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Celldex Therapeutics, Inc.

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Celldex Presents Preliminary Cohort Data from Pilot Study of CDX-301 in Allogeneic Hematopoietic Stem Cell Harvest at the 2016 BMT Tandem Meeting

HAMPTON, N.J., Feb. 20, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today presented new clinical data on CDX-301 (recombinant human Flt3 ligand), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells. An open label, pilot study of CDX-301, alone and in combination with Mozobil (plerixafor), in sibling-matched donors for allogeneic hematopoietic stem cell transplantation (HSCT) recipients who have certain hematologic malignancies is currently enrolling donor/patient pairs. Early data were presented in a poster entitled "Preliminary Safety and Efficacy Data using CDX-301 (Flt3 ligand) as a Sole Agent to Mobilize Hematopoietic Cells Prior to HLA-matched Sibling Donor Transplantation" at the 2016 BMT Tandem Meeting, the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The poster is available on the "Publications" page of the "Science" section of the Celldex website.

Three donor/patient pairs showed that CDX-301 given as a single agent for 5 days was well tolerated and effective at mobilizing hematopoietic stem cells in healthy donors. The stem cell graft contained notable increases in naïve lymphocytes and plasmacytoid dendritic cells compared to administration of G-CSF (granulocyte colony-stimulating factor) and is consistent with preclinical data suggesting a possible better outcome for recipients. Notably, no donors required rescue with either G-CSF or Mozobil in this arm of the study, and none experienced any grade 3 or 4 adverse events. Recipients experienced successful engraftment in an expected time frame. Additional donor/patient pairs are being accrued to a second, planned cohort in order to assess the potential synergies and feasibility of combining CDX-301 with Mozobil in this setting.

"From these data and preclinical studies, CDX-301 appears to be an effective, targeted approach to mobilization comparable to G-CSF. With a relatively short course of treatment, we are observing specificity for mobilized stem cells and a lack of toxicity, instead of broad cellular mobilization and side effects," said Steven Devine, M.D., Professor of Internal Medicine, Division of Hematology, Department of Internal Medicine, and Program Director, Blood and Marrow Transplant Program at The Ohio State Comprehensive Cancer Center.

"CDX-301 shows a favorable safety profile and effectively mobilizes early stem cells when used alone, and we expect even greater yields in the next cohort where we combine with Mozobil," said Thomas Davis, M.D., Executive Vice President and Chief Medical Officer of Celldex Therapeutics . "CDX-301 could potentially provide good engraftment, less graft-versus-host disease and mitigated side effects, which would be a breakthrough for these patients undergoing HSCT. We are also looking forward to receiving data from investigators who are using CDX-301 in other drug combination studies designed to assess its potential in immunotherapy for cancer and other indications."

In addition, CDX-301 has shown impressive results in models of cancer, infectious diseases, inflammatory/autoimmune diseases and immune suppression. Celldex believes CDX-301 may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company's portfolio and in external development. CDX-301 is in clinical development for cancers in combination with vaccines, adjuvants, and other treatments that result in release of tumor antigens to enhance tumor immunogenicity.
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Source: press release, 2/20/16. http://ir.celldex.com/releasedetail.cfm?ReleaseID=955951

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September 25, 2014

Celldex Therapeutics Initiates Pilot Study of CDX-301 in Allogeneic Hematopoietic Stem Cell Transplantation

HAMPTON, N.J., Sept. 25, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced the initiation of a pilot study of CDX-301 for the mobilization and transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HSCT). The study will explore the utility of CDX-301, also known as FMS-like tyrosine kinase-3 ligand or Flt3L, alone and in combination with Mozobil® and is supported by preclinical data demonstrating that the combination of CDX-301 and Mozobil increased hematopoietic stem cell mobilization and improved transplantation of mobilized cells.

The open-label, pilot study will enroll up to 36 participants, or 18 recipient/donor pairs, ages 18 to 65 across two sequentially enrolled cohorts in approximately 10 clinical trial sites in the United States. Study participants include patients (recipients) with specified hematologic malignancies (AML, ALL, MDS, CML, NHL and CLL) and Human Leukocyte Antigen (HLA) sibling-matched healthy volunteers (donors). The primary objective is to assess the safety and tolerability of CDX-301 when given with or without Mozobil. Secondary endpoints will evaluate the adequacy of the resultant grafts as determined by CD34+ yield, the cellular composition of the resultant grafts, and the safety and effectiveness of the resulting grafts across multiple measures.

"Improvements in stem cell mobilization are needed to enhance the potency of hematopoietic stem cell grafts and lower the risk of graft-versus-host disease," said Steven Devine, MD, Professor of Internal Medicine and Director, Blood and Marrow Transplant Program, The Ohio State University Comprehensive Cancer Center. "This study will determine whether CDX-301 alone or in combination with Mozobil can improve the stem cell transplant process, leading to better, safer outcomes for current transplant candidates and potentially expanding the procedure to an even broader range of donors and candidates across a number of malignant and non-malignant indications in the future." Dr. Devine and his team led the preclinical work evaluating CDX-301 and Mozobil for hematopoietic stem cell mobilization and transplantation and played an integral role in generating data and developing the design of this pilot study.

"CDX-301 appears to function as a key immune regulator, both activating and disarming the immune system as needed," said Tom Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics. "CDX-301 has broad potential to support and control immune function across multiple indications including cancer immunotherapy, marrow disorders like sickle cell disease, immunosuppression from trauma, burns and radiation, and even autoimmunity. We look forward to assessing the activity of CDX-301 in this initial setting and expanding the program, including in combination with a number of internal programs, over time."
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Source: press release, 9/25/14. http://ir.celldex.com/releasedetail.cfm?ReleaseID=872544

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A Pilot Study of CDX-301 (rhuFlt3L) With or Without Plerixafor for the Mobilization and Transplantation of Allogeneic Blood Cell Grafts in HLA-Matched Donor/Recipient Sibling Pairs
Estimated Enrollment: 36
Study Start Date: July 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02200380?term=celldex&rank=7

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
CDX-301HematologyBone Marrow Transplant (BMT)FMS-like tyrosine kinase-3 ligandFMS-like tyrosine kinase-3

Mechanism of action: CDX-301 is soluble, recombinant human FMS-like tyrosine kinase-3 ligand (Flt3L) that acts by uniquely binding FMS-like tyrosine kinase-3 (Flt3, CD135), which is expressed on hematopoietic stem cells (HSC), early progenitor cells, immature thymocytes, and steady state dendritic cells, resulting in the proliferation, differentiation, development and mobilization of these cells in the bone marrow, peripheral blood, and lymphoid organs.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2016-10-01 - 2016-12-31

Results: Pending