Epidermal growth factor (RAS Lifesciences)

ATR-04 is in development for epidermal growth factor receptor inhibitor (EGFRi)-induced dermal toxicity, which affects approximately 150,000 patients in the US Reduces methicillin-resistant S. aureus by 99% on ex vivo pig skin Reduces IL-36g, a pro-inflammatory cytokine that drives inflammation in EGFRi-induced toxicity, in human skin model by 75% compared to erlotinib-treated skin Increases human beta defensin 18-fold vs. vehicle on human skin model 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 17, 2024, in two oral sessions entitled “Staphylococcus epidermidis for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity” and “Cutaneous delivery of LEKTI via an engineered strain of Staphylococcus epidermidis for the treatment of Netherton syndrome” at the Society of Investigative Dermatology (SID) 2024 Annual Meeting in Dallas, TX. “We are pleased to announce the first publication of preclinical data around ATR-04 in EGFR inhibitor (EGFRi)-associated dermal toxicity,” said Travis Whitfill, Azitra’s co-founder and COO. “These data show robust preclinical activity of ATR-04 in models of EGFRi-induced dermal toxicities that support an upcoming Investigational New Drug (IND) application to the FDA for a Phase 1b in patients undergoing EGFR inhibitors with dermal toxicity. We anticipate the expansion of our clinical-stage pipeline this year with ATR-04.” ATR-04 is a live biotherapeutic product candidate consisting of an S. epidermidis strain that was isolated from a healthy volunteer and engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin toxicity, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi-induced skin toxicity in the United States. The data in the oral presentations today showcase the preclinical development of ATR-04. ATR-04 led to a decrease in S. aureus across multiple models. In in vitro skin models, ATR-04 treatment led to a 96% reduction in methicillin-resistant S. aureus (MRSA) compared to untreated skin (p<0.0001). In ex vivo pig skin treated with ATR-04, there was a ~99% reduction in MRSA compared to untreated skin (p=0.012). Additionally, in human skin models treated with erlotinib, an EGFRi, ATR-04 reduced IL-36γ by 75% (p=0.009) to levels comparable to untreated skin models. Finally, ATR-04 increased human beta defensin, a key protein involved in host defenses, by 18-fold compared to vehicle. Together, the data show that ATR-04 can address multiple drivers of EGFRi-induced skin toxicity. The presentations are now available on Azitra’s website at . 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 advancement of ATR-04 into a Phase 1b clinical trial; expectation that the initial pre-clinical data for ATR-04 will be consistent with the further pre-clinical data; and the benefits of the Company’s proprietary platform and microbial library. 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 (i) the risk that the further data from the ongoing pre-clinical trial for ATR-04 will not be favorably consistent with the initial pre-clinical data to date, (ii) the risk that the Company’s IND application for ATR-04 may not receive a safe to proceed letter from the FDA, (iii) success in early phases of pre-clinical trials do not ensure later clinical trials will be successful; we may fail to timely raise additional required funding; and those 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.

Its public offering—which closed yesterday—will see Azitra sell 1.5 million shares of common stock at $5 a pop. Bayer-partnered Azitra will use the proceeds of a $7.5 million IPO to push its engineered bacterial treatments for skin conditions into the clinic. The Connecticut-based biotech’s pipeline is based on a library of about 1,500 bacterial strains that the company has screened for potential therapeutic properties. So far, Azitra said it has identified 60 bacterial species that it believes could be engineered into treatments with “significant therapeutic effect.” Chief among them is ATR-12, a genetically modified strain of the bacterium Staphylococcus epidermidis that the biotech had planned to enter into a phase 1b trial for Netherton syndrome—a disorder of the skin, hair and immune system—in the first half of the year, according to a Securities and Exchange Commission filing. While the condition is rare, Azitra said estimates of the syndrome affecting just 1 in 100,000 people “may be underestimated due to misdiagnosis caused by similarities to other skin diseases.” With ATR-12 having received a pediatric rare disease tag from the FDA, the biotech expects to report initial results from the phase 1 trial in the first half of 2024. Azitra has two more wholly owned assets gearing up for human trials. ATR-04 is another engineered S. epidermidis strain designed to treat patients with a papulopustular rash that has been caused by epidermal growth factor receptor inhibitor targeted therapy for cancer. The company hopes to launch an early-stage trial in the first half of next year, subject to FDA go-ahead. Then there’s ATR-01, an engineered recombinant human filaggrin protein designed to treat a scaly skin disease called ichthyosis vulgaris. The biotech is aiming for human trials to begin in late 2024. There are also two strains of bacterial microbes selected from Azitra’s library by Bayer as part of a collaboration initiated in 2019. The German healthcare giant has the exclusive option to license the strains as potential over-the-counter cosmetic products and also has the option to expand the collaboration to cover another four strains. Bayer demonstrated its commitment to the biotech by purchasing $8 million of stock as part of a series B funding round in 2020. Azitra has boosted its ability to engineer the bacterial strains from its library courtesy of an exclusive license from the Fred Hutchinson Cancer Center to use its SyngenicDNA Minicircle Plasmid technology. This allows the biotech to “build plasmids in order to make genetic transformations that have never been previously achieved,” it said in the filing. While this tech wasn’t required to produce the biotech’s current crop of near-clinical candidates, Azitra said it will “open up the ability to make genetic transformations of an expanded universe of microbial species.” The public offering—which closed yesterday—sees Azitra sell 1.5 million shares of common stock at $5 a pop. Underwriters will also have a 45-day option to purchase up to an additional 225,000 shares. The company said it plans to use the net proceeds to fund its clinical trials as well as for product development, R&D, clinical manufacturing and various corporate costs. Azitra is headed up by CEO Francisco Salva, who previously co-founded Acerta Pharma, a blood cancer biotech that was acquired by AstraZeneca in 2016.