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Genmab A/S: Genmab Announces Data to be Presented at 2018 ASH Annual Meeting
14:16
Media Release
* Thirty-five total abstracts on Genmab owned and partnered programs
scheduled for presentation at ASH
* Three abstracts related to Genmab owned programs: DuoBody-CD3xCD20 &
DuoHexaBody-CD37
* Daratumumab: 5 oral presentations; total of 30 accepted including ISS
Copenhagen, Denmark; November 1, 2018 Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that 35 abstracts related to Genmab owned and partnered
programs have been accepted for presentation at the 60th American Society
of Hematology (ASH) Annual Meeting taking place December 1-4 in San Diego,
California. Abstracts accepted for presentation include updates on multiple
daratumumab and ofatumumab trials, as well as pre-clinical data from
Genmabs DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs. All abstracts are
available on the ASH website at www.hematology.org
https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERsZg4aGjERm8OWk2fmt6BgmZmCq57AGm3kSYRhfVh1SpEI8Gn9vjHYI48TIdEgXW6fNBcyJn-1zGUACrka4LvvM=
. Details regarding the key abstracts to be presented are included below.
We are elated that out of the over eighty-five ongoing daratumumab
clinical studies, a record thirty abstracts containing daratumumab data in
multiple myeloma and other indications were accepted for presentation at
this years ASH Annual Meeting. We are also thrilled that three abstracts
related to pre-clinical data from wholly owned Genmab programs were
accepted for inclusion at this prestigious event, including the first
proprietary DuoBody program, DuoBody-CD3xCD20, and the first ever
DuoHexaBody therapeutic program, DuoHexaBody-CD37, said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab.
Late breaking abstracts are not yet available.
Genmab Pre-Clinical Abstracts
DuoBody-CD3xCD20 Shows Unique and Potent Preclinical Anti-Tumor Activity In
Vitro and In Vivo, and is Being Evaluated Clinically in Patients with
B-Cell Malignancies Poster presentation, Saturday, December 1
DuoHexaBody-CD37 a Novel Bispecific Antibody with a Hexamerization
enhancing Mutation Targeting CD37, Demonstrates Superior CDC in Preclinical
B-Cell Malignancy Models Poster presentation, Monday, December 3
Targeting CD37 in B-Cell Malignancies Using the Novel Therapeutic Ab
DuoHexaBody-CD37 Results in Efficient Killing of Tumor B-Cells Ex Vivo via
CDC, Even in Relapsed and/or Refractory Patient Samples Poster
presentation, Monday, December 3
Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.
Oral Presentations:
Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from
GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib,
Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and
Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible
for High-Dose Therapy and Autologous Stem Cell Transplantation Oral
presentation, Saturday, December 1
LYRA A Phase 2 Study of Daratumumab Plus Cycolphosphamide, Bortezomib,
and Dexamethasone in Newly Diagnosed and Relapsed Patients with Multiple
Myeloma Oral presentation, Saturday, December 1
One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus
Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and
Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple
Myeloma: ALCYONE Oral presentation, Saturday, December 1
Poster Presentations:
Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus
Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone
in Relapsed or Refractory Multiple Myeloma Poster presentation, Saturday,
December 1
Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple
Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter,
Phase 1b Study (PAVO) Poster presentation, Saturday, December 1
Pharmacokinetics of Subcutaneous Daratumumab in Patients with Relapsed or
Refractory Multiple Myeloma: Primary Clinical Pharmacology Analysis of the
Open-label, Multicenter, Phase 1b Study (PAVO) Poster presentation,
Saturday, December 1
Split First Dose Administration of Daratumumab for the Treatment of
Patients with Multiple Myeloma: Clinical Pharmacology and Population
Pharmacokinetic Analyses Poster presentation, Saturday, December 1
Updated Results from the Phase 2 CENTAURUS Study of Daratumumab Monotherapy
in Patients with Intermediate-risk or High-risk Smoldering Multiple Myeloma
Poster presentation, Saturday, December 1
Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural
Killer/T-cell Lymphoma (NKTCL), Nasal Type: An Open-label, Single-arm,
Multicenter Phase 2 Study Poster presentation, Saturday, December 1
Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus
Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of
CASTOR Poster presentation, Sunday, December 2
Evaluation of Sustained Minimal Residual Disease Negativity in Relapsed /
Refractory Multiple Myeloma Patients Treated with Daratumumab in
Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus
Dexamethasone: Analysis of POLLUX and CASTOR Poster presentation, Sunday,
December 2
Efficacy of Daratumumab in Combination with Standard of Care Regimens in
Lenalidomide-Exposed or Refractory Patients with Relapsed / Refractory
Multiple Myeloma: Analysis of CASTOR, POLLUX and MMY1001 Studies Poster
presentation, Sunday, December 2
Ofatumumab Abstracts Sponsored by Novartis
Oral Presentation:
Results of the Primary Analysis of COMPLEMENT A+B: A Phase III Study of
Ofatumumab in Combination with Bendamustine Versus Bendamustine Alone in
Patients with Indolent Non-Hodgkins Lymphoma That is Unresponsive or
Relapsed Following Rituximab or Rituximab-containing Regimen Oral
presentation, Sunday, December 2
Poster Presentation:
Long-Term Evaluation of Efficacy and Safety of Ofatumumab Added to
Fludarabine & Cyclophosphamide in Subjects with Relapsed Chronic
Lymphocytic Leukemia: Final Analysis of COMPLEMENT 2 Trial Poster
presentation, Sunday, December 2
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 has
two approved antibodies, DARZALEX (daratumumab) for the treatment of
certain multiple myeloma indications, and Arzerra (ofatumumab) for the
treatment of certain chronic lymphocytic leukemia indications. Daratumumab
is in clinical development for additional multiple myeloma indications and
other blood cancers. A subcutaneous formulation of ofatumumab is in
development for relapsing multiple sclerosis. Genmab also has a broad
clinical and pre-clinical product pipeline. Genmabs 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 and
the HexElect platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic potency.
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. For more information
visit www.genmab.com
https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERhZXV-w9pnlcpf9jlCUpftrylSPDwQAdytaeOTEv-j2Ymcbf24Xp3vVMBphrZk7LKQ==
.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communication
T: +45 33 44 77 20; E: rcg@genmab.com
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 obsolete, and
other factors. For a further discussion of these risks, please refer to the
risk management sections in Genmabs most recent financial reports, which
are available on www.genmab.com
https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERjaHZREk_mM1i19NHQPJXRqDYLL9odaWgZBvP1A-WYCrg-pAye-E_MVZneWnJkI5jw==
. 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 is a trademark of Novartis AG or its
affiliates. DARZALEX is a trademark of Janssen Pharmaceutica NV.
Media Releaseno. 10
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
* i10_181101_MR_ASH Abstracts
https://prlibrary-eu.nasdaq.com/Resource/Download/c2a67b38-0f6b-48d8-9e23-462a62bd65cb
14:16
Media Release
* Thirty-five total abstracts on Genmab owned and partnered programs
scheduled for presentation at ASH
* Three abstracts related to Genmab owned programs: DuoBody-CD3xCD20 &
DuoHexaBody-CD37
* Daratumumab: 5 oral presentations; total of 30 accepted including ISS
Copenhagen, Denmark; November 1, 2018 Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that 35 abstracts related to Genmab owned and partnered
programs have been accepted for presentation at the 60th American Society
of Hematology (ASH) Annual Meeting taking place December 1-4 in San Diego,
California. Abstracts accepted for presentation include updates on multiple
daratumumab and ofatumumab trials, as well as pre-clinical data from
Genmabs DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs. All abstracts are
available on the ASH website at www.hematology.org
https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERsZg4aGjERm8OWk2fmt6BgmZmCq57AGm3kSYRhfVh1SpEI8Gn9vjHYI48TIdEgXW6fNBcyJn-1zGUACrka4LvvM=
. Details regarding the key abstracts to be presented are included below.
We are elated that out of the over eighty-five ongoing daratumumab
clinical studies, a record thirty abstracts containing daratumumab data in
multiple myeloma and other indications were accepted for presentation at
this years ASH Annual Meeting. We are also thrilled that three abstracts
related to pre-clinical data from wholly owned Genmab programs were
accepted for inclusion at this prestigious event, including the first
proprietary DuoBody program, DuoBody-CD3xCD20, and the first ever
DuoHexaBody therapeutic program, DuoHexaBody-CD37, said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab.
Late breaking abstracts are not yet available.
Genmab Pre-Clinical Abstracts
DuoBody-CD3xCD20 Shows Unique and Potent Preclinical Anti-Tumor Activity In
Vitro and In Vivo, and is Being Evaluated Clinically in Patients with
B-Cell Malignancies Poster presentation, Saturday, December 1
DuoHexaBody-CD37 a Novel Bispecific Antibody with a Hexamerization
enhancing Mutation Targeting CD37, Demonstrates Superior CDC in Preclinical
B-Cell Malignancy Models Poster presentation, Monday, December 3
Targeting CD37 in B-Cell Malignancies Using the Novel Therapeutic Ab
DuoHexaBody-CD37 Results in Efficient Killing of Tumor B-Cells Ex Vivo via
CDC, Even in Relapsed and/or Refractory Patient Samples Poster
presentation, Monday, December 3
Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.
Oral Presentations:
Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from
GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib,
Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and
Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible
for High-Dose Therapy and Autologous Stem Cell Transplantation Oral
presentation, Saturday, December 1
LYRA A Phase 2 Study of Daratumumab Plus Cycolphosphamide, Bortezomib,
and Dexamethasone in Newly Diagnosed and Relapsed Patients with Multiple
Myeloma Oral presentation, Saturday, December 1
One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus
Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and
Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple
Myeloma: ALCYONE Oral presentation, Saturday, December 1
Poster Presentations:
Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus
Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone
in Relapsed or Refractory Multiple Myeloma Poster presentation, Saturday,
December 1
Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple
Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter,
Phase 1b Study (PAVO) Poster presentation, Saturday, December 1
Pharmacokinetics of Subcutaneous Daratumumab in Patients with Relapsed or
Refractory Multiple Myeloma: Primary Clinical Pharmacology Analysis of the
Open-label, Multicenter, Phase 1b Study (PAVO) Poster presentation,
Saturday, December 1
Split First Dose Administration of Daratumumab for the Treatment of
Patients with Multiple Myeloma: Clinical Pharmacology and Population
Pharmacokinetic Analyses Poster presentation, Saturday, December 1
Updated Results from the Phase 2 CENTAURUS Study of Daratumumab Monotherapy
in Patients with Intermediate-risk or High-risk Smoldering Multiple Myeloma
Poster presentation, Saturday, December 1
Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural
Killer/T-cell Lymphoma (NKTCL), Nasal Type: An Open-label, Single-arm,
Multicenter Phase 2 Study Poster presentation, Saturday, December 1
Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus
Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of
CASTOR Poster presentation, Sunday, December 2
Evaluation of Sustained Minimal Residual Disease Negativity in Relapsed /
Refractory Multiple Myeloma Patients Treated with Daratumumab in
Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus
Dexamethasone: Analysis of POLLUX and CASTOR Poster presentation, Sunday,
December 2
Efficacy of Daratumumab in Combination with Standard of Care Regimens in
Lenalidomide-Exposed or Refractory Patients with Relapsed / Refractory
Multiple Myeloma: Analysis of CASTOR, POLLUX and MMY1001 Studies Poster
presentation, Sunday, December 2
Ofatumumab Abstracts Sponsored by Novartis
Oral Presentation:
Results of the Primary Analysis of COMPLEMENT A+B: A Phase III Study of
Ofatumumab in Combination with Bendamustine Versus Bendamustine Alone in
Patients with Indolent Non-Hodgkins Lymphoma That is Unresponsive or
Relapsed Following Rituximab or Rituximab-containing Regimen Oral
presentation, Sunday, December 2
Poster Presentation:
Long-Term Evaluation of Efficacy and Safety of Ofatumumab Added to
Fludarabine & Cyclophosphamide in Subjects with Relapsed Chronic
Lymphocytic Leukemia: Final Analysis of COMPLEMENT 2 Trial Poster
presentation, Sunday, December 2
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 has
two approved antibodies, DARZALEX (daratumumab) for the treatment of
certain multiple myeloma indications, and Arzerra (ofatumumab) for the
treatment of certain chronic lymphocytic leukemia indications. Daratumumab
is in clinical development for additional multiple myeloma indications and
other blood cancers. A subcutaneous formulation of ofatumumab is in
development for relapsing multiple sclerosis. Genmab also has a broad
clinical and pre-clinical product pipeline. Genmabs 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 and
the HexElect platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic potency.
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. For more information
visit www.genmab.com
https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERhZXV-w9pnlcpf9jlCUpftrylSPDwQAdytaeOTEv-j2Ymcbf24Xp3vVMBphrZk7LKQ==
.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communication
T: +45 33 44 77 20; E: rcg@genmab.com
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 obsolete, and
other factors. For a further discussion of these risks, please refer to the
risk management sections in Genmabs most recent financial reports, which
are available on www.genmab.com
https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERjaHZREk_mM1i19NHQPJXRqDYLL9odaWgZBvP1A-WYCrg-pAye-E_MVZneWnJkI5jw==
. 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 is a trademark of Novartis AG or its
affiliates. DARZALEX is a trademark of Janssen Pharmaceutica NV.
Media Releaseno. 10
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
* i10_181101_MR_ASH Abstracts
https://prlibrary-eu.nasdaq.com/Resource/Download/c2a67b38-0f6b-48d8-9e23-462a62bd65cb
