Targovax ASA: Third quarter 2018 results

Oslo, Norway, 1 November 2018 - Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, today announces its third quarter 2018 results.

Targovax's management will host an online presentation for investors, analysts and the press at 08:45 CET. The presentation in Norwegian can be followed here, or at: https://www.facebook.com/AXExposure/videos/279295392691286/

An English version can be found on Targovax Events & Presentations from 08:45.

For a more elaborate presentation of Targovax, please visit targovax.com for a replay of the 15 October 2018 Capital Markets Day.

HIGHLIGHTS FOR THE THIRD QUARTER 2018

  • In July, Ludwig Cancer Research and the Cancer Research Institute announced the completion of the safety evaluation for the first dose cohort in the phase I/II trial of ONCOS-102 in combination with MedImmune’s checkpoint inhibitor (CPI) Imfinzi® (durvalumab). The trial continued into the second dose cohort
  • In July, Targovax and Sotio announced that the first patient was dosed in the phase I/II combination trial in prostate cancer of ONCOS-102 with DCVAC, a dendritic cell immune-therapy
  • In September, Targovax announced interim response rate and immune activation results for the first six patients in the phase I combination trial of ONCOS-102 and Keytruda® in checkpoint inhibitor refractory melanoma, including one patient with a complete response
  • In September, Targovax announced publication of new ONCOS-102 in vivo data in the Journal of Medical Virology, showing T-cell activation in a mesothelioma model
  • In September, Targovax announced the appointment of Torbjørn Furuseth as Chief Financial Officer, with Erik Digman Wiklund transitioning to the role of Chief Business Officer

POST-PERIOD HIGHLIGHTS

  • In October, the Company reported the full data set from the TG01 trial in resected pancreatic cancer, including encouraging disease-free survival data
  • In October, the Company hosted a Key Opinion Leader Symposium on oncolytic viruses in New York City, with speakers from Memorial Sloan Kettering Cancer Centre
  • In October, the Company hosted a Capital Markets Day in Oslo, Norway, and provided an update on the TG program development strategy

Øystein Soug, CEO commented: “Targovax has made great progress in 2018. We have four ongoing clinical trials with our lead clinical product, ONCOS-102, and we reported interim response rate and immune activation data from the trials in mesothelioma and checkpoint inhibitor refractory melanoma. In particular, it was encouraging to see a complete response so early in the melanoma trial, which makes us confident that ONCOS-102 has the potential to provide an important future benefit for difficult-to-treat CPI refractory patients. We are now planning to expand the dosing to fully unlock that potential.

The results from the TG01 trial in resected pancreatic cancer have now also been fully analyzed. We see a very encouraging signal of efficacy, compared to historical control, both in terms of disease-free survival and overall survival. Whilst the ONCOS oncolytic virus program will remain our priority, we plan to continue and expand the TG development program. Based on the TG01 data, several academic groups have expressed interest in sponsoring pancreatic cancer combination trials with the TG vaccine. In addition, we will seek to combine TG vaccination with a checkpoint inhibitor in a small proof-of-concept trial.”

Reporting material

Targovax third quarter 2018 report

Targovax third quarter 2018 presentation

The quarterly report and presentation are also available at the website www.targovax.com.

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com

Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no

Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax@fticonsulting.com

About Targovax

Activating the patient's immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It has been shown to activate the immune system to generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced both local and systemic innate and adaptive immune activation, which has been associated with clinical benefit. ONCOS-102’s lead indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial, with a phase Ib safety lead-in cohort. Another trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients.

Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS - mutations known to drive cancer. The TG vaccine program has shown a signal of efficacy compared to historical control in a 32-patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested as monotherapy and will also be tested in combination with KEYTRUDA® (an anti-PD1 check point inhibitor, CPI).