On May 25, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, reported that results from the Phase I clinical trial of MabVax’s therapeutic antibody MVT-5873, being evaluated in advanced pancreatic cancer and other CA19-9 positive cancers, will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in Chicago, IL, June 2 – 6, 2017 (Press release, MabVax, MAY 25, 2017, View Source [SID1234519293]).

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

As part of the presentation, MabVax will discuss the results of the Company’s dose-escalation and safety trial, conducted over the last year in 32 patients with advanced pancreatic and colon cancer. Additionally, single agent MVT-5873 safety profile, efficacy, and reductions in serum CA19-9 levels over time will be presented.

Title of Presentation: Single agent HuMab-5B1 (MVT-5873), a monoclonal antibody targeting sLea, in patients with pancreatic cancer and other CA19-9 positive malignancies.
Abstract Number: 4110
Location: Gastrointestinal (Non-colorectal) Cancer Session
Session Date: Saturday, June 3rd
Time: 8:00 AM to 11:30 AM (CDT)

The Phase I therapeutic trial is an open-label, dose-escalation study evaluating the safety, tolerability and pharmacokinetics of MVT-5873. The first group of patients enrolled assess safety and determined the recommended Phase II dose of the antibody. The second patient group will establish the safety and dose of the antibody when administered with a standard-of-care chemotherapy. Dr. Eileen O’Reilly, associate Director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College is the lead investigator in the MVT-5873 Phase I clinical trial.

On May 25, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the highlights of numerous advances in precision oncology and cancer immunotherapy using the nCounter platform that will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, NanoString Technologies, MAY 25, 2017, View Source [SID1234519292]).

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"The breadth of nCounter-based research at this year’s ASCO (Free ASCO Whitepaper) conference demonstrates the scientific momentum and significant commercial advances that we’ve made in our key markets, most notably immuno-oncology," said Brad Gray, president and chief executive officer of NanoString. "In addition, our new Digital Spatial Profiling technology continues to demonstrate its unique value in characterizing the tumor microenvironment to inform decisions in drug development programs."

More than 35 abstracts will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, which is being held June 2nd through June 6th, 2017 in Chicago, Illinois. The research being presented spans a wide breadth of applications including Targeted Discovery, Biomarker Development and Clinical Practice across multiple oncology indications, including the following.

Targeted Discovery
Multidimensional spatial characterization of the tumor microenvironment (TME) in synchronous melanoma metastases (SMM) to yield insights into mixed responses to therapy in metastatic melanoma (MM) patients (pts). (Abstract # 9575)
NanoString’s new Digital Spatial Profiling research platform was used for spatial characterization of 30 immune markers and signaling proteins in melanoma patient samples to understand correlations and determinants of response.

Molecular characterization of immune-related severe adverse events (irSAE). (Abstract #3076)
NanoString Digital Spatial Profiling was used to profile the immune cell population in tissue affected by immune checkpoint inhibitors-mediated inflammation. Similarities and differences between autoimmune disease and colon-irSAEs were identified at the gene expression and proteomic levels, as regions of inflammation showed higher CD68 and PD-L1 positivity in colon-irSAE specimens versus normal colon or Crohn’s specimens, and reduced beta-catenin levels in both Crohn’s and colon-irSAE specimens relative to normal controls.

Distinct gene expression, mutational profile and clinical outcomes of V600E and V600K/R BRAF-mutant metastatic melanoma (MM). (Abstract #9541)
Gene expression and mutational profiling were used to investigate potential mechanisms explaining the observation that V600K/R metastatic melanoma has inferior response and shorter survival with MAPKi than V600E.

Biomarker Development
Correlation of constitutive PD-1 resistance in HNC with GM-CSF expression and presence of myeloid derived suppressor cells (MDSCs). (Abstract #6049)
A 638-gene immune gene expression panel was used to explore why the majority of INF-G inflamed head and neck squamous cell carcinomas (HNC) tumors do not respond to PD-1 checkpoint blockade. Constitutive resistance to PD-1 checkpoint blockade in inflamed HNC associates with expression of GM-CSF and Myeloid Derived Suppressor Cell (MDSC) markers. Strategies to deplete MDSCs, such as chemotherapy, should be considered in combination or sequentially with anti-PD-1.

Cellular immune biomarkers to prognosticate for survival to adoptive T-cell therapy in advanced nasopharyngeal cancer. (Abstract #6047)
nCounter platform and reagents were used for longitudinal modular transcriptome analysis of PBMC from patients with stage 4c nasopharyngeal carcinoma who received first line chemo-immunotherapy with the aim of identifying signatures associated with positive clinical outcomes.
Results from this study showed that 2-year survivors displayed significant decreased amounts of monocytic myeloid-derived suppressor cells (mMDSCs), compared to non-survivors.

Phase II study of durvalumab (anti-PD-L1 antibody) in combination with R-CHOP or lenalidomide plus R-CHOP in previously untreated, high-risk diffuse large B-cell lymphoma. (Abstract # TPS7573)
NanoString’s Lymphoma Subtyping Test is being used to determine Cell of Origin in an ongoing clinical trial. The primary study objective is to explore the clinical activity of durvalumab with R-CHOP in non-activated B-cell-like (non-ABC) and durvalumab with lenalidomide + R-CHOP (R2-CHOP) in ABC previously untreated DLBCL; secondary objectives are to evaluate safety and identify biomarkers predictive of clinical response.

Association of molecular subtype, proliferation, and immune genes with efficacy of carboplatin versus gemcitabine addition to taxane-based, anthracycline-free neoadjuvant chemotherapy in early triple-negative breast cancer (TNBC): Results of the randomized WSG ADAPT-TN trial. (Abstract #573)
NanoString assays combining the PAM50 breast cancer assay and immune profiling were used to characterize patients in a clinical trial. In early TNBC, basal-like subtype, higher Ki67 (by IHC), and lower HER-2 score were associated with chemo-sensitivity for both neoadjuvant arms. Chemo-resistance pathways differed between the two taxane-based combinations. The positive predictive impact of immunological genes in the nab-pac – carbo arm could influence optimal patient selection for immune-modulative therapy.

Impact of consensus molecular subtyping (CMS) on overall survival (OS) and progression free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance). (Abstract #3511)

CALGB 80405 was a randomized Ph3 trial showing no OS or PFS difference in mCRC pts treated with Bevacizumab (Bev) or Cetuximab (Cet) in the first line. A Nanostring platform was used to determine the CMS classification of 392 KRAS wt (codon 12 and 13) primary tumors and correlated it with OS and PFS in patients enrolled in 80405. Data suggest that CMS is associated with OS and PFS in first line therapy in mCRC patients. Preliminary data suggest that certain CMS may be associated with efficacy of Bev and Cet based chemotherapy.

Clinical Practice
Impact of the Prosigna (PAM50) assay on adjuvant clinical decision making in patients with early stage breast cancer: Results of a prospective multicenter public program. (Abstract # e12062)

In this prospective decision impact study, Prosigna results led to a 39% change in adjuvant therapy indication. Patients with initial indication of CHT were changed to HT alone in > 50% of cases. Thus, Prosigna results influenced the treatment decisions and reinforced its clinical utility in real-world settings. The intrinsic subtype classification based on IHC didn’t show to be an adequate surrogate for the genomic subtypes as determined by Prosigna.

At the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting, NanoString will showcase its nCounter platform, Digital Spatial Profiling and 3D Biology capabilities at booth #20097.



Abstract # Summary Hyperlink

e23198 Molecular classification with NanoString nCounter system in triple-negative breast cancer. View Source

e23103 Molecular sequencing and gene fusion detection in non-small cell lung cancer (NSCLC) patients:
Impact of co-existing alterations. View Source


3076 Molecular characterization of immune-related severe adverse events (irSAE). View Source

8015 Pembrolizumab (Pembro) plus lenalidomide (Len) and low-dose dexamethasone (Dex)
for relapsed/refractory multiple myeloma (RRMM): Efficacy and biomarker analyses. View Source


e21030 Immune cell profiling of melanoma metastases from patients treated with TriMixDC-MEL
dendritic cell therapy in combination with ipilimumab. View Source


3509 Clinical utility of colon cancer molecular subtypes: Validation of two main colorectal molecular
classifications on the PETACC-8 phase III trial cohort. View Source


530 Effects of age, immune landscape, and response to trastuzumab (H) in HER-2 positive (HER2+)
breast cancer in NCCTG (Alliance)-N9831. View Source


TPS7573 Phase II study of durvalumab (anti-PD-L1 antibody) in combination with R-CHOP or lenalidomide
plus R-CHOP in previously untreated, high-risk diffuse large B-cell lymphoma. View Source


E12062 Impact of the Prosigna (PAM50) assay on adjuvant clinical decision making in patients with early
stage breast cancer: Results of a prospective multicenter public program. View Source

7512 Clinical and biologic covariates of outcomes in ZUMA-1: A pivotal trial of axicabtagene ciloleucel
(axi-cel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (r-NHL). View Source

9575 Multidimensional spatial characterization of the tumor microenvironment (TME) in synchronous
melanoma metastases (SMM) to yield insights into mixed responses to therapy in metastatic melanoma
(MM) patients (pts). View Source

e14614 Intra-tumour heterogeneity in the regulation of immune-tolerogenic pathways in primary and metastatic
hepatocellular carcinoma (HCC). View Source

e13052 Molecular profiling of cancer outliers. View Source

e12134 Immune biomarkers and treatment (tx) outcome in hormone receptor-positive (HR+) breast cancer
(BC) patients (pts) treated with preoperative chemotherapy (preop chemo) plus bevacizumab (bev). View Source

3511 Impact of consensus molecular subtyping (CMS) on overall survival (OS) and progression free survival
(PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405
(Alliance). View Source

e12134 Different patterns of non immediate allergic reaction to BRAF inhibitor in two patients with metastatic
melanoma. View Source


e20028 Novel prognostic markers for epithelioid malignant pleural mesothelioma. View Source

e21052 Different patterns of non immediate allergic reaction to BRAF inhibitor in two patients with metastatic
melanoma. View Source

e23091 Effect of bavituximab in combination with nivolumab on tumor immune response in a 3D ex vivo
system of lung cancer patients. View Source

7547 Rapid, real-time central pathology review for E1412: A novel and successful paradigm for future
National Clinical Trials Network diffuse large B cell lymphoma studies. View Source

e20050 Prognostic gene signatures for lung adenocarcinoma using digital multiplexed gene expression in
formalin-fixed paraffin embedded tissue. View Source

9541 Distinct gene expression, mutational profile and clinical outcomes of V600E and V600K/R BRAF-mutant
metastatic melanoma (MM). View Source

5591 High-intermediate risk endometrial cancer: Can gene expression predict recurrence? View Source

6047 Cellular immune biomarkers to prognosticate for survival to adoptive T-cell therapy in advanced
nasopharyngeal cancer. View Source

e12541 Identification of differentially expressed genes associated with clinical response after treatment of
breast cancer skin metastases with imiquimod. View Source

10503 Molecular alterations to predict survival and response to chemotherapy of pediatric low-grade glioma. View Source

e23090 Anti-PD1 treatment to induce M1 polarization of tumor infiltrating macrophages in a 3D ex vivo system
of lung cancer patients. View Source

8557 Biomarkers of pembrolizumab (P) activity in mesothelioma (MM): Results from a phase II trial. View Source

6049 Correlation of constitutive PD-1 resistance in HNC with GM-CSF expression and presence of myeloid
derived suppressor cells (MDSCs). View Source

511 Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative,
HER2-positive breast cancer (BC). View Source

529 Impact of DNA repair deficiency signature on outcomes in triple negative breast cancer (TNBC) patients
treated with AC chemotherapy (SWOG S9313). View Source

e20610 Coexistence of rearranged during transfection (RET) variants and activating EGFR mutations with their
molecular implications in lung adenocarcinomas. View Source

e23205 In silico validation of a prostate cancer recurrence prognostic signature based on pathways related to
stem cells. View Source

e13090 Characterization of germline and tumor genomic profile in unselected young black breast cancer patients. View Source

8573 Pembrolizumab in patients with recurrent thymic carcinoma: Results of a phase II study. View Source

TPS594 CORALLEEN: A phase 2 clinical trial of chemotherapy or letrozole plus ribociclib as neoadjuvant treatment
for postmenopausal patients with luminal B/HER2-negative breast cancer. View Source


11553 CCL5 expression and tumor infiltrating immune cells in triple negative breast cancer. View Source

573 Association of molecular subtype, proliferation, and immune genes with efficacy of carboplatin versus
gemcitabine addition to taxane-based, anthracycline-free neoadjuvant chemotherapy in early triple-negative
breast cancer (TNBC): Results of the randomized WSG ADAPT-TN trial. View Source

On May 25, 2017 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported the presentation of a poster describing the Phase 1 trial of CA-170, an oral small molecule dual inhibitor of immune checkpoints PD-1 and VISTA, in the treatment of patients with advanced solid tumors or lymphomas at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Curis, MAY 25, 2017, View Source [SID1234519291]). The meeting will take place from June 2-6 in Chicago.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In addition, researchers from the Dana-Farber Cancer Institute and Boston Children’s Hospital will be presenting information on an investigator-initiated Phase 1 multicenter trial using CUDC-907, Curis’ proprietary drug candidate, to treat children and young adults with relapsed or refractory solid tumors, CNS tumors and lymphoma.

Additional information on the presentations can be found below and can be accessed at www.am.asco.org.

CA-170 Poster Presentation:

Date/Time: Monday, June 5, 8 AM — 11:30 AM CDT
Abstract Number: TPS3099
Presentation Title: Phase 1 trial of CA-170, a novel oral small molecule dual inhibitor of immune checkpoints PD-1 and VISTA, in patients (pts) with advanced solid tumor or lymphomas

CUDC-907 Poster Presentation:

Date/Time: Sunday, June 4, 8 AM — 11:30 AM CDT
Abstract Number: TPS10576
Presentation Title: Phase 1 multicenter trial of CUDC-907 in children and young adults with relapsed or refractory solid tumors, CNS tumors, and lymphoma

On May 25, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported its financial results for the first quarter ended March 31, 2017 (Press release, BioLineRx, MAY 25, 2017, View Source [SID1234519290]).

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Highlights and achievements during the first quarter 2017 and to date:

Continued advancing the Company’s lead project, BL-8040, in an extensive clinical development program:

Announced plans to initiate Phase 3 pivotal study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation in H2 2017, following successful meeting with the FDA.
Initiated Phase 2b immuno-oncology collaboration with MD Anderson Cancer Center for additional BL-8040 and KEYTRUDA combination study in pancreatic cancer, as part of strategic cancer immunotherapy collaboration between MSD and MD Anderson Cancer Center.
Reported partial results on Phase 2 open label study for BL-8040 as novel stem cell mobilization treatment for allogeneic bone-marrow transplantation. Interim results support BL-8040 as a one-day dosing regimen for rapid mobilization of substantial amounts of stem cells, a significant improvement over the current standard-of-care which requires four-to-six daily injections of G-CSF; and
Reported filing of regulatory submissions to commence a Phase 1b trial for BL-8040 in combination with Genentech’s atezolizumab in acute myeloid leukemia (AML), which will be led by BioLineRx. This study is expected to commence in H2 2017.
In parallel, the Company made significant progress in expanding and accelerating its growth potential:

Acquired Agalimmune Ltd., a UK-based biopharmaceutical company developing cancer immunotherapy treatments, thereby broadening and bolstering BioLineRx’s position in immuno-oncology with a second novel lead compound, AGI-134;
Completed underwritten public offering of American Depository Shares for net proceeds of $26.2 million, which will be used to fund a number of clinical trials, including a Phase 3 pivotal study for BL-8040 in autologous stem-cell mobilization, as well as the aggressive clinical development of both BL-8040 and AGI-134 in the immuno-oncology space.
Expected significant upcoming milestones for 2017 and 2018:

Partial results from immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA expected in H2 2017; top line results expected in H2 2018;
Initiation of Phase 3 pivotal study for BL-8040 in stem-cell mobilization for autologous transplantation in H2 2017;
Initiation of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech’s atezolizumab in pancreatic, gastric, and non-small cell lung cancer, as well as AML, expected in H2 2017; partial results expected in H2 2018;
Completion of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation, top line results expected by year end 2017; and
Initiation of Phase 1 immuno-oncology study for AGI-134 in several solid tumor indications expected in H1 2018.
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "Our 2017 activities have fueled significant excitement at BioLineRx, as we reinforced our position in the high value field of immuno-oncology following our acquisition of a second novel drug compound, AGI-134, and strengthened our balance sheet to fund our main development objectives with support from key fundamental investors. We ended the first quarter with pro forma cash of $57 million, including net proceeds of $26 million from our recent public offering, sufficient to fund – and accelerate – our clinical programs, including both BL-8040 and AGI-134, through late 2019."

"With important catalysts in the next 12-18 months, our team is driven and focused on advancing our asset pipeline. We look forward to providing updates as we execute on our plans," Mr. Serlin concluded.

Financial Results for the First Quarter Ended March 31, 2017

Research and development expenses for the three months ended March 31, 2017 were $3.6 million, an increase of $1.1 million, or 41%, compared to $2.5 million for the three months ended March 31, 2016. The increase resulted primarily from an increase in spending on BL-8040 and an increase in spending on new projects.

Sales and marketing expenses for the three months ended March 31, 2017 were $0.7 million, an increase of $0.4 million, or 175%, compared to $0.3 million for the three months ended March 31, 2016. The increase resulted primarily from market research activities and one-time professional fees related to business development activities.

General and administrative expenses for the three months ended March 31, 2017 were $1.0 million, similar to the comparable period in 2016.

The company’s operating loss for the three months ended March 31, 2017 amounted to $5.3 million, compared with an operating loss of $3.8 million for the corresponding 2016 period.

Non-operating income (expenses) for the three months ended March 31, 2017 and 2016 were not material, and primarily related to fair-value adjustments of warrant liabilities.

Net financial income amounted to $0.5 million for the three months ended March 31, 2017, compared to net financial income of $0.1 million for the corresponding 2016 period. The increase in net financial income related primarily to gains recorded on foreign currency hedging transactions.

The Company’s net loss for the three months ended March 31, 2017 amounted to $4.9 million, compared with a net loss of $3.5 million for the corresponding 2016 period.

The Company held $30.4 million in cash, cash equivalents and short-term bank deposits as of March 31, 2017. In April 2017, the Company completed an underwritten public offering of its American Depositary Shares for net proceeds of $26.2 million.

Net cash used in operating activities for the three months ended March 31, 2017 was $3.8 million, compared with net cash used in operating activities of $4.2 million for the three months ended March 31, 2016. The $0.4 million decrease in net cash used in operating activities was primarily the result of an increase in trade payables and accruals.

Net cash provided by investing activities for the three months ended March 31, 2017 was $1.4 million, compared to net cash provided by investing activities of $1.7 million for the three months ended March 31, 2016. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits, as well as the investment in Agalimmune.

Net cash provided by financing activities for the three months ended March 31, 2017 was $2.1 million, compared to net cash provided by financing activities of $1.6 million for the three months ended March 31, 2016. The increase in cash flows from financing activities primarily reflects funding under the share purchase agreement with LPC.

On May 25, 2017 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated its study of NY-ESO SPEAR T‑cells targeting NY-ESO in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 inhibitor marketed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), in patients with multiple myeloma (Press release, Adaptimmune, MAY 25, 2017, View Source [SID1234519288]). This study is now open for enrollment.

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This is Adaptimmune’s third clinical trial to initiate within the past month. The Company recently announced the initiation of clinical studies with its wholly-owned SPEAR T-cells targeting AFP in hepatocellular carcinoma, as well as its wholly-owned SPEAR T-cells targeting MAGE-A4 in seven malignant solid tumors.

"We are excited to initiate this study as we have already seen encouraging data in a previous single‑agent study of NY‑ESO SPEAR T-cells in patients with advanced myeloma in the context of stem cell transplantation," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "KEYTRUDA has also shown preliminary evidence of activity in multiple myeloma in combination, and there is preclinical evidence to support the view that the combination of NY-ESO SPEAR T-cells and anti-PD-1 therapy may lead to meaningful antitumor activity."

This is an open-label, randomized pilot study designed to evaluate the safety and anti-tumor activity of Adaptimmune’s NY-ESO therapeutic candidate alone or in combination with KEYTRUDA in patients who are HLA-A*02 positive and have relapsed and refractory multiple myeloma expressing NY-ESO-1 and/or LAGE‑1a. The study will enroll up to 20 patients. The primary objective of the study is to evaluate the safety and tolerability of NY-ESO SPEAR T-cell therapy alone or in combination with KEYTRUDA. Additional objectives include anti‑tumor activity, persistence of genetically modified cells in the body, and evaluation of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.

Adaptimmune is developing the NY-ESO SPEAR T-cell program under a strategic collaboration agreement with GSK.

Clinical Trial Collaboration Agreement for use of KEYTRUDA

Adaptimmune has a clinical trial collaboration agreement with Merck & Co., Inc., Kenilworth, NJ, USA for the use of KEYTRUDA in this study. The agreement is between Adaptimmune and Merck & Co., Inc., Kenilworth, NJ, USA, through a subsidiary. Under the agreement, the trial will be sponsored by Adaptimmune. The agreement also includes provision for potential expansion to include Phase III registration studies in the same indication. Additional details were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.