Vicineum

Vicineum™, also known as VB4-845, is a locally administered targeted fusion protein.

After a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial for BCG unresponsive non-muscle invasive bladder cancer, following discussions with the United States Food and Drug Administration, the strategic decision was made to voluntarily pause further development of Vicineum in the United States. In October 2022, a financial advisor was engaged to initiate a formal process for the potential sale of Vicineum to a partner with larger infrastructure and potential synergies. To date, nearly 60 companies have been contacted and Carisma is continuing to assess counterparties to realize any potential value for Vicineum and other legacy assets.

Sesen Bio stockholders of record will be issued one Contingent Value Right (CVR) for each outstanding share of Sesen Bio common stock, representing the right to receive any potential proceeds from the sale of Vicineum and Sesen Bio’s preclinical assets prior to March 31, 2027.

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Publications

VB4-845 | Vicineum

R Dickstein, N Wu, B Cowan, C Dunshee, M Franks, F Wolk, L Belkoff, S Castellucci, J Holzbeierlein, G Kulkarni, A Weizer, D Lamm, S Ali, J Epstein, GP Adams, H Youssoufian, W Kassouf. VISTA, Phase 3 Trial of Vicineum, an EpCAM-Targeted Pseudomonas Exotoxin, in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. Global Congress on Bladder Cancer 2018, September 20-21, 2018; Madrid, Spain

R.L. Dillon, S. Chooniedass, A. Premsukh, G.C. MacDonald, J. Cizeau and G.P. Adams. VB4-845 tumor cell killing in a combination with the anti-PD1, Nivolumab (poster). 2017 American Association for Cancer Research, April 1-5; Washington D.C.

Kowalski M, Guindon J, Brazas L, Moore C, Entwistle J, Cizeau J, Jewett MA, MacDonald GC. A Phase II Study of Oportuzumab Monatox: An Immunotoxin Therapy for Patients with Noninvasive Urothelial Carcinoma in situ Previously Treated with Bacillus Calmette-Guérin. J Urol. 2012 Nov; 188(5):1712-8. doi: 10.1016/j.juro.2012.07.020. Epub 2012 Sep 19.

Premsukh A, Lavoie JM, Cizeau J, Entwistle J, MacDonald GC. Development of a GMP Phase III Purification Process for VB4-845, an Immunotoxin Expressed in E. coli using High Cell Density Fermentation. Protein Expr Purif. 2011 Jul;78 (1):27-37. doi: 10.1016/j.pep.2011.03.009. Epub 2011 Mar 21.

Kowalski M, Entwistle J, Cizeau J, Niforos D, Loewen S, Chapman W, MacDonald GC. A Phase I Study of an Intravesically Administered Immunotoxin Targeting EpCAM for the Treatment of Nonmuscle-Invasive Bladder Cancer in BCG-Refractory and BCG-Intolerant Patients. Drug Des Devel Ther. 2010 Nov 15; 4:313-20. doi: 10.2147/DDDT.S14071.

Jones N, Jewett M, Cuthbert W, Rasamoelisolo M, Entwistle J, MacDonald G, Glover N. A Phase I/II Study of Vicineum™ Given by Intravesical Administration in Patients with Superficial Transitional Cell Carcinoma of the Bladder: Phase I Final Results (abstract). American Urological Association (AUA) 2010 Annual Scientific Meeting, May 29-June 3, 2010.

Jewett M, Jones N, Cuthbert W, Rasamoelisolo M, Entwistle J, MacDonald G, Glover N. A Phase I/II Study of Vicineum™ Given by lntravesical Administration in Patients with Superiicial Transitional of the Bladder: Phase I Final Results (poster). American Urological Association (AUA) 2010 Annual Scientific Meeting, May 29-June 3, 2010.

Brown JG, Entwistle J, Glover N, Macdonald GC. “Preclinical Safety Evaluation of Immunotoxins.”Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials. Edited by Joy A. Cavagnaro. Published Online: 15 Mar 2010. DOI: 10.1002/9780470571224.pse188.

Kowalski M, McCann E, Jones N, Niforos D, Chapman W, MacDonald G. Level Of Expression of EpCAM and Response to Vicineum™ in Non Muscle-Invasive Transitional Cell Carcinoma of the Bladder (abstract). European Urology Supplements, Volume 9, Issue 2, April 2010, Pages 289-290. 25th Annual Congress of the European Association of Urology, April 16-20, 2010; Barcelona, Spain.

Kowalski M, McCann E, Jones N, Niforos D, Chapman W, MacDonald G. Level of Expression of EpCAM and Response to Vicineum in Non Muscle-Invasive Transitional Cell Carcinoma of the Bladder (poster). 25th Annual Congress of the European Association of Urology, April 16-20, 2010; Barcelona, Spain.

Brown J, Rasamoelisolo M, Spearman M, Bosc D, Cizeau J, Entwistle J, MacDonald GC. Preclinical Assessment of an Anti-EpCAM Immunotoxin: Locoregional Delivery Provides a Safer Alternative to Systemic Administration. Cancer Biother Radiopharm. 2009 Aug; 24(4):477-87. doi: 10.1089/cbr.2008.0579.

MacDonald GC, Rasamoelisolo M, Entwistle J, Cuthbert W, Kowalski M, Spearman MA, Glover N. A Phase I Clinical Study of Intratumorally Administered VB4-845, an Anti-Epithelial Cell Adhesion Molecule Recombinant Fusion Protein, in Patients with Squamous Cell Carcinoma of the Head and Neck. Med Oncol. 2009; 26(3):257-64. doi: 10.1007/s12032-008-9111-x. Epub 2008 Oct 28.

MacDonald GC, Rasamoelisolo M, Entwistle J, Cizeau J, Bosc D, Cuthbert W, Kowalski M, Spearman M, Glover N. A Phase I Clinical Study of VB4-845: Weekly Intratumoral Administration of an Anti-EpCAM Recombinant Fusion Protein in Patients with Squamous Cell Carcinoma of the Head and Neck. Drug Des Devel Ther. 2008; 2: 105–114. Published online 2009 Feb 6.

Biggers K, Scheinfeld N. VB4-845, a Conjugated Recombinant Antibody and Immunotoxin for Head and Neck Cancer and Bladder Cancer. Curr Opin Mol Ther. 2008 Apr; 10(2):176-86.

Brown JG, Rasamoelisolo M, Cizeaua J, Bosca D, Entwistle J, Glover N, MacDonald GC. Evaluation of the Immunotoxin, Proxinium™ in Combination with Chemotherapy and Radiotherapy (abstract). AACR Annual Meeting, April 2007.

Brown JG, Rasamoelisolo M, Cizeaua J, Bosca D, Entwistle J, Glover N, MacDonald GC. Evaluation of the Immunotoxin, Proxinium™ in Combination with Chemotherapy and Radiotherapy (poster). AACR Annual Meeting, April 2007.

Fitsialos D, Quenneville J, Rasamoelisolo M, Cross M, Glover N, MacDonald G, Federico MHH, Barrios CHE, Guimarães RC, Nicolau UR. A Phase I Study of VB4-845 in Patients with Advanced, Recurrent Head and Neck Cancer on a Weekly Dosing Scheme (abstract). 2005 ASCO Annual Meeting, May 2005.

Fitsialos D, Quenneville J, Rasamoelisolo M, Cross M, Glover N, MacDonald G, Federico MHH, Barrios CHE, Guimarães RC, Nicolau UR. A Phase I Study of VB4-845 in Patients with Advanced, Recurrent Head and Neck Cancer on a Weekly Dosing (poster). 2005 ASCO Annual Meeting, May 2005.

Quenneville J, Fitsialos D, Rasamoelisolo M, Cross M, Glover N, MacDonald G. A Phase I Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetic (PK) Profile of VB4-845, an Anti-Ep-CAM Immunotoxin, in Subjects with SCCHN (poster). 2005 ASCO Annual Meeting, May 2005.

Di Paolo C, Willuda J, Kubetzko S, Lauffer I, Tschudi D, Waibel R, Plückthun A, Stahel RA, Zangemeister-Wittke U. A Recombinant Immunotoxin Derived from a Humanized Epithelial Cell Adhesion Molecule-Specific Single-Chain Antibody Fragment has Potent and Selective Antitumor Activity. Clin Cancer Res. 2003 Jul; 9(7):2837-48.

 

VB6-845d

J. Cizeau, S. Chooniedass, R. L. Dillon, A. Premsukh, G. P. Adams, G. C. MacDonald, N. Goodwin, H.L. Thompson and B. Archerd. Engineering and characterization of anti-PSMA humabody-deBouganin fusion proteins (poster). 2018 American Association for Cancer Research, April 14-18, 2018; Chicago.

R.L. Dillon, S. Chooniedass, A. Premsukh, G.C. MacDonald, J. Cizeau and G.P. Adams. VB6-845d Tumor Cell Killing Elicits Biologic Features of Immunogenic Cell Death (poster). 2018 American Association for Cancer Research, April 14-18, 2018; Chicago.

S. Chooniedass, R. L. Dillon, A. Premsukh, G. P. Aams, G. C. MacDonald, J. Cizeau. Trastuzumab and C6.5 diabody armed with deBouganin overcome drug resistance to ADCs comprised of anti-microtubule agents (poster). 2017 American Association for Cancer Research, April 1-5; Washington D.C.

S. Chooniedass, R.L. Dillon, A. Premsukh, J. Entwistle, G.P. Adams, P.J. Hudson, G.C. MacDonald, J. Cizeau. VB7-756: a HER2-specific Diabody Armed with deBouganin, a Plant Toxin with a Distinct MOA (poster). 2016 American Association for Cancer Research, April 16-20, New Orleans.

R.L. Dillon, S. Chooniedass, A. Premsukh, G.P. Adams, J. Entwistle, G.C. MacDonald and J. Cizeau. deBouganin Conjugated to Trastuzumab Overcomes Multiple Mechanisms of T-DM1 Drug Resistance (poster). 2016 American Association for Cancer Research, April 16-20, New Orleans.

Chooniedass S, Dillon RL, Premsukh A, Hudson PJ, Adams GP, MacDonald GC, Cizeau J.DeBouganin Diabody Fusion Protein Overcomes Drug Resistance to ADCs Comprised of Anti-Microtubule Agents. Molecules 2016, 21(12), 1741; doi: 10.3390/molecules21121741.

Entwistle J, Kowalski M, Brown J, Cizeau J, MacDonald JC. “The Preclinical and Clinical Evaluation of VB6-845: An Immunotoxin with a De-Immunized Payload for the Systemic Treatment of Solid Tumors.” Antibody-Drug Conjugates and Immunotoxins: From Pre-Clinical Development to Therapeutic Applications. G.L. Phillips (ed.), 2013. DOI 10.1007/978-1-4614-5456-4_19

Entwistle J, Brown JG, Chooniedass S, Cizeau J, MacDonald GC. Preclinical Evaluation of VB6-845: An Anti-EpCAM Immunotoxin with Reduced Immunogenic Potential. Cancer Biother Radiopharm. 2012 Nov;27(9):582-92. doi: 10.1089/cbr.2012.1200.271. Epub 2012 Aug 2.

Chaboureau A, Ragon I, Stibbard S, Cizeau J, Glover N, MacDonald GC. Intracellular Trafficking of VB6-845, an Immunocytotoxin Containing a De-immunized Variant of Bouganin (abstract). AACR Annual Meeting, April 2008.

Chaboureau A, Ragon I, Stibbard S, Cizeau J, Glover N, MacDonald GC. Intracellular Trafficking of VB6-845, an Immunocytotoxin Containing a De-immunized Variant of Bouganin (poster). AACR Annual Meeting, April 2008.

Brown J, Cizeau J, Rasamoelisolo M, Bosca D, Entwistle J, Glover N, MacDonald GC. Complete Regression of Ovarian Cancer Xenografts Following Treatment with the Recombinant Immunocytotoxic Protein, VB6-845 (abstract). AACR Annual Meeting, April 2006.

Brown J, Cizeau J, Rasamoelisolo M, Bosc D, Entwistle J, Glover N, MacDonald GC. Complete Regression of Ovarian Cancer Xenografts Following Treatment with the Recombinant Immunocytotoxic Protein, VB6-845 (poster). AACR Annual Meeting, April 2006.

Brown J, Cizeau J, Bosc D, Rasamoelisolo M, Entwistle J, Glover N, MacDonald GC. A Preclinical Profile of VB6-845: A Recombinant Immunotoxin for Targeting Ovarian Cancer (abstract). AACR Annual Meeting, April 2006.

Brown J, Cizeau J, Bosc D, Rasamoelisolo M, Entwistle J, Glover N, MacDonald GC. A Preclinical Profile of VB6-845: A Recombinant Immunotoxin for Targeting Ovarian Cancer (poster). AACR Annual Meeting, April 2006.

Rasamoelisolo M, Cizeau J, Bosc D, Entwistle J, Glover N, MacDonald GC. Functional and Biological Characterization of VB6-845, a Recombinant Ep-CAM-specific Fab Antibody Genetically-Linked with De-Immunized Bouganin (de-bouganin) (abstract). AACR Annual Meeting, April 2005.

Rasamoelisolo M, Cizeau J, Bosc D, Entwistle J, Glover N, MacDonald GC. Functional and Biological Characterization of VB6-845, a Recombinant Ep-CAM-specific Fab Antibody Genetically-Linked with De-Immunized Bouganin (de-bouganin) (poster). AACR Annual Meeting, April 2005.

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