Merck pipeline

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!


Bellicum Announces Clinical Presentations at the 22nd Congress of the European Hematology Association

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Know more, wherever you are:
Latest on Bellicum Pharmaceuticals’ Cancer Pipeline, book your free 1stOncology demo here.

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

ERYTECH Provides Business Update and Financial Highlights For Q1 2017

On May 18, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, reported provided a financial and business update for the first quarter of 2017 ended March 31, 2017 (Press release, ERYtech Pharma, MAY 18, 2017, View Source;p=irol-newsArticle&ID=2274066 [SID1234519250]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Business Highlights

ERYTECH reported positive Phase 2b data from the French multi-center study of Eryaspase for the treatment of metastatic pancreatic cancer. Results from the study showed significant improvement in both progression-free survival (PFS) and overall survival (OS). The study assessed eryaspase, L-asparaginase encapsulated in red blood cells, as a second-line treatment in combination with chemotherapy in 140-patients with metastatic pancreatic cancer. Eryaspase was added to the standard of care (gemcitabine or FOLFOX) and compared to the standard of care alone in a 2-to-1 randomization.
The company successfully raised €70.5 million in a private placement. ERYTECH issued 3,000,000 new ordinary shares. The company intends to utilize the proceeds from this capital raise to prepare the company for the further clinical development of its pipeline candidates, including the launch of a potential Phase 3 trial in pancreatic cancer and evaluation of clinical development opportunities for eryaspase (GRASPA) in other solid tumor indications. A portion of the capital will be used for general corporate purposes and working capital.
ERYTECH announced the launch of a single arm, multi-center, multi-national investigator-initiated Phase 2 study of eryaspase in approximately 30 acute lymphoblastic leukemia (ALL) patients at 23 sites across 7 Nordic and Baltic countries. The study aims to evaluate the biological activity, safety, and immunogenicity profile of eryaspase in combination with the NOPHO ALL 2008 multi-agent chemotherapy protocol as a second-line therapy in pediatric and adult ALL patients (1 to 45 years old) who experienced hypersensitivity reactions to PEG-asparaginase or silent inactivation.
ERYTECH presented promising preclinical findings on the anti-tumor activity of its new product candidate, erymethionase, at the 2017 ASCO (Free ASCO Whitepaper) GI Symposium and at AACR (Free AACR Whitepaper) 2017. Data obtained from the study demonstrated that erymethionase in combination with daily vitamin B6 supplementation can inhibit tumor growth in a murine model of human gastric adenocarcinoma.
The company entered into a collaboration with Fox Chase Cancer Center for the preclinical development of erymethionase in homocystinuria, a rare inherited disease caused by a deficiency in the enzyme cystathionine beta-synthase (CBS), which is critical for normal methionine metabolism. Under this collaboration, FCCC and ERYTECH will study the potential of erymethionase to lower homocysteine and methionine in the homocystinuria mouse model (CBS-deficient mice) developed at FCCC.
The company presented encouraging preclinical data supporting ERYMMUNE as a potentially strong immunotherapy at the World ADOPT Summit 2017 and 10th Symposium of Vaccinology. Study results showed that ERYMMUNE technology was responsible for a inducing an efficient and antigen-specific immune response for effective cancer immunotherapy.
Financial Highlights

ERYTECH’s key financial figures for the first quarter of 2017, compared with the same period of the previous year are summarized below:
Key figures (in thousands of euros):

Q1 (3 months)
2017 Q1 (3 months)
2016 Variation
Revenues 0 0 0
Other income 1,222 684 538
Total operating income 1,222 684 538
Operating expenses:
Research & development (5,847) (3,638) (2,209)
General & administrative (1,906) (1,473) (433)
Total operating expenses (7,753) (5,111) (2,642)
Operating loss (6,531) (4,427) (2,104)

Financial income 21 97 (77)
Income tax (13) 4 (17)
Net Loss (6,523) (4,325) (2,198)
Net loss for the first quarter of 2017 was €6.5 million, compared to net loss of €4.3 million for the same period of last year. The €2.2 million increase reflected the increased activity to advance the company’s preclinical and clinical development programs. The increase was driven by higher service and contracting fees, mostly related to the clinical and regulatory progress of product development projects, and higher personnel costs, following the staffing of key positions in the preclinical, clinical and pharmaceutical operations domains. Other income, which was mostly comprised of research and development tax credits and grants, increased in the same proportion.

As of March 31, 2017, ERYTECH had cash and cash equivalents totaling €30.5 million, compared with €40.6 million on March 31, 2016. Total net cash utilization was €7.1 million in the first quarter of 2017, which compares with net cash utilization of €5.1 million in the first quarter of 2016. The net loss of the period as well as the net cash utilization in the first quarter of 2017 reflected the increased activity in product development and supporting company’s operations.
A private placement to U.S. and European investors was completed in April 2017. The net proceeds of approximately €64.5 million will enable the company to fund the continued development of its product candidates, and mainly to finance the preparatory steps for the launch of contemplated Phase 3 studies in pancreatic cancer and adult ALL. The company is also sufficiently funded to assess the clinical development opportunities of eryaspase (GRASPA) for the treatment of other solid tumor indications, in addition to its ongoing preclinical and clinical programs.
Gil Beyen, ERYTECH’s Chief Executive Officer commented, "In the first quarter of 2017, we made tremendous progress in our clinical and preclinical R&D programs. We are very pleased with the highly positive results from our Phase 2b trial of eryaspase in metastatic pancreatic cancer patients. The findings from this trial further validate our eryaspase product candidate and our technology platform, and we are now determining next steps to advance the product candidate in pancreatic cancer and in other solid tumors. All of this without losing sight of our development in acute leukemia. The work for resubmission of our European Marketing Authorization Application in ALL is ongoing and the launch of an investigator initiated trial in collaboration with the Nordic Society of Pediatric Hematology and Oncology shows our commitment to bringing GRASPA to ALL patients in need. Next to eryaspase, we have made noteworthy advances in our preclinical programs, notably with erymethionase and our ERYMMUNE platform for which we presented promising preclinical results at different conferences. The very successful private placement in April confirms investors’ confidence in our programs and provides a strong basis to prepare the company for the implementation of its ambitious value-creation strategy. We look forward to accomplishing more milestones this year, including the resubmission of our European MAA for GRASPA in relapsed and refractory ALL, regulatory interactions regarding our further developments in ALL and pancreatic cancer both in Europe and the US, and the Phase 2 results of our AML study."

First Quarter 2017 Conference Call Details

Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:

USA: +1 6467224907 United-Kingdom: +44 2030432440
Switzerland: +41 225809022 Germany: +49 69222229031
France: +33 172001510 Belgium: +32 24029640
Sweden: +46 850334664 Finland : +358 942599700
Netherlands: +31 107138194
Confirmation Code: 64683084#

The webcast can be followed live online via the link:
View Source;Name=&Conference=135308821&PIN=64683084

Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:

USA: +1 877 64 230 18
United-Kingdom: +44(0) 2033679460
France: +33(0)1 72 00 15 00
Confirmation Code: 308821#

Additionally, an archive of the webcast will be available on the "Webcast" section of the Company’s investor relations site at www.erytech.com

Next financial updates:

Financial highlights for the 2nd quarter of 2017: September 11, 2017 (after market close), followed by a conference call and webcast on September 12, 2017 (3:00pm CET/9:00am ET)
Upcoming participations at investor conferences:

BioEquity Europe 2017, May 22-23, Paris
Biotech Agora Conference, May 23, Paris
Gilbert Dupont Annual Healthcare Conference, May 30, Paris
Jefferies 2017 Global Healthcare Conference, June 6-9, New-York
Journée Valeurs Moyennes (SFAF), June 13, Paris
European MidCap Spring Event, June 28, Paris

SYROS TO PRESENT ON SY-1425 IN COMBINATION WITH STANDARD-OF-CARE AND TARGETED THERAPIES IN GENOMICALLY DEFINED SUBSETS OF AML AND MDS PATIENTS

On May 18, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, reported that the Company will present preclinical data on SY-1425, its oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, in combination with hypomethylating agents and anti-CD38 therapies in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25 in Madrid, Spain (Press release, Syros Pharmaceuticals, MAY 18, 2017, View Source;p=irol-newsArticle&ID=2273936 [SID1234519251]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details on the presentation are as follows:

Date & Time: Friday, June 23, from 5:15 – 6:45 p.m. CEST
Presentation Title: Mechanistically Informed Combinations of SY-1425, a Potent and Selective RARα Agonist, with Hypomethylating or Anti-CD38 Targeted Agents in AML and MDS
Session Title: Acute myeloid leukemia – Biology 2
Presenter: Michael R. McKeown, Ph.D., Senior Scientist, Translational Medicine, Syros
Abstract Number: P188
Location: IFEMA – Feria de Madrid, Poster area (Hall 7)

SY-1425 is currently in a Phase 2 clinical trial exploring its safety and efficacy as both a monotherapy and in combination with azacitidine, a standard-of-care hypomethylating agent, in subsets of AML and MDS patients with high expression of RARA pathway-associated genes RARA and IRF8.

Sumitomo Dainippon Pharma announces the Clinical Data will be presented at ASCO 2017

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.