Catalent Showcases SMARTag® ADC Pipeline Progress and New Enhanced Conjugate Class at 16th World ADC San Diego
Catalent, Inc., a global leader in contract development and manufacturing services for advanced therapeutics, has unveiled a series of promising updates to its growing antibody-drug conjugate (ADC) portfolio, spotlighting major innovations derived from its proprietary SMARTag® technology platform. These developments were featured during the 16th annual World ADC San Diego conference, where Catalent presented new preclinical findings supporting advancement of its next-generation ADC candidate, CAT-09-833, as well as the introduction of SMARTag® Enhanced Conjugates, an emerging class of multi-payload ADC formats designed to broaden clinical applicability and improve drug performance.
The scientific presentation, delivered by Dr. Ayodele Ogunkoya, Bioconjugation Group Leader at Catalent, formed part of the conference’s Translational Medicine track and was titled, “SMARTag® Enhanced Conjugates: Novel Payload Combinations to Enhance ADC Efficacy & Payload Delivery.” With more than 1,400 biopharmaceutical stakeholders in attendance, the event served as an ideal showcase for Catalent to highlight both its technology portfolio and its increasing role in supporting the rapidly expanding global ADC therapeutic landscape.
Advancing Next-Generation ADCs for Ovarian Cancer
A central focus of Catalent’s announcement was the first disclosure of preclinical efficacy and tolerability data for CAT-09-833, a novel SMARTag® ADC candidate targeting the tumor-associated antigen MUC1. This receptor is highly expressed on the surface of ovarian cancer cells, including in hard-to-treat populations such as women with platinum-resistant ovarian cancer, a setting marked by high relapse rates, limited therapeutic options, and poor prognosis.
There is a growing body of evidence supporting the potential for ADCs to shift the treatment paradigm for ovarian cancer. Target selection is a key gating factor for drug design, and MUC1 has emerged as a compelling candidate due to its frequent expression and its tumor-selective biology. Importantly, MUC1 expression is complementary to other clinically validated ovarian cancer targets—including folate receptor α—suggesting that CAT-09-833 could serve not only as a standalone therapy but also provide a synergistic therapeutic avenue alongside future combination regimens.
According to Dr. Penelope Drake, Head of R&D Bioconjugates at Catalent, the company’s internal discovery team developed a first-in-class antibody with the potential to uniquely access MUC1-positive tumors via a SMARTag-enabled ADC payload. “There is a growing appreciation for the role that ADCs may play in ovarian cancer treatment,” Drake noted. “Our novel antibody offers a unique way to access this target with an ADC, and the data thus far suggest that CAT-09-833 has a promising preclinical profile. We look forward to seeing the molecule advance and learning more about its potential to help cancer patients.”
The early non-clinical data described at the conference indicate favorable tolerability paired with anti-tumor activity, supporting continued progression toward IND-enabling studies. The observations suggest that CAT-09-833 could provide a new and differentiated therapeutic solution to platinum-resistant ovarian cancer, a patient population urgently in need of improved outcomes.
Introducing SMARTag® Enhanced Conjugates: A New ADC Class
In addition to its pipeline progress, Catalent introduced a major advancement in ADC engineering: SMARTag® Enhanced Conjugates. These new constructs build upon the foundational strengths of the platform to create dual- and triple-payload ADCs that combine cytotoxic and non-cytotoxic functional components within a single molecular architecture.
Traditional ADCs rely solely on potent cytotoxic compounds to kill cancer cells; however, tumor microenvironments often present biological challenges such as stromal barriers, heterogeneity, and limited drug penetration, which can restrict overall response and limit durable benefit. By incorporating non-cytotoxic payloads that enhance penetration, payload delivery, or receptor internalization, SMARTag Enhanced Conjugates aim to improve the therapeutic index of ADCs without compromising systemic safety.
These constructs leverage the SMARTag® system’s highly controlled and tunable drug-to-antibody ratio (DAR) features, supporting rational combination of different payload classes tailored to the biology of a specific tumor. This enables development strategies optimized to maximize anti-tumor performance in diverse histologies, including solid tumor types with complex tumor microenvironments.
One example highlighted during the San Diego presentation involved conjugation with certepetide, an internalizing RGD (iRGD) cyclic peptide licensed from Lisata Therapeutics, Inc. Catalent presented new xenograft data showing that the incorporation of certepetide as a non-cytotoxic co-payload enhanced the overall tissue distribution of both the cytotoxic payload and the ADC antibody backbone within tumors. The preclinical results demonstrated improved ADC efficacy and expanded intratumoral delivery, including in dense solid tumor models where drug penetration frequently limits therapeutic effect.
This design strategy is aimed at unlocking the full potential of ADCs across a broader range of tumor targets and biological settings—especially solid tumors where conventional ADC formats may struggle to produce deep or sustained responses.
Deep Platform Roots and Strategic Expansion
Catalent has long positioned its SMARTag® technology as a key enabler of next-generation ADC innovation. This platform originated from technology spun out of the Bertozzi Laboratory at the University of California, Berkeley in 2008. Since then, Catalent has undertaken ongoing internal research and capital investment to expand its engineering capabilities, conjugation workflows, and manufacturing infrastructure to support differentiated ADC creation.
According to Mike Blank, General Manager at Catalent, the company’s efforts over the last decade have consistently centered on designing ADCs that optimize performance via chemical precision, biological specificity, and payload adaptability. “We have a history of innovation dating back to 2008 when we spun the SMARTag® technology out of the Bertozzi lab at UC Berkeley,” Blank said. “Since then, we have made continuous progress on expanding the capabilities of the platform and understanding the design elements that underpin a successful ADC.”
Blank believes that the introduction of SMARTag Enhanced Conjugates offers a significant evolution in ADC drug design by enabling multi-payload constructs that support new therapeutic hypotheses and disease settings. He added, “We believe the new SMARTag® Enhanced Conjugates represent the latest innovation in ADCs, allowing for the creation of an entirely new class of molecules that we hope will expand the scope of treatable cancer indications, reaching—and ultimately helping—more patients in need.”
Strategic Value in the ADC Market
The global ADC pipeline has expanded rapidly over the last several years, driven by increasing validation of the modality across oncology indications and improvements in payload chemistry, linker design, and target biology. Catalent’s SMARTag developments position the company to play a larger strategic role in this market, both as a technology originator and a manufacturing partner.
By combining its established clinical development and manufacturing footprint with internal discovery-stage work, Catalent seeks to offer an integrated pathway to support partners advancing ADCs from preclinical studies through commercialization. This includes controlled conjugation chemistry, customizable DAR engineering, and scalable GMP production.
Catalent’s participation in the World ADC forum also reflects the company’s broad engagement within the global ADC ecosystem. The annual meeting is widely regarded as the leading commercial and scientific gathering focused on the future of ADCs, offering a forum for emerging data, deal-making, and technology showcasing. More than 1,400 industry professionals—including researchers, biotech executives, and clinical development leaders—attend the conference seeking collaborations and next-generation solutions to accelerate progress in the field.
By presenting the CAT-09-833 dataset and introducing SMARTag Enhanced Conjugates on this high-visibility stage, Catalent positioned its technology and pipeline as an attractive platform for prospective biopharma partnerships. These collaborations could take the form of co-development agreements, licensing arrangements, or custom ADC manufacturing support.
The announcement at the 16th World ADC San Diego underscores Catalent’s multifaceted strategy to advance novel ADC science while building differentiated therapeutic assets with commercial potential. The company’s internal pipeline progress, exemplified by CAT-09-833, demonstrates a willingness to drive early-stage discovery focused on high-unmet need disease areas, such as platinum-resistant ovarian cancer.
Meanwhile, SMARTag® Enhanced Conjugates represent a forward-looking attempt to reshape how ADCs operate within solid tumor environments. By pairing cytotoxic and non-cytotoxic payloads, Catalent is exploring ways to overcome biological barriers that have historically constrained ADC effectiveness. If successful, this approach could generate new therapeutic designs capable of reaching patient populations not served by current ADC modalities.
As Catalent continues to refine its SMARTag technology, enhance its conjugation methodologies, and explore new structural designs, the company aims to deepen its role in driving innovation within the ADC market. Future updates will likely focus on further preclinical characterization, IND-enabling progress for CAT-09-833, and additional data validating Enhanced Conjugate constructs across multiple tumor models.
The SMARTag® ADC technology platform was developed by Catalent’s team in Emeryville, CA, located in the San Francisco Bay Area. This team originated as Redwood Bioscience, a startup co-founded in 2008 by Nobel Laureate Carolyn Bertozzi, and became part of Catalent through acquisition in 2014. At the core of the SMARTag® platform is its proprietary approach to making site-specific conjugates using the aldehyde tag and HIPS (hydrazino-iso-Pictet Spengler) chemistry, which together facilitate flexible design and optimized, stable ADCs.
The platform’s tandem-cleavage linker further enhances tumor-specific payload release, minimizing off-target toxicity and expanding the therapeutic index. Together, these modular components support the generation of both single- and multi-payload constructs. The SMARTag® technology is backed by 26 platform patent families, including 54% that provide protection to 2040 and beyond.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech, and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.
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