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Langnau - Informatie voor beleggers

Waarschuwing: De informatie op deze website dient als verdiepingsmateriaal en is niet zonder meer een beleggingsadvies.

Gastbijdrage door MZ 

Bedrijsprofiel   

Vicinium™, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. [BCG is al eeuwen de gouden standaard, maar Vicinium grijpt juist datgene waarbij BCG niet heeft gewerkt. Waarbij dus nog eens bijna 50% een kans maakt zonder ingrijpende cystectomie waar die voorheen niet was. 'valstar boekt slechtere resultaten en is al op de markt]. Three-month data from the ongoing trial are presented at the 2018 American Urological Association Annual Meeting on May 21, 2018, with 12-month data anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

 


















Ik verwacht ook veel van de combinatie Vicinium + inhibitors, bijv. voor SCCHN. “We also believe Vicinium may have potential treating additional cancers, including squamous cell carcinoma of the head and neck (SCCHN). We are developing an injectable form of Vicinium for the treatment of SCCHN, with Phase 1 trials completed in Russia and Brazil, that have demonstrated anti-tumor activity and safety. Data from these trials also demonstrated that certain patients who were injected with Vicinium in one tumor had responses in non-injected tumors as well, suggesting that Vicinium may promote an anti-tumor immune response and combine well with immunotherapies.      

Corporate presentation:  http://ir.sesenbio.com/events-and-presentations

Info Vicinium:                http://www.sesenbio.com/vicinium.php

Klinische resultaten Vicinium

Complete Response (CR): The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.

Phase 2:  A total of 46 patients were treated with Vicinium with half being administered 30mg/dose once per week for 6 weeks (cohort 1) and the other half (cohort 2) the same dose but administered once per week for 12 consecutive weeks.

In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40 percent at three months, with no drug-related serious adverse events observed in the trial.

https://www.ncbi.nlm.nih.gov/pubmed/22998907

https://clinicaltrials.gov/ct2/show/NCT00462488?term=vicinium&rank=2

Phase 3: Experimental: Vicinium

·        Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.

·        Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.

https://www.businesswire.com/news/home/20180521005913/en/Phase-3-Registration-Trial-Non-Muscle-Invasive-Bladder

https://clinicaltrials.gov/ct2/show/NCT02449239?term=vicinium&rank=1


Concurrentie

In de tussentijd heb ik nog wat opgezocht m.b.t. concurrentie van Vicninium en kwam volgende tegen:

https://rvmais.iweventos.com.br/temas/urooncologia2018/arquivos/palestras/03-03/plenaria/15h00%20Ashish%20Kamat.pdf
Instiladrin (in phase 3):
·       Phase II At 12 months: 40 patients (35%) free of high grade disease 
·       No grade 4/5 AE 
·       No treatment discontinuation due to AE
·       The US FDA has already granted  fast-track and breakthrough therapy designations for the product. Ferring intends to create a new US oncology division with specialist expertise for the potential launches of this product and other advanced therapies and plans to exercise its option on the finalisation of US marketing approval.
·       https://clinicaltrials.gov/ct2/show/NCT02773849
·       https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=224228076
Cold Genesis CG0070 (in phase 2):
·       Clinical trials al een jaar niet bijgewerkt, of trials zijn "terminated"
·       https://www.ncbi.nlm.nih.gov/pubmed/28755959
·       https://clinicaltrials.gov/ct2/results?cond=&term=cg0070&cntry=&state=&city=&dist=

Met name Instiladrin lijkt mij een geduchte tegenstander, die zelfs hogere CR rates heeft behaald.

MZ