Genmab A/S : 2020 Virtual Capital Markets Day – November 13, 2020
11/13/2020 | 08:41am EST
WELCOME
Genmab's
2020 Capital
Markets Day
November 13, 2020
Webcast Live from Utrecht and Princeton
Forward Looking Statement
This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, 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. Further, certain forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation. Genmab does not undertake any obligation to update or revise forward looking statements in this presentation 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 Proprietary* and Partnered Products: Most Advanced Development Phase
Phase 1
Phase 1/2
Phase 2
Phase 3
Approved
•DuoBody-CD40x4-1BB1
•Epcoritamab2
•Tisotumab vedotin7
•DuoHexaBody-CD372
•DuoBody-PD-L1x4-1BB1
•DuoBody-CD3x5T42
•Enapotamab vedotin
•HexaBody-DR5/DR5
•Talquetamab3
•Mim86
•Teclistamab3
•Amivantamab3
•Daratumumab3
•JNJ-637091783
•Camidanlumab tesirine8
•Ofatumumab10
•JNJ-638980813
•PRV-0159
•Teprotumumab11
•JNJ-675712443
•JNJ-702189023
•HuMax-IL84
•Lu AF824225
*Products where Genmab has ownership of at least 50%
1 50/50 co-development with BioNTech; 2 50/50 co-development with AbbVie; 3 Development by Janssen; 4 Development by BMS; 5 Development by Lundbeck; 6 Development by Novo Nordisk; 7 50/50 co-development with
Seagen; 8Development by ADC Therapeutics; 9 Development by Provention Bio; 10 Development by Novartis; 11
Agonistic Activation of T-Cells by HT Functional and Unbiased DuoBody® Library Screening of Multiple IO Targets
Multiple different IO targets and antibody panels belonging to the B7/CD28 and TNF/TNFR families have been tested functionally and unbiased in DuoBody® transactivation screen
DuoBody-CD40x4-1BBwas one of the hits identified from thousands of DuoBody® variants
Tahi Ahmadi, Senior Vice President, Head of Oncology
Kate Sasser, Corporate Vice President, Translational Research
*50/50 Development with BioNTech
Mechanism of Action of GEN1046
GEN1046 is a first-in-class, next generation, checkpoint immunotherapy designed to enhance T-cell and NK cell function through conditional 4-1BBco-stimulation, while simultaneously blocking the PD-L1 axis.
GEN1046 enhances proliferation and cytokine production of activated T-cells, activates immune cells in the tumor-draining lymph nodes, and induces tumor regression in vivo.
Data cut-off: September 29, 2020. Post-baseline scans were not conducted for five patients. aMinimum duration of response (5 weeks) per RECIST v1.1 not reached.
bPR was not confirmed on a subsequent scan.
NE, non-evaluable; NSCLC, non-small cell lung cancer; PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PR, partial response; SD, stable disease; SoD, sum of diameters; uPR, unconfirmed partial response.
Disease control was achieved in 65.6% patients, including 4 partial responses in TNBC (1), ovarian cancer (1), and ICI-pretreated NSCLC (2) patients
As of October 12, 2020, 24 patients were enrolled in expansion cohort 1, which includes patients with NSCLC with progression on or after ICI therapy
12 patients had post-baseline scans; six patients were still on treatment with GEN1046, six patients discontinued
Preliminary efficacy in 12 patients who could be objectively assessed showed two patients who achieved confirmed PR, one with unconfirmed PR, and four patients with SD.
Data cut-off: October 12, 2020.
*Denotes patients with ongoing treatment. aPR was not confirmed by a subsequent scan.
Includes all patients who had at least one post-baseline tumor assessment (schedule is every 6 weeks), and thus could be assessed for clinical benefit; 6 of 12 patients are still on treatment.
BOR, best overall response; ICI, immune checkpoint inhibitor; NA, not available, NE, non-evaluable; NSCLC, non- small cell lung cancer; PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SoD, sum of diameters; TPS, tumor proportion score; uPR, unconfirmed partial response.
At time of ASH Abstract cut off, 67 subjects were enrolled in Phase 1/2 first-in-humandose-finding study in R/R B-cell NHL; epcoritamab demonstrated antitumor efficacy as a single agent, with no DLTs
No discontinuation due to AEs unrelated to PD
In DLBCL: ORR were 66.7% (34% CR) with ≥12 mg (n=18) and 100% (29% CR) with ≥48 mg**
Open-Label Trial to Assess the Safety and Preliminary Efficacy of SubQ Epcoritamab in Combination with Other Agents in Patients with B-cellNon-Hodgkin Lymphoma
Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer: Results From the Phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 Study
Robert L. Coleman,1 Domenica Lorusso,2 Christine Gennigens,3 Antonio González- Martín,4 Leslie Randall,5 David Cibula,6 Bente Lund,7 Linn Woelber,8 Sandro Pignata,9 Frederic Forget,10 Andrés Redondo,11 Reshma Rangwala,12 Signe Diness Vindeløv,13 Menghui Chen,12 Jeffrey R. Harris,12 Leonardo Viana Nicacio,14 Melinda S. L. Teng,14 Margaret Smith,12 Bradley J. Monk,15 Ignace Vergote16
1US Oncology, The Woodlands Houston, TX, USA; 2Multicentre Italian Trials in Ovarian Cancer and Gynaecological Malignancies Group (MITO) and Scientific Directorate and Department of Women and Child Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; 3Department of Medical Oncology, Centre Hospitalier Universitaire de Liège, Liège, Belgium; 4Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Department of Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain; 5Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA; 6Central and Eastern European Gynecologic Oncology Group (CEEGOG) and Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic; 7Aalborg University Hospital, Aalborg, Denmark; 8Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group and University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 9MITO and Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione G. Pascale" IRCCS, Naples, Italy; 10Centre Hospitalier de l'Ardenne, Libramont, Belgium; 11Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Hospital Universitario La Paz-IdiPAZ, Madrid, Spain;
12Genmab US, Inc., Princeton, NJ, USA; 13Genmab, Copenhagen, Denmark; 14Seattle Genetics, Inc., Bothell, WA, USA; 15Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA; 16Belgium and Luxembourg Gynaecological Oncology Group, University of Leuven, Leuven Cancer Institute, Leuven, Belgium.
innovaTV 204 (NCT03438396) is a pivotal phase 2 single-arm, multicenter (United States and Europe) study evaluating tisotumab vedotin in patients with previously treated recurrent and/or metastatic cervical cancer
Key Eligibility Criteria
Recurrent or extrapelvic metastatic cervical cancer
Progressed during or after doublet chemotherapya with bevacizumab (if eligible)
Received ≤2 prior systemic regimensb
ECOG PS 0-1
Enrolled: 102c
Treated: 101*
Tisotumab
Until PD or
vedotin
unacceptable
2.0 mg/kg IV
toxicity
Q3W
Tumor responses assessed using CT or MRI at baseline, every 6 weeks for the first 30 weeks, and every 12 weeks thereafter
Primary Endpoint
ORRd per RECIST v1.1, by independent imaging review committee (IRC)
Secondary Endpoints
ORRd per RECIST v1.1, by investigator
DOR, TTR, and PFS by IRC and investigator
OS
Safety
Exploratory Endpoints
Biomarkers
HRQoL
*Study sample size calculated assuming a confirmed ORR of 21% to 25% with tisotumab vedotin and to provide ≥80% power to exclude an ORR of ≤11%e
aPaclitaxel plus platinum (cisplatin or carboplatin) or paclitaxel plus topotecan. bAdjuvant or neoadjuvant chemotherapy or if administered with radiation therapy, was not counted as a prior systemic regimen. cJune 2018 to April 2019. dResponses were confirmed by subsequent repeat imaging performed ≥4 weeks after initial response assessment. eUsing one-sided exact binomial test at 0.025 significance level.
CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; HRQoL, health-related quality of life; IRC, independent review committee; IV, intravenous; MRI, magnetic resonance imaging; OS, overall survival; PD, progressive disease; Q3W, every 3 weeks; RECIST v1.1, Response Evaluation Criteria In Solid Tumors version 1.1; TTR, time to response.
Antitumor Activity by IRC Assessment
Clinically meaningful and durable responses were observed
Response
1.00
N=101
0.80
0.60
Confirmed ORR (95% CI),a %
24 (15.9−33.3)
in
CR, n (%)
7
(7)
Remaining
0.40
PR, n (%)
17
(17)
0.20
SD, n (%)
49
(49)
0
PD, n (%)
24
(24)
0
Not evaluable, n (%)
4
(4)
No. at risk
24
DOR
Median DOR
(95% CI)
8.3 months (4.2−NR)
2
4
6
8
10
12
Time (months)
22
16
11
8
3
0
Data cutoff: February 06, 2020. Median duration of follow-up: 10.0 months. aBased on the Clopper-Pearson method.
Data cutoff: February 06, 2020. Median duration of follow-up: 10.0 months. CI, confidence interval; OS, overall survival; PFS, progression-free survival.
Jan van de Winkel, President & Chief Executive Officer
Key Events in Genmab's 21-Year Journey
•
2012 - 2015
2019
2003 - 2007
Janssen agreement
•
U.S. IPO
daratumumab
•
Ofatumumab RMS
•
CD38 mAbs generated
•
HexaBody® platform
sBLA
•
Daratumumab selected
•
DARZALEX® 1st
•
CureVac AG agreement
•
GSK agreement
U.S approval
•
HexaBody-CD38
ofatumumab
•
BioNTech agreement
agreement (Janssen)
1999 - 2002
Genmab Founded
Copenhagen IPO
1st partnership (Roche)
Ofatumumab program announced
2008 - 2011
Arzerra® 1st U.S. & EU approvals
DuoBody® platform
Strategy update
1st collab. w/ Seattle Genetics
2016 - 2018
2020
•
DARZALEX®
•
AbbVie partnership
•
1st EU & Japan approvals
•
U.S. Approvals for:
HexElect® platform
•
®
•
Immatics agreement
Kesimpta
•
DARZALEX
•
FASPRO™
•
TEPEZZA®
•
1st DuoBody* awarded
Kesimpta (ofatumumab) developed by Novartis; DARZALEX (daratumumab) and DARZALEX FASPRO ( daratumumab and hyaluronidase-fihj) developed by Janssen; TEPEZZA (teprotumumab) developed by Horizon Therapeutics; *amivantamab developed by Janssen
Genmab A/S published this content on 13 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 November 2020 13:40:04 UTC
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