Press Release - May 24, 2015
Heidelberg, Germany, March 24, 2015 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing targeted cancer immunotherapies today announced the achievement of the second milestone in its development partnership with Amphivena Therapeutics, Inc. (Amphivena). The milestone represents the development candidate selection against an undisclosed target for the treatment of a certain hematologic malignancy. Affimed, which has a two-fold relationship with Amphivena as both investor and licensor, is due to receive a milestone payment of €7.5 million from Amphivena which will be paid in three installments. In addition, in its role as Amphivena shareholder, Affimed will invest its third and last tranche of €0.32 million ($0.36 million).
TandAbs are tetravalent, bi-functional molecules that selectively bind to a tumor antigen on a cancer cell and, through a second specific binding site, also bind to immune effector cells (NK-cells or T-cells), bringing cancer and immune cells into close proximity. This activates the immune effector cell and enables it to eliminate the cancer cell. In its collaboration with Amphivena/Janssen Biotech, Inc. (Janssen), Affimed has first generated antibodies and subsequently bispecific T-cell TandAbs. Achieving the next milestone, the final development candidate for entering IND-enabling studies was selected.
“Our TandAb platform is the basis for antigen-specific immunotherapies which have the potential to establish new treatment paradigms for various cancers” said Adi Hoess, PhD, CEO of Affimed. “Our achievements in this collaboration underscore the strength of Affimed’s TandAb technology to reliably produce development candidates that meet highest selection criteria and may ultimately lead to novel medicines for seriously ill patients.”
In July 2013, Amphivena received a commitment of €12.47 million ($14 million) in equity financing from MPM Capital, Aeris Capital and Affimed. Separately, Amphivena entered into an agreement with Janssen that grants Janssen the exclusive right, at Janssen’s discretion, to acquire Amphivena following IND approval upon pre-negotiated terms and conditions set forth in the agreement. Janssen has provided Amphivena with an initial upfront payment plus additional contingent payments based on reaching predetermined milestones in return for its rights under the agreement. Amphivena uses the proceeds for the pre-clinical development of a novel therapy for a hematological disorder based on Affimed’s proprietary TandAb antibody technology. Affimed has entered into a license and development agreement with Amphivena for the discovery and pre-clinical development of the novel TandAb-based therapy.
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 N.V. (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.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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 are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the risk of cessation or delay of any of the ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, regulatory oversight, product commercialization, intellectual property claims, 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.
Adi Hoess, CEO
Phone: +49 6221 65307-0