IL-10

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

- New proteomic analyses show that rezpegaldesleukin increases the protein levels of immune-regulating pathways while reducing specific serum proteins known to be elevated in patients with atopic dermatitis - SAN FRANCISCO, Sept. 25, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced several presentations for rezpegaldesleukin (REZPEG) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress. In addition to two trial-in-progress posters, new proteomic analyses were presented that showcases a unique serum proteomic profile in patients with atopic dermatitis (AD). "As an agonist, REZPEG has a differentiated mechanism of action which is demonstrated by its unique proteomic profile presented today at EADV 2024," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. "The data show that REZPEG induces important immunoregulatory pathways, such as IL-10, a key anti-inflammatory cytokine. In addition, REZPEG reduced specific cytokines and chemokines which are known to be elevated in patients with atopic dermatitis and other atopy diseases, including IL-15, CCL22, CX3CL1, and IL-19. These data provide a greater mechanistic understanding of how treatment with REZPEG led to dose-dependent efficacy in the Phase 1b study over the 12-week treatment period, including its rapid onset of action, and it also provides insight into pathways that could result in the sustained efficacy that was observed in that study even after treatment was removed." REZPEG is a novel first-in-class regulatory T (Treg) cell stimulator designed to address the imbalance in the immune system underlying autoimmune disorders and chronic inflammatory conditions. REZPEG works by targeting the IL-2 receptor complex and preferentially stimulating the proliferation of Treg cells without stimulating cytotoxic CD8+ T and CD4+ T cells, which drive autoimmune disease, to restore immune balance. REZPEG is currently being evaluated in two Phase 2b studies, one in moderate-to-severe AD and one in severe to very severe alopecia areata (AA). Nektar expects topline data from the AD study in the first half of 2025 and topline data from the AA study in the middle of 2025. "In recent years, significant progress has been made in the treatment of atopic dermatitis. However, some patients still do not respond to the available biologics and small molecules. Therefore, there is a strong need for molecules with different mechanisms of action, particularly those that are immunoregulatory rather than immunosuppressive," said Spyridon Gkalpakiotis, M.D., Ph.D., MBA, a principal investigator on the Phase 2b study of rezpegaldesleukin in atopic dermatitis and Professor in the Department of Dermatovenerology 3FM CU and UHKV at the University Hospital Královské Vinohrady, Prague, Czech Republic. "My colleagues and I are excited to be a part of a study that can potentially offer the hope of durable effects and long-term remission which could change the paradigm of how we treat patients with atopic dermatitis." The poster presentations are available for download at . Key details and takeaways from the presentations are as follows: Abstract 5560/ePoster P0662: "Serum proteomic biomarker analysis of the interleukin-2 receptor pathway agonist rezpegaldesleukin in patients with atopic dermatitis", Yu, et al. Patients with moderate-to-severe AD received 12 or 24 µg/kg REZPEG or placebo once every two weeks for 12 weeks. The Olink proteomics platform was used to measure the levels of soluble serum proteins from patients at baseline and throughout the induction period. REZPEG modulated Treg pathways and those involving lymphocyte immune homeostasis, MHC expression and regulation, ectodomain shedding of cell surface receptors, as well as cellular migration and adhesion processes. As an IL-2 receptor pathway agonist, REZPEG demonstrated a unique serum proteomic profile in AD patients, reducing the expression of serum proteins known to be elevated in patients with AD and demonstrated an effect on the expression levels of known targets for current AD therapy. Abstract 4505/ePoster P0600 (Trial in Progress): "A Phase 2b, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled, International, Multicenter, Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe Atopic Dermatitis", Gkalpakiotis, et al. The Phase 2b trial is enrolling biologic and JAK-inhibitor naïve adults with moderate-to-severe AD. The primary outcome is reduction in Eczema Area and Severity Index (EASI) score from baseline at the end of the treatment induction phase. Secondary and exploratory endpoints include reduction in Investigator's Global Assessment (IGA) AD score, affected total body surface area (BSA) improvement, as well as safety and tolerability. Abstract 2459/ePoster P2080 (Trial in Progress): "A Phase 2b Study Evaluating the Efficacy and Safety of Single Agent Rezpegaldesleukin, an Interleukin-2 Receptor (IL-2R) Pathway Agonist, in the Treatment of Severe to Very Severe Alopecia Areata", Reich, et al. The Phase 2b trial is enrolling JAK-inhibitor naïve patients with severe to very severe alopecia areata. The primary endpoint is percent change from baseline in Severity Alopecia Tool (SALT) score at the end of the treatment period. Secondary and exploratory endpoints include percent change from baseline in SALT score at other assessed timepoints, safety and tolerability, as well as various patient reported outcomes. About REZPEG Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. REZPEG is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance. REZPEG is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. It is wholly-owned by Nektar Therapeutics. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Our pipeline also includes a preclinical candidate NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will," "expect," "develop," "potential," "advance," "anticipate," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for rezpegaldesleukin. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused by health epidemics, including the COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2024. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contact: For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: David Rosen of Argot Partners 646-461-6387 [email protected] SOURCE Nektar Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SON-1010 is a targeted immune activation cancer therapy designed to turn ‘cold’ tumors ‘hot’ Topline safety data of SB101 Phase 1 study expected by Q4 2024 Sept. 18, 2024 -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced the completion of enrollment and initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. The Company expects to report topline data from this study in Q4 2024. Pankaj Mohan, Founder and Chief Executive Officer of Sonnet commented, “This milestone is an important step forward in our development program for SON-1010 as a monotherapy. We are encouraged by the data seen to date demonstrating safety and tolerability being well within expected levels. We are hopeful that we will continue to see extended PK/PD, tumor targeting and clinical activity during treatment. We remain committed to bringing this trial to completion and we expect to report topline safety data in Q4 2024.” SB101 is the Company’s open-label, adaptive-design dose-escalation study to assess the safety, tolerability, and PK/PD of SON-1010 administered to patients with advanced solid tumors. The study enrolled 24 subjects. Primary outcome measures for the study are to evaluate the safety and tolerability of SON-1010 and establish the maximum tolerated dose (MTD) of SON-1010. SON-1010 is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using Sonnet’s Fully Human Albumin Binding (FHAB®) platform, which extends the half-life and activity of the IL-12 component due to binding native albumin in the serum and targets the tumor microenvironment (TME) by strongly binding gp60 and Secreted Protein Acidic and Rich in Cysteine (SPARC). As previously announced, the safety of SON-1010 was reviewed by the Safety Review Committee at each step during dose escalation. The trial uses a ‘desensitizing’ first dose to take advantage of the known tachyphylaxis with rhIL-12, which minimizes toxicity and allows higher maintenance doses. No dose-limiting toxicities have occurred to date. The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild. All have been transient, with no evidence of cytokine release syndrome. As previously announced, one patient with progressive endometrial sarcoma receiving SON-1010 monotherapy in SB101 had stable disease (SD) for almost 2 years before progressing - her ascites had resolved and tumors had shrunk at one point but she never reached a partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) rules. Cytokine analysis following each dose in that study revealed controlled and prolonged induction of interferon gamma (IFNγ) that peaked at 24 to 48 hours and returned to baseline within 2 to 4 weeks. A small increase in IL-10 was observed with each dose as expected in response to IFNγ. There was either a minimal or no signal for IL-1β, IL-6, IL-8, and TNFα, and there was no indication of any potential for cytokine release syndrome (CRS) at these doses. For more information about the SB101 Phase 1 trial in adult patients with advanced solid tumors visit www.clinicaltrials.com and reference identifier NCT05352750. SON-1010 is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. This was selected to bind albumin both at normal pH, as well as at the acidic pH typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only IL-12, but a variety of potent immunomodulators that can be linked using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1010 is designed to deliver IL-12 to local tumor tissue, turning ‘cold' tumors ‘hot' by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells. This first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and is being conducted at several sites across the United States. While the optimal dose is unknown at this stage, the potential to target tumors, the extended PK mechanism, and our preclinical data suggest the therapeutic dose may be lower compared to native human IL-12. The study, utilizing a standard 3+3 oncology design in at least five cohorts, should establish the MTD using subcutaneous injections of SON-1010 every 3 to 4 weeks. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity. This study will form the basis for potential combinations with other types of immunotherapies and the future development of bispecific candidates using the FHAB platform. Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines. Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of solid tumors and ovarian cancer. SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of Platinum-Resistant Ovarian Cancer (PROC). The Company is also evaluating its second program, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of pancreatic cancer. The Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence of a pro-inflammatory cytokine response. Sonnet is currently seeking partnership opportunities to support a Phase 2 trial. 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