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Genmab A/S Detailed Results From The Phase Iii Asclepios I & Ii Studies Of Ofatumumab In Patients With Relapsing Multiple Scl...

13/09/2019 2:04pm

UK Regulatory (RNS & others)


 
TIDMGEN.CO 
 
 
   Company Announcement 
 
 
   -- Details from the ASCLEPIOS I & II studies of subcutaneous ofatumumab 
      (OMB157) versus teriflunomide in patients with relapsing multiple 
      sclerosis (RMS) were presented at the 35th Congress of the European 
      Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 
 
 
   Copenhagen, Denmark; September 13, 2019 -- Genmab A/S (Nasdaq: GMAB) 
announced that its partner for ofatumumab, Novartis, presented positive 
results from the Phase III ASCLEPIOS I and II studies at the 35th 
Congress of the European Committee for Treatment and Research in 
Multiple Sclerosis (ECTRIMS), in Stockholm, Sweden. The head-to-head 
ASCLEPIOS studies investigated the efficacy and safety of monthly 
subcutaneous ofatumumab 20mg versus once daily oral teriflunomide 14mg 
in adults with relapsing forms of multiple sclerosis (RMS) with the 
primary endpoints of reduction in the number of confirmed relapses, 
evaluated as the annualized relapse rate (ARR). Both ASCLEPIOS I and II 
studies met their primary endpoints. Patients with RMS on ofatumumab had 
a reduction in ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs 0.25) 
compared to teriflunomide (both studies p<0.001) in ASCLEPIOS I and II 
studies respectively. Regarding secondary endpoints of the trials, 
ofatumumab showed highly significant suppression of gadolinium (Gd) T1 
lesions when compared to teriflunomide demonstrating a profound 
suppression of new inflammatory activity. Ofatumumab showed a relative 
risk reduction of 34.4% in 3-month confirmed disability progression 
(CDP) (p=0.002) and 32.5% in 6-month CDP (p=0.012) versus teriflunomide 
in pre-specified pooled analyses. The safety profile of ofatumumab as 
seen in the ASCLEPIOS studies was in line with the observations from 
prior Phase II results. Ofatumumab is being developed and marketed 
worldwide by Novartis under a license agreement with Novartis Pharma AG. 
Novartis plans to initiate submissions to health authorities by end of 
2019. 
 
   "We are extremely pleased with the very positive data presented at the 
prestigious ECTRIMS Congress, as these further support our firm belief 
in the potential of subcutaneous ofatumumab to provide an excellent and 
very convenient option to profoundly improve the lives of patients 
living with relapsing multiple sclerosis," said Jan van de Winkel, 
Ph.D., Chief Executive Officer of Genmab. 
 
   About ASCLEPIOS 
 
   The ASCLEPIOS I and II studies (NCT02792218 and NCT02792231) are twin, 
identical design, flexible duration (up to 30 months), double-blind, 
randomized, multi-center Phase III studies evaluating the safety and 
efficacy of ofatumumab 20mg monthly subcutaneous injections versus 
teriflunomide 14mg oral tablets taken once daily in adults with a 
confirmed diagnosis of RMS(1,2) . The studies enrolled 1,882 patients 
with relapsing MS, between the ages of 18 and 55 years, with an Expanded 
Disability Status Scale (EDSS) score between 0 and 5.5(1,2) . The 
studies were conducted in over 350 sites in 37 countries. 
 
   The primary endpoint of both studies was to demonstrate that ofatumumab 
is superior to teriflunomide in reducing the frequency of confirmed 
relapses as evaluated by the ARR in patients treated up to 30 
months(1,2) . Secondary endpoints included time to disability 
progression confirmed at three and six months respectively, confirmed 
disability improvement at six months, gadolinium enhancing T1 lesions, 
number of new or enlarging T2 lesions, serum levels of neurofilament 
light chain (NfL), and rate of brain volume loss(1,2) . Safety and the 
pharmacokinetic properties of ofatumumab were also all measured 
throughout the treatment period(1,2) . 
 
   About Ofatumumab 
 
   Ofatumumab (OMB157) is a fully human CD20 monoclonal antibody (mAb) 
self-administered by a once-monthly subcutaneous injection that is in 
development for relapsing MS. Ofatumumab works by binding to the CD20 
molecule on the B-cell surface and inducing potent B-cell lysis and 
depletion. Positive Phase IIb results in MS patients were presented in 
2014 and showed a marked significant reduction in the number of new 
brain lesions in the first 24 weeks after ofatumumab administration(3) . 
Novartis initiated a Phase III program for ofatumumab in RMS in August 
2016. Ofatumumab is being developed and marketed worldwide by Novartis 
under a license agreement with Novartis Pharma AG. Novartis obtained 
rights for ofatumumab from Genmab in all indications, including MS, in 
December 2015. 
 
   About Multiple Sclerosis 
 
   MS disrupts the normal functioning of the brain, optic nerves and spinal 
cord through inflammation and tissue loss(4) . MS, which affects 
approximately 2.3 million people worldwide(5) , is often characterized 
into the following forms: primary progressive MS (PPMS) and relapsing MS, 
which includes relapsing-remitting MS (RRMS) and secondary progressive 
MS (SPMS)(6) . Approximately 85% of patients initially present with 
relapsing forms of MS(5) . 
 
   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(R) (daratumumab) for the treatment 
of certain multiple myeloma indications, and Arzerra(R) (ofatumumab) for 
the treatment of certain chronic lymphocytic leukemia indications. 
Daratumumab is in clinical development for additional multiple myeloma 
indications, other blood cancers and amyloidosis. A subcutaneous 
formulation of ofatumumab is in development for relapsing multiple 
sclerosis. 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(R) platform for 
generation of bispecific antibodies, the HexaBody(R) platform, which 
creates effector function enhanced antibodies, the HexElect(R) platform, 
which combines two co-dependently acting HexaBody molecules to introduce 
selectivity while maximizing therapeutic potency and the DuoHexaBody(R) 
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 core sites in Utrecht, the Netherlands and Princeton, New Jersey, 
U.S. 
 
 
 
 
 
   Contact: 
 
   Marisol Peron, Corporate Vice President, Communications & Investor 
Relations 
 
   T: +1 609 524 0065; E: 
https://www.globenewswire.com/Tracker?data=UJl-zomiA6uZz1vevnsGTXYkMG9iou-4lKs3u9SSf90cpBxCXhg_857vCq8MSmgzik4GkGcKmvkapJsM8k5A9g== 
mmp@genmab.com 
 
   For Investor Relations: 
 
   Andrew Carlsen, Senior Director, Investor Relations 
 
   T: +45 3377 9558; E: 
https://www.globenewswire.com/Tracker?data=q81oaW4oBkrqmkM8Nu9_LTTyFiJNqv95lR3-sTXNh8Pa4ttQGQ6ZsOTYaV8iSrKXKn9z9lAMYR0FOaKshD7RJA== 
acn@genmab.com 
 
   This Company Announcement 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 
https://www.globenewswire.com/Tracker?data=wGbWJeWtrNgiGgqnwxhZj074TCa7cynrkkSUlMfGsP7KFchZHjp9ZlTKBUogn3SBzHyOTGX4I3tkwg0UwXEngw== 
www.genmab.com and the risk factors included in Genmab's final 
prospectus for our U.S. public offering and listing and other filings 
with the U.S. Securities and Exchange Commission (SEC), which are 
available at 
https://www.globenewswire.com/Tracker?data=wGbWJeWtrNgiGgqnwxhZjzoje5TtaW5Jro4DOot-VRYx8fLSszcyo_eNK1PWDJfUpbDHqplqhHXq3D9JKvlyluaW7YrpAY_gdo__mdmsi4E= 
www.sec.gov. Genmab does not undertake any obligation to update or 
revise forward looking statements in this Company Announcement 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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination with the 
Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody in combination 
with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in combination with 
the HexaBody logo(R) ; DuoHexaBody(R) ; HexElect(R) ; and UniBody(R) . 
Arzerra(R) is a trademark of Novartis AG or its affiliates. DARZALEX(R) 
is a trademark of Janssen Pharmaceutica NV. 
 
   (1) ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared to 
Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS 
I). https://clinicaltrials.gov/ct2/show/NCT02792218. Accessed August 
2019. 
 
   (2) ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared to 
Teriflunomide in Patients With Relapsing Multiple Sclerosis.(ASCLEPIOS 
II). https://clinicaltrials.gov/ct2/show/NCT02792231. Accessed August 
2019. 
 
   (3) Bar-Or A, et al. Subcutaneous ofatumumab in patients with 
relapsing-remitting multiple sclerosis: The MIRROR study. Neurology. 
2018; 90(20):e1805--1814. 
 
   (4) John Hopkins Medicine. Multiple sclerosis (MS). 
https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/multiple_sclerosis/conditions/index.html. 
Accessed August 2019. 
 
   (5) Multiple Sclerosis International Federation. Atlas of MS 2013. 
https://www.globenewswire.com/Tracker?data=gBzf-RuINAXP0u3slf0Pc3Bjdi9O9hofLV5uT1sEv5CBdsIq0l3UvyLw-r94QcedH884AGRG2OfdIJAbyaLGujW3mgSAG0LUMNp-WL7SwE4GkJiG3e8dlsdqaN-5EDJr6Ck1ZCH9QLJ18JJlrowljrZcOKk97hDlHPNmAxdN81NQZwK33iHkHMT8n8ppBSspeDOW6ZuiTvTYR19dprvTPfGogl5pMUKmFTupx6zNHIt5Dom4hRrHrtcR09hGLNGaX78AagDjaT4nlY68YY2P-g== 
http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. Accessed 
August 2019. 
 
   (6) Multiple sclerosis international federation. Types of MS. 
https://www.msif.org/about-ms/types-of-ms/. Accessed August 2019 
 
 
 
   Company Announcement no. 44 
 
   CVR no. 2102 3884 
 
   LEI Code 529900MTJPDPE4MHJ122 
 
   Genmab A/S 
 
   Kalvebod Brygge 43 
 
   1560 Copenhagen V 
 
   Denmark 
 
   Attachment 
 
 
   -- 190913_CA44_Ofatumumab Data at ECTRIMS 
      https://ml-eu.globenewswire.com/Resource/Download/07d8945b-288a-498e-be06-6fea63d1c369 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

September 13, 2019 09:04 ET (13:04 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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