GEN Genmab A/S

Genmab Announces Data to be Presented at 2020 ASH Annual Meeting

Genmab Announces Data to be Presented at 2020 ASH Annual Meeting

Media Release





Copenhagen, Denmark, November 4, 2020

  • More than 40 abstracts on Genmab owned and partnered programs scheduled for presentation at ASH
  • Data from ongoing Phase I/II epcoritamab trial accepted for oral presentation
  • Daratumumab featured in five oral presentations with a total of 37 accepted abstracts, including ISS (Investigator Sponsored Studies) and Market Access abstracts
  • Genmab to host virtual 2020 ASH data review meeting December 8



(Nasdaq: GMAB) announced today that more than 40 abstracts related to Genmab owned and partnered programs were accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting taking place virtually December 5-8.
Abstracts accepted for presentation include data from the ongoing Phase I/II trial of epcoritamab in B-cell non-Hodgkin lymphomas, which will be presented during an oral session of the conference. Accepted abstracts also include pre-clinical data from Genmab’s next generation CD38 antibody, HexaBody®-CD38 and updates on multiple daratumumab clinical trials. In addition, data for teclistamab and talquetamab, two of Janssen’s bispecific antibodies created with Genmab’s DuoBody technology platform, were accepted for oral presentations at the conference.

All abstracts are available on the ASH website at . Details regarding the key abstracts to be presented are included below.

“2020 has been another strong year for Genmab with our proprietary pipeline progressing rapidly. We are very excited to be sharing additional data from our epcoritamab program as an oral presentation at the prestigious ASH conference as well as data from our pre- clinical HexaBody-CD38 program,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We are also very pleased to see that, once again, a significant number of daratumumab abstracts were accepted for presentation, as this confirms our confidence in the broad potential of daratumumab.”

Late breaking abstracts are not yet available.

On December 8 at 12:30 PM EST (6:30 PM CET / 5:30 PM GMT) Genmab will hold its virtual 2020 ASH Data Review and present its 2021 Key Priorities. The event will be webcast live on the following link: . Details, including the webcast link, can also be found on Genmab’s website, .

This meeting is not an official program of the ASH Annual Meeting.

Genmab Abstracts:



Subcutaneous Epcoritamab Induces Complete Responses With an Encouraging Safety Profile Across Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Subtypes, Including Patients With Prior CAR-T Therapy: Updated Dose-Escalation Data– Oral presentation, Sunday, December 6 12.30 PST



Novel semi-mechanistic model leveraging preclinical and clinical data to inform the recommended phase 2 dose (RP2D) selection for epcoritamab (DuoBody CD3×CD20)– Poster presentation, Monday December 7, 7.00 AM – 3.30 PM PST.

Preclinical Anti-Tumor Activity of Hexabody-CD38 in Patient-Derived B Cell Lymphoma and Acute Myeloid Leukemia Xenograft Models– Poster presentation, Sunday, December 6, 7.00 AM – 3.30 PM PST.

Key Abstracts Sponsored by Janssen Biotech, Inc. include:

APOLLO: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)” – Oral Presentation Sunday, December 6, 2020, 12:00 PM PST.

Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of GRIFFIN After 12-months of Maintenance Therapy” – Oral Presentation Monday, December 7, 2020, 7:15 AM PST.

Reduction in Absolute Involved Free Light Chain and Difference Between Involved and Uninvolved Free Light Chain Is Associated with Prolonged Major Organ Deterioration Progression-Free Survival in Patients with Newly Diagnosed AL Amyloidosis Receiving Bortezomib, Cyclophosphamide, and Dexamethasone With or Without Daratumumab: Results From ANDROMEDA” – Oral Presentation Monday, December 7, 2020, 8:00 AM PST.

Updated Analysis of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): the Phase 3 MAIA Study – Poster Presentation Sunday, December 6, 2020, 7.00 AM – 3.30 PM PST.

Updated Phase 1 Results of Teclistamab, a B-cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Relapsed and/or Refractory Multiple Myeloma (RRMM) – Oral Presentation, Saturday, December 5, 2020, 12:45 PM PST.

A Phase 1, First-in-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D (GPRC5D) x CD3 Bispecific Antibody, in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM) – Oral Presentation, Saturday, December 5, 2020, 2:00 PM PST.

About Genmab

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 Tokyo, Japan.

Contact:          

Marisol Peron, Corporate Vice President, Communications & Investor Relations

T: ; E:

For Investor Relations:

Andrew Carlsen, Senior Director, Investor Relations

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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 related to 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 unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the 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 . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such 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.

 

 

 

Media Release no. 16

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Attachment

EN
04/11/2020

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