On August 3, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported second quarter 2016 financial results (Press release, CytomX Therapeutics, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192554 [SID:1234514238]).

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!

"We achieved all targeted milestones in our pipeline this quarter as we continue to execute and drive our lead, wholly-owned programs towards the clinic," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With our transformational Probody technology platform, CytomX intends to unlock the full potential of antibody therapeutics by bringing new and differentiated treatment options to cancer patients."

As of June 30, 2016, CytomX had cash and cash equivalents and investments of $195.8 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

CX-072 (PD-L1 Probody) Program

The CX-072 IND remains on track to be filed in the second half of 2016, with an initial set of study sites expected to open by year-end to support initiation of patient enrollment.
Preclinical development activities to support clinical trial initiation are complete, including pre-IND interactions with FDA, execution of GLP toxicology studies and large-scale GMP manufacturing of clinical material.
As CytomX evolves from a research-stage to a clinical-stage organization, the Company is launching a first-of-its-kind clinical trial program that enables study sites and physicians to access CytomX’s wholly-owned Probody therapeutics under one international umbrella program called PROCLAIM (Probody Clinical Assessment In Man).
The first module within the PROCLAIM program is the 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.
To realize the vision of establishing CX-072 as the PD-(L)1 combination therapy of choice, 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.
CX-2009 (CD166 Probody Drug Conjugate) Program

Plans remain on track for filing an IND for CX-2009, a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen, CD166, in the first half of 2017.
Completed preclinical activities include pre-IND interactions with FDA, execution of a large-scale GMP manufacturing run for clinical material and initiation of GLP toxicology studies.
Clinical data is expected to begin to emerge in the second half of 2017 and throughout 2018.
Other Pipeline Updates

The PD-pathway is one of the most important checkpoint pathways responsible for mediating tumor-induced immune suppression, and PD-(L)1 inhibitors are becoming the cornerstone of combination therapy for many types of cancer.
CX-072 targets tumor-expressed PD-L1. The Company has previously demonstrated that a Probody targeting T-cell PD-1 can also elicit potent anti-tumor activity.
To that end, CytomX expects to nominate a lead candidate for its PD-1 Probody therapeutic in 2016, and will advance the program towards the clinic.
Partnerships

CytomX’s strategy of forming collaborations with major pharmaceutical companies including AbbVie, Bristol-Myers Squibb and Pfizer, continues to validate the potential of the Probody platform to transform antibody therapeutics in cancer.
CytomX continues to make progress with its partners to advance Probody therapeutics and believes that there is robust potential for additional IND filings with partnered programs in 2017 and 2018.
Given the breadth of potential applications of the Probody platform, the Company continues to engage prospective partners regarding additional collaboration opportunities.
Second Quarter Financial Results
Cash, cash equivalents and investments totaled $195.8 million as of June 30, 2016, compared to $186.7 million as of December 31, 2015. The increase reflects a $30.0 million upfront payment received from AbbVie in connection with the collaboration agreements entered in April 2016, a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with its third target selection in January 2016, partially offset by cash used in operations.

Research and development expenses were $12.7 million for the second quarter of 2016, compared to $5.0 million for the second quarter of 2015. The increase was primarily attributable to $3.8 million in manufacturing costs for the Company’s CX-072 and CX-2009 programs in preparation for preclinical and clinical studies, $1.5 million in laboratory and professional services, $0.9 million in non-cash stock-based compensation due to higher stock valuation, $0.9 million in personnel-related expenses due to an increase in headcount and $0.5 million in royalty payments to a third party triggered by the upfront payment in connection with the AbbVie collaboration agreement. The Company expects the manufacturing costs for the two programs to decrease in the third quarter and the costs related to preparation for CX-072 clinical trials to increase.

General and administrative expenses were $4.6 million for the second quarter of 2016, compared to $2.6 million for the second quarter of 2015. The increase was predominantly due to $0.9 million in non-cash stock based compensation due to higher stock valuation, $0.8 million in personnel-related expenses due to an increase in headcount and $0.4 million in additional consulting and professional service expenses associated with operating as a public company.