FDA Grants Fast Track Designation to Padeliporfin ImPACT for Steba biotech

- Ambitious development program for multiple solid tumors with high unmet need, starting with low grade upper tract urothelial cancer (UTUC)

- Follows successful clearance of the IND application in Dec 2020 allowing initiation of pivotal Phase 3 clinical trial in patients with low grade UTUC; results to form basis of application for FDA approval

LUXEMBOURG, Jan. 17, 2021 /PRNewswire/ -- Steba biotech, pioneering developer of the IMmune Photo Activate Cancer Treatment (ImPACT), announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for padeliporfin ImPACT for the treatment of adult patients with low-grade and unifocal high-grade Upper Tract Urothelial Cancer (UTUC). This swiftly follows clearance of the Investigational New Drug (IND) application granted in December 2020 allowing initiation of the pivotal Phase 3 clinical trial of padeliporfin ImPACT in patients with low-grade UTUC, expected to begin enrollment in Q1 2021.

Steba biotech 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 where the needs of the high-risk surgical patient are not being met ? 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.

Barak Palatchi, CEO of Steba, said: "Momentum is building towards unlocking the significant potential of padeliporfin ImPACT in a range of solid tumors ? first with the IND green light and now Fast Track designation. In the last nine months, under the new leadership team, we have transformed the organization with a bold strategy and focused execution. Achieving these important regulatory milestones in quick succession is a powerful acknowledgement of the technology and will accelerate the pace by which we can make padeliporfin ImPACT available for people living with cancer."

Dr David Perry, Head of Steba R&D, said: "There is currently a high unmet medical need in UTUC, given the clinical aim to preserve the patient's kidney, rendering surgery as a last resort. Good initial efficacy data from the Phase 1 clinical trial in patients with UTUC, coupled with strong safety and efficacy data previously obtained in prostate cancer make us confident that padeliporfin ImPACT has the potential to be a well-tolerated, safe and efficacious treatment in UTUC and other cancer indications."

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 itself^[1]. 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 diagnosis^[2]. It currently accounts for 5-10 percent of urinary tract cancers^[3], but prognosis, already worse than bladder cancer, has been worsening over time, increasing the strain on healthcare services^[4].

About Fast Track Designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs, with the intention of getting important new drugs to patients earlier. Specifically, Fast Track designation facilitates meetings with the FDA to discuss aspects of development to support licensure and provides the opportunity to submit sections of a NDA on a rolling basis as data become available. Additionally, another potential benefit of Fast Track designation is priority review, which reduces the standard 10 months NDA review to six months.

About Steba biotech

Steba biotech is a Luxembourg based biotech organization founded in 2002 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.

Disclaimer

This 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. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Steba to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Steba shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

^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.