Full Press Release Details
Copenhagen, Denmark and Lausanne, Switzerland, October 30,
Genmab A/S (Nasdaq: GMAB) and ADC Therapeutics SA
(NYSE: ADCT) today announced that they have executed an amended agreement for ADC Therapeutics to continue the development and
commercialization of camidanlumab tesirine (Cami).
The parties first entered into a collaboration and license agreement
in June 2013 for the development of Cami, an antibody drug conjugate (ADC) which combines Genmab's HuMax -TAC
antibody targeting CD25 with ADC Therapeutics' highly potent pyrrolobenzodiazepine (PBD) warhead technology. Under the terms
of the 2013 agreement, the parties were to determine the path forward for 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 Hodgkin lymphoma patients in this trial who had received a median of five
prior lines of therapy.
Cami is currently being evaluated in a 100-patient pivotal Phase
2 clinical trial intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration
(FDA). The trial is more than 50 percent enrolled and ADC Therapeutics anticipates reporting interim results in the first half
"We have a long-standing relationship with the ADC Therapeutics
team and believe they are an ideal partner for the ongoing development and potential commercialization of Cami," said Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to the continued advancement of this CD25-targeted
"We are delighted to have reached an agreement with Genmab
which will allow ADC Therapeutics to leverage the hematology-focused commercial organization we are building in the U.S. for our
lead program loncastuximab tesirine (Lonca) in non-Hodgkin lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics.
"When we started collaborating with Genmab on the development of Cami in 2013, ADC Therapeutics was a startup. Since that
time, our team has grown significantly to encompass all aspects of ADC research and development. The U.S. commercial organization,
including a hematology sales force, that we are establishing will position us strongly for the commercialization of Cami, if approved."
Under the terms of the amended and restated license agreement,
the parties have agreed to eliminate the defined divestment process which was agreed in 2013 and that envisaged, among other things,
offering the opportunity for third parties to continue the development and commercialization of Cami. The parties have also agreed,
among other things, that Genmab will convert its economic interest in Cami into a mid-to-high single-digit tiered royalty on net
| Genmab A/S | Tel: +45 7020 2728 | Media Release no. xx |
| Kalvebod Brygge 43 | www.genmab.com | Page 1/4 |
| 1560 Copenhagen V, Denmark | CVR no. 2102 3884 | |
| LEI Code 529900MTJPDPE4MHJ122 |
About Camidanlumab Tesirine (Cami)
Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody
drug conjugate (ADC) comprised of a human monoclonal antibody that binds to CD25 (HuMax -TAC, licensed from Genmab
A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, ADCT-301 is
internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing tumor
cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring
tumor cells and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated
anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin
lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and
a Phase 1b clinical trial as monotherapy, and with a planned arm in combination with pembrolizumab, in solid tumors.
Genmab is a publicly traded, international biotechnology company
specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999,
the company is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen
Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta
(subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis
in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc)
for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO
(daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients
with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under
agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan
and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development
by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a
broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation
antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody
platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently
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 opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology
companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
About ADC Therapeutics
ADC Therapeutics SA (NYSE: ADCT) is a late clinical-stage oncology-focused
biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs)
for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience
in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights
for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled
ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor
cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory
Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.
| Genmab A/S | Tel: +45 7020 2728 | Media Release no. xx |
| Kalvebod Brygge 43 | www.genmab.com | Page 2/4 |
| 1560 Copenhagen V, Denmark | CVR no. 2102 3884 | |
| LEI Code 529900MTJPDPE4MHJ122 |
Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company's
lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory
diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint.
In September 2020, ADC Therapeutics submitted a Biologics License Application to the U.S. Food and Drug Administration seeking
accelerated approval 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 100-patient pivotal Phase 2 clinical trial
for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in
HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment
of various advanced solid tumors.
ADC Therapeutics is based in Lausanne (Biop le), Switzerland
and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/
and follow the Company on Twitter and LinkedIn.
For Media Relations:
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: acn@genmab.com
ADC Therapeutics Contacts:
Tel.: +1 917-288-7023
Tel: +41 (0) 43 268 3231
Tel.: +1 973-415-8838
| Genmab A/S | Tel: +45 7020 2728 | Media Release no. xx |
| Kalvebod Brygge 43 | www.genmab.com | Page 3/4 |
| 1560 Copenhagen V, Denmark | CVR no. 2102 3884 | |
| LEI Code 529900MTJPDPE4MHJ122 |
Forward-Looking Statements for
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 may differ materially
from any future results or performance expressed or implied by such statements. The important factors that could cause our actual
results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development
of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties