CS5001 / LigaChem Biosci, ABL Bio, CStone Pharma - LARVOL DELTA

CStone Submits Clinical Trial Application in Australia for CS5001 (ROR1 ADC) in Combination with First-Line Standard-of-Care for DLBCL (PRNewswire) - "CStone Pharmaceuticals...announced the submission of a Phase Ib clinical trial application in Australia for CS5001, its ROR1-targeting antibody-drug conjugate (ADC), in combination with first-line standard-of-care (SoC) for DLBCL....The global multi-center Phase Ib trial for CS5001 is actively enrolling patients across the United States, Australia, and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas, which could potentially expand into a Phase II single-arm registrational study. Additional cohorts, including the first-line DLBCL combination therapy and solid tumor monotherapy and combination therapy arms, will be initiated soon."

New P1 trial • Trial status • Diffuse Large B Cell Lymphoma • Solid Tumor

CS5001-101: A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: CStone Pharmaceuticals | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Breast Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Clinical momentum is lined up starting this year [Google translation] (eDaily) - "...the company plans to disclose LCB71's solid tumor phase 1 clinical trial data at the American Society of Clinical Oncology (ASCO) this year...LCB97, whose technology was transferred to Ono Pharmaceutical in October 2024, is also expected to complete preclinical trials as early as 2025 and submit a phase 1 clinical IND to the U.S. Food and Drug Administration (FDA)....'We expect to submit the phase 1 clinical IND for LCB97 to the FDA between 2025 and 2026.'"

IND • P1 data • Solid Tumor

CS5001: “CS5001 is well tolerated in heavily pre-treated patients with advanced B-cell lymphoma across doses from 33.5 to 156 μg/kg”; B-cell lymphoma (CStone Pharmaceuticals) - CStone ASH 2024 Investor Call: “48% ORR Among 31 Evaluable B-cell Lymphoma; 77% ORR at Preliminary RP2D of 125 μg/kg (Dose Level 8)”

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Safety and Efficacy in Patients with Advanced Lymphomas from a Global Phase 1a/1b, First-in-Human Study of CS5001, a Novel Anti-ROR1 ADC (ASH 2024) - P1 | "Patients with lymphomas were eligible irrespective of baseline ROR1 expression status and they must be eastern cooperative oncology group (ECOG) performance status 0-1, have histologically diagnosed Hodgkin lymphoma (HL) or B-cell non-Hodgkin lymphoma (NHLs) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), etc. and have failed ≥ 2 prior therapies (a prior brentuximab vedotin and at least one checkpoint inhibitor [if eligible] treatment was necessary for relapse or refractory classical HL). Conclusion CS5001 was well tolerated and showed promising efficacy in patients with advanced lymphomas. Current data support continued evaluations for the RP2D and subsequent phase 1b dose expansion."

Clinical • Metastases • P1 data • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • ROR1

CStone Announces First Patient Enrolled in the Global Multicenter Phase 1b Clinical Trial of CS5001 (ROR1 ADC) (CStone Pharma Press Release) - "CStone Pharmaceuticals...announced today the enrollment of the first patient in the global multicenter Phase 1b clinical trial of CS5001, an anti-ROR1 ADC and a key asset in company's Pipeline 2.0."

Enrollment open • Diffuse Large B Cell Lymphoma

Encouraging Efficacy and Safety: CStone Presents Latest Clinical Data on CS5001 for Advanced Lymphoma at the 66th ASH Annual Meeting (PRNewswire) - P1 | N=156 | NCT05279300 | Sponsor: CStone Pharmaceuticals | "CS5001 demonstrated encouraging anti-tumor activity in B-cell lymphomas, with an ORR of 48.4% across all dose levels; a notably higher ORR of 76.9% was observed at DL8 (125 μg/kg) among 13 evaluable patients. Hodgkin Lymphoma (HL): objective responses were observed from effective dose of DL5 (50 μg/kg) and above, including 3 complete responses (CRs) and 3 partial responses (PRs) among 10 evaluable patients at DLs 5-9 (ORR: 60.0%). 2 CRs and 1 PR were observed at DL8 (125 μg/kg) among 3 evaluable patients. Non-Hodgkin Lymphoma (NHL): objective responses were observed from effective dose of DL7 (100 μg/kg) and above, including 3 CRs (2 DLBCL and 1 MCL) and 6 PRs (3 DLBCL, 1 MZL, 1 HGBC and 1 FL) among 16 evaluable patients at DLs 7-9 (ORR: 56.3%). A notably higher ORR of 70.0% was observed at DL8 (125 μg/kg) among 10 evaluable patients."

P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hodgkin Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma

Hanmi Pharmaceutical, ABL, Aptamer, 'Blood Cancer Treatment' Clinical Results Announced at American Society [Google translation] (Chosun Biz) - "According to the pharmaceutical and bio industry on the 5th, Hanmi Pharmaceutical's partner Aptose will present the clinical results of the 'Tuspetinib' triple combination therapy at the annual academic conference of the 'American Society of Hematology (ASH)' to be held in San Diego, USA from the 7th to the 10th (local time)....ABL Bio will also be attending this conference and present the latest clinical data of its ROR1 targeting ADC (antibody-drug conjugate) candidate 'CS5001', which it is jointly developing with LigaChemBio, in a poster form....Cystone plans to disclose the safety and efficacy of CS5001 in lymphoma patients confirmed in the global phase 1a and b trials."

Clinical data • Lymphoma

ABL·LigaChemBio Announces Latest Clinical Data on ADC Candidate Development [Google translation] (Hankyung) - P1 | N=136 | NCT05279300 | Sponsor: CStone Pharmaceuticals | "ABL Bio...announced on the 4th that its partner CStone Pharmaceuticals will present the latest clinical data of ROR1 ADC CS5001 (ABL202/LCB71) as a poster at the 66th American Society of Hematology (ASH) Annual Meeting....This poster presents the latest safety and efficacy data of CS5001 in patients with B-cell lymphoma. According to the published abstract, CS5001 achieved an objective response rate (ORR) of 43.5% in patients with advanced B-cell lymphoma at all dose levels. At the effective dose, an ORR of 60% in patients with Hodgkin's lymphoma and an ORR of 50% in patients with non-Hodgkin's lymphoma were confirmed."

P1 data • B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CStone to Present Latest Clinical Data on CS5001 for Lymphoma at the 66th ASH Annual Meeting (CStone Pharma Press Release) - P1 | N=156 | NCT05279300 | Sponsor: CStone Pharmaceuticals | "At the ASH meeting, CStone will present updated safety and efficacy data from this ongoing study focused on advanced B-cell lymphomas. As of the abstract data cutoff, CS5001 achieved an objective response rate (ORR) of 43.5% among all evaluable patients with advanced B-cell lymphoma across all dose levels. Starting from the initial effective dose, the Hodgkin lymphoma and the non-Hodgkin lymphoma subgroups achieved an ORR of 60.0% and 50.0%, respectively. Updated data following abstract data cutoff, including more patients with lymphoma enrolled at the preliminary recommended phase 2 dose (RP2D) levels, will be detailed in the poster session at the ASH conference."

P1 data • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma

ABL Bio, 'ROR1 Single Antibody' Patent Registration in China [Google translation] (HIT News) - "ABL Bio...announced on the 2nd that it has completed patent registration in China for the ROR1 monoclonal antibody used in the development of antibody-drug conjugates (ADC)...This Chinese patent was applied for internationally by ABL Bio in March 2020, and its rights are guaranteed until 2040. Patent examination is currently underway in the United States and Europe....Its representative ADC pipeline includes ROR1 ADC 'ABL202 (CS5001, LCB71)' jointly developed with domestic ADC specialist RigaChem Biosciences."

Patent • Hematological Malignancies • Oncology • Solid Tumor

CStone Reports 2024 Interim Results and Recent Corporate Updates (PRNewswire) - "Anticipated near-term catalysts include: (i) Sugemalimab: MAA approval for the first-line treatment of Stage IV NSCLC in the U.K. expected in 2024 H2, and more global partnerships expected in 2024; (ii) CS5001: Presentation of the latest clinical safety and efficacy data at international academic conferences (e.g. ASH in 2024 H2), initiation of phase 1b trial with registrational potential in 2024, and global business development (BD) partnerships expected in 2024 or 2025.....(iii) GAVRETO (pralsetinib): Approval for manufacturing localization expected in 2025 H1; (iv) Nofazinlimab: Final OS analysis expected in 2025 H1; seeking ex-China partnership opportunities."

Commercial • Licensing / partnership • MHRA approval • New P1 trial • P1 data • Gastrointestinal Stromal Tumor • Hepatocellular Cancer • Lymphoma • Non Small Cell Lung Cancer

ABL Bio holds a meeting to share dual antibody ADC development strategy [Google translation] (BioTimes) - "ABL Bio...announced on the 26th that it will hold an analyst meeting on Wednesday, July 3 and an online meeting through YouTube..,This meeting was organized to share the company's next-generation dual antibody ADC (Antibody Drug Conjugate) development strategy and to introduce the interim clinical phase 1 data of 'ABL503 (TJ-L14B, Ragistomig)' and 'ABL202 (LCB71, CS5001)' that were announced at the American Society of Clinical Oncology (ASCO) this year....The online meeting is scheduled to be broadcast for approximately 1 hour and 30 minutes starting at 8:40 AM."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

ABL Bio, ROR1 Single Antibody US Patent Decision [Google translation] (HIT News) - "ABL Bio...announced on the 8th that the US patent decision for a single antibody targeting ROR1 (Receptor tyrosine kinase-like Orphan Receptor 1) has been completed. ABL Bio holds the rights to the patent in Korea, Japan, and China, and including this US patent, all of them are expected to be guaranteed until 2039...ABL Bio has developed ABL202 (CS5001, LCB71), a ROR1 antibody-drug conjugate (ADC), in collaboration with domestic bio company Rigachem Biosciences using a ROR1 monoclonal antibody....'ABL202 clinical data are scheduled to be presented at the European Society for Medical Oncology (ESMO) and the American Society of Hematology (ASH) in the second half of the year.'"

P1 data • Patent • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A phase 1a/b, multi-regional, first-in-human study of CS5001, a novel anti-ROR1 ADC, in patients with advanced solid tumors and lymphomas. (ASCO 2024) - P1 | "CS5001 was well tolerated with no DLT identified, PK characteristics were as expected, and encouraging antitumor activities were observed in various advanced solid tumors and lymphomas. Current data support continued evaluations for the recommended phase 2 dose and subsequent phase 1b dose expansion."

Clinical • Metastases • P1 data • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Infectious Disease • Kidney Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Cancer • Pneumonia • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • ROR1

CStone Announces Presentation of Latest First-in-Human Data for CS5001 (ROR1 ADC) at ASCO 2024 (CStone Pharma Press Release) - P1 | N=156 | NCT05279300 | Sponsor: CStone Pharmaceuticals | "As of the data cut-off date in poster, dose-limiting toxicity (DLT) evaluation for the first nine dose levels (7 to 156 μg/kg) in Phase 1a has been completed. No DLTs were observed, and the maximum tolerated dose (MTD) was not reached. Most treatment-related adverse events observed were Grade 1 or 2 (per NCI-CTCAE v5.0), indicating that CS5001 was well tolerated by heavily pretreated patients with advanced solid tumors and lymphomas. PK data suggested dose-proportional exposure of CS5001, with similar exposure for ADC and total antibody, demonstrating excellent stability of CS5001 ADC in circulation....Phase 1b will be initiated in the near term in multiple indications for dose optimization, followed by initiation of potential pivotal trials by the end of 2024."

New trial • P1 data • Trial status • Breast Cancer • Diffuse Large B Cell Lymphoma • Gynecologic Cancers • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

RigaChem Bio proves ADC technology with 1Q sales… Real growth begins [Google translation] (Medipana) - "According to the disclosure, sales in the first quarter of this year were 31,055.84 million won, a 305.6% increase compared to 7,658.04 million won in the same period last year...The reason why RigaChem Bio was able to increase sales equivalent to the previous year's performance in just one quarter was because of the signing of a technology transfer agreement for LCB84 (Trop2-ADC) with Janssen, a global pharmaceutical company, on December 22 last year....RigaChem Bio, which has multiple ADC pipelines, has confirmed that the safety data confirmed in the LCB14 clinical results has been proven again in the clinical results of other pipelines, including LCB71, and major pipelines, including LCB84, will also confirm clinical results in 2025."

Commercial • P1/2 data • Hematological Malignancies • Oncology • Solid Tumor

CStone Announces Abstract Release of CS5001 (ROR1 ADC) First-in-Human Clinical Data on ASCO Website (PRNewswire-Asia) - P1a/1b | N=156 | NCT05279300 | Sponsor: CStone Pharmaceuticals | "Hodgkin Lymphoma: Objective responses were observed from dose level 5 (50 μg/kg) and above, including 1 complete response (CR) and 4 partial responses (PR) among 9 evaluable patients at dose levels 5-9, achieving an objective response rate (ORR) of 55.6%. DLBCL: Objective responses were observed from dose level 7 (100 μg/kg) and above, including 1 CR and 2 PRs among 6 evaluable patients at dose levels 7-9, achieving an ORR of 50.0%. In solid tumors, multiple PRs and stable diseases (SDs) with reduced tumor burden were emerging from dose level 7 (100 μg/kg) and above, notably in NSCLC (1 PR and 3 SDs), pancreatic cancer (1 PR), triple-negative breast cancer (TNBC; 1 SD), and ovarian cancer (1 SD)....Phase 1b will be initiated in the near term in multiple indications for dose optimization, followed by initiation of pivotal trials by the end of 2024."

New trial • P1 data • Trial status • Diffuse Large B Cell Lymphoma • Hodgkin Lymphoma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Triple Negative Breast Cancer

CStone to Present CS5001 (ROR1 ADC) Phase I Results at 2024 ASCO Annual Meeting (CStone Pharma Press Release) - "CStone Pharmaceuticals...announced today the latest data of CS5001 (ROR1 ADC), a key asset of CStone Pipeline 2.0 will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in poster sessions."

P1 data • Lymphoma • Solid Tumor

ABL Bio participates in ‘Bio Korea 2024’ exhibition [Google translation] - "ABL Bio...announced on the 2nd that it plans to participate in the exhibition program of the 'BIO Korea 2024 International Convention' and showcase its bispecific antibody technology...Through this booth exhibition, ABL Bio introduces...ROR1 targeting ADC ABL202, which is currently in development in the non-clinical stage. Information on the concept of bispecific antibody ADC will also be introduced....'This year, including Bio Korea, clinical trials for ABL503, ABL202, and ABL001 will be conducted. Various events are scheduled, including the announcement of results.'"

Clinical • Clinical data • New trial • Hematological Malignancies • Oncology • Solid Tumor

CStone Pharmaceuticals Reports 2023 Annual Results and Business Updates (CStone Pharma Press Release) - "CS5001: to disclose the latest clinical safety and efficacy data at international academic conferences (e.g. ASCO in the first half of 2024, and ESMO/ASH in the second half of 2024); initiate registrational study in 2024; expected to reach global business development ('BD') partnership in 2024 or 2025."

Licensing / partnership • New trial • P1 data • Lymphoma • Solid Tumor

CStone Announces the Latest Business Update (CStone Pharma Press Release) - P1 | N=156 | NCT05279300 | Sponsor: CStone Pharmaceuticals | "Preliminary results from the ongoing FIH global multicenter study of CS5001 have been disclosed for the first time....Promising safety, stability and anti-tumor activity were observed in various hematological and solid malignancies....The data from prior seven dose levels suggests that the drug is safe and well-tolerated; the majority of the adverse events observed were Grade 1 or 2; no dose limiting toxicity (DLT) was observed. CS5001 has exhibited anti-tumor activity in heavily pre-treated patients, with partial responses (PRs) observed in cancer types including advanced Hodgkin's lymphoma and pancreatic cancer. The evaluation at higher dose levels and continued follow-up is ongoing....Updated phase I clinical data is expected to be presented at an international academic conference in the first half of next year."

P1 data • Lymphoma • Solid Tumor

A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: CStone Pharmaceuticals | Trial completion date: Mar 2024 ➔ Jun 2025

Trial completion date • Breast Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

ABL Bio completes patent registration for ROR1 antibody in China [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 5th that it has completed registration of a Chinese patent for the anti -ROR1 antibody that inhibits ROR1 overexpressed in various cancer types, including solid cancer and blood cancer, and its use . Patent rights are guaranteed until 2039....ABL202 is competitive by combining ABL Bio's excellent ROR1 antibody with LegoChem Bio's blood-stable linker and Pro PBD in an optimal ratio, and this is being confirmed as clinical trials progress."

Patent • Hematological Malignancies • Oncology • Solid Tumor

CStone Pharmaceuticals Reports 2023 Interim Results and Updates (PRNewswire-Asia) - "Topline readouts expected: (i) Sugemalimab: topline readout of the pre-specified OS final analysis in the GEMSTONE-303 study of sugemalimab in combination with chemotherapy for the first-line treatment of patients with advanced GC/GEJ in the third quarter of 2023; (ii) Nofazinlimab: topline readout of the global phase III trial of nofazinlimab in combination with LENVIMA® (lenvatinib) for the first-line treatment of patients with advanced HCC in the first quarter of 2024. Early clinical programs: (i) CS5001: update on clinical safety and efficacy by the end of 2023 and conference presentation in the first half of 2024."

P1 data • P3 data: top line • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor