Oncolytic virus

• Some research on emerging viruses can result in variants that gain the ability to infect people but this does not necessarily mean the research is dangerous or that it is not fruitful.
• Concerns have focused on lab research on the virus that causes bird flu in 2012 and on the virus that causes COVID-19 since 2020.
• Clarifying what gain-of-function research really is can help clarify why it is an essential scientific tool.

What is gain of function?

• To study how a living thing operates, scientists can change a specific part of it and then observe the effects.
• These changes sometimes result in the organism’s gaining a function it didn’t have before or losing a function it once had.
• This mutated immune cell, called a CAR-T cell thereby “gains the function” of being able to bind to cancerous cells and kill them.

Medical advances from gain-of-function research

• Only decades later does the research bring a new treatment to the clinic or a new technology within reach.
• The development of most antibiotics have relied on the manipulation of bacteria or mold in gain-of-function experiments.
• Alexander Fleming’s initial discovery that the mold Penicillium rubens could produce a compound toxic to bacteria was a profound medical advance.
• Gain-of-function research in virology has also been critical to the advancement of science and health.

Nature’s gain-of-function experiments

• Many viruses that infect such nonhuman animals as bats, pigs, birds and mice have the potential to spill over into people.
• Gain-of-function experiments in the lab can help scientists anticipate the changes viruses may undergo in nature by understanding what specific features allow them to transmit between people and infect them.
• In contrast to nature’s experiments, these are conducted in highly controlled lab conditions designed to limit infection risk to laboratory personnel and others, including air flow control, personal protective equipment and waste sterilization.
• Scientists have a better appreciation of the tangible risk of bird flu spillover because of gain-of-function experiments published a decade ago.

Oversight on gain of function

• Many researchers would likely agree that gain of function as a general tool is an important way to study biology that should not be restricted, while also arguing that it should be curtailed for research on specific dangerous pathogens.
• While updates to current oversight are not unreasonable, we believe that blanket bans or additional restrictions on gain-of-function research do not make society safer.
• Clarifying which specific research areas are of concern regarding gain-of-function approaches can help identify how the current oversight framework can be improved.

• The Adenovirus-based Oncolytic Viruses segment held a high market share and is expected to attain a significant market share in the forecast period.
• The growing usage demand due to their high accuracy in delivering the gene to the specific region has driven the market share in this segment.
• The need for oncolytic virotherapy as a primary treatment is growing in response to the increased prevalence of cancer.
• Several oncolytic viruses are being studied as a potential treatment for cancer in clinical trials.

• The paper on BT-001 was highlighted at the annual Society for Immunotherapy of Cancer (SITC) conference being held November 8-12, 2022 in Boston, MA.
• Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgenes Invir.IO platform that is armed with an anti-CTLA-4 antibody to illicit a strong and effective anti-tumor response.
• The award has been presented at the SITC Meeting Awards Ceremony, taking place Friday, November 11 from 8:00 8:20 a.m. EST.
• BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent.

• The Company has already attracted a $3 million investment from Proxima Ventures, which it has used to complete preclinical studies and build the team.
• Immunotherapies, which enable a patients immune systemto recognize and target cancer cells, have made a significant difference to cancer patients over the last decade.
• Oncolytic viruses can directly kill cancer cells, alter the tumor microenvironment and sensitize more patients to immunotherapy.
• As a pioneer in this space, VacV has generated viruses with optimal payloads and backbones to create a systemically deliverable, targeted, viral-based cancer immunotherapy.