News Releases

First patient dosed in Phase I/IIa trial of lung cancer immunotherapy vaccine

JANUARY 18, 2022, OXFORD, UK – Cancer Research UK, Vaccitech plc (Nasdaq: VACC) and the Ludwig Institute for Cancer Research (Ludwig), today announce the first patient dosed in the MAGE trial, which is testing a novel immunotherapeutic, VTP-600*, in patients with the most common type of lung cancer.

The phase I/IIa trial is expected to enrol approximately 86 people who have been newly diagnosed with non-small cell lung cancer (NSCLC)** and will be testing the safety and initial efficacy of VTP-600 in these patients. VTP-600 will be given in combination with the current first line treatment for NSCLC***.

If further clinical trials are successful, VTP-600 could prove to be a powerful new treatment for a group of patients in need of better options.

Depending on its effectiveness in NSCLC, VTP-600 could be evaluated in other types of cancer in the future, including breast, bowel, bladder and melanoma.

Cancer Research UK’s Centre for Drug Development (CDD) is managing and providing significant funding for the phase I/IIa trial. Vaccitech Oncology Limited (VOLT)****, a strategic collaboration between Vaccitech and Ludwig, are supplying VTP-600 for the trial.

The Chief Investigator for the trial is Professor Fiona Blackhall, Professor of Thoracic Oncology and Honorary Consultant in Medical Oncology, at The Christie NHS Foundation Trust*****.

VOLT holds an option to license the results of the trial to aid future clinical development and commercialisation of the immunotherapy. If VOLT elects not to exercise its option, Cancer Research UK will have the right to take the programme forward in all cancer indications.

Unlike preventative vaccines, such as the influenza vaccine, which is given to healthy people to protect them against future disease, VTP-600 is given to people who already have lung cancer.

VTP-600 is an immunotherapy, designed to stimulate the body’s immune system to attack cancer cells.

It does this by delivering cancer-associated proteins — known as MAGE-A3 and NY-ESO-1 antigens — to antigen presenting cells (dendritic cells), causing the immune system to produce cytotoxic T cells which are able to target and kill cancer cells expressing these antigens.

It cannot target healthy tissues because MAGE-A3 and NY-ESO-1 are not found on non-cancerous cells.

VTP-600 is a ‘prime-boost’ immunotherapy, meaning an initial ‘prime’ dose is administered, and then a second ‘booster’ dose is given 21 days later. This ‘prime-boost’ approach is expected to improve the size and length of the anti-cancer immune response.

Even though two doses are administered, the immunotherapy comprises three parts. ChAdOx1-MAGE-A3-NY-ESO-1 is the prime immunotherapy administered to all patients, MVA-MAGE-A3 with or without MVA-NY-ESO-1 is given as the second booster immunotherapy, depending on the type of antigens expressed on the patient’s tumour.

In the prime dose, ‘ChAdOx1’ refers to the viral vector used in the vaccine to deliver the antigens. It is a virus which causes a common cold in chimpanzees, but it has been modified so that it can no longer cause disease. ChAdOx1 is the same viral vector used in the Oxford/AstraZeneca Covid-19 vaccine (which was co-invented by Vaccitech) and is being used in phase II trials for other diseases******.

In the boost doses, ‘MVA’ is a second viral vector containing the MAGE-A3 or NY-ESO-1 antigens, and is a Modified Vaccinia Ankara virus, which is a type of poxvirus which has been severely weakened so that it can no longer cause disease.

The trial is expected to run over 2-3 years. More information on the clinical trial can be found at NCT04908111.

Dr Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, said: “We are excited to see that the first patient has been treated with the VTP-600 immunotherapeutic vaccine. NSCLC is the most common type of lung cancer but remains very hard to treat. If successful, this cutting-edge immunotherapy could provide an effective, much-needed new treatment to help more people survive their lung cancer.

“Partnering with Vaccitech and the Ludwig Institute was vital for making this trial a reality, and we are looking forward to seeing how the trial progresses.”

Chief investigator for the MAGE clinical trial, Professor Fiona Blackhall, who is consultant medical oncologist and director of research and innovation at The Christie NHS Foundation Trust said: “There is an urgent need to find better treatments for patients with NSCLC.  The VTP-600 immunotherapeutic vaccine is a cutting-edge technology to target a patient’s immune system to tackle the cancer cells. The trial is planned to open at 10 specialist hospitals across the UK to ensure that as many patients as possible can be given opportunity to participate.”

Vaccitech’s CEO, Bill Enright, said: “We are delighted with the start of this trial, arising from our clinical development partnership with two of the world’s most prestigious cancer research institutions. We’ve seen how our viral vector has transformed the world’s approach to sars-cov2 and has shown promising early results in chronic hepatitis B virus infection. We see this partnership as another important validation of our prime boost platform’s utility in oncology as well as infectious disease.”

“We are pleased that the research arising from the Ludwig Oxford Branch and their colleagues at Oxford University is being tested in this clinical trial to evaluate the benefit it may bring to patients with NSCLC and potentially other cancer patients as well,” added Jonathan Skipper, Executive Vice President for Technology Development, Ludwig Institute for Cancer Research.

Notes to Editor

*VTP-600 is a novel immunotherapeutic vaccine strategy to be trialled in patients with non-small cell lung cancer (NSCLC), in combination with current standard of care/first line treatment. The immunotherapy comprises three immunotherapeutic vaccines: ChAdOx1-MAGE-A3-NY-ESO-1 prime vaccine and two boost vaccines, MVA-MAGE-A3 and MVA-NY-ESO-1 (depending on the patient’s tumour antigen expression). The initial immunotherapy is designed on the back of Vaccitech’s proprietary viral vector platform and contains a chimpanzee adenovirus (ChAdOx1), which will prime the immune system by delivery of MAGE-A3 and NY-ESO-1. MAGE-A3 and NY-ESO-1 are antigens expressed by tumour cells including NSCLC tumour cells. MAGE-A3 is expressed in 48% of squamous NSCLC and 24% of non-squamous NSCLC. NY-ESO-1 has been shown to have an expression rate of 27% across all NSCLC types. Patients with a tumour expressing MAGE-A3 will receive the ChAdOx1-MAGE-A3-NY-ESO-1 prime vaccine, followed by a recombinant Modified Vaccinia Ankara (MVA) boost against MAGE-A3, which is expected to improve the size and length of the induced immune response. Patients with a tumour expressing both MAGE-A3 and NY-ESO-1 will get the same prime vaccine followed by a dual boost with both MVA-MAGE-A3 and MVA-NY-ESO-1.

**Around 80 to 85 out of 100 lung cancers (around 80 – 85%) in the UK are non-small cell lung cancer (NSCLC). The three main types are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. They are grouped together because they behave in a similar way and respond to treatment in a similar way.

***Chemotherapy and anti-PD-1 treatment.

****The Christie NHS Foundation Trust is one of Europe’s largest experimental cancer medicine centres and an international leader in research and development with around 650 clinical studies ongoing at any one time.

*****Vaccitech Oncology Limited (VOLT) is a strategic collaboration between Vaccitech Plc, a clinical-stage T cell immunotherapy company developing products to treat and prevent cancer and infectious diseases and Ludwig Institute for Cancer Research (Ludwig) an international non-profit organisation that conducts innovative cancer research to prevent, detect and control cancer.

******In collaboration with Professor Adrian Hill and Dr Irina Redchenko at the University’s Jenner Institute, researchers from Professor Benoit Van den Eynde’s group at the Ludwig Institute for Cancer Research developed a way to make use of the viral vector vaccine technology used in the creation of the Oxford-AstraZeneca COVID-19 vaccine to improve cancer treatment effectiveness. The ChAdOx1 viral vector is also being used in immunotherapeutic vaccine trials for other indications, such as HBV and HPV.


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