On November 5, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform, reported third quarter 2020 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 5, 2020, View Source [SID1234570073]).

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"As we approach the end of the year, the productivity of our R&D engine is evident with the growing breadth of our clinical pipeline, which is increasingly focused on previously undruggable targets. Between CytomX and our partners, there are now five Probody programs in the clinic, with four in Phase 2 studies, including CX-2029, for which we were excited to announce the treatment of the first patient in the expansion cohorts earlier today," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "So far this year, we have reported single agent anti-cancer activity for CX-072, CX-2009 and CX-2029, and we also are encouraged by the promising Phase 1 tolerability data reported by BMS for the anti-CTLA-4 Probody, BMS-986249. In addition, we continue to advance compelling preclinical candidates targeting EpCAM and EGFR-CD3 toward clinical development. Looking ahead to 2021, we believe we are well positioned for significant data updates from our robust clinical portfolio."

THIRD QUARTER BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS

Clinical Pipeline Progress: Advancing into Multiple Phase 2 Expansion Cohorts

CX-2009: Phase 2 Expansion Studies in HER2 Negative Breast Cancer Subtypes in 2020

CytomX expects to initiate a redesigned, multi-arm Phase 2 study evaluating CX-2009, a first in class anti-CD166 Probody drug conjugate, in patients HER2 negative breast cancer, in the fourth quarter of 2020. CX-2009 is armed with the maytansinoid payload DM4.
This Phase 2 study is expected to be comprised of three arms. Arm A will enroll patients with hormone receptor (ER, PR) positive, HER2 non-amplified breast cancer for treatment with CX-2009 monotherapy (7mg/kg, q3w). Arm B will enroll patients with triple negative breast cancer (TNBC) for treatment with CX-2009 monotherapy (7mg/kg, q3w). Arm C will enroll patients with TNBC for treatment with CX-2009 monotherapy (7mg/kg q3w) in combination with CX-072 (pacmilimab, 1200mg q3w), the Company’s proprietary anti-PD-L1 Probody therapeutic candidate. Additional information is available at ClinicalTrials.gov using the identifier NCT04596150.
Data from the Phase 1 study of CX-2009 in patients with HER2 negative breast cancer were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May and will be updated at San Antonio Breast Cancer Conference later this year.
CX-2029: Initiation of Phase 2 Expansion Cohorts

Today, CytomX, in partnership with AbbVie, announced the treatment of the first patient in the Phase 2 expansion cohorts evaluating CX-2029, a first in class anti-CD71 Probody drug conjugate, as monotherapy in patients with head and neck squamous cell cancer (HNSCC), squamous non-small cell lung cancer (SqNSCLC), esophageal carcinoma, and diffuse large B cell lymphoma (DLBCL). Additional information is available at ClinicalTrials.gov using the identifier NCT03543813. CytomX anticipates initial data from this study in late 2021.
Preliminary clinical data from the first-in-human, Phase 1 dose escalation study of CX-2029 in patients with solid tumors was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May.
Updated data from an August 14, 2020 cutoff of this study is included below: (Figures 1 and 2). Of note:
12 patients with sqNSCLC or HNSCC were enrolled in the Phase 1 dose escalation
4 patients with sqNSCLC were enrolled into the 1, 3 or 5mg/kg cohorts of the study.
3 out of 4 patients had a best response of stable disease or better:
2 patients had confirmed partial responses with a duration of 2.5 months and 5.6 months, dosed at 5 and 3 mg/kg respectively.
1 patient with stable disease enrolled in the 3mg/kg cohort remained on treatment with stable disease for 26 weeks.
1 patient experienced disease progression at the first on-treatment assessment and was enrolled at the 1mg/kg dose level.
8 patients with HNSCC were enrolled into the 2 or 3mg/kg cohorts of the study.
7 out of 8 patients showed a best response of stable disease or better:
1 patient with a confirmed PR remains ongoing at 38 weeks on treatment, with target lesion reduction of greater than 80%.
1 patient with stable disease remains on treatment at 33 weeks.
The remaining patients have come off treatment for disease progression.
None of these 12 patients stopped treatment for a toxicity related issue.
The most commonly occurring Grade 3 or higher adverse event was anemia, occurring in 49% of 45 treated patients across all dose levels. No new safety signals were observed at the updated data cutoff.
BMS-986249: Anti-CTLA-4 Probody Immunotherapeutic

Bristol Myers Squibb continues to enroll patients as part of the Part 2a randomized cohort expansion of the ongoing Phase 1/2a trial of BMS-986249 administered in combination with nivolumab (Opdivo) in patients with metastatic melanoma. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Bristol Myers Squibb presented safety data from the dose escalation stage of a Phase 1/2a trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May.
BMS-986288: Anti-CTLA-4 Non-Fucosylated Probody Immunotherapeutic

Bristol Myers Squibb continues to enroll patients as part of the Part 1 dose escalation study of the ongoing Phase 1/2a trial of BMS-986288 administered as monotherapy and in combination with nivolumab in patients with selected advanced solid tumors. Additional information is available at ClinicalTrials.gov using the Identifier NCT03994601.
Preclinical Pipeline

CX-2043 EpCAM Probody Drug Conjugate

In October, CytomX presented updated preclinical data at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium for CX-2043, a Probody Drug Conjugate targeting EpCAM (Epithelial Cell Adhesion Molecule), a widely expressed tumor antigen. CX-2043 is conjugated to the novel maytansinoid payload, DM-21. CX-2043 demonstrated potent anti-tumor activity across multiple cancer types and superior tolerability in animal models compared to the corresponding antibody drug conjugate. CytomX is advancing CX-2043 towards clinical studies with IND filing projected for late 2021.
CX-904 EGFR-CD3 Probody Bispecific

CytomX continued to advance CX-904, the lead candidate from the Epidermal Growth Factor Receptor-CD3 T-Cell Bispecific program, towards IND-enabling studies. CX-904 is partnered with Amgen as part of a global co-development agreement.
Third Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments totaled $321.1 million as of September 30, 2020, compared to $296.1 million as of December 31, 2019.

Revenue was $17.8 million for the three months ended September 30, 2020, compared to $10.7 million for the three months ended September 30, 2019. The net increase in revenue of $7.1 million was primarily due to an increase of $2.6 million from AbbVie resulting from the recognition of the percentage of completion for the current quarter related to the $40.0 million milestone payment received in March 2020 under the CD71 Co-Development and Licensing Agreement, and an increase of $4.5 million consisting of the $4.0 million related to the recognition of revenue from the $80 million upfront payment, as well as $0.5 million in service revenue, under the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $3.9 million during the three months ended September 30, 2020 to $24.0 million compared to $28.0 million in the corresponding period in 2019. The decrease was largely attributed to a decrease in clinical trial activities primarily due to the COVID-19 pandemic.

General and administrative expenses were essentially flat during the three months ended September 30, 2020, amounting to $8.6 million compared to $8.5 million in the corresponding period in 2019.

Teleconference Scheduled Today at 5:00 p.m. ET (2:00 p.m. PT)

Conference Call & Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 6705899. An archive of the webcast will be available on the CytomX website from November 5, 2020, until November 12, 2020.