Tovecimig

Tovecimig (DLL4 x VEGF-A bispecific antibody) met the primary endpoint in the ongoing randomized Phase 2/3 Study in patients with biliary tract cancer (BTC). Achieved a 17.1% overall response rate (ORR), including one complete response, compared to a 5.3% ORR for paclitaxel alone, in patients with BTC treated in the second-line setting. First patient dosed and actively enrolling patients in an Investigator Sponsored Trial (IST) evaluating tovecimig in patients with BTC in the first-line setting.Successfully completed a pre-IND meeting for CTX-10726 (PD-1 x VEGF-A bispecific antibody), maintaining progress towards expected Q4 2025 IND filing and 2026 clinical data.Advanced the Phase 1 dose-escalation study of CTX-8371 in a post-checkpoint inhibitor patient population to the fourth dosing cohort with no dose-limiting toxicities observed to date; data from this study are expected in the second half of 2025.Ended Q1 with $113 million in cash and marketable securities, which is expected to provide cash runway into the first quarter of 2027. BOSTON, May 08, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, today reported first quarter 2025 financial results and provided a business update. “We’re proud of the progress we’ve made this quarter, especially the achievement of the primary endpoint in our COMPANION-002 trial. These positive data reinforce the potential for tovecimig to fill a striking gap in the treatment paradigm for patients with BTC. We expect to share analyses of the secondary endpoints, including progression free survival (PFS), overall survival (OS) and duration of response (DoR), in the fourth quarter of this year,” said Thomas Schuetz, MD, PhD, Chief Executive Officer and Vice Chairman of the Board of Directors. “In parallel, the first patient has been dosed in the IST at The University of Texas MD Anderson Cancer Center evaluating tovecimig in the front-line setting for patients with BTC, and the study continues to actively enroll.” “We continue to advance CTX-10726, our differentiated PD-1 x VEGF-A bispecific antibody, with IND filing expected in Q4. There has been very promising clinical data from other drugs in this class, and we look forward to beginning Phase 1 studies and reporting clinical data for CTX-10726 in 2026.” “CTX-8371, our PD-1 x PD-L1 bispecific has also progressed to the fourth dosing cohort in patients in whom checkpoint inhibitors have failed, and we look forward to sharing data from the study later this year.” Dr. Schuetz continued, “Finally, our balance sheet remains strong and we ended the quarter with $113 million, funding our cash runway into 2027.” Development Pipeline Updates: Tovecimig (DLL4 and VEGF-A bispecific antibody) Met the primary endpoint in the ongoing randomized Phase 2/3 COMPANION-002 Study in patients with BTC (see press release). The study enrolled 168 adult patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). Tovecimig in combination with paclitaxel achieved a 17.1% ORR, including one complete response, compared to a 5.3% ORR for paclitaxel alone, in patients with BTC treated in the second-line setting.At a prespecified analysis, conducted by blinded independent central radiology (BICR) review, tovecimig plus paclitaxel demonstrated a statistically significant (p=0.031) and clinically meaningful improvement in ORR (the primary endpoint) compared to paclitaxel alone.The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig in combination with paclitaxel versus 42.1% in patients on paclitaxel alone.The pre-specified number of events required to trigger the analyses of the secondary endpoints, including PFS, OS and DoR, has not yet been met due to fewer of these events occurring than were originally modeled. The Company expects to report the results of the analyses of these endpoints in Q4 of this year. The first patient has been dosed in an IST at The University of Texas MD Anderson Cancer Center, and the study is actively enrolling. In the IST, tovecimig is being added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab (see press release).The previously planned Phase 2 colorectal cancer study will be replaced by a Phase 2 basket study of tovecimig, which is expected to begin following the analyses of the secondary endpoint data from the COMPANION-002 BTC trial. The basket study will include a broader set of DLL4+ cancers, such as gastric, ovarian, renal, hepatocellular, and colorectal. CTX-10726 (PD-1 x VEGF-A bispecific antibody) CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered at Compass. CTX-10726 is designed to synergistically deliver VEGF-A blockade and checkpoint inhibition, potentially applicable to multiple solid tumor indications. The bispecific antibody demonstrates a highly stable structure with high affinity target binding. CTX-10726 has exhibited more potent PD-1 blockade in preclinical studies, compared with data reported for other drugs in the class.Advanced preclinical development and IND-enabling studies for CTX-10726.Successfully completed a pre-IND Meeting with the FDA, with expected IND submission in Q4 2025. CTX-471 (CD137 agonist antibody) CTX-471 is a CD137 agonist antibody, which has been shown to bind to a unique epitope of the co-stimulatory molecule 4-1BB with an optimized affinity.In 2024, CTX-471 clinical data were presented at multiple scientific meetings, including data demonstrating durable clinical responses in Phase 1 presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and data showing a correlation between levels of NCAM (CD56) expression and disease control presented at the 39th Society for Immunotherapy of Cancer 2024 Annual Meeting.Phase 2 trial initiation of CTX-471 in patients with tumors expressing NCAM (CD56) is expected in the second half of 2025. CTX-8371 (PD-1 x PD-L1 bispecific antibody) CTX-8371 is a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 and has been shown to exhibit a unique mechanism-of-action that involves cleavage of cell surface PD-1.No dose-limiting toxicities (DLTs) have been observed in the first three dosing cohorts in the Phase 1 dose-escalation study of CTX-8371.Currently evaluating the fourth dosing cohort with preliminary data expected in the second half of 2025. Financial Results Net loss for the quarter ended March 31, 2025, was $16.6 million or $0.12 per share of common stock, compared to $10.8 million or $0.08 per share of common stock for the same period in 2024. Research and Development (R&D) Expenses R&D expenses were $13.1 million for the quarter ended March 31, 2025, as compared to $9.5 million for the same period in 2024, an increase of $3.6 million, or 37%. This increase was primarily attributable to additional spending on manufacturing for tovecimig and CTX-10726 of $2.5 million and $0.9 million on additional personnel costs for R&D personnel. General and Administrative (G&A) Expenses G&A expenses were $4.9 million for the quarter ended March 31, 2025, as compared to $3.2 million for the same period in 2024, an increase of $1.7 million or 51%. The increase was primarily attributable to $1.3 million of additional G&A personnel costs including $1.0 million related to share-based compensation. Cash Position As of March 31, 2025, cash and marketable securities were $113 million as compared to $127 million as of December 31, 2024, providing the Company with an anticipated cash runway into 2027. During the first three months of 2025, $13 million of net cash was used in operating activities. About Compass TherapeuticsCompass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company’s pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com. Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their preclinical and clinical development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, initiate and complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. Investor Contactir@compasstherapeutics.com Media Contact Anna Gifford, Chief of Staff media@compasstherapeutics.com617-500-8099 Compass Therapeutics, Inc. and SubsidiariesCondensed Consolidated Statements of Operations (In thousands, except per share data) Three Months Ended March 31, 2025 2024 (unaudited) Operating expenses: Research and development $13,054 $9,522 General and administrative 4,912 3,248 Loss from operations (17,966) (12,770) Other income 1,333 1,983 Net loss $(16,633) $(10,787) Net loss per share - basic and diluted $(0.12) $(0.08) Basic and diluted weighted average shares outstanding 138,236 136,608 Compass Therapeutics, Inc. and SubsidiariesCondensed Consolidated Balance Sheets (In thousands, except par value) March 31, 2025 December 31, 2024 (unaudited) Assets Current assets: Cash and cash equivalents $41,048 $43,483 Marketable securities 71,587 83,239 Prepaid expenses and other current assets 11,510 6,029 Total current assets 124,145 132,751 Property and equipment, net 231 353 Operating lease, right-of-use ("ROU") asset 6,507 6,731 Other assets 568 568 Total assets $131,451 $140,403 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $1,577 $2,249 Accrued expenses 13,214 6,287 Operating lease obligations, current portion 109 338 Total current liabilities 14,900 8,874 Operating lease obligations, long-term portion 6,272 6,296 Total liabilities 21,172 15,170 Total stockholders' equity 110,279 125,233 Total liabilities and stockholders' equity $131,451 $140,403

本期看点1. 下一代CD47阻断疗法evorpacept联用标准化疗方案治疗复发或难治性B细胞非霍奇金淋巴瘤（R/R B-NHL）的早期临床试验结果亮眼，80%患者获得完全缓解（CR），两年总生存（OS）率为84%。2. T细胞激活剂invikafusp alfa的1/2期临床试验结果积极，在肿瘤突变负荷高（TMB-H），对PD-1/PD-L1耐药且接受过大量前期治疗的难治性患者中的疾病控制率（DCR）为67%。3. Dectin-2靶向抗体BDC-3042在1期临床试验中展现积极抗肿瘤作用，在17例患有6种不同类型肿瘤的患者中，80%（12/15）的可评估患者达到了疾病稳定（SD）或更好的状态。Evorpacept（ALX148）：公布1/2期联合治疗试验数据ALX Oncology公司公布了其CD47抑制剂evorpacept与标准治疗方案利妥昔单抗和来那度胺（R²）联用的1/2期由研究者发起的临床试验（IST）的积极数据，该试验针对复发或难治性B细胞非霍奇金淋巴瘤患者。Evorpacept是一种下一代CD47阻断疗法，它将高亲和性CD47结合结构域与经特殊处理的Fc结构域相结合，因此无法激活Fc受体，有望降低CD47靶向抗体因激活Fc受体可能产生的毒副作用。此外，与其它抗CD47抗体相比，evorpacept的分子量更小，更容易渗透到实体瘤中，从而提高疗效。此次试验共纳入20例惰性（18例）和侵袭性（2例）R/R B-NHL患者，所有患者均曾接受过抗CD20单抗治疗。在中位随访28个月后，联合治疗组患者的两年无进展生存（PFS）率为69%，两年OS率为84%。16例患者（80%）达到CR，最佳总缓解率（ORR）为90%。18例接受evorpacept联用R²方案的惰性NHL患者的CR率为83%，高于历史上在仅使用R²方案的类似患者中观察到的34%的CR率。此外，治疗期间观察到T细胞和抗肿瘤巨噬细胞显著增加。安全性方面，该联合治疗方案耐受性良好，未出现剂量限制性毒性。Invikafusp alfa（STAR0602）：公布1/2期临床试验数据Marengo Therapeutics公司将公布其潜在“first-in-class”T细胞激活剂invikafusp alfa的1/2期临床试验更新结果。Invikafusp alfa是一款双特异性融合蛋白，它不但可以与T细胞受体的Vβ链结合，还可以激活另一条T细胞共刺激信号通路，促进特定效应Vβ T细胞的扩增，从而增强抗肿瘤免疫反应。摘要结果显示，在肿瘤突变负荷高（TMB-H），对PD-1/PD-L1耐药且接受过大量前期治疗的难治性患者中，优化剂量的invikafusp alfa在9名可评估疗效的患者中达到67%的DCR，其中两名患者获得确认部分缓解（PR），一名患者缓解持续时间超过12个月。此外，研究发现CD8阳性、Vβ T细胞的剂量依赖性、选择性扩增，在2期临床推荐剂量下最高扩增600%。扩增的Vβ T细胞表现出记忆表型并表达细胞毒性效应分子。基于初步临床及临床前结果，美国FDA已授予invikafusp alfa治疗TMB-H结直肠癌的快速通道资格。BDC-3042：公布1期临床试验数据Bolt Biotherapeutics公司公布了其抗体疗法BDC-3042的1期剂量递增研究结果。BDC-3042是一种靶向dectin-2的激动剂抗体，dectin-2是一种由肿瘤相关巨噬细胞（TAM）表达的免疫激活受体。作为C型凝集素受体，dectin-2在病原体识别及诱导保护性免疫反应中发挥着关键作用。截至2025年4月7日的数据，BDC-3042在10 mg/kg每两周一次的剂量下表现出良好的耐受性，未出现剂量限制性毒性或药物相关严重不良事件。同时，该药物显示出明确的生物学活性，促炎细胞因子和趋化因子水平呈剂量依赖性升高。BDC-3042展现出潜在的抗肿瘤活性，80%的可评估患者（12/15）的最佳缓解为SD或更好，所有3例非小细胞肺癌患者均实现≥12周的SD，包括1例未确认的PR。Tovecimig（CTX-009）：研究者发起的临床试验完成首例患者给药Compass Therapeutics公司宣布，其靶向DLL4和VEGF-A的双特异性抗体tovecimig（CTX-009）用于一线治疗胆道癌（BTC）的IST研究已完成首例患者给药。Tovecimig通过同时阻断促血管生成的DLL4和VEGF-A信号通路发挥抗肿瘤作用。临床前及早期临床数据显示，其在结直肠癌、胃癌、胆管癌、胰腺癌和非小细胞肺癌等多种实体瘤中具有活性。在既往接受过多种治疗且对已获批抗VEGF疗法产生耐药的晚期癌症患者群体中，已观察到接受tovecimig单药治疗的患者获得了PR。VS-7375：IND申请获得FDA许可Verastem Oncology公司宣布，美国FDA已批准其口服KRAS G12D（ON/OFF）抑制剂VS-7375的IND申请，公司预计将于2025年年中启动一项1/2a期临床研究，并计划在晚期实体瘤（如胰腺癌、结直肠癌和非小细胞肺癌）中开展多个扩展队列试验，包括联合疗法评估。VS-7375由Verastem Oncology与劲方医药合作开发，是一款口服高活性、高选择性小分子KRAS G12D（ON/OFF）抑制剂，通过非共价形式结合KRAS G12D蛋白，抑制其与下游效应蛋白结合，从而在细胞中破坏KRAS G12D对下游通路的持续活化，最终高效抑制肿瘤细胞增殖。参考资料（可上下滑动查看）[1] Korea’s InThera receives IND approval for norovirus vaccine candidate. Retrieved April 25, 2025, from https://www.koreabiomed.com/news/articleView.html?idxno=27327[2] Compass Therapeutics Announces First Patient Dosed in an Investigator Sponsored Trial of Tovecimig in the First-Line Setting for Patients with Biliary Tract Cancer. Retrieved April 25, 2025, from https://www.globenewswire.com/news-release/2025/04/21/3064600/0/en/Compass-Therapeutics-Announces-First-Patient-Dosed-in-an-Investigator-Sponsored-Trial-of-Tovecimig-in-the-First-Line-Setting-for-Patients-with-Biliary-Tract-Cancer.html[3] Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody. 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Retrieved April 25, 2025, from https://www.globenewswire.com/news-release/2025/04/22/3065332/0/en/Kymera-Therapeutics-Announces-First-Patient-Dosed-in-BROADEN-Phase-1b-Atopic-Dermatitis-Clinical-Trial-of-KT-621-a-First-in-Class-Oral-STAT6-Degrader.html[8] Onward Therapeutics Announces IMPD Approval for Its Subsidiary Emercell to Start Clinical Investigation of Allogeneic NK Cell Therapy OT-C001 in Combination with Rituximab. Retrieved April 25, 2025, from https://www.prnewswire.com/news-releases/onward-therapeutics-announces-impd-approval-for-its-subsidiary-emercell-to-start-clinical-investigation-of-allogeneic-nk-cell-therapy-ot-c001-in-combination-with-rituximab-302433928.html[9] CytoAgents Announces Completion of Cohort 1 Dose-escalation Stage of Clinical Phase 1B to Advance Research on Cytokine Release Syndrome. 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Retrieved April 25, 2025, from https://www.abstractsonline.com/pp8/#!/20273/presentation/10430[14] Bolt Biotherapeutics Presents Results from the Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025. Retrieved April 25, 2025, from https://www.globenewswire.com/news-release/2025/04/25/3068520/0/en/Bolt-Biotherapeutics-Presents-Results-from-the-Phase-1-Dose-Escalation-Clinical-Study-of-BDC-3042-at-AACR-Annual-Meeting-2025.html免责声明：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：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2