US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Pancreatic Cancer 2024-02-29SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on Feb 27 that the US FDA had granted an orphan drug designation for pancreatic cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development, based on the pre-clinical data of SNB-101 on pancreatic cancer animal model. SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and the INDs for phase 2 clinical trials are planned in the US and Europe in the second half of this year.   According to SN Bioscience, SNB-101 showed excellent efficacy compared to existing first-line treatments Abraxane® and Onivyde® in pancreatic cancer animal models. Based on this, it has been designated as an orphan drug by the US FDA after application in November last year. Pancreatic cancer is a typical incurable tumor with an extremely low 5-year survival rate, and cytotoxic anticancer drugs such as Abraxane® and Onivyde® are currently used as first-line treatments. This is an area of high medical unmet need with limited second-line treatment option.   Orphan drug designation is a program where the US FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SNB-101 received an ODD from the US FDA for small cell lung cancer in July last year. By receiving an ODD for pancreatic cancer this time, SN Bioscience expects to gain momentum in indication expansion and clinical development.   Orphan drug designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance for clinical trial design for clinical development, exemption from review application fees, and priority review support.   Meanwhile, SN Bioscience received phase 2 approval in Korea for SNB-101 in November last year, and is preparing for phase 2 in the US and Europe in the second half of this year.   About SN BioScience Inc.   SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.   SNB-101   SNB-101 is an anticancer agent that is the world's first nanoparticle formulation of the anticancer drug SN-38. It uses a delivery system sophisticatedly designed via dual nano-micelle technology which is a core platform technology of SN Bioscience. SN-38 is an active metabolite of Irinotecan which is gaining attention for its use in drug-antibody conjugates(ADCs) such as Enhertu® and Trodelvy®. Compared to existing irinotecan products, drug resistance and safety have been significantly improved, and based on the animal studies, it is expected to be effective for lung cancer, pancreatic cancer, and stomach cancer, which were not the indications previously. Scale-up production, the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage, was successful, and clinical trial products were produced at a facility dedicated to anticancer drugs with EU GMP certification.※ Please refer to the link below for the related aritcle."https://www.prnewswire.com/news-releases/sn-bioscience-received-us-fda-orphan-drug-designation-for-its-nano-anti-cancer-drug-snb-101-on-pancreatic-cancer-302075576.html  

SN Bioscience Announces Phase 1 Study Results of SNB-101 (SN-38 Nanoparticle Anti-cancer Drug) at ESMO| Impressive safety and efficacy for solid cancer patients followed by global clinical study plan 2023-10-27 Figure. Efficacy results of SNB-101 (water fall chart) SN Bioscience Co., Ltd. (CEO Younghwan Park) announced the results of the phase 1 clinical study of SNB-101, a nanoparticle anti-cancer new drug pipeline, at ESMO Congress 2023 held in Madrid, Spain from October 20 to 24. This phase 1 clinical study was conducted to evaluate the safety and tolerability of SNB-101 administered to 21 patients with solid tumors in Korea and to determine the recommended dose for phase 2. CHA Bundang Medical Center (Professor Joo-Hang Kim), Catholic University of Korea Seoul ST. Mary's Hospital (Professor Myung A Lee), and Severance Hospital of the Yonsei University (Professor Sun Young Rha) participated in this study.   In this phase 1 clinical study, patients with various solid cancers, such as small cell lung cancer, non-small cell lung cancer, gastric cancer, esophageal cancer, head and neck cancer, and rectal cancer, who failed existing standard therapy were enrolled, and they had previously experienced 1st to 9th lines of treatment.   The results of the phase 1 study showed excellent safety in the dosage range (5 to 50 mg/m2 as of SN-38) and did not reach the maximum tolerable dose (MTD) even when all the cohorts were consumed. The most common adverse drug reactions were hematological, such as neutropenia, and were well manageable. In particular, diarrhea of grade 3 or higher, a major adverse drug reaction that frequently occurs with irinotecan, a drug with same active moiety, was not observed. Accordingly, it was evaluated to have excellent safety and tolerability compared to the competitive drugs.   In terms of the efficacy evaluation results, out of a total of 21 patients, partial response (PR) was 14.3% (3 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer), and stable disease (SD) was 28.6% (6 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer, head and neck cancer, gastric cancer), and progressive disease (PD) was 57.1% (12 patients). The disease control rate (DCR) of all patients was 42.9%, well demonstrating the characteristics of general cytotoxic anti-cancer drugs. In particular, in the high dose group (40~50mg/m2), the DCR was 83.3%, well indicating dose dependency.   SNB-101 is a polymeric nanoparticle with an average particle size of approximately 100 nm, and in the preclinical studies, its distribution to the lungs was significantly higher than that of the anti-cancer drugs in conventional delivery. That aligns well with the efficacy results in lung-related tumors such as small cell lung cancer and non-small cell lung cancer from preclinical and phase 1 clinical studies. Based on the results, SN Bioscience plans to conduct multinational phase 2 clinical study targeting the small cell lung cancer in 2024.   For small cell lung cancer, which is one of the areas with very high unmet medical needs, cisplatin + etoposide combination is currently used as the first line standard therapy. Second line therapies include lurbinectedin (product name: Zebzelca), which was recently approved as an orphan drug, and topotecan and paclitaxel, which are traditional chemotherapeutic regimen. According to the NCCN (National Comprehensive Cancer Network) guidelines, treatments are so limited that clinical studies are listed as second line treatment options. In preclinical studies, SNB-101 showed superior efficacy over the first line therapies as well as the second line therapies that are approved for small cell lung cancer. The goal of phase 2 clinical study is to show the superiority over competitive drugs as monotherapy and/or combination with immunotherapy, based on which, SN BioScience plans to enter the global market through expedited approval process after completing phase 2 clinical study.   [SNB-101]   SNB-101 is the world's first nano-anti-cancer drug in which the active metabolite (SN-38) of Irinotecan, a commercially available anti-cancer drug, is active ingredient, and is applied with double nanomicelle technology, a core platform technology of SN Bioscience. SNB-101 is expected to secure new indications as it does not require a metabolic step for activation as well as the advantage of directly administering SN-38, an active metabolite. SNB-101 is a polymeric nanoparticle of approximately 100 nm characterized by a high accumulation rate, especially in the lung and tumor tissue, when administered intravenously, and has shown a wide range of efficacy in solid cancers such as small cell lung cancer, gastric cancer, colon cancer, and pancreatic cancer in preclinical studies. In addition, since it shows a synergistic effect even when used in combination with commercially available immune-anti-cancer drugs, targeted anti-cancer drugs, and chemical anti-cancer drugs, the possibility of its development as a combination therapy in the future is also very high. SNB-101 has secured mass production technology, which is one of the barriers to the development of nanomedicines and is being produced as a sterile product by a contract manufacturing organization (CMO) specializing in anti-cancer drugs that has received EU GMP certification. Furthermore, the US FDA has designated SNB-101 for orphan drug on SCLC based on the medical needs and its preclinical outcome.   [SN BioScience Inc.]   SN BioScience was established in May 2017 as a drug delivery system R&D biotech company specialized in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has been conducting research and development with a focus on "commercialization." Polymer nano-drug delivery technology and albumin nano-drug delivery technology are their key platforms, and it is currently in the stage of expanding its technology to sustained-release liposomes and albumin nanoparticles.※ Please refer to the link below for the related aritcle."https://www.prnewswire.com/news-releases/sn-bioscience-announces-phase-1-study-results-of-snb-101-sn-38-nanoparticle-anti-cancer-drug-at-esmo-301969813.html  

보령에 나노입자 항암제 "기술이전"| 알부민 기반 나노입자 항암제 후보물질 'SNA-001' 기술이전 및 공동개발 계약2023-01-11 에스엔바이오사이언스는 11일 보령과 알부민나노입자 항암제 후보물질 'SNA-001'의 국내 제조기술 이전 및 공동개발 계약을 체결했다고 밝혔다.계약에 따라 보령은 'SNA-001'의 국내 독점제조 및 판매권리를 보유하게 된다. 계약금 등 상세내용은 공개하지 않았다.에스엔바이오에 따르면 SNA-001은 인체 혈액에 존재하는 알부민에 세포독성 항암제를 정전기적결합을 통해 부착한 약물로 고형암 동물모델에서 항암효과를 보였다.이외에도 보령은 지난 2021년 에스엔바이오가 개발한 고분자 나노입자 항암제 'SNB-101'의 국내 독점판매 권리를 보유하고 있다. SNB-101은 이리노테칸(irinotecan) 활성대사체인 SN-38을 주성분으로 하는 항암제로 현재 고형암을 대상으로 국내 임상 1상을 진행하고 있다.한편 에스엔바이오사이언스는 지난 2017년 5월 설립돼 성남에서 항암제 나노의약품에 특화된 약물전달체(DDS)를 연구개발하고 있다.※ 관련기사 아래 링크 참조http://www.biospectator.com/view/news_view.php?varAtcId=18063 

에스엔바이오사이언스, 알부민 나노입자 항암제 국내 1상 신청| 세계 5번째 대량생산공정 개발 및 해외 기술이전 진행 중2021-11-09  나노약물전달 연구개발기업 에스엔바이오사이언스는 인혈청 알부민(human serum albumin)을 약물전달 시스템으로 활용한 나노입자 항암제(개발명: SNA-001)에 대해 식품의약품안전처에 임상1상 신청을 완료했다고 9일 밝혔다.SNA-001은 anti-microtubule drug을 알부민과 결합시켜 약 150nm로 나노입자화 한 항암제이며 albumin receptor를 통해 종양세포내로 흡수돼 항암효과를 나타내는 작용기전을 가지고 있다.국내 임상 1상은 총 34명의 진행성 유방암 환자를 대상으로 다기관 임상으로 진행되며 약물의 안전성, 유효성 및 약동학적 특성 (Cmax, Tmax, AUCt, t1/2)등을 평가할 예정이다.알부민은 약 6만6000 dalton의 혈액 내 약물수송을 담당하는 단백질로서 매우 우수한 생체적합성으로 다양한 약물과 정전기적 또는 화학적 결합을 통해 세포내로 약물을 전달하는 전달체로서 연구돼 왔다.그러나 이러한 장점에도 불구하고 나노입자인 상태로 스케일업이 매우 어려워 그동안 Teva등 전세계 3~4개 회사만 대량생산에 성공했으며 이에 따라 실제 적용되는 약물도 제한적이다. 에스엔바이오사이언스는 이미 1상에 진입한 나노입자 항암제인 SNB-101(주성분: firtecan)을 통해 축적된 나노입자 약물에 대한 생산공정기술을 활용하여 세계 5번째로 대량생산 공정 개발을 완료했다.특히 에스엔바이오사이언스에 따르면 회사가 개발한 제조공정기술은 90% 이상의 수율과 7% 이내의 입자크기 편차를 가지는 매우 우수한 제조공정으로 약 70~80%정도의 수율을 가지는 경쟁사 대비 탁월한 품질과 재현성 있는 제조공정이라는 평가다.SNA-001은 전임상시험을 통해 유방암 동물모델에서 우수한 효과를 나타냈으며, 나노입자의 in vivo 거동에 대한 특성분석을 통해 free drug 및 encapsulated drug의 농도, 주요장기(organ)에서의 약물축척 등 핵심적인 평가지표에서도 적합한 결과를 나타냈다.한편 SNA-001은 내년 상반기 일본 1상 신청 및 유럽 전임상시험을 계획하고 있으며 국내 상위권 제약회사 및 해외 3곳의 제약회사와 비밀유지계약을 체결하고 기술이전 또는 판권 계약을 협의 중에 있는 것으로 알려졌다.또한 그동안 대량생산기술 미확보로 인하여 연구단계에 머물렀던 면역억제제, 세포독성 항암제에 대해 알부민 나노입자 기술을 적용해 내년 하반기 전임상에 진입할 예정이다. ※ 관련기사 아래 링크 참조https://www.mdtoday.co.kr/news/view/1065601625098938  

이중나노미셀 기술 "미국, 유럽 특허등록"| 이중나노미셀 적용 첫 항암제 'SNB-101' 고형암 대상 1상 진행 중2021-07-22 에스엔바이오사이언스는 22일 나노입자 항암제 제조기술인 이중나노미셀 조성물 및 제조방법에 대해 미국, 유럽, 호주, 러시아 등에서 특허를 취득했다고 밝혔다.이중나노미셀 기술은 초기부터 상업화를 위해 대량생산에도 적합하게 개발됐으며, 나노의약품의 임상단계 진입에 장벽 중 하나인 균일품질을 유지하는 스케일업에도 성공해 첫 파이프라인인 'SNB-101'에 적용됐다.에스엔바이오사이언스 관계자는 "주요국 특허등록에 따라 이중나노미셀 기술을 다른 약물에도 적용하는 것을 고려 중"이라며 "특히 최근 주목받고 있는 mRNA 전달기술의 단점을 보완한 기술로도 개발할 계획이다"고 말했다.한편 이중나노미셀기술을 이용한 첫 항암제 파이프라인인 SNB-101은 지난해 한국 식약처와 미국 식품의약국(FDA)으로부터 고형암을 대상으로 임상 1상을 승인을 받아 현재 분당차병원, 서울성모병원 등에서 진행 중이다. 또 내년 상반기 미국, 유럽, 한국 등에서 임상 1b/2a상을 진행할 계획이다.※ 관련기사 아래 링크 참조http://www.biospectator.com/view/news_view.php?varAtcId=13737 

보령제약-에스엔바이오사이언스, ‘나노 입자 항암제’ 독점 판매계약 | 이리노테칸 활성대사체 SN-38 성분 나노항암제 'SNB-101'..고형암 대상 1상 진행 중..| 제품 발매 후 10년간 독점 판매권 확보2021-02-24 보령제약은 23일 에스엔바이오사이언스와 나노입자 항암제 ‘SNB-101(나노화 SN-38)’에 대한 국내 독점판매 계약을 체결했다고 밝혔다.   발표에 따르면 보령제약은 이번 계약을 통해 ‘SNB-101’의 제품 발매 후 국내 독점 판매권을 10년간 보유하게 된다. 보령제약과 에스엔바이오는 국내를 포함해 아시아 15개국에 대한 독점 판매권과 관련한 추가 계약 체결도 협의중이다.   SNB-101은 ‘이중나노미셀’ 기술을 이용해 개발한 나노약물전달 의약품으로 이리노테칸(Irinotecan) 활성대사체인 SN-38이 주성분이다.   이리노테칸은 체내에서 전체 투여량의 약 5% 정도만 활성형 SN-38로 변환돼 항암효과를 나타내며, 변환되지 못한 이리노테칸은 부작용을 일으키는 단점을 보이는 한계가 있다. 나노입자 항암제인 SNB-101은 SN-38을 직접 투여할 수 있어 치료효과를 높이고 부작용을 줄일 수 있을 것이란 설명이다.   SNB-101은 전임상에서 기존 이리노테칸 약물보다 높은 종양 내 약물축적율을 보였고 췌장암, 위암, 대장암, 유방암, 폐암 등 다양한 고형암 마우스모델에 단독투여시 기존 이리노테칸 주사제보다 높은 종양성장 억제효과를 나타냈다고 설명했다.   SNB-101은 지난해 11월 고형암 환자를 36명을 대상으로 안전성, 내약성, 유효성, 약동학적 특성을 연구하기 위한 1상 임상시험을 시작했다. 현재 분당차병원, 서울성모병원, 신촌세브란스병원 등에서 임상을 진행 중이다.   안재현 보령제약 대표는 “에스엔바이오와의 SNB-101 판권계약 체결이 보령제약의 항암분야 사업 역량 강화에 도움이 될 것으로 기대한다”며 “보령제약은 미래성장동력을 확보하고 강화해 나가기 위해 혁신적이고 유망한 기술에 대한 다양한 형태의 지속적으로 협업을 추진해 나갈 것”이라고 말했다.   박영환 에스엔바이오 대표는 “이번 계약체결을 통해 전임상시험 결과에서 항암효과를 보인 ‘SNB-101’의 국내 및 글로벌 시장 진출에 대한 가능성을 확보하게 됐다”며 “항암제 사업에서 우수한 역량을 보유한 보령제약과의 협업을 통해 SNB-101의 시장성을 입증하고 항암치료제 개발을 선도하는 기업으로 입지를 다져나갈 것”이라고 말했다.※ 관련기사 아래 링크 참조http://www.biospectator.com/view/news_view.php?varAtcId=12584