2023

Landscape Review Series

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www.beacon-intelligence.com Copyright Hanson Wade 2024

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 Market and Development Challenges
We understand the challenges you face in developing your ADC drugs.

Difficulty Tracking The Increasingly Global ADC Landscape

Significant growth and expansion, particularly across Asia, where the
average annual growth rate over the last 10 years has outpaced that of the
USA, at 51% compared to 23%, creates a progressively complex
landscape to track and stay ahead of. The increasing global nature of ADC
development makes insights critical, but harder to track than ever before.

Complexity of Managing Associated Toxicity

Managing the associated toxicity of inhibitor payloads in your ADC
preclinical development remains a significant hurdle to cross. However,
our research shows that with adequate preclinical studies, including the
cell lines and animal models, you can increase your chances of validating
the correct payload and target specificity, efficacy, and safety.

Understand The Investment Community With Confidence

Even with the recent discontinuations of a few HER-2 ADCs in the clinic,
there remains heavy competition and investment in the space, with some of
the largest 2023 deals coming in that area. In 2023, two major deals of
$3.5bn were announced including BioNTech with DualityBio, and Bliss
Biopharmaceutical with Eisai, Inc. showing the huge commercial benefits
still available despite the heavy competition.

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Welcome & Contents
Welcome to the Beacon ADC 2023 Landscape Review Series.
We are kicking off the series with a thorough examination of the 2023 ADC drug landscape. There is a lot to cover from
development progression to new clinical ADCs, payloads to discontinuations.
Using data derived from Beacon ADC as of the 1st January 2024, we have compiled everything you need to know about the
2023 ADC drug landscape right here.
Stay tuned for upcoming releases in this series by visiting the 2023 ADC Landscape Review Series webpage.

Contents Coming Soon in The Series

• Introduction • The Trial Landscape NEW
• The Drug Landscape • The Commercial Landscape and Future of ADCs

Some information has been removed from this section. If you would like to obtain the complete version, or speak with one of our ADC
specialists, please do not hesitate to contact beacon@hansonwade.com to discuss your drug development and commercial data needs.

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 Introduction
A brief overview of the wider drug conjugate landscape.

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Drug Conjugate Landscape
As of the end of 2023, Beacon has identified 2007 drug conjugate programs, 1262 (63%) of which are antibody cytotoxic or non-cytotoxic drug
conjugates (marked by the red box below).
This landscape review will focus on traditional and novel ADCs including multispecific ADCs, antibody fragments drug conjugates, and
antibody novel payload conjugates such as immune stimulators.

Drug Conjugate Landscape Covered by Beacon ADC

Traditional ADC 1001
Novel Antibody Drug Conjugate 261
Small Molecule Ligand-Drug Conjugate 262
Radioconjugate 191
Radioimmunoconjugate 113
Immunotoxin 76
Peptide-Drug Conjugate 55
Protein-Drug Conjugate 22
Antibody/Small Molecule and Drug-Conjugated Nanoparticle 21
Antibody-Liposomal Drug Conjugate 5
0 200 400 600 800 1000 1200
Number of Drugs

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 The Drug Landscape
A review of ADC drug development in 2023.

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 Drug Status
Approved 1% Of the total 1262 ADCs, 331 (26%) have entered
the clinic. 63% of the clinical drugs are either
approved or being actively investigated in trials.
Preclinically Not
Active 25% 74% of ADCs are still in the preclinical stage of
Clinically development. Compared to the clinical space,
Clinically Active the proportion of active ADCs is slightly higher in
17% Discontinued 5%
the preclinical space, with 65% being active.
Compared to last year, the proportions of not
active ADCs had an increase of 6% and 2% in
Total clinic and preclinic, respectively.
1262
Preclinically Unfortunately, we did not see any new ADC
Discontinued
ADCs
Clinically Not approved last year, which ended a 4-year streak
< 1% Active 4% of seeing at least one new approval each year.

Preclinically
Active 48%

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ADC Development Progression
1 1 1
3

8 4

7
This graph shows the dynamics of how ADCs have
progressed to new phases over 2023 with 55 ADCs
entering the clinic for the first time.​
38 2
A total of 12 ADCs advanced from phase 1 and phase 1/2
to phase 2 while 9 ADCs initiated phase 3 trials progressing
from earlier stage trials.

1 Additionally, there were already 8 preclinical ADCs

registered on the trial registries last year or early this year
for initiating their FIH trial in 2024. These drugs are not
17 included in the analyses of the 2023 clinical drug
landscape.

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 New Clinical ADCs
The explosive growth in the number of new ADCs entering the clinic slowed down in 2023, ending up with a similar number of new clinical
ADCs entering the clinic as 2022.
Although the total number of new clinical ADCs did not increase, the number of new clinical ADCs developed by Asian developers has
continued to grow. The AAGR of companies from Asia and the US were 51% and 23% in the last 10 years, respectively.
Of the 36 new clinical ADCs from Asian developers, 34 new drugs were developed by Chinese developers. The remaining two were from
Japan and Singapore.

Geographic Distribution of the New Clinical ADCs Each Year by Main Developers'
60 Headquarters
Asia Europe United States
50
Number of Drugs

40

30

20

10

0
1997 2000 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

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 Companies of New Preclinical ADCs
Additionally, we investigated the location of new preclinical ADCs disclosed in 2023 by the country of their main developers’ headquarters and
found that most new preclinical drugs were mainly from the US, China, and South Korea.
There has also been interest in the development of ADCs in European companies, especially the UK and Germany.

Geographic Distribution of 2023 New Preclinical ADCs by Main Developers' Headquarters

70
60
Number of Drugs

50
40
30
20
10
0

India

United Kingdom

Germany

Netherlands
United States

Singapore

Japan

Switzerland

Italy

Czech Republic
South Korea
China

Denmark

Spain

France
North Asia Europe
America

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Mechanism of Action (MoA) and Payloads
Topoisomerase I inhibitors took second place as the most prevalent payload class from DNA damaging agents in 2022. The trend of using
topoisomerase I inhibitor payload has continued to grow in 2023.
Although tubulin inhibitor payload leads the current clinical ADC payload space, we observed more ADCs using topoisomerase I inhibitor
entering the clinic in 2023.

Clinical ADCs by MoA Class

120

100
Total Clinically Active ADCs New Clinical ADCs in 2023 New Clinical ADCs in 2022
Number of Drugs

80

60

40

20

0
Tubulin inhibitor Topoisomerase I DNA Damaging Immunomodulator Others Undisclosed
inhibitor agent

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Targets
A total of 25 targets were explored by the 2023 clinical entrants. HER-2 was again one of the most sought-after disclosed ADC targets, even
though HER-2 targeted therapy markets are becoming increasingly competitive. 3 out of the 6 HER-2 new clinical ADCs are novel format
ADCs. Two of them were bispecific ADCs, and one was an immune-modulating ADC.
There were four targets that are marked in the red boxes below entering the clinic for the first time.

Targets of New Clinical ADCs in 2023

10
8
Number of Drugs

6
4
2
0
Nectin-4

CLDN18.2

B7-H3

c-MET
HER-2

SIGLEC3

Fibronectin extra-domain B

CEACAM5; CEACAM6

PD-L1

CEACAM5
CD19

Folate Receptor Alpha

CD70

MUC-1

DR5

HER-3

LIV-1
Undisclosed

TROP-2

CD123

EGFR

GPRC5D
P-Cadherin

EphA5

CD79b

Tfr1
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 Discontinued Drugs
Last year, there were six ADCs discontinued with an announcement from the developer listed below.
Highest
Drug Disease Site
Developer Phase of Target Payload DAR Discontinuation Reason
Name Indication Specific
Development
ImmunoGen, Inc.; Discontinued due to tusamitamab's inability to
Non-squamous meet its dual primary endpoint of PFS
Tusamitamab Abbvie; Sanofi;
Non-small Cell 3 CEACAM5 DM4 3.9 N compared to docetaxol in phase 3 CARMEN-
ravtansine Innovent Biologics
Lung Cancer LC03 trial (NCT04154956)
(Suzhou) Co. Ltd.
Cofetuzumab Non-Small Cell Discontinued due to strategic fit with Pfizer's
Abbvie; Pfizer 1 PTK7 PF-06380101 4 N operations
pelidotin Lung Cancer
Due to the strategic transformation and market
HER2-positive competitive landscape, TOT BIOPHARM
TAA013 TOT BIOPHARM 3 HER-2 DM1 3.5 N decided to terminate the development of
Breast Cancer
TAA013
Abzena; OBI Pharma; Advanced Solid Y Discontinued due to limited potential on cancer
OBI-999 1/2 Globo H MMAE 4 treatment
Odeon Therapeutics Tumors ThioBridge®

Rheumatoid
Arthritis; Discontinuation was due to the benefit-risk
ABBV-154 Abbvie Polymyalgia 2 TNF-alpha Steroid 4 N profile not being sufficiently differentiating from
Rheumatica; that of other available treatments.
Crohn's Disease
R/R acute myeloid Patients developed a Grade 5 serious adverse
Magenta
leukemia; event, or SAE (respiratory failure and cardiac
MGTA-117 Therapeutics; 1 cKIT Amanitin 2 N/A
myelodysplastic arrest resulting in death).
Heidelberg Pharma
syndromes
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Beacon ADC Database
Our cutting-edge ADC database provides targeted filtering, milestone benchmarking and visualization,
download capabilities, and custom updates. You can find any precise data you need, fast, and with the
confidence that you have full visibility of the entire ADC drug and commercial landscape at your fingertips
in one easy-to-use platform.

With our world-class ADC database, you have access to 2000+ drugs and 2900+ trials covering the drug
conjugates field from novel and traditional ADCs to Immunotoxins and ligand conjugated nanoparticles. You
will also unlock 1600+ deals and 1700+ company profiles enabling unparalleled insights into the latest
commercial deals. Monitor your competitors and opportunities as well as benchmark deals.

Give yourself a ruthless advantage and be at the forefront of emerging trends, new developers and deals in
the ADC field with real-time, personalized updates and alerts, as well as exclusive in-depth monthly
reports curated by our specialist analyst team especially for our customers.

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Thank you
Make Faster, Better Drug
Development Decisions
beacon@hansonwade.com | www.beacon-intelligence.com

Copyright: Hanson Wade 2024

This report has been created through considerable effort by Hanson Wade’s Beacon ADC research team. Unauthorized copying and/or distribution of this document
constitutes copyright infringement. All rights reserved.

www.beacon-intelligence.com Copyright Hanson Wade 2024