On August 4, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported second quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 4, 2022, View Source [SID1234617557]).
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"Our commitment to destroying cancer differently is stronger than ever at CytomX and we firmly believe that our multi-modality Probody therapeutic platform has the potential to deliver differentiated medicines for the treatment of people with cancer. Our company restructuring announced in July puts CytomX in the strongest possible position to maintain our technological leadership and advance our exciting, emerging pre-clinical and early clinical pipeline, capitalizing on our continued learnings from the clinic," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "We also continue to work intensively with our partners to advance multiple novel product candidates towards clinical proof of concept," continued Dr. McCarthy.
Second Quarter Business Highlights and Recent Developments
Strategic realignment – CytomX announced restructuring plans to focus on its early-stage pipeline development, including partnered programs, and to realign capital resources, extending cash runway into 2025.
T-cell-engaging bispecific (TCB) EGFRxCD3 program – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment, and is partnered with Amgen. The first patient was dosed in a Phase 1 study of CX-904 in patients with advanced solid tumors.
Ipilimumab Probody program – BMS-986249 and BMS-986288 are Probody versions of the CTLA4-targeting antibodies, ipilimumab and non-fucosylated ipilimumab, respectively, and are being developed by Bristol Myers Squibb. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab versus ipilimumab plus 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. Bristol Myers Squibb plans to present updated Phase 1 results for BMS-986249 at the ESMO (Free ESMO Whitepaper) Congress 2022 with the poster presentation titled "Anti–Cytotoxic T Lymphocyte Antigen-4 (CTLA 4) Probody BMS-986249 ± Nivolumab (NIVO) in Patients With Advanced Cancers: Updated Phase 1 Results." BMS-986288 is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors.
CD71-directed antibody-drug conjugate (ADC) program – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor, that is being co-developed by CytomX and AbbVie. Patient enrollment into the Phase 2 expansion study is now complete in all three solid cancer indications, including the esophageal/gastro-esophageal junction (E/GEJ) cancer cohort. The diffuse large B-cell lymphoma cohort was deprioritized due to strategic and competitive reasons and did not enroll any patients. A data update for the fully enrolled squamous non-small cell lung cancer cohort is expected in the fourth quarter of 2022. Data from the E/GEJ cancer cohort continues to mature.
CD166-directed ADC program – Praluzatamab ravtansine is a conditionally activated ADC directed toward CD166 and is wholly-owned by CytomX. In a three-arm Phase 2 study, praluzatamab ravtansine demonstrated single-agent activity in heavily-pretreated patients with advanced hormone receptor-positive, HER2-non-amplified breast cancer at the starting dose of 7 mg/kg every three weeks, but median progression-free survival data did not support further evaluation at this dose. While the emerging safety profile of the 6 mg/kg dose is encouraging, CytomX is not advancing this program alone and will seek a collaboration partnership.
Interferon (IFN) alpha-2b program – CX-801 is a wholly-owned IFN alpha-2b Probody. In preclinical studies, CX-801 demonstrated a wide therapeutic index with an enhanced tolerability profile versus unmasked IFN, without compromising its potent antitumor effects. CytomX continued to advance this program with the goal of submitting an investigational new drug application (IND) in the second half of 2023. Preclinical data for the program were presented at AACR (Free AACR Whitepaper) 2022.
EpCAM-directed ADC program – CX-2051 is a wholly-owned conditionally activated ADC directed toward the epithelial cell adhesion molecule (EpCAM), with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has prioritized the development of CX-2051 and an IND submission is planned in the second half of 2023.
Early-stage programs – CytomX continued to work internally and with existing partners Astellas, AbbVie, Amgen, and Bristol Myers Squibb on the broad application of its multi-modality Probody platform to additional product candidates.
Publication – CytomX continued to publish key results supporting its platform and pipeline, taking the total preclinical and clinical manuscripts published since 2021 to eight. Nonclinical efficacy and safety of CX-2029 was published in the peer-reviewed journal Molecular Cancer Therapeutics. Preclinically, the anti-CD71 conditionally activated ADC exhibited a highly efficacious and acceptable safety profile that demonstrates the utility of the Probody platform to target CD71, an otherwise undruggable target. View Source
Priorities for 2022/2023
Complete company restructuring by end of 2022
Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022
Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer in the fourth quarter of 2022
Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904
Submit INDs for CX-801 and CX-2051 in the second half of 2023
Second Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $228 million as of June 30, 2022, compared to $305 million as of December 31, 2021.
Total revenue was $18 million for the three months ended June 30, 2022 compared to $16 million for the corresponding period in 2021. The increase in total revenue was largely related to the CD71 collaboration with AbbVie.
Research and development expenses increased by $5 million during the three months ended June 30, 2022 to $31 million compared to $26 million for the second quarter of 2021. The increase was primarily due to higher personnel-related expenses and laboratory contract services in support of our pre-clinical and clinical pipeline.
General and administrative expenses increased by $2.4 million during the second quarter of 2022 to $11.7 million. The increase was mainly in personnel and professional expenses.
Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (800) 715-9871 (domestic) or (646) 307-1963 (international) and reference the conference ID 4032732. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website.