First patient dosed in ERX-315-101 Clinical Trial
Sydney, Australia – November 18, 2024: We are excited to announce that the first patient in our ERX-315-101 Phase 1 clinical trial has successfully received their first doses of ERX-315 at The Kinghorn Cancer Center (TKCC) in Sydney, Australia. ERX-315 is Etira’s first-in-class small molecule drug designed to selectively induce catastrophic endoplasmic reticulum stress in cancer cells. For detailed MOA please see our paper in Nature Cancer here: https://www.nature.com/articles/s43018-022-00389-8
ERX-315-101 is a first-in-human Phase 1 trial to assess the safety and tolerability of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies. Interested individuals can learn more about the trial, eligibility criteria, and how to participate by visiting the link here: https://clinicaltrials.gov/study/NCT06533332
TKCC is a major Australian cancer center focusing on translational research and personalised cancer care with a mission to align world-class cancer research with rapid translation to the clinic. TKCC is located in Darlinghurst suburb of Sydney and affliated with St Vincent’s Hospital Sydney, a world-class public hospital.
About ERX-315
ERX-315 is Etira’s lead investigational therapy that induces sustained and uncompensated endoplasmic reticulum stress in cancer cells resulting in cancer cell death, while sparing normal cells. Preclinical studies demonstrated cytotoxic activity of ERX-315 against multiple cancer types including breast (multiple subtypes), ovarian, pancreatic, liver and endometrial cancers. The groundbreaking discovery that inducing endoplasmic stress causes selective cancer cell death was published in 2022 in Nature Cancer.
About Etira
Etira is a clinical-stage biopharmaceutical company headquartered in Dallas and committed to developing multiple effective drug therapies for patients with therapy-resistant cancers. Leveraging a proprietary molecular platform, Etira’s first-in-class drugs address major cancer vulnerabilities. Etira is led by a dedicated team committed to developing innovative treatments to overcome untreatable cancers and impact the lives of patients. For more information, please visit www.etira.life
Forward-looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Etira’s future operating performance and goals, the anticipated benefits of therapies, expectations, beliefs and development objectives for Etira’s product pipeline and clinical trials. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Etira and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: Etira has limited experience conducting clinical trials (and will rely on a third party to operate its clinical trials) and may not be able to complete the clinical trial (including opening clinical trial sites, dosing additional patients, and enrolling and dosing an adequate number of clinical trial participants) when expected and may not generate results (including final or initial safety, tolerability and efficacy data in the anticipated timeframe (or at all); benefits of product candidates seen in preclinical analyses may not be evident when tested in clinical trials or when used in broader patient populations (if approved for commercial sale); Etira has a limited operating history and has not generated any revenue to date from product sales, and may never become profitable; other companies may be able to identify and develop product candidates more quickly than the Company and commercially introduce the product prior to the Company; the Company may not be able to file INDs for development candidates on time, or at all, due to technical or financial reasons or otherwise; the Company may utilize cash resources more quickly than anticipated; Etira will need to raise capital in the future and if we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our development programs or future commercialization efforts (which may delay filing of INDs, dosing patients, reporting clinical trial results and filing new drug applications); we may be unable to advance our preclinical development programs into and through the clinic for safety or efficacy reasons or commercialize our product candidates or we may experience significant delays in doing so as a result of factors beyond Etira’s control; the Company may not be able to realize the benefits of Fast Track designation (and such designation may not advance any anticipated approval timelines); Etira may expend limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success; our products candidates may cause adverse or other undesirable side effects (or may not show requisite efficacy) that could, among other things, delay or prevent regulatory approval; our dependence on third parties for conducting clinical trials and producing drug product; our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates or the scope of intellectual property protection obtained is not sufficiently broad; and delays and other impact on the clinical trial. You should not place undue reliance on forward-looking statements in this presentation, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Etira specifically disclaims any duty to update these forward-looking statements.
Stay tuned for updates on the progress of the ERX-315-101 clinical trial and activation of additional trial sites, as we continue this exciting journey!
