On December 19, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported an update on its lead programs and 2020 clinical portfolio outlook (Press release, CytomX Therapeutics, DEC 19, 2019, View Source [SID1234552501]).
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"Our clinical pipeline today reflects the continued progress we have made in advancing our two wholly-owned lead programs, CX-072 and CX-2009, from initial clinical proof of concept into Phase 2 clinical development," said Sean McCarthy, D. Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Throughout 2019, we have also gained additional momentum in our partnered clinical programs. Bristol-Myers Squibb is advancing the anti-CTLA-4 probody, BMS-986249, into Phase 2 and the CytomX team continues Phase 1 dose escalation of CX-2029, an anti-CD71 probody drug conjugate, in partnership with AbbVie. All four of these clinical stage programs have the potential to make a meaningful difference for cancer patients and we look forward to providing updates in 2020."
PROCLAIM-CX-072 is a Phase 1/2 clinical program studying CX-072, an anti-PD-L1 Probody therapeutic in patients with solid tumors.
In November 2019, the Company announced the initiation of a Simon 2 Stage Phase 2 clinical trial studying CX-072 in combination with YERVOY (ipilimumab) in relapsed or refractory melanoma. Stage 1 of this study aims to enroll up to 40 patients.
The Phase 1 expansion arm of PROCLAIM-CX-072 studying CX-072 as monotherapy in selected tumor types, has completed enrollment. Data presented at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) confirmed evidence of clinical activity in several cancer types including triple negative breast cancer, squamous cell carcinoma and cutaneous squamous cell carcinoma with an encouraging safety profile. At this time, CytomX plans to focus further clinical development within this program on combinations with CX-072, including the ongoing Phase 2 study with ipilimumab.
PROCLAIM-CX-2009 is a Phase 1/2 clinical program studying CX-2009, an anti-CD166 Probody drug conjugate, as monotherapy for the treatment of solid tumors.
The Phase 1 dose escalation and refinement stages of this trial are complete. Data reported at the 2019 Annual Meeting of the American Association of Cancer Research from the Phase 1 dose escalation trial showed encouraging anti-cancer activity and tolerability in several tumor types, including breast cancer, ovarian cancer and head and neck cancer. Based on these results, CytomX is initiating a Phase 2 expansion study of CX-2009 monotherapy at 7 mg/kg administered every three weeks in up to 40 patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer.
"We continue to see forward progress across our wholly-owned and partnered clinical programs, affirming that CytomX’s Probody platform can potentially lead to innovative therapies that improve patient outcomes," said Amy Peterson, M.D., chief development officer of CytomX Therapeutics.
2020 Clinical Outlook Across The CytomX Portfolio
PROCLAIM-CX-072
Presentation of final data is anticipated from the expansion arms of the Phase 1/2 trial of CX-072 as monotherapy in multiple selected tumor types.
Initial data is anticipated from the first stage of the ongoing Phase 2 trial of CX-072 in combination with ipilimumab in relapsed or refractory melanoma.
PROCLAIM-CX-2009
Updated data is anticipated from the CX-2009 Phase 1 dose escalation and dose ranging studies.
Enrollment of the Phase 2 expansion study of CX-2009 in hormone receptor (ER, PR) positive, HER2 negative breast cancer is anticipated throughout 2020.
PROCLAIM-CX-2029, an anti-CD71 Probody Drug Conjugate
CytomX and its partner, AbbVie, anticipate the presentation of initial data from the Phase 1 dose escalation portion of the PROCLAIM-CX-2029 Phase 1/2 study.
BMS-986249, an anti-CTLA-4 Probody Therapeutic
CytomX’s partner, Bristol-Myers Squibb (BMS), anticipates presenting data from the completed Phase 1 portion of the Phase 1/2a study evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in advanced solid tumors.
BMS is initiating the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment.