[ad_1]
Company announcement
- Genmab will not promote the development of enapotamab vedotin
- Data from expansion cohorts did not meet strict proof-of-concept criteria
- Genmab to prioritize the development of other innovative candidate products
Copenhagen, Denmark; November 24, 2020 – Genmab A / S (Nasdaq: GMAB) announced today that it will not advance the development of enapotamab vedotin. While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and / or predictive biomarkers. Consequently, the data from the expansion cohorts did not meet the stringent Genmab criteria for proof of concept.
“We are committed to developing innovative antibody products for cancer patients; however, data from the enapotamab vedotin expansion cohorts, unfortunately, do not support the advancement of this candidate product. This decision will allow us to focus more of our resources and energy on other programs in our robust next generation of pipeline antibody therapies, “said Jan van de Winkel, Ph.D., CEO of Genmab.
About Enapotamab Vedotin
Enapotamab vedotin is an AXL-targeted antibody-drug conjugate (ADC) in which the monoclonal antibody is conjugated to the antimitotic drug monomethyl auristatin E. AXL is an overexpressed signaling molecule in various hematologic and solid neoplasms. In the context of malignancy, evidence suggests that AXL overexpression drives wide-ranging processes, including epithelial to mesenchymal transition, tumor angiogenesis, resistance to chemotherapeutic and targeted agents, and decreased antitumor immune response. Enapotamab vedotin is wholly owned by Genmab and the drug linker technology used for enapotamab vedotin was licensed by Seagen Inc.
About Genmab
Genmab is a publicly traded international biotechnology company specializing in the creation and development of differentiated antibody therapies for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX® (daratumumab, pursuant to an agreement with Janssen Biotech, Inc.) for the treatment of certain indications for multiple myeloma in territories such as the US, Europe and Japan, Kesimpta® (subcutaneous ofatumumab, in agreement with Novartis AG), for the treatment of adults with recurrent forms of multiple sclerosis in the US and TEPEZZA® (teprotumumab, under an agreement with Roche that sublicensees Horizon Therapeutics plc) for the treatment of thyroid eye disease in the US A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO ™ (daratumumab and hyaluronidase-fihj) in the USA and Europe for the treatment of adult patients with certain indications for multiple myeloma. The first approved Genmab-created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain indications of chronic lymphocytic leukemia, is available in Japan and is also available in other territories through compassionate use or cancer access programs. Daratumumab is in clinical development by Janssen for the treatment of additional indications for multiple myeloma, other blood cancers, and amyloidosis. Genmab also has a wide range of clinical and preclinical products. Genmab’s technology foundation consists of patented and validated next-generation antibody technologies – the DuoBody® platform for the generation of bispecific antibodies, the HexaBody® platform, which creates enhanced antibodies with effector function, the HexElect® platform, which combines two co-dependent acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create joint or wholly owned opportunities for future products. Genmab has alliances with leading pharmaceutical and biotech companies. Genmab is based in Copenhagen, Denmark, with offices in Utrecht, the Netherlands, Princeton, New Jersey, the US, and Tokyo, Japan.
Contact:
Marisol Peron, Corporate Vice President, Communications and Investor Relations
T: +1 609 524 0065; E: [email protected]
For investor relations:
Andrew Carlsen, Senior Director of Investor Relations
T: +45 3377 9558; E: [email protected]
This company announcement contains forward-looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied in such statements. Important factors that could cause our actual results or performance to differ materially include, but are not limited to, risks associated with preclinical and clinical development of products, uncertainties related to the result, and conducting clinical trials, including safety concerns. unforeseen, uncertainties related to the product. manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the inapplicability or lack of protection of our patents and rights, our relationships with affiliated entities, changes and developments in technology that may make our products or technologies obsolete, and other factors. For more information on these risks, see the risk management sections in Genmab’s most recent financial reports, which are available at www.genmab.com and risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward-looking statements in this company release or to confirm these statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A / S and / or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO ™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.
Company announcement no. 49
CVR no. 2102 3884
LEI code 529900MTJPDPE4MHJ122
Genmab A / S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
