Update – Oncolytic Virus Trials for Neuroendocrine Cancer

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What exactly are Oncolytic Viruses?

Oncolytic Viruses infect and break down cancer cells but not normal cells. Oncolytic viruses can occur naturally or can be made in the laboratory by changing other viruses. Certain oncolytic viruses are being studied in the treatment of cancer. Some scientists say they are another type of immunotherapy whilst others say it’s too early to classify them as such. The good news is that Neuroendocrine Cancer seems to figure in this work with two of these viruses apparently working on mice to date. Listed below are two active projects involving NETs, one directly and one indirectly.

Whenever I post about a new trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (MAST)

Neuroendocrine Neoplasms are considered solid tumours. 

Imugene Limited, a clinical-stage immuno-oncology company, and City of Hope, one of the largest cancer research and treatment organizations in the United States, today announced that the first patient was dosed in Phase 1 clinical trial evaluating the safety of novel cancer-killing virus CF33-hNIS VAXINIA when used in people with advanced solid tumors. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.  

Interestingly, the principal investigator is listed as a NET Specialist. No conclusions should be drawn from this knowledge, and I have no information to suggest that Neuroendocrine patients are included in the patient population of 100 for this trial.  The trial is being carried out in 2 US locations:  City of Hope Duarte, California, and Next Oncology, Fairfax, Virginia.  Additional clinical sites will be opened across the U.S. in 2022 (no details as of 26 Jun 22).  Recruitment commenced Apr/May 2022, primary completion date of December 2024.

The clinical trial (NCT05346484) is here to read – click here.  As always, the exclusion and inclusion criteria are important.  Also read more here

ELC-021 (added 15th December 2021)

Elicera Therapeutics enters into an agreement with Baylor College of Medicine for contract manufacturing of next-generation oncolytic virus, ELC-201

ELC-201 is a next-generation oncolytic virus with a combined three mode-of-actions in the treatment of cancer. The drug candidate has been genetically modified with the company’s proprietary immune-enhancing platform technology, iTANK, in addition to 4-1BBL, both of which lead to strong activation of the patient’s endogenous CD8+ killer T-cells, leading to a broad parallel attack on cancer cells. ELC-201 is applicable for the treatment of most cancers. A clinical phase I/II-study is planned to be initiated in the second half of 2023.  The work is based on high-profile long-standing research conducted by Professor Magnus Essand’s research group at Uppsala University and has resulted in the development of four drug candidates, including two CAR T cells and two oncolytic viruses. 

The Uppsala Trial – AdVince

Updated 21st March 2021

Thanks to a fellow patient for this update from Professor Essand. 

“The AdVince trial is actively recruiting NET patients with liver metastases. The AdVince trial is a so-called phase I dose escalation study with four dose levels and we are currently treating at dose level three (so far without observing severe toxicity). As for all phase I studies, the primary endpoint is safety and to determine maximum tolerable dose of the oncolytic AdVince virus. We are of course also looking for efficacy. We have for practical reasons so far only included local patients for the dose-escalation part (phase I). This is because of the complex treatment schedule with virus infusion on days 1, 8, 22 and 50 and follow up examinations on day 80. Patients are hospitalised three-four nights during each treatment because we are required from the authorities to collect blood, urine and saliva samples to follow virus replication. The clinical phase II (efficacy) trial will open after completion of the phase I part (hopefully 2022) and we hope to make the clinical protocol somewhat easier then, not having to hospitalise patients that long”.

Updated 6th July 2020

AdVince has so far been tested in six patients in Sweden by Prof Essand, who is one of the two largest shareholders in Elicera. The company has now opened a second clinical site in Tubingen in Germany and is gearing up for a trial of 12 patients.  Here’s a quote from the Professor:

“Since it is the first time this medication is being tested in humans, the Medical Product Agency (Swedish FDA) and ethics committee require that we start with dose escalation (phase I) to show that the treatment is safe. We have four dose levels with three patients per dose level and each patient is treated four times over two months and then evaluated one month later. We have treated six patients so far and thereby finished the two lowest dose level so far without observing any severe toxicity and encouraging responses. However, the trial is ongoing and it is still too early to draw any firm conclusions”.

Original blog info – The Uppsala Trial – AdVince

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The Oncolytic Virus AdVince is removed from the freezer ready for the Neuroendocrine Cancer Trial

Read here for an update released 7th June 2019.

I’ll briefly describe what’s happening and then you can link to my Facebook article if you need more background.

The trial is called AdVince after Vince Hamilton who funded it. Unfortunately, he died before he saw any output but his forward-thinking and benevolence live on and might hopefully help NET patients in the longer term. It’s quite a small trial and is being conducted in Uppsala University Sweden, a famous European NET Centre of Excellence and where many people from across the world attend to take advantage of PRRT availability and experience and is home to famous NET specialist Kjell Öberg, MD, PhD, a professor of endocrine oncology.

A Swedish man (Jan-Erik Jannsson) was the first to get the virus to their cancer (NETs) using a genetically modified virus.

Unfortunately, I was given the news from a source close to the trial that Jan died last year of pneumonia.  I have no evidence to suggest his death is in anyway connected to the trial, but I’m told he was an ill man prior to the trial commencing.  I have therefore dedicated this post to him.  RIP Jan.

Jan

The initial data presented by the trial indicated that AdVince can be safely evaluated in phase I/IIa clinical trial for patients with liver-dominant NET.  The last I heard from the trial is that they are trying to recruit a further 12 patients to Phase IIa (the trial document allows for up to 36). 

Read more background on my Facebook post here: Click here

The trial document on the Clinical Trials Website: Click here

Then read this status update from the trial sponsors released in March 2018

Summary

I see many news Oncolytic Virus news items but mostly associated with cell lines (i.e. lab dish work).  Clearly, it’s still early days in the Oncolytic Virus field with minimum breakthroughs in terms of success on humans. In terms of the Neuroendocrine connection. We are waiting to hear from Uppsala about how the human test of AdVince is coming along. My agents are scanning the internet every day looking for any comments.

If you want to learn more about Oncolytic Viruses in general – there’s a great summary here.

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. 

Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 

 
 

Thanks for reading.

Ronny

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Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

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