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    Imugene, Vaxinia and Oncolytic Viruses - An emerging market


    Imugene may not be exploding in value as there are many others chasing their dream. That being to conquer the emerging oncolytic virus market. Oncolytic viruses (OVs) are emerging therapeutic agents that can selectively target cancer cells and trigger immune activation. The application of OVs in combination with cancer immunotherapy in various solid tumors has become a promising therapeutic strategy. Given the breadth of this emerging therapeutic market, aside from awaiting clinical trial results, how does Big Pharma decide whose train to board when it comes to choosing an oncolytic virus?According to GlobalData, there are 270+ companies, spanning technology vendors, established pharmaceutical companies, and up-and-coming start-ups engaged in the development and application of oncolytic viruses.


    Maybe Big Pharma dont wait for clinical trial results from third parties to arrive, they simply develop their own. Pharmaceutical-technology.com in November last year noted Merck & Co (Merck) is one of the leading patent filers in oncolytic viruses. The biopharmaceutical company is focused on the discovery, development, manufacturing and marketing of prescription medicines, biologic therapies, vaccines, and animal health products. It offers prescription products for therapy areas related to cardiovascular, cancer, immune disorders, infectious, respiratory, and diabetes. Gebasaxturev is an oncolytic virus, which is under development for the treatment of gastrointestinal tract, central nervous system, and head and neck cancer. C. H. Boehringer Sohn and Sanofi are some of the other key patent filers in oncolytic viruses.


    Back in November 2006, over 17 years ago now, Oncolytic virus research got a welcome boost when Chinese regulators approved the world's first oncolytic viral therapy for cancer, Shanghai Sunway Biotech's genetically modified adenovirus H101. “It's fantastic for the field,” said John Bell , Ph.D., of the Ottawa Health Research Institute in Canada, at the time. “We needed to have something that was a success, and so I think this is a good first start.”Oncolytic viruses mediate antitumor responses through direct tumor cell lysis and induction of host antitumor immunity. However at the time, the therapeutic efficacy of oncolytic viruses against malignant ascites had rarely been explored. The adenovirus H101 displayed efficacy, safety, and an immunomodulatory effect in the treatment of malignant ascites. Malignant ascites (MA) is a common complication in late-stage malignancies that occurs as a consequence of peritoneal dissemination.The presence of ascites has been associated with a decreased quality of life and poor survival (approximately 1–2 months). See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8971678/ for more.


    Then as many would be aware T - Vec was the first FDA Approved oncolytic virus, almost ten years ago now, in 2015. T-Vec was approved at the time to treat advanced melanoma.


    Outside of T -Vec, another drugthat is today striving for FDA Approval alongside Imugene’s Vaxinia is Ikena Oncology’s IK - 930. Trial results for IK - 930 were released around the same time as Imugene released results in their Vaxinia (MAST) Trial last November.



    Ikena Oncology


    Like Imugene Ikena Oncology is searching for answers to the huge unmet need surrounding the treatment of solid tumours in cancer patients. The company is currently trialling their flagship candidate IK 930. Twenty-six patients with a range of solid tumors were treated in the dose escalation portion of the study as of October 31, 2023. The most common tumor type enrolled was EHE.


    EHE is a slow-growing, invasive tumor with no approved treatment options and is challenging to measure due to diffuse infiltration of multiple organs. It can occur in multiple areas of the body, including the liver, lungs, bones, and blood vessels. People with EHE suffer symptoms that relentlessly affect their quality of life and are consistent with the site of the EHE growth, including liver failure, respiratory issues, and gastrointestinal symptoms, which are frequently accompanied by severe pain across the body. With no approved standard of care, there is substantial need for innovative treatments that can provide clinical benefit and symptom relief and slow or limit the progression of disease.


    IK-930 - Trial Results November 2023



    In their study seven patients with EHE have been treated with IK-930 in the dose escalation portion of the trial. Ongoing results show:

    • 7 out of 7 EHE patients reached stable disease as a best response so far as measured by RECIST
    • 3 out of the 7 patients experienced tumor shrinkage in multiple target and non-target lesions
    • 4 out of 7 highly symptomatic EHE patients enrolled across multiple dose levels reported symptomatic improvement and subjective improvement of quality of life such as improved energy, weight gain, and pain control


    CG Oncology - another contender

    CG's lead asset, cretostimogene grendenorepevec, an oncolytic virus immunotherapy, is under development for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancerCG Oncology’s virus—a harmless adenovirus—is another contender. The virus carries a gene that spurs infected cancer cells to produce an immune-stimulating molecule, promoting attacks by T cells.


    As noted in my previous posts science.org discussed the drugs phase 3 trial tests in patients with a form of bladder cancer that hadn’t penetrated the muscular wall of the organ. If tumors like these grow unchecked, patients often need to have their bladders removed, but the virus may delay or prevent that outcome. Doctors assessed the participants in the trial every 3 months after the treatment began. In 76% of the patients, tumors were undetectable at one or more of these checkups. And in 74% of that group, the tumors did not return for at least 6 months.

    “It’s an interim analysis, but what we’ve seen is a good start,” says urologic oncologist Mark Tyson of the Mayo Clinic, who has several patients enrolled in the trial and unveiled the findings at the Society of Urologic Oncology conference. Researchers will track the patients for a total of 3 years to determine whether the benefits persist, says Tyson, who has no connection to CG Oncology.


    Where to now?

    pubmed.ncbi.nlm.nih.gov notes that In cancer treatment, combination therapy using oncolytic viruses alongside standard cancer treatment methods and other immunotherapy-based treatments can expect more promising results in the future.
    nature.com concludes in a recent article on the discussion of oncolytic viruses that from the accidental discovery of tumor shrinkage after infection with natural viruses to the widespread use of engineered OVs for targeted tumor therapy, OV therapy has gradually shown its powerful and magical antitumour ability, especially in solid tumours. It is not only a demon that can only invade and attack, but rather serve as a powerful tool of a genetically modified vector. It has displayed its targeting fidelity and antitumor immunity in many ways if it is properly harnessed.

    At 10 parts to the 8 - The plot thickens

    Many on these threads are burning a candle for Professor Yuman Fong’s oncolytic virus Vaxinia, and the solid tumour patients in the ongoing Vaxinia (MAST) Trial. Can Vaxinia capitalise if not improve on its November 2023 results? Are tumours to haveswollen once infected, and ultimately shrink? Time shall tell. There is much to compare Vaxinia’s progress with, as outlined above. There are ample competitors, hundreds of them. Yet Professor Fong’s resolve to pit his oncolytic virus against “any type of cancer,” makes even the most strident critic wary of what his virus promises at higher dosage rates. Could it deliver the knockout punch?


    DYOR Seek investment advice as and when required Opinions only

    Last edited by Watmighthavben: 21/02/24
 
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