On December 12, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in France occurred recently, with the first French patients being dosed (Press release, Blue Earth Diagnostics, DEC 12, 2018, View Source [SID1234532031]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

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Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Detection and localization of recurrent prostate cancer is a significant unmet medical need. Today’s announcement signifies Blue Earth Diagnostics’ commitment in maximizing access to Axumin for clinicians and their patients across Europe and a key milestone towards our goal."

On December 12, 2018 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that Dr Jose Saro has been appointed as Chief Medical Officer to lead the Group’s therapeutic development strategy and drive the in-house programmes into the clinic (Press release, Avacta, DEC 12, 2018, View Source [SID1234532032]).

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Dr Saro brings over 20 years’ experience in the pre-clinical, translational and early clinical development of oncology assets, spanning small molecules, biologics and drug conjugates. Dr Saro joins Avacta from Roche where he held the role of Senior Translational Medicine Leader at the Roche Innovation Center Zurich in which he focused on immuno-oncology and the development of combination products.

Prior to his position at Roche, Dr Saro was Executive Director Oncology Global Development and Medical Affairs at Bristol Myers Squibb, based in Paris, where he led and contributed to many oncology clinical development programmes, including Sprycel, Ipilimumab (Yervoy anti-CTLA4), Nivolumab (anti-PD1), anti-PDL1, anti KIR, anti LAG3, Brivanib, MEK inhibitor and Elotuzumab.

Previously, Dr Saro was Executive Director of Translational Medicine and Early Clinical Development (Oncology) at Novartis. Prior to that, he held senior positions at Eisai, and Wyeth.

Dr Saro has also experience of the small biotech environment, having spent several years as Vice President Oncology Clinical Development at PharmaMar, an oncology focused biotech. There, he was Head of Clinical Research & Development teams, comprising approximately 45 people, located in both Madrid and Boston, MA.

Alastair Smith, Chief Executive of Avacta Group commented: "I am delighted that Dr Jose Saro is joining Avacta to lead the therapeutic development strategy and to drive the in-house Affimer programmes into the clinic. His extensive experience in developing pre-clinical assets and translating those into clinical development will be an invaluable asset to Avacta.

Jose joins Avacta at a hugely exciting time as we progress towards the first Affimer clinical studies, which is a significant value inflection point for both the technology and Group. We very much look forward to working with Jose on our established programmes and on leveraging his knowledge to expand the pipeline of innovative and valuable immuno-oncology assets for the future."

Dr Jose Saro commented: "Due to their simple structure, Affimer proteins can be formatted to deliver the right characteristics required for the next generation of immuno-oncology therapeutics.

There are many opportunities for such a platform technology, and the recent collaboration with Tufts University Medical School is one example of a potentially game changing approach that is possible with Affimers.

I am very excited to be part of Avacta as it continues to develop such transformative approaches using the Affimer platform, that I believe will be a huge benefit to many oncology patients who currently have limited therapeutic options."

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On December 12, 2018 AVEO Oncology (NASDAQ: AVEO) reported that it has entered into a clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with FOTIVDA (tivozanib), AVEO’s oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) in first-line hepatocellular carcinoma (HCC), or liver cancer, in a Phase 1/2 study (Press release, AVEO, DEC 12, 2018, View Source [SID1234532033]).

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AVEO will serve as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company. The Phase 1 portion of the study is expected to commence in 2019.

"We are thrilled to collaborate with AstraZeneca to explore another tivozanib-immunotherapy combination and look forward to understanding the potential of combining tivozanib with durvalumab in liver cancer," said Michael Bailey, president and chief executive officer of AVEO. "TKI-immunotherapy combinations have demonstrated important clinical potential across multiple tumor types, though toxicities associated with these combinations have limited their potential use. Our goal is to establish tivozanib as the TKI of choice for use with immunotherapies by demonstrating efficacy with reduced toxicity."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3, and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

About Durvalumab (IMFINZI)

Durvalumab (IMFINZI) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with immuno-oncology (IO) agents, small molecules, and chemotherapies across a range of tumors and stages of disease.

On December 12, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported the publication of a peer-reviewed paper in Cell Reports authored by Aduro scientists and Novartis collaborators as part of their ongoing research to study intratumoral stimulator of interferon genes (STING) pathway activation as a potential therapeutic approach for the treatment of cancer (Press release, Aduro Biotech, DEC 12, 2018, View Source;p=RssLanding&cat=news&id=2380389 [SID1234532015]). In this study, researchers determined an intratumoral dosing regimen of STING pathway activator, ADU-S100, optimized for adaptive immunity in mouse models. While high doses of ADU-S100 were effective at clearing injected tumors, researchers found that higher tumor ablative dosing regimens could compromise durable anti-tumor immunity. Lower immunogenic doses of ADU-S100 were shown to optimally elicit CD8+ T cell responses required for systemic and durable anti-tumor immunity, and were also found to be efficacious in combination with checkpoint inhibitor therapy.

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"We previously established that intratumoral STING pathway activation by ADU-S100 results in tumor regression in preclinical models. Our publication in Cell Reports now highlights the importance of optimizing the therapeutic dose regimen for STING agonists with the aim to balance innate and adaptive immune responses triggered by STING activation in the tumor microenvironment," stated Andrea van Elsas, Ph.D. chief scientific officer of Aduro. "Our findings support the use of immunogenic doses of ADU-S100 with checkpoint inhibitors to drive efficacious anti-tumor CD8+ T cell responses. We are encouraged by the potential of ADU-S100 as a novel treatment for cancer as we continue clinical evaluation of our lead compound in combination with checkpoint inhibitors."

The paper titled "Magnitude of Therapeutic STING Activation Determines CD8+ T-Cell Mediated Anti-Tumor Immunity," can be accessed online ahead of the print version in the peer-reviewed Journal Cell Reports.

ADU-S100 is the first STING pathway activator compound to enter the clinic and is currently being evaluated in a Phase 1 clinical trial as a single agent and in combination with ipilimumab (see www.clinicaltrials.gov, identifier NCT02675439) and in a Phase 1b combination trial with spartalizumab (PDR001), Novartis’ investigational anti-PD-1 monoclonal antibody (see www.clinicaltrials.gov, identifier NCT03172936).

About STING Pathway Activator Technology
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Natural activation of STING is not always sufficient to prevent the growth and spread of cancer cells. In preclinical models, ADU-S100 directly activates STING to further amplify the natural anti-tumor response. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

Aduro’s lead molecule, ADU-S100, is the first therapeutic in development specifically targeting STING. In collaboration with Novartis, it is being tested in a Phase 1 clinical trial as a single agent and in combination with ipilimumab, and in a Phase 1b combination trial with spartalizumab (PDR001), an investigational anti-PD-1 monoclonal antibody. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. The trials are evaluating the ability of ADU-S100 to activate the immune system and recruit specialized immune cells to attack the injected tumor, leading to a broad immune response that seeks out and kills distant metastases.