On November 7, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported third quarter 2023 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 7, 2023, View Source [SID1234637131]).

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"2023 has been a year of highly focused execution against our key priorities, including continued progress in Phase 1 dose escalation for CX-904 and the advancement of our next-generation molecules CX-2051 and CX-801 towards IND filings later this year. We have continued to diligently manage our financial resources and drive towards value-inflecting pipeline milestones," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

Continued Dr. McCarthy, "Looking ahead to 2024, we are on track to provide initial CX-904 Phase 1 dose escalation data and to initiate our clinical evaluation of CX-2051 and CX-801, leading to a potentially milestone-rich 2024 and 2025."

Third Quarter Business Highlights and Recent Developments

Pipeline

CX-904, T-cell-engaging bispecific (TCB) targeted to EGFRxCD3, Phase 1 dose escalation data anticipated in the first half of 2024 – 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. CX-904 is partnered with Amgen in a global co-development alliance and is being evaluated in an ongoing Phase 1 study in patients with advanced solid tumors. Backfilling of certain dose escalation cohorts is being initiated during Q4 2023. Initial Phase 1a data for CX-904 is anticipated in the first half of 2024. A decision to initiate Phase 1b expansion cohorts in certain EGFR positive tumor types is anticipated in 2024.
Preclinical profile of EpCAM-directed antibody drug conjugate CX-2051 presented at 2023 World ADC Conference – In October 2023, Dr. Marcia Belvin, chief scientific officer, CytomX Therapeutics, presented data characterizing the preclinical profile for CX-2051. CX-2051 is tailored for treatment of EpCAM-expressing cancers by matching target expression and tumor sensitivity with a topoisomerase-1 inhibitor payload. EpCAM is a broadly expressed, previously validated anti-cancer target that to date has been limited in its development potential due to systemic, on-target off-tumor dose-limiting toxicities. CX-2051 is designed to mask target binding in normal tissues to potentially mitigate systemic toxicities and open a therapeutic window. CX-2051 could potentially address a large patient population as EpCAM is highly expressed across many indications including colorectal, gastric, endometrial, and ovarian cancers. The IND for CX-2051 is expected to be filed by the end of 2023. CX-2051 Phase 1 dose escalation in solid tumors is anticipated in 2024, with metastatic colorectal cancer as a priority indication.
IND filing for CX-801 (Interferon alpha-2b) expected by year-end 2023 – CX-801 is a dually masked, Probody Therapeutic interferon alpha-2b. Interferon-alpha 2b was the first approved cancer immunotherapy but has been limited in its clinical use due to systemic toxicities. Preclinically, Probody IFN-a2b has demonstrated a widened predicted therapeutic index with an improved tolerability profile compared to unmasked interferon alpha-2b, including preferential anti-cancer activity in the tumor microenvironment and increased anti-tumor effects when combined with checkpoint inhibitors. In November 2023, at the Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, additional preclinical data were presented demonstrating enhancement of PD-1 anti-tumor efficacy and inflammation of the tumor microenvironment by Probody IFN-a2b. An IND filing for CX-801 is expected by the end of 2023 with planned clinical initiation in 2024.
Continued progress in Phase 2 clinical evaluation of Bristol Myers Squibb’s anti-CTLA-4 non-fucosylated Probody, BMS-986288 – In the first quarter of 2023, BMS prioritized the BMS-986288 Probody program as its lead next-generation CTLA-4 program and advanced the program to Phase 2. BMS-986288 is a masked version of a non-fucosylated anti-CTLA-4 antibody, BMS-986218, which is designed to be more potent than ipilimumab (YERVOY). BMS-986288 utilizes CytomX’s Probody technology to potentially localize the potent effect of the non-fucosylated CLTA-4 antibody to tumors while reducing systemic toxicity. The Phase 2 clinical evaluation of BMS-986288 is ongoing and includes proof of concept studies for microsatellite stable (MSS) colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). BMS anticipates data from the study will be available in 2024. CytomX and BMS continue to collaborate on multiple preclinical research programs.
Corporate Alliances

Continued progress in strategic alliances – Throughout 2023, CytomX made substantial progress across its research alliances including with Astellas, where, in January, the first T-cell engaging bispecific clinical candidate was nominated to proceed to IND enabling activities. Additionally, CytomX initiated activities under its newest collaborations with Regeneron and Moderna. Preclinical research programs continue to progress across each of the Company’s collaborations (Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna) which extend the reach of the Company’s Probody pipeline and provide for the potential to build value through the achievement of future milestones and royalties.
Company Priorities and Potential Milestones for 2023 and 2024

CX-904 (EGFRxCD3): Continue enrollment into Phase 1a dose escalation. Phase 1a dose escalation data are expected in the first half of 2024. A decision to initiate Phase 1b expansion cohorts in certain EGFR positive tumor types is anticipated in 2024.
CX-2051 (EpCAM): File IND by the end of 2023 and begin Phase 1 dose escalation in solid tumors with known EpCAM expression in 2024, with metastatic colorectal cancer as a priority indication
CX-801 (IFNa2b): File IND by the end of 2023, with clinical initiation in 2024
Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288 including proof-of-concept studies in MSS CRC and NSCLC. BMS anticipates data from the study will be available in 20241.
CX-2029 (CD71): Based on current priorities, the Company will not be directing significant additional investment in this program in the near-term.
Collaborations: Continuation of drug discovery activities with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna
Third Quarter 2023 Financial Results

Cash, cash equivalents and investments totaled $194.1 million as of September 30, 2023, compared to $180.9 million as of June 30, 2023. The cash balance as of September 30, 2023, includes approximately $30.0 million of gross proceeds from the financing transaction that closed with BVF Partners L.P. in July of 2023, partially offset by cash burn of $16.8 million during the third quarter of 2023.

Total revenue was $26.4 million for the three months ended September 30, 2023, compared to $11.1 million for the corresponding period in 2022 and was driven primarily by a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration and the recent collaborations with Regeneron and Moderna.

Research and development expenses decreased by $14.0 million during the three months ended September 30, 2023, to $16.4 million, compared to $30.4 million for the corresponding period in 2022. The reduction in research and development expenses was primarily due to a decrease in personnel related expenses, as well as winding down of laboratory contract services and clinical study activities related to the CX-2009 and CX-2029 programs, partially offset by an increase in laboratory contract services related to IND enabling activities.

General and administrative expenses decreased by $3.7 million during the three months ended September 30, 2023, to $6.8 million, compared to $10.5 million for the corresponding period in 2022. The reduction in general and administrative expenses was primarily due to a decrease in personnel related expenses as a result of the workforce reduction in 2022, reduced external vendor services, and lower building rent as a result of a partial sublease of the Company’s headquarters.

Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website.