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Torbjörn Furuseth, Targovax

New clinical trial at Oslo University Hospital

Our member Targovax has announced a new clinical trial for skin cancer patients at Oslo University Hospital.

The second part of a clinical trial for patients with refractory advanced melanoma (a type of skin cancer) will take place at Oslo University Hospital.

“We are excited that we can offer this treatment alternative to patients in our home country, and hopefully it will help us to recruit more patients faster,” said Torbjørn Furuseth, Chief Financial Officer, Targovax.

Targovax is a Norwegian biotech company that develops oncolytic viruses called ONCOS-102 to destroy cancer cells. The treatment is targeted towards solid tumours that are especially hard to treat. The ultimate goal is to activate the patient’s immune system to fight cancer.

Promising results

“The trial is until now conducted at three top hospitals in the US, where competition for patients to clinical trials is high. Oslo University Hospital is also a great cancer center, and currently there are no trials offered to this patient population,” said Furuseth.

Three out of nine patients responded to the treatment during the first part of the clinical trial. This included one complete response and two partial responses.

Dr. Magnus Jäderberg, CMO of Targovax, said: “It is promising to see this level of clinical responses after only three ONCOS-102 injections, including a complete response, which is rare in this heavily pre-treated patient population.”

A forceful combination

The treatment involves a combination of an oncolytic virus and an anti-PD1 checkpoint inhibitor.

The oncolytic virus is a modified virus that has been developed to selectively attack and kill cancer cells. You can read more about the oncolytic viruses on Targovax’s official website.

The anti-PD1 checkpoint inhibitor disrupts the interaction between proteins on the surface of cancer cells. This stops the cancer from evading the immune system.

“Earlier this year, we decided to expand the trial to test a more intensified schedule of ONCOS-102, and it will be interesting to see whether this regimen can generate more and deeper clinical responses,” said Dr. Alexander Shoushtari, Principal Investigator, Memorial Sloan Kettering Cancer Centre, New York.

The second part of the clinical trial is currently enrolling new patients.

 

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Doctor examining the birthmark of a female patient

Promising start for expansion group of Targovax clinical trial

Targovax, one of the members of Oslo Cancer Cluster, has begun an expansion patient group in the clinical trial of a drug to treat skin cancer.

The company Targovax is developing immune activators to target solid tumours that are difficult to treat. The drug in question, called ONCOS-102, is aimed at patients with malignant melanoma (skin cancer) who have either been through chemotherapy, biological therapy or surgery and experienced a recurrence or progression of the cancer.

 

How does it work?

The immune activators work by activating the patient’s own immune system to attack the cancer cells. The drug that is now being tested is a genetically modified oncolytic adenovirus, a type of virus that has been designed to infect in the cancer cells and then replicate.

 

Initial positive results

Targovax, a member of the Oslo Cancer Cluster, are developing a treatment for skin cancer.

In September 2018, the first six patients had been treated with 3 injections of the drug and all of them showed a strong activation of their immune systems – one patient even had a complete response. The results suggested that the patients could benefit from more injections of the drug.

“The results seen to date with only three injections of ONCOS-102 are promising, and we are confident that by increasing to twelve injections we will release the full potential of ONCOS-102 to reactivate these patients to respond to Keytruda treatment,” said Magnus Jäderberg, CMO of Targovax.

 

Expansion patient group

On 11 February 2019, the first patient in the expansion group of the phase I trial was injected with ONCOS-102. The patient will be treated in combination with pembrolizumab, also known as Keytruda, an immunotherapy drug that works as an immune checkpoint inhibitor. This means that the drug involves antibodies, which “unlock” the protective mechanisms of the cancer cells so the immune system then can destroy them.

 

For more information, read the full press release from Targovax.

Targovax in phase IIa with cancer vaccine

Immunotherapy specialist Targovax reaches Phase IIa in operable pancreatic cancer with its TG01 immunotherapy. RAS specific immune responses were induced in all 6 patients in Phase I, and no substantial side effects were observed in the patients. The clinical trial has now expanded from Norway to two sites in the UK.

 

Oslo Cancer Cluster member Targovax started in 2010 to develop targeted immunotherapy in the form of therapeutic cancer vaccines. The TG01 vaccine has been given as treatment to cancer patients, in combination with chemotherapy after surgery, to prevent relapse. TG01 is granted Orphan Drug Status for pancreatic cancer in both EU and USA. The promising Phase I results has triggered a $2M (12.5 MNOK) milestone from current owners.

 

Clinical trial in phase II
Gustav Gaudernack, professor emeritus at Oslo University Hospital, and one of the inventors of the technology, states: “I have great expectations for the principle of treating patients with peptide based immunotherapy, which educates the patients’ immune system to fight cancer. It is exciting that the TG01 project now reaches this important milestone in combination with chemotherapy”.

The clinical trial has now formally entered Phase IIa, and the trial is expanding from Norway to two sites in UK, namely The Christie NHS Foundation Trust in Manchester, and The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool.

UK Principal Investigator Professor Daniel Palmer says: “Vaccination targeting RAS mutations is an extremely promising area of research and with our considerable experience in conducting multicentre immunotherapy trials, we are looking forward to help expand Targovax’s TG01 trial into Phase IIa.”

Important milestone
CEO Hanne Mette Kristensen commented: “Through this important milestone, we have significantly reduced risk in TG01 development by confirming observations of specific immune response and safety for the patients. This is very encouraging. We will continue to work towards confirming the link between TG01 treatment and effect on survival for these patients. We are proud that the two UK sites now participate in the clinical trial – we see this as a quality mark. ”

Targovax’ RAS specific immunotherapy triggers both cytotoxic- and helper T-cell- immune responses, educating the patients’ immune system to recognize and kill the cancer cells.

New IPR is established as a basis for expanding pipeline to broader indications.

“Based on these results, Targovax is now focused on completing the ongoing Phase IIa study with TG01 in surgically resected cancer. In addition, the company is initiating preparations for a randomized Phase II, and completing a Phase I trial with TG02 in larger indications such as colorectal cancer and non-small cell lung cancer (NSCLC),” concludes Kristensen.

Read more in the press release on Targovax’ website.

 

About Targovax
Targovax develops immunotherapy in the form of therapeutic cancer vaccines. TG01 is being developed for pancreatic cancer as its first indication. The drug has been investigated in exploratory trials in patients with promising results. The company is located in Lysaker, close to Oslo, Norway.

TG01 and RAS
TG01 is a therapeutic cancer vaccine which means that it educates the body’s immune system to recognize and kill the cancer cells. TG01 is based on pioneering research into RAS mutations in the Norwegian Radium Hospital (now Oslo University Hospital) and Norsk Hydro. Mutation of RAS disrupts normal cell division signaling and contributes to development of cancer cells and tumors. RAS mutations are found in approximately 25% of all cancers and in particular in pancreatic cancer (80-90%), colorectal cancer (40%) and non-small cell lung cancers (30%). Lead candidateTG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase IIa trials in surgically resected pancreatic cancer, patients start treatment 1-8 weeks after surgery.

Pancreas cancer and other RAS-mutated cancer forms
Pancreatic cancer is a disease affecting 116 000 patients each year in EU and USA, and approximately 690 persons each year in Norway. Approx 15-20% of these are discovered at an early stage and are operable. The mortality is high, and the prognosis for these patients has been more or less unchanged the last 30 years. Approximately 80-90% of patients with pancreatic cancer have RAS mutations in the cancer cells.
RAS mutations are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.