Press Release - November 5, 2015
Heidelberg, Germany, November 5, 2015 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today announced that two of the Company’s abstracts have been chosen for poster presentations at the 57th annual American Society of Hematology (ASH) conference, being held December 5-8, 2015 in Orlando, Florida.
Abstract #2747
Title: “CD30/CD16A TandAb AFM13-Induced Target Cell Lysis by NK-Cells is Enhanced by CD137 Co-Stimulation and Blocking PD-1”
Session Name: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents Date, Time & Location: Sunday, Dec 6, 6:00 p.m. – 8:00 p.m., Hall A
Abstract #2763
Title: “In Vitro and In Vivo Characterization of CD19/CD3 TandAb AFM11 and CD19/CD16A TandAb AFM12 Targeting NHL”
Session Name: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents Date, Time & Location: Sunday, Dec 6, 6:00 p.m. – 8:00 p.m., Hall A
AFM13 is a first-in-class bispecific NK-cell TandAb, which binds NK-cells (natural killer cells) specifically via CD16A and has a second binding domain for CD30, a cancer-specific target. CD16A is expressed on NK-cells, highly potent cytotoxic effector cells of the innate immune system, enabling AFM13 to selectively bind these effector cells. AFM13 redirects the NK-cells to CD30-expressing cancer cells and binds both targets with high affinity, establishing a bridge whereby the NK-cells are activated and redirected to kill the cancer cells. AFM13 is designed to treat CD30-positive malignancies including Hodgkin lymphoma (HL) and T-cell lymphoma (TCL) and is currently in phase 2 studies in HL patients. Like all TandAbs, AFM13 is a stable, off-the-shelf, targeted immunotherapeutic which does not require continuous infusion due to a favorable half-life in a patient’s bloodstream, yet is tunable by dosing adjustment when required. This highly specific NK-cell antibody and the related bispecific platform are unique to Affimed.
AFM12 is a bispecific NK-cell TandAb, which binds NK-cells specifically via CD16A and has a second binding domain for CD19, a target on cancer cells. CD16A is expressed on NK-cells, highly potent cytotoxic effector cells of the innate immune system, enabling AFM12 to selectively bind these effector cells. AFM12 redirects the NK-cells to CD19- expressing cancer cells and binds both targets with high affinity, establishing a bridge, whereby the NK-cells are activated and redirected to kill the cancer cells.
AFM11 is a bispecific T-cell TandAb, which binds T-cells specifically via CD3 and has a second binding domain for CD19, a target on cancer cells. T-cells are highly potent cytotoxic effector cells of the adaptive immune system. They have the ability to proliferate when activated, thereby amplifying and accelerating their cytotoxic activity. AFM11 redirects these effector cells to CD19 expressing cancer cells and binds to both targets, CD3 and CD19, with high affinity, thereby activating and redirecting the T-cells to kill the cancer cells. CD19 is expressed at an abnormally high level in all B-cell malignancies and AFM11 is specifically designed to treat these B-cell malignancies including Non-Hodgkin lymphoma. AFM11 is currently in phase 1 clinical development. Like all TandAbs, AFM11 is a stable, off-the-shelf, targeted immunotherapeutic which does not require continuous infusion due to a favorable half-life in a patient’s bloodstream, yet is tunable by dosing adjustment when required.
Affimed develops TandAbs and Trispecific Abs to substantially increase the efficacy, specificity and/or extend the therapeutic window of current therapeutics. TandAbs and Trispecific Abs are a new generation of proprietary, tumor-cell engaging antibodies with a tetravalent architecture characterized by four binding domains. These tetravalent molecules bind to tumor and immune cells with high affinity. Although generation of such complex antibodies is very challenging, Affimed has succeeded in producing them economically and at high quality. Leveraging this expertise, Affimed has implemented three platform technologies:
Affimed’s TandAbs have already demonstrated promising signs of therapeutic activity in patients and robust and efficient production processes for these highly stable molecules have been established in mammalian cell systems. Affimed’s Trispecific Abs, which target two distinct tumor epitopes and engage T- or NK-cells to lyse the tumor cells that express both targets, are validated preclinically.
Affimed (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. Affimed’s product candidates are being developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. The most potent cells of the human defense arsenal are types of white blood cells called natural killer cells, or NK-cells, and T-cells. Affimed’s proprietary, next-generation bispecific antibodies, called TandAbs for their tandem antibody structure, are designed to direct and establish a bridge between either NK-cells or T-cells and cancer cells, triggering a signal cascade that leads to the destruction of cancer cells. Affimed has focused its research and development efforts on three proprietary TandAb programs for which it retains global commercial rights. For more information, please visit www.affimed.com.
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates our intellectual property position, our collaboration activities, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Caroline Stewart, Head IR & Communication
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Anca Alexandru or Gretchen Schweitzer
MacDougall Biomedical Communications
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