{"id":3509,"date":"2024-06-04T12:10:58","date_gmt":"2024-06-04T05:10:58","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=3509"},"modified":"2024-06-04T12:10:58","modified_gmt":"2024-06-04T05:10:58","slug":"remegen-reports-proof-of-concept-phase-i-ii-clinical-study-results-for-self-developed-potential-first-in-class-antibody-drug-conjugate-rc88","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=3509","title":{"rendered":"RemeGen Reports Proof-of-Concept Phase I\/II Clinical Study Results for Self-Developed, Potential First-in-Class Antibody-Drug Conjugate RC88"},"content":{"rendered":"

YANTAI, China<\/span>, June 4, 2024<\/span> \/PRNewswire\/ —\u00a0RemeGen Co., Ltd.<\/a>\u00a0(“RemeGen” or “the Company”) (9995.HK,\u00a0SHA:\u00a0688331), a commercial-stage biotechnology company,\u00a0presented the results of the first-in-human, single-arm, open-label, multi-center Phase I\/II study evaluating RC88 in patients with MSLN-expressing advanced solid tumors on June 3<\/span>, at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) held in Chicago<\/span> from May 31-June 4, 2024<\/span>. The first author,\u00a0Professor Liu Yutao,\u00a0from the Chinese Academy of Medical Sciences Cancer Hospital,\u00a0presented RemeGen’s poster session\u00a0(Poster #422) of this study that focused on efficacy and safety in patients with ovarian cancer, non-squamous non-small cell lung cancer, and cervical cancer<\/a>.<\/p>\n

\n<\/div>\n

RC88 is a novel, first-in-class, antibody-drug conjugate (ADC) developed by RemeGen that targets mesothelin (MSLN) with a monomethyl auristatin E (MMAE) payload. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues. RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to MMAE which acts as a microtubule inhibitor. RC88\u00a0has a high affinity for MSLN\u00a0and\u00a0can specifically bind to MSLN overexpressing tissues. In this study, RC88\u00a0has demonstrated\u00a0a terminating effect on tumor cells with various\u00a0levels of\u00a0MSLN expression. RC88 has demonstrated anti-tumor activity and a manageable RC88 monotherapy safety profile in MSLN-positive advanced solid tumors. Preclinical studies showed that RC88 can selectively deliver a potent cytotoxic payload to MSLN-expressing cells through internalization, thus inducing G2\/M arrest and apoptosis.<\/p>\n

Patients with MSLN-expressing advanced malignant solid tumors that had\u00a0failed standard therapies were enrolled in this study. For the Phase II study, the primary endpoint was overall response rate (ORR) per RECIST v1.1 criteria-based endpoints, with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and safety.<\/p>\n

As of February 21, 2024<\/span>, 170\u00a0patients with advanced solid tumor were enrolled. The dose escalation phase was completed, and 2.0 mg\/kg and 2.5 mg\/kg Q3W doses were expanded into\u00a0Phase II.<\/p>\n

In the ovarian cancer (OC) cohort, 54\u00a0patients were enrolled, all with 2+ or 3+ MSLN expression. Of these, 40\u00a0(74.1%) had an\u00a0ECOG score of 1; 33 (61.1%) had received prior bevacizumab treatment, and 28\u00a0(51.9%) had prior PARP inhibitor (PARPi) exposure. As of March 22, 2024<\/span>, a total of 31 patients in the 2.0mg\/kg group who had received two to four lines of prior therapies were efficacy-evaluable. Among them,\u00a0the ORR\u00a0and confirmed ORR (cORR) were 45.2% (14\/31, 95%CI 27.3, 64.0) and 41.9% (13\/31, 95%CI 24.5, 60.9), respectively. The median\u00a0DoR was 8.02 months (95%CI 2.83, 8.54).<\/p>\n

In the non-squamous non-small cell lung cancer (NSCLC) cohort, 16 EGFR\/ALK wild-type (WT) patients were efficacy-evaluable. The ORR and cORR were 31.3% (5\/16) and 25% (4\/16), respectively. Among the above patients with MSLN high expression (PS2#\u226550), the ORR, cORR, median PFS and median DoR were 41.7% (5\/12), 33.3% (4\/12), 6.87 months and 9.13 months, respectively.<\/p>\n

In the cervical cancer (CC) cohort, 18 patients who had progressed on previous systemic therapies\u00a0were enrolled. The ORR and cORR were 33.3% (6\/18) and 27.8% (5\/18), respectively. Among the 12 patients that received \u2265\u00a02\u00a0lines of therapies, the ORR and cORR were 41.7% (5\/12) and 33.3% (4\/12), respectively.<\/p>\n

“Currently, chemotherapy is the standard of care for OC with an ORR rate of 12%. The promising results of 41.9% ORR from this study underscore the potential of RC88 to significantly improve outcomes for patients with MSLN-expressing advanced solid tumors,” said Dr. Fang Jianmin, CEO of RemeGen. “We are committed to advancing our innovative therapies to address these huge unmet medical needs and enhance patient care.”<\/p>\n

About RemeGen Co. Ltd.<\/p>\n

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in\u00a0China\u00a0committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout\u00a0China\u00a0and\u00a0the United States<\/span>. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit:\u00a0www.remegen.com<\/a><\/p>\n

About RC88<\/p>\n

Independently developed by RemeGen,\u00a0RC88 is a novel antibody drug conjugate (ADC) targeting mesothelin (MSLN). It uses the company’s innovative bridging technology to connect antibodies and payloads. By design,\u00a0 RC88 molecule\u00a0can mediate the endocytosis of antibodies by binding to MSLN-positive tumor cells, thereby effectively delivering cytotoxins to cancer cells and achieving improved tumor killing effects.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

YANTAI, China<\/span>, June 4, 2024<\/span> \/PRNewswire\/ —\u00a0RemeGen Co., Ltd.<\/a>\u00a0(“RemeGen” or “the Company”) (9995.HK,\u00a0SHA:\u00a0688331), a commercial-stage biotechnology company,\u00a0presented the results of the first-in-human, single-arm, open-label, multi-center Phase I\/II study evaluating RC88 in patients with MSLN-expressing advanced solid tumors on June 3<\/span>, at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) held in Chicago<\/span> from May 31-June 4, 2024<\/span>. The first author,\u00a0Professor Liu Yutao,\u00a0from the Chinese Academy of Medical Sciences Cancer Hospital,\u00a0presented RemeGen’s poster session\u00a0(Poster #422) of this study that focused on efficacy and safety in patients with ovarian cancer, non-squamous non-small cell lung cancer, and cervical cancer<\/a>.<\/p>\n

\n<\/div>\n

RC88 is a novel, first-in-class, antibody-drug conjugate (ADC) developed by RemeGen that targets mesothelin (MSLN) with a monomethyl auristatin E (MMAE) payload. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues. RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to MMAE which acts as a microtubule inhibitor. RC88\u00a0has a high affinity for MSLN\u00a0and\u00a0can specifically bind to MSLN overexpressing tissues. In this study, RC88\u00a0has demonstrated\u00a0a terminating effect on tumor cells with various\u00a0levels of\u00a0MSLN expression. RC88 has demonstrated anti-tumor activity and a manageable RC88 monotherapy safety profile in MSLN-positive advanced solid tumors. Preclinical studies showed that RC88 can selectively deliver a potent cytotoxic payload to MSLN-expressing cells through internalization, thus inducing G2\/M arrest and apoptosis.<\/p>\n

Patients with MSLN-expressing advanced malignant solid tumors that had\u00a0failed standard therapies were enrolled in this study. For the Phase II study, the primary endpoint was overall response rate (ORR) per RECIST v1.1 criteria-based endpoints, with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and safety.<\/p>\n

As of February 21, 2024<\/span>, 170\u00a0patients with advanced solid tumor were enrolled. The dose escalation phase was completed, and 2.0 mg\/kg and 2.5 mg\/kg Q3W doses were expanded into\u00a0Phase II.<\/p>\n

In the ovarian cancer (OC) cohort, 54\u00a0patients were enrolled, all with 2+ or 3+ MSLN expression. Of these, 40\u00a0(74.1%) had an\u00a0ECOG score of 1; 33 (61.1%) had received prior bevacizumab treatment, and 28\u00a0(51.9%) had prior PARP inhibitor (PARPi) exposure. As of March 22, 2024<\/span>, a total of 31 patients in the 2.0mg\/kg group who had received two to four lines of prior therapies were efficacy-evaluable. Among them,\u00a0the ORR\u00a0and confirmed ORR (cORR) were 45.2% (14\/31, 95%CI 27.3, 64.0) and 41.9% (13\/31, 95%CI 24.5, 60.9), respectively. The median\u00a0DoR was 8.02 months (95%CI 2.83, 8.54).<\/p>\n

In the non-squamous non-small cell lung cancer (NSCLC) cohort, 16 EGFR\/ALK wild-type (WT) patients were efficacy-evaluable. The ORR and cORR were 31.3% (5\/16) and 25% (4\/16), respectively. Among the above patients with MSLN high expression (PS2#\u226550), the ORR, cORR, median PFS and median DoR were 41.7% (5\/12), 33.3% (4\/12), 6.87 months and 9.13 months, respectively.<\/p>\n

In the cervical cancer (CC) cohort, 18 patients who had progressed on previous systemic therapies\u00a0were enrolled. The ORR and cORR were 33.3% (6\/18) and 27.8% (5\/18), respectively. Among the 12 patients that received \u2265\u00a02\u00a0lines of therapies, the ORR and cORR were 41.7% (5\/12) and 33.3% (4\/12), respectively.<\/p>\n

“Currently, chemotherapy is the standard of care for OC with an ORR rate of 12%. The promising results of 41.9% ORR from this study underscore the potential of RC88 to significantly improve outcomes for patients with MSLN-expressing advanced solid tumors,” said Dr. Fang Jianmin, CEO of RemeGen. “We are committed to advancing our innovative therapies to address these huge unmet medical needs and enhance patient care.”<\/p>\n

About RemeGen Co. Ltd.<\/p>\n

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in\u00a0China\u00a0committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout\u00a0China\u00a0and\u00a0the United States<\/span>. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit:\u00a0www.remegen.com<\/a><\/p>\n

About RC88<\/p>\n

Independently developed by RemeGen,\u00a0RC88 is a novel antibody drug conjugate (ADC) targeting mesothelin (MSLN). It uses the company’s innovative bridging technology to connect antibodies and payloads. By design,\u00a0 RC88 molecule\u00a0can mediate the endocytosis of antibodies by binding to MSLN-positive tumor cells, thereby effectively delivering cytotoxins to cancer cells and achieving improved tumor killing effects.<\/p>\n

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