LEKTI

Xenetic to supply recombinant DNase I to Tokyo Medical University for evaluation as a treatment of Ewing sarcoma in unique preclinical model FRAMINGHAM, MA / ACCESSWIRE / October 17, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat oncology indications, today announced it has entered into a Materials Transfer Agreement with Tokyo Medical University to advance the development of its systemic DNase program. Under the terms of the agreement, Professor Takuro Nakamura of the Department of Experimental Pathology, Institute of Medical Science at Tokyo Medical University will lead the research program evaluating the effects of human recombinant DNase I (rhDNase I) when given in combination with chemotherapy in a proprietary immunocompetent preclinical mouse model of Ewing sarcoma. Professor Takuro Nakamura's proprietary immunocompetent Ewing sarcoma model encompasses the biological characteristics, morphology and gene expression profiles of human Ewing sarcoma and has demonstrated translational relevance. Ewing sarcoma is an aggressive orphan pediatric cancer that grows in bones or soft tissues, accounting for between 2 to 3 percent of all childhood cancers. There is a lack of effective treatment options for children with recurrent and metastatic disease where the five-year survival rate is only 20 to 30 percent for patients that have relapsed. Clinical studies conducted at Tel Aviv Medical Center between 2010 and 2021 [1] showed that the formation of neutrophil extracellular traps (NETs) in the tumor microenvironment of Ewing sarcoma is an independent prognostic factor, with a clear association between NETs burden and poor prognosis. According to research from these clinical studies, elevated levels of NETs at diagnosis predicted a poor response to neoadjuvant chemotherapy, relapse, and death from the disease. Xenetic's proprietary recombinant DNase I is an enzyme that digests NETs in tumor microenvironment. The preclinical studies are designed to evaluate the efficacy of DNase to reduce NETs burden and to increase the efficacy of chemotherapy given in an adjuvant setting. James Parslow, Interim Chief Executive Officer and Chief Financial Officer of the Company stated, "As part of our overall development strategy, we aim to leverage relationships like the one established with Tokyo Medical University. Our commitment to the DNase program remains steadfast, and we are pleased to enter into this agreement to further expand our growing body of data." About DNase-Based Oncology Platform Xenetic's DNase-based oncology platform is designed to target NETs, which are weblike structures composed of extracellular chromatin coated with histones and other proteins. In cancer, NETs are expelled by activated neutrophils into the tumor microenvironment and blood, thereby promoting cancer spread and local and systemic immunosuppression. Reduction of NETs burden via application of Xenetic's proprietary recombinant human DNase I has been shown to improve efficacy of immunotherapy, adoptive cell therapy and chemotherapy in preclinical animal models. About Xenetic Biosciences Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company's DNase platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. For more information, please visit the Company's website at www.xeneticbio.com and connect on X , LinkedIn , and Facebook . Forward-Looking Statements This press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "remain," "focus", and other words of similar meaning, including, but not limited to, all statements regarding the Materials Transfer Agreement with Tokyo Medical University, including the design of preclinical studies, our aim to leverage relationships like the one established with Tokyo Medical University, our commitment to the DNase program, and our expectations that such agreement will further expand our growing body of data, and all statements regarding expectations for our DNase-base oncology platform, including statements regarding our focus on advancing innovative immune-oncology technologies addressing hard to treat cancers, the DNase platform improving outcomes of existing treatments, NETs, and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) failure to achieve the expected outcomes and realize the anticipated benefits from our collaboration agreements, including the agreement with Tokyo Medical University; (2) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the agreement with Tokyo Medical University; (3) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (4) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (5) failure to realize the anticipated potential of the DNase or PolyXen technologies; (6) the ability of the Company to obtain funding and implement its business strategy; and (7) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak, and geopolitical events, such as the Russian invasion of Ukraine and conflict in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation, and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law. Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 xbio@jtcir.com 1 https://onlinelibrary.wiley.com/doi/full/10.1111/cas.15992 SOURCE: Xenetic Biosciences, Inc. Released October 17, 2024

BRANFORD, Conn.--( BUSINESS WIRE )--Azitra, Inc. (NYSE American: AZTR), a precision dermatology company, announced that it has initiated dosing the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary and exploratory endpoints assessing efficacy signals and biomarkers. Azitra expects to report interim safety data from the Phase 1b trial in early 2025 with full results anticipated in the second half of 2025. ATR-12 is Azitra's lead candidate, a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active subunit of the LEKTI protein to treat Netherton syndrome, a chronic genetic skin disease that can be life threatening. "Dosing the first patient in our Phase 1b trial of ATR-12 marks a vital milestone for Azitra and for patients suffering from Netherton syndrome," said Francisco Salva, CEO of Azitra. "We are exhilarated to start dosing patients and look forward to executing this trial and delivering clinical data." Mary Spellman, MD, Azitra’s acting CMO, added, “We are thrilled to begin this clinical trial of ATR-12 in patients with Netherton syndrome. These patients often suffer from poor quality of life due to debilitating disease. This first-in-human study will inform future studies for the treatment of Netherton syndrome, including in pediatric patients and for longer treatment durations.” The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in approximately 12 adult patients with Netherton syndrome. Patients will be treated with 10 9 CFU / g twice daily with ATR-12 or its vehicle control on the contralateral side of the body twice daily for 14 days. The primary objective is to assess the safety and tolerability of topical ATR-12 application. Secondary objectives include evaluating efficacy signals (e.g., investigator and patient global assessments) and skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives include evaluating pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses. About ATR-12 ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses an active subunit of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one to nine in every 100,000. ATR-12 has been engineered to deliver the missing LEKTI protein when applied topically. Azitra has initiated a 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints (NCT06137157). Azitra expects to announce initial safety data in early 2025. About Azitra, Inc. Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis , or S. epidermidis , which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/ . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the presentation of data from the Phase 1b study of ATR-12 and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies. Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to successfully complete our Phase 1b trial for ATR-12 and preclinical studies of other product candidates and obtain required approval before commercialization; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks are described in our Form 10-Q filed with the SEC on August 12, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

BRANFORD, CT, USA I August 20, 2024 I Azitra, Inc. (NYSE American: AZTR), a precision dermatology company announced that it has successfully screened the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The patient is scheduled to initiate treatment by the end of the month. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary and exploratory endpoints assessing efficacy signals and biomarkers. Azitra expects to report interim safety data from the Phase 1b trial in early 2025 with full results anticipated in the second half of 2025. ATR-12 is Azitra’s lead candidate, a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active subunit of the LEKTI protein to treat Netherton syndrome, a chronic genetic skin disease that can be life threatening. “Enrolling the first patient in our Phase 1b trial of ATR-12 will mark a significant milestone for Azitra and, more importantly, for patients suffering from Netherton syndrome, who currently have limited treatment options,” said Travis Whitfill, founder and COO of Azitra. “Our recent preclinical data demonstrate ATR-12’s potential to effectively deliver an active LEKTI subunit into the skin and address the underlying mechanisms of Netherton syndrome.” Mary Spellman MD, Azitra’s acting CMO, added, “We are thrilled to begin this clinical trial of ATR-12 in Netherton syndrome patients. These patients suffer from poor quality of life and often debilitating disease, and this trial will inform future studies for the treatment of Netherton syndrome in pediatric patients and for longer treatment durations.” The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in approximately 12 adult patients with Netherton syndrome. Patients will be treated with 10 9 CFU / g twice daily with ATR-12 or its vehicle control on the contralateral side of the body twice daily for 14 days. The primary objective is to assess the safety and tolerability of topical ATR-12 application. Secondary objectives include evaluating efficacy signals (e.g., investigator and patient global assessments) and skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives include evaluating pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses. The trial design is supported by compelling preclinical data recently presented at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting. Key findings included: About ATR-12 ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses an active subunit of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one to nine in every 100,000. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial in adult patients (NCT06137157). Azitra has secured clinical sites and identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints. Azitra expects to announce initial safety data before year end. About Azitra, Inc. Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the Company’s library of strains for drug like molecules. The Company’s initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis , or S. epidermidis , which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/ . SOURCE: Azitra