SPARC

PRINCETON, NJ / ACCESSWIRE / February 29, 2024 / Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, announced today the publication of clinical data on SON-1010 in Frontiers in Immunology. SON-1010, Sonnet's lead proprietary monofunctional compound, combines the company's fully-human albumin-binding (FHAB) construct with single-chain interleukin 12 (IL‑12). The paper, entitled "A phase I trial of SON-1010, a tumor-targeted, interleukin-12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers", demonstrated safety and tolerability up to 300 ng/kg as a single ascending dose. In the B16F10 melanoma model, a single dose of SON-1010 results in a marked reduction of tumor growth that was concomitant with increased IFNg, along with augmented immune cell numbers and activity in the tumor microenvironment (TME). The study of SON‑1010 in healthy volunteers, called SB102 (NCT05408572), was first announced in July 2022 and was done in parallel with the ongoing SB101 study in cancer patients (NCT05352750). The results from SB102 provide the initial ‘desensitizing dose' for further dose escalation of the maintenance dose in SB101, to establish the maximum tolerated dose for this molecule. "The publication of these data is an important milestone for Sonnet that provides additional scientific validation of our FHAB technology." said Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "The SB102 study was designed to elucidate the PK and PD of SON-1010 in normal, healthy volunteers, and shows that the drug is safe in the dose range tested, while also providing an appreciably extended half-life. When combined with checkpoint inhibitors, we hypothesize that the targeted immune enhancing components of the SON-1010 mechanism have the potential to turn cold tumors hot. We also believe that our pipeline, which includes compounds with bifunctional combinations of Interleukins 15 and 18, could potentially prove useful in combination with cell-based therapies. We are diligently pursuing these applications, as well." While doses above 100 ng/kg were tolerated, participants generally experienced more treatment-emergent adverse effects (TEAEs) than those receiving the lowest dose of 50 ng/kg. All TEAEs were transient and were consistent with published experience using recombinant IL‑12. More precise pharmacokinetic (PK) and pharmacodynamic (PD) data can be obtained using this non-genotoxic cancer therapy in healthy individuals, without a background of immunosuppression. PK analysis showed two-compartment elimination in SB102 with a mean half-life of 104 hours, compared with one-compartment elimination in SB101, which correlated with prolonged but controlled and dose-related increases in IFNg. This is evidence for target-mediated drug disposition (TMDD), which implies delivery to and retention of SON-1010 in tumor tissue. There were minimal responses with other cytokines and no evidence of cytokine release syndrome. "IL-12 has been studied in healthy volunteers in the past and has shown great promise in animal models of cancer treatment for decades, yet developmental progress in human trials has typically been hindered by toxicity before the therapeutic dose can be reached." said Richard Kenney, M.D., Sonnet's Chief Medical Officer. "Extending the PK by binding to the neonatal Fc receptor (FcRn), combined with targeting retention in the TME through binding to gp60 and SPARC, contributes to TME localization of SON-1010. This may be the key to enhancing the therapeutic window and inducing successful immune responses in the TME, as the PD will also be extended to allow better activation of immune cell penetration and replacement of immune inhibitors." The manuscript can be accessed through the following link: About SON-1010 SON-1010 is an immunotherapeutic drug candidate that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment FHAB. The FHAB single chain was selected to bind well at normal pH, as well as at an acidic pH that is typically found in the tumor microenvironment (TME). The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose-sparing, enhanced pK, and an opportunity to improve the safety and efficacy pro IL-12. A variety of other potent immunomodulators can be combined with the platform to orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as Secreted Protein Acidic and Rich in Cysteine (SPARC), several types of cancer such as non-small cell lung cancer, melanoma, colorectal cancer, 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, with the intention of turning ‘cold' tumors ‘hot' by stimulating IFNg, which activates both innate and adaptive immune cells in the TME, as well as increasing the production of Programed Death Ligand 1 (PD-L1) on tumor cells. About Sonnet BioTherapeutics Holdings, Inc. Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of 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 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. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Sonnet BioTherapeutics Investor Contact: Jack Yauch Solebury Strategic Communications 862-754-1024 jyauch@soleburystrat.com SOURCE: Sonnet BioTherapeutics, Inc. View the original press release on accesswire.com

CARLSBAD, Calif., Oct. 18, 2023 /PRNewswire/ -- Advanced Biologics (known commercially as Biologica Technologies), a California-based company known for their innovative biologic solutions, announced today their successful merger with Isto Biologics, a global leader in regenerative and autologous therapies. The merger will seamlessly integrate Advanced Biologics' proprietary products into Isto's esteemed and growing portfolio of allografts found within their Influx™ line. "We are thrilled for our entire Advanced Biologics/Biologica team to join forces with Isto Biologics, said Amit Govil, President of Advanced Biologics. "This merger brings together the clinical, commercial, and research-driven expertise of both companies' and a shared commitment to help patients heal faster." Advanced Biologics has maintained a commercial partnership with Isto Biologics since 2020, catalyzed by the development of Isto's Integrative Bone Matrix, SPARC™. SPARC is a novel inductive bone matrix that stemmed from Advanced Biologics' proprietary tissue processing method used in their well-known allograft, OsseoGen®. SPARC is known for its increased levels of osteoinductive, chemotactic, angiogenic and proliferative growth factors. The integration of Advanced Biologics' product commercialization initiatives into Isto's growing allograft portfolio provides a unique opportunity to help patients heal faster and enable both customer bases to benefit from the broadened product set. "Over the past four years, our collaboration with Advanced Biologics has been impressive," said Harry Holiday, Chairman of the Board at Isto Biologics and Managing Director at Thompson Street Capital Partners (TSCP). "Investing in Advanced Biologics and embarking on this strategic combination amplifies both Isto's and Advanced Biologics' comprehensive biologics portfolios, paving a path forward for continued growth and patient healing." "With this merger, our combined team is now elevated with greater clinical expertise and deeper customer support to provide our surgeon champions with the best products available on the market," said Don Brown, CEO of Isto Biologics. About Advanced Biologics/Biologica Technologies Advanced Biologics (ABC) is a 3-time, Orthopedics This Week - New Technology Award winning biologics company focused on developing innovative and clinically relevant biologic solutions across a wide degree of medical specialties. To better serve customers, Advanced Biologics created Biologica Technologies in 2015 as a separate, stand-alone company to serve as the sales, marketing and clinical research group. Advanced Biologics' core proprietary technology offers the ability to access intracellular growth factors (GFs) found within allograft tissue. ProteiOS® growth factor and OsseoGEN® cellular bone matrix are among the first products based on the technology and possess the highest concentration of GFs within their respective biologic categories. The company is privately-held and headquartered in Carlsbad, CA. About Isto Biologics Isto Biologics is a leading biologics and cellular therapy company in the orthopedic space. Isto Biologics is focused on Helping Patients Heal Faster™ through innovative solutions for bone regeneration and cell-based therapies. The company's flagship product offerings include the market-leading Magellan® Autologous Platelet Separator, and bone-growth products including InQu® Bone Graft Extender & Substitute, and the Influx™ product family. For more information, visit istobiologics.com SOURCE Advanced Biologics

In collaboration with leading cancer centers, research results to be presented from seven studies across a breadth of tumor types and genomic alterations demonstrating Caris' impact on precision medicine IRVING, Texas, Oct. 17, 2023 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present seven studies across a breadth of tumor types at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain from October 20-24, 2023 (Booth #513). The findings demonstrate the power of Caris' comprehensive clinico-genomic database that enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment. Continue Reading "The research being presented at this year's ESMO Congress is a testament to Caris' continued commitment to data-driven molecular innovation and large-scale collaboration to answer some of the pressing questions in precision oncology today," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris POA. "The findings of these studies illustrate the power of comprehensive molecular profiling to identify underlying tumor biology setting the stage for therapeutics that improve patient outcomes. Alongside our POA partners, we are pioneering new approaches to help deliver the right treatments to the right patients at the right time." Research results to be presented demonstrate Caris Life Sciences' impact on precision medicine Tweet this "More than ever before, our comprehensive molecular profiling coupled with rich clinical data is enabling Caris to help clinicians make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines," said George W. Sledge, Jr., M.D., Executive Vice President and Chief Medical Officer of Caris. "Data presented at this year's ESMO Congress highlight not only our efforts to achieve these goals but also the value of Caris' comprehensive approach to molecular profiling, built on our extensive data, to better understand the biological hallmarks of cancers and ultimately improve outcomes for all cancer patients." Data to be presented by Caris and the POA include the results of a molecular analysis of more than 278,000 tumors that indicate potential new therapeutic opportunities in gastrointestinal cancers. Other notable topics explored in these abstracts include a real-world data analysis of gene expression and outcomes in breast cancer, exploration of the tumor-immune microenvironment in lung cancer, and genomic and immune profiling of patients with a rare and aggressive form of eye cancer: Therapeutic opportunities for Porcupine inhibition in Gastrointestinal cancer (Abstract Number: 222P) October 21, 2023 An Analysis of Proviral Insertion Site of Moloney Murine Leukemia Virus 1 Kinase Expression (PIM1) and Clinical Outcomes in Advanced Breast Cancer (ABC) (Abstract Number: 494P) October 21, 2023 Multi-omics evaluation of TFE3-fusions and potential association with immuno-metabolic vulnerabilities in alveolar soft part sarcoma (ASPS) and translocation-positive renal cell carcinoma (tRCC) (Abstract Number: 2281P) October 21, 2023 Landscape of Delta-like-ligand 3 (DLL3) expression across neuroendocrine neoplasms (NENs) (Abstract Number: 1188P) October 22, 2023 Chemokine expression in uveal melanoma and association with tumor genetics and response to immunotherapy (Abstract Number: 1132P) October 22, 2023 STAT3, ACTA2, and SPARC stromal markers predict response to Gemcitabine/Cisplatin/Nab-paclitaxel (GCN) in patients with advanced pancreatic adenocarcinoma (aPDAC) (Abstract Number: 1645P) October 23, 2023 Tumor-immune microenvironment analysis of de novo and acquired KRAS-mutated non-small cell lung cancer (Abstract Number: 1399P) October 23, 2023 Abstract summaries of this research will be available onsite at Caris' booth #513. The full abstracts are available through the official ESMO website. The POA includes 89 cancer centers, academic institutions, research consortia and healthcare systems. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and molecular testing in oncology. By leveraging the comprehensive genomic, transcriptomic and proteomic profiling available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker-directed trials sponsored by biopharma. Additionally, POA member institutions have access to the most comprehensive clinico-genomic database in the industry, which includes matched molecular and clinical outcomes data from hundreds of thousands of cancer patients, covering over 1 million data points per patient. About Caris Life Sciences Caris Life Sciences® (Caris) is the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, clinico-genomic database and computing capability needed to analyze and unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next-generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media Contact: Lisa Burgner [email protected] 214.294.5606 SOURCE Caris Life Sciences