KLK7

On Wednesday, Triveni Bio became the latest immunology and inflammation startup this year to announce a $100 million-plus financing round. Money has come thick and fast to I&I companies this year, and Triveni’s Series B comes less than a year after it announced a $92 million Series A. The new round was led by Goldman Sachs and included Fidelity, Deep Track Capital and other previous investors in the company, like Atlas Venture and OrbiMed. With the raise, Triveni will fund its lead experimental eczema antibody drug, TRIV-509, and plans to ask the FDA to let it start clinical trials of its lead program in the first quarter of 2025. That study will be in healthy volunteers, medical chief Bhaskar Srivastava told Endpoints News , and the company is seeking to develop the asset for atopic dermatitis, or eczema. Srivastava joined the company in June, leaving his post as SVP of clinical development at Nimbus Therapeutics. TRIV-509 targets kallikreins 5 and 7, and is involved in what’s called barrier dysfunction — when the skin can’t act as a proper protector from allergens and other irritants in people with atopic dermatitis. Triveni CEO Vishal Patel described barrier dysfunction as a hallmark feature of atopic dermatitis, as well as inflammation. “The barrier part, in particular, is novel because that is a unique part of that atopic dermatitis vicious cycle that really hasn’t been prosecuted in the past,” Patel told Endpoints. The company is also working on a follow-on compound called TRIV-573 that combines kallikrein 5/7 inhibition with IL-13, a well-known target (one of Dupixent’s targets). Triveni’s third program is an antibody treatment for hereditary pancreatitis.

ATR-12 has nanomolar inhibition of key protease in vitro that drives Netherton syndrome Topical application of ATR-12 to ex vivo human skin results in superior LEKTI delivery compared to topical LEKTI application ATR-12 reduces IL-36g, a pro-inflammatory cytokine that drives Netherton syndrome Safe and well tolerated in minipigs BRANFORD, Conn.--(BUSINESS WIRE)-- Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced preclinical data from the Company’s platform and pipeline. The data are being presented on Friday, May 10, 2024, in two oral sessions entitled “Engineered Staphylococcus Epidermidis as a Protein Delivery System for Treating Skin Diseases” and “Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome” at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting in Baltimore, MD. The data in the two oral presentations today showcase the preclinical development of ATR-12 and the clinical study design of a Phase 1b study in Netherton syndrome patients. In vitro data show that LEKTI (lympho-epithelial Kazal-type-related inhibitor) protein secreted by ATR-12 has nanomolar inhibition of a key protease that drives Netherton syndrome, kallikrein (KLK) 5 (IC50=26 nM). Additionally, in human ex vivo Netherton syndrome models, ATR-12 supernatant reduces protease activity nearly 7-fold to levels comparable to healthy skin. Furthermore, in ex vivo human skin models, ATR-12 led to a higher amount of LEKTI delivery to the skin compared to topically applied LEKTI alone (6.1 µg/cm2 vs. 2.3 µg/cm2, p=0.008) after 24 hours and resulted in deeper biodistribution of LEKTI. Application of ATR-12 in human skin cell culture reduced IL-36γ by 92% compared to skin extracts induced to overexpress IL-36γ. Topical application of ATR-12 to in vitro human skin treated with erlotinib reduced IL-36γ by 69%. In studies conducted in minipigs with abraded skin, topical application of ATR-12 resulted in 11.9 ng/cm2 of LEKTI on the surface of the skin vs. 2.6 ng/cm2 in the vehicle group at day 14. ATR-12 application was safe and well-tolerated in GLP toxicology studies with minipigs. The oral presentation entitled “Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR-12) for Netherton Syndrome” also provides the study design for an active clinical trial of ATR-12 in Netherton syndrome patients. The Phase 1b study (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in adults (n=12) with Netherton syndrome. Patients will be treated twice daily with 109 CFU / g ATR-12 for 14 days. The primary objective is to assess the safety and tolerability of topical application of ATR-12, and the secondary objectives are to evaluate efficacy signals (e.g., investigator and patient global assessments) and to evaluate the skin pharmacokinetics of LEKTI. Exploratory objectives include the evaluation of pharmacodynamic parameters, including anti-LEKTI response, cytokine responses, biomarkers such as KLK5, KLK7, IL-36γ, trypsin-like activity, and chymotrypsin-like activity. “We are thrilled to announce full preclinical data around ATR-12 as well as our clinical plan in Netherton syndrome that demonstrate proof-of-concept data supporting the use of genetically engineered skin commensals to deliver proteins to the skin,” said Travis Whitfill, Azitra’s co-founder and COO. “These data show the robust preclinical activity of ATR-12 in Netherton syndrome models and further supports the rationale behind our Phase 1b clinical trial in Netherton syndrome patients.” The presentations are now available on Azitra’s website at . About ATR-12 ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses a fragment 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 . 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, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, the timing of having a signed license agreement with Bayer, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical 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 pre-clinical 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 concerning Azitra's programs and operations are described in its annual report on Form 10-K filed with the SEC on March 15, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. View source version on businesswire.com: Contacts Norman Staskey Chief Financial Officer staskey@azitrainc.com Hayden IR James Carbonara (646) 755-7412 james@haydenir.com Source: Azitra, Inc. View this news release online at:

--Series A proceeds fund advancement of the company's lead program through clinical proof-of-concept study in atopic dermatitis and progression of broader precision I&I pipeline-- --Pipeline strategy to prosecute genetically validated targets linked to monogenic diseases with functional antibodies for precision populations across multiple indications-- WALTHAM, Mass., Oct. 26, 2023 /PRNewswire/ -- Triveni Bio Inc., a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of I&I disorders, today announced a $92 million series A financing co-led by Atlas Venture and Cormorant Asset Management, with participation from OrbiMed, the private equity business of Viking Global Investors, Invus, Polaris Partners, Alexandria Venture Investments, and other investors. Triveni Bio's lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7), promising targets for the treatment of atopic dermatitis, asthma, and other I&I indications. "TRIV-509 works via a unique mechanism that directly impacts barrier dysfunction, inflammation, and itch. Novel therapeutic approaches for I&I diseases are much needed, especially for atopic dermatitis patients who generally have an inadequate response to Th2-targeted therapies," said Jennifer Dovey, Ph.D., Chief Scientific Officer of Triveni Bio. The financing will support the advancement of TRIV-509 from preclinical development to a Phase 2a clinical trial and fuel a pipeline of novel antibodies with two additional development candidate nominations expected in 2024. "We are grateful for the support of our investors who understand the upfront benefit of leveraging human genetics – especially learnings from rare Mendelian forms of disease – to expose novel drug targets relevant across multiple common diseases with shared traits," said industry veteran Vishal Patel, Ph.D., who joined Triveni Bio as Chief Executive Officer. "Triveni Bio is at a key inflection point as we transition into a clinical stage company with a compelling therapeutic pipeline and talented team." Triveni Bio is the result of a merger between Amagma Therapeutics, which was founded by Tillman Gerngross, Ph.D. and Leonard Zon, M.D. with funding from Polaris; and Modify Therapeutics, which was founded and seeded by Atlas. "The teams saw an opportunity to bridge highly complementary talent, technologies, and approaches to create a data-driven precision medicine company," said Jean-François Formela, M.D., partner at Atlas Venture and Board Chair of Triveni Bio. "We are excited to co-lead this round alongside Atlas and other committed investors. We look forward to working with the Triveni team to bring novel and highly promising biological therapies to patients suffering from inflammatory disorders," said Raymond Kelleher, M.D., Ph.D., Managing Director at Cormorant. Triveni Bio's data platform leverages both public and private datasets to identify novel genetically validated disease nodes, predict and stratify patient subpopulations, and provide novel insights into disease mechanisms – achieved in part through a collaboration with Nashville Biosciences. About Triveni Bio Triveni Bio is a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of I&I disorders. The company's approach establishes proof-of-concept at the earliest stages of drug development. Through a strong understanding of genetics and mechanistic biology, our pipeline is powered for indication expansion where we know we can have the most impact. To learn more, visit . SOURCE Triveni Bio