t epotinib c-Met kinase inhibitor Non-small cell lung cancer tepotinib c-Met kinase inhibitor Hepatocellular cancer avelumab anti-PD-L1 mAb Merk el cell cancer 1L 1 sprifermin fibroblast growth factor 18 O steoarthritis atacicept anti-Blys /anti-APRIL fusion protein Systemic lupus erythematosus atacicept anti-Blys /anti-APRIL fusion protein IgA nephropathy abituzumab anti-CD 51 mAb Systemic sclerosis with interstitial lung dis. evobrutinib BTK inhibitor R heumatoid arthritis evobrutinib BTK inhibitor Systemic lupus erythematosus evobrutinib BTK inhibitor Multiple sclerosis 1 Merck pipeline M2698 p70S6K & Akt inhibitor Solid tumors M3814 DNA-PK inhibitor Solid tumors M9831 (VX-984) DNA-PK inhibitor Solid tumors M6620 (VX-970) ATR inhibitor Solid tumors M4344 (VX-803) ATR inhibitor Solid tumors M7583 BTK inhibitor Hem atological malignancies avelumab anti-PD-L1 mAb Solid tumors avelumab anti-PD-L1 mAb Hem atological malignancies M9241 (NHS-IL12) 8 Cancer immunotherapy Solid tumors M7824 anti-PD-L1/ TGFbeta trap Solid tumors M1095 (ALX-0761) 10 anti-IL-17 A/F nanobody Psoriasis Registration Phase III Phase II Phase I cladribine 4 tablets lymphocyte targeting agent Relapsing-remitting multiple sclerosis avelumab 6 anti-PD-L1 mAb Merk el cell cancer (EU) avelumab-anti-PD-L1 mAb Non-small cell lung cancer 1L 1 avelumab-anti-PD-L1 mAb Non-small ce ll lung cancer 2L 2 avelumab-anti-PD-L1 mAb Gastric cancer 1L-M 1M avelumab-anti-PD-L1 mAb Gastric cancer 3L 3 avelumab-anti-PD-L1 mAb O varian cancer platinum resistant/refractory avelumab-anti-PD-L1 mAb O varian cancer 1L 1 avelumab-anti-PD-L1 mAb Urothelial cancer 1L-M 1M avelumab-anti-PD-L1 mAb Renal cell cancer 1L 1 avelumab-anti-PD-L1 mAb Locally advanced head and neck cancer MSB 11022 9 proposed biosimilar of adalimumab Chronic plaque psoriasis 1 First Line treatment; 1M First Line maintenance treatment; 2 Second Line treatment; 3 Third Line treatment; 4 As announced on July 18, 2016, the EMA has accepted for review the Marketing Authorization Application (MAA) of Cladribine Ta ble ts for the treatment of relapsing-remitting multiple sclerosis. 5 As announced on March 23, 2017, the US FDA has granted accelerated approved of avelumab for the treatment of adults and pedia tri c patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for metastatic MCC outside of the US. 6 As announced on October 31, 2016, the EMA has validated for review Merck’s MAA for avelumab, for the proposed indication of m eta static Merkel cell cancer. 7 As announced on May 9, 2017 the US FDA granted accelerated approval of avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved f or metastatic UC outside of the US. 8 Sponsored by the National Cancer Institute (USA). 9 On April 24, 2017 the divestment of Merck’s Biosimilars business to Fresenius was announced. Closing is expected in H2, 2017, s ubject to regulatory approvals and other conditions. 10 As announced on March 30, 2017 in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. May 18, 2017 Recently Registered avelumab 5-anti-PD-L1 mAb Merk el cell cancer (US) avelumab 7-anti-PD-L1 mAb Urothelial cancer (US) Neurology Oncology Immunology Immuno-Oncology B iosimilars P ipeline products are under clinical investigation and have not been proven to be s afe and effective. T here is no guarantee any product will be approved in the s ought-after indication.

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On May 18, 2017 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that three abstracts have been accepted for presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held in Madrid, Spain on June 22-25, 2017 (Press release, Bellicum Pharmaceuticals, MAY 18, 2017, View Source;p=RssLanding&cat=news&id=2273891 [SID1234519217]).

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Bellicum’s presentation of the overall cohort of children with malignant and non-malignant diseases treated with BPX-501 was selected as one of the Congress’ five best abstracts, and will be reviewed during the Presidential Symposium.

Additional oral and poster presentations selected include clinical data on BPX-501 for the treatment of pediatric leukemias, hemoglobinopathies and erythroid disorders. The abstracts are now available online at the EHA (Free EHA Whitepaper) conference website.

EHA Presentation Details

Oral Presentation – Presidential Symposium
Title: BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Facilitates HLA Haploidentical Stem Cell Transplant in Children with Both Hematological Malignancies and Non-Malignant Conditions
Session Title: Presidential Symposium
Date: Friday, June 23
Time: 3:45 – 4:00 PM CEST
Location: Hall A
Abstract Code: S146

Oral Presentation
Title: Impact of Post-Transplant Infusion of Donor T-Cells Genetically Modified with Inducible Caspase 9 Suicide Gene (BPX-501 Cells) on Children with Leukemia Given Alpha-Beta T-Cell Depleted Haplo-HSCT
Session Title: Stem cell transplantation – Clinical 1
Date: Saturday, June 24
Time: 5:00 – 5:15 PM CEST
Location: Room N103
Abstract Code: S495

Poster Presentation
Title: The Use of BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Together with HLA-Haploidentical Stem Cell Transplant to Treat Children with Hemoglobinopathies and Erythroid Disorders
Session Title: Stem cell transplantation – Clinical 1
Date: Friday, June 23
Time: 5:15 – 6:45 PM CEST
Location: Poster Area (Hall 7)
Abstract Code: P381

On May 18, 2017 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) reported that a total of 12 presentations including clinical data for investigational anti-cancer agents napabucasin (BBI608), amcasertib (BBI503) and WT2725 will be presented at the poster session of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 2 to June 6, 2017 (Press release, Dainippon Sumitomo Pharma, MAY 17, 2017, View Source [SID1234519264]).

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Napabucasin: Study results, 7 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 9052 A phase 1b/2 study of napabucasin with weekly paclitaxel in advanced, previously treated non-squamous non-small cell lung cancer. June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 201 Study： NCT01325441 Non-small cell lung cancer 3529 Phase 1b/II study of cancer stemness inhibitor napabucasin (BBI-608) in combination with FOLFIRI +/- bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts). June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 246 Study： NCT02024607 Colorectal cancer 4106 A phase Ib/II study of cancer stemness inhibitor napabucasin (BBI-608) in combination with gemcitabine (gem) and nab-paclitaxel (nabPTX) in metastatic pancreatic adenocarcinoma (mPDAC) patients (pts). June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 118 Study： NCT02231723 Pancreatic cancer 5548 A phase 1b/2 study of napabucasin with weekly paclitaxel in advanced, previously treated platinum resistant ovarian cancer. June 3, 2017 1：15 PM-4：45 PM (local time) , Hall A 201 Study： NCT01325441 Ovarian Cancer 9553 A phase Ib study of napabucasin plus weekly paclitaxel in patients with advanced melanoma. June 3, 2017 1：15 PM-4：45 PM (local time) , Hall A 201 Study： NCT01325441 Melanoma 2 1084 A phase 2 study of napabucasin with weekly paclitaxel in previously treated metastatic breast cancer. June 4, 2017 8：00 AM-11：30 AM (local time) , Hall A 201 Study： NCT01325441 Breast cancer 4077 BBI608-503-103HCC: A phase Ib/II clinical study of napabucasin (BBI608) in combination with sorafenib or amcasertib (BBI503) in combination with sorafenib (Sor) in adult patients with hepatocellular carcinoma (HCC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A BBI HCC 103 Study： NCT02279719 Hepatocellular carcinoma

Napabucasin: Study design, 2 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type TPS3619 CanStem303C trial: A phase III study of napabucasin (BBI-608) in combination with 5-fluorouracil (5-FU), leucovorin, irinotecan (FOLFIRI) in adult patients with previously treated metastatic colorectal cancer (mCRC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A CanStem303C Study： NCT02753127 Colorectal cancer TPS4148 CanStem111P trial: A phase III study of napabucasin (BBI-608) plus nab-paclitaxel (nab-PTX) with gemcitabine (gem) in adult patients with metastatic pancreatic adenocarcinoma (mPDAC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A CanStem111P Study： NCT02993731 Pancreatic cancer

Amcasertib: Study results, 2 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 6032 A phase 1b/2 study of amcasertib, a first-in-class cancer stemness kinase inhibitor in advanced head and neck cancer. June 5, 2017 1：15 PM-4：45 PM (local time) , Hall A 101 Study： NCT01781455 Head and Neck cancer 6036 A phase 1b/2 study of amcasertib, a first-in-class cancer stemness kinase inhibitor, in advanced adenoid cystic carcinoma. June 5, 2017 1：15 PM-4：45 PM (local time), Hall A 101 Study： NCT01781455 Adenoid Cystic Carcinoma 3

WT2725: Study results, 1 presentation Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 2066 Initial phase 1 study of WT2725 dosing emulsion in patients with advanced malignancies. June 5, 2017 1：15 PM-4：45 PM (local time), Hall A D8350004Study ：NCT01621542 Solid tumors, Hematologic malignancies *The abstract is now available on the official website of ASCO (Free ASCO Whitepaper). There is the link to applicable abstract on abstract number of each study. (Reference)

【About napabucasin:BBI608】 Napabucasin is an investigational first-in-class anti-cancer agent created by Boston Biomedical, Inc., wholly-owned subsidiary of Sumitomo Dainippon Pharma. Napabucasin is an orally -administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3.

【About amcasertib:BBI503】 Amcasertib is an investigational anti-cancer agent created by Boston Biomedical, Inc. Amcasertib is an orally-administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases.

【About WT2725】 WT2725 is an investigational therapeutic cancer peptide vaccine derived from Wilms’ tumor gene 1 (WT1) protein. WT2725 is expected to treat various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific cytotoxic T-lymphocytes that attack WT1-expressing cancer cells.

On May 17, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported it will present data about the company’s portfolio of approved and investigational oncology medicines during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 2-6, in Chicago. A total of 23 abstracts have been accepted across several tumor types including brain cancer, hematologic malignancies, breast cancer, lung cancer and other solid tumors (Press release, AbbVie, MAY 17, 2017, View Source [SID1234519180]).

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Researchers will present efficacy and safety data on depatuxizumab mafodotin (previously known as ABT-414), an antibody-drug conjugate (ADC) being studied for the treatment of adults with amplified-epidermal growth factor receptor (EGFR) newly diagnosed or recurrent glioblastoma (GBM). GBM is one of the most aggressive cancers, with a five-year survival rate of approximately 6 percent in the U.S. and 24 European countries.1,2 The most common genetic alteration in GBM, EGFR-amplification, occurs in approximately 50 percent of GBM patients.3,4

Additionally, researchers will present data from studies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, a member of the Roche Group, for investigational uses across multiple hematologic malignancies; ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK), across multiple hematologic malignancies and chronic graft versus host disease (cGVHD); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein; and other early-stage investigational compounds.

AbbVie will also share early-stage research from its oncology pipeline. AbbVie is utilizing technologies and new approaches to help advance cancer therapies that may become foundational to the next generation of cancer treatments.

"AbbVie’s data presentations at this year’s ASCO (Free ASCO Whitepaper) meeting reinforce our diverse and comprehensive oncology pipeline, focused on bringing new medicines to patients, especially in areas where few options exist in cancer," said Tom Hudson, M.D., vice president of oncology discovery and early development, AbbVie. "By combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners including scientists, industry peers and patients, we aim to discover and develop medicines that will drive transformational improvements in cancer treatment."

AbbVie abstracts:

Ibrutinib

Long-Term Efficacy and Safety with Ibrutinib (ibr) in Previously Treated Chronic Lymphocytic Leukemia (CLL): Up to Four Years Follow-Up of the RESONATE Study; Byrd et al.; Abstract 7510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 1:15 p.m.-2:30 p.m. CDT
Ibrutinib vs Chlorambucil: Immunophenotypic and Quantitative Impacts on Circulating Immune Cells in Chronic Lymphocytic Leukemia (CLL); Solman et al.; Abstract 7524; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
A Randomized, Double-Blind Phase III Study of Ibrutinib versus Placebo in Combination with Corticosteroids in Patients with New Onset Chronic Graft Versus Host Disease; Miklos et al.; Abstract TPS7072; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab Versus Placebo in Combination with Rituximab in Patients with Treatment-Naïve Follicular Lymphoma (PERSPECTIVE); Fowler et al.; Abstract TPS7576; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.- 11:30 a.m. CDT

Venetoclax

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax Combined with Azacitidine Versus Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia; Potluri et al.; Abstract TPS7069; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Phase 2, Open-Label Study of Venetoclax in Combination with Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; Bueno et al.; Abstract TPS8056; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Venetoclax (VEN) in Patients with Relapsed Non-Hodgkin Lymphoma (NHL); Davids et al.; Publication

Depatuxizumab mafodotin (ABT-414)

Efficacy Analysis of ABT-414 with or without Temozolomide (TMZ) in Patients (pts) with EGFR-Amplified, Recurrent Glioblastoma (rGBM) from a Multicenter, International Phase I Clinical Trial; van den Bent et al.; Abstract 2003; Oral Presentation; Sunday, June 4, 2017; 9:00 a.m.-9:12 a.m. CDT

Rovalpituzumab tesirine (Rova-T)

A Phase III Study of Rovalpituzumab Tesirine Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients with Extensive Disease Small Cell Lung Cancer (ED SCLC); Komarnitsky et al.; Abstract TPS8583; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Molecular Profiling of Small Cell Bladder Cancer (SCBC) to Reveal Gene Expression Determinants of Aggressive Phenotype; Koshkin et al.; Abstract 4529; Poster Presentation; Sunday, June 4, 2017; 8:00 a.m.-11:30 a.m. CDT
A Study of Rovalpituzumab Tesirine in Frontline Treatment of Patients with DLL3 Expressing Extensive Small Cell Lung Cancer; Hann et al.; Abstract TPS2598; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
An Open-Label Study of Rovalpituzumab Tesirine in Patients with DLL3-Expressing Advanced Solid Tumors; Kavalerchik et al.; Abstract TPS2597; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Rovalpituzumab Tesirine (Rova-T) as a Therapeutic Agent for Neuroendocrine Prostate Cancer (NEPC); Puca et al.; Abstract 5029; Poster Presentation; Monday, June 5, 2017; 1:15 p.m.-4:45 p.m. CDT

Veliparib

Phase 1/2 Study of Veliparib (V) Combined with Carboplatin (Cb) and Etoposide (E) in Patients (Pts) with Extensive-Stage Disease (ED) Small Cell Lung Cancer (SCLC) and Other Solid Tumors: Phase 1 Results; Atrafi et al.; Abstract 8530; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Tolerability of Veliparib (V) in Combination with Carboplatin (C)/Paclitaxel (P): Based Chemoradiotherapy (CRT) in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC); Kozono et al.; Abstract 8546; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Breast Conservation after Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results from an International Randomized Trial (BrighTNess); Golshan et al.; Abstract 514; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
Phase 3 Study Evaluating Efficacy and Safety of Veliparib (V) Plus Carboplatin (Cb) or Cb in Combination with Standard Neoadjuvant Chemotherapy (NAC) in Patients (Pts) with Early Stage Triple-Negative Breast Cancer (TNBC); Geyer et al.; Abstract 520; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

Elotuzumab

Phase 3 ELOQUENT-2 Study: Extended Four Year Follow-Up (FU) of Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) vs Ld in Relapsed/Refractory Multiple Myeloma (RRMM); Lonial et al.; Abstract 8028; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
CheckMate 602: An Open-Label, Randomized, Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma; Lonial et al.; Abstract TPS8052; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

ABBV-221

Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR; Calvo et al.; Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

ABBV-399

Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC); Angevin et al.; Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC); Awad et al.; Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT

ABT-348

Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib; Maitland et al.; Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

The ASCO (Free ASCO Whitepaper) 2017 Annual Meeting abstracts are available at View Source

On May 17, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported that abstracts from two clinical studies of its IDO pathway inhibitors, indoximod and navoximod (GDC-0919), used in combination with other agents, are now available on the website of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, NewLink Genetics, MAY 17, 2017, View Source [SID1234519192]).

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An infographic accompanying this announcement is available at View Source

"The IDO pathway is a key immuno-oncology target and NewLink Genetics has two separate and distinct IDO pathway inhibitors in clinical development. Indoximod, which is wholly owned by NewLink Genetics, has a proposed differentiated mechanism within the IDO pathway and acts as a tryptophan mimetic having a direct effect on immune cells to reverse immune suppression used by cancer to protect itself. Navoximod is our direct enzymatic inhibitor of IDO and is partnered with Genentech/Roche," said Charles J. Link, Jr., M.D., Chief Executive Officer and Chief Scientific Officer of NewLink Genetics.

Indoximod in combination with the therapeutic cancer vaccine, PROVENGE

Results from a randomized, double-blind, placebo-controlled, multi-institutional Phase 2 investigator initiated study with indoximod in combination with the therapeutic cancer vaccine, PROVENGE (sipuleucel-T), for patients with metastatic castration resistant prostate cancer will be presented as a poster (Abstract number 3066) by Gautam Gopalji Jha, M.D., Adjunct Assistant Professor, Division of Hematology and Oncology, University of Minnesota, at ASCO (Free ASCO Whitepaper) in Chicago on Monday, June 5, 2017, 8:00 a.m. – 11:30 a.m. CT, titled, A phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

In the study, forty-six patients were randomized into two arms to receive either twice daily oral indoximod (n=22) or placebo (n=24) for 6 months beginning the day after the third and final PROVENGE infusion. Conclusions indicate that treatment with the IDO pathway inhibitor, indoximod, post PROVENGE therapy, leads to significant improvement in radiographic progression free survival (rPFS) when compared to placebo and is well-tolerated.

Key findings presented from the study include:

Statistically significant improvement in median rPFS was 10.3 months in the treatment arm compared to 4.1 months in the placebo arm (p = 0.011)
Median Overall Survival (OS) has not yet been reached
Patients tolerated therapy with indoximod with no significant differences in adverse events between the two arms
There was no statistical difference in the primary endpoint of ELISPOT assay immune response to PA2024, the PROVENGE-related fusion protein, in the 35 of 46 patients who had clinical samples available for testing
"These data further support the hypothesis that targeting the IDO Pathway in combination with a broad backbone of treatment regimens including chemotherapy, anti-PD-1 antibodies and therapeutic vaccines across multiple indications has the potential to provide meaningful clinical benefit without compromising tolerability," commented Nicholas N. Vahanian, M.D., President and Chief Medical Officer of NewLink Genetics.

Navoximod in combination with TECENTRIQ (atezolizumab) in multiple solid tumors

Initial data from a Phase 1b dose-escalation study of navoximod in combination with TECENTRIQ for patients with locally advanced or metastatic solid tumors conducted by our partner, Genentech/Roche, will be presented in an oral presentation (Abstract number 105) by Howard A. "Skip" Burris, III, M.D., President Clinical Operations and Chief Medical Officer, Sarah Cannon Research Institute, at ASCO (Free ASCO Whitepaper) in Chicago on Sunday, June 4, 2017, 10:24 a.m. CT. The presentation is titled, A phase 1b dose-escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients with locally advanced or metastatic solid tumors.

This Phase 1b, open-label, dose-escalation study is designed to characterize safety and tolerability. Secondary objectives include identifying a maximum tolerated dose (MTD) and recommended Phase 2 dose, and evaluating pharmacokinetics, pharmacodynamics, and anti-tumor activity. Patients were given TECENTRIQ (1200 mg IV every 3 weeks) and escalating doses of navoximod (orally twice daily, for 21 days) using a standard 3+3 design. Initial results from this study (n=52, non-selected heterogeneous population during the dose escalation) found the combination was generally well-tolerated, with peripheral IDO1 modulation, and some early activity signals. Patients were previously treated with prior systemic therapies with a median number of 3 and a range of 1-9. Two patients also received prior immunotherapy.

The design of the trial includes the initial dose-escalation phase reported in this abstract, followed by disease-specific expansion cohorts (enrollment target is 305 patients) for patients with select tumor types including non-small-cell lung cancer (NSCLC), renal cell cancer (RCC), urothelial bladder cancer (UBC), triple negative breast cancer (TNBC), to further evaluate safety, response, and peripheral and tumor pharmacodynamics. Updates for this study will continue to be reported by Genentech/Roche.

Dr. Vahanian continued, "We are encouraged by the clinical profile for the combination of navoximod and atezolizumab from the first phase of this combination trial and look forward to the data for the disease-specific expansion cohorts which are currently accruing patients."