Innovating
Antibodies,
Improving Lives
Investor Presentation November 2020
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.
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Our Core Purpose, Strategy & Vision Guide Our Work
Core Purpose | Our Strategy | Vision |
To improve the lives of patients | Turn science into medicine | By 2025, our own product has |
by creating & developing innovative | transformed cancer treatment and | |
antibody products | Build a profitable & successful biotech | we have a pipeline of knock-your- |
socks off antibodies |
Focus on Core Competence
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The Genmab Difference
Innovation Powerhouse Transforming Cancer Treatment & Creating Value
Strong pipeline | |
of 1st-in-class / | |
best-in-class | |
products | |
Proprietary | |
technologies | Deep insight into |
allow us | antibody biology |
to build a | & disease targets |
world-class | |
pipeline | |
Match in-house | |
expertise with | |
strategic | |
partnerships |
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Track Record & Growth
Over 20 Years
of Achievement
37 Cumulative INDs since 1999
23 Genmab created product candidates in Ongoing Clinical Trials
Multiple Genmab-created Products
Approved
7 Years of Profitability
-
Expanding Top Line
Dual-listed in US & DK with 2019 US IPO
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Solid Foundation Built
on a Differentiated Pipeline
Potential 1st-in-Class/Best-in-Class
Our Own Clinical Pipeline
• | Tisotumab Vedotin5 | • | DuoBody-CD40x4-1BB7 |
• | Enapotamab Vedotin | • | DuoBody-PD-L1x4-1BB7 |
• | HexaBody®-DR5/DR5 | • | DuoHexaBody®-CD376 |
• | Epcoritamab (DuoBody®-CD3xCD20)6 | • | DuoBody-CD3x5T46 |
R&D Engine
Technologies & Pre-Clinical(innovaTV
• DuoBody technology 206) study
• HexaBody technology in
• HexElect® technology Japanese
• DuoHexaBody® technology population
• Rich Pre-Clinical Pipeline incl. HexaBody-CD388
Solid Financial Base
Approved Partnered Products
•DARZALEX® (daratumumab) / DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)1
•Kesimpta® (ofatumumab)2 •TEPEZZA® (teprotumumab)3 •Arzerra® (ofatumumab)4
Programs Built on Genmab's Innovation
Partner-owned Programs in the Clinic
- 15 product candidates in clinical development w/ partners
- Incl. 7 DuoBody products with Janssen, 1 with Novo Nordisk
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1In dev. by Janssen; 2 in dev. by Novartis; 3In dev. by Horizon; 4Commercialized by Novartis, no longer in active development. 550:50 w/ Seattle Genetics; 650:50 w/ AbbVie; 750:50 w/ BioNTech, GEN1046 & GEN1042 respectively; 8Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen Biotech, Inc
DARZALEX® (daratumumab) & DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj): Redefining Treatment of Multiple Myeloma
First-in-class CD38 antibody in development to treat cancer
Collaboration with Janssen: Genmab entitled to tiered royalty of 12-20% of net sales
Approved in certain territories for various multiple myeloma (MM) indications1
DARZALEX FASPRO first and only SubQ CD38 mAb approved in U.S. for treatment of MM
$ | 2019 WW net sales by J&J: $2,998M |
See local country prescribing information for approved indications
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DARZALEX Approvals: US and EU
On Track for Approval Across All Lines of MM Treatment
US Approvals
US Submissions:
November | November | June 2017, | May 2018, | September 2019, | May 2020, | August 2020 | ||
June 2019, | DARZALEX FASPRO | |||||||
2016, RRMM | RRMM | FLMM NTE | February 2019, | |||||
2015, | (CASTOR; | FLMM NTE | FLMM TE | (COLUMBA; | RRMM | |||
Monotherapy | (EQUULEUS), | (ALCYONE), | Split dosing | (CASSIOPEIA), | (CANDOR), | |||
POLLUX), | (MAIA), D-Rd | PLEIADES) | ||||||
(SIRIUS) | D-Vd,D-Rd | D-Pd | D-VMP | D-VTd | D-Kd | |||
Subcutaneous | ||||||||
EU Approvals
EU Submissions: | ||||||
April 2016, | February 2017, | June 2018, FLMM | December | November | January 2020, | June 2020, |
Monotherapy | RRMM (CASTOR; | NTE (ALCYONE), | 2018, | 2019, FLMM | FLMM TE | Subcutaneous |
(SIRIUS) | POLLUX), D-Vd, | D-VMP | Split dosing | NTE (MAIA), | (CASSIOPEIA), | (COLUMBA; |
D-Rd | D-Rd | D-VTd | ||||
PLEIADES) |
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Daratumumab
Proving to be the Critical Driver Across Different Combinations & Treatment Lines
sCR Odds Ratio1 or CR+2
MRD-neg rate
PFS risk reduction
Frontline | Relapsed/Refractory | ||||||
Transplant Eligible | Transplant Ineligible | ||||||
Ph 3 | Ph 2 | Ph 3 | Ph 3 | Ph 3 | Ph 3 | Ph 3 | |
CASSIOPEIA1,3 | GRIFFIN1,4 | ALCYONE2,4 | MAIA2,4 | POLLUX2,4 | CASTOR2,4 | CANDOR2,4 | |
(D-VTd vs. VTd) | (D-VRd vs VRd) | (D-VMP vs. VMP) | (D-Rd vs. Rd) | (D-Rd vs. Rd) | (D-Vd vs Vd) | (D-Kd vs Kd) | |
1.60 | 1.57 | ~2x | ~2x | >2x | 3x | ~3x | |
1.5x | 2.5x | 4x | >3x | ~5x | >7x | ~10x | |
53% | NA | 58% | 44% | 56% | 69% | 37% | |
(HR, 0.47) | (HR, 0.42) | (HR, 0.56) | (HR, 0.44) | (HR, 0.31) | (HR, 0.63) | ||
Ongoing Phase 3: CEPHEUS (D-VRd, NDMM NTE), PERSEUS (D-VRd, NDMM TE)
3Data as per ASCO 2019; | 4Data as per ASH 2019 | 9 |
Improved Survival for Patients with Multiple Myeloma
Overall Survival Analysis from ALCYONE Trial
Kaplan-Meier estimates of overall survival in intention-to-treat population. Mateos, MV et al, 'Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly | 10 |
diagnosed multiple myeloma (ALCYONE): a randomized, open-label, phase 3 trial,' The Lancet, published online December 9, 2019 | |
Kesimpta® (ofatumumab)
Approved in Relapsing Multiple Sclerosis
Human CD20 Antibody - well validated target
Injection for SubQ use approved for RMS in the US
First B-cell therapy that can be self-administered by patients at home using Sensoready® autoinjector pen
Developed by Novartis: Regulatory submission also | |
made in EU | |
$ | Genmab 10% royalty payment of net sales |
Second Genmab-created product with blockbuster potential
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Tisotumab Vedotin
Genmab's Most Advanced Asset with Potential in Solid Tumors
Fully human antibody-drug conjugate (ADC) targeting Tissue
Factor (TF) in development to treat solid tumors
License and collaboration agreement with Seattle
Genetics 50:50
Very favorable topline results, Phase 2 recurrent or metastatic cervical cancer
Ongoing trials in cervical, ovarian cancer, other solid tumors
Expanding development, additional studies planned
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Tisotumab Vedotin in Cervical Cancer
Designed to Address a High Unmet Medical Need
Recurrent or metastatic cervical cancer
- Poor prognosis advanced / recurrent cervical cancer
- RR standard therapies generally <15%
- Median OS 6-8 months
- Data ORR & survival after progression on 1L bevacizumab + doublet chemotherapy are limited
Conclusions*
(previously treated recurrent or metastatic cervical cancer)
- Compelling and durable antitumor activity with manageable and tolerable safety profile
- ORR 24%; CR: 7%
- Median DOR 8.3 mo
- Median PFS (4.2 mo) and OS (12.1 mo) encouraging
Clinically meaningful and durable responses observed*
N=101 | |||
Confirmed ORR (95% CI),a % | 24 (15.9−33.3) | ||
CR, n (%) | 7 | (7) | |
PR, n (%) | 17 | (17) | |
SD, n (%) | 49 | (49) | |
PD, n (%) | 24 | (24) | |
Not evaluable, n (%) | 4 | (4) | |
Response | 1.00 | DOR | |||||||||||||||||||||||||||||||||||||
0.60 | |||||||||||||||||||||||||||||||||||||||
in | 0.80 | ||||||||||||||||||||||||||||||||||||||
Remaining | 0.40 | Median DOR | |||||||||||||||||||||||||||||||||||||
(95% CI) | |||||||||||||||||||||||||||||||||||||||
0.20 | |||||||||||||||||||||||||||||||||||||||
8.3 months | |||||||||||||||||||||||||||||||||||||||
(4.2−NR) | |||||||||||||||||||||||||||||||||||||||
0 | |||||||||||||||||||||||||||||||||||||||
0 | 2 | 4 | 6 | 8 | 10 | 12 | |||||||||||||||||||||||||||||||||
Time (months) | |||||||||||||||||||||||||||||||||||||||
No. at risk 24 | 22 | 16 | 11 | 8 | 3 | 0 |
*Data from innovaTV 204 study, Coleman R, et al. Tisotumab Vedotin in Cpreviously Treated Recurrent or Metastatic Cervical Cancer: Results from the Phase 2 innovaTV 204 / GOG-3023/ENGOT-cx6 Study, ESMO September 21, 2020. Data cutoff: February 06, 2020. Median13
duration of follow-up: 10.0 months. CI, confidence interval; CR, complete response; DOR, duration of response; IRC, independent review committee; NR, not reached; ORR, objective response rate; PD, disease progression; PR, partial response; SD, stable disease.
Enapotamab Vedotin
Potential in Solid Tumors
Fully human ADC, targets tumor-associated AXL
AXL over-expressed on many resistant tumors
Ph 1/2 study ongoing solid tumors
Expansion cohorts recruiting
ADC technology license from Seattle Genetics
Fully owned by Genmab
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Epcoritamab (DuoBody-CD3xCD20)
Potential for Improved Efficacy & Safety in B Cell Malignancies
Potential best-in-class therapeutic
T cell-mediated killing of CD20-expressing cells
SubQ Ph 1/2 trials in B cell malignancies ongoing
50:50 co-development Genmab and AbbVie
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Epcoritamab: Dose Escalation Data Presented at EHA25 Virtual Congress 2020*
Anti-tumor activity
- 86% ORR in FL ≥ 0.76mg
- 60% ORR, incl. 3 pts who failed prior CAR-T treatment, in DLBCL/HGBCL ≥12 mg
- Emerging prelim. data highly encouraging with substantial single-agent efficacy
- Induces rapid and deep responses in heavily pretreated pts with B-NHL across different subtypes
Safety
- No DLTs observed; MTD has not been reached
- No treatment-related deaths
- No discontinuation due to AEs unrelated to disease progression
- No Grade ≥ 3 CRS events observed
T cell | Target |
B cell |
CD3
CD20
Cytotoxic
activity
Dose-escalation data with subcutaneous epcoritamab indicate potential for best-in-class therapy
*Dose escaltion data presented on EHA25 Virtual Congress 2020 poster, Data cut-off dates: safety, April 24 2020; efficacy, May 14 2020 | 16 |
DuoHexaBody-CD37 (GEN3009)
Building Our Pipeline: First DuoHexaBody in the Clinic
Combination of DuoBody & HexaBody platforms
Novel target for hematologic malignancies
Unique mechanism-of-action
Dose escalation ongoing
50:50 co-development Genmab and AbbVie
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DuoBody-CD3x5T4 (GEN1044)
Latest in the Clinic
Based on proprietary DuoBody technology
CD3 bispecific, T cell mediated cytotoxicity of 5T4+ tumor cells
5T4 expressed on multiple solid tumors limited expression in healthy tissue
Dose-escalation ongoing
50:50 co-development Genmab and AbbVie
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DuoBody-PD-L1x4-1BB (GEN1046)
Bispecific Next Generation Checkpoint Immunotherapy
First-in-Class Bispecific antibody targeting PD-L1 & 4-1BB (CD137)
Designed to activate T cells through conditional 4-1BBco-stimulation, while simultaneously blocking the PD1/PD-L1 axis
Combining T cell stimulation with checkpoint blockade
Ph 1/2 study ongoing in solid tumors
50:50 co-development Genmab and BioNTech
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DuoBody-CD40x4-1BB (GEN1042)
Bispecific Agonistic Antibody
Bispecific antibody targeting CD40 & 4-1BB (CD137)
Conditionally activates T cells and APC in presence of CD40-expressing cells
Phase 1/2 study ongoing in solid tumors
50:50 co-development Genmab and BioNTech
See local country prescribing information for approved indications | 20 |
HexaBody-DR5/DR5 (GEN1029)
First HexaBody in Clinical Development
Targets 2 distinct DR5 epitopes
HexaBody platform - DR5 clustering & DR5 agonist activity
First 100% Genmab-owned HexaBody product in clinic
Phase 1/2 study ongoing in multiple solid tumors
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2020 Guidance: Recurring Revenue Growth and Focused Investments
Income | DKKM | ~USDM* | Key Observations | |
Statement | ||||
Revenue | 9,250 | - 9,850 | 1,423 | - 1,515 |
Operating Expenses | (3,850) | - (3,950) | (592) | - (608) |
Operating Income | 5,350 | - 5,950 | 823 - 915 | |
Summary P&L
- DARZALEX royalties of ~DKK 4.1bn to ~DKK 4.5bn to drive recurring revenue growth
- Nearly 90% of USD 750M upfront from AbbVie collab. recognized immediately
- Growth in operating expenses driven by expanding and accelerating our clinical pipeline
DARZALEX Sales of USD 3.9bn - USD 4.2bn
- Significant opportunity for growth in 1L MM market
- SubQ DARZALEX approvals in H1 in U.S. & EU
- Market share gain in the U.S. and RoW driven by uptake in all lines of treatment
- 8 approved indications in U.S., late stage to 1L MM
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*2020 Guidance - November 4, 2020 / USD 1.00 = DKK 6.50.
Key 2020 Priorities
Building a Strong Differentiated Product Pipeline
Priority | | Targeted Milestones |
Genmab proprietary* | | » Tisotumab vedotin1 - Phase 2 innovaTV 204 safety & efficacy analysis in recurrent/metastatic |
products | ** | cervical cancer and engage U.S. FDA for BLA submission subject to trial results |
» Tisotumab vedotin - data on other solid tumor types | ||
» Enapotamab vedotin - data to support late stage development | ||
| » Epcoritamab (DuoBody-CD3xCD20)2 Phase 1/2 - decision on recommended Phase 2 dose & | |
initiate expansion cohorts | ||
» HexaBody-DR5/DR5 Phase 1/2 - advance dose escalation | ||
| » DuoBody-PD-L1x4-1BB3 Phase 1/2 - initiate expansion cohorts | |
» DuoBody-PD-L1x4-1BB initial data in H2 2020 | ||
| » File INDs and/or CTAs for 2 new products | |
Daratumumab4 | | » U.S. FDA and EMA decision on Phase 3 COLUMBA multiple myeloma SubQ submission |
» sBLA and MAA Submission Phase 3 ANDROMEDA amyloidosis | ||
» sBLA and MAA submission Phase 3 APOLLO multiple myeloma | ||
Ofatumumab5 | | » U.S. FDA decision on regulatory dossier submission in multiple sclerosis |
Teprotumumab6 | | » U.S. FDA decision on Phase 3 OPTIC active thyroid eye disease submission |
*Certain product candidates in development with partners, as noted. | 23 |
**Data anticipated in 2021
1. 50:50 dev. w/ Seattle Genetics; 2. 50:50 dev w/ AbbVie; 3. 50:50 dev. w/ BioNTech; 4. In dev. by Janssen; 5. In dev. by Novartis; 6. In dev. by Horizon Therapeutics
Delivering on Genmab's Promise:
Innovating Antibodies, Improving Lives
Developing new capabilities to bring own product to market
Pipeline of 1st-in-class /best-in- class therapies advancing through clinic
World-class team with track record of success
Creating
Substantial
Value
Unique R&D engine & | Significant earnings potential |
from marketed products | |
strategic alliances | |
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Innovating Antibodies, Improving Lives
Appendix
A Leading International Biotech With Large Free Float
Approx. | Approx. Warrants | |
ADSs, Nasdaq | Market Cap* | |
Global Select | DKK 151bn | outstanding*: |
USA | USD ~24bn | 985,691 (~2%) |
Ordinary | Shares | Shares | Diluted shares: |
shares Nasdaq | world-wide incl: | outstanding*: | ~66M |
Copenhagen, DK | USA, UK, DK, NL | ~65M |
As of September 30, 2020 | 26 |
Genmab & AbbVie: Collaboration Overview
A broad, long-term oncology collaboration with Genmab and AbbVie working together to jointly make all strategy, clinical development and commercialization decisions
*Source: Company information and filings.
50/50 partnership across three clinical next- generation bispecific antibody product candidates (epcoritamab, DuoHexaBody-CD37,DuoBody-CD3x5T4)
Genmab to book epcoritamab sales in the U.S. and Japan; AbbVie to commercialize epcoritamab RoW - Genmab to receive tiered royalties on RoW net sales
Worldwide co-commercialization and profit split of all other programs
Discovery Research Collaboration
Fourth* largest oncology partnership with total | |
potential value ~USD 3.9bn (up-front cash + | |
milestone payments) to Genmab | 27 |
Advancing Pipeline: Delivering on Our Promise & Creating Value
Accelerating Development of Potential "Next Winners"
Delivering on Genmab's Promise to Patients
DuoBody-CD3xCD20 (epcoritamab)
- Potential best-in-class:SubQ administration
- Pre-clinical /preliminary clinical data shows encouraging safety & efficacy
- Expeditious and comprehensive clinical development plan
- RP2D decision & expansion cohorts initiation
- 50:50 AbbVie
DuoBody-PD-L1x4-1BB (GEN1046)
- Potential first-in-class:Next generation IO
- Unmet medical need
- FiH clinical study: escalation phase is ongoing
- 50:50 BioNTech
Track Record of Success
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Advancing Pipeline: Delivering on Our Promise & Creating Value
Delivering on Genmab's Promise to Patients
Bolstering early stage portfolio
•DuoBody-CD40x4-1BB1;DuoHexaBody-CD372;DuoBody-CD3x5T42;HexaBody-CD383
Adding new technologies
Data sciences
Expanding early stage discovery programs
Enhancing clinical development capabilities | |
Track Record of Success | 29 |
1GEN1042, 50:50 w/ BioNTech; 250:50 w/ AbbVie; 3Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement w/ Janssen Biotech, Inc
Genmab's Commitment to Society
Building a Socially Responsible & Sustainable Company
Anchored in our Core Purpose | CSR Committee comprised | Focus on four main areas |
of representatives from | ||
& Vision | ||
variety of functions, chaired by | ||
CEO | ||
• To improve the lives of | • Ensures that Genmab carries | • Employee well-being, including |
patients by creating and | out CSR activities effectively | health, safety & development |
developing innovative | & communicates clearly and | • Ethics in relation to pre-clinical |
antibody products | openly | |
and clinical studies | ||
• By 2025 our own product has | • Focus on Environment, | |
• Environment, including waste | ||
transformed cancer | Society and Governance | |
management & recycling | ||
treatment and we have a | reporting | |
• Business ethics & transparency | ||
pipeline of knock-your-socks- | ||
off antibodies |
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Innovation Powerhouse:
Cutting Edge Proprietary Technologies
Technology | Principle | Applications | ||
DuoBody | Bispecific antibodies | Dual targeting | ||
HexaBody | Target-mediated | Enhanced potency |
enhanced hexamerization | ||
DuoHexaBody | Bispecific antibodies with target- | Dual targeting + |
mediated enhanced | ||
enhanced potency | ||
hexamerization | ||
HexElect | Two co-dependent antibodies | Dual targeting + |
with target-mediated enhanced | ||
enhanced potency & selectivity | ||
hexamerization | ||
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Innovative Clinical and Pre-Clinical Pipeline
Genmab's Proprietary1 Products
Product | Target | Developed By Disease Indications | Most Advanced Development Phase |
Pre-Clinical | 1 | 1/2 | 2 | 3 | Approved | |||
Tisotumab vedotin | TF | 50:50 Genmab | Cervical cancer | |||||
/ Seattle | ||||||||
Genetics | Ovarian cancer | |||||||
Solid tumors | ||||||||
Enapotamab vedotin | AXL | Genmab | Solid tumors | |||||
Epcoritamab | CD3, CD20 | 50:50 Genmab | Hematological malignancies | |||||
(DuoBody-CD3xCD20) | / AbbVie | |||||||
DuoBody-PD-L1x4-1BB | PD-L1, | 50:50 Genmab | Solid tumors | |||||
(GEN1046) | 4-1BB | / BioNTech | ||||||
HexaBody-DR5/DR5 | DR5 | Genmab | Solid tumors | |||||
(GEN1029) | ||||||||
DuoBody-CD40x4-1BB | CD40, | 50:50 Genmab | Solid tumors | |||||
(GEN1042) | 4-1BB | / BioNTech |
DuoHexaBody-CD37 | CD37 | 50:50 Genmab | Hematologic malignancies | ||||
(GEN3009) | / AbbVie | ||||||
DuoBody-CD3x5T4 | CD3, 5T4 | 50:50 Genmab | Solid tumors | ||||
(GEN1044) | / AbbVie | ||||||
IND/CTAs in 2020 | Genmab | ||||||
HexaBody-CD38 (GEN3014)2 | 32 | ||||||
1Certain product candidates in development with partners, as noted. 2Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen Biotech, Inc
Products Created by Genmab*
Including Proposed Label Expansions for Marketed Products
Product | Target | Developed By | Disease Indications | Most Advanced Development Phase |
Pre-Clinical | 1 | 1/2 | 2 | 3 | Approved |
DARZALEX | CD38 | Janssen (Tiered | ||||||
(daratumumab) & | royalties to Genmab | |||||||
DARZALEX | on net global sales) | Multiple myeloma1 | ||||||
FASPRO | ||||||||
(daratumumab and | ||||||||
hyaluronidase-fihj) | ||||||||
Daratumumab | AL Amyloidosis | |||||||
Non-MM blood cancers | ||||||||
Kesimpta | CD20 | Novartis (Royalties | ||||||
(ofatumumab) | to Genmab on net | Relapsing multiple sclerosis1 | ||||||
global sales) | ||||||||
Arzerra | CD20 | Novartis | Chronic lymphocytic leukemia1,2 | |||||
(ofatumumab) | ||||||||
TEPEZZA | Horizon | |||||||
(teprotumumab-trbw) | Therapeutics (under | |||||||
IGF-1R | sublicense from | Thyroid eye disease1 | ||||||
Roche, royalties to | ||||||||
Genmab on net global sales)
Teprotumumab | Diffuse cutaneous systemic sclerosis |
*Out-licensed products marketed by partner 1See local country prescribing information for precise indications, 2Not in active development
Partner-owned Products Incorporating Genmab's Innovation*
Product | Target | Developed By | Disease Indications | Most Advanced Development Phase | |||||
Pre-Clinical | 1 | 1/2 | 2 | 3 | Approved |
Amivantamab | EGFR, cMet | Janssen |
(JNJ-61186372) | ||
Teclistamab | BCMA, CD3 | Janssen |
(JNJ-64007957) | ||
PRV-015 | IL-15 | Provention Bio |
(AMG 714) | ||
Camidanlumab tesirine | ||
(ADCT-301) | CD25 | ADC Therapeutics |
Mim8 | FIX(a), FX | Novo Nordisk |
Talquetamab | GPRC5D, CD3 | Janssen |
(JNJ-64407564) | ||
JNJ-63709178 | CD123, CD3 | Janssen |
JNJ-63898081 | PSMA, CD3 | Janssen |
JNJ-67571244 | CD33, CD3 | Janssen |
JNJ-70218902 | Undisclosed | Janssen |
HuMax-IL8 | IL8 | BMS |
Lu AF82422 | alpha-Synuclein | Lundbeck |
Non-small-cell lung cancer | |
(NSCLC) | |
Relapsed or refractory MM | |
Celiac disease | |
Relapsed /Refractory Hodgkin | |
Lymphoma | |
Solid tumors | |
Healthy volunteers & hemophilia A | |
Relapsed or refractory MM | |
Acute Myeloid Leukemia (AML) | |
Solid tumors | |
Relapsed or refractory AML or | |
MDS | |
Solid tumors | |
Advanced cancers | |
Parkinson's disease | 34 |
*Out-licensed Products under development by a third-party incorporating Genmab technology and innovation
Solid Foundation Built on a Differentiated Pipeline
Tisotumab Vedotin Clinical Program
innovaTV 204
Recurrent or metastatic
cervical cancer
- Potentially registrational 102 pts
- Single arm, monotherapy
- 1° endpoint: confirmed ORR
- 2° endpoints: duration of response, PFS, OS
innovaTV 205
Recurrent or metastatic
cervical cancer
• In combo or mono
w/ bevacizumab, pembrolizumab, or carboplatin or weekly monotherapy recurrent or stage IVB cervical cancer
- Up to 170 pts
- 1° endpoint: ORR
-
2° endpoints: Safety, duration of response, time to response,
PFS, OS
innovaTV 207
Solid tumors
- Basket study
- Up to 250 pts
- Single arm, monotherapy
- 1° endpoint: ORR
-
2° endpoints: Safety, disease control rate, duration of response, time to response,
PFS, OS
innovaTV 208
Ovarian cancer
- Ovarian cancer, fallopian tube cancer, peritoneal cancer
- Up to 182 pts, incl 12 pt safety run-in
- Monotherapy
- 2 schedules: q3wk & dose dense
- 1° endpoints: Safety & ORR
35
Tisotumab Vedotin
Cervical Cancer Market Size
United States3 | Japan6 | Europe2 | |||
New Diagnoses | Deaths | New Diagnoses | Deaths | New Diagnoses | Deaths |
12,578 | 4,115 | 9,390 | 3,654 | 58,373 | 24,404 |
3rd most common gynecologic | 2nd most common gynecologic | 3rd most common gynecologic |
cancer in US4 | cancer in Japan6 | cancer in Europe2* |
In developed countries, incidence rates are low (<7.9 per 100,000 women) compared with developing countries in sub-Saharan Africa and Central and South America, where incidence is especially high (>30 per 100,000 women)5
*Europe is defined as the 40 countries in the four United Nations-defined areas of Europe and the European Union (EU-27). | |
References: 1. American Cancer Society 2. .EUCAN (2012) 3. Centers for Disease Control and Prevention. Cervical Cancer Statistics (2017) 4. UpToDate. | 36 |
5. Ginsburg O et al. Lancet 2017 6. HPV Information Centre Japan (2017) |
HexaBody-CD38 (GEN3014)
Expanding the Potential of CD38 Antibodies
Incorporates | Highly promising | Could potentially | IND/CTA planned |
proprietary | data pre-clinical | add to and broaden | in H2 2020 |
HexaBody | models for MM, | DARZALEX | |
technology | lymphoma & AML | franchise | |
37
Covering All Stages of MM and Beyond: Key Ongoing* Industry Sponsored Trials
Disease
High Risk Smoldering MM
Front line MM (transplant & non- transplant)
Relapsed or Refractory MM
ALL
Therapy
Subcutaneous
Monotherapy
Dara + VRd
Dara + VMP (Asia Pacific)
Dara + VRd
Dara + R (maintenance)
Dara + combinations
Dara + I.O. (PD1 & PDL1)
Dara + SoC chemo
Development Phase
Pre-Clinical | 1 | 1/2 | 2 | 3 |
AQUILA | ||||
CENTAURUS | ||||
CEPHEUS | ||||
OCTANS | ||||
PERSEUS | ||||
AURIGA | ||||
NINLARO® (Ph II), Venclexta® (Ph II), Selinexor | (Ph I/II) | |||
Opdivo® (Ph I/II), Tecentriq® (Ph I) |
DELPHINUS
V = Velcade® , MP = melphalan-prednisone , T = thalidomide d = dexamethasone, R = Revlilmid®, K = Kyprolis®, Pom = Pomalyst®
- Fully recruited
*Does not include trials that may still be ongoing but have clinical data and/ or | 38 |
are the basis for an existing approval. | |
Daratumumab Efficacy in Newly Diagnosed Multiple Myeloma
Updated Phase 3 MAIA Trial (D+Rd, NTE): ASH Dec 2019
• Median PFS not reached in D-Rd arm
• MRD-negativity significantly higher with D-Rd vs. Rd (29% vs 9%; P<0.0001)
• No new safety concerns
• Results continue to support use of D-Rd in 1st line treatment of TIE pts with NDMM
39
D = daratumumab; R = lenalidomide; d = dexamethasone; PFS = progression free survival; MRD - minimal residual disease
Ongoing Daratumumab Clinical Trials
Janssen Sponsored Phase 3 & 4
Daratumumab Trials Sponsored by Pharma / Biotech
Ct.gov Identifier | Phase | Sponsor | Indication | Therapy |
NCT03768960 | 4 | J&J Private Ltd | Relapsed or Refractory MM | Daratumumab (MMY4008) |
NCT02252172 | 3 | Janssen | Untreated MM | Daratumumab + Rd (MAIA) |
NCT02195479 | 3 | Janssen | Untreated MM | Daratumumab + VMP (ALCYONE) |
NCT02541383 | 3 | Janssen | Untreated MM | Daratumumab + VTd (CASSIOPEIA) |
NCT02076009 | 3 | Janssen | Relapsed or Refractory MM | Daratumumab + Rd (POLLUX) |
NCT02136134 | 3 | Janssen | Relapsed or Refractory MM | Daratumumab + Vd (CASTOR) |
NCT03180736 | 3 | Janssen | Relapsed or Refractory MM | Daratumumab + Pom-d (APOLLO) |
NCT03201965 | 3 | Janssen | Amyloidosis | Daratumumab + CyBorD (ANDROMEDA) |
NCT03217812 | 3 | Janssen | Untreated MM | Daratumumab + VMP (Asia Pacific) (OCTANS) |
NCT03234972 | 3 | Janssen | Relapsed or Refractory MM | Daratumumab + Vd vs Vd (LEPUS) |
NCT03277105 | 3 | Janssen | Relapsed or Refractory MM | Daratumumab SubQ vs IV (COLUMBA) |
NCT03301220 | 3 | Janssen | Smoldering MM | Daratumumab SubQ (AQUILA) |
NCT03652064 | 3 | Janssen | Untreated MM | Daratumumab + VRd (CEPHEUS) |
NCT03710603 | 3 | Janssen/EMN | Untreated MM | Daratumumab + VRd (PERSEUS) |
NCT03901963 | 3 | Janssen | Untreated MM / Maintenance | Daratumumab + R (AURIGA) |
40
Ongoing Daratumumab Clinical Trials
Janssen Sponsored Phase 1 & 2
Daratumumab Trials Sponsored by Pharma / Biotech
Ct.gov Identifier | Phase | Sponsor | Indication | Therapy | |
NCT03384654 | 2 | Janssen | Relapsed / Refractory ALL / LL | Dara + Vincristine + Prednisone + Doxorubicin (DELPHINUS) | |
NCT02951819 | 2 | Janssen | Untreated and Relapsed MM | Daratumumab + CyBorD (LYRA) | |
NCT02874742 | 2 | Janssen | Untreated MM | Daratumumab + VRd (GRIFFIN) | |
NCT02316106 | 2 | Janssen | Smoldering MM | Monotherapy (CENTAURUS) | |
NCT02927925 | 2 | Janssen | NKTCL, Nasal Type | Monotherapy (VOLANS) | |
NCT03412565 | 2 | Janssen | Newly diag. & relapsed / refractory MM | Daratumumab SubQ + Rd, VMP & VRd (PLEIADES) | |
NCT03871829 | 2 | Janssen | Dara retreatment | Daratumumab SubQ+ Kd vs Kd (LYNX) | |
NCT03011034 | 2 | Janssen | MDS | Daratumumab (or talacotuzumab) (MDS2002) | |
NCT01615029 | 1/2 | Janssen | Relapsed and Refractory MM | Daratumumab + Rd (GEN503) | |
NCT02852837 | 1 | Janssen | Relapsed or Refractory MM | Monotherapy (in China) (MMY1003) | |
NCT02519452 | 1 | Janssen | Relapsed or Refractory MM | Monotherapy, subcutaneous (PAVO) | |
NCT02918331 | 1 | Janssen | Untreated MM | Daratumumab + Rd (Japan) (MMY1006) | |
NCT03242889 | 1 | Janssen | Relapsed or Refractory MM | Daratumumab subq (Japan) (MMY1008) | |
NCT01998971 | 1 | Janssen | Various MM | Daratumumab + backbone regimens (Vd, VMP, VTd, Pom-d, Kd, KRd) | |
(EQUULEUS) | |||||
NCT04108195 | 1 | Janssen | Multiple Myeloma | Daratumuamb + either talquetamab or teclistamab (MMY1002) | |
NCT04121260 | 1 | Janssen | Multiple Myeloma | Subcutaneous monotherapy (in China) (MMY1010) |
41
Ongoing Daratumumab Clinical Trials
Other Industry Sponsored Trials
Daratumumab Trials Sponsored by Pharma / Biotech
Ct.gov Identifier Phase | Sponsor | Indication |
Therapy
NCT03158688 3
NCT01946477 2
NCT02807454 2
NCT03439293 2
NCT03314181 2
NCT02807558 2
NCT02773030 1/2
NCT02343042 1/2
NCT03481556 1/2
Amgen | Relapsed or Refractory MM |
Celgene | Relapsed or Refractory MM |
Celgene | Relapsed and Refractory MM |
Takeda | Relapsed or Refractory MM |
AbbVie | Relapsed or Refractory MM |
Syros Pharma | AML or MDS |
Celgene | Relapsed or Refractory MM |
Karyopharm | Relapsed or Refractory MM |
Oncopeptides | Relapsed or Refractory MM |
AB | |
Daratumumab + Kd (CANDOR)
Daratumumab + Pom-d
Daratumumab + Imfinzi (FUSION)
Daratumumab + NINLARO (ixazomib) + Dex
Daratumumab + Venetoclax + Dex (w/ or w/out bortezomib) Daratumumab + SY-1425
Daratumumab + CC-220 + Dex
Daratumumab + Selinexor + Dex (STOMP)
Daratumumab + Melflufen + Dex (ANCHOR)
NCT01592370 | 1/2 | BMS | Relapsed or Refractory MM |
NCT03837509 | 1/2 | Incyte | Relapsed or Refractory MM |
NCT03989414 | 1/2 | Celgene | Various MM |
NCT02431208 | 1 | Roche | Resistant or Refractory MM |
NCT03068351 | 1 | Roche | Resistant or Refractory MM |
NCT04045028 | 1 | Genentech | Relapsed or Refractory MM |
NCT04136756 | 1 | Nektar Thera. | Salvage for MM |
Daratumumab + nivolumab
Daratumumab + INCB001158
Daratumumab + CC-92480
Daratumumab + Tecentriq (atezolizumab)
Daratumumab + RO6870810
Daratumumab + tiragolumab
Daratumumab + NKTR-255
42
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Genmab A/S published this content on 03 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 November 2020 20:15:09 UTC