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Genmab A / S (Nasdaq: GMAB) and ADC Therapeutics SA (NYSE: ADCT) today announced that they have entered into an amended agreement whereby ADC Therapeutics will continue to develop and commercialize camidanlumab-tesirine (Cami).
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In June 2013, the parties signed a cooperation and license agreement for the first time for the development of Cami, an antibody-drug conjugate (AWK) that supports the HuMax®Genmab’s -TAC antibody that binds to CD25 combined with ADC Therapeutics’ potent pyrrolobenzodiazepine warhead (PBD) technology. Under the terms of the 2013 agreement, the parties should pave the way for the continued development and commercialization of Cami upon completion of a Phase 1a / b clinical trial. ADC Therapeutics previously announced that Cami achieved an overall response rate of 86.5%, including a complete response rate of 48.6%, in this study in patients with Hodgkin lymphoma who had received a median of five previous lines of therapy.
Cami is currently being investigated in a pivotal phase 2 clinical trial with 100 patients. The study is designed to support the filing of a BLA (Biologics License Application) application with the US FDA. The study is more than 50 percent proven, and ADC Therapeutics expects interim results in the first half of 2021.
“We have a long history of working with ADC Therapeutics and believe that this team is an ideal partner for the ongoing development and potential commercialization of Cami,” said Jan van de Winkel, Ph.D., and Chief Executive Officer at Genmab. “We look forward to the further development of the CD25 targeting AWK.”
“We are pleased to have entered into an agreement with Genmab that will enable ADC Therapeutics to leverage the hematology-focused commercial organization we are building in the United States for our main Loncastuximab-Tesirine (Lonca) program in non-Hodgkin lymphoma “comments Chris Martin, Chief Executive Officer, ADC Therapeutics. “When we started working with Genmab on the development of Cami in 2013, ADC Therapeutics was still a start-up. Since then, our team has grown significantly and now deals with all aspects of AWK research and development As the US trade organization is being set up, which also includes a hematology sales division, we will be ideally positioned for the commercialization of Cami – provided that approval is granted. ”
According to the terms of the amended and reformulated license agreement, the parties have agreed to discontinue the sale process decided in 2013. Among other things, this envisaged giving third parties the opportunity to continue the development and marketing of Cami. The parties have also agreed that Genmab will convert its economic interest in Cami into a tiered license fee in the mid to high single-digit range on net sales.
About camidanlumab-tesirine (Cami)
Camidanlumab-Tesirin (Cami, formerly ADCT-301) is an antibody-drug conjugate (AWK) that consists of a monoclonal antibody linked to CD25 (HuMax®-TAC, licensed from Genmab A / S) binds and is conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. As soon as ADCT-301 docks with a CD25-expressing tumor cell, the AWK is introduced into the cell, where enzymes release the PBD-based agent and kill the cell. This applies to both CD25-expressing tumor cells and CD25-expressing Tregs. The intra-tumoral release of the PBD “warhead” can also lead to the “bystander killing” of neighboring tumor cells. It has also been shown that PBDs induce immunogenic cell death. All of these properties of Cami can enhance immune-mediated anti-tumor activity. Cami is being used in a pivotal phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL) and in a phase 1a / 1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and in a Phase 1b clinical trial as monotherapy and with a planned arm in combination with pembrolizumab with solid tumors investigated.
Genmab is a publicly traded, international biotechnology company that specializes in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Established in 1999, the company has developed the following approved antibodies: DARZALEX® (Daratumumab, under an agreement with Janssen Biotech, Inc.) for the treatment of specific multiple myeloma indications in regions such as the US, Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under an agreement with Novartis AG), for the treatment of adults with relapsing multiple sclerosis in the United States and TEPEZZA® (Teprotumumab, under an agreement with Roche to sublicense Horizon Therapeutics plc) for the treatment of patients with thyroid-related eye disease (Graves’ disease) in the United States. A subcutaneous formulation of daratumumab, known in the US as DARZALEX FASPRO ™ (daratumumab and hyaluronidase-fihj), has been approved in the US and Europe for the treatment of adult patients with certain indications of multiple myeloma. The first therapy developed and approved by Genmab, the drug Arzerra® (Ofatumumab, under an agreement with Novartis AG), which is approved for the treatment of certain indications of chronic lymphocytic leukemia, is available in Japan and in other countries through compassionate use programs or programs available for access to oncology. Daratumumab is in clinical development at Janssen and is intended for the treatment of other indications of multiple myeloma, other blood cancers and amyloidosis. In addition, Genmab has a broad clinical and preclinical product pipeline. Genmab’s technology base consists of validated and proprietary next-generation antibody technologies – the DuoBody®-Platform for generating bispecific antibodies, the HexaBody®-Platform for the generation of antibodies with improved effector function, the HexElect®-Platform for the combination of two codependent HexaBody molecules to introduce selectivity while maximizing therapeutic effectiveness and the DuoHexaBody®Platform to improve the potential effectiveness of bispecific antibodies through hexamerization. The company intends to use these technologies to create opportunities for full or joint ownership of future products. Genmab has alliances with world-class pharmaceutical and biotechnology companies. The company is headquartered in Copenhagen, Denmark and has offices in Utrecht (The Netherlands), Princeton (New Jersey, USA) and Tokyo (Japan).
About ADC Therapeutics
ADC Therapeutics SA (NYSE: ADCT) is a late-stage clinical research biotechnology company focused on oncology and a pioneer in developing and commercializing high-potency and targeted antibody-drug conjugates (AWK) for patients with hematologic malignancies and solid tumors. The company is developing AWK based on decades of experience in the field and utilizing next generation pyrrolobenzodiazepine (PBD) technology, which ADC Therapeutics holds the proprietary rights to for its goals. The strategic target selection for PBD-based AWK and significant investments in early clinical development have enabled ADC Therapeutics to establish an in-depth clinical and research pipeline of therapies for the treatment of hematologic and solid tumors. The company is currently investigating several PBD-based antibody-drug conjugates in ongoing clinical studies – from “FIH” studies (first in human, first-time use in humans) to confirmatory phase 3 clinical studies in the US and Europe – and has numerous preclinical AWKs in development.
Loncastuximab-Tesirine (Lonca, formerly ADCT-402), the company’s lead product candidate, was shown in a pivotal Phase 2 clinical trial of 145 patients for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL “), which showed an overall response rate (ORR) of 48.3%, exceeding the intended primary endpoint. In September 2020, ADC Therapeutics filed with the U.S. Food and Drug Administration for an accelerated license application (BLA) for Lonca for the treatment of patients with relapsed or refractory DLBCL. Camidanlumab-Tesirine (Cami, formerly ADCT-301), the company’s second lead product candidate, is being evaluated in a pivotal Phase 2 clinical trial of 100 patients for the treatment of patients with relapsed or refractory Hodgkin lymphoma (HL) after a Phase 1 clinical study in HL patients showed an ORR of 86.5% at the dose selected for phase 2. The company is also evaluating Cami as a novel immuno-oncology approach to the treatment of various advanced solid tumors.
ADC is headquartered in Lausanne (Biopôle), Switzerland, and has offices in London, the San Francisco Bay Area and New Jersey. More information is available at https://adctherapeutics.com/. You can also follow the company on Twitter and LinkedIn.
Forward-looking statements for Genmab
This media release contains forward-looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance could differ materially from future results or performance expressly or implicitly mentioned 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 the preclinical and clinical development of products, uncertainties relating to the outcome and the conduct of clinical trials, including unforeseen safety issues, Imponderables in connection with product manufacture and the lack of market acceptance for our products, as well as our inability to control growth, the competitive environment in relation to our business areas and markets, our inability to attract and retain appropriately qualified personnel, the impracticability or the lack of it Protecting our patents and property rights, our relationships with affiliated companies, changes and developments in technology that may render our products or technologies obsolete, and other factors. Please refer to the Risk Management sections of Genmab’s latest financial reports available at www.genmab.com and the risk factors in Genmab’s latest Annual Report on Form 20-F and others at the for further explanation of these risks US Securities and Exchange Commission (SEC), available at www.sec.gov. Genmab undertakes no obligation to update or revise any forward-looking statements in this news release or to confirm such statements to reflect subsequent events or circumstances after the date of publication or with respect to actual results, except as required by law.
Genmab A / S and / or its subsidiaries are the owners of 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 group companies. DARZALEX® and DARZALEX FASPRO ™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.
Forward-Looking Statements for ADC Therapeutics
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