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Agenus Value Stock - Dividend - Research Selection


ISIN: US00847G7051 , WKN: A1JLKZ

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Description of the company

We are a clinical-stage immuno-oncology (“I-O”) company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer. Our approach to cancer immunotherapy involves a diverse portfolio consisting of antibody-based therapeutics, adjuvants and cancer vaccine platforms. We, in collaboration with our partners, have developed a number of immuno-modulatory antibodies against important nodes of immune regulation. These include antibodies targeting CTLA-4, GITR and OX40 that are in clinical development, and our anti-PD-1 antibody anticipated to enter the clinic in the first half of 2017. Our discovery pipeline includes a number of proprietary checkpoint modulating (“CPM”) antibodies against innovative targets such as TIGIT and 4-1BB (also known as CD137). We believe that tailored combination therapies are essential to combat some of the most resistant cancers. Accordingly, our immune education strategy focuses on pursuing antibodies as well as vaccine candidates in conjunction with adjuvants. We believe we are uniquely positioned to treat cancers because we have a portfolio of product candidates and technologies that spans across these multiple therapeutic categories.


We are a vertically integrated biotechnology company equipped with a suite of technology platforms and a good manufacturing practice (“GMP”) manufacturing facility with the capacity to support early phase clinical programs. In addition to our broad and synergistic pipeline, we have established a world-class I-O research and clinical development team, including experts that have contributed to the development, in-licensing and registrational trajectory of staple antibody therapeutics such as Yervoy®, Avelumab and Humira®, among others.


Our common stock is currently listed on The Nasdaq Capital Market under the symbol “AGEN.”



Our Vision

We envision combination therapies as the cornerstone of future oncology treatment regimens. In addition, we believe that a balanced portfolio of product candidates should focus on both validated targets as well as more novel, innovative targets. CTLA-4 and PD-1 antagonists have recently been recognized as the first clinically validated immunotherapy combination. Based on this finding, we believe that these two antibodies acting in combination, as well as other more innovative immuno-modulatory antibodies or immune education approaches, could be a focal point of the next generation of I-O combinations. Thus, we plan to pursue our proprietary PD-1 and CTLA-4 antibody programs aggressively through the clinic, and follow on with future combination therapies that integrate our cancer vaccine platforms as well as our antibodies against novel targets. One of our core visions is to substantially expand the small patient populations that benefit from existing immune-based therapies.


Our Strategy

The breadth of our portfolio gives us the ability to combine our antibodies, vaccines, and adjuvants to explore and optimize cancer treatments. Our strategy is to develop these agents either alone or in combinations to yield best-in-class treatments. In addition, our clinical development strategy is tailored to achieve our goal of becoming a commercial organization in the next four years. We are pursuing a tiered risk profile and targeting compressed timelines for regulatory filing. We plan to adopt a rapid and de-risked path to registration by co-targeting PD-1 and CTLA-4 in indications where blockade of these checkpoints has been found efficacious. In addition, we plan to pursue novel breakthrough indications to further expedite market entry. Second line cervical cancer is one such indication where we believe there is a niche opportunity in certain markets. In addition, our programs are anticipated to pose moderate regulatory risk and will entail: 1) pursuit of optimal I-O antibody and vaccine combinations with CTLA-4 and/or PD-1 targeted antibodies as the backbone; 2) advancement of our antibody programs against innovative targets, such as 4-1BB and TIGIT, to the clinic alone or in combination with other products in our pipeline; and 3) continued advancement of vaccine candidate opportunities. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.


Our Assets

Our I-O assets include antibody-based therapeutics, adjuvants and cancer vaccine platforms. We believe that we are the third company, along with Bristol-Myers Squibb (“BMS”) and AstraZeneca, to have a CTLA-4 checkpoint inhibitor in the clinic. Once our PD-1 antagonist is in clinical development, we could be the only company, other than BMS, to feature both CTLA-4 and PD-1 assets in its clinical pipeline. To complement our portfolio of foundational CPMs, we have a number of antibody programs against more innovative targets involved in immune modulation. These include 4-1BB and TIGIT as well as a number of undisclosed targets with a potential to be best-in-class or first-in-class antibody-based therapeutics. We also have three proprietary cancer vaccine platforms: Prophage™ vaccine, AutoSynVax™ vaccine (“ASV”) and PhosphoSynVax™ vaccine (“PSV”). Additionally, our autologous (Prophage) and synthetic (ASV™ and PSV™) vaccine candidates are protein complexes that consist of heat shock proteins (“HSPs”) and peptides that are either tumor-derived or tailor-made based on the unique genomic fingerprint of a patient’s tumor, respectively. Highlighting our combination treatment approach, a Phase 2 clinical trial sponsored by the National Cancer Institute (“NCI”) is currently in progress to evaluate the efficacy of Prophage in combination with Merck’s PD-1 antagonist, Keytruda®, in patients with newly diagnosed glioblastoma (“ndGBM”). Our QS-21 Stimulon adjuvant is partnered with GlaxoSmithKline plc. (“GSK”) and is a key component in multiple GSK vaccine programs that have a prophylactic or therapeutic impact in a variety of infectious diseases and cancer.


Our Antibody Discovery Platforms and CPM Programs

Checkpoint antibodies regulate immune response against pathogens that invade the body and are achieving positive outcomes in a number of cancers that were untreatable only a few years ago. Two classes of checkpoint targets include:


1. inhibitory checkpoints that help suppress an immune response in order to prevent excessive immune reaction resulting in undesired inflammation and/or auto-immunity, and

2. stimulatory checkpoints that can enhance or amplify an antigen-specific immune response.

We possess a suite of antibody discovery platforms that have enabled us to improve the speed, cost and quality of our product development efforts. In addition to the use of our antibody discovery platforms that are designed to drive the discovery of future CPM antibody candidates, we are planning to employ a variety of techniques to identify and optimize our antibody candidates. For example, while we have been primarily focused on monoclonal antibodies over the past two years, we are beginning to explore multispecific antibody technologies, collaborations, and product candidate opportunities.

In April 2016, we presented preclinical data at the American Association for Cancer Research (“AACR”) conference for our anti-CTLA-4 programs, AGEN1884 and AGEN2041 (both partnered with Recepta Biopharma SA (“Recepta”) for certain South American territories). The presentations covered preclinical pharmacology for each antibody, including detailed studies that demonstrate AGEN1884 and AGEN2041 bind to CTLA-4 expressed on T cells and potently block engagement of CD80 and CD86, leading to enhanced T cell responsiveness. We also reported data that AGEN1884 or AGEN2041 augmented vaccine response in primates. This finding demonstrates that both antibodies are functional and we believe exemplifies their utility in combination with therapeutic cancer vaccines. In 2017 at AACR, we plan to present evidence that our clinical-stage CTLA-4 antagonist (AGEN1884) combines effectively with our clinic-ready PD-1 antagonist antibody (AGEN2034) and other antibodies targeting the PD-1/PD-L1 axis to promote superior T cell immune responses compared to either monotherapy. Furthermore, in mice a surrogate CTLA-4 targeted antibody augments vaccine-induced immune responses when combined with our ASV vaccine candidate. In April 2016, we also announced that the first patient had been dosed in our Phase 1 clinical trial of AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. In 2017, we plan to initiate combination trials with our clinical stage CTLA-4 and PD-1 antagonists and define the optimal dose of the combination for pivotal trials.

In the past year there has been third party validation of the clinical benefit of antibody combination approaches, most specifically the importance of targeting CTLA-4 as the backbone of these combination strategies. Regimens involving lower and less frequent dosing of CTLA-4 antibody in combination with PD-1 inhibitors have been shown to yield more pronounced clinical efficacy than either agent alone. Importantly, this was achieved without the added toxicity. Many experts believe that the combination of CTLA-4 antibodies with PD-1 blockade using a tolerable dosing regimen is a foundational I-O regimen. We expect our anti-PD-1 antibody candidate, AGEN2034, to enter the clinic in the first half of 2017.

We are planning to develop our anti-PD-1 antibody as a monotherapy as well as in combination with our anti CTLA-4 antibody in second line cervical cancer. Chemoradiation therapy is the current standard of care for earlier lines of treatment. In distant metastatic patients, platinum based chemotherapy, with or without bevacizumab, is the current standard of care. However, there are no established therapies for second line cervical cancer and the five-year survival rate of recurrent/metastatic cervical cancer is 16.8%. Cervical cancer is a malignancy that is driven by the persistent infection by certain types of human papilloma virus (“HPV”). Anti PD-1/PD-L1 have shown to be active in virally induced disease and, specifically, HPV induced squamous cell cancer of the head and neck. In these tumors, anti PD-1 blockade might induce objective responses as well as prolongation of survival.

In addition to pursuing validated targets, our discovery pipeline also includes a number of antibody programs against innovative immunomodulatory targets such as TIGIT and 4-1BB (also known as CD137). 4-1BB is a co-stimulatory molecule involved in mediating recruitment of immune infiltrates into the tumor microenvironment. We have selected a lead agonist that targets this molecule, which exhibits compelling pharmacologic properties and could confer clinical advantages and poise this molecule to be a best-in-class therapeutic. TIGIT is a co-inhibitory checkpoint expressed on innate and adaptive immune cell populations. Preclinical models indicate that antibody-mediated TIGIT blockade not only serves to stimulate lymphocyte activation and cytotoxic activity, but also synergizes with PD-1/PD-L1 inhibition to promote anti-tumor immunity. We have selected a lead molecule for this target that is advancing through preclinical development.


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