August 2026 was a busy month for the antibody-drug conjugate (ADC) field, with activity spanning the full arc of development. Highlights included early discovery partnerships, manufacturing alliances, a practice-changing phase 3 readout in lung cancer, and the first dosing of a novel Treg-depleting ADC.
Taken together, the month’s news underscores two converging trends: a maturing ADC supply chain that increasingly resembles the broader biologics contract-manufacturing landscape, and a pipeline that is diversifying well beyond the topoisomerase-inhibitor payloads that built the category’s first wave of blockbusters.
Doubling Down on Next-Generation Payloads
On August 28, Genentech/Roche entered a global collaboration and license agreement with the Shanghai-based biotech DualityBio. The deal includes a $45 million upfront payment, more than $1 billion in potential development, regulatory, and commercial milestones, and tiered royalties on any resulting sales [1].
The partnership centers on DualityBio’s proprietary DUPAC (DualityBio Unique Payload Antibody Conjugate) payload platform. According to the company, this platform, one of four proprietary ADC technology platforms being developed by the company, generates short-half-life payloads designed to help ADCs overcome resistance mechanisms that increasingly limit the use of topoisomerase-inhibitor-based conjugates such as trastuzumab deruxtecan and sacituzumab govitecan [2].
Under the deal structure, DualityBio will lead discovery and early development against oncology targets selected by Genentech. Genentech will assume responsibility for later-stage global development once candidates clear Phase 1a.
The agreement is notable less for its size than for its place in a broader pattern. It is the third Chinese ADC licensing deal Roche has struck in 2026, following an earlier agreement with MediLink in January and a companion-target collaboration with Nurix in June. This deal also arrives alongside a flurry of platform and degrader-conjugate deals across the industry this year.
Genentech/Roche already markets two FDA-approved ADCs—polatuzumab vedotin (Polivy®) for diffuse large B-cell lymphoma and ado-trastuzumab emtansine (Kadcyla®) for HER2-positive breast cancer. This gives the DualityBio collaboration a built-in commercial and regulatory infrastructure to build on.
A Second Wave of Payload Innovation: Heidelberg Pharma and Huadong Medicine
Also on August 28, Germany’s Heidelberg Pharma expanded its long-running strategic relationship with China’s Huadong Medicine, its second-largest shareholder, to jointly develop a new generation of ADCs against as many as six additional targets [3]. The expanded agreement combines Heidelberg’s proprietary ATAC platform—built around amanitin-class toxin payloads—with Huadong’s antibody discovery and clinical development capabilities, and explicitly contemplates dual-payload and multispecific ADC architectures. The companies’ existing collaboration, dating to 2022, has already advanced HDP-101 (pamlectabart tismanitin), a BCMA-directed ATAC candidate for multiple myeloma, into bridging studies in China; the new agreement broadens that relationship into earlier-stage joint discovery rather than territory-based licensing alone.
Manufacturing Capacity Becomes a Strategic Asset
Two announcements this month reflected the growing recognition that ADC manufacturing—not just antibody or payload discovery—is itself a competitive differentiator.
On August 3, Fujifilm and Taiho Pharmaceutical announced a strategic partnership to develop manufacturing technologies for next-generation ADCs [4]. The collaboration will optimize production processes for ADC candidates built on Araris Biotech’s AraLinQ conjugation platform, combining Taiho’s drug-discovery expertise with Fujifilm’s biologics contract development and manufacturing experience. Fujifilm has separately indicated plans to launch an integrated, Japan-based ADC manufacturing service—covering antibody production, conjugation, and formulation under one roof—in 2027, mirroring the “one-stop shop” strategy pursued by larger Western CDMOs.
On August 17, Shanghai Henlius Biotech and Sandoz expanded their existing oncology biosimilars partnership to cover up to ten proposed monoclonal antibody and antibody-drug conjugate biosimilar products or components [5]. The initial tranche includes a cetuximab biosimilar (HLX05-N), an evolocumab biosimilar, and a belimumab biosimilar, with Sandoz paying Henlius up to $322 million in upfront, milestone, and option payments. While the agreement is framed primarily around monoclonal antibodies rather than approved ADC biosimilars specifically, it signals that biosimilar developers are now positioning ADC components within their broader oncology biosimilar strategies as the ADC class matures and reference products approach patent-cliff timelines.
AI and Diagnostics Move Into ADC Development
Precision-medicine tools are increasingly being layered onto ADC development programs to address a persistent puzzle in the field: target expression alone often fails to predict which patients will respond.
On August 11, Nucleai announced an ongoing translational research collaboration with Gilead Sciences, in which Nucleai is applying its AI-powered tissue analytics platform to Gilead’s global ADC clinical development programs [6]. The companies have analyzed a large dataset of hematoxylin-and-eosin and immunohistochemistry whole-slide images spanning multiple oncology indications, with the stated goal of generating candidate spatial biomarkers that go beyond simple target-expression scoring to capture tumor microenvironment context—an increasingly important consideration as ADC resistance mechanisms are shown to involve factors well beyond antigen density.
On August 27, Natera and the privately held biotech Angiex announced a collaboration to incorporate Natera’s Signatera circulating tumor DNA assay into Angiex’s ongoing phase 1 trial of AGX101, an investigational Nuclear-Delivered ADC directed against Transmembrane 4 L Six Family Member 1 (TM4SF1), a cell-surface protein that regulates cell growth, motility, and tumor angiogenesis, considered an emerging target expressed on both tumor cells and tumor-associated endothelium [7]. Longitudinal Signatera testing will be used to explore whether circulating tumor DNA (ctDNA) dynamics can complement radiologic assessment, particularly in cases where imaging changes are difficult to interpret as either response or pseudoprogression.
Portfolio Realignment: LigaChem Takes Sole Control of an ADC Program
Not every August headline involved new capital flowing into ADCs. On August 6, NextCure and LigaChem Biosciences formalized a transition agreement under which LigaChem assumed full responsibility for LNCB74, a B7-H4-directed ADC the companies had co-developed since 2022 [8]. NextCure had disclosed weeks earlier that it was opting out of continued cost-sharing for undisclosed strategic reasons unrelated to any safety or efficacy signals; LigaChem will now fund the ongoing phase 1 dose-escalation trial in breast, ovarian, and endometrial cancers as the sole developing party, while paying NextCure for future milestones and royalties. The episode is a reminder that, amid the month’s dealmaking enthusiasm, smaller biotechs are also actively triaging crowded ADC portfolios—LigaChem alone lists more than a dozen ADC-related global licensing and co-development arrangements.
Signals from AACR: Where the Science Is Headed
Reviews presented at the 2026 Annual Meeting of the American Association for Cancer Research and published by Cancer Research Catalyst in mid-August offered a window into the technologies likely to shape the ADC field over the next several years [9]. Several threads stood out. Multi-domain logic-gate antibody architectures—engineered to require sequential binding to two or three tumor antigens before releasing their full cytotoxic payload—were presented as a strategy to concentrate killing in the most clearly malignant cells while sparing tissue that expresses only one target antigen.
Separately, a growing subset of investigational ADCs are being designed not against tumor cells directly but against components of the tumor microenvironment itself, including intratumoral regulatory T cells and cancer-associated fibroblasts, on the theory that disabling these supportive cell populations can restore anti-tumor immune activity and amplify bystander killing. A parallel set of resistance-focused strategies—combining HER2-directed ADCs with EGFR antibodies, degrading the truncated p95HER2 protein, or substituting alternative topoisomerase-inhibitor chemistries, such as exatecan, for deruxtecan—reflects the field’s growing focus on extending durability in patients who have already progressed on first-generation ADCs.
Clinical Trial Highlights
DESTINY-Lung04 (NCT05048797; trastuzumab deruxtecan/Enhertu®). On August 17, AstraZeneca and Daiichi Sankyo announced positive topline results from this phase 3 trial testing trastuzumab deruxtecan against platinum-pemetrexed chemotherapy plus pembrolizumab (Keytruda®; Merck & Co/MSD) as first-line treatment for unresectable, locally advanced, or metastatic HER2 exon 19- or 20-mutant, nonsquamous non-small cell lung cancer. The 454-patient trial met its primary endpoint, with trastuzumab deruxtecan producing a statistically significant and clinically meaningful improvement in progression-free survival by blinded independent central review; overall survival remains under evaluation, and the companies characterized the safety profile as consistent with the drug’s known label, with no new safety signals identified. If the full dataset supports regulatory filing, this would be the first phase 3 demonstration of a HER2-directed ADC outperforming standard chemoimmunotherapy in the first-line NSCLC setting—a potential shift that would make upfront HER2 mutation testing more consequential at diagnosis.
DS1025, also known as DS1025a (NCT07681882; Daiichi Sankyo). On August 27, Daiichi Sankyo dosed the first patient in a first-in-human phase 1 trial of DS1025, described as a potential first-in-class CD25-directed ADC. Built on the company’s DXd conjugation technology, DS1025 pairs a CD25-targeting antibody with an immuno-oncology-optimized cytotoxic payload intended to selectively deplete intratumoral regulatory T cells and thereby restore anti-tumor immune activity. The open-label, dose-escalation study plans to enroll up to 45 patients with advanced or metastatic solid tumors across sites in Asia and Europe, evaluating safety and tolerability as primary endpoints and objective response rate, duration of response, and pharmacokinetics as secondary and exploratory measures.
CT-P73 (Celltrion). On August 13, Celltrion announced that the FDA granted fast track designation to CT-P73, a tissue factor-directed ADC, for recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy. Celltrion cited preclinical data suggesting antitumor activity and a safety profile comparable to or better than tisotumab vedotin (Tivdak®), the currently approved tissue factor-directed ADC in this setting. CT-P73 is one of three Celltrion ADC candidates—alongside a c-MET-directed and a nectin-4-directed program—now in phase 1 development, all of which have received fast track designation.
IDE849 (IDEAYA Biosciences). On August 31, IDEAYA Biosciences announced a successful FDA Type C meeting establishing the design of a phase 3 registrational trial for IDE849, a DLL3-directed, topoisomerase-1-payload ADC, in extensive-stage small cell lung cancer. The planned ~400-patient global trial, targeted to begin by year-end 2026, will randomize patients previously treated with the DLL3-directed bispecific tarlatamab (Imdelltra) 1:1 to IDE849 monotherapy versus investigator’s choice of topotecan or amrubicin, using objective response rate by blinded independent central review to support potential accelerated approval and overall survival to support full approval within a single seamless design.
Clinical trials
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations – ClinicalTrials.gov ID NCT05048797
First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors – ClinicalTrials.gov ID NCT07681882
Prescribing Information
Clinicians and pharmacists preparing for potential label expansions or evaluating current ADC therapies should keep the following approved prescribing information in view:
- Trastuzumab deruxtecan (Enhertu®) carries a boxed warning for interstitial lung disease/pneumonitis and embryo-fetal toxicity. As DESTINY-Lung04 raises the prospect of earlier-line use, monitoring for pulmonary symptoms and confirming pregnancy status before initiation remain central to safe administration regardless of treatment line. [Prescribing Information]
- Polatuzumab vedotin (Polivy®; Genentecj/Roche), marketed by Genentech, is currently approved in combination regimens for previously untreated and relapsed or refractory diffuse large B-cell lymphoma; its established safety and monitoring framework—including attention to peripheral neuropathy and cytopenias associated with its MMAE payload—provides the commercial and regulatory foundation Genentech is building on with its DualityBio collaboration. [Prescribing Information]
- Tisotumab vedotin (Tivdak®; Pfizer/Genmab) remains the only FDA-approved tissue factor-directed ADC and the current benchmark against which investigational candidates such as CT-P73 are being compared; its label includes warnings for ocular toxicity, peripheral neuropathy, and hemorrhage that will be relevant reference points as newer tissue factor-directed agents advance. [Prescribing Information]
- Tarlatamab (Imdelltra®; Amgen), while a bispecific T-cell engager rather than an ADC, is the current standard against which DLL3-directed ADCs such as IDE849 are being positioned in the post-progression small cell lung cancer setting, underscoring how ADCs and engineered antibody formats are increasingly being sequenced against, rather than developed in isolation from, one another.[Prescribing Information]
Highlights of Prescribing Information
Pembrolizumab (Keytruda®; Merck & Co/MSD)[Prescribing Information]
References
[1] DualityBio Enters a Global Collaboration and License Agreement with Genentech to Develop Next-Generation ADCs Built on DualityBio’s DUPAC Novel Payload Platform. News release. DualityBio. August 28, 2026.
[2] DualityBio. DUPAC Platform overview. en.dualitybiologics.com. Accessed August 2026.
[3] Heidelberg Pharma and Huadong Medicine Sign Additional Collaboration Agreement to Jointly Develop New Antibody Drug Conjugates. News release. Heidelberg Pharma AG. August 28, 2026.
[4] Fujifilm and Taiho Pharmaceutical Enter into Strategic Partnership for Development of Next-Generation Antibody-Drug Conjugate (ADC) Manufacturing Technologies. News release. FUJIFILM Corporation. August 3, 2026.
[5] Henlius and Sandoz Enter Strategic Collaboration to Unlock Global Value of Biosimilars Platform. News release. Shanghai Henlius Biotech, Inc. August 17, 2026.
[6] Nucleai Advances AI-Powered Tissue Intelligence Through Large-Scale Oncology ADC Collaboration. News release. Nucleai. August 11, 2026.
[7] Natera and Angiex Partner to Assess Response to Investigational Nuclear-Delivered Antibody-Drug Conjugate Using Signatera. News release. Natera, Inc. August 27, 2026.
[8] NextCure, Inc. Form 8-K, filed August 2026 (LNCB74 Transition and Continuation Agreement with LigaChem Biosciences, effective July 1, 2026; agreement executed August 6, 2026). U.S. Securities and Exchange Commission. [SEC Filing]
[9] Chneible, S. Smart Chemotherapy Gets Smarter: Advances in Antibody-drug Conjugates. Cancer Research Catalyst, American Association for Cancer Research. August 14, 2026. Online. Last accessed on August 31, 2026.
[10] Enhertu Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival as First-Line Treatment of Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial. News release. Daiichi Sankyo / AstraZeneca. August 17, 2026.
[11] DS1025 Enters Clinical Development in Patients with Advanced Solid Tumors as Novel CD25 Directed ADC in Industry-Leading ADC Portfolio of Daiichi Sankyo. News release. Daiichi Sankyo. August 27, 2026.
[12] FDA Grants Fast Track Designation for Celltrion’s CT-P73. News release. Celltrion, Inc. August 13, 2026.
[13] IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer. News release. IDEAYA Biosciences, Inc. August 31, 2026.
Featured image: © 2026 CH/JCO. Used with permission.
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