Shares in Immunicum AB surged more than 40 percent Monday on promising signals from a Phase I/II trial of its kidney cancer vaccine, Intuvax.
The optimism is based on preliminary data from a very small-scale study. The open-label trial recruited just 12 patients with metastatic renal cancer – and it will not report fully until early next year. The last patient has just completed therapy.
Already, however, two patients who would ordinarily have poor survival prospects have attained an average of 14 months survival, and all study participants remain alive. The Gothenburg, Sweden-based company said that high-risk patients would ordinarily live for just five months without treatment, or for eight months if treated with therapies such as Sutent (sunitib malate), the multiple receptor tyrosine kinase inhibitor marketed by Pfizer Inc., of New York.
The study recruited both high-risk patients and those with an intermediate level of risk. Most have been not been followed sufficiently long enough to allow any firm conclusions to be drawn about the impact of the therapy, but the news so far is positive."We have some good indications that the immune system is activated against the cancer," Immunicum CEO Jamal El-Mosleh told BioWorld Today. "We've seen a massive infiltration of CD8+ T-cells in the primary tumors. Also, we've not seen any of these T-cells infiltrating healthy tissue." None of the patients has exhibited any adverse effects, he added.
The primary endpoint of the study is safety – it was a first-in-human study for the technology – but survival and markers of immune response are also being followed.
Intuvax comprises a preparation of allogeneic dendritic cells obtained from healthy donors, which is injected intra-tumorally following an ex-vivo, proprietary processing step. The cells are alive, but their function is to stimulate the recipient's immune response, not to present antigens. "We have the antigens in vivo, in the patient's tumor," El-Mosleh said.
The company has various ways of processing the cells, but the basic cancer vaccine is applicable to any solid tumor indication. The therapy is based on some 20 years of research on the factors underpinning organ transplant rejection. (See BioWorld International, Nov. 30, 2011 .)
The company has received clearance from Sweden's Medical Products Agency (Läkemedelsverket) to commence a Phase I/II trial in liver cancer, which will get under way late this year or early next year. "First read-out will probably be around six months after we initiate the study, or even a little bit later," El-Mosleh said. The company is also planning to undertake a Phase II trial of Intuvax in renal cell carcinoma, although it has not yet finalized the study design.
Business development is also on the agenda. "During the fall we will intensify our partnering work," he said.
Immunicum, a spinout from Sahlgrenska University Hospital, in Gothenburg, completed a small-scale initial public offering on April 22, raising gross proceeds of SEK30.2 million (US$4.6 million) on the Nasdaq OMX First North exchange.
It priced the offering at SEK8 per share. The small-cap stock (STOCKHOLM:IMMU) ended the day at SEK16.40, a gain of 42.6 percent.
The company has raised SEK46 million since its formation in 2007, El-Mosleh said, and it has enough funding to complete the present trial and the planned liver cancer study.