Forwarded from 알파카 주식 목장 (파카파카알파카)
리가켐바이오의 파이프라인인 LCB14에 대해 다뤄보았습니다..! 유방암 시장에서 어떻게 ADC 약품(엔허투)가 로슈의 HER2 프랜차이즈를 대체하고 있는지 거시적인 관점을 위주로 설명드려볼까 합니다.
개인적으로 저는 LCB14가 지켜야만 하는 로슈와 빼앗아야만 하는 아스트라제네카 사이에서 큰 기회를 얻을 수 있는 ADC 파이프라인이 되리라 생각하는데요. 아래 포스팅에서는 그 이유를 알 수 있다고 생각합니다.
유방암 시장에서 두 글로벌 빅파마가 격돌하고 있고, 그 가운데에서 ADC 약품이 적극적으로 시장을 확대하는 트렌드를 쭉 살펴보시면 LCB14에게 열린 기회의 장을 넓은 관점에서 보이리라 생각합니다. 어쩌면 알테오젠의 엔허투SC와 리가켐바이오의 LCB14가 격돌하는 꿈의 시간이 곧 현실이 될 수 있지 않을까 합니다.
오늘 장중 내내 얻어맞아서 정신이 어지럽지만, 힘내시며 함께 공부해보시죠..!!
https://blog.naver.com/foreconomy/223629484509
개인적으로 저는 LCB14가 지켜야만 하는 로슈와 빼앗아야만 하는 아스트라제네카 사이에서 큰 기회를 얻을 수 있는 ADC 파이프라인이 되리라 생각하는데요. 아래 포스팅에서는 그 이유를 알 수 있다고 생각합니다.
유방암 시장에서 두 글로벌 빅파마가 격돌하고 있고, 그 가운데에서 ADC 약품이 적극적으로 시장을 확대하는 트렌드를 쭉 살펴보시면 LCB14에게 열린 기회의 장을 넓은 관점에서 보이리라 생각합니다. 어쩌면 알테오젠의 엔허투SC와 리가켐바이오의 LCB14가 격돌하는 꿈의 시간이 곧 현실이 될 수 있지 않을까 합니다.
오늘 장중 내내 얻어맞아서 정신이 어지럽지만, 힘내시며 함께 공부해보시죠..!!
https://blog.naver.com/foreconomy/223629484509
NAVER
리가켐바이오 LCB14 : 지켜야만 하는 로슈 vs 빼앗아야만 하는 AZ
LCB14는 HER2를 타겟으로 하는 ADC 신약인데, HER2는 특히 유방암 부분에서 글로벌 빅파마의 치열한 경쟁이 발생하고 있는 분야입니다. 따라서 이번 포스팅에서는 유방암 시장에서 기존 표준 치료법을 ADC가 침투하고 있는 트렌드를 소개하면서 LCB14의 가치를 고민해볼까 합니다. 이전 LCB84나 LCB71 글에서도 언급한 것처럼, 세부적인 디테일보다 ADC를 둘러싼 트렌드가 어떻게 변화하고 있는지 파악하는 것이 투자에 있어 매우 중요하다고 보고…
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IKS012,_a_novel_ADC_design_with_favorable_efficacy_and_safety_for.pdf
2.6 MB
[EORTC-NCI-AACR Symposium]
IKS012, a novel ADC design with favorable efficacy and safety for treatment of Folate Receptor Alpha-positive cancers
IKS012, a novel ADC design with favorable efficacy and safety for treatment of Folate Receptor Alpha-positive cancers
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지난 금요일 CStone Pharmaceuticals(2616.HK) 주가가 12.4% 상승했습니다. 주된 이유는 23일 CStone이 발표한 CEO Dr. Yang의 지분 확대 소식이였을 것으로 추정되는데요, 해당 보도자료에 따르면 2024년 6월 이후 2,269,500주를 시장에서 매수하며 보유 주식수를 9,799,000주, 지분율 기준으로는 5.44%까지 늘렸다고 하네요. Dr. Yang에 따르면 회사의 전망에 대한 확신의 의미로 지분을 늘렸다고 밝혔습니다. 이미 잘 알려진 바와 같이 CStone은 리가켐바이오 ROR1-ADC 'CS5001'의 글로벌 1상을 진행 중이며, 해당 파이프라인을 CStone의 "Key Clinical Program in Pipeline 2.0"으로 소개한 바 있습니다(2024 Interim Results Presentation 참고)
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Forwarded from 바이바이바이오🤡DS 제약/바이오 김민정
오노약품 공업 실적발표
3분기 R&D 비용은 약 35bn엔 증가,
그 중 26bn엔은 Deciphera 향
나머지 900mn엔(약 814억원)는 #리가켐바이오 L1CAM ADC 인수 upfront 비용이 크게 차지할 것으로 추정
#리가켐바이오
3분기 R&D 비용은 약 35bn엔 증가,
그 중 26bn엔은 Deciphera 향
나머지 900mn엔(약 814억원)는 #리가켐바이오 L1CAM ADC 인수 upfront 비용이 크게 차지할 것으로 추정
#리가켐바이오
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1739 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
Results
As of 2 July 2024, 23 patients with advanced lymphomas (11 HL and 12 B-cell NHLs [10 DLBCL, 1 FL, 1 MCL]) were treated at 33.5 關g/kg (n= 2), 50 關g/kg (n= 2), 75 關g/kg (n= 5), 100 關g/kg (n= 8), 125 關g/kg (n= 5), 156 關g/kg (n= 1); 18 (78.3%) patients had discontinued the treatment and 5 (21.7%) were ongoing. The median age was 50 years (range, 30-81); 12 (52.2%) patients were male; 19 (82.6%) patients were Asian; 18 (78.3%) patients had an ECOG PS of 1 and most patients (19, 82.6%) had 3 lines of prior anti-tumor treatments.
No DLT was observed and MTD was not reached. For the lymphomas, treatment related adverse events (TRAEs) occurred in 20 (87.0%) patients; the most commonly reported TRAEs were anaemia (n= 9, 39.1 %), white blood cell count decreased (n= 6, 26.1 %), decreased appetite (n= 6, 26.1%), aspartate aminotransferase increased (n= 5, 21.7 %). Grade 3 TRAEs occurred in 11 (47.8%) patients; the most common events were fatigue, gamma-glutamyltransferase increased and pneumonia (n=3 [13.0%] each).
Encouraging anti-tumor activity was observed in advanced HL and B-cell NHLs, with objective response rate (ORR) of 43.5% across all the dose levels. For HL, objective responses were observed from dose level 5 (50 關g/kg) and above, including 2 complete responses (CRs) and 4 partial responses (PRs) among 10 evaluable patients at dose levels 5-10 [ORR: 60.0%]. For B-cell NHLs, objective responses were observed from dose level 7 (100 關g/kg) and above, including 2 CR (1 DLBCL and 1 MCL) and 2 PRs (2 DLBCL) among 8 evaluable patients at dose levels 7-10 (ORR: 50.0%). Dose escalation and backfilling enrollment are still ongoing; updated data from more patients with lymphomas will be presented at the conference.
Results
As of 2 July 2024, 23 patients with advanced lymphomas (11 HL and 12 B-cell NHLs [10 DLBCL, 1 FL, 1 MCL]) were treated at 33.5 關g/kg (n= 2), 50 關g/kg (n= 2), 75 關g/kg (n= 5), 100 關g/kg (n= 8), 125 關g/kg (n= 5), 156 關g/kg (n= 1); 18 (78.3%) patients had discontinued the treatment and 5 (21.7%) were ongoing. The median age was 50 years (range, 30-81); 12 (52.2%) patients were male; 19 (82.6%) patients were Asian; 18 (78.3%) patients had an ECOG PS of 1 and most patients (19, 82.6%) had 3 lines of prior anti-tumor treatments.
No DLT was observed and MTD was not reached. For the lymphomas, treatment related adverse events (TRAEs) occurred in 20 (87.0%) patients; the most commonly reported TRAEs were anaemia (n= 9, 39.1 %), white blood cell count decreased (n= 6, 26.1 %), decreased appetite (n= 6, 26.1%), aspartate aminotransferase increased (n= 5, 21.7 %). Grade 3 TRAEs occurred in 11 (47.8%) patients; the most common events were fatigue, gamma-glutamyltransferase increased and pneumonia (n=3 [13.0%] each).
Encouraging anti-tumor activity was observed in advanced HL and B-cell NHLs, with objective response rate (ORR) of 43.5% across all the dose levels. For HL, objective responses were observed from dose level 5 (50 關g/kg) and above, including 2 complete responses (CRs) and 4 partial responses (PRs) among 10 evaluable patients at dose levels 5-10 [ORR: 60.0%]. For B-cell NHLs, objective responses were observed from dose level 7 (100 關g/kg) and above, including 2 CR (1 DLBCL and 1 MCL) and 2 PRs (2 DLBCL) among 8 evaluable patients at dose levels 7-10 (ORR: 50.0%). Dose escalation and backfilling enrollment are still ongoing; updated data from more patients with lymphomas will be presented at the conference.
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효능이 나오기 시작한 저용량군에서부터 최대 용량군까지의 반응률(Dose Level 5-10 / 7-10, 적응증에 따라 상이)을 모두 합산했을때 이번 초록에서 공개된 ORR이 산출됩니다. ORR 43.5%라는 수치 역시 HL, B-cell NHL 환자들의 효능이 나오기 시작한 가장 낮은 용량군부터 합산된 데이터입니다. 향후 RP2D 용량군(향후 공개 예정)에서만의 효능 데이터를 확인하게 되면 저용량군이 빠지게 되기 때문에 효능 데이터는 이번 공개된 초록 대비 상승할 수 있는 가능성이 있습니다. 참고하시기 바랍니다.
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1738 Updated Results from the Phase 2 Waveline-004 Study of Zilovertamab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Results: A total of 98 patients were enrolled and received 1 dose of zilovertamab vedotin. The median age was 66 years (range, 19-88), 63 patients (64%) were male, 86 (92%) had an ECOG PS of 0 or 1, and 70 (71%) had received 3 prior lines of therapy. Of these 98 patients, 57 (58%) were ineligible for ASCT or CAR-T therapy. At data cutoff, 61 patients (62%) had discontinued treatment, most commonly due to progressive disease (37 [38%]), and treatment was ongoing for 37 patients (38%). Median time from first dose to data cutoff was 4.5 months (range, 0.2-13.2) for patients who received 1 dose of zilovertamab vedotin (all-patients-as-treated population; N = 98) and 5.6 months (range, 0.9-13.2) for patients who had 1 postbaseline scan (efficacy analysis population; n = 79). ORR was 29% (95% CI, 19-40); 10 patients (13%) had a CR, 13 (16%) had a PR, and 10 (13%) had SD; DCR was 42% (95% CI, 31-53). Median DOR was 3.0 months (range, 0.0+ to 8.8+); an estimated 40% of responders had a response duration 6 months. Median PFS was 2.5 months (95% CI, 1.9-3.0); the 6-month PFS rate was 15%. Median OS for all 98 patients was 10.6 months (95% CI, 5.1-NR); the 6-month OS rate was 62%. Treatment-related adverse events (AEs) occurred in 78 patients (80%), of which the most common (25%) were neutrophil count decreased (48%) and anemia (26%). Grade 3-5 treatment-related AEs occurred in 51 patients (52%); most commonly (15%) neutrophil count decreased (39%) and anemia (15%). One patient (1%) experienced a grade 2 treatment-related infusion reaction. Eighteen patients (18%) experienced peripheral neuropathy regardless of treatment of whom 2 (2%) had a grade 3 or 4 event. Median time to onset of first peripheral neuropathy was 29.5 days (range, 3-284). Dose modification because of peripheral neuropathy was required for 10 patients (10%); 6 (6%) experienced dose reduction and 4 (4%) experienced dose interruption. Treatment-related AEs led to discontinuation in 4 patients (4%; 2 diabetic ketoacidosis, 1 septic shock, and 1 acute kidney injury). Two patients (2%) died because of treatment-related AEs (1 septic shock, 1 acute kidney injury).
(Zilovertamab Vedotin은 MSD가 개발 중인 ROR1 ADC입니다)
Results: A total of 98 patients were enrolled and received 1 dose of zilovertamab vedotin. The median age was 66 years (range, 19-88), 63 patients (64%) were male, 86 (92%) had an ECOG PS of 0 or 1, and 70 (71%) had received 3 prior lines of therapy. Of these 98 patients, 57 (58%) were ineligible for ASCT or CAR-T therapy. At data cutoff, 61 patients (62%) had discontinued treatment, most commonly due to progressive disease (37 [38%]), and treatment was ongoing for 37 patients (38%). Median time from first dose to data cutoff was 4.5 months (range, 0.2-13.2) for patients who received 1 dose of zilovertamab vedotin (all-patients-as-treated population; N = 98) and 5.6 months (range, 0.9-13.2) for patients who had 1 postbaseline scan (efficacy analysis population; n = 79). ORR was 29% (95% CI, 19-40); 10 patients (13%) had a CR, 13 (16%) had a PR, and 10 (13%) had SD; DCR was 42% (95% CI, 31-53). Median DOR was 3.0 months (range, 0.0+ to 8.8+); an estimated 40% of responders had a response duration 6 months. Median PFS was 2.5 months (95% CI, 1.9-3.0); the 6-month PFS rate was 15%. Median OS for all 98 patients was 10.6 months (95% CI, 5.1-NR); the 6-month OS rate was 62%. Treatment-related adverse events (AEs) occurred in 78 patients (80%), of which the most common (25%) were neutrophil count decreased (48%) and anemia (26%). Grade 3-5 treatment-related AEs occurred in 51 patients (52%); most commonly (15%) neutrophil count decreased (39%) and anemia (15%). One patient (1%) experienced a grade 2 treatment-related infusion reaction. Eighteen patients (18%) experienced peripheral neuropathy regardless of treatment of whom 2 (2%) had a grade 3 or 4 event. Median time to onset of first peripheral neuropathy was 29.5 days (range, 3-284). Dose modification because of peripheral neuropathy was required for 10 patients (10%); 6 (6%) experienced dose reduction and 4 (4%) experienced dose interruption. Treatment-related AEs led to discontinuation in 4 patients (4%; 2 diabetic ketoacidosis, 1 septic shock, and 1 acute kidney injury). Two patients (2%) died because of treatment-related AEs (1 septic shock, 1 acute kidney injury).
(Zilovertamab Vedotin은 MSD가 개발 중인 ROR1 ADC입니다)
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현재 진행 중인 World ADC summit Plenary session(전체 회의)에서 리가켐바이오 링커 기술에 대한 언급이 있었습니다.
“현재 Topo1i나 Microtubule inhibitors로 상업화된 ADC들의 페이로드가 제한된 상황 속에서 새로운 혁신을 위해서는 링커의 혁신이 필요하다. 대표적으로 glucronide linker의 사례만 보더라도 CStone이 리가켐바이오의 링커를 통해 PBD 페이로드의 적용 가능성을 보여줬다. Topo1i가 시장의 큰 변화를 가져다 준 것 처럼 링커 혁신을 통한 새로운 페이로드 적용 가능성에도 주목할 필요가 있다.”
라는 내용이였습니다.
“현재 Topo1i나 Microtubule inhibitors로 상업화된 ADC들의 페이로드가 제한된 상황 속에서 새로운 혁신을 위해서는 링커의 혁신이 필요하다. 대표적으로 glucronide linker의 사례만 보더라도 CStone이 리가켐바이오의 링커를 통해 PBD 페이로드의 적용 가능성을 보여줬다. Topo1i가 시장의 큰 변화를 가져다 준 것 처럼 링커 혁신을 통한 새로운 페이로드 적용 가능성에도 주목할 필요가 있다.”
라는 내용이였습니다.
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https://www.cstonepharma.com/en/html/news/3749.html
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.
The global multicenter Phase 1 trial of CS5001 is actively enrolling in the United States, Australia, and China for Phase 1a dose-escalation. A Phase 1b dose-expansion study with potential for registration across multiple tumor types is expected to be initiated shortly.
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.
The global multicenter Phase 1 trial of CS5001 is actively enrolling in the United States, Australia, and China for Phase 1a dose-escalation. A Phase 1b dose-expansion study with potential for registration across multiple tumor types is expected to be initiated shortly.
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