On November 3, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported third quarter 2016 financial results (Press release, CytomX Therapeutics, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219490 [SID1234516221]).
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"This quarter was marked by a number of significant milestones in our Probody pipeline, most notably the filing of our Investigational New Drug (IND) application for CX-072, our PD-L1-targeting Probody therapeutic for the treatment of cancer patients," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We have also made strong technical progress in our alliance with Bristol Myers Squibb on anti-CTLA-4 Probody therapeutics and look forward to presentations of preclinical proof-of-concept data at the European Society for Medical Oncology Symposium on Immuno-Oncology and the Society for Immunotherapy in Cancer 31st Annual Meeting & Associated Programs."
As of September 30, 2016, CytomX had cash and cash equivalents and investments of $180.5 million. The Company continues to expect full year net cash utilization of $20.0 to $25.0 million in 2016. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations through 2018.
Business Highlights and Recent Developments
PROCLAIM-072 (PD-L1 Probody) Program
IND application filed with the U.S. FDA for PROCLAIM-072 clinical study of CX-072, a PD-L1-targeting Probody therapeutic for the treatment of cancer patients.
Pending ongoing discussions with the FDA regarding clinical protocol finalization, initial clinical sites are expected to be open by year end to support first patient enrollment.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018.
CX-2009 (CD166 Probody Drug Conjugate) Program
The IND for CX-2009, a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen CD166, remains on track to be filed during the first half of 2017.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018.
Other Pipeline Updates
Pursuant to CytomX’s partnership with AbbVie, AbbVie exercised a licensing option with Seattle Genetics for the clinically and commercially validated payload, MMAE, for conjugation to the CD71 Probody Drug Conjugate that is being advanced in preclinical studies.
Upcoming Presentations
CytomX and partner Bristol-Myers Squibb will present updates on their respective Probody programs at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on Immuno-Oncology, held November 4-5, 2016, in Lausanne, Switzerland, and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs, held November 9-13, 2016, in National Harbor, MD.
ESMO
Title: Next Generation Anti-CTLA-4 Antibodies
Presenter: Alan J. Korman, Ph.D., vice president, immuno-oncology, Bristol-Myers Squibb Company
Date: Saturday, November 5, 2016
Time: 8:00-8:20 a.m. CET
Session: Beyond PD-1/PD-L1 Axis Blockade: Combinations or New Molecules
SITC
Title: CD3-EGFR Probody T Cell-Engaging Bispecific Induces Tumor Regressions and Substantially Increases Safety Window in Preclinical Studies
Presenter: Bryan A. Irving, Ph.D., vice president, immunology, CytomX Therapeutics
Date: Wednesday, November 9, 2016
Time: 11:45-11:50 a.m. EST
Sub-Session II: Pre-Clinical New Agents in Development
Title: Probody Therapeutic Targeting PD-1 Provides Preclinical Anti-tumor Efficacy While Minimizing Induction of Autoimmunity as a Single Agent and in Combination with CTLA-4 Blockade
Presenter: Kimberly A. Tipton, senior scientist, CytomX Therapeutics
Date: Friday, November 11, 2016
Time: 12:15-1:30 p.m. and 6:15-7:30 p.m. EST
Session: Poster
Title: Next Generation Anti-CTLA-4 Antibodies
Presenter: Alan J. Korman, Ph.D., vice president, immuno-oncology, Bristol-Myers Squibb Company
Date: Saturday, November 12, 2016
Time: 9:10-9:35 a.m. EST
Session: Beyond Single-Agents: The Future of Combination Immunotherapy
Third Quarter Financial Results
Cash, cash equivalents and investments totaled $180.5 million as of September 30, 2016, compared to $186.7 million as of December 31, 2015. The decrease reflects cash used in operations, partially offset by a $30.0 million upfront payment received from AbbVie in connection with the collaboration agreements entered in April 2016, and a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with its third target selection in January 2016.
Research and development expenses were $13.3 million for the third quarter of 2016, compared to $9.2 million for the third quarter of 2015. The increase was primarily attributable to $1.7 million in manufacturing costs for the CX-072 and CX-2009 programs, $1.2 million to advance CX-072 into Phase 1 clinical development, $0.9 million in personnel-related expenses due to an increase in headcount and $0.7 million in non-cash stock-based compensation due to higher stock valuation.
General and administrative expenses were $5.0 million for the third quarter of 2016, compared to $4.1 million for the third quarter of 2015. The increase was predominantly due to $0.6 million in non-cash stock based compensation due to higher stock valuation, $0.2 million in personnel-related expenses due to an increase in headcount and $0.2 million in additional consulting and professional service expenses associated with operating as a public company.
About PROCLAIM
CytomX is launching the PROCLAIM (Probody Clinical Assessment In Man), a first-of its-kind clinical trial program that enables clinical study sites and physicians to access CytomX’s wholly-owned Probody therapeutics under one international umbrella. The first module within the PROCLAIM program is an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf (vemurafenib) in anti-PD-(L)1 inhibitor naïve patients with certain cancers. CX-072 is a PD-L1-targeting Probody therapeutic for the treatment of cancer patients. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:
Safety: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.
Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018. The IND application for CX-072 is currently under review with FDA.