A Multicenter Open-label Phase 1/1b Study to Evaluate Safety, Feasibility and Early Treatment Effect of Padeliporfin VTP Using Robotic Assisted Bronchoscopy and Cone Beam CT Guidance in Patients With Peripheral Lung Cancer

Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects.
Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Surgery will be performed at 5-21 days following the VTP procedure.
Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.

Start Date30 May 2024

Sponsor / Collaborator

IMPACT Biotech Ltd

NCT05919238 / Active, not recruitingPhase 1

A Multicenter Open-label Phase 1 Trial to Evaluate Safety and Preliminary Efficacy of Endovascularly Applied Vascular Targeted Photodynamic Therapy (VTP) for Patients With Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma

This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the superior mesenteric artery (SMA) in patients with stage III, locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

Start Date15 May 2024

Sponsor / Collaborator

IMPACT Biotech Ltd

EUCTR2020-004494-41-IT / Unknown statusPhase 3

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer - ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

Start Date28 Sep 2021

Sponsor / Collaborator

Steba Biotech NV

100 Clinical Results associated with Padeliporfin

100 Translational Medicine associated with Padeliporfin

100 Patents (Medical) associated with Padeliporfin

Literatures (Medical) associated with Padeliporfin

30 Sep 2023·Translational andrology and urology

Advances in chemoablation in upper tract urothelial carcinoma: overview of indications and treatment patterns.

Review

Author: Gottlieb, Josh ; Linehan, Jennifer ; Murray, Katie S

Localized upper tract urothelial carcinoma (UTUC) is a difficult disease for clinicians to treat, due to the multitude of oncological and patient factors to consider. Despite the challenges of diagnostic staging, endoscopic management, and disease recurrence, there is still a need for local therapeutic options that do not subject patients to the morbidities of radical nephroureterectomy (RNU). Intraluminal chemotherapies have allowed for improved oncological control in patients with low-grade disease receiving renal-sparing treatment approaches. This narrative review discusses the treatment modalities available for localized low-grade UTUC, with a focus on the current status of chemoablation. The OLYMPUS trial was a pivotal study that lead to the Food and Drug Administration (FDA) approval of UGN-101 (mitomycin-C) in April 2020 for the treatment of low-grade UTUC, and intraluminal chemotherapy is now a widely used modality for managing this disease. The trial reported a complete response (CR) rate of 59%, and an estimated treatment durability of 82% at 1 year. However, a concern was the reported 44% ureteral stricture rate using the retrograde approach. More research is currently underway to determine the ideal instillation method for intraluminal therapies (e.g., retrograde vs. antegrade). Lastly, we discuss upcoming treatment options. Newer novel agents like padeliporfin vascular targeted photodynamic (VTP) therapy (brand name TOOKAD) are currently being studied, which will in hope provide additional treatment options for UTUC patients.

01 May 2023·The Journal of urology

Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma

Article

Author: Lin, Oscar ; Tracey, Andrew T. ; Nogueira, Lucas M. ; Dalbagni, Guido ; Sjoberg, Daniel D. ; Alvim, Ricardo G. ; Pietzak, Eugene J. ; Solit, David B. ; Benfante, Nicole E. ; Demac, Quinlan ; Donat, S. Machele ; Bochner, Bernard H. ; Reisz, Peter A. ; Hakimi, A. Ari ; Yip, Wesley ; Kim, Kwanghee ; Al-Ahmadie, Hikmat ; Vanden Berg, Rand W. ; Scherz, Avigdor ; Coleman, Jonathan A. ; Bajorin, Dean F.

PURPOSE:

Vascular-targeted photodynamic therapy with the intravascular photosensitizing agent padeliporfin (WST-11/TOOKAD-Soluble) has demonstrated therapeutic efficacy as an ablative treatment for localized cancer with potential adaptation for endoscopic management of upper tract urothelial carcinoma. This Phase I trial (NCT03617003) evaluated the safety of vascular-targeted photodynamic therapy with WST-11 in upper tract urothelial carcinoma.

MATERIALS AND METHODS:

Nineteen patients underwent up to 2 endoscopic vascular-targeted photodynamic therapy treatments, with follow-up for up to 6 months. Patients who had residual or recurrent upper tract urothelial carcinoma (any grade/size) failing prior endoscopic treatment or unable or unwilling to undergo surgical resection were eligible for inclusion. The primary endpoint was to identify the maximally tolerated dose of laser light fluence. A dose escalation model was employed, with increasing light fluence (100-200 mW/cm) using a modified continual reassessment method. The secondary endpoint was treatment efficacy, defined by absence of visible tumor and negative urine cytology 30 days posttreatment.

RESULTS:

Fourteen (74%) patients received the maximally tolerated dose of 200 mW/cm, 2 (11%) of whom experienced a dose-limiting toxicity. The initial 30-day treatment response rate was 94% (50% complete, 44% partial). Eight patients underwent a second treatment, with a final observed 68% complete response rate. Leading toxicities were flank pain (79%) and hematuria (84%), which were transient. No ureteral strictures associated with treatment were identified during follow-up.

CONCLUSIONS:

Vascular-targeted photodynamic therapy with WST-11 has an acceptable safety profile with strong potential as an effective, kidney-sparing endoscopic management option for upper tract urothelial carcinoma. The recently initiated multicenter Phase 3 ENLIGHTED trial (NCT04620239) is expected to provide further evidence on this therapy.

01 Jul 2022·World journal of urologyQ2 · MEDICINE

Alternative- and focal therapy trends for prostate cancer: a total population analysis of in-patient treatments in Germany from 2006 to 2019

Q2 · MEDICINE

Article

Author: Aksoy, Cem ; Heers, Hendrik ; Groeben, Christer ; Flegar, Luka ; Borkowetz, Angelika ; Zacharis, Aristeidis ; Eisenmenger, Nicole ; Derigs, Marcus ; Huber, Johannes

Abstract:

Purpose:

Focal therapy (FT) offers an alternative approach for prostate cancer (PCa) treatment in selected patients. However, little is known on its actual establishment in health care reality.

Patients and methods:

We defined FT as high-intensity focused ultrasound (HIFU), hyperthermia ablation, cryotherapy, transurethral ultrasound ablation (TULSA) or vascular-targeted photodynamic therapy (VTP) TOOKAD®. We analyzed the nationwide German hospital billing database for a PCa diagnosis in combination with FT. For analyses on the hospital level, we used the reimbursement.INFO tool based on hospitals’ quality reports. The study period was 2006 to 2019.

Results:

We identified 23,677 cases of FT from 2006 to 2019. Considering all PCa cases with surgery, radiotherapy or FT, the share of FT was stable at 4%. The annual caseload of FT increased to a maximum of 2653 cases in 2008 (p < 0.001) and then decreased to 1182 cases in 2014 (p < 0.001). Since 2015, the cases of FT remained on a plateau around 1400 cases per year. The share of HIFU was stable at 92–96% from 2006 to 2017 and decreased thereafter to 75% in 2019 (p = 0.015). In 2019, VTP-TOOKAD® increased to 11.5% and TULSA to 6%. In 2006, 21% (62/299) of urological departments performed FT and 20 departments reached > 20 FT procedures. In 2019, 16% (58/368) of urological departments performed FT and 7 departments reached > 20 FT. In 2019, 25 urological departments offered FT other than HIFU: 5 centers hyperthermia ablation, 11 centers VTP TOOKAD®, 3 centers cryotherapy, 6 centers TULSA.

Conclusion:

The FT development in Germany followed the Gartner hype cycle. While HIFU treatment is the most commonly performed FT, the share of newer FT modalities such as VTP-TOOKAD® and TULSA is remarkably increasing.

News (Medical) associated with Padeliporfin

02 Jun 2024

·www.biospace.com

ImPact Biotech Presents Additional Interim Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer

Promising response rate in patients with low-grade upper tract urothelial cancer (UTUC); complete response (CR) observed in 77% (10/13) of patients who completed the Induction Treatment Phase Padeliporfin VTP safe and efficacious, consistent with prior results and reinforcing initial clinical data from ENLIGHTED Preliminary efficacy data presented in a poster session at ASCO; additional interim analysis expected in 2H 2024 and completion of enrollment anticipated by the end of 2024 TEL AVIV, Israel, June 02, 2024 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin vascular targeted photodynamic (VTP) therapy to treat a range of solid tumors, today announced additional efficacy and safety data from ENLIGHTED (ENdoluminal LIGHT ActivatED), its ongoing pivotal Phase 3 clinical trial evaluating Padeliporfin VTP in patients with low-grade UTUC. The interim results, which demonstrate Padeliporfin VTP treatment was well-tolerated alongside further efficacy, are being presented today in a poster session at the American Society of Clinical Oncology 2024 Annual Meeting in Chicago, Illinois. “These results emphasize the potential of Padeliporfin VTP as a viable treatment option for patients with low-grade UTUC,” said Vitaly Margulis, M.D., Professor of Urology at UT Southwestern Medical Center. “UTUC is difficult to treat, as it is not easily resectable without inflicting organ damage and current standards of care commonly require onerous treatment regimens that do not match surgery in efficacy. These results highlight Padeliporfin VTP as a compelling alternative to achieve profound efficacy, while sparing the kidney or ureter. I am encouraged by this dataset and look forward to the continued analysis of Padeliporfin VTP and its capacity to alter the treatment paradigm for patients with UTUC.” The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. As of January 21, 2024, the data cut-off for this presentation, 17 patients had begun treatment of which 13 had completed ITP and were evaluable for efficacy. Key interim results from the Phase 3 ENLIGHTED study of Padeliporfin VTP: Clinical Profile: Ten of the 13 (77%) response-evaluable patients achieved a CR at the end of ITP. Safety and Tolerability Profile: Padeliporfin VTP was well-tolerated with a safety pro with the previous data obtained from the Phase 1 study and preliminary Phase 3 results. Adverse events (AEs) observed were primarily Grade 1 or 2, mostly gastrointestinal-related. Grade 3 events were observed in 9% of patients. All AEs resolved within two to seven days. There were no Grade 4 or 5 serious adverse events observed. “We are pleased to see Padeliporfin VTP making continued clinical progress in the ENLIGHTED Phase 3 study,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “This dataset underscores our conviction that Padeliporfin VTP may provide immense clinical benefit as an alternative that delivers efficacy more in line with surgical intervention than standard-of-care therapeutics but without the associated risk of organ injury or loss. We look forward to the sustained evaluation of Padeliporfin VTP as a differentiated novel treatment in low-grade UTUC and to sharing additional data as this study progresses, as we also seek to explore its potential across other unresectable solid tumors in parallel.” ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment by the end of 2024. The Company anticipates an interim analysis from this study to be presented in 2H 2024. In addition, ImPact plans to evaluate Padeliporfin VTP in other solid tumors, including pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC and non-small cell lung cancer (NSCLC). At ASCO, the Company also presented a trials-in-progress poster featuring the design of its Phase 1 study in PDAC, which is expected to initiate patient dosing in the coming weeks. The objectives of this two-part, dose-escalation and -expansion study are as follows: in part A, to evaluate safety and tolerability of Padeliporfin VTP in locally advanced, unresectable PDAC; and in Part B, further evaluate preliminary efficacy, with responses defined by conversion from unresectable to resectable, at the recommended dose identified in Part A. About ImPact Biotech ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: and the ENLIGHTED clinical trial website (for the US): . Contacts Global Head of Business Development Guy Schmidt guy.schmidt@impactbiotech.com Precision AQ Josh Rappaport josh.rappaport@precisionaq.com

Phase 3Clinical ResultASCOPhase 1

06 May 2024

·www.biospace.com

ImPact Biotech Presents Preliminary Phase 3 Results from ENLIGHTED Study of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer

Encouraging response rate shown; CR in 67% (6/9) of patients who completed the Induction Treatment Phase Padeliporfin VTP generally well-tolerated, consistent with prior results and reinforcing differentiated organ-sparing pro > Preliminary data presented in a podium session at AUA; additional interim results to be presented at ASCO TEL AVIV, Israel, May 06, 2024 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin vascular targeted photodynamic (VTP) therapy to treat a range of solid tumors, today announced positive preliminary results from ENLIGHTED (ENdoluminal LIGHT ActivatED), its ongoing pivotal Phase 3 clinical trial evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (UTUC). As of the cut-off date, Padeliporfin VTP treatment was well-tolerated and demonstrated clinical benefit and in all evaluable patients, consistent with the pro with prior results. The preliminary results were presented in a podium presentation by Professor Ronald P. Kaufman Jr., M.D., an investigator in the ENLIGHTED study, during the American Urology Association (AUA) 2024 Annual Meeting in San Antonio, Texas. “UTUC is notoriously hard to resect and current standards of care commonly require treatments which may be challenging,” said Dr. Kaufman, Professor of Urology at Albany Medical College. “I’m encouraged by these early results, which highlight Padeliporfin VTP as a compelling treatment alternative which provides a kidney sparing option, with selective tumor ablation and responses that are so far achieved with a safe, minimally invasive procedure. I look forward to continued evaluation of this exciting investigational product exploring its potential impact on the treatment landscape.” The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 global sites, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, to locally activate Padeliporfin in the tumor. ITP consists of one-to-three courses of VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. As of October 31, 2023, the data cut-off for this presentation, 12 patients had begun treatment of which nine had completed ITP. Key preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP: Clinical Profile: Six of the nine (67%) response-evaluable patients achieved a CR at the end of ITP. Safety and Tolerability Profile: Padeliporfin VTP was well-tolerated and safety pro consistent with the previous data obtained from the Phase 1 study. Adverse events (AEs) observed were mostly Grade 1 or 2, with Grade 3 events in three patients. All events were resolved within two days and there were no Grade 4 or 5 serious adverse events observed. “We were excited to present a first look at our Phase 3 results for Padeliporfin VTP at AUA. Importantly, these preliminary results from ENLIGHTED reinforce proof-of-concept data from the Phase 1 study, showing Padeliporfin VTP offers strong potential as a safe and effective, kidney-sparing alternative for endoscopic management of UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We believe this represents important differentiation as a potential novel treatment in low-grade UTUC, compared to available endoscopic and therapeutic options, and we look forward to sharing additional data at ASCO in the coming weeks.” In addition, ImPact will present a poster containing updated interim data, from a cut-off date beyond the presentation at AUA, at the American Society for Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, in Chicago, Illinois. The Company continues to recruit patients for the ENLIGHTED study and expects to complete enrollment by the end of 2024. ImPact also plans to evaluate Padeliporfin VTP in other solid tumors, including pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC and non-small cell lung cancer (NSCLC). The Company expects to initiate a Phase 1 study in PDAC in the coming weeks and plans to share design of this study in a trials-in-progress poster session at ASCO. About ImPact Biotech ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: and the ENLIGHTED clinical trial website (for the US): . Contacts Global Head of Business Development Guy Schmidt guy.schmidt@impactbiotech.com Stern Investor Relations, Inc. Josh Rappaport josh.rappaport@sternir.com

Phase 3Clinical ResultASCOPhase 1

24 Apr 2024

·www.biospace.com

ImPact Biotech to Present Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at Upcoming Medical Conferences

Preliminary results from Phase 3 ENLIGHTED study in low grade upper tract urothelial cancer (UTUC) to be presented at AUA and ASCO Trial design for Phase 1 study of Padeliporfin VTP in pancreatic ductal adenocarcinoma (PDAC) to be presented at ASCO TEL AVIV, Israel, April 24, 2024 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat a range of solid tumors, today announced three abstracts, including preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment of patients with low-grade UTUC, were accepted for presentation at upcoming medical conferences. “We look forward to sharing preliminary data from ENLIGHTED, our ongoing Phase 3 study of Padeliporfin VTP in low grade UTUC, at AUA and ASCO. We are eager to build upon proof-of-concept data from our Phase 1 study, which showed powerful effect and a good safety profile, as we seek to demonstrate advantages over the current standard of care in this indication,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “In addition, we continue to expand applications of our platform to treat other solid tumors. In pancreatic cancer (PDAC), a hard-to-treat cancer, our goal is to convert unresected patients with locally advanced disease to resectable ones, thereby expanding the treatable population. We have opened clinical sites in a Phase 1 study in this indication that is on track to begin dosing patients in the coming weeks.” In a podium presentation at the American Urology Association (AUA) 2024 Annual Meeting, taking place May 3 – 6, in San Antonio, Texas, the Company will present preliminary data from ongoing ENLIGHTED study. Presentation details are as follows: Abstract Title: Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for treatment of low-grade upper tract urothelial cancer (LG UTUC): Phase 3 preliminary results Presenter: Prof. Ronald Kaufman Abstract Number: 24-4646 Session Title: PD20-02: Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): Phase 3 preliminary results Session Date: May 4, 2024 Two abstracts were also selected for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, in Chicago, Illinois. This includes additional data, from a data cutoff beyond the presentation at AUA, from the Phase 3 ENLIGHTED study in low grade UTUC as well as a trials-in-progress poster highlighting design of the planned Phase 1 study of Padeliporfin VTP in PDAC, which is expected to begin recruiting patients in the coming several weeks. Presentation details are as follows: Abstract Title: ENLIGHTED phase 3 study: Efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) for treatment of low-grade upper tract urothelial cancer (LG UTUC). Authors: Vitaly Margulis, Ronald P. Kaufman Jr., Gautier Marcq, Neal D. Shore, Marc Colombel, Edward M. Uchio, Sarah P. Psutka, Marcos Aller, Steffen Rausch, Carles Raventos, Asaf Shvero, Axelle Mroz, Natalia Kudinova, Yaniv Cohen, Inna Krasnopolskaya, Genia Alpert, Avigdor Joshua Scherz, Jonathan Coleman. Abstract Number: TPS4204 Session Title: Genitourinary Cancer – Kidney and Bladder Session Date/Time: June 2, 2024, 9:00am-12:00pm CDT Abstract Title: Phase 1 study to evaluate safety and preliminary efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) in patients with locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). Authors: Nadine Abi-Jaoudeh, Jennifer Brooke Valerin, David K Imagawa, Dina Preise, Zachary Sacks, Yaniv Cohen, Julia Rothman, Keren Brook, Eyal Morag, Avigdor Joshua Scherz, Inna Krasnopolskaya, Genia Alpert, Vincent Chung, Laleh Golkar Melstrom, Jonathan Kessler. Abstract Number: TPS4622 Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: June 1, 2024, 1:30pm-4:30pm CDT About ImPact Biotech ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: Contacts Global Head of Business Development Guy Schmidt guy.schmidt@impactbiotech.com Stern Investor Relations, Inc. Josh Rappaport Josh.rappaport@sternir.com

Phase 3Phase 1ASCOClinical Result

100 Deals associated with Padeliporfin

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XD07	DB15575

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Adenocarcinoma of prostate	EU	Steba Biotech NV	10 Nov 2017
Adenocarcinoma of prostate	IS	Steba Biotech NV	10 Nov 2017
Adenocarcinoma of prostate	LI	Steba Biotech NV	10 Nov 2017
Adenocarcinoma of prostate	NO	Steba Biotech NV	10 Nov 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	MX	Steba Biotech NV	01 May 2013
Localized Prostate Carcinoma	Phase 3	PA	Steba Biotech NV	01 May 2013
Localized Prostate Carcinoma	Phase 3	PE	Steba Biotech NV	01 May 2013
Prostatic Cancer	Phase 3	CA	Steba Biotech SA	01 May 2006
Recurrent Prostate Carcinoma	Phase 3	CA	Steba France SASU	01 May 2006
Age Related Macular Degeneration	Phase 2	US	Steba Biotech NV	01 Jun 2010
Age Related Macular Degeneration	Phase 2	FR	Steba Biotech NV	01 Jun 2010
Choroidal Neovascularization	Phase 2	US	Steba Biotech NV	01 Jun 2010
Choroidal Neovascularization	Phase 2	FR	Steba Biotech NV	01 Jun 2010
Glycogen Storage Disease Type II	Phase 2	US	Steba Biotech NV	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04620239 (ENLIGHTED, ASCO2024)	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma Maintenance	100	Padeliporfin VTP	diyxexudop(rujshvcnms) = veevteaeqw xjywwffbrv (zsykhuhjzp )	Positive	24 May 2024
NCT04620239 (ENLIGHTED, Biospace) Manual	Phase 3	Transitional Cell Carcinoma	9	Padeliporfin	ccsukllunf(imdrqqhleb) = vocudoowmj hmcfbtrlzu (kvnjgxdmdf )	Positive	06 May 2024
ENLIGHTED (AUA2024)	Phase 3	Renal Pelvis and Ureter Urothelial Carcinoma Maintenance	12	Padeliporfin VTP	ukdobgnxdn(mbihvhaqsr) = resolved within 2 days uplfljajol (szvllvcmvd ) View more	Positive	01 May 2024
NCT03315754 (CTgov)	Phase 2	Localized Prostate Carcinoma	50	TOOKAD Soluble 4 mg/kg	oomntbmoud(gurzzrdglc) = ltoyqcuscz tuipqgbmao (vynighadvf, lzxehzcxvl - vyjvtgyubh) View more	-	02 Aug 2023
NCT03315754 (ASCO2021) Manual	Phase 2	Prostatic Cancer	46	padeliporfin	owoxzypqvc(yeqgjowmjh) = xrsrymxzyy tvdjdwbrle (pbenxyyrbd ) View more	Positive	28 May 2021
NCT03617003 (ASCO_GU2021) Manual	Phase 1	Renal Pelvis and Ureter Urothelial Carcinoma	14	phototherapy +WST11	ywvjjhcgay(lectpmocjq) = kqjcvsffdl sskzbjvigg (benlhdemng ) View more	Positive	20 Feb 2021
2019 ARVO Annual Meeting (ARVO2019)	Not Applicable	-	5	WST11	xktnicyziz(otqnxtppha) = rjqavvjnta wtgmocfswx (bfwrnqdnmp ) View more	-	01 Jul 2019
NCT01310894 (CLIN1001 PCM301, Pubmed \| Lancet Oncol) Manual	Phase 3	Prostatic Cancer	-	Padeliporfin	ckbidknopa(khfssmsulf) = unrbuaixch ixpuaakkam (afomyjboty ) View more	Positive	01 Feb 2017
NCT01310894 (CLIN1001 PCM301, Pubmed \| Lancet Oncol) Manual	Phase 3	Prostatic Cancer	-	active surveillance	ckbidknopa(khfssmsulf) = xynxrziujn ixpuaakkam (afomyjboty ) View more	Positive	01 Feb 2017
NCT00946881 (Pubmed \| J Urol)	Phase 1/2	Prostatic Cancer	30	WST11 vascular targeted photodynamic therapy	ylwogrifax(jyuggqfiwd) = wdwuuvfxeo uyuskkilvi (qqtwpiyhpo )	-	01 Oct 2016
NCT00975429 \| NCT00707356 \| NCT01310894 (Pubmed \| World J Urol)	Not Applicable	Localized Prostate Carcinoma	-	Tookad Soluble (Salvage radical prostatectomy)	hgfwlinevg(blzfapntpp) = zwnsuafgyp diuhkktjet (lsowngjvyh ) View more	-	01 Jul 2015

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