Celsion (CLSN) Announces Data on Immunotherapy Candidate

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Celsion Corporation CLSN announced data from a preclinical study on its immunotherapy candidate, GEN-1 IL-12, in combination with Avastin and Doxil for the treatment of ovarian cancer.

GEN-1 is Celsion’s DNA-based immunotherapy. The company conducted the study to evaluate the efficacy of a combined treatment regimen that consisted of weekly administrations of GEN-1 with therapeutically relevant doses of Doxil and Avastin in a mouse model.

Results from the study showed that the combination of GEN-1 with Avastin and Doxil resulted in a 98% reduction in tumor burden when compared to the untreated control group in a SKOV3 human cell line implanted into immunocompromised (nude) mice.

Celsion is currently enrolling patients in a dose-escalating phase Ib study, OVATION, in newly diagnosed ovarian cancer patients. The trial combines GEN-1 with neo-adjuvant therapies. The aim of the trial is to ascertain a starting dose for the follow-on phase I/II study, which combines GEN-1 with Avastin and Doxil. The company plans to complete enrollment in the OVATION study in 2016. The phase I/II combination trial is expected to begin in mid-2016.

Celsion had also reported positive safety results from a phase I study on GEN-1 as monotherapy in patients with peritoneally metastasized ovarian cancer. Results from a phase Ib study in combination with PEGylated doxorubicin in patients suffering from platinum-resistant ovarian cancer were encouraging.

Meanwhile, GEN-1 also showed preclinical activity in glioblastoma multiforme (brain cancer). Consequently, Celsion plans to initiate a phase I study for this indication soon.

Immuno-oncology has been in focus of late as most leading pharmaceutical companies continue to make significant investments for the development of immuno-oncology therapies.

We note that Bristol-Myers Squibb’s BMY immune-oncology drug, Opdivo, is approved for the treatment of metastatic squamous non-small cell lung cancer and unresectable or metastatic melanoma.

Celsion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are AbbVie Inc. ABBV and Novo Nordisk A/S NVO. Both have a Zacks Rank #2 (Buy).

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