On November 4, 2025 Catalent, Inc., a leading global contract development and manufacturing organization, reported 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.

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The updates were presented at the 16th 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."

(Press release, Catalent, NOV 4, 2025, https://www.catalent.com/catalent-news/catalents-smartagadc-pipeline-and-new-enhanced-conjugates-offering-featured-at-16th-world-adc-san-diego/ [SID1234659383])

On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Single Intratumoral Drug Injection Yields Complete Response (CR) in Metastatic Breast Cancer (MBC) Bone Lesions", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 10, 2025.

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The abstract presents preliminary clinical data from a recently completed Phase 2a trial (NCT05280067) performed at the University of British Columbia evaluating ZetaMet (Zeta-BC-003) for safety and efficacy for the treatment of MBC lytic bone lesions in Stage 4 breast cancer patients. Phenotypes treated within the study, TNBC, HR+, HR+/HER2+, and HERS2+/HR-. Each patient underwent a single fluoroscopy-guided injection of ZetaMet while under sedation. All achieved a complete response (CR), ceased tumor activity, with no serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs) and many demonstrated a reconstitution of trabecular bone, which further underscores the potential of ZetaMet to not only halt disease progression but restore skeletal integrity.

The findings build on prior compassionate use cases published in peer-reviewed journals with two-year follow-up, reinforcing ZetaMet’s potential to prevent SREs and improve overall survival. The abstract will be published in SABCS 2025 Proceedings and featured in Clinical Cancer Research.

With the trial now complete and comprehensive analyses underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to Health Canada (HC) and the U.S. Food and Drug Administration (FDA) to inform future planning discussions.

Presentation Details:

Abstract Number: 3549
Presentation Number: PS1-13-18
Presentation Title: Single Intratumoral Drug Injection Yields Complete Response in Metastatic Breast Cancer Bone Lesions: Results from Phase 2a Trial
Poster Presentation: Wednesday, December 10, 2025, 12:30-2:00pm CST
"The promising Phase 2a findings for ZetaMet mirror our earlier peer-reviewed results, reinforcing the strength of our clinically validated strategy in treating metastatic breast cancer." said Joe C. Loy, CEO of Zetagen Therapeutics. "We observed that both treated and adjacent non-treated lesions within the same vertebral body achieved complete response, with no signs of tumor activity and no skeletal-related events—all using the same drug concentration validated in our preclinical studies—strongly affirming the scientific foundation of our approach".

About ZetaMet (Zeta-BC-003)
ZetaMet (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule, administered intratumorally to minimize off target toxicity, delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet.

Zetagen with FDA and Health Canada (HC) approval via the Expanded Access (Compassionate Use) program has treated eight (8) patients with ZetaMet (Zeta-BC-003) with results published multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of seven (7) lytic lesions (radiated and non-radiated), reduction in pain, significant attrition of opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i] To view this publication via open access, go to: View Source

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659381])

On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.

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In a head-to-head comparison with standard-of-care therapies Tamoxifen and Abemaciclib (i.e., Verzenio), a single intratumoral injection of Zeta-BC-007 significantly outperformed both agents. Mice treated with Zeta-BC-007 containing NME + NaN + ABE showed a 66% reduction in tumor volume and complete absence of tumor activity by day 60, while all mice in the TAM and ABE groups succumbed to disease.

"Zeta-BC-007 represents a significant leap forward in intratumoral cancer therapy. By combining a novel molecular entity with synergistic therapeutics in a lipid-based hydrogel, we’ve demonstrated not only superior tumoricidal activity but also extended survival in preclinical models. These results reinforce our commitment to developing localized, non-systemic treatments that challenge the limitations of conventional cancer care."

— Bryan S. Margulies, PhD, Co-founder and CSO, Zetagen Therapeutics

"These results mark a pivotal moment in our journey to redefine primary breast cancer treatment," said Joe C. Loy, CEO of Zetagen Therapeutics. "the ability of Zeta-BC-007 to deliver potent tumoricidal effects through a single localized injection — without systemic toxicity — represents a new frontier in oncology. We believe this platform has the potential to transform how solid tumors are treated."

Presentation Details:

Abstract Number: 3638
Presentation Number: PSA-06-30
Presentation Title: Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)
Poster Presentation: Thursday, December 11, 2025, 5:00-6:30pm CST
About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, the novel formulation enables controlled release of multiple small molecules — with one being our novel molecular entity coupled with any other fat-soluble drugs; including other companies CDK4 or CDK4/6 protein inhibitors or any anticancer therapeutic. Designed for solubility within adipose tissue, ZetaPrime is a paradigm-shifting intratumoral approach to adjuvant therapy that targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659380])

On November 4, 2025 Vivesto AB, an oncology-focused development company, reported that positive results were obtained from preclinical studies in an animal model of Acute Myeloid Leukemia (AML), in which Cantrixil was combined with drugs used in standard of care treatments. Vivesto also announced that a new international patent application covering the treatment of hematological cancer with Cantrixil in combination with other treatments has been filed, with the potential to significantly strengthen the IP position.

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The drug candidate Cantrixil has been evaluated in vivo in combination with other anti-cancer drugs in an animal model involving difficult to treat human AML cancer. The results demonstrate clear positive effects of Cantrixil alone and even stronger effects when Cantrixil was combined with other anti-cancer drugs. These positive results confirm previous preclinical in vitro and in vivo efficacy data that have shown strong effects of Cantrixil alone and synergistic effects when combined with standard of care treatments, and support continued development of Cantrixil in hematological cancer, especially in AML.

"Hematological cancer is one of Vivesto’s priority focus areas, and we are pleased to report successful results from yet another preclinical study supporting further development of the Cantrixil program. The next steps involve further pre-clinical studies ahead of moving the program into clinical development," said Erik Kinnman, CEO of Vivesto. "Vivesto also filed a new international patent application for the treatment of hematological cancer with Cantrixil that may further increase the value of the program."

Vivesto is continuing the planning of activities needed to bring Cantrixil into clinical trials, and in parallel will investigate opportunities to partner the project to optimize the development program.

(Press release, Vivesto, NOV 4, 2025, View Source [SID1234659379])

On November 4, 2025 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"Werewolf is delivering on the promise of its proprietary PREDATOR platform of conditionally activated immune therapeutics, marked by significant progress for our lead INDUKINETM clinical programs, WTX-124 and WTX-330, and our first INDUCER T-cell engager candidate, WTX-1011," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "For WTX-124, which received Fast Track Designation last month, we plan to provide an update later in the fourth quarter of 2025 on the path to a registration-enabling trial based on interim Phase 1/1b clinical trial data and feedback from an End of Phase 1 meeting with the FDA. At the same time, we plan to provide an update on the current Phase 1b/2 clinical trial of WTX-330 and a potential development plan for this program. Finally, we continue to make progress in IND-enabling studies for WTX-1011, our first INDUCER T cell Engager development candidate, and plan to nominate a differentiated target candidate by year-end."

Recent Highlights and Upcoming Milestones
Clinical-Stage INDUKINE Molecules:
•WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
◦Fast Track Designation received from the US FDA for the use of WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy. Fast Track Designation is intended to expedite the development of drugs to address a serious unmet medical need and provide opportunities for frequent FDA interactions.
◦All expansion arms are either actively enrolling patients or fully enrolled in the ongoing Phase 1/1b clinical trial at a recommended dose of 18 mg administered intravenously every two weeks (IV Q2W). Enrollment is expected to be completed in all arms by the first quarter of 2026.
◦In the fourth quarter of 2025, Werewolf plans to release interim data from the monotherapy and combination expansion arms and to provide feedback from the Company’s End of Phase 1 meeting with the FDA. These inputs are expected to provide insight into potential registrational pathways for WTX-124 in advanced or metastatic cutaneous melanoma.
◦At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Pharmacokinetic insight into the IL-2 INDUKINE prodrug WTX-124: real-time assessment of tumor-specific activation and immune modulation."

•WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
◦Actively enrolling in a Phase 1b/2 clinical trial (WTX-330×2102) in locally advanced or metastatic solid tumors. An update on the clinical trial is expected to be released in the fourth quarter of 2025, with guidance on potential further development plans.
◦At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Sequential administration of WTX-124 and mWTX-330, IL-2 and IL-12 INDUKINE molecules, enhanced anti-tumor activity in mice bearing poorly immunogenic EMT6 tumors without systemic toxicity."
Preclinical-Stage INDUCER Molecules:
•WTX-1011: a potential first-in-class conditionally activated anti-STEAP1 T-cell engager to provide an improved therapeutic index.
◦STEAP1 is a promising prostate cancer target with limited expression in normal tissues, but notable toxicities are associated with existing anti-STEAP1 T-cell engager therapy.
◦Preclinical data demonstrated that PREDATOR masking technology successfully silenced peripheral activity and prevented cytokine release.
•Utilizing a novel and highly effective anti-CD3 masking strategy, Werewolf expects to nominate a differentiated target candidate in the fourth quarter of 2025.
•At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Development of conditional T cell engagers (INDUCERTM molecules) with a highly effective masking approach to reduce dose-limiting cytokine release and off-target peripheral toxicity."
Preclinical-Stage INDUKINE Partnering Opportunities:
•Werewolf’s previously announced development candidates available for partnering include: WTX-712, its Interleukin-21 (IL-21) INDUKINE molecule, and WTX-518, its binding protein resistant Interleukin-18 (IL-18) INDUKINE molecule, each for the treatment of cancer, and WTX-921, a first-of-its-kind Interleukin-10 (IL-10) INDUKINE molecule for the treatment of inflammatory bowel disease (IBD) and potentially other inflammatory diseases.
Financial Results for the Third Quarter of 2025:
•Cash position: As of September 30, 2025, cash and cash equivalents were $65.7 million, compared to $77.6 million as of June 30, 2025. The Company believes its cash and cash equivalents as of September 30, 2025, will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026.
•Research and development expenses: Research and development expenses were $11.6 million for the third quarter of 2025, compared to $12.5 million for the same period in 2024.
•General and administrative expenses: General and administrative expenses were $4.1 million for the third quarter of 2025, compared to $4.6 million for the same period in 2024.
•Net loss: Net loss was $16.4 million for the third quarter of 2025, compared to $16.7 million for the same period in 2024.

(Press release, Werewolf Therapeutics, NOV 4, 2025, View Source [SID1234659378])