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Special Report Special Report

market represents the largest share, ac- FRα ADC for treating ovarian cancer sign for the contract ADC market. The in continuation payments over the formed in 2020, to develop and com- develop, manufacture, and commer-
counting for approximately 40% of the with the potential for expansion into Clarivate analysis shows that 33 dis- next 24 months (as reported in October mercialize datopotamab deruxtecan, cialize MediLink Therapeutics’
contract ADC market, followed by the other solid tumour indications. Piveki- closed blockbuster deals (defi ned as 2023), and potential additional pay- Daiichi Sankyo’s proprietary tropho- YL-211 against solid tumours world-
conjugation/linker segment at 30%, mab sunirine, currently in Phase II, is deals with a value of $1-bn or more) in ments of up to $16.5-bn contingent blast cell-surface antigen 2 (TROP2)- wide; and
the HPAPI/cytotoxic payload segment an anti-CD123 ADC targeting blastic the past fi ve years (2019-2023) represent upon the achievement of future sales directed ADC for treating several multi-  Ispen, a Paris-based bio/pharma
at 20%, and the fi ll-fi nish segment at plasmacytoid dendritic cell neoplasm a signifi cant jump in activity and valua- milestones, for a total potential conside- ple tumour types, including breast and company, and Sutro Biopharma,
10%, according to the Root Analysis (BPDCN), a rare blood cancer, which tion in the ADC fi eld (see Figure 2). ration of up to $22-bn. In aggregate, lung cancer. The drug is under regu- a South San Francisco, California-
study. was granted FDA breakthrough therapy the three programs have multi-billion latory review in the US for treating a based bio/pharma company, for a
designation for treating relapsed/ Overall, oncology continues to be dollar worldwide commercial revenue certain form of breast cancer, with an projected $899-mn to develop and
Bio/pharmaceutical M&A for ADCs refractory BPDCN. the leading focus for ADC-related potential for each company in the mid- expected Prescription Drug User Fee commercialize Sutro Biopharma’s
surge deal-making activity. Over the past 10 2030s timeline, according to informa- Act review date of January 29, 2025. In STRO-003 for treating solid
Pfi zer’s $43-bn acquisition of Sea- Also completed in 2024 was J&J’s years (2014-2023), oncology leads all tion from Merck in announcing the deal March 2024, the European Medicines tumours.
gen in December 2023 was not only the $2-bn acquisition of Ambrx Biopharma, ADC-related deals in both volume and last October. The companies will jointly Agency (EMA) validated two market-
high-mark among recent ADC deals, which gave J&J several clinical and value, accounting for 392 deals with a develop and potentially commercialize ing authorization applications for the ADC market: clinical development
but also was the largest acquisition in preclinical ADC programs in multiple projected total valuation of $206-bn, these ADC candidates worldwide, drug, respectively, to treat certain forms On a development basis, the Clari-
the industry in 2023. Seagen’s port- cancer indications, including ARX517, according to the Clarivate analysis. In except in Japan, where Daiichi Sankyo of breast and lung cancer. The valida- vate analysis estimates that there are
folio includes four approved medicines an ADC for treating prostate cancer, comparison, the next largest therapeu- will maintain exclusive rights. Daiichi tions begin the scientifi c review process more than 1,200 active clinical trials
that are indicated across solid tumours ARX788, an ADC for treating breast tic sector in ADC-related deal-making Sankyo is solely responsible for manu- by the EMA’s Committee for Medicinal for ADCs, the majority of which have
and hematologic malignancies, includ- cancer, and ARX305, an ADC for is in infectious diseases with nine deals facturing and supply. Products for Human Use. Clarivate occurred over the past fi ve years. Al-
ing three ADCs: Adcetris (brentuximab treating renal-cell carcinoma. with a projected value of approximately projects the ADC as a potential though cancer drugs have been the
vedotin), Padcev (enfortumab vedotin), $806-mn. The companies had a setback for blockbuster (defi ned as sales of $1-bn focus of most ADC research activity to
and Tivdak (tisotumab vedotin). The Another key ADC-related M&A one of these three ADC candidates, patri- or more) with expected sales of $2.70-bn date, 13 non-oncology ADC assets are
company also commercializes Tukysa was the $1.8-bn acquisition by Gen- One of the key deals was a $22-bn tumab deruxtecan, when the US Food for breast cancer and non-small-cell being evaluated in clinical trials that
(tucatinib), which was approved in mab, a Copenhagen-based bio/pharma global development and commerciali- and Drug Administration (FDA) issued lung cancer indications combined by started in the last fi ve years, according
2023 for treating certain types of ceutical company, of ProfoundBio zation agreement between Merck & a Complete Response Letter (CRL) in 2029, according to Clarivate’s ‘Drugs to the Clarivate data. These trials cover
colorectal cancer in combination with (Suzhou) Co. Ltd. Co. and Daiichi Sanyko in ADCs, an- June 2024 for the companies’ biologics to Watch 2024’ report. the following indications: age-related
trastuzumab. Clinical development nounced in October 2023, for three of license application for the drug due to macular degeneration (AMD), AL
programs are ongoing for each of these ADC-related deal-making also on Daiichi Sankyo’s ADC oncology drug fi ndings pertaining to an inspection of a As of April 12, 2024, 32 ADC- amyloidosis, Crohn’s disease, diabetic
medicines for potential new tumour the rise candidates: patritumab deruxtecan, third-party manufacturing facility. The related deals have been announced or macular oedema, Duchenne muscular
types or expanded indications in earlier Aside from outright acquisitions, ifi natamab deruxtecan, and raludotatug CRL did not identify any issues with completed, according to the Clarivate dystrophy, infl uenza, kidney disease,
lines of therapy, with catalysts expected an escalation in the number and value deruxtecan. Under the deal, Merck the effi cacy or safety data submitted. analysis. The largest disclosed deals rheumatoid arthritis, non-alcoholic steato-
annually through 2027. of partnering deals among bio/pharma agreed to pay Daiichi Sankyo a $4-bn The companies said that they will work (of more than $500-mn) have been hepatitis (NASH, a liver disease),
companies in ADCs is also a positive upfront payment in addition to $1.5-bn with FDA and its third-party manu- between: scleroderma, familial amyotrophic late-
Overall, 15 ADC-related mergers facturer to resolve the issues.  Bristol-Myers Squibb and Systim- ral sclerosis, and hepatitis B virus in-
and acquisitions (M&A) relating to mune, a Redmond, Washington- fection. Of these, an ADC, KSI-501, for
ADCs have occurred in the past fi ve Merck’s partnership with Daiichi based bio/pharma company, for a treating AMD, by Kodiak Sciences, a
years (2019-2023), according to a re- Sankyo followed Merck’s $9.5-bn projected $8.4-bn to co-develop and Palo Alto, California-based bio/pharma
cent analysis on the ADC market by license and collaboration agreement, co-commercialize Systimmune’s company, is the furthest along in deve-
Clarivate, a business intelligence fi rm. formed in 2022, with Kelun-Biotech, a BL-B01D1 in the US for treating lopment, with a Phase III trial slated
Seven of these, or nearly 50%, occurred bio/pharma company based in Chengdu, metastatic or unresectable non- to start in June 2024, according to the
in 2023 alone. Sichuan Province, China, to develop small-cell lung cancer; Clarivate analysis.
seven investigational preclinical ADCs  Merck KGaA and Caris Discovery,

Completed ADC-related M&A thus to treat cancer. That deal came in at the therapeutic research arm of ADC companies under the radar
far in 2024 (as of mid-April 2024) in- number one in terms of deal value in Caris Life Sciences, an Irvine, Texas- In its analysis, Clarivate also high-
clude AbbVie’s $10-bn acquisition of 2022 and second for the last fi ve years based molecular science and tech- lighted seven lesser-known companies
Immunogen, which netted Amgen (2019-2023), according to the Clarivate nology company, for a projected specializing in ADCs to watch, which
Immunogen’s commercial ADC, Elahere analysis. All of the top ADC deals over $1.4-bn to identify targets and deve- show promise either in terms of their
(mirvetuximab soravtansine-gynx), for the past fi ve years were in oncology. lop ADCs for cancer worldwide; pipeline assets or ADC-related tech-
treating platinum-resistant ovarian  Roche and MediLink Therapeutics, nologies.
cancer. ImmunoGen’s pipeline includes Fig. 2: ADC-related deals Daiichi Sankyo is also partnered a Suzhou, China-based bio/pharma
a Phase I asset, IMGN-151, an anti- Source: Clarivate, Cortellis Deals Intelligence; only deals with disclosed values included. with AstraZeneca in a $6-bn ADC deal, company, for a projected $1-bn to  Adcendo ApS (Frederiksberg, Den-

182 Chemical Weekly August 20, 2024 Chemical Weekly August 20, 2024 183

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