On November 05, 2015 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel cancer stem cell (CSC) and immuno-oncology therapeutics, reported financial results for the quarter ended September 30, 2015 (Press release, OncoMed, NOV 5, 2015, View Source [SID:1234507972]). The company ended the third quarter with $175.2 million in cash, cash equivalents, and short term investments.

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"Our internally discovered research and development pipeline continues to advance, with both demcizumab and tarextumab in two randomized Phase 2 clinical trials each," said Paul J. Hastings, Chairman and Chief Executive Officer. "We now have seven product candidates in 17 clinical trials, and are advancing two additional immuno-oncology product candidates to IND filings."

Pipeline Update

Demcizumab (anti-DLL4, OMP-21M18)

Enrollment continues in the randomized Phase 2 YOSEMITE pancreatic cancer and Phase 2 DENALI non-small cell lung cancer (NSCLC) trials.

Planning advances for a Phase 1b trial testing combination of demcizumab with pembrolizumab (an anti-PD1 antibody). Participating institutions include Memorial Sloan Kettering Cancer Center, Columbia University, Royal Marsden Hospital.
Tarextumab (anti-Notch 2/3, OMP-59R5)

Completed enrollment in the randomized Phase 2 ALPINE pancreatic cancer trial in August. A readout of the trial data, including overall survival results from both intent-to-treat and Notch3 biomarker populations, is anticipated in the second half of 2016.
Enrollment continues in the randomized Phase 2 PINNACLE small cell lung cancer (SCLC) trial.

Presented Notch3 biomarker results at the World Congress on Lung Cancer in September highlighting the role of overexpression of Notch3 as a poor prognostic factor in SCLC patients and as a potential biomarker for tarextumab treatment. Updated survival data continued to suggest greater benefit of tarextumab in a dose-dependent fashion, with median overall survival not yet reached in patients with high Notch3 tumors receiving higher doses of tarextumab.

Wnt Pathway Programs

Reached an agreement with Bayer to enroll up to 24 additional subjects, including some subjects who will undergo serial tumor biopsies, in the Phase 1b clinical trial of vantictumab (anti-Fzd7, OMP-18R5) in breast cancer and the Phase 1b clinical trial of ipafricept (Fzd8-Fc, OMP-54F28) in ovarian cancer, to further elucidate the profile of these product candidates and generate additional data to inform Bayer’s opt-in decisions. Bayer has agreed to reimburse OncoMed for all out-of-pocket expenses to support this additional patient enrollment. Delivery of opt-in packages to Bayer for both vantictumab and ipafricept is now anticipated in late 2016/early 2017.

Brontictuzumab (anti-Notch1, OMP-52M51)

De-prioritized and discontinued the Phase 1a hematologic malignancy trial to focus on solid tumor indications in biomarker selected populations. Data will be presented at an upcoming medical meeting.

Data to be presented on November 8, 2015 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting in November in Boston show single-agent activity of brontictuzumab in Notch1 biomarker positive solid tumor subjects.

Advanced plans to clinically test brontictuzumab in combination with standard-of-care in solid tumor indications with a focus on patients whose tumors overexpress the active form of Notch1.
Anti-DLL4/VEGF (OMP-305B83) and Anti-RSPO3 (OMP-131R10)

Enrollment continues in Phase 1a study of anti-DLL4/VEGF bispecific in solid tumors.
Presented pre-clinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) of the immune mediated anti-cancer effects of OncoMed’s anti-DLL4/VEGF bispecific antibody.

Advance plans to study anti-DLL4/VEGF in Phase 1b in combination with standard-of-care.
Enrollment continues in Phase 1a/b study of anti-RSPO3 in solid tumors.

Immuno-oncology Research

Presented new data for GITRL-Fc showing potent single-agent anti-tumor activity and activity in combination with checkpoint inhibitors at the Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. OncoMed is advancing GITRL-Fc into IND-enabling studies with the goal of ultimately filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration.

Advanced preclinical testing of an immuno-oncology antibody under the collaboration with Celgene with goal of achieving formal designation as a clinical development candidate in the collaboration by the end of 2015 followed by an IND filing in 2016.

Third Quarter 2015 Financial Results

Cash, cash equivalents and short-term investments totaled $175.2 million as of September 30, 2015, compared to $200.2 million as of June 30, 2015.

Revenues for the third quarter 2015 totaled $4.7 million, as compared to $19.0 million in the third quarter of 2014. Revenues were higher in the third quarter of 2014 primarily due to milestone revenues from the GlaxoSmithKline and Bayer collaborations achieved during that period.

Research and development (R&D) expenses for the third quarter 2015 were $24.7 million compared with $21.0 million for the same period in 2014. Increases in R&D expenditures in the three months ended September 30, 2015 were primarily attributable to increased personnel expenses, increased program costs associated with the advancement of demcizumab and tarextumab into randomized Phase 2 trials, as well as increased costs related to advancement of our anti-DLL4/VEGF and anti-RSPO3 programs into clinical development.

General and administrative (G&A) expenses for the quarter ended September 30, 2015 were $4.5 million, compared to $3.5 million for the same three-month period in 2014. The increased costs during the third quarter 2015 were attributable to higher employee-related costs, increased patent expenses, and financial expenses related to the June 2015 S-3 shelf registration filing.

Net loss for the third quarter 2015 was $24.5 million ($0.81 per share), compared to $5.5 million ($0.18 per share) for the same three-month period of 2014. The change in net loss for the third quarter of 2015 was primarily due to an increase in operational expenses and lower milestone revenues.

On November 5, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported that Great Ormond Street Hospital (GOSH) and University College London (UCL) will present encouraging data from a first in man clinical use of UCART19, at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando during the poster session (Press release, Cellectis, NOV 5, 2015, View Source [SID:1234507990]).

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GOSH has treated in June 2015 a young leukemia patient under a special license from the Medicines & Healthcare products Regulatory Agency(MHRA) with Cellectis’ TALEN gene edited allogeneic UCART19 product candidate because no other therapies were available for refractory relapsed Acute Lymphoblastic Leukemia (ALL) following mismatched allogeneic stem cell transplantation.

In response to an unsolicited request from Professor Waseem Qasim, Consultant Immunologist at GOSH and Professor of Cell and Gene Therapy at University College London (UCL) Institute of Child Health, Cellectis gave its approval for the use of its UCART19 product candidate and technologies under GOSH’s "Specials" license and responsibility, for the particular clinical needs of that individual patient.

Professor Qasim says: "The successful treatment of a patient with UCART19 cells represents a landmark in the use of new gene engineering technology. If replicated in other patients, it could represent a huge step forward in treating leukaemia and other cancers."

"We are very glad for this young patient to have benefited from our highly innovative TALEN gene edited allogeneic CAR T therapy UCART19. We expect to accelerate our clinical development of TALEN gene-edited allogeneic CAR-T therapies to further confirm this encouraging clinical proof of concept," said Doctor Mathieu Simon, MD, Executive Vice President, Chief Operating Officer at Cellectis.

"Our team aims to provide to patients, with unmet medical needs, access to the first allogeneic CAR-T therapy, UCART19 made with Cellectis’ TALEN gene-editing technologies," said Doctor André Choulika, Founder, Chairman and Chief Executive Officer of Cellectis. "Cellectis had, is and will invest significant amounts of energy and creativity to provide cancer patients with an accessible, cost-effective, off-the-shelf allogeneic CAR-T therapies across all geographies. UCART19 has been provided for to a patientwho could not undergo an autologousCAR-T therapy. Our goal is to make our product candidates accessible to anyone."

About UCART19
UCART19 is a potential best-in-class allogeneic engineered T-cell product for treatment of CD19 expressing hematologic malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Servier has an option under the collaboration agreement to acquire the exclusive rights to further develop and commercialize UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, "off the shelf" T-cell based medicinal product.

About Great Ormond Street Hospital (GOSH)
Great Ormond Street Hospital for Children NHS Trust is the country’s leading centre for treating sick children, with the widest range of specialists under one roof. With the UCL Institute of Child Health, they are the largest centre for paediatric research outside the US and play a key role in training children’s health specialists for the future.

About the UCL department of hematology
The UCL department of hematology is the major tertiary referral center in the UK for all types of hematological malignancies. They have assumed a global leadership position in stem cell transplantation and adoptive cell therapy for leukemia patients.

On November 5, 2015 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the third quarter ended September 30, 2015 (Press release, Dynavax Technologies, NOV 5, 2015, View Source [SID:1234508006]).

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The Company had $220.7 million in cash, cash equivalents and marketable securities as of September 30, 2015, compared to $93.4 million at June 30, 2015. The balance at September 30, 2015 includes approximately $164 million of net proceeds from sales of common stock in the third quarter and reflects payment of all principal and accrued interest, prepayment charges and other fees totaling approximately $11 million under a loan agreement.

Operating expenses of $29.6 million for the quarter ended September 30, 2015 increased by $4.8 million compared to the quarter ended June 30, 2015 primarily due to production, clinical trial and commercial preparation costs.

We recently initiated a clinical trial to evaluate the combination of our cancer immunotherapeutic product candidate SD-101 and Merck’s KEYTRUDA (pembrolizumab) in patients with metastatic melanoma. All study visits for HBV-23, the Phase 3 clinical study of HEPLISAV-B, were completed in October 2015. Top line results of this study are expected to be released in early 2016.

The net loss allocable to common stockholders for the quarter ended September 30, 2015 was $30.1 million, or $0.82 per basic and diluted share. The net loss allocable to common stockholders for the quarter ended June 30, 2015 was $23.6 million, or $0.80 per basic and diluted share.

On November 5, 2015 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the third quarter ended September 30, 2015 (Press release, Celldex Therapeutics, NOV 5, 2015, View Source [SID:1234508026]).

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"Celldex continues to advance one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "As we move closer to final data from the ACT IV study in newly diagnosed glioblastoma, we continue to build on the potential promise of RINTEGA in the recurrent setting and look forward to presenting long-term survival data from the ReACT study at the SNO meeting later this month. In the third quarter we continued to execute on all fronts, including enrolling patients to seven ongoing Celldex-sponsored clinical trials. In addition, there are now numerous investigator initiated studies ongoing with additional concepts under discussion. We look forward to data in 2016 from several of these studies that we believe will further support the critical role of immunotherapy in oncology."

Program Updates:

RINTEGA ("rindopepimut"; "rindo"; CDX-110), an EGFRvIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)

The ACT IV study is a randomized, double-blind, placebo controlled study of RINTEGA plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. 745 patients were enrolled into ACT IV to reach the required 374 patients with minimal residual disease (assessed by central review) needed for analysis of the primary overall survival endpoint. All patients, including those with disease that exceed this threshold, will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability, and quality of life. The study design includes interim analyses conducted by an independent Data Safety and Monitoring Board (DSMB) at 50 and 75% of events (deaths). The first interim analysis occurred in June 2015, and the DSMB recommended continuation of the study as planned. The Company anticipates that the study will reach the required number of events to perform the second interim analysis in late 2015 and that the analysis will occur in early 2016.

As previously reported, data from the Phase 2 ReACT study in patients with recurrent glioblastoma were presented in an oral session at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School, and the lead investigator of the ReACT study. Patients on the RINTEGA arm experienced a statistically significant overall survival (OS) benefit, and an impressive, emerging long-term survival benefit was observed. The primary endpoint of the study, progression-free survival at six months (PFS6), was met, and a clear advantage was demonstrated across multiple, clinically important endpoints including long-term progression-free survival, objective response rate (ORR) and need for steroids. The Company will present an update on overall survival and long-term survival in a podium presentation at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) on Friday, November 20th at 1:30 PM CT/2:30 PM ET.

Glembatumumab vedotin ("glemba"; CDX-011), an antibody-drug conjugate targeting gpNMB in multiple cancers

Enrollment continues in the Company’s Phase 2b randomized study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB, a molecule associated with poor outcomes for triple negative breast cancer patients and the target of glembatumumab vedotin. Enrollment is open across the United States, Canada and Australia. Trial expansion into the European Union (EU) is underway, and the Company plans to open enrollment in up to 50 sites in the EU in early 2016. Based on current projections, enrollment will be completed in the second half of 2016.

Patient enrollment continues in the Phase 2 study of glembatumumab vedotin in metastatic melanoma.

Celldex continues to advance plans to expand the study of glembatumumab vedotin in other cancers in which gpNMB is expressed.
A Phase 2 study in squamous cell lung cancer is expected to commence in Q1 2016.
Celldex and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (CRADA) under which the NCI will sponsor two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma.
Varlilumab ("varli"; CDX-1127), a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade

The Phase 1/2 study of varlilumab and nivolumab (Opdivo) in adult patients with advanced non-small cell lung cancer, metastatic melanoma, colorectal cancer, ovarian cancer, and head and neck squamous cell carcinoma is actively enrolling patients. This study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb. The companies are sharing development costs.

In April 2015, Celldex announced that it had entered into a clinical trial collaboration with Roche to evaluate the combination of varlilumab and atezolizumab (anti-PDL1) in a Phase 1/2 study in renal cell carcinoma. Under the terms of this agreement, Roche will provide study drug, and Celldex will be responsible for conducting and funding the study, which is expected to open to enrollment in Q4 2015.

Additional combination studies of varlilumab continue to enroll patients including:
A Phase 1/2 safety and tolerability study examining the combination of varlilumab and sunitinib (Sutent) in patients with metastatic clear cell renal cell carcinoma (CC-RCC); and,
A Phase 1/2 safety and tolerability study examining the combination of varlilumab and ipilimumab (Yervoy) in patients with Stage III or IV metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive Celldex’s CDX-1401.

Celldex will present a preclinical poster on the contribution of varlilumab’s immune stimulating properties versus regulatory T cell (Treg) depletion in multiple tumor models on Friday, November 6, 2015 at 6:15 PM ET at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

Oncothyreon recently completed evaluation of two dosing cohorts in the Oncothyreon-led Phase 1b trial of ONT-10, a therapeutic vaccine targeting the tumor-associated antigen MUC1, in combination with varlilumab in patients with advanced breast and ovarian cancers. Preliminary data from these two cohorts did not demonstrate sufficient activity to move forward with the program, and Oncothyreon does not plan to enroll additional patients in the Phase 1b trial. Varlilumab biomarker analyses from peripheral blood samples from this study are consistent with prior experience including an increase in activated T cells and natural killer cells and a decrease in regulatory T cells.

Patient treatment in the Phase 1 dose-escalation study of varlilumab is complete. Any incremental data updates will be included in a future scientific presentation/publication.

Efforts are underway for additional Phase 2 studies of varlilumab, and the Company will provide updates on these studies as they are initiated.
CDX-1401, an antibody-based NY-ESO-1-specific therapeutic vaccine for multiple solid tumors

A Phase 1/2 study examining the combination of varlilumab and ipilimumab (Yervoy) continues to enroll patients with Stage III or IV metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, an off-the-shelf antibody-based dendritic cell targeted vaccine.

Celldex continues to support several external collaborations, including a National Cancer Institute sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which recently completed enrollment.
CDX-301 (recombinant human Flt3L), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells

CDX-301 is being developed as a combination product with other immuno-oncology agents in investigator-sponsored studies.

A pilot study of CDX-301 alone and in combination with Mozobil in hematopoietic stem cell transplantation was initiated in September 2014 and is currently enrolling patients and sibling-matched donors. The Company anticipates presenting early data from this study in Q1 2016.
Third Quarter and First Nine Months 2015 Financial Highlights and 2015 Guidance

Cash position: Cash, cash equivalents and marketable securities as of September 30, 2015 were $304.6 million compared to $334.0 million as of June 30, 2015. The decrease of $29.4 million was primarily driven by our third quarter net cash used in operating activities of $27.8 million. As of September 30, 2015 Celldex had 98.6 million shares outstanding.

Revenues: Total revenue was $1.0 million in the third quarter of 2015 and $3.7 million for the nine months ended September 30, 2015, compared to $1.1 million and $2.1 million for the comparable periods in 2014. The increase in the nine months ended September 30, 2015 was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $24.7 million in the third quarter of 2015 and $76.3 million for the nine months ended September 30, 2015, compared to $26.2 million and $77.4 million for the comparable periods in 2014.

G&A Expenses: General and administrative (G&A) expenses were $8.5 million in the third quarter of 2015 and $22.8 million for the nine months ended September 30, 2015, compared to $5.0 million and $14.4 million for the comparable periods in 2014. The increase in G&A expenses was primarily attributable to higher personnel-related expenses as we prepare for potential product launches and a $3.3 million increase year to date in RINTEGA and glembatumumab vedotin commercial planning costs over the $2.6 million spent in the comparable period in 2014.

Net loss: Net loss was $32.0 million, or ($0.32) per share, for the third quarter of 2015 and $94.5 million, or ($0.98) per share, for the nine months ended September 30, 2015, compared to a net loss of $28.1 million, or ($0.31) per share and $86.3 million, or ($0.97) per share for the comparable periods in 2014.

Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2017; however, this could be impacted by our clinical data results from the RINTEGA program and their potential impact on our pace of commercial manufacturing and the rate of expansion of our commercial operations.

On November 5, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"), reported that researchers from Moffitt Cancer Center in Tampa, Florida, presented a poster titled, "Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity via High Mobility Group Box 1," at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting in National Harbor, Maryland (Press release, Provectus Pharmaceuticals, NOV 5, 2015, http://www.pvct.com/pressrelease.html?article=20151105.2 [SID:1234508057]).

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Authors Hao Liu, Pasquale Patrick Innamarato, Krithika Kodumudi, Amy Weber, John L Robinson, Satoshi Nemoto, Georgina Crago, Timothy McCardle, Erica Royster, Amod A Sarnaik and Shari Pilon-Thomas state that their "results reveal a clinically relevant immunoadjuvant pathway triggered by tumor cell death secondary to ablation with RB." The data presented were from nonclinical models of melanoma in mice and clinical data from the team’s recent clinical mechanism of action study (Clinical Trials ID NCT01760499). To view the poster, visit http://www.pvct.com/publications/SITC-Poster-2015.pdf.

In the reported work, the authors showed that tumor-specific T cells were increased in the blood of both mouse and man after tumor ablation with PV-10. This was initiated by tumor cell necrosis, leading to release of High Mobility Box Group 1 (HMBG1), one of a class Damage-Associated Molecular Pattern molecules (DAMPs) released by dying cancer cells that can lead to activation of dendritic cells. HMBG1 release was observed in vitro and after ablation of melanoma tumors in mice and clinical trial participants. This was also correlated with dendritic cell activation and infiltration into lymph nodes draining ablated tumors.

Eric Wachter, Ph.D., Chief Technology Officer of Provectus, observed, "The data reported by our collaborators at Moffitt further clarify the mechanism by which tumor ablation with PV-10 can initiate a finely tuned immune response against injected tumor cells. This has important potential implications for overall response and durability of response when PV-10 is used as a single agent therapy, while the central role played by T cells in this response is notable for combination of PV-10 with other agents that function on T cells."

Provectus is currently enrolling patients in a phase 3 study of PV-10 as a single agent therapy for patients with locally advanced cutaneous melanoma (Clinical Trials ID NCT02288897) and in a phase 1b study of PV-10 in combination with the immune checkpoint inhibitor pembrolizumab in patients with metastatic melanoma (Clinical Trials ID NCT02557321).