Designation confers advantages including marketing exclusivity and tax credits Padeliporfin ImPACT pivotal Phase 3 trial in UTUC to start end Q1 2021 LUXEMBOURG, March 08, 2021 (GLOBE NEWSWIRE) -- Steba Biotech, the IMmune Photo Activate Cancer Treatment (IMPACT) specialist today announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin ImPACT for the treatment of adult patients with Upper Tract Urothelial Cancer (UTUC). The FDA has already given the green light to the Investigational New Drug (IND) application, allowing initiation of the pivotal Phase 3 clinical trial of Padeliporfin ImPACT in patients with low-grade UTUC, which is expected to begin enrollment later this month. Padeliporfin ImPACT has also received Fast Track designation from the FDA for the treatment of adult patients with low-grade and unifocal high-grade UTUC. Orphan drug status confers a number of advantages for product development, including a tax credit for the cost of clinical trials undertaken in the US, marketing exclusivity for seven years, written recommendations from the FDA on clinical and preclinical studies needed for approval and a fast-track procedure for regulatory review. Barak Palatchi, CEO of Steba Biotech, said, “We are delighted to receive Orphan Drug Designation for Padeliporfin ImPACT in UTUC, further validating Steba’s technology and the benefits our product could bring to people suffering from UTUC. It has been less than a year since we embarked on our new strategy, refocusing Padeliporfin ImPACT on diseases for patients with limited treatment options. In UTUC, the current standard of care is nephrectomy; our hope is that Padeliporfin ImPACT offers these patients an effective treatment option that preserves their kidney. UTUC is the first indication of our ambitious 3-year plan. We are looking forward to exploring the possibility of offering Padeliporfin ImPACT to more patients coping with life threatening cancers.” Steba is focusing on the development of Padeliporfin ImPACT as an innovative oncology platform with the potential to offer surgery-like efficacy, combined with organ preservation in UTUC and other solid tumors for high-risk surgical patients with unmet needs – either because surgery is not the preferred clinical option (e.g., to delay the loss of a kidney) or the risk of surgery is too high. About Padeliporfin ImPACT Padeliporfin ImPACT (Immune Photo Activated Cancer Therapy) offers surgery-like efficacy combined with organ preservation. ImPACT is Steba’s oncology platform comprising the intravenous delivery of an inactive drug, padeliporfin. Upon activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which enhances cancer cell eradication. About UTUC Upper tract urothelial carcinoma (UTUC) is a type of cancer that grows either from the urothelium, a thin, continuous, protective layer of cells which line the ureter from kidney to bladder or the kidney lining itself1. UTUC obstructs the flow of urine from the kidney causing severe flank pain and blood to appear in urine, which may not be visible with the naked eye and delays diagnosis2. It currently accounts for 5-10 percent of urinary tract cancers3, but prognosis, already worse than bladder cancer, has been worsening over time, increasing the strain on healthcare services4. About Steba biotech Steba biotech is a Luxembourg based biotech organization founded in 1996 with operations in the EU, Israel and the US. Steba biotech is focused on the development of a novel oncology platform to treat a range of solid tumors with padeliporfin ImPACT (Immune Photo Activated Cancer Therapy). Under the guidance of a new leadership team, Steba biotech is implementing a bold three-year strategy concentrating on a range of solid tumors with a high medical need such as UTUC, lung and esophagus. Steba biotech’s strong relationships with The Weizmann Institute in Israel and Memorial Sloan Kettering Cancer Center in the US have produced exciting early results in a range of solid tumor types, including UTUC, esophageal, and lung. These early programs are now being accelerated into the clinic, supported by the safety and efficacy profile already established during earlier research in low-risk prostate cancer. 1. Upper Tract Urothelial Carcinoma. (n.d.). Accessed January 8, 2021; https://www.urotoday.com/library-resources/upper-tract-urothelial-carcinoma/109835-upper-tract-urothelial-carcinoma.html.2. Taylor, W. S. (2019). Delays to Diagnosis and Management of Upper Tract Urothelial Carcinoma. Journal of Endoluminal Endourology, 2(3), e5–e11. https://doi.org/10.22374/jeleu.v2i3.45.3. Soria, F., Shariat, S. F., Lerner, S. P., Fritsche, H.-M., Rink, M., Kassouf, W., Thalmann, G. N. (2016). Epidemiology, diagnosis, preoperative evaluation and prognostic assessment of upper-tract urothelial carcinoma (UTUC). World Journal of Urology, 35(3), 379–387. doi: 10.1007/s00345-016-1928-x.4. Eylert, M., Hounsome, L., Verne, J., Bahl, A., Jefferies, E., & Persad, R. (2013). Prognosis is deteriorating for upper tract urothelial cancer: data for England 1985-2010. BJU International, 112(2), E107-E113. doi: 10.1111/bju.12025. Contacts Chief Commercial Officer (BD & IR)Chris Grimes-Cromptonc.firstname.lastname@example.orgInvestor RelationsLifeSci AdvisorsGuillaume van Renterghemgvanrenterghem@lifesciadvisors.com +41 76 735 01 31 DisclaimerThis press release contains certain forward-looking statements concerning Steba Biotech and its business. Such forward looking statements are based on assumptions that Steba considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks and to the development of economic conditions, financial markets and the markets in which Steba operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Steba or not currently considered material by Steba. 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