A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy

This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.

开始日期2019-11-13

申办/合作机构

PharmAbcine Inc.

NCT03722342

/ Unknown status临床1期

A Phase 1b, Open-Label, Safety and Tolerability Study of TTAC-0001 in Combination With Pembrolizumab in Patients With Recurrent Glioblastoma

This is a phase 1b, open-Label clinical trial to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of TTAC-0001 administered in combination with pembrolizumab in patients with recurrent glioblastoma.

开始日期2019-01-16

申办/合作机构

PharmAbcine Inc.

100 项与奥伐西单抗相关的临床结果

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100 项与奥伐西单抗相关的转化医学

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100 项与奥伐西单抗相关的专利（医药）

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项与奥伐西单抗相关的文献（医药）

2022-01-01·Cancer treatment and research communications

Reassessing vascular endothelial growth factor (VEGF) in anti-angiogenic cancer therapy

Review

作者: Ojo, Oluwafemi Adeleke ; Iyobhebhe, Matthew ; Maimako, Rotdelmwa Filibus ; Elebiyo, Tobiloba C ; Evbuomwan, Ikponmwosa O ; Adeyemi, Oluyomi S ; Oluba, Olarewaju M ; Rotimi, Damilare

Vascularization is fundamental to the growth and spread of tumor cells to distant sites. As a consequence, angiogenesis, the sprouting of new blood vessels from existing ones, is a characteristic trait of cancer. In 1971, Judah Folkman postulated that tumour growth is angiogenesis dependent and that by cutting off blood supply, a neoplastic lesion could be potentially starved into remission. Decades of research have been devoted to understanding the role that vascular endothelial growth factor (VEGF) plays in tumor angiogenesis, and it has been identified as a significant pro-angiogenic factor that is frequently overexpressed within a tumor mass. Today, anti-VEGF drugs such as Sunitinib, Sorafenib, Axitinib, Tanibirumab, and Ramucirumab have been approved for the treatment of advanced and metastatic cancers. However, anti-angiogenic therapy has turned out to be more complex than originally thought. The failure of this therapeutic option calls for a reevaluation of VEGF as the major target in anti-angiogenic cancer therapy. The call for reassessment is based on two rationales: first, tumour blood vessels are abnormal, disorganized, and leaky; this not only prevents optimal drug delivery but it also promotes hypoxia and metastasis; secondly, tumour growth or regrowth might be blood vessel dependent and not angiogenesis dependent as tumour cells can acquire blood vessels via non-angiogenic mechanisms. Therefore, a critical assessment of VEGF, VEGFRs, and their inhibitors could glean newer options such as repurposing anti-VEGF drugs as vascular normalizing agents to enhance drug delivery of immune checkpoint inhibitors.

2021-06-01·Monoclonal antibodies in immunodiagnosis and immunotherapy

Development of Anti-Human CC Chemokine Receptor 9 Monoclonal Antibodies for Flow Cytometry

Article

作者: Kato, Yukinari ; Yanaka, Miyuki ; Nanamiya, Ren ; Takei, Junko ; Hosono, Hideki ; Kaneko, Mika K. ; Tanaka, Tomohiro ; Asano, Teizo ; Sano, Masato ; Nakamura, Takuro

CC chemokine receptor 9 (CCR9) belongs to the beta chemokine receptor family and is mainly distributed on the surface of immature T lymphocytes and enterocytes. This receptor is highly expressed in rheumatoid arthritis, colitis, type 2 diabetes, and various tumors. Therefore, more sensitive monoclonal antibodies (mAbs) need to be developed to predict the prognosis of many high CCR9 expression diseases. Because CCR9 is a structurally unstable G protein-coupled receptor, it has been difficult to develop anti-CCR9 mAbs using the traditional method. This study developed anti-human CCR9 (hCCR9) mAbs for flow cytometry using a Cell-Based Immunization and Screening (CBIS) method. Two mice were immunized with hCCR9-overexpressed Chinese hamster ovary (CHO)-K1 cells (CHO/hCCR9), and hybridomas showing strong signals from CHO/hCCR9 and no signals from CHO-K1 cells were selected by flow cytometry. We established an anti-hCCR9 mAb, C₉Mab-1 (IgG₁, kappa), which detected hCCR9 in MOLT-4 leukemia T lymphoblast cells and CHO/hCCR9 cells by flow cytometry. Our study showed that an anti-hCCR9 mAb was developed more rapidly by the CBIS method than the previous method.

2021-05-01·Journal of pharmaceutical and biomedical analysis3区 · 医学

A robust reporter assay for the determination of the bioactivity of IL-4R-targeted therapeutic antibodies

3区 · 医学

Article

作者: Wang, Lan ; Yu, Xiaojuan ; Wang, Junzhi ; Yu, Chuanfei ; Wang, Kaiqin ; Liu, Chunyu

Type 2 inflammatory cytokines, including IL-4, IL-5 and IL-13, contribute considerably to the pathogenesis of asthma. Anti-IL-4R monoclonal antibody (mAb) has been approved for the therapeutic treatment of asthma, and many mAbs with the same target are in the different stages of R&D and clinical trials. Bioactivity determination is required to ensure the quality control of mAbs. However, current ELISA and SPR assays or cell-based anti-proliferation assays for IL-4R mAbs are either not mechanism-of-action (MOA) representative or tedious and time consuming. Therefore, we developed a reporter gene assay (RGA) based on the HEK-293 cell line that stably expressed signal transducer and activator of transcription 6 (STAT6) and the luciferase reporter controlled by STAT6 binding elements. Anti-4R mAb could bind to IL-4R, and block the interaction between IL-4 and IL-4R, resulting in the reduction of IL-4 induced STAT6 controlled luciferase expression. After careful optimization of the experiment parameters, the RGA method demonstrated optimal dose-response curve between anti-IL-4R mAb concentration and luciferase expression level. Validation according ICH-Q2 proved the excellent assay performance characteristics of the established RGA, including specificity, accuracy, precision, linearity and range. The established transgenic cell line was stable for the bioactivity determination of anti-IL-4R mAb up to 46 generations, and the RGA was also suitable for the bioactivity determination of anti-IL-4 mAbs, and potentially of anti-IL-13 mAbs. The established RGA could be adopted to determine the bioactivity during the development, characterization, lot release, stability, and comparability studies of anti-IL-4R mAbs.

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2024-10-15

·PRNewswire

PharmAbcine Announces Safety Approval for 4mg Single-dose Cohort in Phase 1 Clinical Trial of PMC-403 for Neovascular Age-related Macular Degeneration

Safety Review Committee (SRC) approves single ascending dose 4mg cohort in Phase 1 trial of PMC-403, preparing for multiple ascending dose 4 mg cohort. PMC-403 is being explored in broader therapeutic areas, including rare vascular disease systemic capillary leak syndrome (SCLS) and kidney diseases. DAEJEON, South Korea, Oct. 14, 2024 /PRNewswire/ -- PharmAbcine, Inc. (KOSDAQ: 208340), a clinical-stage public company developing next-generation therapeutics to address unmet medical needs, today announced that its TIE2-activating antibody candidate, PMC-403, has received unanimous safety approval from the Safety Review Committee (SRC) for the 4mg single ascending dose (SAD) cohort in its Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD). The Company is now preparing to begin enrollment for the 4mg multiple ascending dose (MAD) cohort. PMC-403 is a novel TIE2-activating antibody with a unique mechanism that stabilizes pathological, leaky blood vessels. TIE2 receptors, expressed on endothelial cells, play a critical role in vessel normalization processes such as angiogenesis and intercellular adhesion, thereby inhibiting the progression of AMD. This Phase 1 trial targets patients with neovascular AMD who no longer respond to anti-VEGF standard therapies. The safety and tolerability of the 4mg single dose were successfully confirmed, laying the groundwork for advancing to the multiple-dosing phase. Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, stated, "The successful completion of the 4mg single-dose study is a significant milestone, highlighting the potential of PMC-403 as a breakthrough treatment for AMD. As we move forward with the multiple-dose study, we aim to gather additional safety and efficacy data to establish a robust foundation for Phase 2 trials." Macular degeneration, a leading cause of blindness, results from aging-related damage to the retina, particularly due to the development of abnormal blood vessels in the macula. The global aging population has led to a rapid increase in cases, and current treatments with anti-VEGF inhibitors are often insufficient for complete treatment. Consequently, there is a growing demand for therapies with novel mechanisms of action. PharmAbcine plans to continue its research with the goal of initiating a Phase 2 trial after confirming the safety and efficacy of the 4mg multiple-dose cohort. The Company expects PMC-403 to play a pivotal role in the global market for AMD treatments. Beyond ophthalmology, PMC-403 is being explored in therapeutic areas, including vascular-related rare diseases, Acute Respiratory Distress Syndrome, Inflammatory Bowel Disease, Duchenne Muscular Dystrophy, Traumatic Spinal Cord Injury, oncology and kidney diseases. The Company has collaborated with Dr. Kirk Druey, former Chief of the NIH's Lung and Vascular Inflammation Section, to explore PMC-403's efficacy in animal models for Systemic Capillary Leak Syndrome (SCLS, also known as Clarkson disease). In a recent interview, Dr. Druey expressed excitement about PMC-403's potential in treating SCLS patients. While there is currently no approved treatment for SCLS, PMC-403 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of SCLS on February 21, 2023. For more information about the Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD), please visit (). For more information about PMC-403 in SCLS, please visit Dr. Druey's interview on the NIH "I am Intramural" blog (). About PharmAbcine Inc. PharmAbcine is a clinical-stage public company developing next-generation IgG-based therapeutics to treat cancer, neovascular eye diseases, and unmet vascular-related needs. The Company's main pipeline includes clinical assets olinvacimab, PMC-403, and PMC-309. Olinvacimab, the Company's lead asset, is undergoing a Phase II trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging results from a Phase Ib olinvacimab plus pembrolizumab trial, which delivered 50% ORR, 67% DCR, and a clean safety profile. PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional, leaky, and disorganized pathological vessels. It is being tested for neovascular AMD in Phase 1 trials in Korea. PMC-403 is also being explored in other therapeutic areas related to pathological blood vessels, including rare and non-rare vascular-related diseases. PMC-309, a novel anti-VISTA antagonist IgG effective in pan-pH conditions, is an immune checkpoint regulator targeting MDSC (myeloid-derived suppressor cells) and M2 macrophages, which play a pivotal role in maintaining an immunosuppressive tumor microenvironment. A Phase I study is ongoing in Australia, and a Phase Ib/II study combining PMC-309 with pembrolizumab is planned. For additional information about PharmAbcine, visit or follow us on YouTube and LinkedIn. For investor relations and public relations inquiries, please contact: IR/PR Team E-mail: [email protected] SOURCE PharmAbcine WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期孤儿药临床2期临床结果临床申请

2024-07-09

·drugs

Approval for the First Dose Cohort in Phase 1a/b Clinical Trial of PMC-309 in Patients with Advanced or Metastatic Solid Tumors

DAEJEON, South Korea, July 8, 2024. PharmAbcine Inc., a clinical-stage biotech company focusing on next-generation antibody therapeutics, announced that PMC-309, VISTA-targeting immuno-oncology program, received safety approval for the first dose cohort (0.2mg/kg) in Phase 1a/b clinical trial for patients with advanced or metastatic solid tumors in Australia. The second dose cohort (0.5mg/kg) is currently ongoing. The first dose cohort (0.2mg/kg) of PMC-309 was initially administered in January 2024 and received safety approval in April 2024. Currently, the second dose cohort (0.5mg/kg) has been administered to two patients, with the third patient scheduled to receive treatment soon. PMC-309 is an IgG1 monoclonal antibody specifically binding to VISTA on immunosuppressive cells, demonstrating excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 offers a differentiated mechanism of action, contributing to anti-cancer effects through the activation of T cells, monocytes, and the proliferation of M1 macrophages. This open-label Phase 1a/b clinical trial involves a total of 67 patients and comprises two phases: Phase 1a and Phase 1b. Phase 1a includes PMC-309 monotherapy and combination therapy with KEYTRUDA (pembrolizumab) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Phase 1b will evaluate the safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA at the RP2D. The clinical trial is being conducted at four institutions in Australia. Dr. Jin-San Yoo, Chief Executive Officer of PharmAbcine Australia Pty, the Australian subsidiary of PharmAbcine Inc., stated, "It has been 10 years since the first generation of immuno-oncology drugs entered the market. During this time, these drugs have been administered to numerous cancer patients. While some patients have benefited, many have developed resistance, and others have passed away. The need for next-generation immuno-oncology drugs is critical. The confirmation of the safety of the first dose cohort of PMC-309 is just the beginning of this trial. We look forward to gradually verifying the safety and efficacy of PMC-309 through the planned higher dose cohorts. We are also preparing for the combination trial of PMC-309 with KEYTRUDA in collaboration with MSD without any delays." He added, "We are committed to providing new treatment options to patients suffering from the limitations of first-generation immuno-oncology drugs." For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT05957081. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About PharmAbcine Inc. PharmAbcine is a clinical stage public company developing next generation IgG based therapeutics to treat cancer, neovascular eye diseases, and vascular related unmet needs. The Company's main pipeline include clinical assets olinvacimab, PMC-403, and PMC-309. Olinvacimab, the Company's lead asset, is ongoing a Phase 2 trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging result from Phase 1b olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile. PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional leaky disorganized pathological vessels and can be used for vascular-related eye disease, including wet AMD (Age-related Macular Degeneration). PMC-403 is currently undergoing Phase 1 trial for neovascular AMD patients in Korea. PMC-403 is also being explored to expand into wider therapeutic areas related to pathological vessels including vessel-related rare diseases and non-rare diseases. PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH conditions, is an immune checkpoint regulator that targets MDSC (myeloid derived suppressor cells) and M2 macrophages which play pivotal role in maintaining immunosuppressive TME (Tumor Microenvironment). Phase 1a is ongoing at multicenter in Australia and Phase 1b in combination with MSD's pembrolizumab PMC-309 + Pembrolizumab combo is in plan. PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii expressed on cancer cells and can be applied to various modalities including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and Radio-Immunotherapy. SOURCE PharmAbcine Keytruda (pembrolizumab) FDA Approval History Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床1期临床2期免疫疗法临床申请

2024-07-08

·PRNewswire

PharmAbcine Announces Safety Approval for the First Dose Cohort in Phase 1a/b Clinical Trial of PMC-309 in Patients with Advanced or Metastatic Solid Tumors

PMC-309 receives safety approval for first dose cohort (0.2mg/kg), and second dose cohort (0.5mg/kg) is currently underway in Australia. DAEJEON, South Korea, July 8, 2024 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on next-generation antibody therapeutics, announced that PMC-309, VISTA-targeting immuno-oncology program, received safety approval for the first dose cohort (0.2mg/kg) in Phase 1a/b clinical trial for patients with advanced or metastatic solid tumors in Australia. The second dose cohort (0.5mg/kg) is currently ongoing. The first dose cohort (0.2mg/kg) of PMC-309 was initially administered in January 2024 and received safety approval in April 2024. Currently, the second dose cohort (0.5mg/kg) has been administered to two patients, with the third patient scheduled to receive treatment soon. PMC-309 is an IgG1 monoclonal antibody specifically binding to VISTA on immunosuppressive cells, demonstrating excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 offers a differentiated mechanism of action, contributing to anti-cancer effects through the activation of T cells, monocytes, and the proliferation of M1 macrophages. This open-label Phase 1a/b clinical trial involves a total of 67 patients and comprises two phases: Phase 1a and Phase 1b. Phase 1a includes PMC-309 monotherapy and combination therapy with KEYTRUDA® (pembrolizumab) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Phase 1b will evaluate the safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA® at the RP2D. The clinical trial is being conducted at four institutions in Australia. Dr. Jin-San Yoo, Chief Executive Officer of PharmAbcine Australia Pty, the Australian subsidiary of PharmAbcine Inc., stated, "It has been 10 years since the first generation of immuno-oncology drugs entered the market. During this time, these drugs have been administered to numerous cancer patients. While some patients have benefited, many have developed resistance, and others have passed away. The need for next-generation immuno-oncology drugs is critical. The confirmation of the safety of the first dose cohort of PMC-309 is just the beginning of this trial. We look forward to gradually verifying the safety and efficacy of PMC-309 through the planned higher dose cohorts. We are also preparing for the combination trial of PMC-309 with KEYTRUDA® in collaboration with MSD without any delays." He added, "We are committed to providing new treatment options to patients suffering from the limitations of first-generation immuno-oncology drugs." For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT05957081. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About PharmAbcine Inc. PharmAbcine is a clinical stage public company developing next generation IgG based therapeutics to treat cancer, neovascular eye diseases, and vascular related unmet needs. The Company's main pipeline include clinical assets olinvacimab, PMC-403, and PMC-309. Olinvacimab, the Company's lead asset, is ongoing a Phase 2 trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging result from Phase 1b olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile. PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional leaky disorganized pathological vessels and can be used for vascular-related eye disease, including wet AMD (Age-related Macular Degeneration). PMC-403 is currently undergoing Phase 1 trial for neovascular AMD patients in Korea. PMC-403 is also being explored to expand into wider therapeutic areas related to pathological vessels including vessel-related rare diseases and non-rare diseases. PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH conditions, is an immune checkpoint regulator that targets MDSC (myeloid derived suppressor cells) and M2 macrophages which play pivotal role in maintaining immunosuppressive TME (Tumor Microenvironment). Phase 1a is ongoing at multicenter in Australia and Phase 1b in combination with MSD's pembrolizumab PMC-309 + Pembrolizumab combo is in plan. PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii expressed on cancer cells and can be applied to various modalities including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and Radio-Immunotherapy. For additional information about PharmAbcine, visit or follow on YouTube and LinkedIn. For licensing deals, joint venture, co-development, and collaboration in research or antibody discovery inquiries, please contact: Business Development Team E-mail: [email protected] Office line: +82 70 4279 5100 For investor relations and public relations inquiries, please contact: IR/PR Team E-mail: [email protected] SOURCE PharmAbcine

免疫疗法临床1期临床2期临床申请

100 项与奥伐西单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性三阴性乳腺癌	临床2期	澳大利亚	PharmAbcine Inc.	2021-09-30
转移性三阴性乳腺癌	临床2期	澳大利亚	Merck Sharp & Dohme Corp.	2021-09-30
复发性胶质母细胞瘤	临床2期	-	PharmAbcine Inc.	2016-02-04
晚期癌症	临床1期	韩国	PharmAbcine Inc.	2011-11-01

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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


PS10-18 (SABCS2021)	临床1期	转移性三阴性乳腺癌 PR+ \| HER2-negative	11	Olinvacimab 12mg/kg + Pembrolizumab 200mg	夢膚鏇窪鏇選廠鬱簾憲(齋醖築顧膚蓋鏇鹽淵艱) = Haemangiomas were seen in 8 pts accounting for 47 events of CTCAE grade 1 and 21 events of grade 2 製積願鹹鬱鹹獵夢獵鬱 (製鏇築顧淵遞夢艱範遞 ) 更多	积极	2021-02-15
NCT03722342 (ASCO 12020 \| ASCO 22020) 人工标引	临床1期	复发性胶质母细胞瘤	9	olinvacimab+pembrolizumab	觸襯醖築構鏇廠鑰簾鏇(構衊餘鬱鑰夢醖構醖繭) = blurred vision, fatigue, and seizure 餘艱廠製醖獵餘艱顧齋 (艱網簾淵膚積遞獵壓積 ) 更多	积极	2020-05-29
NCT03033524 (ASCO 12017 \| ASCO 22017) 人工标引	临床2期	复发性胶质母细胞瘤	12	Olinvacimab	繭齋廠餘膚艱齋鑰淵憲(齋糧醖鏇網築觸廠襯鑰) = All SAEs were unrelated to the study drug apart from G2 bleeding haemangioma and G2 cerebral haemorrhage. 範艱餘選醖繭衊製餘鹽 (積鬱夢膚衊鏇夢鏇鏇糧 )	积极	2017-06-02
NCT01660360 (ASCO2015)	临床1期	难治恶性实体肿瘤	26	Tanibirumab	憲範齋願願壓觸範襯鏇(餘遞壓繭壓鑰糧遞糧餘) = 淵蓋鏇糧艱範製鏇顧鬱鹹構衊鬱選糧憲壓顧網 (壓鹹艱鹽艱鏇構願獵艱 ) 更多	-	2015-05-20