CytomX Therapeutics Update
CytomX Therapeutics (CTMX) announced plans to focus on its emerging preclinical and early clinical pipeline and realign its capital resources to drive these efforts.
Sean McCarthy, D.Phil. Chief Executive Officer and Chairman, CytomX Therapeutics, said, “With the Probody® therapeutic platform, CytomX has pioneered a new and strategic field of biologics drug discovery and development. Our leadership position will continue as we incorporate learnings from our broad clinical experience and advance our next wave of innovative product candidates. In the context of the challenging current investment climate for biotechnology, we are making a change to ensure CytomX remains well positioned for the future. We are restructuring the organization to focus on our earlier stage capabilities and programs, as well as our partnerships, leveraging our multi-modality Probody platform to accelerate the development of next-generation therapeutics to destroy cancer differently.”
Dr. McCarthy added updates in business and strategy, stating that the strategic realignment aimed at accelerating early-stage pipeline development, which includes the partnered programs, while extending the cash runway:
He stated that the reason for the Company’s restructuring its business is to prioritize internal investments in its emerging pre-clinical and early clinical pipeline. The restructuring results in a reduction to its workforce, primarily development and general and administrative staff, by approximately 40%. He stated that the outcome of these changes is to extend the firm’s cash runway into 2025.
He explained that the reason CytomX is maintaining its robust research, translational, and early development organizations is to support the ongoing internal pipeline efforts with two Investigational New Drug Applications (INDs) planned for 2023.
Dr. McCarthy confirmed that CytomX remains committed to its current alliances with AbbVie, Amgen, Astellas, and Bristol Myers Squibb, which include the clinical-stage programs CX-2029, CX-904, and BMS-986249.
The Company will continue to emphasize future business development and new alliance formation as an integral part of its corporate strategy.
Dr. McCarthy said, “This difficult decision to restructure CytomX regrettably leads to the deqparture of many valued team members who have been dedicated to our vision and mission and whose contributions have been critical to the Company’s success to date. On behalf of myself and the Board of Directors, we thank them for their efforts and wish everyone the very best in their future endeavors.”
Overview of CytomX Pipeline of Conditionally Activated Product Candidates:
The New Emerging INDs
- Interferon alpha-2b (IFN alpha-2b) program CX-801: A wholly-owned IFN alpha-2b Probody.
- CX-801: Demonstrating a wide therapeutic index with an enhanced tolerability profile versus unmasked IFN, without compromising its potent antitumor effects.
- CX-801: Having a broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors
- An IND submission is planned in 2023.
- EpCAM-directed ADC program CX-2051: This program is a wholly-owned conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers.
- An IND submission is planned in 2023.
CX-2043: CytomX’s DM21-conjugated EpCAM-directed ADC,
Current Clinical Programs:
T-cell-engaging bispecific (TCB) EGFRxCD3 program CX-904:
This program is designed to target both the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells.
CX-904 is currently in a Phase 1 dose-escalation study and is part of CytomX’s partnership with Amgen.
CD71-directed antibody-drug conjugate (ADC) program CX-2029:
This program has shown encouraging activity in patients with squamous non-small cell lung cancer in a Phase 2 expansion study.
Enrollment in this cohort is complete and a data update is expected in the second half of 2022.
CX-2029 is part of CytomX’s partnership with AbbVie.
Ipilimumab Probody program BMS-986249 and BMS-986288:
Probody versions of the CTLA-4-targeting antibodies, ipilimumab and non-fucosylated ipilimumab, respectively – both being developed by Bristol Myers Squibb.
BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. BMS-986288 is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors.
CD166-directed ADC program Praluzatamab ravtansine:
This program demonstrated single-agent activity in a Phase 2 study in heavily-pretreated patients with advanced hormone receptor-positive,
Deprioritized and seeking partnership. HER2-non-amplified breast cancer
As announced on July 6, 2022, based on results of a three-arm Phase 2 study, CytomX is deprioritizing internal investment in this program and will be seeking a partnership to further advance the asset.
Anticipated Future Pipeline Milestones
Data update for CX-2029 from the ongoing Phase 2 expansion study in patients with squamous non-small cell lung cancer.
Updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer in the second half of 2023 IND submissions for CX-801 and CX-2051.
We have no doubt that CytomX Therapeutics has solid science and expert scientists. However, the firm has faced negative results with their lead product, which caused a selloff of its stocks. This press release confirmed that CytomX is capable of creating new drugs that fill their pipeline and attract top-tier firms to collaborate.
We expect this firm to act like Celldex, which ahd its beginnings with the same problems that CytomX did and rebounded. We realize that a total rebounding will take time, but we believe the firm will do whatever it takes to make that happen as well as to have approved products in the shortest time possible.
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