On December 5, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported key presentations of clinical and scientific data related to its products at the San Antonio Breast Cancer Symposium (SABCS), being held in San Antonio, Texas, from December 6-10, 2016 (Press release, Spectrum Pharmaceuticals, DEC 5, 2016, View Source [SID1234516921]).

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For more information about the SABCS meeting and for a complete list of abstracts, please refer to the conference website at View Source

The following are key ROLONTISTM (eflapegrastim) related abstracts being presented at the SABCS meeting:

Abstract # Type Title First Author Date/Time
Location: Hall 1
OT1-01-11 Poster
Randomized phase 3 study of a novel, long-acting G-CSF (eflapegrastim) versus pegfilgrastim in the management of chemotherapy-induced neutropenia in early-stage breast cancer patients receiving docetaxel and cyclophosphamide (TC) (ADVANCE study)

Schwartzberg Wednesday, Dec 7
5:00 PM
P5-11-09 Poster
Sustained efficacy of eflapegrastim in breast cancer patients in a phase 2, open-label, dose-ranging study

Vacirca Friday, Dec 9
5:00 PM
P5-11-07 Poster
Pharmacokinetics of eflapegrastim in a phase 2 open-label dose-ranging study in breast cancer patients receiving TC regimen

Vacirca Friday, Dec 9
5:00 PM
P5-11-08 Poster
Immunogenicity of eflapegrastim in a Phase 2 Open-Label Dose-Ranging Study of eflapegrastim in Breast Cancer Patients Receiving TC Regimen

Vacirca Friday, Dec 9
5:00 PM
The following key poziotinib related abstract will be presented at the SABCS meeting:

Abstract # Type Title First Author Date/Time
Location: Hall 1
OT1-02-10 Poster
A phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) who have received prior HER2 regimens for MBC

Lathrop Wednesday, Dec 7
5:00 PM

On December 5, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported advances in precision oncology using the Prosigna Breast Cancer Gene Signature Assay and the PAM50 gene signature, the basis for Prosigna, will be presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) (Press release, NanoString Technologies, DEC 5, 2016, View Source [SID1234516969]). In addition, numerous customers will be presenting data generated using NanoString’s nCounter Analysis System, including several involving immuno-oncology.

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"The volume and impact of the clinical research being presented at the SABCS underscores our commitment to improving the lives of breast cancer patients," said Brad Gray, president and chief executive officer of NanoString Technologies. "These studies demonstrate that our Prosigna Assay can improve decision-making in early-stage breast cancer today, and that a modified companion diagnostic version of this assay has future potential in triple negative breast cancer. The studies also show that our nCounter Analysis System is continuing to grow in prominence as an important tool among breast cancer researchers."

NanoString and its collaborators will present three oral presentations and fourteen posters covering Prosigna/PAM50 and other nCounter-based research at SABCS, which is being held December 6-10, 2016.

Following are details for each presentation of data involving Prosigna and the PAM50 gene signature (all times are in Central Standard Time):

Wednesday, December 7, 2016

Abstract: P1-07-10
Poster: Prediction of 10 year distant recurrence (DR) using the Prosigna (PAM50) assay in histological subgroups of a Danish Breast Cancer Cooperative Group (DBCG) cohort of postmenopausal Danish women with hormone receptor-positive (HR+) early breast cancer (EBC) allocated to 5yr of endocrine therapy (ET) alone
Authors: Laenkholm A-V, Jensen M-B, Buckingham W, Schaper C, Knoop A, Eriksen JO, Rasmussen BB, Ferree S, Haffner T, Kiboel T, Ejlertsen B.
Location: Hall 1
Time: 5:00 – 7:00 p.m.

Abstract: P1-09-09
Poster: Efficacy and gene expression results from SOLTI1007 NEOERIBULIN phase II clinical trial in HER2-negative early breast cancer
Authors: Prat A, Ortega V, Villagrasa P, Paré L, Galván P, Oliveira M, Nucíforo P, Lluch A, Morales S, Amillano K, Lopez R, Gonzalez R, Manso L, Martinez J, Llombart A, De la Peňa L, Di Cosimo S, Rubio IT, Harbeck N, Baselga J, Cortés J
Location: Hall 1
Time: 5:00 – 7:00 p.m.
Thursday, December 8, 2016

Abstract: P2-05-04
Poster: Evaluation of intra-tumor heterogeneity, test reproducibility and their impact in breast cancer samples assessed by Prosigna: results from a Decision Impact prospective study and a matched case-control study
Authors: Rouzier R, Bonneau C, Cayre A, Hequet D, Gentien D, Bonhomme A, Mouret-Reynier M-A, Dubot C, Cottu P, Roulot A, Morel P, Salomon A, Callens C, Guinebretiere J-M, Penault-Llorca F
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-03-03
Poster: Molecular differences between screen-detected and interval breast cancers are largely explained by PAM50 subtypes
Authors: Czene K, Ivansson E, Klevebring D, Tobin NP, Lindström LS, Holm J, Prochazka G, Hilliges C, Palmgren J, Törnberg S, Humphreys K, Hartman J, Frisell J, Rantalainen M, Lindberg J, Hall P, Bergh J, Grönberg H, Li J
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-05-16
Poster: Establishment of molecular profiling for individual treatment decisions in early breast cancer – clinical impact of PAM50 and PAM50 risk of recurrence score after more than 16 years follow up.
Authors: Naume B, Borgen E, Falk RS, Ohnstad HO, Lien TG, Aaserud M, Sveli MAT, Kyte JA, Kristensen V, Geitvik G, Schlichting E, Wist E, Sørlie T, Russnes H
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: S3-03
Oral Session: General Session 3
Poster: PAM50 intrinsic subtype as a predictor of pathological complete response following neoadjuvant dual HER2 blockade without chemotherapy in HER2-positive breast cancer: First results of the PAMELA clinical trial
Authors: Prat Aparicio A, Cortes Castan J, Pare L, Galvan P, Bermejo B, Martínez N, Vidal M, Pernas S, Lόpez R, Muñoz M, Nuciforo P, Fasani R, Morales S, Oliveira M, de La Peña L, Peláez A, Llombart A
Location: Hall 3
Time: 10:00 a.m.
Friday, December 9, 2016

Abstract: S6-05
Oral Session: General Session 6: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC
Authors: Sestak I, Buus R, Cuzick J, Dubsky P, Kronenwett R, Ferree S, Sgroi D, Schnabel C, Baehner R, Mallon E, Dowsett M.
Location: Hall 3
Time: 4:15 p.m.
Saturday, December 10, 2016

Abstract: P6-07-01
Poster: Development of a Prosigna (PAM50)-based classifier for the selection of advanced triple negative breast cancer (TNBC) patients for treatment with enzalutamide
Authors: Danaher P, Skewis L, Mashadi-Hossein A, Carey C, Ram N, Gowen-MacDonald J, Harris E, Cesano A, Ferree S, Uppal H, Buckingham W.
Location: Hall 1
Time: 7:30 – 9:00 a.m.
Additional abstracts and posters demonstrate the diverse applications and robust performance of the nCounter Analysis System in immuno-oncology and biomarker validation, including:

Wednesday, December 7, 2016

Abstract: P1-05-22
Poster: The value of RNA-Seq for the detection of clinically actionable targets in breast cancer – A small cohort analysis
Authors: Meissner T, Amallraja A, Mark A, Andrews A, Connolly C, Young B, De P, Williams C, Leyland-Jones B
Location: Hall 1
Time: 5:00 p.m.
Thursday, December 8, 2016

Abstract: P2-04-07
Poster: Immune profiling of post neoadjuvant high metastatic risk (RCB-II/III) residual disease in patients with early triple negative breast cancers
Authors: Irshad S, Cheang M, Gazinka P, Naidoo K, Buus R, Pinder S, Dowsett M, Tutt A
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-04-19
Poster: Elucidating the tumor immune microenvironment phenotype in early stage untreated BRCA mutated breast cancer patients
Authors: Force J, Abbott S, Broadwater G, Kimmick G, Westbrook K, Hwang S, Kauff N, Stashko I, Weinhold K, Nair S, Hyslop T, Blackwell K, Castellar E, Marcom PK
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: S4-01
Oral Session: General Session: A novel BRD4 inhibitor enhances endocrine therapy efficacy and circumvents endocrine-resistance in estrogen receptor-positive breast cancer models
Authors: De Angelis C, Nardone A, Cataldo ML, Fu X, Trivedi M, Yi S, Breckenridge D, Chamnsess GC, Vitorino P, Osborne CK, Schiff R
Location: Hall 3
Time: 3:15 – 5:00 p.m.

Abstract: PD5-06
Poster: Prognostic value of molecular tumor infiltrating lymphocyte (mTIL) signatures in HER2-positive breast cancer patients in N9831 and FinHer/FinXX trials
Authors: Chumsri S, Serie DJ, Mashadi-Hossein A, Tenner KS, Lauttia SL, Moreno-Aspitia A, McLaughlin SA, Nassar A, Warren S, Danaher P, Colon-Otero G, Lindman H, Joensuu H, Perez EA, Thompson EA
Location: Stars at Night Ballroom 1&2 – 3rd Level
Time: 5:00 – 7:00 p.m.
Friday, December 9, 2016

Abstract: P4-07-06
Poster: MicroRNAs associated with acquired taxane resistance in a breast cancer cell line model
Authors: Taylor KJ, Chong T, D’Costa A, Yao C, Gourley C, Cameron DA, Bartlett JMS, Spears M
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P4-12-09
Poster: The immune response in triple negative breast cancer
Authors: Gillgrass AE, Pond GR, Levine MN, Whelan TJ, Hassell JA, Bane AL
Location: Hall 1
Time: 7:30 – 9:00 a.m.
Saturday, December 10, 2016

Abstract: P6-07-07
Poster: ESR1 amplification and 5′-3′ exon imbalance in metastatic breast cancer
Authors: Oesterreich S, Basudan A, Preideigkeit N, Hartmaier RJ, Bahreini A, Gyanchandani R, Leone JP, Lucas PC, Hamilton RL, Brufsky AM, Lee AV
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P6-09-47
Poster: The development of personalized diagnostic tests and therapeutic strategies in breast cancer
Authors: Kutasovic JR, Rozali E, Miranda M, Lakhani SR, Al-Ejeh F
Location: Hall 1
Time: 7:30 – 9:00 a.m.
You can learn more about the Prosigna Breast Cancer Gene Signature at booth #525.

On December 5, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA), a rare cancer-focused innovative biotechnology company, reported clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the ongoing Phase 1/2 and pivotal ALTA trials in patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC) and intracranial central nervous system (CNS) metastases (Press release, Ariad, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227425 [SID1234516925]). These data, being presented today at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer (WCLC) being held in Vienna, showed that in patients with measurable brain metastases, the confirmed intracranial objective response rate (ORR) was 53 percent in the Phase 1/2 trial, and the confirmed intracranial ORR was 67 percent in Arm B (brigatinib 180 mg with seven-day lead-in at 90 mg once daily) in the ALTA trial. Median intracranial progression-free survival (PFS) in ALTA Arm B was 18.4 months.

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"Although crizotinib is initially effective in most patients with advanced ALK rearranged lung cancer, patients eventually develop resistance to crizotinib, often with new or progressive brain metastases," said presenting author Scott N. Gettinger, M.D., associate professor of medicine at Yale Cancer Center. "We are clearly encouraged by these data that demonstrate efficacy in the brain, with median intracranial PFS of over one and a half years, in patients with crizotinib refractory disease."

The ALTA Trial

The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on their most recent crizotinib therapy. Patients were randomized one-to-one to receive either 90 mg of brigatinib once per day (QD) (Arm A), or 180 mg QD with a seven-day lead-in at 90 mg QD (Arm B). In addition, patients were stratified by presence of brain metastases at baseline and best response to prior crizotinib therapy. Patient enrollment is complete, with the last patient enrolled in September 2015. Median follow-up in all patients with intracranial CNS metastases at baseline enrolled in the ALTA trial was 10.7 months as of May 31, 2016.

Phase 1/2 Study

The Phase 1/2 study of brigatinib included a dose-escalation portion that enrolled patients with advanced solid tumors, particularly those with NSCLC, who were either refractory to available therapies or had no standard treatment available to them. The Phase 2 portion of the trial includes five expansion cohorts. The trial enrolled 137 patients with 79 patients having ALK+ NSCLC. All but eight ALK+ NSCLC patients had failed prior crizotinib therapy. Patient enrollment in the trial is complete, with the last patient enrolled in July 2014. Median follow-up in ALK+ NSCLC patients with intracranial CNS metastases at baseline in the Phase 1/2 study was 24.9 months as of May 31, 2016.

Key Data from Oral Presentation on Patients with Baseline CNS Metastases from Phase 1/2 and ALTA Trials

Follow-up Data as of May 31, 2016; Last IRC Data in ALTA Trial was July 13, 2016, and Last Brain Scan in Phase 1/2 Trial was October 8, 2015

In the Phase 1/2 trial of brigatinib, 50/79 (63%) of ALK+ NSCLC patients had IRC-assessed baseline brain metastases. In the ALTA trial, 153/222 (69%) of ALK+ NSCLC patients had IRC-assessed baseline brain metastases. The efficacy analysis of Phase 1/2 trial data was based on an evaluable population (patients with at least one on-study brain scan, n=46), and the analysis of ALTA trial data was based on the intention-to-treat (ITT) population (n=153).
As of May 31, 2016, 42 percent and 55 percent of ALK+ NSCLC patients with brain metastases at baseline remained on study in the Phase 1/2 and ALTA populations respectively.
For patients with measurable brain lesions, the confirmed intracranial ORR was 53 percent (8/15) in the Phase 1/2 trial, and confirmed intracranial ORRs were 67 percent (12/18) in Arm B and 46 percent (12/26) in Arm A in the ALTA trial.
There were 31 patients in the Phase 1/2 trial with only non-measurable brain lesions, and of these, 35 percent had complete resolution of lesions. In ALTA, there were 55 patients in Arm B and 54 in Arm A with only non-measurable lesions; of these, 18 percent and seven percent of patients, respectively, had complete resolution of lesions.
For patients with any brain metastases at baseline:
Median duration of intracranial response in confirmed responders was 11.4 months in the Phase 1/2 trial (n=19); and was not yet reached in either arm of the ALTA trial (n=22 in Arm B and n=16 in Arm A).
Median intracranial PFS was 14.6 months in the Phase 1/2 trial (n=46); and 18.4 months (95% confidence interval [CI] 12.8 – not reached) and 15.6 months (95% CI 9.0-18.3 months) in ALTA Arm B and Arm A, respectively (n=73/n=80).
In the Phase 1/2 trial (n=46), for patients with any brain metastases at baseline, investigator-assessed whole-body ORR was 74 percent, median duration of response was 24 months and median PFS was 14.5 months. In ALTA (Arms B and A, respectively), for patients with any brain metastases at baseline, investigator-assessed whole-body ORR was 58 percent and 39 percent, median duration of response was not yet reached and 12 months, and median PFS was 12.9 months and 9.2 months.
In patients with any brain metastases at baseline in the ALTA trial, the most common treatment-emergent adverse events (AEs), grade 3 or higher (excluding neoplasm progression), were (n=151 treated; Arm B/A): increased creatine phosphokinase (CPK) (12%/1%), hypertension (7%/4%), increased lipase (3%/4%), malignant pleural effusion (1%/4%) and pneumonia (4%/1%).
The oral presentation, "Brigatinib Activity in Patients with ALK+ NSCLC and Intracranial CNS Metastases in Two Clinical Trials," (Abstract #4374, Oral ID OA08.06) will be presented today, Monday, December 5, 2016 in the Schubert 1 Auditorium at 11:57 am ET/16:57 GMT.

Investor and Analyst Briefing and Webcast

Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD will host an investor and analyst briefing on Wednesday, December 7 at 4:00 p.m. Central European Time (10:00 a.m. Eastern Time) to discuss the data presented at WCLC. Dr. Clackson will be joined by Karen Reckamp, M.D., associate professor in the Department of Medical Oncology & Therapeutics Research and co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope Comprehensive Cancer Center (COHCCC).

The live webcast can be accessed by visiting the investor relations section of the Company’s website at View Source The call can be accessed by dialing 844-249-9386 (domestic) or 270-823-1534 (international) five minutes prior to the start time and providing the pass code 20888507. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.

About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC. The FDA has accepted brigatinib’s New Drug Application based on data from an earlier datacut, and has granted ARIAD’s request for Priority Review. The FDA has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA). ARIAD intends to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017, based on this datacut.

ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy and safety of brigatinib in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor. More information on brigatinib clinical trials, as well as the expanded access program (EAP) for ALK+ NSCLC can be found here.

On December 5, 2016 Novartis reported results from the first-ever international survey of patients with myeloproliferative neoplasms (MPNs), specifically myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET), which indicate that the majority of patients living with these MPNs experience a reduced quality of life (Press release, Novartis, DEC 5, 2016, View Source [SID1234516970]). The findings also reveal that many patients struggle with emotional distress and experience a negative impact on their ability to work. These data were presented for the first time at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA (abstract #4267, 12/5/16 6:00 PM PDT)[1].

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MPNs are a group of rare and life-threatening blood cancers. People living with an MPN can have a poor quality of life and shortened survival rate[2]. Two of the most debilitating MPNs are MF and PV, as compared to ET[3]. MF and PV are associated with a range of symptoms and complications, including fatigue, night sweats, itchy skin, enlarged spleen and cardiovascular events[2-5]. The international MPN LANDMARK Survey included 699 patients with representation across six countries and four continents and was conducted to gain a better understanding of how MPNs impact a patient’s quality of life, activities of daily living, work productivity and emotional well-being[1].

"Rare blood cancers like MPNs are often not well-recognized, yet these diseases can have a significant impact on even the simplest tasks in a patient’s daily life," said Bruno Strigini, CEO of Novartis Oncology. "We hope the survey results illuminate the awareness of these debilitating blood cancers, emphasizing the need to help optimize patient care."

In the international survey, patients reported that their disease negatively impacted their ability to complete daily activities by 40%. Patients also noted a 35% impairment on their capacity to work. Furthermore, employed patients who missed work over the last seven days due to their disease reported missing an average of 3.1 hours due to their disease and/or symptom burden[1].

"These results help quantify the daily difficulty of living with an MPN, which can help patients explain disease burden to family, friends, colleagues and physicians who may be unfamiliar with these conditions," said Dr. Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, London, United Kingdom. "The survey results also help paint the full picture of the impact of the disease, which will enable physicians to manage the total patient in hopes of increasing quality of life."

Results also demonstrated that more than 75% of patients who experienced symptoms suffered a significant reduction in quality of life due to their symptoms (83% of MF patients, 72% of PV patients, 74% of ET patients); these numbers are consistent with previously-reported literature[2],[6]. The most commonly-reported symptom across disease areas in the last 12 months was fatigue (54% of MF patients, 45% of PV patients, 64% of ET patients), which was also the symptom patients cited they most wanted to resolve. In addition to physical symptoms, approximately one-third of patients in the study felt anxious or worried about their disease, with the greatest impact seen on those with MF and PV (34% of MF patients, 29% of PV patients, 26% of ET patients)[1].

About the International MPN LANDMARK Survey
The international MPN LANDMARK survey is a cross-sectional survey of patients with MPNs (myelofibrosis (MF), polycythemia vera (PV), essential thrombocythemia (ET)) and physicians who treat these conditions across Germany, Italy, United Kingdom, Japan, Canada and Australia. Patients (174 MF, 223 PV, 302 ET) who partook in the survey completed an online questionnaire to measure MPN-related symptoms experienced over the past year and the impact of their condition on their quality of life and ability to work. Additional survey results will be presented next year.

Findings from the international survey complement results from the Incyte-funded MPN LANDMARK survey conducted in the US[1].

About Myeloproliferative Neoplasms (MPNs)
Myeloproliferative neoplasms (MPNs) are a group of related and rare blood cancers in which bone marrow cells responsible for the body’s blood cells develop and function abnormally. Specific MPN conditions include myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET)[4],[5],[7].

In patients with MF, their bone marrow can no longer produce enough normal blood cells, causing the spleen to enlarge[8]. MF affects approximately one in every 100,000 people and has similar survival rates as other malignancies, such as breast cancer and colon cancer[2],[9-12].

PV is associated with an overproduction of blood cells that can cause serious cardiovascular complications if left inadequately controlled, such as blood clots, stroke and heart attack[5],[13]. PV affects up to three per 100,000 people globally each year[2],[5].

ET is characterized by an overproduction of platelets and complications which commonly include blood clotting and/or bleeding[7].

On December 5, 2016 Immune Design, a clinical-stage immunotherapy company focused on oncology, reported new data that highlight the broad product reach potential of both its Specific Antigen and Endogenous Antigen/Intratumoral immunization approaches (Press release, Immune Design, DEC 5, 2016, View Source [SID1234516927]).

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ZVexMulti offers the potential to create products that deliver multiple tumor antigens (conserved and/or neo-antigens) to dendritic cells (DCs) in vivo within the same product

Immune Design recently presented preclinical data at SITC (Free SITC Whitepaper) 2016 (Poster #195) showing that immunization with ZVexMulti (multi-genome ZVex) vectors expressing multiple antigens resulted in consistent induction of polyfunctional CD8 T cells against all delivered antigens, thereby overcoming the limitation of antigen competition. Moreover, immune responses were as high as, or higher than, those obtained by combining individually manufactured vectors, demonstrating the versatility and potency of ZVexMulti.

Immune Design scientists have also investigated the potential for ZVexMulti to deliver multiple MHC Class I and II putative neo-antigens in the CT.26 colon carcinoma model. Immune Design believes that ZVexMulti has the potential to deliver a significantly large number of neo-antigens, thus obviating the need for a proprietary predictive algorithm tools. These experiments were performed outside of the previously announced collaboration with Gritstone Oncology, which the two parties have agreed to terminate.

"These data collectively illustrate the range and flexibility of Immune Design’s product discovery platforms to target both conserved tumor antigens and neo-antigens," said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. "These approaches offer the potential to reach a broad patient population, while addressing some of the current limitations of other immunization approaches."

G100 ASH (Free ASH Whitepaper) data demonstrate eradication of lymphomas via synergy with local radiation

At the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California, on Monday, December 5 at 6pm Pacific, Immune Design is presenting data (Abstract #4166, Session: 625, "Intratumoral G100 Rescues Radiation-Induced T Cell Depletion and Has Synergistic Anti-Tumor Effect with Local Irradiation in A20 Lymphoma") showing the synergistic effects of the G100 product candidate in combination with local radiation therapy in eradicating lymphomas in preclinical models. These data further support Immune Design’s ongoing randomized Phase 2 study in patients with follicular non-Hodgkin’s lymphoma (NHL).

The research, authored by Ramesh Rengan, Eric Ford and Jeffery L. Schwartz of the University of Washington Department of Radiation Oncology, and Hailing Lu, Jessica Hewitt, Frank Hsu and Jan ter Meulen of Immune Design, evaluated the immune response and therapeutic effects of intratumoral administration of G100 alone, local radiation alone and G100 and local radiation given in concomitant therapy in a preclinical model of lymphoma. Results of combination therapy demonstrated:

Synergistic antitumor effects in both injected as well as uninjected tumors (abscopal effects)
Synergistic induction of pro-inflammatory cytokine and chemokine environment, as well as induction of genes governing antigen processing and presentation
Increased infiltration of T cells, including both CD4 and CD8 T cells, in treated tumors
In contrast, tumors that received only radiation but no G100 had significantly decreased levels of T lymphocytes as compared to untreated tumors
"These findings highlight the potential beneficial effect that immunotherapy with G100 could provide when given with radiation by modulating the tumor microenvironment to generate a systemic, durable T-cell anti-tumor response," said Ramesh Rengan, M.D., Associate Professor, University of Washington Department of Radiation Oncology. "As shown in this model, G100 may hold potential as a treatment for lymphoma patients."

About ZVex and ZVexMulti

ZVex is Immune Design’s discovery platform, initially designed to deliver a single RNA tumor antigen selectively directly to the patient’s DCs to generate tumor antigen-specific polyclonal cytotoxic T cells (CTLs). ZVex is an engineered recombinant viral vector that selectively targets DCs in vivo to deliver any RNA gene of interest. Further development of this platform has yielded ZVexMulti, enabling Immune Design to deliver multiple RNA tumor antigens within the same product candidate.

About G100

G100 is a product candidate from Immune Design’s GLAASTM discovery platform. It is a synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), formulated in a stable and oil emulsion. G100 is one of the molecules utilized in Immune Design’s intratumoral immune activation, or Endogenous Antigen, approach. It leverages the activation of the innate immune system, including DCs, in the tumor microenvironment to create a robust immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate existing tumor-infiltrating lymphocytes and promote antigen-presentation and the recruitment of T cells to the tumor to affect clinical outcome, as well as convert immunosuppressive M2-type tumor associated macrophages to a pro-inflammatory, M1-type.