On Novembber 6, 2018 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 third quarter 2018 financial results (Press release, CytomX Therapeutics, NOV 6, 2018, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2018-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2018-financial" rel="nofollow">View Source [SID1234530888]).
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As of September 30, 2018, CytomX had cash, cash equivalents and short-term investments of $464.6 million.
"During the third quarter, CytomX made broad progress across our highly innovative pipeline of Probody therapeutics," said Sean McCarthy D.Phil., president and chief executive officer. "CX-072, our lead PD-L1 Probody drug candidate, continues to advance in the clinic, as evidenced by our presentations at ESMO (Free ESMO Whitepaper) that reinforce the encouraging safety and clinical activity profiles of CX-072 as both a monotherapy and in combination with ipilimumab. These clinical data also provide further proof-of-concept for our unique platform. During the quarter, we also initiated a clinical trial for CX-2029, a CD71-directed Probody drug conjugate partnered with AbbVie, continued to advance CX-2009, our PDC targeting CD166, and recently filed an IND for CX-188, our Probody therapeutic targeting PD-1. The ongoing translation of our novel science into the clinic is exciting to see."
Business Highlights and Recent Developments
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program
CX-072 is a potentially best in class Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
CytomX presented updated interim clinical data from two arms of the Phase 1/2 PROCLAIM-CX-072 program with a data cutoff of August 3, 2018 at the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting.
CX-072 monotherapy was studied in PD-L1/PD-1 inhibitor naïve patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Parts A and A2).
The Maximum Tolerated Dose (MTD) was not reached.
Of the 46 patients treated, Grade 3/4 treatment-related adverse events (TRAE) were reported in five patients (11%) and Grade 3/4 immune-related adverse events (irAEs) were observed in 3 patients (7%).
Of the 18 patients treated at doses of 3 mg/kg or above, 3 (17%) achieved an objective response with 1 confirmed and ongoing partial response (PR) and 2 unconfirmed PRs observed. Stable disease was observed in 8 patients (44%) for an overall Disease Control Rate (DCR) of 61%.
CX-072 in combination with Yervoy (ipilimumab) was studied in patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Part B).
Of the 20 patients treated, Grade 3/4 TRAEs were reported in four patients (20%) and Grade 3/4 immune-related adverse events (irAEs) were reported in 2 patients (10%).
Of the 14 patients treated with 3 mg/kg of ipilimumab and 0.3 – 10 mg/kg of CX-072, 3 (21%) achieved an objective response with 1 confirmed complete response (CR), and 2 confirmed PRs observed. Stable disease was observed in 21% of patients for an overall DCR of 43%.
CytomX continues to enroll and dose patients in monotherapy expansion cohorts in 8 undisclosed tumor types at the dose of 10mg/kg (Part D). Initial clinical data from Part D is expected in 2019.
CytomX continues to enroll and dose patients in a combination trial of CX-072 plus Zelboraf (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
CytomX will be presenting clinical translational data from Part A2 of the CX-072 monotherapy trial later this week as a poster and in a rapid-fire oral presentation at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
The Company will be hosting an Analyst and Investor event on Saturday, November 10th at SITC (Free SITC Whitepaper) that will be webcast. Webcast details can be found under the Investor and News section of the Company’s website at www.CytomX.com.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program
CX-2009 is a first in class Probody drug conjugate (PDC) that targets CD166, a broadly and highly expressed tumor antigen.
In the second quarter of 2017, CytomX initiated the PROCLAIM-CX-2009 Phase 1/2 clinical program to evaluate the safety and preliminary anti-tumor efficacy of CX-2009.
Part A (monotherapy dose escalation) was initiated at a dose of 0.25 mg/kg with an anticipated top dose of 6 mg/kg. As of November 2, 2018, the enrolling dose level was 10 mg/kg.
Part A2, was initiated in the second quarter of 2018. In Part A2, patients with CD166+++ expressing tumors are enrolled to receive CX-2009 at doses of 4 mg/kg and above already cleared in Part A (6 patients per dosing cohort). Biopsies are mandatory in A2. As of November 2, 2018, patients were being enrolled in a 9 mg/kg dosing cohort.
CytomX anticipates providing a comprehensive update on the CX-2009 program in the first half of 2019 following the substantial completion of Parts A and A2.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program
CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC.
CytomX initiated Part A of the PROCLAIM-CX-2029 Phase 1/2 clinical program in July 2018.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program
CytomX filed an Investigational New Drug (IND) application for CX-188 in October and expects to commence dose escalation studies following IND clearance from the U.S. Food and Drug Administration.
Financial Highlights
In July, CytomX completed an underwritten public offering of 5,867,347 common shares which resulted in net proceeds of $134.6 million to CytomX.
Third Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments totaled $464.6 million as of September 30, 2018, compared to $374.1 million as of December 31, 2017.
Revenue was $12.5 million for the three months ended September 30, 2018, compared to $24.1 million for the three months ended September 30, 2017. The decrease was primarily attributable to the recognition during the third quarter of 2017, in full in accordance with ASC 605, of $14.0 million in revenue (net of the associated sublicense fee of $1.0 million) related to the milestone payment from AbbVie after meeting certain milestones required to begin GLP toxicology studies under the collaboration agreement with AbbVie ("AbbVie CD71 Agreement"). This increase was partially offset by an increase in the third quarter of 2018 of $1.5 million in revenue resulting from the change in method of revenue recognition related to the AbbVie CD71 Agreement from straight-line under ASC 605 to percentage-of-completion under ASC 606 and an increase of $1.5 million in revenue related to the Amgen Collaboration and Licensing Agreement ("Amgen Agreement") executed in September 2017.
Research and development expenses decreased by $1.4 million during the three months ended September 30, 2018 compared to the corresponding period in 2017. The decrease was primarily attributed to the recognition, during the third quarter of 2017, of $10.7 million of non-cash in-process research and development expense and $1.2 million of sublicense fee payable to the University of California, Santa Barbara, both as a result of the Amgen Agreement. These amounts were partially offset by increases in the third quarter of 2018 of $3.2 million in personnel-related expenses and other allocated overhead expenses resulting from an increase in headcount, $2.7 million in lab contracts and services expenses primarily related to CX-2009 Phase 1/2 clinical development and $4.0 million in clinical trial expenses primarily related to CX-072, CX-2009 and CX-2029.
General and administrative expenses increased by $1.9 million during the three months ended September 30, 2018 compared to the corresponding period in 2017. This increase was largely attributed to an increase of $2.1 million in personnel related expenses due to increases in headcount.
Conference Call and Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the Investor and News page of CytomX’s website at View Source or by dialing (877) 809-6037 or (615) 247-0221 and using the passcode 9616738. A replay of the webcast will be available on the CytomX website from November 6, 2018 to November 13, 2018.