On March 30, 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 therapeutic technology platform, reported the achievement of a clinical milestone in conjunction with the CX-2029 program, triggering a $40 million payment from AbbVie to CytomX (Press release, CytomX Therapeutics, MAR 30, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-milestone-achievement-abbvie-cd71" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-milestone-achievement-abbvie-cd71" rel="nofollow">View Source [SID1234556046]). The company also provided an update on its lead wholly owned clinical programs.

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"CytomX has made excellent progress during 2020, including the establishment of a major new strategic alliance with Astellas, the initiation of a randomized Phase 2 study by our partner, Bristol Myers Squibb, evaluating the anti-CTLA-4 Probody, BMS-986249, in front line melanoma, and today the achievement of a significant clinical and financial milestone within our AbbVie alliance. This progress underscores the increasing validation of our Probody platform and illustrates how our partnering strategy continues to contribute meaningfully to the advancement of our pipeline," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "From our position of strength, against the pressures that the COVID-19 pandemic backdrop is placing on the healthcare system and clinical trial enrollment across the biopharma sector, we are today announcing steps to reprioritize our clinical portfolio and optimize resource allocation with the goal of maximizing long-term value. These steps will afford an increased emphasis on our work on undruggable targets such as CD166 and CD71 and the continued advancement of additional potential first-in-class programs towards future IND filings."

Achievement of $40 Million Phase 1 Dose Escalation Milestone in CX-2029 AbbVie Partnership

In April 2016, AbbVie and CytomX entered into a Co-Development and Licensing Agreement under which the two companies are co-developing CX-2029, a Probody drug conjugate against CD71. CD71, also known as the transferrin receptor 1 ("TfR1"), is a cell surface protein essential for iron uptake in dividing cells. CD71 is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells. CD71 has high potential as an anti-cancer target but is widely considered undruggable due to its presence on most dividing healthy cells. CX-2029 is designed to potentially create a therapeutic window for this novel target.

Under the agreement, CytomX is responsible for clinical development up to initial clinical proof of concept. AbbVie will lead late-stage clinical development and global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the United States. The $40 million milestone announced today was reached by CytomX through the achievement of pre-specified criteria for the dose escalation phase of the ongoing Phase 1/2 clinical trial, PROCLAIM-CX-2029 (NCT003543813). CytomX and AbbVie are finalizing plans for the advancement of CX-2029 to Phase 2 expansion cohorts in select tumor types. Preliminary clinical data from the Phase 1 dose escalation phase of PROCLAIM-CX-2029 is expected to be presented in 2020.

"We are encouraged by the progress of CX-2029 in the dose escalation studies executed by CytomX and look forward to seeing the data emerge from the expansion cohort phase," said Mohit Trikha, Ph.D., vice president and head of oncology early development and Bay Area Site Head, AbbVie.

Clinical Pipeline Update

CytomX is conducting multiple clinical trials worldwide and is committed to protecting the safety of its study participants and the physicians and staff that operate these clinical studies.

In assessing the evolving COVID-19 pandemic, and the emerging challenges for clinical trial execution within our studies and across the industry, CytomX has made the decision to temporarily pause new patient enrollment and new site activation in the PROCLAIM-CX-2009-001 study evaluating the CD166-targeting Probody drug conjugate CX-2009. This study includes the Phase 2 expansion study evaluating CX-2009 as monotherapy in patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer. CytomX continues to closely monitor emerging Health Authority guidance and IRB/Ethics Committee recommendations. CytomX intends to resume the CX-2009 clinical program as soon as practicable.

CytomX has also made the strategic decision to terminate the PROCLAIM-CX-072-002 study (NCT03993379) evaluating the anti-PD-L1 Probody CX-072 in combination with Yervoy (ipilimumab) in melanoma. This decision comes following a re-evaluation of the evolving clinical, competitive and commercial landscapes in immuno-oncology, taken together with impact of the COVID-19 pandemic. This decision allows for resources to be redirected towards CytomX’s potential first-in-class assets, including a combination of CX-072 and CX-2009, and to the generation of additional clinical candidates for advancement to IND filing and clinical trials.

Teleconference Scheduled Today at 6:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 6:00 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 7169589. An archive of the webcast will be available on the CytomX website from March 30, 2020, until April 6, 2020.