This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.

Start Date01 Dec 2021

Sponsor / Collaborator

Serpin Pharma, LLC

[+1]

NCT04225533 / CompletedPhase 1/2

SP16 Inflammatory Response Inhibition Trial

This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.

Start Date24 Feb 2020

Sponsor / Collaborator

Serpin Pharma, LLC

[+1]

NCT03651089 / CompletedPhase 1

Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Administration of SP16-a SERPIN-like, Small Peptide Agonist of the Low Density Lipoprotein-like Receptor 1-in Healthy Individuals

This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1 (LRPP1) hypothesized to have anti-inflammatory activity.

Start Date16 Jul 2018

Sponsor / Collaborator

Serpin Pharma, LLC

[+2]

100 Clinical Results associated with Serpin Pharma, LLC

0 Patents (Medical) associated with Serpin Pharma, LLC

Literatures (Medical) associated with Serpin Pharma, LLC

01 May 2023·The Journal of Immunology

Restoration of CD4 +T helper cells without modulating the hepatic inflammatory pattern is not sufficient to prevent HCC

Author: Manjili, Masoud H ; Austin, Dana ; Mirshahi, Faridoddin ; Isbell, Madison ; Sanyal, Arun ; Wang, Xiang-Yang Shawn ; Gelber, Cohava ; Koelsch, Nicholas James ; Idowu, Michael ; Guo, Chubquing

AbstractRecent studies suggest that progression of nonalcoholic fatty liver disease (NAFLD) to hepatocellular carcinoma (HCC) is associated with a decreased frequency of the hepatic CD4 +T cells, as well as a predominance of the inflammatory immunological pattern. To determine whether the inhibition of chronic inflammation could prevent the progression of NAFLD to HCC, we used a novel LRP-1 agonistic peptide, SP16, during a progressive NAFLD in an animal model of NAFLD, i.e., DIAMOND mice. Tumor progression, circulating inflammatory cytokines as well as the hepatic immune cells were analyzed using 44-plex cytokine array and multi-color flow cytometry. Although SP16 restored the hepatic CD4 +T cells and slightly increased Th2 subset, it failed to modulate the CD4 +Th1 dominant pattern in the liver or prevent HCC. These data suggest that the hepatic immune pattern, which could produce a collective function independent from its cellular components, is more important than CD4 +T cell recovery during disease progression. Our data also suggest that administration of SP16 very early during NAFLD could shift a predominant Th1 pattern towards an equilibrium Th1=Th2=Th17 pattern which has been found to protect DIAMOND mice from from the progression of NAFLD to HCC. Future studies will determine if modulation of the inflammatory immune response by SP16 when administered early during NAFLD progression will prevent HCC.This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Breast Cancer Research Program under Award No. W81XWH2210793, Massey Cancer Center Multi-Investigator Award, grant number 2017-MIP-02, NIH R01DK105961, and VA Merit Award 1I01BX003275. Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the U.S. Department of Defense. Services and products in support of the research project were generated by the Virginia Commonwealth University Flow Cytometry Shared Resource, supported, in part, with funding from NIH-NCI Cancer Center Support Grant P30 CA016059.

Cells

SERPIN-Derived Small Peptide (SP16) as a Potential Therapeutic Agent against HIV-Induced Inflammatory Molecules and Viral Replication in Cells of the Central Nervous System

Article

Author: El-Hage, Nazira ; Gelber, Cohava ; Rodriguez, Myosotys ; Austin, Dana ; Gineste, Cyrille ; Soler, Yemmy

Despite the success of combined antiretroviral therapy (cART) increasing the survival rate in human immunodeficiency virus (HIV) patients, low levels of viremia persist in the brain of patients leading to glia (microglia and astrocytes)-induced neuroinflammation and consequently, the reactivation of HIV and neuronal injury. Here, we tested the therapeutic efficacy of a Low-Density Lipoprotein Receptor-Related Protein 1 (LRP-1) agonistic small peptide drug (SP16) in attenuating HIV replication and the secretion of inflammatory molecules in brain reservoirs. SP16 was developed by Serpin Pharma and is derived from the pentapeptide sequence of the serine protease inhibitor alpha-1-antitrypsin (A1AT). The SP16 peptide sequence was subsequently modified to improve the stability, bioavailability, efficacy, and binding to LRP-1; a scavenger regulatory receptor that internalizes ligands to induce anti-viral, anti-inflammatory, and pro-survival signals. Using glial cells infected with HIV, we showed that: (i) SP16 attenuated viral-induced secretion of pro-inflammatory molecules; and (ii) SP16 attenuated viral replication. Using an artificial 3D blood-brain barrier (BBB) system, we showed that: (i) SP16 was transported across the BBB; and (ii) restored the permeability of the BBB compromised by HIV. Mechanistically, we showed that SP16 interaction with LRP-1 and binding lead to: (i) down-regulation in the expression levels of nuclear factor-kappa beta (NF-κB); and (ii) up-regulation in the expression levels of Akt. Using an in vivo mouse model, we showed that SP16 was transported across the BBB after intranasal delivery, while animals infected with EcoHIV undergo a reduction in (i) viral replication and (ii) viral secreted inflammatory molecules, after exposure to SP16 and antiretrovirals. Overall, these studies confirm a therapeutic response of SP16 against HIV-associated inflammatory effects in the brain.

CellsQ3 · BIOLOGY

Cannabinoids Reduce Extracellular Vesicle Release from HIV-1 Infected Myeloid Cells and Inhibit Viral Transcription

Q3 · BIOLOGY

ArticleOA

Author: Zhou, Weidong ; Sharif, Sarah Al ; Branscome, Heather ; Kim, Yuriy ; Jenabian, Mohammad-Ali ; Costiniuk, Cecilia T. ; Langford, Dianne ; Khatkar, Pooja ; DeMarino, Catherine ; Cotto, Bianca ; Liotta, Lance A. ; Agbottah, Emmanuel T. ; Kashanchi, Fatah ; Gelber, Cohava ; Cowen, Maria

Of the 37.9 million individuals infected with human immunodeficiency virus type 1 (HIV-1), approximately 50% exhibit HIV-associated neurocognitive disorders (HAND). We and others previously showed that HIV-1 viral RNAs, such as trans-activating response (TAR) RNA, are incorporated into extracellular vesicles (EVs) and elicit an inflammatory response in recipient naïve cells. Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC), the primary cannabinoids present in cannabis, are effective in reducing inflammation. Studies show that cannabis use in people living with HIV-1 is associated with lower viral load, lower circulating CD16+ monocytes and high CD4+ T-cell counts, suggesting a potentially therapeutic application. Here, HIV-1 infected U1 monocytes and primary macrophages were used to assess the effects of CBD. Post-CBD treatment, EV concentrations were analyzed using nanoparticle tracking analysis. Changes in intracellular and EV-associated viral RNA were quantified using RT-qPCR, and changes in viral proteins, EV markers, and autophagy proteins were assessed by Western blot. Our data suggest that CBD significantly reduces the number of EVs released from infected cells and that this may be mediated by reducing viral transcription and autophagy activation. Therefore, CBD may exert a protective effect by alleviating the pathogenic effects of EVs in HIV-1 and CNS-related infections.

News (Medical) associated with Serpin Pharma, LLC

31 Jan 2024

·www.prnewswire.com

BIRD - Israel-U.S. Binational Industrial R&D Foundation to invest $9.6 million in 10 new projects: The approved projects, with an overall budget of $24.5 million, involve innovations in the areas of Agrotech, Biotechnology, Electronics, Energy, Foodtech, Healthcare IT, and Life Science

TEL AVIV, Israel, Jan. 31, 2024 /PRNewswire/ -- During its meeting on December 19, 2023, held in Washington D.C., the Board of Governors of the Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation approved $9.6 million in funding for ten new projects between U.S. and Israeli companies. In addition to the grants from BIRD, the projects will access private-sector funding, boosting the total investment in all projects to $24.5 million. The BIRD Foundation promotes collaborations between U.S. and Israeli companies in various technological sectors for joint product development. In addition to providing conditional grants of up to $1.5 million, the Foundation assists by working with companies to identify potential strategic partners and facilitate introductions. The submitted projects are reviewed by evaluators appointed by the National Institute of Standards and Technology (NIST) of the U.S. Department of Commerce and the Israel Innovation Authority. The ten projects approved by the Board of Governors are in addition to the over 1000 projects that the BIRD Foundation has approved for funding during its 46-year history. To date, BIRD's total investment in joint projects is over $390 million, helping to generate direct and indirect sales of more than $10 billion. The projects approved are: Celleste Bio (Misgav, Israel) and Mondelez International (Chicago, IL) to develop and produce on-demand non-fat cocoa solids and cocoa-based powder using cell-based technology. CENS Materials (Beer Sheva, Israel) and LiCAP Technologies (Sacramento, CA) to develop a dry electrode process with carbon nanotube technology dispersion to advance EV battery capacity and performance while lowering production costs. Diptera.ai (Jerusalem, Israel) and Vectech, Inc. (Baltimore, MD) will utilize advances in artificial intelligence to build a process and system to monitor and control the Anopheles Stephensi mosquito, a highly competent malaria vector. Greatnix, dba Opmed.AI (Herzliya, Israel), and Mayo Clinic (Rochester, MN) to advance the development of an AI-driven Planner that optimizes procedure scheduling, enhances operating room efficiency, and maximizes resource utilization. Hypervision (Yokneam Illit, Israel) and Light Polymers (Santa Clara, CA) will develop a liquid crystal-based polarized coating technology, methods & systems tailored for Virtual Reality and Mixed Reality optics. Imagindairy (Haifa, Israel) and Ginkgo Bioworks (Boston, MA) to develop and manufacture non-whey dairy proteins at scale and cost parity for novel food products. Israel Aerospace Industries (Lod, Israel) and MELD Printworks (Christiansburg, VA) to develop and approve large civil aviation components utilizing Additive Friction Stir Deposition technology. LahakX (Ramat Hasharon, Israel) and Aero Systems West (San Martin, CA) to develop a heavy payload spraying drone swarm for agriculture and fire prevention. Sheba Medical Center (Ramat Gan, Israel) and Serpin Pharma (Manassas, VA) will perform a Phase II clinical trial to provide a targeted therapeutic to restore immune balance for patients with acute myocardial infarction. Tissue Dynamics (Rehovot, Israel) and ATCC, (Manassas, VA), will develop an advanced organoid kit for cardiac toxicity assessment. Ms. Mojdeh Bahar, Associate Director for Innovation and Industry Services at the U.S. National Institute of Standards and Technology (NIST), and co-Chair of BIRD's Board of Governors said : "This competition cycle attracted an impressive range of proposals exploring the frontiers of technology in areas vital to our future, including advanced manufacturing techniques, next-generation biotechnologies, and exciting developments in EV battery production. After a rigorous evaluation by our Board, we're proud to announce the 10 winning projects. We congratulate this cycle's grant recipients and look forward to the successful commercialization of their products." Dr. Einat Magal, Acting Chief Scientist of Innovation at the Ministry of Innovation, Science and Technology, and co-Chair of BIRD's Board of Governors said: "One of the expressions of the decades-long strong partnership between Israel and the U.S. is the support shared by both countries in the high-tech industry that finds its expression through the work of the BIRD Foundation. Especially during the recent difficult times, this collaborative work bears greater significance and is a testament to the added value brought by both the Israeli and the U.S. companies. We congratulate the companies of the ten excellent projects that were selected and hope that this collaboration will continue to bear successful fruits in the future as it did in the past." Mr. Jaron Lotan, Executive Director of the BIRD Foundation, said: "At BIRD, we take great pride in awarding grants to a record number of projects that strengthen U.S.-Israeli collaborations, emphasizing innovations geared towards delivering commercial products. In this cycle, we witnessed a diverse range of projects across sectors and geographical regions, showcasing our commitment to fostering impactful partnerships and promoting innovation across diverse realms." The deadline for submission of Executive Summaries for the next BIRD cycle is March 7, 2024. Approval of projects will take place in June 2024. About the BIRD Foundation The BIRD ( Binational Industrial Research and Development) Foundation encourages and facilitates cooperation between U.S. and Israeli companies in a wide range of technology sectors and offers funding to selected projects. The Foundation supports projects without receiving any equity or intellectual property rights from the participating companies or the projects themselves. BIRD funding is repaid as royalties from sales of products that were commercialized as a result of BIRD support. The Foundation provides funding of up to 50% of a project's budget, beginning with R&D and ending with the initial stages of sales and marketing. The Foundation shares the risk and does not require repayment if the project fails to reach the sales stage. Contact: Limor Nakar-Vincent, Deputy Executive Director of Business Development and BIRD Energy +972-36988315 [email protected] SOURCE The BIRD Foundation

Phase 2

100 Deals associated with Serpin Pharma, LLC

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Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Serpin Peptide 16 ( LRP1 )	Acute Lung Injury More	Phase 2
SP-9	Cystic Fibrosis More	Discontinued
SP-14	Shock, Septic More	Discontinued

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