On August 6, 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 second quarter 2020 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 6, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2020-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2020-financial" rel="nofollow">View Source [SID1234563092]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"CytomX made broad progress across our clinical and preclinical programs during the second quarter as we further advanced our technology platform, partnerships, and lead drug candidates to several important inflection points," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We continue to show leadership in defining new therapeutic antibody modalities with demonstrated potential to address significant unmet medical needs in the treatment of cancer, a mission that remains as important as ever despite the unprecedented challenges being posed by the COVID-19 pandemic."

SECOND QUARTER BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS

Clinical Pipeline Progress: ASCO (Free ASCO Whitepaper)20 Data Presentations and Program Next Steps

In May, CytomX presented broad clinical pipeline progress at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program from four Probody programs advancing in, or towards, Phase 2 studies:

CX-2029 and CX-2009, Probody Drug Conjugates designed to target the previously undruggable targets, CD71 and CD166, respectively
BMS-986249, a Probody version of the anti-CTLA-4 immunotherapeutic antibody, ipilimumab (Yervoy) and
CX-072, a Probody immunotherapeutic targeting PD-L1.
CX-2029 Phase 1 Data: Preliminary Validation of CD71 as a Novel Oncology Target and Advancement to Phase 2 Expansion Cohorts

CytomX and its partner AbbVie presented preliminary clinical data from the first-in-human, Phase 1 dose-escalation study of CX-2029, a Probody drug conjugate targeting the previously undruggable target, CD71 (transferrin receptor), in patients with solid tumors.
Evidence of target lesion reduction was seen at doses of ≥2 mg/kg including confirmed partial responses in squamous non-small cell lung cancer (sqNSCLC) and squamous head and neck cancer (HNSCC), which were observed at 3 mg/kg.
CX-2029 was generally well tolerated with anemia and infusion-related reactions being the most common adverse events, supporting 3 mg/kg as the Phase 2 expansion dose.
Phase 2 expansion cohorts are expected to be initiated in the second half of 2020 in patients with sqNSCLC, HNSCC, esophageal cancer, and diffuse large B-cell lymphoma.
CX-2009: Phase 2 Strategies Focused in HER2 Negative Breast Cancer Subtypes

CytomX presented updated clinical data from the first-in-human, dose-escalation, monotherapy Phase 1 study of CX-2009, a Probody drug conjugate targeting the previously undruggable target, CD166, in seven selected tumor types.
Evidence of target lesion reduction was observed at doses of ≥4 mg/kg including confirmed and unconfirmed partial responses in patients with HER2- breast cancer.
CX-2009 was generally well tolerated at doses up to 7 mg/kg, the dose selected for Phase 2 expansion studies.
The previously initiated Phase 2 expansion study of CX-2009 study in HER2 negative/hormone receptor positive (HER2-/HR+) breast cancer was paused in March 2020 due to the impact of the COVID-19 pandemic. In the intervening period, this study strategy has been revised to further focus patient enrollment criteria and is expected to be re-initiated during the second half of 2020. The revised Phase 2 study will continue to evaluate CX-2009 as monotherapy at 7 mg/kg administered every three weeks and enroll at least 40 patients.
CytomX also expects to initiate a Phase 2 expansion study during the second half of 2020 evaluating CX-2009 as monotherapy and in combination with CX-072, the Company’s anti-PD-L1 Probody therapeutic candidate, in patients with triple negative breast cancer (TNBC).
BMS-986249: Anti-CTLA-4 Probody Immunotherapeutic

Bristol Myers Squibb presented safety data from the dose escalation stage of a Phase 1/2a trial of BMS-986249, a Probody version of the anti-CTLA-4 antibody ipilimumab.
This trial assessed the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BMS-986249 as monotherapy or in combination with the anti PD-1 antibody nivolumab (Opdivo) in patients with advanced cancers. The doses of BMS-986249 ranged from 240 mg to 2400 mg (approximately 3 – 30 mg/kg).
BMS-986249 was generally well tolerated as monotherapy and in combination with nivolumab. The types of treatment-related adverse events were consistent with CTLA-4 blockade, and the overall data align with the proposed Probody mechanism of action. No new safety signals were observed.
Bristol Myers Squibb has initiated the Part 2a randomized cohort expansion of the ongoing Phase 1/2a trial of BMS-986249 in combination with nivolumab in patients with metastatic melanoma.
During the second quarter, Bristol Myers Squibb also presented a comprehensive preclinical dataset from the anti-CTLA-4 Probody immunotherapeutics, BMS-986249 and BMS-986288, a non-fucosylated Probody of ipilimumab, at the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II. These data support the strategy of expanding the therapeutic index for CTLA-4 therapy using CytomX’s Probody technology and provides rationale for the ongoing clinical studies of these agents.

CX-072: Anti-PD-L1 Probody Immunotherapeutic

CytomX presented data from seven expansion cohorts evaluating CX-072, an anti-PD-L1 Probody therapeutic administered at 10 mg/kg. CX-072 demonstrated durable anti-tumor activity in patients with IO-sensitive tumors such as TNBC, anal squamous cell carcinoma, cutaneous squamous cell carcinoma, and tumors with high mutational burden.
Grade 3/4 TRAEs were 10% and 5.9% for those patients who received monotherapy < 6 months and ≥ 6 months, respectively. Long term patients experienced fewer immune-related adverse events (irAEs) and had no grade 3+ irAEs.
The clinical profile of CX-072 continues to be consistent with this agent being a differentiated combination therapy partner. CX-072 will next be evaluated in combination with CX-2009 in TNBC.
Preclinical Pipeline Progress

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.
CX-2043 EpCAM Probody Drug Conjugate

CytomX continued to advance CX-2043, the lead candidate from the epithelial cell adhesion molecule (EpCAM)-targeting Probody Drug Conjugate program, towards IND-enabling studies.
Astellas Collaboration

CytomX launched discovery activities within the Astellas strategic collaboration that was announced in the first quarter and focused on the discovery, research, development, and commercialization of novel T-cell engaging bispecific antibodies.
COVID-19 Pandemic and Business Continuity

CytomX is committed to ensuring the health, safety and well-being of its clinical study participants, study site staff, and our employees. CytomX continues to closely monitor the COVID-19 pandemic situation and is following local, state, and federal guidelines, including emerging Health Authority guidance and IRB/Ethics Committee recommendations with respect to the conduct of our worldwide clinical trials. In accordance with state and local guidelines, CytomX is following a work-from-home protocol for many of its employees with only select staff, including those in research functions that require laboratory access, having access to CytomX’s corporate offices where multiple layers of safety measures have been put in place.

Second Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments totaled $346.4 million as of June 30, 2020, compared to $296.1 million as of December 31, 2019.

Revenue was $16.6 million for the three months ended June 30, 2020, compared to $9.0 million for the three months ended June 30, 2019. The net increase in revenue of $7.6 million was primarily due to an increase of $3.4 million from the Amgen EGFR project as a result of a higher percentage of completion progress in the second quarter of 2020, and an increase of $4.2 million related to the recognition of revenue from the $80 million upfront payment under the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $6.8 million during the three months ended June 30, 2020 compared to that in the corresponding period in 2019. The decrease was largely attributed to $3.4 million for the University of California, Santa Barbara (UCSB) fees paid in 2019 relating to the amendment to the license agreement, and a $0.8 sublicense fee also paid to UCSB in 2019 relating to a $10.0 million milestone earned by the Company for AbbVie’s selection of a second target under the Amended and Restated Discovery Collaboration and License Agreement with AbbVie in 2019 and a decrease of $2.3 million in clinical related expenses due to the decrease in clinical trial activities.

General and administrative expenses decreased by $0.7 million during the three months ended June 30, 2020 compared to that in the corresponding period in 2019 primarily due to a decrease in stock base compensation expense.

Teleconference Scheduled Today at 5:30 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:30 p.m. ET. 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 5399347. An archive of the webcast will be available on the CytomX website from August 6, 2020, until August 20, 2020.