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Argos Therapeutics Announces Pilot Clinical Trial of AGS-003 as Neoadjuvant Immunotherapy for Localized Renal Cell Carcinoma

On August 10, 2015 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported the initiation of a single-center pilot clinical trial of AGS-003 as a neoadjuvant immunotherapy in patients with localized renal cell carcinoma (Press release, Argos Therapeutics, AUG 10, 2015, View Source [SID:1234507122]). The study is being conducted at Roswell Park Cancer Institute (RPCI) in Buffalo, New York, and is designed to enroll a maximum of ten patients who will be treated with AGS-003 before nephrectomy in order to assess immune system response and tumor effects.

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"There is tremendous potential for approaches that use the body’s own defense mechanisms to treat cancer, and we are dedicated to advancing promising approaches in this rapidly expanding area of cancer research," said Thomas Schwaab, MD, PhD, chief of strategy, business development & outreach, associate professor in the departments of urology and immunology and urology clinic director at Roswell Park Cancer Institute and principal investigator for the AGS-003 pilot study. "AGS-003 has shown strong potential in trials targeting metastatic renal cell carcinoma, and we look forward to advancing research to determine whether this therapy can help the body build an effective immune response to kill tumor cells in patients with localized disease. The goal is to develop a treatment that will interrupt the cancer’s progression before it has a chance to spread to additional organs."

AGS-003 is an autologous dendritic-cell-based immunotherapy designed to induce a memory T-cell response specific to each patient’s unique tumor antigens. It is produced using a small sample from a patient’s own tumor and dendritic cells derived from a leukapheresis procedure. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable-risk metastatic renal cell carcinoma patients. Argos is evaluating AGS-003 in the pivotal phase 3 ADAPT trial in combination with standard targeted therapy for the treatment of metastatic renal cell carcinoma. The ADAPT trial is fully enrolled; interim data analyses are expected next year, with final data expected in the first part of 2017.

The pilot study is in patients with localized renal cell carcinoma, who must be eligible to undergo a partial or radical nephrectomy. Patients will receive five weekly doses of AGS-003 prior to surgery and will remain in the study for approximately six months.

"With this pilot study, for the first time we will be able to assess the effects of AGS-003 in patients with kidney cancer that has not spread to nearby lymph nodes or other parts of the body," said Charles Nicolette, chief scientific officer and vice president of research and development at Argos Therapeutics. "It is also an important opportunity to manufacture AGS-003 using a needle biopsy procedure for tumor collection prior to surgery and to directly study immune changes within the primary tumor before and after administration of AGS-003."

To learn more about the clinical research study, call 1-877-ASK-RPCI (1-877-275-7724) or send an e-mail to [email protected].

Dr. Schwaab was also recently named to Argos’ inaugural Scientific Advisory Board and receives compensation from Argos for this service.

Sanofi, Evotec and Apeiron Biologics Enter Collaboration To Develop Novel Small Molecule Immuno-Oncology Treatments

On August 10, 2015 Sanofi reported that it has entered a research collaboration and license agreement with Evotec and Apeiron Biologics to discover and develop first-in-class small molecule-based immuno-oncology therapies to treat solid and hematological cancers by enhancing the anti-tumor activity of the human immune system (Press release, Sanofi, AUG 9, 2015, View Source [SID:1234507179]).

"Immuno-oncology has emerged as a particularly promising field to create potentially curative treatment options for many cancer patients," said Victoria Richon, Vice-President and Head of Cancer Research, Discovery and Early Development for Sanofi. "Partnering with Evotec and Apeiron Biologics will significantly advance our shared vision toward realizing the full value of these innovative small molecule treatments."

Based on Evotec’s technological expertise and Apeiron Biologics’ experience with immunology, the new collaboration will focus on the identification of novel small molecules and their targets to develop next-generation therapies in immuno-oncology. These treatments are expected to complement currently available checkpoint inhibitors. The collaboration is based on the initial successful outcome of a phenotypic high throughput screen of potential compounds for development that was commissioned by Apeiron Biologics and conducted by Evotec. Under the collaboration, Sanofi has the option of screening its own compound libraries to identify new small molecule candidates for development.

"We are pleased and proud that our joint efforts in immuno-oncology with Apeiron have led to this partnership with Sanofi," said Dr. Werner Lanthaler, Chief Executive Officer of Evotec. "The collaboration is a great example of an efficient translation from early-stage research to pharma development."

"It is encouraging to see that our work, even at an early stage, can attract interest from one of the world’s leading, large biopharmaceutical companies," said Dr. Hans Loibner, Chief Executive Officer of Apeiron Biologics. "We look forward to applying all the different skills and resources bundled in this collaboration for the benefit of this treatment concept and ultimately for the benefit of patients."

Under the terms of the agreement, Sanofi will have sole responsibility for all development, regulatory, commercial and manufacturing activities of the products resulting from the collaboration. Sanofi will support two years of funding for Evotec and Apeiron to conduct the research program, which will include potential early success milestone payments. Upon continuation, as decided by Sanofi, Evotec will be entitled to receive further development, regulatory and commercial milestone payments, which could total more than €200 million, and royalties on net sales.

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Argos Therapeutics Announces Pilot Clinical Trial of AGS-003 as Neoadjuvant Immunotherapy for Localized Renal Cell Carcinoma

Sanofi, Evotec and Apeiron Biologics Enter Collaboration To Develop Novel Small Molecule Immuno-Oncology Treatments

10-Q – Quarterly report [Sections 13 or 15(d)]

10-Q – Quarterly report [Sections 13 or 15(d)]

10-Q – Quarterly report [Sections 13 or 15(d)]