Celldex Therapeutics Presents Favorable Safety Profile and Immune Response Data from Phase 1/2 Study of Varlilumab and Nivolumab at the AACR Annual Meeting 2016

On April 18, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported new safety and immune response data from the Phase 1 portion of a Phase 1/2 dose escalation and cohort expansion study examining the investigational combination of varlilumab, Celldex’s CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb’s anti-PD-1 immunotherapy Opdivo (nivolumab) (Press release, Celldex Therapeutics, APR 18, 2016, View Source [SID:1234510993]). The data were presented today in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans. The Phase 1 portion of the study, conducted in patients with solid tumors, has completed enrollment (n=36) and primarily enrolled patients with colorectal (n=20) and ovarian cancer (n=8). The primary objective of the Phase 1 portion of the study was to evaluate the safety and tolerability of the combination. The Phase 2 portion of the study is open to enrollment.

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Key Highlights:

Combining the potent immune activator, varlilumab, with the PD-1 inhibitor, nivolumab, showed acceptable tolerability and safety across all dose levels without any evidence of increased autoimmunity or inappropriate immune activation.
Combination therapy led to marked changes in the tumor microenvironment including increased infiltrating CD8+ T cells and increased PD-L1 expression, which have been shown to correlate with a greater magnitude of treatment effect from checkpoint inhibitors in other clinical studies.
Additional favorable immune biomarkers, such as increase in inflammatory chemokines and decrease in T regulatory cells, were also noted.
In a subset of patients (n=17) on study who had both pre- and post-tumor biopsies available, preliminary evidence suggest a correlation between biomarker data and stable disease or better in seven of these patients (4 ovarian cancer, 2 colorectal cancer, 1 squamous cell carcinoma of the head and neck).
"The combination of varlilumab and nivolumab demonstrated acceptable tolerability across all dose levels of varlilumab, showing that immune stimulation through CD27 was safely combined with PD-1 blockade," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "In addition, we observed favorable changes in intratumoral immune biomarkers, most notably an increase in tumor infiltrating lymphocytes, which is recognized to correlate with improved clinical outcome. Based on the strong preclinical data, scientific rationale and these recent results, we are very excited for the Phase 2 portion of the trial, which is now open to enrollment across six different indications."

The Phase 2 portion of the study includes cohorts in advanced non-small cell lung cancer (n=35), colorectal cancer (n=18), ovarian cancer (n=18), head and neck squamous cell carcinoma (n=18), renal cell carcinoma (n=25) and glioblastoma (n=20). The primary objective of the Phase 2 study is overall response rate for all cohorts except glioblastoma, where the primary objective is the rate of 12-month overall survival. Secondary objectives include pharmacokinetics assessments, determining the immunogenicity of varlilumab when given in combination with nivolumab and further assessing the anti-tumor activity of combination treatment, including duration of response, time to response, progression-free survival and overall survival. The study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb Company. The companies are sharing development costs.

Celldex and its collaborating investigators are presenting seven posters at the AACR (Free AACR Whitepaper) Annual Meeting. As of Monday, April 18, four of these posters have been presented and summaries of these, including the Phase 1/2 varlilumab/nivolumab combination study, can be found below.

Title: Phase 1 results from the combination of an immune activating anti-CD27 antibody (varlilumab) in combination with PD-1 blockade (nivolumab): activation across multiple immune pathways without untoward immune-related adverse events

The Phase 1, dose-escalation portion of the study assessed the safety and tolerability of varlilumab at doses ranging from 0.1 to 10 mg/kg when administered with nivolumab (3 mg/kg). Enrollment to the Phase 1 study portion is complete with a total of 36 patients treated. Data for 35 patients are included in the poster: colorectal cancer (n=20), ovarian cancer (n=8), metastatic melanoma (n=4) and head and neck squamous cell carcinoma (n=3). 69% of patients had three or more prior therapies.

All dose levels of the combination therapy showed acceptable tolerability and safety, without identification of a maximum tolerated dose. In the Phase 2 portion of the study, varlilumab will be administered at 3 mg/kg, which is based upon cumulative data across multiple studies.

The safety profile of the varlilumab and nivolumab combination has been consistent with that of each agent individually, and no unexpected toxicities have been observed. The most frequent treatment related adverse events, occurring in more than 10% of patients, were fatigue (25.7%), lymphopenia (20%), nausea (20%), chills (17.1%), arthralgia (14.3%), pruritus (14.3%) and rash (11.4%), the majority of which were grade 1 or 2. Two patients experienced drug-related serious adverse events. In the 10 mg/kg cohort, grade 4 hepatitis and grade 3 renal insufficiency was observed in a patient with ovarian cancer. Also in the 10 mg/kg cohort, grade 2 paresthesia (tingling/numbness) was observed in a patient with colorectal cancer.

Biomarker data from all varlilumab dose levels indicate increases in inflammatory chemokines and decreases in circulating T regulatory cells, which is generally consistent with varlilumab monotherapy. Importantly, in tissue biopsies from patients, the authors noted, where pre-treatment and on-study specimens were available (n=17), a marked increase of tumor infiltrating lymphocytes and an increase in PD-L1 expression. Although the Phase 1 portion of the study was focused on immune response and safety, a correlation between this biomarker readout and stable disease or better (n=7) was observed in this preliminary dataset.

The poster is available on the "Publications" page of the "Science" section of the Celldex website.

Title: In situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy

The potential activity of CDX-301 (recombinant human Flt3 ligand) is being explored in an investigator-sponsored, Phase 1/2 study of CDX-301 and poly-ICLC in combination with low-dose radiotherapy in patients with low-grade B-cell lymphomas conducted by the Icahn School of Medicine at Mount Sinai. CDX-301 is a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells. To date, the study has enrolled 12 patients with indolent non-Hodgkin lymphoma. The authors presented flow cytometry and mass cytometry data from selected patients, which demonstrate the ability of CDX-301 to induce dendritic cell mobilization.

The poster is available on the "Publications" page of the "Science" section of the Celldex website.

Title: IHC and RT-PCR Assays for Detection of Cancer Antigen NY-ESO-1 in Human Tissues

The Company presented data from the development of diagnostic assays for NY-ESO-1, the target of CDX-1401, an antibody-based NY-ESO-1-specific therapeutic vaccine for multiple solid tumors. Samples from 75 solid tumor types and 38 normal adjacent tissue samples were analyzed by immunohistochemistry (IHC) and quantitative RT-PCR assays, which were developed to determine NY-ESO-1 expression. The validated diagnostic tests for use in the clinical development of CDX-1401 and preliminary screening suggest that several cancers, including non-small cell lung cancer (NSCLC), melanoma and ovarian cancer, express NY-ESO-1, which is consistent with published literature.

The poster is available on the "Publications" page of the "Science" section of the Celldex website.

Title: Targeting the melanosome: overcoming MAPK-inhibitor resistance in melanoma
Abstract: 296

Research collaborators examined the role of MiTF-regulated melanosomal differentiation antigens (MDAs), such as gpNMB, as potential therapeutic targets that could potentially overcome MAPK inhibitor resistance in melanoma. MiTF is a transcription factor that has been identified as an indicator of melanoma resistance, and through the interrogation of the TCGA melanoma database, the authors found it to be strongly correlated with MDAs, including gpNMB. In a preclinical study investigating resistance mechanisms in melanoma, glembatumumab vedotin, an antibody-drug conjugate that targets gpNMB, demonstrated synergies with therapies for BRAF mutated melanoma and overcame phenotypes associated with resistance, suggesting use of glembatumumab vedotin may be particularly effective as a single-agent or in combination in this refractory patient population.

About Varlilumab
Varlilumab is a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade. CD27 can be effectively manipulated with activating antibodies to induce potent anti-tumor responses and may result in fewer toxicities due to its restricted expression and regulation. Varlilumab is a potent anti-CD27 agonist that induces activation and proliferation of human T cells when combined with T cell receptor stimulation. In lymphoid malignancies that express CD27 at high levels, varlilumab may have an additional mechanism of action through a direct anti-tumor effect. Varlilumab has completed a single-agent Phase 1 dose-escalation study, demonstrating potent immunologic activity consistent with its mechanism of action and anti-tumor activity in patients with advanced, refractory disease. No maximum tolerated dose was reached and minimal toxicities were observed. Celldex has initiated a broad development program for varlilumab to explore its role as an immune activator in combination with a number of complementary investigational and approved oncology drugs.

About CDX-301
CDX-301 (Flt3L) is a potent hematopoietic cytokine that has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In addition, CDX-301 has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. Celldex believes this ligand may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company’s portfolio.

About CDX-1401
CDX-1401 is a next-generation, off-the-shelf cancer vaccine designed to activate the patient’s immune system against cancers that express the tumor marker, NY-ESO-1. CDX-1401 consists of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 genetically linked to the NY-ESO-1 tumor antigen. Celldex has accessed NY-ESO-1 through a licensing agreement with the Ludwig Institute for Cancer Research. By selectively delivering the NY-ESO-1 antigen to dendritic cells in the body, CDX-1401 is intended to induce robust immune responses against the antigen-expressing cancer cells.

About Glembatumumab Vedotin
Glembatumumab vedotin is a fully-human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB). gpNMB is a protein overexpressed by multiple tumor types, including breast cancer, melanoma, lung cancer, uveal melanoma and osteosarcoma. gpNMB has been shown to be associated with the ability of the cancer cell to invade and metastasize and to correlate with reduced time to progression and survival in breast cancer. The gpNMB-targeting antibody, CR011, is linked to a potent cytotoxic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. Glembatumumab vedotin is designed to be stable in the bloodstream but to release MMAE upon internalization into gpNMB-expressing tumor cells, resulting in a targeted cell-killing effect. Glembatumumab vedotin is in development for the treatment of locally advanced or metastatic breast cancer with an initial focus in triple negative disease, stage III and IV melanoma, uveal melanoma and osteosarcoma.

Opdivo is a registered trademark of Bristol-Myers Squibb Company.

Celator® Pharmaceuticals Announces New Data for VYXEOS™ in FLT3-ITD Mutated AML Cells Derived from Patients with Newly Diagnosed AML to be Presented at the American Association for Cancer Research Annual Meeting

On April 18, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that data for VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, LA, April 16-20, 2016 (Press release, Celator Pharmaceuticals, APR 18, 2016, View Source [SID:1234510992]).

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The research was conducted in the laboratory of Dr. Jeffrey Tyner at Oregon Health & Science University. The objective of the research was to examine the ex vivo sensitivity of acute myeloid leukemia (AML) cells derived from newly diagnosed patients to VYXEOS. This work supports the observed clinical benefit of VYXEOS in high-risk AML patients and may provide a means of identifying patient genotypes/phenotypes most sensitive to VYXEOS.

"We continue to learn more about the unique activity of VYXEOS in AML and enhance our ability to match this performance with specific patient characteristics that could be predictive of improved outcomes," said Lawrence Mayer, Ph.D., President and Chief Scientific Officer at Celator. "The research being undertaken by Dr. Tyner reflects Celator’s goal to elucidate the clinical benefits of VYXEOS by expanding our scientific understanding of its mechanism of action, particularly in AML cells with important molecular phenotypes."

Details on the AACR (Free AACR Whitepaper) poster presentation:
Presentation Title:
CPX-351 cytotoxicity against fresh AML blasts is increased for FLT3-ITD+ cells and correlates with drug uptake and clinical outcomes
Date/Time:
Sunday, April 17, 2016 – 1:00pm-5:00pm
Session Category:
Poster Presentation
Session Title:
ET01-03, Combination Chemotherapy
Location:
New Orleans Convention Center, Halls G-J Poster Section 15
Abstract Number:
287

Celator Reports on Previously Suspended Investigator-Initiated Clinical Study

On April 18, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that an investigator-initiated clinical study at a university was reported as suspended on www.clinicaltrials.gov (Press release, Celator Pharmaceuticals, APR 18, 2016, View Source [SID:1234510991]). The study had previously been suspended due to institutional resource considerations at the university, unrelated to VYXEOS (CPX-351). The study is a phase 2 study of VYXEOS for the treatment of acute myeloid leukemia or higher risk myelodysplastic syndrome patients, who relapsed, or were refractory to, prior therapy with hypomethylating agents. Celator understands that the study has since been re-opened.

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"To eliminate any confusion, we want to inform investors, the medical community and study participants of these circumstances," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals.

Calithera Biosciences Announces Four Preclinical Presentations at the American Association for Cancer Research Annual Meeting 2016

On April 18, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported preclinical data for each of its therapeutic candidates, CB-839 and CB-1158, at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 16-20, 2016, in New Orleans, Louisiana (Press release, Calithera Biosciences, APR 18, 2016, View Source;p=RssLanding&cat=news&id=2157903 [SID:1234510990]). CB-839 is a potent, selective, orally bioavailable glutaminase inhibitor currently in phase I clinical trials. CB-1158 is a first-in-class immuno-oncology agent targeting arginase, a key immuno-suppressive enzyme that limits T-cell proliferation in a wide range of tumors.

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"Both CB-839 and CB-1158 have the distinction of targeting metabolic checkpoints which we believe through rational combinations, have the potential to be transformational in the treatment of cancer. For CB-839, we look forward to initiating a trial in combination with anti-PD-1 in the second quarter. We have made significant progress on our CB-1158 program, and remain on track to file an IND application in mid-2016," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.

CB-839

Preclinical data will be presented in a poster titled, "Glutaminase inhibition with CB-839 enhances anti-tumor activity of PD-1 and PD-L1 antibodies by overcoming a metabolic checkpoint blocking T cell activation," by Matt Gross, Director of Pharmacology at Calithera Biosciences (Abstract #2329). Included in the presentation are the results of studies investigating the preclinical anti-tumor activity of CB-839 in combination with an anti-PD-L1 or an anti-PD-1 antibody. The combination of CB-839 and anti-PD-L1 or anti-PD-1 increased the number of tumor regressions seen in the CT-26 syngeneic colon carcinoma model. Synergistic effects with CB-839 and anti-PD-L1 were also observed in a B16 melanoma model. The mechanism of action of anti-PD-L1 combined with CB-839, two agents that affect metabolism in the tumor microenvironment, is being explored in further studies.

The following two abstracts were also presented at the meeting by Calithera’s collaborators:

Neurofibromatosis type 1 (NF1) status determines sensitivity of soft tissue sarcoma and melanoma cell lines to glutaminase inhibitors (Abstract #19). Presenter: Tahir Sheikh, PhD, Laboratory of Gary Schwartz, MD, Columbia University

GLS inhibitor CB-839 modulates cellular metabolism in AML and potently suppresses AML cell growth when combined with 5-azacitidine (Abstract #1004). Presenter: Tianyu Cai, PhD, Laboratory of Marina Konopleva, MD, University of Texas MD Anderson Cancer Center

CB-1158

Preclinical data was presented in a poster titled, "Immuno-oncology agent CB-1158 is a potent and selective arginase inhibitor and causes an immune mediated anti-tumor response," by Melissa Works, PhD, Scientist at Calithera Biosciences (Abstract #552). CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, demonstrated single agent efficacy in animal models. Inhibition of tumor growth was accompanied by an increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment. CB-1158 increased CD8+ T-cell infiltrates in a lung tumor model. The addition of CB-1158 to anti-CTLA-4 and anti-PD-1, significantly inhibited tumor growth and reduced metastases in a mouse model that was resistant to dual checkpoint inhibitor therapy. CB-1158 was well tolerated as a single agent and in combination with checkpoint inhibitors in animal studies.

Arginase is a critical immunosuppressive enzyme that inhibits T-cell proliferation and function. Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of two of the body’s cancer-fighting immune cells, known as cytotoxic T -cells and natural killer (NK) cells. Arginase inhibitors can restore arginine levels and reverse the immuno-suppressive effect of arginase-secreting myeloid-derived suppressor cells (MDSCs). MDSCs are present in many human tumors and are correlated with poor prognosis. CB-1158 has the potential for anti-tumor activity in a variety of malignancies, including non-small cell lung cancer, colorectal cancer, gastric cancer and bladder cancer, among other tumor types that are highly infiltrated with MDSCs.

bluebird bio to Present Immuno-Oncology and Gene Therapy Data at the ASGCT 19th Annual Meeting

On April 18, 2016 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies for cancer, reported that data from clinical, preclinical, and research and manufacturing programs will be highlighted in ten presentations at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 19th Annual Meeting, taking place May 4-7, 2016 in Washington, D.C (Press release, bluebird bio, APR 18, 2016, View Source;p=RssLanding&cat=news&id=2158031 [SID:1234510988]).

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Two oral presentations given by bluebird’s academic collaborators will highlight previously presented data from bluebird bio’s ongoing gene therapy clinical trials. David Williams, M.D., chief of hematology/oncology at Boston Children’s Hospital will present interim data from the Starbeam Study of Lenti-D in cerebral adrenoleukodystrophy, and Marina Cavazzana, M.D., Ph.D., of Hospital Necker, University Paris Descartes, will present interim data from the HGB-205 study of LentiGlobin in severe sickle cell disease and transfusion-dependent β-thalassemia.

Eight additional presentations will be featured at the meeting, highlighting progress across the company’s preclinical, research and process development activities.

"As bluebird continues to build a differentiated T cell oncology franchise, we are excited to present three oncology abstracts that highlight our work on the next generation of technology for T cell-based immunotherapy – including methods of generating T cells with sustained anti-tumor activity, small-molecule regulated chimeric antigen receptors (CARs) and genome editing to generate improved CAR T cells," said Philip Gregory, D.Phil., chief scientific officer, bluebird bio. "From our hematopoietic stem cell programs, we will also share updates in five presentations covering improvements in scalable manufacturing, transduction efficiency and assay development – critical areas for making gene therapy available to more patients."

The abstracts are now available online on the ASGCT (Free ASGCT Whitepaper) Annual Meeting website.

Details of bluebird bio’s oral presentations are as follows:

Title: A Phase 2/3 Study of the Efficacy and Safety of Ex Vivo Gene Therapy With Lenti-D Lentiviral Vector for the Treatment of Cerebral Adrenoleukodystrophy
Abstract Number: 250
Session: Clinical Trials Spotlight Symposium
Date: Thursday, May 5, 2016
Time: 9:00 – 9:20 a.m.
Location: Thurgood Marshall North/East
Note: Data previously presented at the 2016 American Academy of Neurology Annual Meeting

Title: Small Molecule-regulated Antigen Recognition System for Inducible T Cell Targeting of Cancer Cells
Abstract Number: 277
Session: Cancer-Immunotherapy, Cancer Vaccines I
Date: Thursday, May 5, 2016
Time: 5:15 – 5:30 p.m.
Location: Washington 4

Title: Clinical Outcomes of Gene Therapy with BB305 Lentiviral Vector for Sickle Cell Disease and β-Thalassemia
Abstract Number: 279
Session: Hematologic & Immunologic Diseases I
Date: Thursday, May 5, 2016
Time: 4:00 – 4:15 p.m.
Location: Washington 5-6
Note: Data previously presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Title: Towards the Clinical Application of BCMA CAR T cells: The Importance of Reduced Tonic Signaling and Methods to Enhance Memory T Cells
Abstract Number: 747
Session: Cancer-Immunotherapy, Cancer Vaccines III
Date: Saturday, May 7, 2016
Time: 10:45 – 11:00 a.m.
Location: Thurgood Marshall North

Details of bluebird bio’s poster presentations are as follows:

Title: PGE2 Increases Lentiviral Vector Transduction Efficiency of Human HSC
Abstract Number: 229
Session: Hematologic & Immunologic Diseases I
Date: Wednesday, May 4, 2016
Time: 5:30 p.m. – 7:30 p.m.
Location: Exhibit Hall C & B South

Title: Staurosporine Increases Lentiviral Transduction of Human CD34+ Cells
Abstract Number: 221
Session: Hematologic & Immunologic Diseases I
Date: Wednesday, May 4, 2016
Time: 5:30 p.m. – 7:30 p.m.
Location: Exhibit Hall C & B South

Title: Qualification of a p24 ELISA Assay for Quantitation of Total Lentiviral Vector Concentration
Abstract Number: 473
Session: Pharmacology/Toxicology Studies or Assay Development
Date: Thursday, May 5, 2016
Time: 6:00 p.m. – 8:00 p.m.
Location: Exhibit Hall C & B South

Title: Efficient Generation of CART Cells by Homology Directed Transgene Integration into the TCR-Alpha Locus
Abstract Number: 323
Session: Targeted Genome Editing II
Date: Thursday, May 5, 2016
Time: 6:00 p.m. – 8:00 p.m.
Location: Exhibit Hall C & B South

Title: Development of a Stable Producer Cell Line for Scalable Lentiviral Vector Production for Gene Therapy of Hemoglobinopathies
Abstract Number: 458
Session: Vector and Cell Engineering/Manufacturing I
Date: Thursday, May 5, 2016
Time: 6:00 p.m. – 8:00 p.m.
Location: Exhibit Hall C & B South

Title: Characterization of Nanoparticles in Lentiviral Vector Preparations
Abstract Number: 709
Session: Vector and Cell Engineering/Manufacturing II
Date: Friday, May 6, 2016
Time: 6:00 p.m. – 8:00 p.m.
Location: Exhibit Hall C & B South