DELYTACT The Latest Entrant In The Oncolytic Virus Therapy Market
09 Dec 2022
Orphan DrugClinical ResultFast TrackPhase 2Drug Approval
One of the biggest threats to human health and life has always been cancer, and as instances rise each year, so do the financial and emotional burdens placed on patients and their families. While conventional treatment methods have been helpful in improving the patients’ survival and quality of life, little effect has been seen in patients with advanced forms of cancer, generating the need for new approaches for cancer management. In the last six decades, the discovery of oncolytic viruses has changed the research paradigm for cancer therapy and has emerged as one of the newest strategies for cancer management. The approval of three oncolytic viruses has further helped in grabbing the attention of pharmaceutical companies and researchers alike, which has been the main driver in promoting their growth.
Global Oncolytic Virus Immunotherapy Market and Clinical Trials Insight 2028 Report Overview:
Global Oncolytic Virus Immunotherapy Therapy Market Overview
Global Oncolytic Virus Immunotherapy Therapy Market Opportunity: > USD 1 Billion By 2028
Insight On More Than 180 Oncolytic Virus Immunotherapies In Clinical Trials
Patent Information On More Than 60 Therapies in Clinical Trials
IMLYGIC, Oncorine, Delytact: Availability, Dosage and Price Analysis
Oncolytic Virus Immunotherapy Clinical Pipeline By Country, Phase, Indication, Organization, Patient Segment
Oncolytic Virus Immunotherapy Application By 10 Cancer
Recent Strategic Partnerships, Collaborations, Mergers and Acquisitions
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Oncolytic viruses, naturally or through genetic modifications, have the capacity to proliferate in cancer cells. The modality has been studied extensively in several types of cancer, and some of these OVs have also gained approval by regulatory bodies. Globally, Oncorine was the first oncolytic virus to be granted approval by a regulatory authority. It was approved in China in 2005 for the treatment of head and neck cancer. This was followed by the approval of Imlygic for treating melanoma by the FDA and EMA and is the only OV to have those approvals. More recently, Delytact received a conditional approval by Japan’s drug approval authority in June, 2021. The drug was given approval for the treatment of malignant glioma, which was a big milestone because no other OV has gained approval for brain cancer, demonstrating that the blood-barrier crossing abilities of these viruses can be utilized for the treatment of cancers of the brain.
Delytact was developed jointly by Daichii Sankyo and Professor Tomoki Todo of the University of Tokyo’s Institute of Medical Science. It is a herpes simplex virus type 1 (HSV-1) which has been mutated to replicate exclusively in cancer cells. Oncolytic virus selectively replicate in cancer cells until cell death occurs post which, antitumor antigens produced by the virus are released in the tumor environment which allows the immune system to attack cancer cells by identifying the cancer antigens. It was granted a Sakigake fast-track designation in 2016 which was followed by an orphan regenerative medical product designation for malignant glioma in July, 2017.
It has been given a 7 years limited time approval by the PMDA under which the company has to verify the safety and efficacy of the drug in the next seven years, after which the drug can be fully approved in the market. This approval was based in the data from a single-arm phase II trial which showed that treatment with Delytact improved the chances of survival in patients with residual or recurrent glioblastoma previously treated with radiotherapy and chemotherapy with Temodar (temozolomide). Regardless of the approval being only for a limited time, approval of Delytact given hope to many patients suffering from gliomas and also to researchers and pharmaceutical companies having drugs for brain cancer under development.
Candel Therapeutics, DNAtrix and Transgene are some other companies apart from Daichii Sankyo who have OVs against brain cancer in clinical trials. While all these clinical trials are in early stages, the pursuers are expecting optimistic results for their respective drugs and from the approval process based on the designations held by Delytact and the conditions of its approval.
Oncolytic viruses have been a lot of attention lately, mostly by the approval of Amgen’s Imlygic, which is among the handful of major pharmaceutical companies working on oncolytic virotherapy. The commercial performance of all these drugs will further fuel the development activities and allow the entry of more drugs in the development pipeline and the market.
Contact:
Neeraj Chawla
Kuick research
Research Head
+91-981410366
neeraj@kuickresearch.com
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