On November 5, 2015 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that a record number of abstracts were accepted for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, Florida, December 5-8, 2015, including the following:

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Several oral and poster data presentations on ADCETRIS (brentuximab vedotin) as both monotherapy and combination therapy in multiple Hodgkin lymphoma (HL) disease settings, supporting the company’s goal to establish ADCETRIS as the foundation of care for HL;

Data presentations on ADCETRIS in frontline non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphomas (PTCL), to be presented in oral and poster sessions;

Phase 1 clinical data for SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia (AML) as monotherapy and in combination with hypomethylating agents (HMAs) to be presented in two oral sessions; preclinical data supporting HMA combination strategy to be presented in poster session;

Updated phase 1 clinical data to be presented for SGN-CD19A (denintuzumab mafodotin) in acute lymphoblastic leukemia (ALL) and NHL in oral and poster sessions; and

Preclinical data from two new ADCs for hematologic malignancies, SGN-CD19B and SGN-CD123A, using the company’s proprietary pyrrolobenzodiazepine (PBD) technology to be presented in oral sessions (Press release, Seattle Genetics, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107576 [SID:1234508059]).

"There will be more than 20 data presentations, including 13 orals, from corporate and investigator studies, representing the largest presence Seattle Genetics has ever had at ASH (Free ASH Whitepaper)," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "Our broad ADCETRIS development program continues to generate data that support its potential as the foundation of care for Hodgkin lymphoma and other CD30-expressing lymphomas. We are also excited to share updates from our ongoing SGN-CD33A and SGN-CD19A programs and to present preclinical data from two new programs, SGN-CD19B and SGN-CD123A, which will advance into the clinic in 2016."

With more than 15 years of experience and innovation, Seattle Genetics is the leader in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. More than 25 ADCs in clinical development utilize Seattle Genetics’ proprietary ADC technology. ADCETRIS is the first drug approved utilizing this technology.

ADCETRIS is currently not approved for the treatment of frontline HL, frontline NHL, salvage HL in patients eligible for autologous transplant, GVHD or as a combination therapy for HL or NHL.

Multiple corporate and investigator presentations will be featured at ASH (Free ASH Whitepaper). Abstracts can be found at www.hematology.org and include the following:

Saturday, December 5, 2015

Frontline Treatment of CD30+ Peripheral T-Cell Lymphomas with Brentuximab Vedotin in Combination with CHP: 3-Year Durability and Survival Follow-up (Abstract #1537, poster presentation)

A Phase 1 Study of Denintuzumab Mafodotin (SGN-CD19A) in Adults with Relapsed or Refractory B-Lineage Acute Leukemia (B-ALL) and Highly Aggressive Lymphoma (Abstract #1328, poster presentation)

AMC-085: A Pilot Trial of AVD and Brentuximab Vedotin in the Upfront Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma. A Trial of the AIDS Malignancy Consortium (Abstract #1526, poster presentation)

Risk Factors and a Prognostic Score in Patients with Relapsed or Refractory Hodgkin Lymphoma (rrHL) after Treatment with Autologous Stem Cell Transplantation (ASCT) (Abstract #1978, poster presentation)

Multicenter Phase I Trial of Brentuximab Vedotin for Steroid Refractory Acute Graft-vs.-Host Disease (GVHD) (Abstract #1930, poster presentation)

Sunday, December 6, 2015

A Phase 1 Study of Denintuzumab Mafodotin (SGN-CD19A) in Relapsed/Refractory B-Lineage Non-Hodgkin Lymphoma (Abstract #182, oral presentation at 7:45 a.m. ET)

TARC Predicts PET-Normalization and Event Free Survival in Relapsed/Refractory Hodgkin Lymphoma Patients Treated with Brentuximab Vedotin (Abstract #180, oral presentation at 8:45 a.m. ET)

A Phase 1 Trial of SGN-CD33A as Monotherapy in Patients with CD33-Positive Acute Myeloid Leukemia (AML) (Abstract #324, oral presentation at 5:45 p.m. ET)

SGN-CD123A, a Pyrrolobenzodiazepine Dimer Linked Anti-CD123 Antibody Drug Conjugate, Demonstrates Effective Anti-Leukemic Activity in Multiple Preclinical Models of AML (Abstract #330, oral presentation at 5:45 p.m. ET)

Five-Year Survival Data Demonstrating Durable Responses from a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #2736, poster presentation)

Updated Efficacy and Safety Data from the AETHERA Trial of Consolidation with Brentuximab Vedotin after Autologous Stem Cell Transplant (ASCT) in Hodgkin Lymphoma Patients at High Risk of Relapse (Abstract #3172, poster presentation)

Brentuximab Vedotin in Combination with Multi-Agent Chemotherapy is Well Tolerated and Effective as Frontline Treatment for Primary Mediastinal B-Cell Lymphoma (Abstract #2694, poster presentation)

Monday, December 7, 2015

Post Transplant Outcome of a Multicenter Phase II Study of Brentuximab Vedotin As First Line Salvage in Relapsed/Refractory HL Prior to AHCT (Abstract #519, oral presentation at 7:30 a.m. ET)

SGN-CD33A Plus Hypomethylating Agents: A Novel, Well-Tolerated Regimen with High Remission Rate in Frontline Unfit AML (Abstract #454, oral presentation at 7:45 a.m. ET)

Preliminary Safety and Efficacy of the Combination of Brentuximab Vedotin and Ipilimumab in Relapsed/Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Cancer Research Group (E4412) (Abstract #585, oral presentation at 11:00 a.m. ET)
Targeted BEACOPP Variants in Patients with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma: Final Analysis of a Randomized Phase II Study (Abstract #580, oral presentation at 11:15 a.m. ET)

The Combination of Brentuximab Vedotin (Bv) and Bendamustine (B) Demonstrates Marked Activity in Heavily Treated Patients with Relapsed or Refractory Hodgkin Lymphoma (HL) and Anaplastic Large T-Cell Lymphoma (ALCL): Results of an International Multicenter Phase I/II Experience (Abstract #586, oral presentation at 11:15 a.m. ET)

Brentuximab Vedotin in Combination with Dacarbazine or Bendamustine for Frontline Treatment of Hodgkin Lymphoma in Patients Aged 60 Years and Above: Interim Results of a Multi-Cohort Phase 2 Study (Abstract #587, oral presentation at 11:30 a.m. ET)
Evaluation of the Regimen Brentuximab Vedotin Plus ESHAP (BRESHAP) in Refractory or Relapsed Hodgkin Lymphoma Patients: Preliminary Results of a Phase I-II Trial from the Spanish Group of Lymphoma and Bone Marrow Transplantation (GELTAMO) (Abstract #582, oral presentation at 11:45 a.m. ET)

SGN-CD19B, a Pyrrolobenzodiazepine (PBD)-Based Anti-CD19 Drug Conjugate, Demonstrates Potent Preclinical Activity Against B-Cell Malignancies (Abstract #594, oral presentation at 11:45 a.m. ET)

Brentuximab Vedotin with RCHOP As Frontline Therapy in Patients with High-Intermediate/High-Risk Diffuse Large B-cell Lymphoma (DLBCL): Results from an Ongoing Phase 2 Study (Abstract #814, oral presentation at 5:15 p.m. ET)

SGN-CD33A in Combination with Hypomethylating Agents Is Highly Efficacious in Preclinical Models of AML (Abstract #3785, poster presentation)

Brentuximab Vedotin Plus Bendamustine: A Highly Active Salvage Treatment Regimen for Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #3982, poster presentation)

A Phase I Trial of Brentuximab Vedotin in Combination with Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma (Abstract #3988, poster presentation)

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials, including the phase 3 ALCANZA trial and two additional phase 3 studies, ECHELON-1 in frontline classical HL and ECHELON-2 in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory HL and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 55 countries. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About SGN-CD33A (Vadastuximab Talirine)

SGN-CD33A (vadastuximab talirine) is a novel ADC targeted to CD33 utilizing Seattle Genetics’ newest ADC technology. CD33 is expressed on most AML cells. The CD33 antibody is attached to a highly potent DNA binding agent, a pyrrolobenzodiazepine (PBD) dimer, via a proprietary site-specific conjugation technology to a monoclonal antibody with engineered cysteines (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the site-specific conjugation technology (EC-mAb) allows uniform drug-loading of the cell-killing PBD agent to the anti-CD33 antibody. The ADC is designed to be stable in the bloodstream and to release its potent DNA binding agent upon internalization into CD33-expressing cells. SGN-CD33A is being evaluated in ongoing phase 1 clinical trials for patients with AML.

About SGN-CD19A (Denintuzumab Mafodotin)

SGN-CD19A (denintuzumab mafodotin) is an ADC targeting CD19, a protein expressed broadly on B-cell malignancies. Denintuzumab mafodotin is comprised of an anti-CD19 monoclonal antibody linked to a synthetic cytotoxic cell-killing agent, monomethyl auristatin F (MMAF). The ADC is designed to be stable in the bloodstream, and to release its cytotoxic agent upon internalization into CD19-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity. SGN-CD19A is being evaluated in two ongoing phase 1 clinical trials for patients with B-cell ALL and aggressive NHL as well as a phase 2 clinical trial in relapsed or refractory DLBCL.

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).

On November 5, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported initial data from a Phase 1b/2 study of the company’s lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient (pazopanib) in patients with advanced recurrent ovarian cancer (Press release, OXiGENE, NOV 5, 2015, View Source [SID:1234508054]). The data are from the ongoing "PAZOFOS" study and were presented at the 19th International Meeting of the European Society of Gynaecological Oncology (ESGO) in Nice, France.

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"The initial results we’ve seen to date from the Phase 1b portion of PAZOFOS are encouraging and we expect to move into the phase 2 portion of the study in early 2016," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the trial. "We are excited about continuing our clinical evaluation of this complementary combination—a combination that utilizes the potential synergistic effects of CA4P and pazopanib and could offer a new treatment approach for patients with relapsed ovarian cancer."

Dr. Rustin reported that 12 patients have been enrolled in the phase 1b portion of the study. Nine of the patients were evaluated for objective response using RECIST criteria, showing two partial responses, five stable diseases and two progressive diseases. Eight of the ten patients with evaluable data demonstrated decreases in the tumor marker CA125, with three achieving a response according to CGIC criteria. Dr. Rustin also noted that four patients were still on treatment, and that the efficacy data are currently preliminary and unverified. Safety data showed that the combination of CA4P and pazopanib was generally well tolerated with no Grade 4-5 adverse events (AEs). The most commonly reported AEs were hypertension, fatigue, and pain. The Development Safety Update Report #1 submitted to the regulatory body stated that no definitive conclusions can be made regarding the benefit of treatment in the small subset of patients treated so far.

"The results seen thus far with CA4P combined with pazopanib broaden and strengthen the body of evidence indicating that CA4P can be effectively used as a component of combination therapy for patients with solid tumors," said William D. Schwieterman, MD, OXiGENE’s President and CEO. "We look forward to the continued results from this trial, and to advancing CA4P in combination with Avastin in phase 2/3 studies in platinum-resistant ovarian cancer and glioblastoma multiforme in 2016."

PAZOFOS is a randomized, controlled clinical study consisting of a phase 1b dose escalation portion (CA4P plus pazopanib) and a phase 2 portion comparing CA4P plus pazopanib versus pazopanib alone. The study is designed to enroll up to 128 patients at up to ten sites in the United Kingdom. The primary endpoint for the phase 2 portion is progression-free survival; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.

PAZOFOS is sponsored by The Christie NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). CA4P and pazopanib are being provided by OXiGENE and GlaxoSmithKline/Novartis, respectively.

About CA4P

CA4P (also known as fosbretabulin) is a vascular disrupting agent and is OXiGENE’s lead investigational drug. CA4P exerts its anti-tumor effects by targeting an established tumor’s immature endothelial cells within the tumor’s blood vessels, compromising the tumor vasculature and leading to widespread ischemia and necrosis of the cells within the central core of the tumor. OXiGENE plans to advance CA4P in clinical development in combination with approved anti-angiogenic agents which prevent the growth of new tumor blood vessels. Following an extensive clinical review, OXiGENE recently announced its plans to focus on initiation of two late-stage clinical programs for CA4P in 2016. These planned programs combine CA4P with standard-of-care in platinum-resistant ovarian cancer and in glioblastoma multiforme. In addition to PAZOFOS, CA4P is also being evaluated in an ongoing study in neuroendocrine tumors.

On November 5, 2015 Geron Corporation (Nasdaq: GERN) reported financial results for the third quarter ended September 30, 2015 (Filing, 8-K, Geron, NOV 5, 2015, View Source [SID:1234508051]).

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For the third quarter of 2015, the company reported net income of $27.2 million, or $0.17 per share, compared to a net loss of $9.5 million, or $(0.06) per share, for the comparable 2014 period. Net income for the first nine months of 2015 was $8.5 million, or $0.05 per share, compared to a net loss of $26.7 million, or $(0.18) per share, for the comparable 2014 period. The company ended the third quarter of 2015 with $151.8 million in cash and investments.

Revenues for the third quarter of 2015 were $35.4 million compared to $160,000 for the comparable 2014 period. Revenues for the first nine months of 2015 were $36.2 million compared to $975,000 for the comparable 2014 period. Revenues for the three and nine month periods ending September 30, 2015 included the full recognition of the $35.0 million upfront payment from Janssen Biotech, Inc. (Janssen) as collaboration revenue upon the company’s transfer of the imetelstat license rights and completion of technology transfer-related activities outlined under the imetelstat collaboration agreement with Janssen. The upfront cash payment was received in December 2014 and recorded as deferred revenue at that time.

Total operating expenses for the third quarter of 2015 were $8.3 million compared to $10.1 million for the comparable 2014 period. Research and development expenses for the third quarter of 2015 were $4.1 million compared to $6.0 million for the comparable 2014 period. General and administrative expenses for the third quarter of 2015 were $4.3 million compared to $4.1 million for the comparable 2014 period.

Total operating expenses for the first nine months of 2015 were $28.1 million compared to $28.3 million for the comparable 2014 period. Research and development expenses for the first nine months of 2015 were $13.8 million compared to $16.4 million for the comparable 2014 period. General and administrative expenses for the first nine months of 2015 were $12.9 million compared to $11.9 million for the comparable 2014 period. Year-to-date operating expenses for 2015 also included restructuring charges of $1.3 million in connection with the company’s organizational resizing announced in March 2015.

The decrease in research and development expenses for the three and nine month periods ending September 30, 2015, compared to the same periods in 2014, was primarily the net result of lower costs for the manufacturing of imetelstat and reduced personnel-related costs resulting from the organizational resizing, partially offset by increased costs for the development of imetelstat for hematologic myeloid malignancies in collaboration with Janssen. The company expects research and development expenses to increase during the remainder of the year as the development of imetelstat continues in collaboration with Janssen. The increase in general and administrative expenses for the three and nine month periods ending September 30, 2015, compared to the same periods in 2014, was primarily the result of higher non-cash stock-based compensation expense and increased legal costs associated with the company’s patent portfolio.

Interest and other income for the third quarter of 2015 amounted to $187,000 compared to $91,000 for the comparable 2014 period. Interest and other income for the first nine months of 2015 was $481,000 compared to $273,000 for the comparable 2014 period. The increase in interest and other income for the three and nine month periods ending September 30, 2015, compared to the same periods in 2014, primarily reflects higher yields on the company’s investment portfolio. The company has not incurred any impairment charges on its investment portfolio.

Recent Company Events

● Two papers were published in the September 3, 2015 issue of The New England Journal of Medicine (NEJM) with results from two clinical studies in which imetelstat was shown to have disease-modifying activity thought to be associated with the selective inhibition of the malignant progenitor cell clones responsible for the underlying disease in two hematologic myeloid malignancies, essential thrombocythemia (ET) and myelofibrosis (MF). The papers are available online at www.NEJM.org.

● In September 2015, the first patient was dosed in the IMbark study, a Phase 2 clinical trial to evaluate the activity of two dose levels of imetelstat in patients with DIPSS intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to a JAK inhibitor. Multiple medical centers across North America, Europe and Asia are planned to participate in this clinical trial. For more information about the IMbark study being conducted by Janssen, please visit View Source

● Three abstracts describing clinical and non-clinical data on imetelstat were accepted for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held in Orlando, Florida from December 5-8, 2015. The abstracts were published on November 5, 2015 on the ASH (Free ASH Whitepaper) website at www.hematology.org.

On November 5, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported that three posters featuring the company’s research activities are being presented during the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 4-8, 2015, in National Harbor, Maryland (Press release, Five Prime Therapeutics, NOV 5, 2015, View Source [SID:1234508048]). The posters will be made available at View Source following the presentations.

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cmFPA008, an Anti-Mouse CSF-1R Antibody, Combines with Multiple Immunotherapies to Reduce Tumor Growth in Nonclinical Models
Bellovin D, Wondyfraw N, Levin A, et al
Thursday, November 5, 2015

The authors sought to determine whether inhibition of CSF1R when combined with other immuno-oncology therapeutics enhanced the anti-tumor impact. The results show that treatment with cmFPA008, a surrogate antibody targeting mouse CSF1R, resulted in a marked reduction in tumor-associated macrophages (TAMs) and an increase in the relative abundance and activation of cytotoxic CD8+ T cells in preclinical models. In multiple murine tumor models, treatment with cmFPA008 also induced an increase in PD-L1 and significantly enhanced anti-tumor efficacy when combined with an anti-PD1 antibody. In addition, co-administration of cmFPA008 with an agonistic anti-CD40 antibody significantly enhanced tumor suppression compared to either therapy alone. The results provide support for ongoing clinical efforts to evaluate FPA008 as an anti-cancer immunotherapy, particularly in combination with other immuno-oncology therapeutics, including agonists of CD40. Five Prime has initiated a Phase 1a/1b clinical trial with Bristol-Myers Squibb to investigate the efficacy of FPA008 in combination with the anti-PD1 therapeutic OPDIVO (nivolumab) in six tumor types. Five Prime is also developing an agonist antibody to glucocorticoid-induced tumor necrosis factor receptor (GITR) that is expected to enter the clinic in 2017.

Identification of Novel Immune Regulators of Tumor Growth Using RIPPSSM Screening in vivo
Brennan T, Bellovin D, De La Torre J, et al
Friday, November 6, 2015

Five Prime is using its proprietary Rapid In Vivo Protein Production System (RIPPS) screening platform to discover novel protein therapeutics, targets, and drug combinations that can be used in alone or in combinations with other immuno-oncology agents. The authors screened 350 immune cell targets by RIPPS in the CT-26 tumor model and identified proteins that either enhance (potential drug target) or inhibit (potential therapeutic) tumor growth and display favorable changes in TIL (tumor-infiltrating lymphocyte) profiles. Five Prime identified several proteins with novel tumor-inhibiting or tumor-promoting activities. One of these proteins has been evaluated further and displays both strong CD3 infiltrate activity into the tumor and synergistic activity with PD1 blockade. Five Prime is conducting additional studies on each protein in other tumor models and in combination with known immune-modulating drugs.

Identification of a Novel T Cell Co-Inhibitory Receptor and Potential Therapeutic Antibody Target in Oncology
Sallee N, Karasyov A, Bellovin D, et al
Friday, November 6, 2015

In order to identify novel immune regulatory proteins and evaluate their potential as immuno-oncology therapeutic targets, Five Prime screened a subset of its library of human extracellular proteins in vitro for the ability to modulate immune responses. The authors discovered a number of novel T cell co-inhibitors, including one referred to as Novel Co-Inhibitor 1 (or NCI1), which was identified through its inhibitory activity on anti-CD3-stimulated human T cells in an in vitro assay. To confirm its activity, the authors demonstrated that the native protein expressed on an antigen-presenting cell line could inhibit antigen-stimulated CD8+ T cell activation and that blocking antibodies against this protein relieved the inhibition in vitro. This inhibitory activity translated to a murine system and overexpression of the protein in tumor-bearing mice resulted in increased tumor growth. However, blocking NCI1 with an antibody did not have a significant effect on tumor growth as a single agent in in vivo models, and the company is prioritizing other potential targets. The authors will report the further characterization of NCI1.