Pipeline Previews

February 2014 | Volume 13 | Issue 2 | Feature | 217 | Copyright © 2014

Abstract

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

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Agenus and Cancer Vaccine for Melanoma

Agenus Inc, a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, has announced initiation of a randomized Phase 2 trial with Prophage for melanoma, and Bristol-Myers Squibb's Yervoy® (ipilimumab) for the treatment of Stage III and IV metastatic melanoma. The combination has the potential to trigger a more effective immune response against the tumor than Yervoy alone.

The Phase 2, randomized, open label, single-center, investigator- sponsored trial is designed to evaluate the safety, feasibility and immunogenicity of the combination of Prophage vaccine and Yervoy with or without low dose cyclophosphamide (a chemotherapy agent used in this study as an immunomodulator of regulatory cells) in 25 patients with unresectable Stage III or IV metastatic melanoma. The trial will be conducted at the University of Texas Health Science Center at Houston and led by clinical investigator Jorge Quesada MD.

Agenus’ Prophage Series vaccines are tailor-made for each patient by processing tumor removed from the patient. Malignant cells express proteins, which can be recognized as non-self by the immune system. This recognition by T-lymphocytes can trigger the immune system to attack the cancerous tissue, and under favorable circumstances help the patient fight the cancer. Because each patient’s cancer cells contains their own set of genetic changes, the best chance to mount an effective immune attack on the cancer resides in stimulating the immune response to the abnormal proteins expressed in that patient’s cancer. Agenus’ heat shock protein vaccines are processed by the company and then re-introduced into the patient as a vaccine which is intended to stimulate a targeted immune attack on their cancer cells.

Prophage Series vaccines are based on Agenus’ heat shock protein platform technology. Prophage Series G-100 and G-200 vaccines are currently in Phase 2 programs for the treatment of newly diagnosed and recurrent glioblastoma multiforme.

Merck and MK-3475

Merck has started a rolling submission to the FDA of a Biologics License Application for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. The company expects to complete the application in the first half of 2014.

MK-3475 is currently being studied in three clinical trials for advanced melanoma including a Phase III trial of MK-3475 versus ipilimumab in ipilimumab-naïve advanced melanoma patients. Enrollment is complete in the advanced melanoma cohorts in the company’s Phase IB trial and the Phase II trial comparing two doses of MK-3475 versus chemotherapy in patients with advanced melanoma who have progressed after prior therapy. In April 2013, Merck announced that MK-3475 received a Breakthrough Therapy designation for advanced melanoma from the FDA.

Intralesional Bevacizumab and Locally Advanced Basal Cell Carcinoma

A study published in The Journal of European Academy of Dermatology and Venereology, and authored by G. Gaitanis, and I.D. Bassukas, seeks to report on the feasibility and effectiveness of intralesional bevacizumab, an anti-VEGF antibody, as an in-add adjuvant to immunocryosurgery (cryosurgery sessions during daily topical imiquimod application) for the treatment of locally advanced basal cell carcinoma.

Seven patients (six uncontrollable or extensive local disease; one tumour unresponsive to repeated immunocryosurgery) were treated with 1–3 sessions of intralesional injections of bevacizumab (25 mg) at the day of cryosurgery during ongoing immunocryosurgery. Follow-up after treatment was 18–48 months.

In 4 of the 7 cases tumours cleared completely and 3 out of 7 remained relapse free during follow-up. A relapsed tumour and a further case that did not clear after repeated immunocryosurgery cycles were excised with significantly reduced burden of surgery. Finally, two cases with previously locally uncontrollable BCC tumours regressed significantly and stabilized.

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