Author: Fujimoto, Roger ; Mathy, Joanna E ; Fang, Zheng ; Poulin, Danielle L ; Zhu, Shejin ; Ma, Sue ; Anderson, Leah J ; Puyang, Xiaoling ; Wiedmann, Brigitte ; Lin, Kai ; Compton, Teresa

The current standard of care for hepatitis C virus (HCV) infection, pegylated alpha interferon in combination with ribavirin, has a limited response rate and adverse side effects. Drugs targeting viral proteins are in clinical development, but they suffer from the development of high viral resistance. The inhibition of cellular proteins that are essential for viral amplification is thought to have a higher barrier to the emergence of resistance. Three cyclophilin inhibitors, the cyclosporine analogs DEBIO-025, SCY635, and NIM811, have shown promising results for the treatment of HCV infection in early clinical trials. In this study, we investigated the frequency and mechanism of resistance to cyclosporine (CsA), NIM811, and a structurally unrelated cyclophilin inhibitor, SFA-1, in replicon-containing Huh7 cells. Cross-resistance between all clones was observed. NIM811-resistant clones were selected only after obtaining initial resistance to either CsA or SFA-1. The time required to select resistance against cyclophilin inhibitors was significantly longer than that required for resistance selection against viral protein inhibitors, and the achievable resistance level was substantially lower. Resistance to cyclophilin inhibitors was mediated by amino acid substitutions in NS3, NS5A, and NS5B, with NS5A mutations conferring the majority of resistance. Mutation D320E in NS5A mediated most of the resistance conferred by NS5A. Taken together, the results indicate that there is a very low frequency and level of resistance to cyclophilin-binding drugs mediated by amino acid substitutions in three viral proteins. The interaction of cyclophilin with NS5A seems to be the most critical, since the NS5A mutations have the largest impact on resistance.

News (Medical) associated with SFA-001

22 Nov 2024

·www.businesswire.com

B-cell Lymphoma Pipeline Insight 2024, with Comprehensive Insights for 295+ Companies and 300+ Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "B-cell Lymphoma - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This "B-cell Lymphoma- Pipeline Insight, 2024" report provides comprehensive insights about 295+ companies and 300+ pipeline drugs in B-cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence B-cell Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve B-cell Lymphoma. B-cell Lymphoma Emerging Drugs Chapters This segment of the B-cell Lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. B-cell Lymphoma: Therapeutic Assessment This segment of the report provides insights about the different B-cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as: Major Players in B-cell Lymphoma There are approx. 295+ key companies which are developing the therapies for B-cell Lymphoma. The companies which have their B-cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma. The report covers 300+ products under different phases of clinical development like: Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration B-cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Subcutaneous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Monoclonal antibody Small molecule Peptide Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. B-cell Lymphoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses B-cell Lymphoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging B-cell Lymphoma drugs. B-cell Lymphoma Report Insights B-cell Lymphoma Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs B-cell Lymphoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing B-cell Lymphoma drugs? How many B-cell Lymphoma drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of B-cell Lymphoma? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the B-cell Lymphoma therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for B-cell Lymphoma and their status? What are the key designations that have been granted to the emerging drugs? Key Players Lisocabtagene maraleucel Hoffmann-La Roche Nektar Therapeutics Miltenyi Biomedicine AVM Biotechnology Lin BioScience Incyte Corporation ADC Therapeutics Genor Biopharma Beijing InnoCare Pharma Tech Co., Ltd. CARGO Therapeutics Chia Tai Tianqing Pharmaceutical Group Co., Ltd. SystImmune LIBO PHARMA Abclon BeiGene Cellectis Iovance Biotherapeutics, Inc. Guangzhou Excelmab Y-mAbs Therapeutics TG Therapeutics Sutro Biopharma AbbVie Aleta Biotherapeutics Janssen Research & Development Lantern Pharma Beijing Immunochina Medical Science and Technology Bantam Pharmaceutical Lin Bioscience SFA Therapeutics neoX Biotech March Biosciences HUTCHMED Key Products Bristol Myers Squibb Glofitamab NKTR-255 Zamtocabtagene autoleucel MB-CART20.1 AVM0703 LBS-007 Parsaclisib Loncastuximab tesirine GB-241 ICP-248 CRG-022 TQB3702 GNC-038 NM-IL-12 AT101 BGB-16673 UCART20x22 IOV-2001 EX103 CD38-SADA TG-1801 STRO-001 ABBV-319 ALETA-001 JNJ-80948543 LP-284 INS19 CAR-T Cells BTM 3566 LBS-007 SFA-001 NXD07 MB-105 HMPL A067 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/qxd94m About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2ASCOCell TherapyPhase 1

22 Oct 2024

·www.prnewswire.com

SFA Therapeutics Strengthens Intellectual Property in Autoimmune Disease and Hepatocellular Carcinoma

JENKINTOWN, Pa., Oct. 22, 2024 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the expansion of its intellectual property in autoimmune disease and hepatocellular carcinoma. SFA Therapeutics has been issued a new patent in the United States (11963938) and has been allowed two patent applications in Canada (2,974,510) and in Korea (10-2017-7023391) with patent coverage through 2036. SFA Therapeutics has also been issued one new patent in Korea (10-2646764) with patent coverage through 2038. The United States patent and the allowed Canadian and Korean patent applications protect the short chain fatty acid composition that comprises SFA's proprietary oral small-molecule biosynthetic compound SFA-001. SFA-001 is a potent immunomodulator being evaluated for the prevention, delay of onset, and treatment of hepatocellular carcinoma. In preclinical studies, SFA-001 demonstrated cytotoxicity against two common human liver cancer cell lines expressing the hepatitis B oncoprotein, HBx. Huh7x and Hep3BX are highly sensitive to SFA-001 without damage to normal liver cells. In 2019, the United States Food and Drug Administration granted an Orphan Drug Designation (ODD) to SFA-001 for the treatment of hepatocellular carcinoma. The Korean patent protects the short chain fatty acid composition that comprises SFA-002, SFA Therapeutics' lead candidate and Phase-2 ready potent immunomodulator being evaluated for the treatment of psoriasis. SFA-002 acts on multiple therapeutic pathways with the aim of restoring balance to the immune system. While SFA-002 inhibits pathways of pro-inflammatory cytokines such as IL-17, IL-23, TNF-α, and IFN-y, it also increases Treg differentiation and upregulates the anti-inflammatory cytokine IL-10. "As SFA's clinical development progresses, we understand the importance of strengthening our intellectual property portfolio to protect SFA Therapeutics' proprietary therapeutic candidates," said Dr. Ira Spector, Chief Executive Officer of SFA Therapeutics. "The expansion of our patent portfolio allows us to continue the research and development necessary to bring drug candidates like SFA-001 and SFA-002 through the clinic to patients of autoimmune and inflammatory diseases. This brings the total number of issued and allowed SFA Therapeutics patents to 15, with 33 additional patents pending." "These patents demonstrate the novel nature of SFA Therapeutics' platform and drug candidates which are developed by adding disease-specific adjuvants to compounds that are naturally found in the human body," said Dr. Mark Feitelson, Chief Scientific Officer of SFA Therapeutics. "Our therapeutic candidates target multiple pathways in autoimmune and inflammatory conditions, working to inhibit pro-inflammatory cytokines, up-regulate anti-inflammatory targets, and suppress autoimmunity. We believe the intellectual property protected by these patents has the potential to not only manage symptoms from diseases, but to also address the underlying cause of these conditions and prevent or delay their onset." About SFA Therapeutics SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, a potent immunomodulator, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis. SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer. SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit to learn more. Company Contact Ira Spector, Ph.D. SFA Therapeutics, Inc. +1 267-584-1080 Media Contacts Tony Russo, Ph.D. Russo Partners, LLC [email protected] Maddie Stabinski Russo Partners, LLC [email protected] SOURCE SFA Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugPhase 2Clinical ResultPhase 1Immunotherapy

30 May 2024

·www.prnewswire.com

SFA Therapeutics Announces Completion of Enrollment in Phase 1b Trial of SFA-002 for Psoriasis

JENKINTOWN, Pa., May 30, 2024 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the completion of enrollment of 15 patients in cohort 2 of its Phase 1b clinical trial of SFA-002 for the treatment of mild-to-moderate chronic plaque psoriasis. "This clinical milestone is essential to our ongoing evaluation of the safety and efficacy of SFA-002 for the treatment of psoriasis. As an endogenous biosynthetic compound, SFA-002 has the potential to be a disease-modifying therapeutic that targets multiple pathways with greater efficacy and less side effects for patients," stated Dr. Stefan Weiss, Chief Medical Officer of SFA Therapeutics. "As we approach the conclusion of our Phase 1b trial, we look forward to entering Phase 2 studies in the second half of the year," stated Ira Spector, Chief Executive Officer of SFA Therapeutics. "The encouraging topline and safety results from cohort 1 of the Phase 1b clinical trial demonstrate the promise of SFA-002 to be a successful treatment for psoriasis. We anticipate additional Phase 1b data readouts from cohort 1 along with topline data from cohort 2 in the coming months." SFA Therapeutics previously reported positive topline efficacy and safety results from cohort 1 of its Phase 1b clinical trial of SFA-002. In 14 evaluable subjects with difficult-to-treat scalp psoriasis and palmoplantar psoriasis, including six subjects on the three-month extension, 92% of patients demonstrated a PASI improvement of greater than 50. 72% of subjects showed an improvement of greater than PASI 75. Two subjects achieved PASI 100 (100% clearance). No related adverse events or toxicities were observed during the treatment period and follow-up, with no rebound effects observed. About SFA Therapeutics SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis. SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer. SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit to learn more. Company Contact Ira Spector, Ph.D. SFA Therapeutics, Inc. +1 267-584-1080 Media Contacts Tony Russo, Ph.D. Russo Partners, LLC [email protected] Maddie Stabinski Russo Partners, LLC [email protected] SOURCE SFA Therapeutics, Inc.

Phase 1Phase 2Orphan DrugClinical Result

100 Deals associated with SFA-001

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis, Liver	Preclinical	US	SFA Therapeutics, Inc.Startup	05 Dec 2018
Hepatitis B	Preclinical	US	SFA Therapeutics, Inc.Startup	05 Dec 2018
Hepatocellular Carcinoma	Preclinical	US	SFA Therapeutics, Inc.Startup	05 Dec 2018
Nonalcoholic Steatohepatitis	Preclinical	US	SFA Therapeutics, Inc.Startup	-

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