CytomX Therapeutics Outlines 2024 Company Priorities and Milestones
- CX-904 (EGFRxCD3 T-cell engager) initial Phase 1a dose escalation data anticipated in the 2nd half of 2024 -
- IND application filed for conditionally activated EpCAM-directed ADC (CX-2051) with Phase 1 initiation in EpCAM positive tumors expected in the 1st half of 2024 -
- IND application filed for conditionally activated interferon alpha-2b (CX-801) with Phase 1 initiation as monotherapy and in combination with PD-(L)1 anticipated in the 1st half of 2024 -
- Broad pipeline progress anticipated within research and development partnerships including ongoing Phase 2 clinical trial of anti-CTLA-4 Probody® BMS-986288 -
“With INDs recently filed for wholly-owned programs, CX-2051 and CX-801, and continued progress in dose escalation with our Probody® T-Cell engager, CX-904, CytomX is well positioned as we enter 2024. Our current lead programs build on more than a decade of Probody platform experience at CytomX and integrate key design elements that leverage previously validated oncology targets, potent effector mechanisms and tailored masking strategies,” said
“CytomX’s multi-modality pipeline is highly relevant at this moment in time in oncology R&D. CX-904 is a potentially differentiated EGFR-CD3 T-cell engager in an ongoing Phase 1 clinical trial and, with both CX-2051 and CX-801 also expected to enter the clinic in 2024, we have a broad opportunity to make a meaningful difference in the treatment of cancer,” said
CX-904, EGFRxCD3 T-cell Engager
CX-904 is a conditionally activated Probody T-cell engager designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is partnered with Amgen in a global co-development alliance and is being evaluated in an ongoing Phase 1 study in patients with advanced solid tumors that have known EGFR expression. Backfilling of certain dose escalation cohorts has been initiated and dose ranging continues. Initial Phase 1a dose escalation data is anticipated in the second half of 2024. The Phase 1a data will inform a potential decision during 2024 to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types. The decision to potentially initiate Phase 1b expansion cohorts will be taken in conjunction with Amgen.
CX-2051, Antibody Drug Conjugate (ADC) targeting EpCAM
EpCAM is a high potential oncology target that has been clinically validated by locally administered, previously approved cancer therapies. However, efforts to generate systemically administered anti-EpCAM therapeutics have, to date, 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 epithelial 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. An IND application has been filed for this program and clinical initiation in EpCAM expressing solid tumors is expected in the first half of 2024.
CX-801, Interferon-alpha 2b (IFNα2b)
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. An IND application has been filed for this program. Phase 1 initiation for CX-801 as a monotherapy and in combination with checkpoint inhibition is expected in the first half of 2024.
BMS-986288, Non-fucosylated CTLA-4-targeting Probody Therapeutic
Research and Development Partnerships
CytomX has multiple active research and development partnerships with major biotechnology and pharmaceutical companies (Amgen, Astellas,
2024 PRIORITIES AND
CytomX enters 2024 in a strong strategic position and with significant momentum in its pipeline. The company’s key pipeline programs are progressing towards clinical proof of concept and key milestones in 2024 including:
- CX-904 (EGFRxCD3): Continued enrollment into Phase 1a dose escalation. Phase 1a initial dose escalation data are expected in the second half of 2024. These data are expected to inform a potential decision, to be taken with Amgen, to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types in 2024.
- CX-2051 (EpCAM): Initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression including metastatic colorectal cancer as one priority indication is expected in the first half of 2024.
- CX-801 (IFNα2b): Initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma is expected in the first half of 2024.
- Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288 including proof-of-concept studies in MSS CRC and NSCLC.
Bristol Myers Squibbanticipates data from the study will be available in 2024.
- Collaborations: Continuation of drug discovery and development activities with
Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna with potential pre-clinical and clinical milestones possible in 2024 and and beyond.
- Financial: CytomX ended the third quarter of 2023 with
$194 millionof cash and cash equivalents. Cash runway is projected to the second half of 2025, excluding any potential milestones from existing collaborations or new business development.
About CytomX Therapeutics
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
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2051, BMS-986288, CX-904, and CX-801, the potential benefits or applications of CytomX’s Probody therapeutic platform, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of BMS-986288 and CX-904, and the timing of the commencement of clinical trials or initial and ongoing data availability for CX-801 and CX-2051, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody therapeutic technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of BMS-986288, CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in
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Source: CytomX Therapeutics Inc.