SN BioScience Investigational Drug Access Policy   1. Purpose SN BioScience is committed to advancing healthcare by developing innovative therapies. Our Investigational Drug Access Policy outlines the procedures for granting access to SNB-101, our investigational drug, to patients in need before its full regulatory approval.   2. Scope This policy governs two scenarios: 1) Continuation of treatment post-clinical trials. 2) Compassionate or emergency use outside of clinical trials.   3. Policy 3.1 Criteria: SN BioScience will consider early access to SNB-101 based on the following criteria: ·        Any use of SN BioScience’s investigational products outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including SN BioScience policies and procedures. ·        The patient's condition must be serious or life-threatening, with no satisfactory alternative treatments available. ·        We must have a minimum level of evidence to determine appropriate dosing and safety measures, as well as evidence the investigational product is likely to be efficacious, before considering early access. Further, excessive risk to any patients who may receive the investigational product before marketing approval must be avoided. ·        A benefit-risk analysis, considering both clinical data and the patient's individual circumstances, must support early access. ·        Early access must not impede ongoing clinical trials or regulatory approval processes. ·        Adequate supply of the investigational drug must be ensured.   3.2 Continued Treatment After Clinical Trials: Patients participating in clinical trials may be eligible for continued treatment with SNB-101 after the trial concludes, but before regulatory approval. Decisions will be based on the severity of the disease, available evidence of efficacy and safety, and the absence of alternative treatments. Patients will be informed about the possibility of continued treatment before enrolling in a trial and will provide consent for ongoing data collection.   3.3 Compassionate or Emergency Use: For patient’s ineligible for clinical trials, suffering from serious or immediately life-threatening conditions, and with no alternative treatments available, SN BioScience may consider early access to SNB-101. Similar to post-trial treatment, patients will provide consent for ongoing data collection.   3.4 Discontinuation of Early Access: Early access will be phased out upon regulatory approval and commercial availability of SNB-101. If evidence suggests insufficient efficacy or safety, SN BioScience will discontinue early access and assist patients in transitioning to alternative treatments.   3.5 Treating Physician Criteria and Responsibilities: The physician(s) attending to the patients who are receiving an investigational product through compassionate use access must be properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:  ·        Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.  ·        Any SN BioScience requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.   4. Conclusion SN BioScience is dedicated to ensuring patient safety while providing access to investigational therapies. This policy reflects our commitment to advancing healthcare while upholding ethical and regulatory standards.   5. Contact Information snbs@snbioscience.com   End of Policy

SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer2024-05-10 SEOUL, South Korea, May 9, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a new drug for polymer nanoparticle anticancer under clinical trial. SNB-101 was designated as an orphan drug for small cell lung cancer and pancreatic cancer in July of last year and February of this year, respectively. By receiving fast-track designation this time, it is evaluated that it has laid the groundwork that can be commercialized immediately after completion of phase 2 clinical trials.  Despite a long period of research and development, SCLC still remains a field with high medical unmet needs. Currently, the first-line standard treatment is a combination therapy of cisplatin and etoposide, a classic cytotoxic anticancer drug, and 'clinical trials' are included as second-line treatments in the NCCN guidelines. 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. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Fast Track designation facilitates the interactions with the FDA and allows a rolling review for the submission package so it can be reviewed in each section, rather than waiting until every section of the NDA is completed. Additionally, it may be possible to apply for accelerated approval after the completion of phase 2 clinical trials and priority review immediately after the completion of phase 3 clinical trials when qualified.  SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. The nano micelle technology, a core platform technology of SN Bioscience, has been applied. Preclinical and phase 1 clinical results showed that it significantly reduced digestive system adverse events (nausea, vomiting, diarrhea, etc.) compared to existing anticancer drugs, and especially showed excellent efficacy in patients related to lung cancer through lung targeting. The phase 1 clinical trial has been completed, IND for phase 2 has been approved in Korea, and global clinical trials are scheduled to begin after IND approval for phase 2 in the US and Europe in the second half of this year. Following small cell lung cancer and pancreatic cancer, attempts are being made to expand its indications to other solid cancers such as colon cancer, gastric cancer, and biliary tract cancer, and will be verified through phase 2 clinical trials.  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]The development name, SNB-101, is the world's first anticancer drug developed from SN-38 as nanoparticles. 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®. Tolerability and safety have been dramatically improved compared to existing products, and it is expected to be effective in lung cancer, pancreatic cancer, and gastric cancer, were not the indications before. Scale-up production, the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage, was successful, and clinical trial products are produced at a facility dedicated to anticancer drugs with EU GMP.※ Please refer to the link below for the related article SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer (prnewswire.com) 

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  

US FDA Grants Orphan Drug Designation of SNBioScience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer 2023-07-20SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on July 19 that the US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development. 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 IND for phase 2 has been filed after phase 1 clinical trial in Korea.   SNB-101 showed excellent efficacy in animal small cell lung cancer models, and based on this, it has been designated as an orphan drug by the US FDA after application in April and review. Small cell lung cancer accounts for 15-20% of all lung cancers with a very poor prognosis. The current standard treatment (first-line treatment) is classic drugs, Cisplatin + Etoposide. However, as there are very limited options for second-line treatment and others, it is an area with very high medical unmet needs.   Orphan drug designation is a program where the FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SN Bioscience expects the designation as an orphan drug to accelerate the development of SNB-101, which is being developed as a treatment for orphan drugs including small cell lung cancer.   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 on clinical trial design for clinical development, exemption from review application fees, and priority review support.   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 the world's first product to use the active metabolite (SN-38) of Irinotecan as an API, and dual nano-micelle technology which is a core platform technology of SN Bioscience is applied. 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 previously included as indications. 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/us-fda-grants-orphan-drug-designation-of-sn-biosciences-nano-anti-cancer-drug-snb-101-for-small-cell-lung-cancer-301882684.html  

SN BioScience and Boryung Announce the Licensing Agreement on Generic Version of Abraxane 2023-01-26- First Generic of Abraxane in Korea, World 4th Commercial Scale-Up- Global tech-transfer expected to US, Japan, and EuropeSN BioScience (CEO Park Young-hwan) and Boryeong (CEO Jang Doo-hyun) signed a domestic manufacturing technology transfer and co-development contract for the albumin nanoparticle anticancer drug (code name: SNA-001) developed by SN BioScience for the first time in Korea and the fourth time in the world. Through this contract, Boryeong will have exclusive manufacturing and distribution rights in Korea for "SNA-001." SN BioScience will receive milestones and double-digit royalties according to the development stage. SN BioScience also signed a domestic distribution agreement with Boryeong in February 2021 for SNB-101, a polymer nanoparticle new drug, and expects a variety of cooperations in the field of anticancer drugs in the future.   "SNA-001" is a product that electrostatically binds cytotoxic anticancer drugs to albumin using albumin present in human blood as a drug carrier. Abraxane is a global blockbuster first developed by Abraxis BioScience Inc (acquired by Celgene who became a subsidiary of BMS), with sales of $1.5 billion worldwide in 2020.   Albumin has been studied as a carrier that delivers various drugs into cells through electrostatic or chemical bonds with excellent biocompatibility as about 66,000 Dalton of drug transport protein in the blood. Despite the advantages, there has been challenges in commercial scale-up. Even BMS, the original manufacturer, has gone through global shortages from 2019 to 2021 due to manufacturing/quality issues. Only a few companies around the world, such as Teva, have succeeded in scale-up production to date. Based on the commercial scale-up technology for nanoparticle drugs accumulated through SNB-101 (API: SN-38, firtecan), a nanoparticle anticancer drug that has already entered phase 1, SN BioScience has completed the development of a commercial-scale manufacture process for the Abraxane's generic for the fourth time in the world. SN BioScience developed a superior manufacturing process with a yield of more than 90% and a particle size deviation of less than 7%, which is evaluated as having excellent quality and reproducibility compared to products of competitors with a yield of about 70 to 80%.   SNA-001 showed excellent efficacy in solid cancer animal models in non-clinical studies. In the characterization of the in vivo behavior of nanoparticles, it was suitable for key evaluation indicators such as free and encapsulated drug concentrations and drug accumulation in major organs.   Based on the above, SN BioScience is discussing the technology transfer with global leading pharmaceutical companies in the United States, Japan, and Europe, while on the other hand, it is discovering new indications by applying albumin-based nanoparticle platforms to various anticancer drugs. The company is also planning to file phase 1 IND for two to three new nanoparticle anticancer drugs in the second half of this year.   About SN BioScience Inc   SN BioScience is a biotech company established in May 2017, 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 been developing nanoliposomes and nanoparticle drug carriers based on drug metrology and pharmacokinetics. The main pipelines include polymeric nanoparticle anticancer drugs (on-going phase I in Korea) and albumin nanoparticle anticancer drugs (phase I IND filed).   About Boryung Co., Ltd   Founded in 1957, Boryeong Co., Ltd. is a top-tier pharmaceutical company in Korea that manufactures and sells drugs for chronic diseases such as hypertension, diabetes, brain disease, and anticancer, with sales of about USD 550 million in 2022. In addition, the company has produced various and successful research results, including Kanarb Tab., a new drug for high blood pressure, and has the highest market share in Korea, especially in the field of anticancer drugs.※ Please refer to the link below for the related aritcle."https://www.prnewswire.com/news-releases/sn-bioscience-and-boryung-announce-the-licensing-agreement-on-generic-version-of-abraxane-301731256.html