• Presented preclinical efficacy and tolerability data for CAT-09-833, a SMARTag® ADC targeting MUC1 featuring a novel, tumor-selective antibody
• Introduced SMARTag® Enhanced Conjugates, a new class of ADCs, with innovative cytotoxic and non-cytotoxic payload combinations on a single antibody designed to benefit patients by amplifying efficacy without compromising safety

Catalent, Inc., a leading global contract development and manufacturing organization, today highlighted new innovations from its SMARTag® antibody-drug conjugate (ADC) technology platform. The company announced preclinical efficacy and tolerability data demonstrating the potential of CAT-09-833, a SMARTag® ADC targeting MUC1, for the treatment of platinum-resistant ovarian cancer. The company also introduced SMARTag® Enhanced Conjugates, a new class of ADCs that combines different payload types to benefit more patients by amplifying efficacy without compromising safety.

The updates were presented at the 16^th World ADC San Diego conference in a session in the Translational Medicine track entitled “SMARTag® Enhanced Conjugates: Novel Payload Combinations to Enhance ADC Efficacy & Payload Delivery.” The presentation was made by Ayodele Ogunkoya, Ph.D., Bioconjugation Group Leader, Catalent. World ADC provides a leading opportunity for Catalent to spotlight its ADC technologies and services to more than 1,400 ADC biopharma attendees actively seeking new partnerships and solutions.

“There is a growing appreciation for the role that ADCs may play in ovarian cancer treatment. The MUC1 tumor-associated antigen, which is highly expressed in ovarian tumors, demonstrates expression complementary to that of other ovarian ADC targets, such as folate receptor alpha,” said Penelope Drake, Ph.D., Head of R&D Bioconjugates, Catalent. “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.”

Catalent’s new SMARTag® Enhanced Conjugates incorporate both cytotoxic and non-cytotoxic payloads to create unique dual- and triple-payload ADCs that can be optimized to the specific biology of the target tumor to amplify the effect of the cytotoxic payload without compromising safety. They are enabled by the SMARTag® platform, which allows for a tunable drug-to-antibody ratio (DAR). Catalent presented data from a xenograft model demonstrating that the use of certepetide as a non-cytotoxic payload can yield improved ADC efficacy and broaden the distribution of the ADC cytotoxic payload and antibody in the tumor microenvironment. Certepetide is an internalizing RGD (iRGD) cyclic peptide that Catalent licensed (along with its analogs) from Lisata Therapeutics, Inc. for use with its SMARTag® technology platform, with a goal of selectively targeting and penetrating solid tumors with ADCs more effectively.

Mike Blank, General Manager, Catalent, said, “We have a history of innovation dating back to 2008 when we spun the SMARTag® technology out of the Bertozzi lab at UC Berkeley. Since then, we have made continuous progress on expanding the capabilities of the platform and understanding the design elements that underpin a successful ADC. 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.”

About Catalent’s SMARTag® ADC Platform

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.

About Catalent

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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"We look forward to seeing the molecule advance and learning more about its potential to help cancer patients."