On August 8, 2017 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2017 (Press release, Celldex Therapeutics, AUG 8, 2017, View Source [SID1234520147]).
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"In the second quarter, we continued to see strong physician enthusiasm for our Phase 2 METRIC study of glembatumumab vedotin in triple negative breast cancer and recently met our target enrollment of 300 patients," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We expect enrollment will be formally closed by the end of September to allow all patients currently in the screening queue the opportunity to complete the screening process and enroll in the study."
"In June, we presented data from glemba’s Phase 2 program in checkpoint refractory metastatic melanoma and the Phase 1 dose-escalation varlilumab/Opdivo combination study in solid tumors, both in oral presentations at ASCO (Free ASCO Whitepaper). We anticipate a productive second half of the year as we complete enrollment across multiple early-stage studies and look forward to topline data from the METRIC study in the first half of 2018."
Recent Highlights
Continued progress in METRIC enrollment: Target enrollment (n=300) in METRIC has been reached. Given the lack of treatment options for patients with triple negative breast cancers, previously screened patients whose tumors overexpress gpNMB will be allowed to enter the study before enrollment is formally completed, which is estimated to occur by the end of September 2017. The Company expects topline data from the study approximately six to eight months after formal closing of enrollment. METRIC is a Phase 2b randomized study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB.
Single-agent glembatumumab vedotin Phase 2 study in checkpoint-refractory metastatic melanoma presented in an oral presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June: Mature data (n=62) from the study were presented at ASCO (Free ASCO Whitepaper). As previously reported in October 2016, the primary endpoint of the cohort (threshold of 6 or more objective responses in 52 evaluable patients) was exceeded. 7 of 62 (11%) patients experienced a confirmed response, and an additional three patients also experienced single timepoint partial responses. Since data were reported in October, one patient converted from a confirmed partial response to a confirmed complete response. Median overall survival (OS) for all patients was 9.0 months (95% CI: 6.1, 13.0). Patients who experienced rash in Cycle 1 experienced a more prolonged OS with a median of 15.8 months (p=0.026, HR=0.44) as compared to those who did not experience rash.
Enrollment recently completed in the glembatumumab vedotin and varlilumab combination arm, and data from this portion of the study are expected in the fall of 2017. Enrollment continues in the glembatumumab vedotin plus checkpoint inhibitor (Opdivo or Keytruda) arm in patients who failed prior checkpoint therapy, a population with limited treatment options.
Phase 1 varlilumab/Opdivo study presented in an oral presentation at ASCO (Free ASCO Whitepaper): Updated data (n=36) from the Phase 1 portion of this study were presented at ASCO (Free ASCO Whitepaper). The majority of patients enrolled in this study had PD-L1 negative tumor at baseline and presented with stage IV, heavily-pretreated disease. 80% of patients enrolled presented with refractory or recurrent colorectal (n=21) or ovarian cancer (n=8), a population expected to have minimal response to checkpoint blockade. The primary objective of the Phase 1 portion of the study was to evaluate the safety and tolerability of the combination. The combination was well tolerated at all varlilumab dose levels tested without any evidence of increased autoimmunity or inappropriate immune activation. Notable disease control was observed across multiple dosing regimens (stable disease or better for at least 3 months). Three partial responses (PR) were observed including a patient with PD-L1 negative, MMR proficient colorectal cancer, a patient with low PD-L1 (5% expression) squamous cell head and neck cancer and a patient with PD-L1 negative ovarian cancer. A subgroup analysis was conducted in patients with ovarian cancer based on an observed increase of PD-L1 and tumor-infiltrating lymphocytes in this patient population. In patients with paired baseline and on-treatment biopsies (n=13), only 15% were PD-L1 positive (≥ 1% tumor cells) at baseline compared to 77% during treatment (p=0.015). Patients with increased tumor PD-L1 expression and tumor CD8 T cells correlated with better clinical outcome with treatment (stable disease or better).
The Phase 2 portion of the combination study includes cohorts in colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, and is currently enrolling patients. The Company plans to complete enrollment across all cohorts in the Phase 2 portion of the study in the first quarter of 2018 and will work with Bristol-Myers Squibb to present data from the study at a future medical meeting.
Phase 1 study of CDX-0158 continues to enroll patients: This dose escalation study in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors is designed to determine the maximum tolerated dose, recommend a dose for further study and characterize the safety profile of CDX-0158. Data from the study continue to be expected by year-end 2017.
CDX-3379 advancing to Phase 2: The Company has finalized plans for an open-label Phase 2 study in patients with recurrent/metastatic head and neck squamous cell cancer who are refractory to Erbitux (cetuximab). The Company anticipates initiating this study in the fourth quarter of 2017.
Enrollment ongoing in Phase 1 study of CDX-014: This study in advanced renal cell carcinoma (clear cell and papillary) is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex continues to expect the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
Second Quarter and First Six Months 2017 Financial Highlights and Updated 2017 Guidance
Cash position: Cash, cash equivalents and marketable securities as of June 30, 2017 were $154.0 million compared to $167.0 million as of March 31, 2017. The decrease was primarily driven by second quarter cash used in operating activities of $20.8 million. This decrease was partially offset by the receipt of $8.7 million from sales of common stock under the Cantor agreement. At June 30, 2017, Celldex had 127.4 million shares outstanding.
Revenues: Total revenue was $3.8 million in the second quarter of 2017 and $5.4 million for the six months ended June 30, 2017, compared to $1.4 million and $2.7 million for the comparable periods in 2016. The increase in revenue was primarily due to the manufacturing service agreement with the International AIDS Vaccine Initiative.
R&D Expenses: Research and development (R&D) expenses were $25.0 million in the second quarter of 2017 and $50.8 million for the six months ended June 30, 2017, compared to $25.7 million and $53.2 million for the comparable periods in 2016.
The $0.7 million decrease in second quarter R&D expenses was primarily due to a decrease in varlilumab contract manufacturing expenses of $4.3 million, partially offset by an increase in glembatumumab vedotin contract manufacturing expenses of $1.9 million and increases in personnel and facility costs related to the Kolltan acquisition.
The $2.4 million decrease in year-to-date R&D expenses was primarily due to decreases in varlilumab and Rintega contract manufacturing expenses of $5.1 million and $2.6 million, respectively, partially offset by an increase in glembatumumab vedotin contract manufacturing expenses of $3.4 million and increases in personnel and facility costs related to the Kolltan acquisition.
G&A Expenses: General and administrative (G&A) expenses were $6.5 million in the second quarter of 2017 and $13.8 million for the six months ended June 30, 2017, compared to $7.8 million and $17.1 million for the comparable periods in 2016.
The $1.3 million decrease in second quarter G&A expenses was primarily due to lower commercial planning costs of $0.6 million and lower stock-based compensation of $0.4 million.
The $3.3 million decrease in year-to-date G&A expenses was primarily due to lower commercial planning costs of $2.4 million and lower stock-based compensation of $0.9 million.
Loss on Fair Value Remeasurement of Contingent Consideration: Loss on the fair value remeasurement of contingent consideration related to the Kolltan acquisition was $1.0 million in the second quarter of 2017 and $4.4 million for the six months ended June 30, 2017, primarily due to changes in discount rates and the passage of time.
Net loss: Net loss was $28.6 million, or ($0.23) per share, for the second quarter of 2017 and $62.8 million, or ($0.51) per share, for the six months ended June 30, 2017, compared to a net loss of $32.0 million, or ($0.32) per share, and $66.6 million, or ($0.67) per share, for the comparable periods in 2016.
Financial guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2017, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2018; however, this guidance assumes Celldex elects to pay future Kolltan contingent milestones, if any, in stock rather than cash.