Affimed, founded in 2014, is a clinical-stage biopharmaceutical company focused on discovering and developing cancer immunotherapies. The Company’s research and development pipeline consists of AFM13, AFM11, AFM21, TandAb and Trispecific Ab. The Company’s product candidates are being developed in the field of immuno-oncology, which represents an approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. The Company’s bispecific antibodies, which it calls TandAbs, are designed to direct and establish a bridge between either NK-cells or T-cells and cancer cells. The Company’s TandAbs brings NK-cells or T-cells into proximity and triggers a signal cascade that leads to the destruction of cancer cells. The Company intends to initially develop its two clinical-stage product candidates in orphan or high-medical need indications, including as a salvage therapy for patients who have relapsed after, or are refractory to, that is who do not respond to treatment with, standard therapies, which is referred to as relapsed/refractory. The Company intends to establish a commercial sales force in the United States and Europe to commercialize the product candidates when and if they are approved. The Company is also conducting research with its collaborator Amphivena Therapeutics, Inc., which Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, or Janssen.
The Company’s lead candidate, AFM13, is a NK-cell TandAb designed for the treatment of certain CD30-positive (CD30+) B- and T-cell malignancies, including Hodgkin Lymphoma, or HL. AFM13 selectively binds with CD30, a clinically validated focus in HL patients, and CD16A, an integral membrane glycoprotein receptor expressed on the surface of NK-cells, triggering a signal cascade that leads to the destruction of tumor cells that carry CD30. The Company is initially developing AFM13 for HL in the salvage setting for patients who have relapsed after, or are refractory to, Adcetris (brentuximab vedotin), a CD30-focused chemotherapy approved by the United States Food and Drug Administration, or FDA, as a salvage therapy for HL.
The Company also plans to support an academic phase Ib/IIa clinical trial of AMF13 in patients with CD30+ lymphoma. The Company is performing preclinical studies investigating the combination of AFM13 with check point inhibitors, or CPIs (collaboration with Stanford University), and lenalidomide (collaboration with Mayo Clinic). The Company’s second clinical-stage candidate, AFM11, is a T-cell TandAb designed for the treatment of certain CD19+ B-cell malignancies, including non-Hodgkin Lymphoma, or NHL, Acute Lymphocytic Leukemia, or ALL, and Chronic Lymphocytic Leukemia, or CLL. AFM11 binds selectively with CD19, a clinically validated focus in B-cell malignancies. It also binds to CD3, a component of the T-cell receptor complex, triggering a signal cascade that leads to the destruction of tumor cells that carry CD19.
The Company’s third TandAb program, AFM21, is in preclinical development. AFM21 selectively binds Epidermal Growth Factor Receptor variant III, or EGFRvIII, a receptor for solid tumors and is prominent in a portion of patients with glioblastoma, hormone refractory prostate cancer and head and neck cancer. AFM21 also binds CD3, directing T-cells to destroy tumor cells that carry EGFRvIII. The Company generates its pipeline of product candidates from three platform technologies-based on its tetravalent antibody architecture characterized by four binding domains (in a TandAb, two for immune cell focusing and two for tumor cell focusing, and in a Trispecific Ab, two for immune cell focusing and one each for two distinct tumor cell focuses). NK-cell TandAbs are bispecific antibodies to bind with high affinity to a specific focus on a tumor cell and to NK-cells and thereby direct the NK-cell to eliminate the tumor cell. T-cell TandAbs are bispecific antibodies are designed to bind with high affinity to a specific focus on a tumor cell and to T-cells and thereby direct the T-cell to eliminate the tumor cell. Trispecific Abs for dual focusing of tumor cells are antibodies are designed to bind with high affinity to two different focuses on the tumor cell and to either T-cells or NK-cells and thereby direct the T-cell or NK-cell to eliminate the tumor cell.
AbCheck is the Company’s wholly owned, independently run antibody screening platform company. AbCheck combines three different technologies to supply antibodies. AbCheck offers phage display antibody libraries, yeast display and affinity maturation algorithm technologies. AbCheck works with Daiichi Sankyo, Pierre Fabre and others. The Company’s patent portfolios for its programs include AFM13, AFM11, EGFRvIII T-cell TandAb (AFM21), TandAb platform and Trispecific abs. The Company owns and controls its AFM13 (CD30 NK-cell TandAb) patent portfolio, which includes three patent families. TandAb is the Company’s engineered antibody format, and is the methods of making or using such bispecific, tetravalent domain antibodies. The second patent family on AFM13 is granted for the use of the specific focus combination for the treatment of cancer using a bispecific molecule. The Company’s third patent family relates to AFM13, the recruitment of immune effector cells via a specific receptor. The Company owns and controls the AFM11 patent portfolio for the engineered antibody format, TandAb, and on which the AFM11 compound is-based upon.
The Company’s TandAbs consist of four FV domain fragments derived from two different parent antibodies. The FV regions of one antibody bind specifically to a disease focus, such as CD30 on a tumor cell, and the FV regions of the other antibody bind specifically to receptors of an immune cell, such as an NK cell. The Company’s markets include HL and CD30-positive Malignancies, NHL, CD19-positive Malignancies and EGFRvIII-positive Malignancies. The Company’s three main product candidates include AFM13, AFM11 and AFM21.
AFM13 is a NK-cell TandAb that binds with CD30 expressing tumor cells while at the same time binding to CD16A surface proteins to activate NK-cells. AFM13 is intravenously administered in order to recruit NK-cells in peripheral blood and transport them to the tumor by binding to CD30. Adcetris delivers a toxin (monomethyl auristatin E) to the cells that carry the CD30 receptor. The Company has conducted a Phase I dose escalation clinical trial in patients with relapsed/refractory HL. The Company plans to support an investigator initiated phase Ib/IIa clinical trial of AMF13 in patients with CD30+ lymphoma.
AFM11 is a T-cell TandAb that binds with the CD19 receptor on certain tumor cells and CD3, a component of the T-cell receptor complex. CD19 is expressed on multiple B-cell malignancies, including various forms of NHL, ALL and CLL.
AFM21 selectively binds Epidermal Growth Factor Receptor variant III, or EGFRvIII, a receptor that appears to be for certain solid tumors and is prominent in a proportion of patients with glioblastoma, hormone refractory prostate cancers and head and neck cancers. AFM21 also binds CD3, directing T-cells to destroy tumor cells that carry EGFRvIII.
The Company competes with 4SC AG, Novartis AG, Gilead Sciences, MABLife, Bristol-Myers Squibb, Daiichi Sankyo, Juno Therapeutic, Bellicum and Kite Pharma.
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Please note the Technical Indicators and Fundamental Factors listed below will fluctuate as market prices change.
- 100% Technical buy signals
- Trend Spotter buy signal
- Above its 20 day moving average but above its 50 and 100 DMA
- 7 new highs and up 19.36% in the last year
- Relative Strength Index 74.21%
- Technical support level at $13.68
- Recently traded at $14.49 with a 50 day moving average of $10.54
- Market Cap: $425.38 Million
- P/E: 20.09
- EPS: $0.72
- Dividend: $0.00
- Dividend Yield: NA
- Beta: NA
- Revenue expected to grow 92.10% this year and another 77.40% next year
- Earnings estimates for the next 5 years have not been projected
- Strong Buy: 3
- Out perform: 0
- Hold: 0
- Under perform: 0
- Sell: 0
- No Opinion: 0