DLL4

Enrollment in COMPANION-002, the Phase 2/3 randomized study of CTX-009 (DLL4 x VEGF-A bispecific antibody) in patients with advanced biliary tract cancer (BTC), continues to progress well; top-line data from this study are expected by the end of 2024.Enrollment in COMPANION-003, the Phase 2 study of CTX-009 in patients with advanced colorectal cancer (CRC) was completed in the first quarter of 2024; top-line data from Stage 1 of this study are expected by mid-year 2024. Initiated planning of a Phase 2 monotherapy study of CTX-471 (CD137 agonist antibody) in patients with advanced melanoma whose tumors express a newly identified biomarker of CTX-471 activity. Additionally, enrollment of patients in the combination arm of CTX-471 with KEYTRUDA® Phase 1b study is ongoing. Advanced CTX-8371 (PD-1 x PD-L1 bispecific antibody) into Phase 1 first-in-human study and expect to dose first patient by early second quarter. Ended 2023 with $152 million in cash and marketable securities, which is expected to provide cash runway into mid-year 2026. BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported full 2023 financial results and provided business update. “2023 was an important year for Compass as we strategically shifted our focus toward the clinical development of our lead program, CTX-009, which is currently being evaluated in patients with advanced biliary tract cancer and advanced colorectal cancer,” said Vered Bisker-Leib, PhD, Chief Executive Officer. “This year we expect to report top-line data from Stage 1 of the Phase 2 COMPANION-003 trial by mid-year and top-line data from our Phase 2/3 COMPANION-002 trial by the end of the year. Our balance sheet remains strong and we ended the year with $152 million, extending our cash runway into the middle of 2026.” “In 2023, we made significant progress across our clinical programs,” said Thomas Schuetz, MD, PhD, Co-Founder and President of Research & Development at Compass. “In the monotherapy study of CTX-471, our novel CD137 agonist antibody, we reported additional partial responses in patients with advanced melanoma, a complete response in a patient with small cell lung cancer, and a partial response in a patient with mesothelioma, all of whom had previously progressed on a checkpoint blocker. Importantly, we have identified a potential biomarker of response in biopsy specimens from this study and we are now planning a Phase 2 study in patients whose tumors express this biomarker. We also initiated the combination arm of the CTX-471 with KEYTRUDA® Phase 1b study under clinical collaboration with Merck. Finally, we filed and obtained regulatory clearance to begin clinical trials with CTX-8371, our novel checkpoint blocker, and advanced this bispecific into a first-in-human study.” Development Pipeline Updates: CTX-009 (DLL4 and VEGF-A bispecific antibody) Continue to enroll patients in COMPANION-002, a U.S. Phase 2/3 randomized study of CTX-009 in combination with paclitaxel in patients with advanced BTC. This study is designed to enroll 150 patients who have received one prior systemic therapy.The primary endpoint of the study is overall response rate (ORR), and secondary endpoints include progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR) and duration of response (DOR).Enrollment is expected to be completed by mid-year 2024; top-line data are expected by year end 2024. Completed enrollment of patients in Stage 1 of COMPANION-003, a U.S. Phase 2 study of CTX-009 as a monotherapy in patients with advanced, metastatic CRC. The study design is an Adaptive Simon Two-Stage. Stage 1 of the study enrolled 37 patients with CRC who have received two or three prior systemic therapies irrespective of their KRAS mutation status.Top-line data is expected by mid-year 2024.If adequate efficacy is observed in Stage 1, the study will continue to Stage 2 where 47 additional patients are expected to be enrolled. CTX-471 (CD137 agonist antibody) CTX-471 is a CD137 agonist antibody, which binds to a unique epitope of the co-stimulatory molecule 4-1BB with an optimized affinity.In the Phase 1B monotherapy study, five responses were observed, all in patients who previously received checkpoint inhibitors. A durable partial response (PR) in a patient with SCLC has converted to a complete response (CR), as confirmed by a PET scan. Additionally, a new PR in a patient with advanced melanoma, was observed, leading to an objective response rate (ORR) in the subset of patients with advanced melanoma of 27% (3 of 11). The fifth response occurred in a patient with mesothelioma.Ongoing analysis of biopsy specimens from the Phase 1b study revealed a potential biomarker of response. As a result, planning for a Phase 2 monotherapy study in patients with melanoma whose tumors express this biomarker is underway.Ongoing enrollment of up to 60 patients in the Phase 1b dose-expansion cohort of the combination arm of CTX-471 and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) with melanoma, NSCLC and SCLC, who will be randomly assigned to one of two doses. 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 exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1.Following the FDA acceptance of the IND for CTX-8371, clinical sites were opened and the first patient is expected to be dosed by early second quarter. Financial Results Net loss for the year ended December 31, 2023, was $42.5 million or $0.33 per common share, compared to $39.2 million or $0.37 per common share for the same period in 2022. Research and Development (R&D) Expenses R&D expenses were $38.1 million for the year ended December 31, 2023, as compared to $30.0 million for the same period in 2022, an increase of $8.1 million or 27%. This increase was primarily attributable to a $10.7 million increase in clinical and manufacturing costs related to our lead program, CTX-009. General and Administrative (G&A) Expenses G&A expenses were $12.2 million for the year ended December 31, 2023, as compared to $11.7 million for the same period in 2022, an increase of $0.6 million or 5%. The increase was primarily attributable to higher stock compensation expense of $1.0 million offset by lower insurance costs of $0.3 million. Cash Position As of December 31, 2023, cash and marketable securities were $152.5 million as compared to $186.6 million as of December 31, 2022, providing the Company with an anticipated cash runway into mid-2026. During 2023, the Company decreased its cash position by $34.1 million, primarily from $40.6 million of net cash used in operating activities. About Compass TherapeuticsCompass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company 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 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, 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, Senior Manager of Communications media@compasstherapeutics.com617-500-8099 Compass Therapeutics, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(In thousands, except per share data) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 (unaudited) Operating expenses: Research and development $12,428 $9,929 $38,120 $29,997 General and administrative 2,961 2,959 12,243 11,658 Total operating loss (15,389) (12,888) (50,363) (41,655)Other income 1,974 1,294 7,869 2,430 Net loss $(13,415) $(11,594) $(42,494) $(39,225)Net loss per share - basic and diluted $(0.11) $(0.10) $(0.33) $(0.37) Compass Therapeutics, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(In thousands, except par value) December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $24,228 $34,946 Marketable securities 128,233 151,663 Prepaid expenses and other current assets 1,420 8,182 Total current assets 153,881 194,791 Property and equipment, net 898 1,567 Operating lease, right-of-use ("ROU") asset 1,776 2,967 Other assets 320 320 Total assets $156,875 $199,645 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $4,090 $3,382 Accrued expenses 2,514 11,690 Operating lease obligations, current portion 1,197 1,097 Total current liabilities 7,801 16,169 Operating lease obligations, long-term portion 536 1,838 Total liabilities 8,337 18,007 Total stockholders' equity 148,538 181,638 Total liabilities and stockholders' equity $156,875 $199,645

"细胞和基因治疗（CGT）作为革命性的治疗手段，在治疗效果和作用机制方面相较于传统药物具有多方位的优势，是推动医疗领域迎来划时代变革的主导力量。截至2023，全球CGT在研管线超过2000个，呈逐季度上升趋势。但基于CGT药物制备工艺十分复杂，存在技术平台要求、成本高、具备规模化生产能力以及风险控制难等问题，目前，各国针对CGT药物密集出台了大量产业支持政策和监管政策，以提升行业规范性和不断发展。为更好支持CGT药物开发，我们整理了CGT药物CMC生产工艺相关指导原则及政策文件资料包，仅供行业内研究人员交流学习，快扫描二维码，领取海量资料吧！扫码立即领取海量资料！"细胞与基因疗法CMC生产相关原料在免疫细胞治疗药物的生产过程中，CMC生产相关原料如细胞因子IL-15、IL-7以及激活抗体OKT3/CD28抗体等因可调节免疫细胞的激活扩增、持续活化和抗肿瘤能力，而被广泛应用于免疫细胞药物的制备生产。作为细胞治疗药物生产的关键原材料，FDA、CDE等对这些物料的使用均有明确的规定，其中FDA建议使用上市批准或临床级别的物料，国内规定要优先选择低风险级别的原材料，优先顺序如：药品级> GMP级> RUO级。因此使用安全性、有效性以及合规的细胞因子等原料对于免疫细胞治疗药物的成功研发和顺利申报上市至关重要。ACROBiosystems百普赛斯致力于开发高质量的、应用于免疫细胞治疗药物生产、临床阶段的相关试剂，特在拥有GMP级质量管理体系平台的基础上，结合细胞治疗药物生产规范，以更严格的质量管理和药品级放行检测标准，开发了一系列如IL-2、IL-7、IL-15、IL-21、DLL4、OKT3抗体和抗CD28抗体、CD3/CD28磁珠、Cas酶等GMP级别的细胞因子、激活抗体、磁珠、酶等产品，全面支持T、NK、iPSCs、DC等多种细胞类型的规模化生产，以助力细胞治疗药物的开发进程。扫码咨询产品优势ACROBiosystems百普赛斯严格遵循GMP生产质量规范，生产厂房具备药品级生产许可证、药品级B+A级洁净室。生产用细胞株按中美药典经全面检定无病毒和外源因子污染，生产过程无动物源性（AOF）, 生产工艺具有完善的病毒灭活去除步骤，产品分装采用全自动无菌灌装设备和药用级包材，并对终产品的病毒等外源因子污染物、工艺杂质进行全面严格检测控制。ACROBiosystems百普赛斯严格打造完善的GMP级质量管理体系，提供真正的GMP级别产品。此外，GMP级别产品已全部完成FDA的DMF备案，备案号：037338，全面支持客户的申报要求，助力细胞治疗药物开发进程。产品数据✍ 经细胞水平验证，GMP级别 IL-21细胞因子，具有较高生物活性。GMP Human IL-21 Protein (Cat. No. GMP-L21H25) stimulates secretion of IFN-γ by NK-92 human natural killer lymphoma cells stimulated with 10 ng/mL GMP Human IL-15 Protein (Cat. No. GMP-L15H13). The specific activity of GMP Human IL-21 Protein (Cat. No. GMP-L21H25) is > 1ⅹ10^5 U/mg (QC tested).✍ 经细胞水平验证，ACROBiosystems百普赛斯自主开发的GMP级别DLL4重组蛋白，可很好的支持造血干细胞向淋巴细胞祖细胞（Lymphopoietic progenitor cell）的分化培养。CD34+ CD45+ hematopoietic cells were seeded on GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) - coated plates and differentiated for 26 days, then flow cytometry was used to detect the expression of T-cell progenitor markers, CD7 and CD5. GMP Human DLL4 Protein, Fc Tag (Cat. No.GMP-DL4H28) together with other growth factors could induce the formation of CD7+ and CD7+ CD5+ T-cell progenitors. However, the cells cultured without GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) - coated plates expressed neither CD5 nor CD7.产品列表ACROBiosystemsinquiry@acrobiosystems.com15117918562（备注：姓名+公司）

We continue to open clinical sites and enroll patients in COMPANION-002, the Phase 2/3 randomized study of CTX-009 (DLL4 x VEGF-A bispecific antibody) in patients with advanced biliary tract cancer (BTC). Consistent with prior guidance, top line data from this study continue to be expected in the second half of 2024.Enrollment of patients in COMPANION-003, the Phase 2 study of CTX-009 in patients with advanced colorectal cancer (CRC), has been extended into the first quarter of 2024. We expect to report top-line data from this study by mid-year 2024.Further evidence of clinical activity has been observed in the Phase 1b, monotherapy study of CTX-471. First, one patient with small cell lung cancer with a previously reported partial response has converted to a complete response, as confirmed by a PET scan, while continuing therapy on CTX-471. Second, in addition to the four responses previously reported, a new partial response has been observed in a patient with advanced melanoma, bringing the overall response rate (ORR) in patients with advanced melanoma in this study to 27% (3 of 11).Following FDA acceptance of the CTX-8371 IND in late 2023, we expect to dose the first patient in 1Q 2024.As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.Effective January 9, 2024, Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and Chief Executive Officer will transition to President of Research and Development and be appointed Vice Chair of the Compass board of directors.Ended 2023 with an estimated $152 million in cash and marketable securities, which is expected to provide cash runway for the company into mid-year 2026. BOSTON, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported a business update. “We made significant progress in the fourth quarter of the year across our portfolio, and we look forward to reporting top-line data from COMPANION-003 by mid-year and COMPANION-002 in the second half of the year. We are also excited to report additional responses in our Phase 1b monotherapy study of CTX-471, including a complete response in a patient with small cell lung cancer. We hope to see additional efficacy signals in the second part of our Phase 1b study, where we are studying CTX-471 in combination with KEYTRUDA® in patients with melanoma, NSCLC and SCLC,” said Vered Bisker-Leib, PhD, incoming Chief Executive Officer of Compass. “We are excited to have Vered Bisker-Leib elevated to the Chief Executive Officer role recognizing many years of strong performance. We are equally pleased that our founding CEO, Thomas Schuetz, will continue to play a key role at the Company,” said Carl Gordon, PhD, Chair of Compass’ Board. Development Pipeline Updates: CTX-009 (DLL4 and VEGF-A bispecific antibody) We continue to enroll patients in COMPANION-002, a U.S. Phase 2/3 study of CTX-009 in combination with Paclitaxel in BTC. This randomized Phase 2/3 study is designed to enroll 150 patients with BTC who have received one prior systemic therapy.The primary endpoint of the study is overall response rate (ORR), and secondary endpoints include progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR) and duration of response (DOR).Enrollment is expected to be completed by mid-year 2024; top line data are expected from this study in the second half of 2024. Enrollment of patients in COMPANION-003, a U.S. Phase 2 study of CTX-009 as a monotherapy in patients with advanced, metastatic CRC, has been extended to first quarter 2024. The study design is an Adaptive Simon Two-Stage, with Stage 1 of the study enrolling 37 patients; if 3 or more responses are confirmed in Stage 1, the study will advance to Stage 2, and an additional 47 patients will be enrolled. The study is enrolling patients with CRC who have received two or three prior systemic therapies irrespective of their KRAS mutation status.Patients are being evaluated for safety and tolerability, as well as clinical response.We expect to report top-line data from this study by mid-year 2024. CTX-471 (CD137 agonist) CTX-471 is a CD137 agonistic antibody, which binds to a unique epitope of the co-stimulatory molecule 4-1BB with an optimized affinity.We continue to dose and follow patients in the Phase 1b monotherapy study of CTX-471 where five responses have been observed, all in patients who previously received checkpoint blocker(s). A durable PR in a patient with SCLC has converted to a CR, as confirmed by a PET scan. Additionally, a new PR in a patient with advanced melanoma, was observed, leading to an ORR in the subset of patients with advanced melanoma of 27% (3 of 11). The fifth response occurred in a patient with mesothelioma.Phase 1b combination arm of CTX-471 and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with select solid tumors is ongoing. The dose-escalation portion of the study has been fully enrolled and enrollment in the dose expansion cohorts has begun. In the expansion cohort, we plan on enrolling 60 patients with melanoma, NSCLC and SCLC, who will be randomized into two doses. 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 exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1.Following the FDA acceptance of the IND for CTX-8371, the first patient is expected to be dosed in the Phase 1 clinical trial in the first quarter of 2024. Corporate Highlights: The Company’s CEO succession plan is effective as of January 9, 2024, with the elevation of Vered Bisker-Leib, PhD, to Chief Executive Officer and her addition to the Compass board of directors.Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and current Chief Executive Officer will transition to President of Research and Development and assume the role of Vice Chair of the Compass board of directors. About Compass TherapeuticsCompass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company 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 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, 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, Communications Manager media@compasstherapeutics.com617-500-8099