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Genmab and ADC Therapeutics Announce Expanded Agreement for Camidanlumab Tesirine (Cami)

Saturday, October 31, 2020

Genmab A / S and ADC Therapeutics SA announced  that they have entered into an amended agreement that will allow ADC Therapeutics to develop and commercialize Camidanlumab-Tesirin (Cami) will continue.

In June 2013, the parties entered into a collaborative and licensing agreement for the first time to develop Cami, an antibody-drug conjugate (AWK) that incorporates Genmab's HuMax ® -TAC antibody that binds to CD25 with the highly effective pyrrolobenzodiazepine warhead technology (PBD technology) from ADC Therapeutics. 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 been working with ADC Therapeutics for a long time 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 AWK targeting CD25."

“ 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 program, Loncastuximab-Tesirine (Lonca) in non-Hodgkin lymphoma "Said Chris Martin, Chief Executive Officer at ADC Therapeutics. "When we started working with Genmab to develop Cami in 2013, ADC Therapeutics was still a start-up. Since then, our team has grown significantly and is now dealing with all aspects of AWK research and development. With the US trade organization currently being set up, which also includes a hematology sales division, we will be ideally positioned for the commercialization of Cami - provided 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 offering 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), which 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. In addition, PBDs have been shown to induce immunogenic cell death. All of these properties of Cami can enhance immune-mediated anti-tumor activity.

About Genmab

Genmab is a publicly traded, international biotechnology company that specializes in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has developed the following approved antibodies: DARZALEX ® (daratumumab, under an agreement with Janssen Biotech, Inc.) for the treatment of certain indications of multiple myeloma in regions such as the United States, Europe and Japan, Kesimpta ® (subcutaneous ofatumumab , under an agreement with Novartis AG), for the treatment of adults with relapsing multiple sclerosis in the USA 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 additional indications of multiple myeloma, other blood cancers and amyloidosis. In addition, Genmab has a broad clinical and preclinical product pipeline. The technology basis of Genmab consists of validated and proprietary antibody technologies of the next generation - 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 at the same time maximizing the 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 (Netherlands), Princeton (New Jersey, USA) and Tokyo (Japan).

About ADC Therapeutics

ADC Therapeutics SA 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 ownership 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 build 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 pre-clinical AWK in development.

Loncastuximab-Tesirine (Lonca, formerly ADCT-402), the company's lead product candidate, was used in a pivotal Phase 2 clinical trial with 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 with 100 patients for the treatment of patients with relapsed or refractory Hodgkin lymphoma (HL) after a phase 1 clinical trial in HL patients at the dose selected for phase 2 resulted in an ORR of 86.5% showed. 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, Uncertainties in connection with the manufacture of products 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 suitably qualified personnel, the impracticability or 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. For more information about these risks, see the Risk Management sections of Genmab's latest financial reports available at the competitive environment in relation to our businesses and markets, our inability to attract and retain appropriately qualified personnel, the unenforceability or lack of protection of our patents and property rights, our relationships with affiliated companies, and changes and developments in technology that result in our products or technologies may become obsolete; and other factors. For more information on these risks, see the Risk Management sections of Genmab's latest financial reports available at the competitive environment in relation to our businesses and markets, our inability to attract and retain appropriately qualified personnel, the unenforceability or lack of protection of our patents and property rights, our relationships with affiliated companies, and changes and developments in technology that result in our products or technologies may become obsolete; and other factors. For more information on these risks, see the Risk Management sections of Genmab's latest financial reports available at our relationships with affiliates, 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 our relationships with affiliates, changes and developments in technology that may render our products or technologies obsolete, and other factors. For more information on these risks, see the Risk Management sections of Genmab's latest financial reports available atwww.genmab.com , as well as the risk factors in Genmab's latest Annual Report on Form 20-F and others with the 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 affiliates. DARZALEX ®and DARZALEX FASPRO ™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA ® is a trademark of Horizon Therapeutics plc.

Forward-Looking Statements for ADC Therapeutics

This press release contains statements that constitute forward-looking statements. All statements contained in this press release that are not historical facts, including statements regarding our future operating results and financial condition, our business strategy, our product candidates, our research pipeline, ongoing and planned preclinical and clinical studies, regulatory filings and approvals, addressable patient populations, Research and development costs, timing and probability of success, as well as management's plans and goals for future operations, are forward-looking statements. Forward-looking statements are based on the estimates and assumptions of our management as well as on information that is currently available to our management. Such statements are subject to risks and uncertainties and actual results could differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the US Securities and Exchange Commission. There can be no assurance that such future results will be achieved. The forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update any forward-looking statements contained in this press release to reflect changes in our expectations or changes in events, conditions or circumstances, on which these statements are based, unless we are required to do so under applicable law. No representations or warranties are made (either express or implied) as to the accuracy of such forward-looking statements.

The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. You should therefore compare the translations with the original language version of the publication.

Contacts
Contact person at Genmab:

For media:
Marisol Peron, Corporate Vice President, Communications & Investor Relations
Tel .: +1 609 524 0065; E: mmp@genmab.com

For investors:
Andrew Carlsen, Senior Director, Investor Relations
Tel .: +45 3377 9558; E: acn@genmab.com

Contact person at ADC Therapeutics:

For investors:
Amanda Hamilton
ADC Therapeutics
amanda.hamilton@adctherapeutics.com
Tel: +1 917-288-7023

For EU media:
Alexandre Müller
Dynamics Group
amu@dynamicsgroup.ch
Tel .: +41 (0) 43 268 3231

For US media:
Annie Starr
6 Degrees
astarr@6degreespr.com
Tel .: +1 973-415-8838

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