Gothenburg, Sweden, March 10, 2016 - Immunicum AB (publ), striving to develop sophisticated, safe and efficient therapeutic cancer treatments with powerful and long lasting immune responses, today announced an update on the Company's Phase I/II trial in liver cancer. The Company also announced that the first patient in the extended part of the study has been treated in the first-line setting with the cancer immune primer INTUVAX.
As has been previously announced, Immunicum initiated a Phase I/II study (IM-102) in liver cancer in October 2013. Patients that previously failed on first-line treatments began second-line treatment with the cancer immune primer INTUVAX. No serious side effects have been related to the vaccine. All patients had experienced tumor progression (tumor growth) after conventional first-line treatment (local chemoembolization or systemic treatment with Sorafenib) before they were put on treatment with INTUVAX. Two of the study patients, however, had a very rapid disease-progression before the first vaccine dose and, as a result, died before the second respectively the third dose could be given.
"We are very pleased with our initial results. Eleven patients diagnosed with primary hepatocellular carcinoma (HCC) have so far been treated with INTUVAX in the second-line setting. Nine of those patients received all three scheduled INTUVAX doses and five of those patients have passed their expected median survival date", commented Jamal El-Mosleh, CEO of Immunicum. "We can also report that four of the nine fully treated patients are still alive, and that three of these have not yet passed their expected median overall survival" continued Mr. El-Mosleh.
Additionally, as has been previously announced, Immunicum has received approval from the Medical Products Agency to expand the study by including up to an additional six patients in the study. These patients are approved to receive INTUVAX as first-line treatment, in combination with local chemoembolization of the tumor or the tyrosine kinase inhibitor Sorafenib.
Immunicum today also announced that the first patient in the extended part of the Phase I/II trial in liver cancer has been treated with the Company's cancer immune primer INTUVAX as first-line treatment in combination with standard treatment protocols.
As was previously announced, Immunicum also treated a patient with bile duct cancer, first wrongly diagnosed with primary liver cancer. The patient has been treated with three doses of INTUVAX and has also received standard treatment with gemcitabin (G), which is known to inhibit the immunosuppressive cells in tumors, in combination with cisplatin (C). This patient is still alive 25 months after the first vaccination, compared with an expected average median overall survival of 11.7 months in patients with bile duct cancer treated with G/C (Valle et al N Engl J Med 2010: 362 : 1273).
"We look forward to the opportunity to give INTUVAX as first-line treatment in combination with particularly Sorafenib since Sorafenib is known to be able to dampen immunosuppression by reducing the number of myeloid suppressor cells in the bone marrow, blood and liver tumors in mouse models. Just as INTUVAX appears to work synergistically with Sunitinib in our Phase I/II study in renal cancer, and with gemcitabin and cisplatin in the treated patient with bile duct cancer, we believe that INTUVAX in combination with Sorafenib can generate a synergistic anti-tumor effect in patients with liver cancer", says Immunicum's Chief Scientific Officer, Alex Karlsson-Parra.
For further information, please contact:
Jamal El-Mosleh, CEO, Immunicum
Phone: +46 (0) 31 41 50 52
Immunicum's Certified Adviser is Redeye AB
Phone: +46 (0) 8 545 013 31. www.redeye.se
INTUVAX is a cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated white blood cells, so called dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells is expected to lead to an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T lymphocytes.
About Immunicum AB (publ)
Immunicum AB (publ) develops cancer immune primers for the treatment of tumor diseases. A clinical phase II trial for the Company's most advanced product - INTUVAX® against kidney cancer - has been initiated. The project portfolio contains an additional clinical phase I/II study in liver cancer and an upcoming clinical phase I/II study in gastrointestinal stromal tumors (GIST).