Vicineum (oportuzumab monatox) / Cardinal Health, Hikma, CARISMA Therap - LARVOL DELTA

Developments in conservative treatment for BCG-unresponsive non-muscle invasive bladder cancer. (PubMed, Expert Opin Pharmacother) - "We aimed to review the most important bladder-preserving strategies for BCG unresponsive disease, from those used in the past, even though rarely used nowadays (intravesical chemotherapy with single agents), to current available therapies (e.g. intravesical instillation with Gemcitabine-Docetaxel), and to future upcoming treatments (Oportuzumab Monatox). At present, bladder-preserving treatments in BCG-unresponsive patients are represented by the use of intravesical instillations, systemic immunotherapies, both with good short-term and modest mid-term efficacy, and numerous clinical trials ongoing, with encouraging initial results, in which patients could be recruited."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Final Results of a Phase I, Single-Arm Clinical Trial of the Combination of Durvalumab and Vicineum in BCG Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer Patients (NCT03258593) (AUA 2024) - P1 | "The combination of Vicineum and Durvalumab was safe and well tolerated and had a 12-week response rate of almost 50%, with a prolonged (>12 months) benefit in some patients with high risk NMIBC who have failed BCG treatment."

Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-1

Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs) (Sesen Bio) - "Sesen Bio...announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)....The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality."

FDA event • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

Antibody Drug Conjugates in Bladder Cancer: Current Milestones and Future Perspectives. (PubMed, Curr Treat Options Oncol) - "In particular, enfortumab-vedotin (EV) has shown promising results with a recent cohort of a clinical trial demonstrating that EV is effective as neoadjuvant monotherapy as well as in combination with pembrolizumab in metastatic setting. Similar promising results have been shown by other classes of ADC in other trials including sacituzumab-govitecan (SG) and oportuzumab monatox (OM). ADCs are likely to become a mainstay treatment option in the urothelial carcinoma playbook as either a monotherapy or combination therapy. The cost of the drug presents a real challenge, but further trial data may justify the use of the drug as mainstay treatment."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Antibody-drug conjugates for urothelial carcinoma. (PubMed, Urol Oncol) - "The anti-Nectin-4 ADC enfortumab vedotin has demonstrated efficacy in prospective studies in patients with advanced urothelial carcinoma in several settings either alone or in combination with pembrolizumab...Common adverse events include rash and neuropathy for enfortumab vedotin and myelosuppression and diarrhea for sacituzumab govitecan. Several anti-human epidermal growth factor receptor 2 ADCs are in clinical trials, and in localized bladder cancer, the anti-epithelial cell adhesion molecule ADC oportuzumab monatox is being studied in patients refractory to intravesical bacillus calmette-guerin therapy. Antibody-drug conjugates for urothelial carcinoma are approved and emerging as therapies for patients with advanced urothelial carcinoma, filling a prior void for treatment of progressive disease. Ongoing studies are also evaluating these agents in the neoadjuvant and adjuvant settings."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Pain • Solid Tumor • Urothelial Cancer • NECTIN4

Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG (clinicaltrials.gov) - P3 | N=133 | Completed | Sponsor: Sesen Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Completed | N=40 ➔ 14 | Trial completion date: Dec 2024 ➔ Oct 2022 | Trial primary completion date: Aug 2024 ➔ Aug 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-1 • PD-L1

[VIRTUAL] PHASE 3 RESULTS OF VICINIUM IN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2020) - P3 | "This Phase 3 study showed that Vicinium was well-tolerated, demonstrated clinically meaningful anti-tumor activity and may delay and/or prevent RC. Source of Funding: Sesen Bio"

P3 data

Vicinium: Expiry of patents related to the use in the treatment of bladder and head and neck cancer in US, EU, Canada, China, Israel and Japan in April 2024 and June 2025 (Sesen Bio) - Annual Report 2022: Expiry of patents in US in February 2029; Expiry of patents related to treatment regimens in US, Australia, Canada, China, EU, Hong Kong and Japan in 2036

Patent • Bladder Cancer • Head and Neck Cancer • Oncology

Sesen Bio Stockholders Approve Merger with Carisma Therapeutics (Businesswire) - "Sesen Bio...announced that its stockholders have voted to approve all proposals, including the pending merger with Carisma Therapeutics Inc. ('Carisma'), at the Company’s Special Meeting of Stockholders....'Looking ahead, our stockholders are positioned to benefit from the upside potential of ownership in the combined company, as well as the CVR, which provides additional potential cash upside from any sale of Sesen Bio’s legacy assets, including Vicineum, and from the potential $30 million milestone payment under the Roche Asset Purchase Agreement'....The merger is expected to close on March 7, 2023, subject to customary closing conditions."

M&A • Oncology

ALT-803 in the treatment of non-muscle-invasive bladder cancer: Preclinical and clinical evidence and translational potential. (PubMed, Front Immunol) - "The United States Food and Drug Administration (FDA) approved valrubicin (1998) and pembrolizumab (2020) for the treatment of BCG-unresponsive (BCGu) NMBIC...However, the FDA previously rejected the application for oportuzumab monatox (OM) due to a lack of data comparing it with pembrolizumab on August 20, 2021. Interestingly, the clinical efficacy and safety of ALT-803 were higher than that of pembrolizumab and OM, suggesting that ALT-803 may be approved by FDA. This review aims to further knowledge of the preclinical and clinical evidence of ALT-803 in the treatment of NMIBC and discuss its translational potential."

Journal • Preclinical • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8

"Sesen Bio Pauses Clinical Development for Vicineum in BCG-Unresponsive NMIBC https://t.co/ObjCJpPlV2 vía @onclive" (@urogomez_)

Clinical

Sesen Bio Announces Strategic Decision to Pause Clinical Development of Vicineum in the US (Businesswire) - "Sesen Bio...today announced that it has made the strategic decision to voluntarily pause further development in the US of its lead asset, Vicineum. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA)....Additionally, the Company intends to seek a partner for the further development of Vicineum....'We now turn our primary focus to the careful assessment of strategic alternatives, which we hope to have complete by the end of the year'."

Clinical • Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

"$SESN Sesen Bio Announces Strategic Decision to Pause Clinical Development of Vicineum™ in the US https://t.co/b9KPcTDAjM" (@stock_titan)

Clinical

Vicineum: Expiry of patents related to methods of treating cancer using an immunotoxin in EU, Canada, China, Hong Kong and Israel between Apr 2024 and in US between Apr 2024 and Jun 2025 (Sesen Bio, Jefferies 2022 Virtual Healthcare Conference) - Expiry of patents related to dosing strategies for targeting EPCAM positive bladder cancer in US, Australia and Japan in Mar 2036 and EU, Canada, China and Hong Kong in 2036 or later

Patent • Bladder Cancer • Oncology

Vicineum: Expiry of patents related to methods of treating cancer using an immunotoxin in EU, Canada, China, Hong Kong and Israel between Apr 2024 and in US between Apr 2024 and Jun 2025 (Sesen Bio, Jefferies 2022 Virtual Healthcare Conference) - Expiry of patents related to dosing strategies for targeting EPCAM positive bladder cancer in US, Australia and Japan in Mar 2036 and EU, Canada, China and Hong Kong in 2036 or later

Patent • Bladder Cancer • Oncology

Emerging treatment landscape of non-muscle invasive bladder cancer. (PubMed, Expert Opin Biol Ther) - "New treatment options are emerging, demonstrating promising clinical activity, namely, pembrolizumab, atezolizumab, oportuzumab monatox, nadofaragene firadenovec, and N-803. The increasing number of newer therapeutic agents for patients with NMIBC poses challenges regarding the choice of the most suited treatment option for each patient and the best treatment sequence, given their diverse mechanisms of action and varying degrees of activity. Tailored treatment approaches are advocated, based on a deeper comprehension of disease features, available therapies, patient's characteristics, and consequently, on the identification and validation of prognostic and predictive biomarkers."

Journal • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • Urothelial Cancer

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • EPCAM • PD-1 • PD-L1

Sesen Bio Provides Strategic Update (Businesswire) - "...'We plan to request a meeting with the FDA in the coming weeks to align on the remaining outstanding items related to an additional Phase 3 clinical trial'."

FDA event • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Vicineum: Patent expiry in US 2029 (Sesen Bio) - Annual Report 2021: Expiry of patents related to treating regimen in US, Australia, Japan, Canada, EU and Hong Kong in 2036

Patent • Oncology

Sesen Bio Reports Fourth Quarter and Full-Year 2021 Financial Results and Anticipated Regulatory Path Forward for the Company’s Lead Product Candidate, Vicineum (Businesswire) - "On January 7, 2022, the FDA granted Sesen Bio’s request for a Type C Meeting to discuss the study protocol for an additional Phase 3 clinical trial that the Company plans to conduct for potential resubmission of a BLA for Vicineum for the treatment of non-muscle invasive carcinoma in situ (CIS) of the bladder in patients previously treated with adequate or less than adequate BCG. The Type C Meeting has been scheduled for March 28, 2022....The Company intends to work cooperatively with the FDA in preparing for an additional Phase 3 clinical trial for Vicineum."

FDA event • New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

"$SESN Sesen Bio Announces Anticipated Regulatory Path Forward for Vicineum™ https://t.co/rUkFx3P9ja" (@stock_titan)

Sesen Bio Announces Anticipated Regulatory Path Forward for Vicineum (Businesswire) - "Sesen Bio...announced its anticipated regulatory path forward for Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the US Food and Drug Administration (FDA), which occurred on December 8, 2021 (Clinical Type A Meeting)...Following the productive Clinical Type A Meeting, the Company believes it has greater clarity regarding the requirements for resubmission of the BLA and the trial design....The Company expects to hold a Type C meeting with the FDA in early 2022 to discuss the protocol for the additional clinical trial."

FDA event • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

Oportuzumab monatox: “The CHMP noted the withdrawal of initial marketing authorization application [treatment and prevention of recurrence of carcinoma-in-situ of the urinary bladder and prevention of recurrence of high-grade Ta and/or T1 papillary tumors]” (European Medicines Agency) - CHMP Final Minutes of the meeting on 13-16 Sep 2021

European regulatory • Bladder Cancer • Oncology

Sesen Bio Reports Third Quarter 2021 Financial Results and Business Update (Businesswire) - "During the quarter, the Company continued to work on its path forward to address chemistry, manufacturing, and controls (CMC) and clinical issues identified by the US Food & Drug Administration (FDA) in its Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer...Research and development expenses for the third quarter of 2021 were $5.0 million compared to $10.2 million for the same period in 2020."

Clinical • Commercial • Bladder Cancer • Genito-urinary Cancer • Oncology