-tumor activity of IMA402 (Phase I)
* To evaluate anti-tumor activity of IMA402 (Phase II)
* To describe the PK of IMA402 (Phase I/II)

开始日期2023-08-09

申办/合作机构

Immatics Biotechnologies GmbH

100 项与 IMA-402 相关的临床结果

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100 项与 IMA-402 相关的转化医学

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100 项与 IMA-402 相关的专利（医药）

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项与 IMA-402 相关的新闻（医药）

2025-05-13

·GlobeNewswire-Health Care

Immatics Announces First Quarter 2025 Financial Results and Business Update

IMA203 PRAME Cell Therapy: Randomized-controlled Phase 3 trial, SUPRAME, in previously treated advanced melanoma ongoing and expected to complete enrollment in 2026IMA203 PRAME Cell Therapy: Phase 1b clinical trial ongoing with updated data in metastatic melanoma with substantially longer follow-up and additional uveal melanoma patients to be presented in an oral presentation at the 2025 ASCO Annual Meeting IMA203CD8 PRAME Cell Therapy (GEN2): Phase 1a clinical trial in solid tumors ongoing with next data update, including dose escalation and ovarian cancer data, planned in 2025IMA402 PRAME Bispecific: Phase 1a clinical trial in solid tumors ongoing with next data update at relevant dose levels planned in 2025Combination of IMA203 PRAME cell therapy and Moderna’s PRAME adaptive immune modulating therapy: FDA granted IND clearance for a Phase 1 trialIMA401 MAGEA4/8 Bispecific: Phase 1a clinical trial, including a checkpoint inhibitor combination, ongoing with next data update with a focus on head and neck cancer planned in 2025Cash and cash equivalents as well as other financial assets of $588.1 million1 (€543.8 million) as of March 31, 2025; cash reach into 2H 2027 Houston, Texas and Tuebingen, Germany, May 13, 2025 – 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 provided a business update and reported financial results for the quarter ended March 31, 2025. “Our focus in the first quarter of 2025 was led by the execution of our SUPRAME Phase 3 clinical trial in melanoma as well as our other clinical-stage PRAME product candidates,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “At the upcoming ASCO Annual Meeting, we will present another Phase 1b clinical update on our PRAME cell therapy, IMA203, in melanoma with substantially longer follow-up. We also look forward to providing clinical trial updates for our cell therapy and bispecific programs later this year, highlighting the potential of our therapies in and beyond melanoma. We maintain a strong cash position, enabling us to rapidly advance the development of all our clinical programs, with a specific focus on progressing IMA203 toward commercialization and delivering this highly differentiated PRAME therapy to cutaneous and uveal melanoma patients with unmet medical needs as quickly as possible.” First Quarter 2025 and Subsequent Company Progress PRAME Programs IMA203 PRAME Cell TherapyIMA203 is Immatics’ lead PRAME cell therapy, currently being evaluated in a Phase 3 trial (SUPRAME) in patients with previously treated advanced melanoma. IMA203 has the potential to become the first PRAME therapy to enter the market. In parallel, Immatics is preparing its in-house, state-of-the-art cell therapy manufacturing facility to serve its planned commercial supply. As part of maximizing the PRAME cell therapy opportunity, Immatics plans to expand IMA203 into uveal melanoma through the ongoing Phase 1b clinical trial. The current addressable patient population of PRAME/HLA-A*02:01-positive 2L unresectable or metastatic cutaneous melanoma in the US and EU52 is ~7,300 plus ~1,300 uveal melanoma patients in the US and EU5. Phase 3 trial, SUPRAME, for IMA203 in previously treated, advanced cutaneous melanoma Based on the positive Phase 1b clinical data, Immatics has advanced its PRAME cell therapy, IMA203, into a randomized-controlled Phase 3 clinical trial, SUPRAME, evaluating the efficacy, safety and tolerability of IMA203 TCR T-cell therapy vs. investigator's choice of treatment in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor.Primary endpoint for seeking full approval will be blinded independent central review (“BICR”)-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints for the trial include objective response rate (ORR), safety, duration of response (DOR), overall survival (OS) and patient-reported outcomes.The trial will be conducted internationally with approximately 50 sites in the US and Europe.Patient enrollment and randomization for the trial was initiated in early 2025 and is expected to be completed in 2026. In April 2025, Immatics received regulatory approval from the German regulatory authority, Paul-Ehrlich-Institute (PEI), to commence the IMA203 SUPRAME Phase 3 trial in Germany.A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death)3, anticipated to occur after approximately 200 patients. Immatics aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval.IMA203 PRAME cell therapy development is supported by the FDA RMAT designation. Advantages of the RMAT designation (which includes all benefits of Breakthrough Therapy designation) include potential priority review of the BLA and frequent interactions with the US FDA as an opportunity to expedite development and review.A trial-in-progress poster on SUPRAME will be presented in a poster presentation by the SUPRAME lead principal investigator, Jason Luke, MD, FACP, FASCO, at the 2025 ASCO Annual Meeting on June 2, 2025. Phase 1b trial for IMA203 PRAME cell therapy in solid tumors with a focus on uveal melanoma In addition to cutaneous melanoma, Immatics intends to expand the IMA203 opportunity to treat uveal melanoma patients and will continue to evaluate IMA203 in this patient population through the ongoing trial.Updated data from the Phase 1b trial of IMA203 in metastatic melanoma with substantially longer follow-up compared to the last presentation in October 2024, and including data from additional uveal melanoma patients enrolled since then, will be highlighted by Martin Wermke, MD, in an oral presentation at the 2025 ASCO Annual Meeting on May 31, 2025.In April 2025, Nature Medicine published a manuscript covering prior clinical results on IMA203. The publication includes data from 40 heavily pretreated patients with PRAME cancers, mostly treated during the Phase 1a dose escalation part of the trial. Cell therapy manufacturing capabilities The IMA203 PRAME cell therapy products are manufactured from a patient's leukapheresis (with no surgery required) within 7-8 days, followed by 7-day QC release testing at >95% success rate4 to achieve the target dose (1-10x109 TCR T cells).Immatics’ proprietary manufacturing process, timeline, capabilities and facility support late-stage clinical development and commercial cell therapy supply. IMA203CD8 PRAME Cell Therapy (GEN2)IMA203CD8 is the Company’s second-generation cell therapy product candidate targeting PRAME. Given its pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product in multiple PRAME cancers, starting with gynecologic cancers. Clinical data demonstrated enhanced pharmacology of IMA203CD8, which opens the possibility of addressing hard-to-treat solid tumor indications with both high- and medium-level PRAME copy numbers, such as ovarian cancer, uterine cancer, squamous non-small cell lung carcinoma, triple negative breast cancer and others.Phase 1a dose escalation in solid tumors is ongoing to evaluate higher doses of IMA203CD8 with and without IL-2. As of today, patients are being treated with up to ~8 billion total GEN2 TCR T cells.The next clinical trial update, which will report on the continued dose escalation in multiple PRAME cancers, including ovarian cancer patients treated at relevant doses, is planned in 2025. IMA402 PRAME Bispecific To expand the PRAME opportunity to additional solid cancer types and earlier lines of treatment, the Company is developing its half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept (“PoC”) in last-line melanoma, Immatics plans to explore its potential in gynecologic cancers, NSCLC, breast cancer, and other solid tumor indications as well as earlier treatment lines of solid cancers, such as first-line (1L) cutaneous melanoma. First clinical data from the early Phase 1a dose escalation trial demonstrated initial signs of dose-dependent and PRAME target expression-dependent clinical activity.Phase 1a dose escalation at higher dose levels to determine the optimal therapeutic dose is advancing and currently ongoing at dose level 11 (12 mg).The next Phase 1a clinical trial update with clinical data at relevant dose levels in second-line or later (2L) melanoma is planned in 2025. Combination of IMA203 PRAME Cell Therapy and PRAME Adaptive Immune Modulating Therapy In February 2025, the FDA granted IND clearance for a Phase 1 trial evaluating Immatics’ IMA203 PRAME cell therapy in combination with Moderna’s PRAME adaptive immune modulating therapy. The first-in-human, Phase 1a/1b trial is a multicenter, open-label, dose escalation/de-escalation (adaptive design) trial evaluating the safety, tolerability and efficacy of the combination therapy in an estimated 15 patients with advanced or recurrent cutaneous melanoma and synovial sarcoma. Immatics is responsible for conducting the Phase 1 trial. Each party retains full ownership of its investigational PRAME compound, and the parties will fund the clinical study on a cost sharing basis. In November 2024, Immatics presented preclinical proof-of-concept data at SITC supporting this combination. Other Programs IMA401 MAGEA4/8 Bispecific Immatics is further harnessing the potential of its proprietary bispecific platform to develop innovative therapeutics and unlock more cancer types. The Company’s half-life extended TCR Bispecific, IMA401 targeting MAGEA4/8, is progressing through a Phase 1 trial in patients with late-stage NSCLC, head & neck cancer, bladder cancer and other solid tumor indications, with the primary goal of developing this product candidate in earlier treatment lines. Clinical proof-of-concept data from the Phase 1a dose escalation trial showed initial anti-tumor activity in multiple tumor types, including durable confirmed objective responses, a manageable tolerability profile and a half-life of 14+ days, which supported the switch to q2w dosing (once every two weeks). The Phase 1a trial is ongoing and the Company continues to focus enrollment on indications with high MAGEA4/8 target expression, such as lung and head and neck cancer. Dose refinement for IMA401 as monotherapy and in combination with a checkpoint inhibitor is ongoing. Through the combination, Immatics aims to generate relevant clinical data to position IMA401 as a combination therapy in earlier treatment lines.The next update on IMA401 Phase 1a data, with a focus on head and neck cancer, is expected in 2025, and the Company plans to share data with a focus on non-small cell lung carcinoma in 2026. Moderna CollaborationImmatics generated regulatory support data for one of Moderna’s mRNA product candidates that leveraged Immatics’ XPRESIDENT® and its bioinformatics and AI platform XCUBE™. Pursuant to the Collaboration Agreement under the Database/Vaccine Program, Immatics received a milestone payment triggered by the initiation of the first Phase 1 clinical trial for the Moderna product candidate. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents as well as other financial assets total $588.1 million1 (€543.8 million) as of March 31, 2025, compared to $653.8 million1 (€604.5 million) as of December 31, 2024. The decrease is mainly due to ongoing research and development activities and includes unrealized foreign exchange translational losses of $14.2 million1 (€13.1 million). Revenue: Total revenue, consisting of revenue from collaboration agreements, was $20.1 million1 (€18.6 million) for the three months ended March 31, 2025, compared to $32.8 million1 (€30.3 million) for the three months ended March 31, 2024. The decrease is mainly the result of the one-time revenue associated with the termination of the Genmab collaboration during the three months ended March 31, 2024. Research and Development Expenses: R&D expenses were $45.3 million1 (€41.9 million) for the three months ended March 31, 2025, compared to $34.7 million1 (€32.1 million) for the three months ended March 31, 2024. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials. General and Administrative Expenses: G&A expenses were $13.1 million1 (€12.1 million) for the three months ended March 31, 2025, compared to $12.5 million1 (€11.6 million) for the three months ended March 31, 2024. Net Profit and Loss: Net loss was $43.2 million1 (€39.9 million) for the three months ended March 31, 2025, compared to a net loss of $2.4 million1 (€2.2 million) for the three months ended March 31, 2024. The increase mainly resulted from lower revenue recognized and unrealized non-cash foreign exchange rate losses. Full financial statements can be found in our Report on 6-K filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and published on the SEC website under www.sec.gov. Upcoming Investor Conferences Bank of America Healthcare Conference, Las Vegas (NV) – May 13 - 15, 2025 Jefferies Global Healthcare Conference, New York (NY) – June 3 - 5, 2025 Cantor Global Healthcare Conference, New York (NY) – September 3 - 5, 2025 To see the full list of events and presentations, visit https://investors.immatics.com/events-presentations. - END - About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on LinkedIn and Instagram. Forward-Looking StatementsCertain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND or CTA filing for pre-clinical stage product candidates, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: MediaTrophic Communications Phone: +49 171 1855682 immatics@trophic.eu Immatics N.V. Jordan Silverstein Head of Strategy Phone: +1 346 319-3325 InvestorRelations@immatics.com Immatics N.V. and subsidiariesCondensed Consolidated Statement of Loss of Immatics N.V. Three months ended March 31, 2025 2024 (Euros in thousands) Revenue from collaboration agreements 18,582 30,269 Research and development expenses (41,908) (32,108) General and administrative expenses (12,067) (11,642) Other income 19 12 Operating result (35,374) (13,469) Change in fair value of liabilities for warrants 1,597 1,043 Other financial income 6,264 11,381 Other financial expenses (13,336) (677) Financial result (5,475) 11,747 Loss before taxes (40,849) (1,722) Taxes on income 994 (518) Net loss (39,855) (2,240) Net loss per share: Basic (0.33) (0.02) Diluted (0.33) (0.03) Immatics N.V. and subsidiaries Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V. Three months ended March 31, 2025 2024 (Euros in thousands) Net loss (39,855) (2,240) Other comprehensive income/(loss) Items that may be reclassified subsequently to profit or loss Currency translation differences from foreign operations (2,711) 336 Total comprehensive loss for the period (42,566) (1,904) Immatics N.V. and subsidiariesCondensed Consolidated Statement of Financial Position of Immatics N.V. As of March 31, 2025 December 31, 2024 (Euros in thousands) Assets Current assets Cash and cash equivalents 242,844 236,748 Other financial assets 300,914 367,704 Accounts receivables 5,600 5,857 Other current assets 24,205 19,246 Total current assets 573,563 629,555 Non-current assets Property, plant and equipment 49,820 50,380 Intangible assets 1,600 1,629 Right-of-use assets 15,577 13,332 Other non-current assets 1,132 1,250 Total non-current assets 68,129 66,591 Total assets 641,692 696,146 Liabilities and shareholders’ equity Current liabilities Provisions 2,257 — Accounts payables 18,395 20,693 Deferred revenue 25,295 35,908 Liabilities for warrants 133 1,730 Lease liabilities 3,046 2,851 Other current liabilities 6,644 6,805 Total current liabilities 55,770 67,987 Non-current liabilities Deferred revenue 29,165 34,161 Lease liabilities 15,341 13,352 Deferred tax liability 4,810 5,804 Total non-current liabilities 49,316 53,317 Shareholders’ equity Share capital 1,216 1,216 Share premium 1,166,466 1,162,136 Accumulated deficit (629,396) (589,541) Other reserves (1,680) 1,031 Total shareholders’ equity 536,606 574,842 Total liabilities and shareholders’ equity 641,692 696,146 Immatics N.V. and subsidiaries Condensed Consolidated Statement of Cash Flows of Immatics N.V. Three months ended March 31, 2025 2024 (Euros in thousands) Cash flows from operating activities Net loss (39,855) (2,240) Taxes on income (994) 518 Loss before tax (40,849) (1,722) Adjustments for: Interest income (5,463) (6,294) Depreciation and amortization 3,140 3,014 Interest expenses 249 194 Equity-settled share-based payment 4,330 4,297 Net foreign exchange differences and expected credit losses 12,248 (4,553) Change in fair value of liabilities for warrants (1,597) (1,043) Losses from disposal of fixed assets 40 — Changes in: Decrease in accounts receivables 257 2,312 (Increase)/decrease in other assets (90) 1,134 Decrease in deferred revenue, accounts payables and other liabilities (16,021) (31,674) Interest received 14,673 2,484 Interest paid (249) (194) Income tax paid (4,874) (560) Net cash provided by/(used in) operating activities (34,206) (32,605) Cash flows from investing activities Payments for property, plant and equipment (3,075) (9,174) Payments for intangible assets (60) (2) Proceeds from disposal of property, plant and equipment 47 — Payments for investments classified in Other financial assets (258,644) (290,599) Proceeds from maturity of investments classified in Other financial assets 308,540 57,957 Net cash (used in)/provided by investing activities 46,808 (241,818) Cash flows from financing activities Proceeds from issuance of shares to equity holders — 185,669 Transaction costs deducted from equity — (11,548) Repayment/(payment) of lease liabilities (737) 524 Net cash provided by/(used in) financing activities (737) 174,645 Net increase/(decrease) in cash and cash equivalents 11,865 (99,778) Cash and cash equivalents at beginning of the year 236,748 218,472 Effects of exchange rate changes and expected credit losses on cash and cash equivalents (5,769) 3,399 Cash and cash equivalents at end of the period 242,844 122,093 Immatics N.V. and subsidiaries Condensed Consolidated Statement of Changes in Shareholders’ Equity of Immatics N.V. (Euros in thousands) Sharecapital Sharepremium Accumulateddeficit Otherreserves Totalshare-holders’equity Balance as of January 1, 2024 847 823,166 (604,759) (1,636) 217,618 Other comprehensive income — — — 336 336 Net loss — — (2,240) — (2,240) Comprehensive loss for the period — — (2,240) 336 (1,904) Equity-settled share-based compensation — 4,297 — — 4,297 Share options exercised 1 682 — — 683 Issue of share capital – net of transaction costs 183 173,257 — — 173,440 Balance as of March 31, 2024 1,031 1,001,402 (607,000) (1,300) 394,133 Balance as of January 1, 2025 1,216 1,162,136 (589,541) 1,031 574,842 Other comprehensive loss — — — (2,711) (2,711) Net loss — — (39,855) — (39,855) Comprehensive loss for the period — — (39,855) (2,711) (42,566) Equity-settled share-based compensation — 4,330 — — 4,330 Share options exercised — — — — — Issue of share capital – net of transaction costs — — — — — Balance as of March 31, 2025 1,216 1,166,466 (629,396) (1,680) 536,606 1 All amounts translated using the exchange rate published by the European Central Bank in effect as of March 31, 2025 (1 EUR = 1.0815 USD).2 France, Germany, Italy, Spain, United Kingdom. 3 Centrally assessed by BICR using RECIST v1.1.4 As of August 23, 2024. Attachment PDF Version

临床1期细胞疗法免疫疗法财报临床3期

2024-11-24

·药明康德

一次注射有效半年的下一代RNAi疗法；12周减少肝脏脂肪近70%的MASH疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. RNAi疗法nucresiran治疗转甲状腺素蛋白（ATTR）介导淀粉样变性患者的早期临床试验结果亮眼，单次给药后第15天，患者平均血清转甲状腺素蛋白（TTR）水平降低超过90%，并维持至试验第6个月。 2. 抗体偶联药物PYX-201在一项1期临床试验中，在头颈部鳞状细胞癌患者中的疾病控制率（DCR）达100%，客观缓解率（ORR）达50%。 3. 用于治疗代谢功能障碍相关性脂肪性肝炎（MASH）和肥胖症的胰高血糖素样肽-1（GLP-1）/胰高血糖素双重受体激动剂pemvidutide在一项早期临床试验中展现积极疗效，患者用药12周后肝脏脂肪含量（LFC）相对基线减少68.5%。药明康德内容团队整理 Nucresiran（ALN-TTRsc04）：公布1期临床试验的新数据 Alnylam Pharmaceuticals公司公布了其下一代RNAi疗法nucresiran（曾用名ALN-TTRsc04）用于治疗转甲状腺素蛋白介导淀粉样变性患者的1期临床研究的最新数据。Nucresiran通过Alnylam专有IKARIA平台所开发，旨在迅速降低突变型和野生型TTR的水平，从根本上治疗ATTR淀粉样变性。Nucresiran具有实现更深层次和更持久TTR快速降低的潜力，从而能够减少用药频率。此次公布的显示，单次给予300 mg或更高剂量的nucresiran，可在第15天实现患者平均血清TTR水平快速降低超过90%，且这一效果持续至试验第6个月。数据表明，nucresiran具有每半年或每年进行一次皮下注射的潜力。Alnylam计划在2025年第一季度公布3期临床开发方案。 PYX-201：公布1期临床试验数据 Pyxis Oncology公司公布了其候选抗体偶联药物PYX-201治疗多种类型实体瘤的1期剂量递增研究的初步积极数据。PYX-201以微管抑制剂（优化的auristatin）作为有效载荷，能独特地靶向肿瘤细胞外基质（ECM）中的一种非细胞结构成分——纤连蛋白B结构域（Extradomain-B Fibronectin，EDB+FN）。截至2024年10月4日的数据，在6例疗效可评估的头颈部鳞状细胞癌患者中，观察到确认的ORR为50%，包括1例确认的完全缓解（CR）和2例确认的部分缓解（PR），DCR为100%。在所有6种研究者感兴趣的实体瘤（头颈部鳞状细胞癌、卵巢癌、非小细胞肺癌、HR+/HER2-乳腺癌、三阴性乳腺癌和肉瘤）患者（n=31）中，ORR为26%，研究人员还观察到剂量依赖性的缓解。此外，PYX-201通常耐受性良好，具有良好的安全性。 Pemvidutide：公布1b期临床试验数据 Altimmune公司公布了pemvidutide治疗代谢功能障碍相关性脂肪性肝病（MASLD）的1b期试验的最新数据。Pemvidutide是一种GLP-1/胰高血糖素双重受体激动剂，目前正在开发用于治疗MASH和肥胖症。该研究中，94名超重或肥胖且LFC≥10%的受试者按1：1：1：1的比例被分配接受pemvidutide（1.2 mg、1.8 mg和2.4 mg）或安慰剂，每周一次皮下注射，持续12周。数据显示，患者血浆中与心血管不良后果相关的多类炎症脂质有所减少。患者接受pemvidutide治疗12周后，LFC相对基线减少了68.5%，总胆固醇和甘油三酯分别最多降低了12.2%和44.6%。研究结果支持pemvidutide对MASH合并症的潜在益处，包括动脉粥样硬化、心脏病和代谢综合征。 IMA402：公布1期临床试验的初步数据 Immatics公司公布了其下一代半衰期延长的T细胞受体（TCR）双特异性分子IMA402的1期剂量递增试验数据。IMA402靶向由HLA-A*02呈递的黑色素瘤抗原PRAME。PRAME是一种在各种实体瘤中经常表达的蛋白质，因此IMA402具潜力治疗广泛的癌症患者群体。截至2024年11月6日的数据，IMA402在接受治疗的33例患者中表现出良好的耐受性。最常见的治疗相关不良事件多为轻度至中度细胞因子释放综合征（CRS）和短暂的淋巴细胞减少症。早期药代动力学数据表明，IMA402的中位半衰期约为7天，有望支持每两周一次的给药方案。9例PRAME检测阳性或未接受PRAME检测的患者中有7例实现了靶病灶缩小，1例皮肤黑色素瘤患者获得了确认的PR，靶病灶已缩小40.2%。 ▲1期剂量递增试验的初步数据（图片来源：参考资料[6]） Mipletamig：公布1b/2期临床试验的初步数据 Aptevo Therapeutics公司公布了其正在进行的1b/2期临床试验RAINIER中首例患者的治疗情况。该研究针对18岁及以上新确诊为急性髓系白血病且不符合强化诱导化疗条件的成人患者，旨在评估使用mipletamig联用标准治疗维奈托克和阿扎胞苷作为一线疗法的效果。APVO436是一种创新双特异性重组蛋白，它像两个单克隆抗体连接在一起，可以同时靶向肿瘤细胞表面的CD123和T淋巴细胞表面的CD3，从而将宿主免疫系统的T细胞重定向到患者的肿瘤细胞上，以快速和完全摧毁表面表达CD123的肿瘤细胞。此次公布的结果显示，首例患者在治疗的前30天内白血病细胞减少了90%，延续了先前研究中观察到的总体疗效趋势。 ST-503：IND申请获得FDA许可 Sangamo Therapeutics公司宣布，美国FDA批准了其在研表观遗传调节剂ST-503的IND申请，用于治疗特发性小纤维神经病变引起的顽固性疼痛（iSFN），这是一种慢性神经病理性疼痛。大量的证据表明，钠通道在介导神经病理性疼痛的病理生理过程中起着重要作用。开发特异性靶向Nav1.7钠通道的小分子药物具有挑战性，因为不同钠通道之间的结构相似性很高，难以实现选择性并避免脱靶效应。ST-503以腺相关病毒（AAV）为载体，携带工程化的锌指抑制子（ZFR），能够特异性地靶向编码Nav1.7钠通道的人类基因SCN9A，该基因在疼痛信号传导中起关键作用。在动物模型中，通过直接靶向SCN9A基因，ST-503被证明可以特异性地减少感觉神经元中Nav1.7钠通道的表达，并在单次鞘内给药后显著减少对疼痛的高敏感性。临床前研究表明，ST-503在非人灵长类动物中具有良好的耐受性，观察到显著的Nav1.7减少且没有脱靶效应，这显示了ST-503治疗慢性神经病理性疼痛的潜力。Sangamo公司正在准备进行1/2期临床研究，以评估单次剂量ST-503的安全性、耐受性和初步疗效，该药物将通过鞘内给药的方式给予iSFN患者，并计划于2025年中期开始患者招募。 ENS-002：1期临床试验完成首例受试者给药 Concerto Biosciences公司宣布，其用于治疗特应性皮炎的微生物组疗法ENS-002的1期临床试验已完成首例受试者给药。ENS-002是该公司利用一种名为kChip的强大筛选技术，从超过600万个皮肤微生物群落中发现的可缓解湿疹的细菌组合，该组合中包含三种菌株，能够抑制皮肤炎症的关键驱动因素金黄色葡萄球菌（S.aureus）。与类固醇和免疫抑制剂相比，该候选疗法旨在解决特应性皮炎背后的微生物组缺陷，以提供一条缓解更持久且副作用更少的潜在新治疗途径。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose. Retrieved November 18, 2024 from https://investors.alnylam.com/press-release?id=28541 [2] Altimmune Presents New Data on the Effect of Pemvidutide on Inflammatory Lipids in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) at The Liver Meeting® 2024. Retrieved November 22, 2024 from https://ir.altimmune.com/news-releases/news-release-details/altimmune-presents-new-data-effect-pemvidutide-inflammatory [3] Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain. Retrieved November 22, 2024 from https://www.businesswire.com/news/home/20241119527555/en/Sangamo-Therapeutics-Announces-U.S.-FDA-Clearance-of-IND-Application-for-ST-503-for-the-Treatment-of-Idiopathic-Small-Fiber-Neuropathy-a-Type-of-Chronic-Neuropathic-Pain [4] Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/20/2984764/0/en/Pyxis-Oncology-Announces-Favorable-Preliminary-PYX-201-Clinical-Phase-1-Part-1-Data.html [5] First Patient Dosed in Aptevo's Ongoing RAINIER Trial Achieves 90% Reduction in Leukemic Blasts Within the First 30 Days of Treatment, Continues Overall Efficacy Trend Seen in Prior Mipletamig AML Studies. Retrieved November 22, 2024 from https://aptevotherapeutics.gcs-web.com/news-releases/news-release-details/first-patient-dosed-aptevos-ongoing-rainier-trial-achieves-90 [6] Immatics Announces Third Quarter 2024 Financial Results, Business Update and First Clinical Data on TCER® IMA402 Targeting PRAME. Retrieved November 22, 2024 from https://investors.immatics.com/news-releases/news-release-details/immatics-announces-third-quarter-2024-financial-results-business [7] Celldex Announces First Patient Dosed in Phase 1 Healthy Volunteer Study of CDX-622, a Bispecific Antibody, for the Treatment of Inflammatory Diseases. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/20/2984404/0/en/Celldex-Announces-First-Patient-Dosed-in-Phase-1-Healthy-Volunteer-Study-of-CDX-622-a-Bispecific-Antibody-for-the-Treatment-of-Inflammatory-Diseases.html [8] Insilico Medicine receives IND clearance from FDA for ISM5939, an oral ENPP1 inhibitor treating solid tumors. Retrieved November 20, 2024, from https://www.eurekalert.org/news-releases/1065685 [9] AmacaThera Announces Phase 1 Results of First-in-Human Study with AMT-143, Exceeding Expectations and Paving the Way for a Novel Approach to Post-Operative Pain Relief. Retrieved November 20, 2024, from https://www.prnewswire.com/news-releases/amacathera-announces-phase-1-results-of-first-in-human-study-with-amt-143-exceeding-expectations-and-paving-the-way-for-a-novel-approach-to-post-operative-pain-relief-302310726.html [10] LAPIX Therapeutics Announces Positive Topline Phase 1 Clinical Data Results with LPX-TI641 for the Treatment of Autoimmune Diseases. Retrieved November 20, 2024, from https://www.globenewswire.com/news-release/2024/11/20/2984711/0/en/LAPIX-Therapeutics-Announces-Positive-Topline-Phase-1-Clinical-Data-Results-with-LPX-TI641-for-the-Treatment-of-Autoimmune-Diseases.html [11] Ocugen Announces Compelling Preliminary Data for OCU410—a Single Dose Novel Modifier Gene Therapy to Treat Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. Retrieved November 20, 2024, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-announces-compelling-preliminary-data-ocu410-single-dose [12] Genethon presents positive initial results from a phase 1/2/3 trial of its gene therapy (GNT0004) for Duchenne Muscular Dystrophy at ASGCT Breakthroughs in Muscular Dystrophy in Chicago. Retrieved November 22, 2024, from https://www.eurekalert.org/news-releases/1065424 [13] REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA. Retrieved November 18, 2024, from https://www.prnewswire.com/news-releases/regenxbio-initiates-pivotal-phase-of-affinity-duchenne-trial-of-rgx-202-gene-therapy-and-reports-positive-functional-data-302307989.html [14] Children's Hospital of Philadelphia Researchers Announce Promising Results from First-of-its-Kind, Multicenter, Phase 1 Gene Therapy Trial for Danon Disease. Retrieved November 22, 2024, from https://www.prnewswire.com/news-releases/childrens-hospital-of-philadelphia-researchers-announce-promising-results-from-first-of-its-kind-multicenter-phase-1-gene-therapy-trial-for-danon-disease-302308857.html [15] Spirovant Sciences Doses First Patient in the SAAVe Phase 1/2 Clinical Trial of Its Investigational, Aerosol-Delivered Genetic Medicine for the Treatment of Cystic Fibrosis. Retrieved November 22, 2024, from https://www.prnewswire.com/news-releases/spirovant-sciences-doses-first-patient-in-the-saave-phase-12-clinical-trial-of-its-investigational-aerosol-delivered-genetic-medicine-for-the-treatment-of-cystic-fibrosis-302304959.html [16] Intellia Announces First Clinical Evidence from Ongoing Phase 1 Study that Nexiguran Ziclumeran (nex-z), an In Vivo CRISPR/Cas9-Based Gene Editing Therapy, May Favorably Impact Disease Progression in Transthyretin (ATTR) Amyloidosis. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/16/2982349/0/en/Intellia-Announces-First-Clinical-Evidence-from-Ongoing-Phase-1-Study-that-Nexiguran-Ziclumeran-nex-z-an-In-Vivo-CRISPR-Cas9-Based-Gene-Editing-Therapy-May-Favorably-Impact-Disease.html [17] CERo Therapeutics, Inc. Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Its Lead Compound CER-1236 in Acute Myelogenous Leukemia. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/15/2982017/0/en/CERo-Therapeutics-Inc-Receives-FDA-Clearance-of-Investigational-New-Drug-Application-to-Initiate-Phase-1-Clinical-Trial-of-Its-Lead-Compound-CER-1236-in-Acute-Myelogenous-Leukemia.html [18] Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE1831 in IgG4-Related Disease. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-investigational-new-drug-application-for-ace1831-in-igg4-related-disease-302306506.html [19] Fate Therapeutics Presents 6-Month Follow-up Data on First Patient Treated in Phase 1 Autoimmunity Study with Fludarabine-free Conditioning and FT819 Off-the-shelf, 1XX CAR T-cell Product Candidate at ACR Convergence. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/18/2982757/24675/en/Fate-Therapeutics-Presents-6-Month-Follow-up-Data-on-First-Patient-Treated-in-Phase-1-Autoimmunity-Study-with-Fludarabine-free-Conditioning-and-FT819-Off-the-shelf-1XX-CAR-T-cell-P.html [20] Cabaletta Bio Presents Positive Clinical Safety and Efficacy Data on CABA-201 at ACR Convergence 2024. Retrieved November 22, 2024 from https://www.cabalettabio.com/news-media/press-releases/detail/119/cabaletta-bio-presents-positive-clinical-safety-and [21] Adicet Bio Announces First Lupus Nephritis Patient Dosed in Phase 1 Clinical Trial of ADI-001 in Autoimmune Diseases. Retrieved November 22, 2024 from https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-announces-first-lupus-nephritis-patient-dosed-phase-1 [22] Fate Therapeutics Highlights FT522 Off-the-shelf, ADR-armed CAR NK Cell Product Candidate at 2024 ACR Convergence. Retrieved November 22, 2024 from https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-ft522-shelf-adr-armed-car-nk-cell [23] RESTEM Presents Phase 1 Data of its ULSC Program in Polymyositis/Dermatomyositis at ACR Convergence 2024. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/18/2982728/0/en/RESTEM-Presents-Phase-1-Data-of-its-ULSC-Program-in-Polymyositis-Dermatomyositis-at-ACR-Convergence-2024.html [24] Theolytics Doses First Patient in Phase I/IIa Trial of THEO-260 in Ovarian Cancer. Retrieved November 22, 2024 from https://www.theolytics.com/post/theolytics-doses-first-patient-in-phase-i-iia-trial-of-theo-260-in-ovarian-cancer [25] Virion Therapeutics Reports First-Ever Clinical Responses with VRON-0200, a Novel Checkpoint Modifier for HBV Functional Cure, at AASLD's The Liver Meeting. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/virion-therapeutics-reports-first-ever-clinical-responses-with-vron-0200-a-novel-checkpoint-modifier-for-hbv-functional-cure-at-aaslds-the-liver-meeting-302304358.html [26] GigaGen Doses First Patient in Phase 1 Trial of Recombinant Polyclonal Drug Candidate, GIGA-2339, for Hepatitis B Virus. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/19/2983574/0/en/GigaGen-Doses-First-Patient-in-Phase-1-Trial-of-Recombinant-Polyclonal-Drug-Candidate-GIGA-2339-for-Hepatitis-B-Virus.html [27] Concerto Biosciences Announces First Participant Dosed with Live Biotherapeutic ENS-002 in Phase 1 Trial for Atopic Dermatitis. Retrieved November 22, 2024 from https://www.prnewswire.com/news-releases/concerto-biosciences-announces-first-participant-dosed-with-live-biotherapeutic-ens-002-in-phase-1-trial-for-atopic-dermatitis-302310102.html [28] Contineum Therapeutics Expands Clinical Development of PIPE-791 With FDA Authorization of Its Investigational New Drug (IND) Application for Chronic Pain. Retrieved November 22, 2024 from https://www.businesswire.com/news/home/20241114778987/en/Contineum-Therapeutics-Expands-Clinical-Development-of-PIPE-791-With-FDA-Authorization-of-Its-Investigational-New-Drug-IND-Application-for-Chronic-Pain/ [29] Karolinska Development’s portfolio company Umecrine Cognition presents positive interim data from Phase 1b/2a clinical study. Retrieved November 22, 2024 from https://www.globenewswire.com/news-release/2024/11/18/2982478/0/en/Karolinska-Development-s-portfolio-company-Umecrine-Cognition-presents-positive-interim-data-from-Phase-1b-2a-clinical-study.html [30] Omega Therapeutics Announces Successful Completion of Phase 1 Trial for Novel Epigenomic Controller, Prioritized Pipeline, Leadership Changes, and Third Quarter 2024 Financial Results. Retrieved November 22, 2024 from https://ir.omegatherapeutics.com/news-releases/news-release-details/omega-therapeutics-announces-successful-completion-phase-1-trial 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果siRNA临床1期临床2期

2024-11-18

·GlobeNewswire-Health Care

Immatics Announces Third Quarter 2024 Financial Results, Business Update and First Clinical Data on TCER® IMA402 Targeting PRAME

The Company will now target five major cancer types with its four clinically active compounds across both TCR-T cell therapies and TCR-based Bispecifics Today, Company discloses first clinical data from the TCR Bispecific molecule, TCER® IMA402 targeting PRAME, in the Phase 1 dose escalation trial, demonstrating a favorable tolerability profile and signs of dose-dependent and PRAME expression-dependent clinical activity, including first objective responses in melanoma patients; early pharmacokinetics data indicate a median half-life of 7 days, potentially enabling bi-weekly dosing; dose escalation is ongoingSUPRAME, the randomized-controlled Phase 3 trial to evaluate ACTengine® IMA203 in 2L+ metastatic melanoma patients, planned to commence in December 2024; pre-specified interim data analysis planned for early 2026Recently, Company presented Phase 1b clinical data on ACTengine® IMA203 targeting PRAME that demonstrate deep and durable responses in heavily pretreated metastatic melanoma patients treated at RP2D; IMA203 continues to maintain a favorable tolerability profile in patients treated across all dose levelsNext-generation ACTengine® IMA203CD8 Phase 1a dose escalation data demonstrate enhanced pharmacology and potency per cell; TCR-T candidate to be evaluated for future development in solid cancers with medium-level PRAME copy numbers, such as ovarian and endometrial cancerClinical proof-of-concept data from the ongoing Phase 1 dose escalation trial with TCER® IMA401 targeting MAGEA4/8 demonstrate initial clinical anti-tumor activity in multiple tumor types and a manageable tolerability profile; dose escalation is ongoing$150 million public offering completed on October 15, 2024As of September 30, 2024, cash and cash equivalents as well as other financial assets amount to $549.2 million1 (€490.5 million), not including the cash inflow from the public offering on October 15, 2024; updated cash reach guidance into 2H 2027 Houston, Texas and Tuebingen, Germany, November 18, 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 provided a business update and reported financial results for the quarter ended September 30, 2024. The Company also reported the first clinical data update from the ongoing Phase 1 dose escalation trial evaluating its next-generation, half-life extended TCR Bispecific molecule, TCER® IMA402 targeting PRAME. “This year, Immatics has demonstrated the strength of its pipeline by announcing data on clinical activity for its four clinical-stage assets across two therapeutic modalities. These include ACTengine® IMA203 targeting PRAME positioned in 2L+ melanoma now moving forward into the Phase 3 trial SUPRAME targeting BLA filing in early 2027; ACTengine® IMA203CD8 targeting hard-to-treat solid cancers with an initial focus on ovarian and endometrial cancers; and TCER® IMA401 targeting MAGEA4/8 demonstrating clinical proof-of-concept during dose escalation and positioned in squamous NSCLC and head and neck cancer. Today, we are very pleased to announce first clinical data on TCER® IMA402 targeting PRAME, which show promising signals of anti-tumor activity during early dose escalation and is initially positioned in 1L+ melanoma,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “With our enhanced cash runway into the second half of 2027, Immatics is well positioned to advance all four candidates to highly relevant value inflection points with a specific focus on delivering meaningful clinical signals in multiple solid cancers in the coming year.” Third Quarter 2024 and Subsequent Company Progress TCR Bispecifics Programs TCER® IMA402 (PRAME) Today, Immatics is providing the first clinical data update from the ongoing Phase 1 dose escalation trial evaluating its next-generation, half-life extended TCR Bispecific molecule, TCER® IMA402 targeting PRAME. Patient Population: As of the data cut-off on November 6, 2024, 33 heavily pretreated patients with recurrent and/or refractory solid tumors have been treated with a dose range from 0.02 mg to 4 mg of IMA402 monotherapy. The treated patient population is composed of patients with a median of three and a maximum of five lines of prior systemic treatments. The safety population includes all 33 patients treated with IMA402, of which 21 patients were evaluable for efficacy analysis and are PRAME-positive or were not tested for PRAME. Of these 21 patients, eight patients received at least one dose of IMA402 at dose level 7 (DL7, 3 mg), and one patient received IMA402 at dose level 8 (DL8, 4 mg). Based on preclinical in-vivo data, relevant anti-tumor efficacy was expected starting at ~3 mg human equivalent dose, which aligns with the initial clinical anti-tumor activity reported today. Safety: IMA402 demonstrated a favorable tolerability profile in the 33 patients treated. The most common treatment-related adverse events (AEs) were mostly mild to moderate cytokine release syndrome (CRS) and transient lymphopenia. Step dosing has been implemented and dose escalation is ongoing. The maximum tolerated dose has not yet been determined. Pharmacokinetics: Early pharmacokinetic data indicate a median half-life of approximately seven days, potentially enabling bi-weekly dosing. Initial Anti-Tumor Activity: Initial signs of clinical activity have been observed and are associated with PRAME expression and IMA402 dose levels administered. In the PRAME-negative patient population across all doses and indications, only one patient out of seven (14%) showed tumor shrinkage of -2.9%.In comparison, in the PRAME-positive or non-tested patients across all indications treated with low dose levels (DLs 1-6), tumor shrinkage was observed in 25% (3/12) of patients, including one unconfirmed partial response in a cutaneous melanoma patient. Nine patients with tumors that tested PRAME-positive or were not tested for PRAME received a relevant dose (8 patients at DL7 and 1 patient at DL8). 78% (7/9) thereof experienced shrinkage of their target lesions, including several patients with significant ongoing tumor shrinkage: one cutaneous melanoma patient with an ongoing (at 3 months post first dose at data cut-off) confirmed partial response with -40.2% tumor shrinkage treated at DL7;two patients with ongoing (at 6+ weeks and 8+ months) stable diseases with significant tumor shrinkage (-27.5% in a patient with cutaneous melanoma at DL8 and at first scan; -25% in a patient with uveal melanoma deepening over time and treated at escalating doses starting at DL4 and currently at DL7);one ovarian cancer patient with ongoing (at 3 months) stable disease and tumor shrinkage of -13% started at DL6 and currently at DL7. Early Signs of Clinical Activity Associated with PRAME Expression and IMA402 Dose *Patients who received DL7 or higher, either from start or as part of intra-patient dose-escalation; #continuing treatment; PD: Progressive Disease; SD: Stable Disease; PR: Partial Response; cPR: confirmed Partial Response; BOR: Best Overall Response; BL: Baseline; NT: not tested or not evaluable for PRAME expression More information and details on the IMA402 clinical data are available on the Events & Presentations page of the Immatics corporate website: https://investors.immatics.com/events-presentations Based on these initial signs of dose-dependent and PRAME target expression-dependent clinical activity observed during dose escalation, the Company will continue to evaluate IMA402 at higher dose levels to determine the optimal therapeutic dose. The next data update on IMA402 is planned for 2025. TCER® IMA401 (MAGEA4/8) On September 16, 2024, Immatics announced the proof-of-concept clinical data for the first candidate of its next-generation, half-life extended TCR Bispecifics platform, TCER® IMA401 (MAGEA4/8), during an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024. As of data cut-off on July 23, 2024, 35 heavily pretreated patients with recurrent and/or refractory solid tumors were treated with IMA401 monotherapy across nine escalating dose levels. The treated patient population was composed of patients with 16 different solid tumor indications who were both HLA-A*02:01 and MAGEA4/8-positive, had received a median of four and up to eight lines of prior systemic treatments and the majority had an ECOG performance status of ≥ 1. Proof-of-concept clinical data from the Phase 1a first-in-human dose escalation basket trial showed initial anti-tumor activity in multiple tumor types, durable objective responses, including confirmed responses ongoing at 13+ months, a manageable tolerability profile and a half-life of 14+ days. Treatment with IMA401 monotherapy in patients with relevant IMA401 doses and MAGEA4/8high levels (N=17) demonstrated: Objective response rate of 29% with confirmed responses observed in 25% of patients Disease control rate of 53% and tumor shrinkage of 53% As the clinical trial progresses, the Company aims to further leverage the potential of IMA401 by focusing on the enrollment of indications with high MAGEA4/8 target expression, such as lung and head and neck cancer patients, seeking to optimize the treatment schedule and also exploring the incremental clinical benefit available to patients through combining IMA401 with a checkpoint inhibitor. The next data update on IMA401 is expected in 2025. ACTengine® Cell Therapy Programs ACTengine® IMA203 On November 8, 2024, Immatics announced an expanded clinical dataset that included all infused patients in the Phase 1b dose expansion part of the trial (N=41), consisting of the 28 melanoma patients reported on October 10, 2024, and 13 non-melanoma patients, of which 10 non-melanoma patients were reported on November 8, 2023. As of the data cut-off on August 23, 2024, treatment with IMA203 monotherapy in the melanoma patient population has demonstrated: Confirmed objective response rate of 54% and an objective response rate of 62% Disease control rate of 92% and tumor shrinkage in 88% of patients12.1 months median duration of response, 6 months median progression-free survival and >1-year median progression-free survival in patients with deep responsesMedian overall survival has not yet been reached IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 events in the entire safety population (N=70 Phase 1a and Phase 1b patients across all dose levels and all tumor types). Based on the Phase 1b data and discussions with the U.S. Food and Drug Administration, Immatics is on track to commence SUPRAME, the registration-enabling Phase 3 randomized-controlled clinical trial in melanoma for IMA203, in December 2024. SUPRAME 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, including nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (U.S. only) or chemotherapy. The primary endpoint for full approval will be median PFS and secondary endpoints will include objective response rate, safety, duration of response, no overall survival detriment and patient-reported outcomes. Patient enrollment for SUPRAME is forecast to be completed in 2026, and a pre-specified interim analysis is planned for early 2026. Immatics aims to submit a Biologics License Application (BLA) in early 2027 for full approval. ACTengine® IMA203CD8 (GEN2) monotherapy On November 8, 2024, Immatics announced updated Phase 1 dose escalation clinical data on its next-generation ACTengine® IMA203CD8 TCR-T cell therapy in 44 heavily pretreated HLA-A*02:01 and PRAME-positive patients with solid tumors, thereof 41 patients being evaluable for efficacy. Of note, these patients had been treated at substantially lower doses compared to IMA203 (GEN1), i.e. in a range of 0.2-0.48x109 TCR-T cells/m2 BSA (dose level 3) to 0.801-1.2x109 TCR-T cells/m2 BSA (dose level 4c) T cells infused. As of the data cut-off on September 30, 2024, treatment with IMA203CD8 monotherapy demonstrated: Confirmed objective responses observed in 41% of patientsMedian duration of response of 9.2 months at a median follow-up of 13.1 monthsTumor shrinkage of 84% and disease control rate at week 6 of 85%10 out of 17 responses were ongoing, of which three confirmed responses were ongoing at 14+, 15+ and 24+ months Deep responses with ≥50% tumor size reduction were observed in 11 out of 17 responders. This group included two patients with complete response of target lesions, of which one patient showed a complete metabolic response according to PET-CT scan IMA203CD8 monotherapy has maintained a manageable tolerability profile in the 44 patients treated. Based on the enhanced pharmacology of IMA203CD8 demonstrated in this trial, the evaluation of higher doses of IMA203CD8 in the ongoing dose escalation trial opens the possibility of addressing hard-to-treat solid tumor indications with a medium-level of PRAME copy numbers, such as ovarian cancer and endometrial cancer. Corporate Development In September 2024, Immatics regained full clinical development and commercialization rights to IMA401 due to ongoing portfolio prioritization efforts within Bristol Myers Squibb. The Phase 1 dose escalation trial with IMA401 is ongoing and will continue to be conducted by Immatics. Third Quarter 2024 Financial Results Cash Position: Cash and cash equivalents as well as other financial assets total $549.2 million1 (€490.5 million) as of September 30, 2024, compared to $476.8 million1 (€425.9 million) as of December 31, 2023. The increase is mainly due to the public offering in January 2024, partly offset by ongoing research and development activities. Following the $150 million public offering in October 2024, the Company now projects a cash runway into the second half of 2027. Revenue: Total revenue, consisting of revenue from collaboration agreements, was $56.7 million1 (€50.6 million) for the three months ended September 30, 2024, compared to $6.6 million1 (€5.9 million) for the three months ended September 30, 2023. The increase is mainly the result of a one-time revenue associated with the termination of the IMA401 collaboration by Bristol Myers Squibb during the three months ended September 30, 2024. Research and Development Expenses: R&D expenses were $43.6 million1 (€38.9 million) for the three months ended September 30, 2024, compared to $34.1 million1 (€30.5 million) for the three months ended September 30, 2023. The increase mainly resulted from costs associated with the advancement of the clinical pipeline candidates.General and Administrative Expenses: G&A expenses were $12.5 million1 (€11.2 million) for the three months ended September 30, 2024, compared to $10.0 million1 (€8.9 million) for the three months ended September 30, 2023. Net Profit and Loss: Net loss was $9.6 million1 (€8.6 million) for the three months ended September 30, 2024, compared to a net loss of $29.7 million1 (€26.5 million) for the three months ended September 30, 2023. The decrease in net loss results from the increase in recognized revenue in the period. Full financial statements can be found in the 6-K filed with the Securities and Exchange Commission (SEC) on November 18, 2024, and published on the SEC website under www.sec.gov. Upcoming Investor Conferences Jefferies London Healthcare Conference, London, United Kingdom – November 19 – 21, 2024 To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations. About IMA402TCER® IMA402 is a drug candidate owned by Immatics. IMA402 is Immatics’ second TCER® molecule from the bispecifics pipeline and is directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies. - END - About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on X, Instagram and LinkedIn. Forward-Looking StatementsCertain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND or CTA filing for pre-clinical stage product candidates, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: Media Trophic Communications Phone: +49 171 3512733 immatics@trophic.eu Immatics N.V. Jordan Silverstein Head of Strategy Phone: +1 346 319-3325 InvestorRelations@immatics.com Immatics N.V. and subsidiariesCondensed Consolidated Statement of Loss of Immatics N.V. Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 (Euros in thousands, exceptper share data) (Euros in thousands, exceptper share data) Revenue from collaboration agreements 50,559 5,926 99,583 38,076 Research and development expenses (38,906) (30,498) (106,230) (85,396) General and administrative expenses (11,156) (8,881) (32,925) (27,825) Other income 17 186 54 1,134 Operating result 514 (33,267) (39,518) (74,011) Change in fair value of liabilities for warrants 3,833 (1,395) 4,228 (7,103) Other financial income 5,889 9,748 18,707 14,414 Other financial expenses (12,589) (1,575) (5,342) (4,146) Financial result (2,867) 6,778 17,593 3,165 Loss before taxes (2,353) (26,489) (21,925) (70,846) Taxes on income (6,217) — (7,720) — Net loss (8,570) (26,489) (29,645) (70,846) Net loss per share: Basic (0.08) (0.32) (0.29) (0.90) Diluted (0.11) (0.32) (0.31) (0.90) Immatics N.V. and subsidiariesCondensed Consolidated Statement of Comprehensive Loss of Immatics N.V. Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 (Euros in thousands) (Euros in thousands) Net loss (8,570) (26,489) (29,645) (70,846) Other comprehensive income Items that may be reclassified subsequently to profit or loss Currency translation differences from foreign operations (1,377) 429 (579) 769 Total comprehensive loss for the year (9,947) (26,060) (30,224) (70,077) Immatics N.V. and subsidiariesCondensed Consolidated Statement of Financial Position of Immatics N.V. As of September 30,2024 December 31,2023 (Euros in thousands) Assets Current assets Cash and cash equivalents 189,199 218,472 Other financial assets 301,321 207,423 Accounts receivables 2,951 4,093 Other current assets 19,306 19,382 Total current assets 512,777 449,370 Non-current assets Property, plant and equipment 48,424 43,747 Intangible assets 1,506 1,523 Right-of-use assets 13,327 13,308 Other non-current assets 1,199 2,017 Total non-current assets 64,456 60,595 Total assets 577,233 509,965 Liabilities and shareholders’ equity Current liabilities Provisions 5,144 — Accounts payables 22,095 25,206 Deferred revenue 68,928 100,401 Liabilities for warrants 14,765 18,993 Lease liabilities 2,825 2,604 Other current liabilities 15,155 9,348 Total current liabilities 128,912 156,552 Non-current liabilities Deferred revenue 52,597 115,527 Lease liabilities 13,198 12,798 Other non-current liabilities — 4 Total non-current liabilities 65,795 128,329 Shareholders’ equity Share capital 1,031 847 Share premium 1,010,648 823,166 Accumulated deficit (626,938) (597,293) Other reserves (2,215) (1,636) Total shareholders’ equity 382,526 225,084 Total liabilities and shareholders’ equity 577,233 509,965 Immatics N.V. and subsidiariesCondensed Consolidated Statement of Cash Flows of Immatics N.V. Nine months ended September 30, 2024 2023 (Euros in thousands) Cash flows from operating activities Net loss (29,645) (70,846) Taxes on income 7,720 — Loss before tax (21,925) (70,846) Adjustments for: Interest income (18,185) (8,993) Depreciation and amortization 9,149 5,432 Interest expenses 654 620 Equity-settled share-based payment 13,112 16,299 Loss from disposal of fixed assets 1 Net foreign exchange differences and expected credit losses 4,018 (760) Change in fair value of liabilities for warrants (4,228) 7,103 Changes in: Decrease in accounts receivables 1,142 596 Decrease/(increase) in other assets (2,623) 658 (Decrease) in deferred revenue, accounts payables and other liabilities (91,113) (15,641) Interest received 11,098 4,904 Interest paid (654) (221) Income tax paid — — Net cash used in operating activities (99,554) (60,849) Cash flows from investing activities Payments for property, plant and equipment (14,598) (21,506) Payments for intangible assets (148) (158) Payments for investments classified in other financial assets (356,596) (299,018) Proceeds from maturity of investments classified in other financial assets 266,361 229,557 Proceeds from disposal of property, plant and equipment 1 — — — Net cash used in investing activities (104,980) (91,125) Cash flows from financing activities Proceeds from issuance of shares to equity holders 174,554 90,404 Transaction costs deducted from equity (2,039) Repayments related to lease liabilities (1,228) (2,877) Net cash provided by financing activities 173,326 85,488 Net decrease in cash and cash equivalents (31,208) (66,486) Cash and cash equivalents at beginning of the year 218,472 148,519 Effects of exchange rate changes, expected credit losses and accrued intereston cash and cash equivalents 1,935 1,413 Cash and cash equivalents at end of the year 189,199 83,446 Immatics N.V. and subsidiariesCondensed Consolidated Statement of Changes in Shareholders’ Equity of Immatics N.V. (Euros in thousands) Sharecapital Sharepremium Accumulateddeficit Otherreserves Totalshare-holders’equity Balance as of January 1, 2023 767 714,177 (500,299) (1,481) 213,164 Other comprehensive income — — — 769 769 Net loss — — (70,846) — (70,846) Comprehensive loss for the year — — (70,846) 769 (70,077) Equity-settled share-based compensation — 16,299 — — 16,299 Share options exercised — 140 — — 140 Issue of share capital – net of transaction costs 80 88,145 — — 88,225 Balance as of September 30, 2023 847 818,761 (571,145) (712) 247,751 Balance as of January 1, 2024 847 823,166 (597,293) (1,636) 225,084 Other comprehensive income — — — (579) (579) Net loss — — (29,645) — (29,645) Comprehensive loss for the year — — (29,645) (579) (30,224) Equity-settled share-based compensation — 13,112 — — 13,112 Share options exercised 1 1,113 — — 1,114 Issue of share capital – net of transaction costs 183 173,257 — — 173,440 Balance as of September 30, 2024 1,031 1,010,648 (626,938) (2,215) 382,526 1 All amounts translated using the exchange rate published by the European Central Bank in effect as of September 30, 2024 (1 EUR = 1.1196 USD). 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临床1期临床结果免疫疗法财报细胞疗法

100 项与 IMA-402 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
难治性癌症	临床2期	德国	Immatics Biotechnologies GmbH	2023-08-09
难治性癌症	临床2期	荷兰	Immatics Biotechnologies GmbH	2023-08-09
实体瘤	临床2期	德国	Immatics Biotechnologies GmbH	2023-08-09
实体瘤	临床2期	荷兰	Immatics Biotechnologies GmbH	2023-08-09

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05958121 (GlobeNewswire) 人工标引	临床1期	实体瘤	33	TCER® IMA402 (PRAME Negative)	衊餘廠顧衊鹹願壓廠獵(憲膚糧憲觸餘夢憲廠鬱) = 鏇顧鹹製製憲築廠廠構廠選壓襯窪襯窪壓醖築 (繭構夢觸築蓋鬱鬱鹹廠 ) 更多	积极	2024-11-18
NCT05958121 (GlobeNewswire) 人工标引	临床1期	实体瘤	33	TCER® IMA402 (PRAME Positive or were not tested)	衊餘廠顧衊鹹願壓廠獵(憲膚糧憲觸餘夢憲廠鬱) = 願衊築積襯繭夢鹹範壓廠選壓襯窪襯窪壓醖築 (繭構夢觸築蓋鬱鬱鹹廠 )	积极	2024-11-18
ESMO2022	临床1期	实体瘤	-	IMA402	構糧艱積鹹鬱積鏇艱餘(鑰齋範鬱壓選觸繭壓窪) = 築範壓繭願網鑰鬱鹹齋醖築鑰襯憲鹽餘壓鹹夢 (齋願選顧襯鏇願醖淵簾 ) 更多	-	2022-09-10