EpCAM x TOP1

- Initiation of CX-2051 Phase 1 clinical study in EpCAM positive tumors including colorectal cancer anticipated in 1H 2024 - - Initiation of CX-801 Phase 1 clinical study in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma also anticipated in 1H 2024 - Jan. 24, 2024 -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) applications for the conditionally activated Probody® therapeutics CX-2051, an EpCAM-directed ADC, and CX-801, a dually-masked version of interferon-alpha 2b. CX-2051 has been cleared for the initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression and CX-801 has been cleared for the initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Both programs are expected to start Phase 1 studies in the first half of 2024. “CX-2051 and CX-801 have the potential to address major unmet needs in oncology and we are excited to advance these programs into Phase 1 clinical studies. CX-2051 is an ADC conjugated to a next-generation topoisomerase-1 inhibitor payload that we believe is tailored to certain EpCAM-expressing tumors, including colorectal cancer,” said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics. “CX-801 is designed to overcome previous limitations of interferon-directed therapies due to systemic toxicity and establish CX-801 as a cornerstone of combination regimens, including with checkpoint inhibitors, across a wide range of tumor types,” continued Dr. Chu. “The parallel advancement of these programs toward the clinic demonstrates the continued high productivity of the CytomX team and the versatile, multi-modality nature of our Probody® platform. The product design principles behind CX-2051 and CX-801 integrate over a decade of continuous innovation and experience at CytomX,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. “We look forward to the clinical initiation of these programs as we enter a potentially milestone-rich period for the company in 2024 and 2025.” EpCAM is a high potential oncology target that has been clinically validated by locally administered, previously approved cancer therapies. However, to date, efforts to generate systemically administered anti-EpCAM therapeutics have not been successful due to toxicities in certain epithelial tissues, notably in the gastrointestinal tract. CX-2051, a conditionally activated ADC, is tailored to optimize the therapeutic index for EpCAM-expressing cancers. The cytotoxic payload utilized in CX-2051 is a derivative of camptothecin, a topoisomerase-1 inhibitor, a class of drug that has shown potent clinical anti-cancer activity in the ADC context for multiple targets. CX-2051 has demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including colorectal cancer. Phase 1 clinical initiation in EpCAM expressing solid tumors is expected in the first half of 2024. Further details on the design and preclinical optimization of CX-2051 can be found here: Interferon-alpha 2b is an immunotherapeutic cytokine that has demonstrated clinical activity and gained regulatory approval previously in multiple cancer types, including metastatic melanoma, renal cancer and bladder cancer. IFNα2b provides a potentially superior approach to activating anti-tumor immune responses compared to other cytokines. CX-801 is a dually masked, conditionally activated version of IFNα2b that has the potential to become a cornerstone of combination therapy for a wide range of tumor types, including in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. Phase 1 initiation for CX-801 solid tumors including melanoma, renal, and head and neck squamous cell carcinoma anticipated in the first half of 2024. Further details on the design and preclinical optimization of CX-801 can be found here: CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its Probody® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines and checkpoint inhibitors. CytomX’s clinical pipeline includes the cancer immunotherapeutic candidates CX-904 and BMS-986288. CX-904, partnered with Amgen, is a conditionally activated T-cell-engaging antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells. BMS-986288, partnered with Bristol Myers Squibb, is a conditionally activated CTLA-4-targeting antibody that is a non-fucosylated version of ipilimumab. In addition, CytomX has a diverse, emerging portfolio of wholly-owned drug candidates including CX-2051, a conditionally activated ADC directed toward epithelial cell adhesion molecule, EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers, and CX-801, an interferon alpha-2b Probody cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter. The content above comes from the network. if any infringement, please contact us to modify.

SOUTH SAN FRANCISCO, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that the Company presented advances within its conditionally-activated ADC portfolio, including the next generation EpCAM-ADC, CX-2051, at the World ADC conference taking place September 6-9, 2022, in San Diego, CA. “The momentum in the field of ADC therapeutics is incredibly exciting and holds great promise for the innovation and development of novel oncology therapeutics. Our pioneering work and experience in applying our versatile Probody® platform to the ADC modality has the potential to expand the universe of addressable targets and to further increase the therapeutic window of future molecules entering the clinic,” said Marcia P. Belvin, Ph.D., senior vice president and head of research at CytomX. “CX-2051, our EpCAM-targeted, conditionally activated ADC, is strategically tailored to optimize the therapeutic index for systemic treatment of EpCAM-expressing epithelial cancers, which is an area of high unmet need where, to date, efforts have not been successful due to dose-limiting toxicities.” “Our strategy with CX-2051 is to match payload mechanism of action with tumor sensitivity, and we have selected the topoisomerase-1 inhibitor, camptothecin, as the payload for our newest ADC,” Dr. Belvin continued. “Topoisomerase-1 inhibitor-conjugated ADCs are showing impressive clinical activity, and importantly, the safety profiles of camptothecin and its derivatives have been well characterized. Additionally, two camptothecin derivatives, irinotecan and topotecan, have been approved by the U.S. Food and Drug Administration for clinical use - irinotecan for pancreatic and colorectal cancer, and topotecan for ovarian, cervical, and small cell lung cancer. We plan to pursue multiple indications with this new therapeutic candidate and look forward to progressing to an investigational new drug application submission in the second half of 2023.” Presentation highlights include: Review of clinical activity for the conditionally activated ADCs CX-2029 and praluzatamab ravtansine (CX-2009), targeting CD71 and CD166, respectively. CD71 and CD166 have historically been inaccessible targets for traditional ADCs due to their high expression levels on normal tissues. The data presented demonstrate clinical anti-cancer activity and a therapeutic window for these previously undruggable targets. The molecular structure of CX-2051, a masked, conditionally activated, EpCAM-targeting ADC with a next generation camptothecin-based linker payload. CX-2051 highlights the potential for CytomX’s Probody technology to unlock a new ADC target (EpCAM/Trop-1), which is a target that has previously yielded promising clinical results only through locally administered therapies. CX-2051 preclinical data indicating strong anti-cancer activity and tolerability with a favorable predicted therapeutic index. The full presentation is available at the following link: Tailoring the Selection of Target, Payload, & Tumor Type to Maximize the Therapeutic Index of Conditionally Activated ADCs Marcia P. Belvin, Ph.D., Senior Vice President, Head of Research, CytomX Therapeutics Presentation Link About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities. Three of these candidates are in Phase 2 studies across multiple cancer types, including CX-2029 and praluzatamab ravtansine. CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. Praluzatamab ravtansine is an investigational conditionally activated ADC directed toward CD166 and is being studied in patients with advanced breast cancer. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets such as CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter.