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Hot Stocks
BioLineRx completes patient recruitment in Phase 2a COMBAT/KEYNOTE-202 study » 07:07
01/22/20
01/22
07:07
01/22/20
07:07
BLRX

BioLineRx

$2.52 /

+0.03 (+1.20%)

"We are pleased to…

"We are pleased to see the triple combination arm of our Phase 2a pancreatic study advance according to plan," stated Philip Serlin, CEO of BioLineRx. "This follows very promising initial results that were presented last month at the ESMO IO conference, demonstrating robust and durable responses to the triple combination treatment. As previously stated, we remain on track to announce progression-free and overall survival data from the triple combination arm in mid-2020."

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Over a week ago
Hot Stocks
BioLineRx receives Orphan Drug designation from European Comission for BL-8040 » 07:03
01/14/20
01/14
07:03
01/14/20
07:03
BLRX

BioLineRx

$2.37 /

-0.03 (-1.25%)

BioLineRx announced that…

BioLineRx announced that the European Commission, or EC, has granted Orphan Drug Designation to its lead oncology candidate, Motixafortide, or BL-8040, for the treatment of pancreatic cancer, based on a positive opinion from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency, or EMA. Last year, Motixafortide received Orphan Drug Designation for the treatment of Pancreatic Cancer from the FDA. Motixafortide is currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with Merck & Co. The EMA grants orphan medicinal product designation to investigational drugs intended to treat, prevent or diagnose a life-threatening or chronically debilitating disease affecting fewer than five in 10,000 people in the EU and for which no satisfactory treatment is available or, if such treatment exists, the medicine must be of significant benefit to those affected by the condition.

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Over a month ago
Conference/Events
European Society for Medical Oncology to hold a conference » 04:55
12/14/19
12/14
04:55
12/14/19
04:55
BLRX

BioLineRx

$2.38 /

-0.23 (-8.81%)

, BD

Budget Group

$0.00 /

+ (+0.00%)

, IDRA

Idera Pharmaceuticals

$1.59 /

-0.05 (-3.05%)

, MRK

Merck

$89.18 /

+0.84 (+0.95%)

, PFE

Pfizer

$38.31 /

-0.23 (-0.60%)

, NKTR

Nektar

$21.28 /

-0.53 (-2.43%)

ESMO Immuno-Oncology…

ESMO Immuno-Oncology Congress 2019 will be held in Geneva, Switzerland on December 11-14.

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Hot Stocks
BioLineRx CEO 'very excited' about data from Phase 2a COMBAT/KEYNOTE-202 study » 07:08
12/13/19
12/13
07:08
12/13/19
07:08
BLRX

BioLineRx

$2.61 /

-0.01 (-0.38%)

, MRK

Merck

$88.95 /

+0.6 (+0.68%)

"Metastatic…

"Metastatic pancreatic cancer has a very poor response to chemotherapy, and immunotherapy treatments have failed to show any effect as single agents," said Manuel Hidalgo, MD, PhD, Chief of the Division of Hematology and Medical Oncology and a Senior Member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study. "These promising initial results presented today show an overall response rate almost double the current chemotherapy standard-of-care treatment in second-line patients. The results are even stronger when taking into account the extended durability of clinical benefit seen to date in this study (median of 7.8 months), compared to approximately three months of response duration with other treatments for second-line pancreatic cancer. I look forward to the survival data expected in mid-2020." "We are very excited by the positive data accumulating from this triple combination arm of our Phase 2a pancreatic study under our collaboration with Merck (MRK)," stated Philip Serlin, CEO of BioLineRx (BLRX). "These data continue to confirm our hypothesis relating to the synergistic effect of cytotoxic chemotherapy, along with the trafficking, tumor microenvironment modulation and T-cell infiltration effects seen in PDAC patients from previous dual combination trials of BL-8040 with checkpoint inhibitors. It is therefore very encouraging to see robust and durable responses to the triple combination treatment, especially as we continue to see a trend of patients receiving treatment for an extended period that move from stable disease to partial response. We hope to see these results translate into an extended survival benefit for these patients, which we expect to announce in mid-2020, and we hope will pave the way for use of immunotherapy in pancreatic cancer and in other cold tumors."

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Hot Stocks
BioLineRx provides update on Phase 2a COMBAT/KEYNOTE-202 study » 07:06
12/13/19
12/13
07:06
12/13/19
07:06
BLRX

BioLineRx

$2.61 /

-0.01 (-0.38%)

BioLineRx announced…

BioLineRx announced updated data from the triple combination arm of the ongoing Phase 2a COMBAT/KEYNOTE-202 study. The data was delivered today in an oral presentation entitled, "A Multi-Center Phase 2a Trial to Assess the Safety and Efficacy of BL-8040 in Combination with Pembrolizumab and Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma", at the European Society of Medical Oncology Immuno-Oncology Congress 2019, which is being held December 11-14 in Geneva, Switzerland. As of December 12, 36 out of 40 patients have been enrolled in the study. As of December 5, 2019 (the cutoff date for the presentation data), 30 patients were evaluable for safety and 22 were evaluable for efficacy. All patients enrolled were originally diagnosed with stage IV metastatic pancreatic adenocarcinoma and had progressed following first-line treatment with gemcitabine-based chemotherapy. Best response for the evaluable population of 22 patients showed 7 partial response and 10 stable disease patients - resulting in an overall response rate of 32% and a disease control rate of 77%; this compares favorably to the current chemotherapy standard-of-care treatment in second-line patients with ORR of 17% and DCR of 52%; The combination showed continuity of effect - 5 patients with stable disease became partial responders as treatment continued; Out of the 7 partial responders, 5 are still on treatment, with a current maximum treatment time of 330+ days; and 4 responders showed a reduction in tumor burden of greater than50%; Median duration of clinical benefit until progression for the 17 patients with disease control is 7.8 months; The study is ongoing; progression-free and overall survival data remain on track for mid-2020; The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone; adverse event and severe adverse event profiles are as expected with chemotherapy-based treatment regimens.

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Conference/Events
European Society for Medical Oncology to hold a conference » 04:55
12/13/19
12/13
04:55
12/13/19
04:55
BLRX

BioLineRx

$2.61 /

-0.01 (-0.38%)

, BD

Budget Group

$0.00 /

+ (+0.00%)

, IDRA

Idera Pharmaceuticals

$1.64 /

+ (+0.00%)

, MRK

Merck

$89.56 /

+0.6 (+0.67%)

, PFE

Pfizer

$38.54 /

+0.3 (+0.78%)

, NKTR

Nektar

$21.81 /

+0.21 (+0.97%)

ESMO Immuno-Oncology…

ESMO Immuno-Oncology Congress 2019 will be held in Geneva, Switzerland on December 11-14.

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Conference/Events
European Society for Medical Oncology to hold a conference » 04:55
12/12/19
12/12
04:55
12/12/19
04:55
BLRX

BioLineRx

$2.62 /

-0.13 (-4.73%)

, BD

Budget Group

$0.00 /

+ (+0.00%)

, IDRA

Idera Pharmaceuticals

$1.64 /

-0.06 (-3.53%)

, MRK

Merck

$88.96 /

-0.12 (-0.13%)

, PFE

Pfizer

$38.24 /

-0.25 (-0.65%)

, NKTR

Nektar

$21.60 /

-0.83 (-3.70%)

ESMO Immuno-Oncology…

ESMO Immuno-Oncology Congress 2019 will be held in Geneva, Switzerland on December 11-14.

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Conference/Events
European Society for Medical Oncology to hold a conference » 08:36
12/11/19
12/11
08:36
12/11/19
08:36
BLRX

BioLineRx

$2.75 /

+0.15 (+5.77%)

, BD

Budget Group

$0.00 /

+ (+0.00%)

, IDRA

Idera Pharmaceuticals

$1.70 /

-0.09 (-5.03%)

, MRK

Merck

$89.08 /

+0.37 (+0.42%)

, PFE

Pfizer

$38.49 /

+0.17 (+0.44%)

, NKTR

Nektar

$22.43 /

-0.72 (-3.11%)

ESMO Immuno-Oncology…

ESMO Immuno-Oncology Congress 2019 will be held in Geneva, Switzerland on December 11-14.

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Hot Stocks
BioLineRx reports preliminary Phase 2a data from triple combination cancer study » 07:10
12/05/19
12/05
07:10
12/05/19
07:10
BLRX

BioLineRx

$2.75 /

-0.1 (-3.51%)

BioLineRx announced…

BioLineRx announced preliminary data from the triple combination arm of the ongoing Phase 2a COMBAT/KEYNOTE-202 study showing that the combination of BL-8040, Keytruda and chemotherapy shows high response and disease control rates in patients with metastatic pancreatic cancer. The data will be presented at the European Society of Medical Oncology Immuno-Oncology Congress December 11-14 in Geneva, Switzerland. As of September 30, 22 patients were dosed, of which 15 were evaluable. All patients enrolled were originally diagnosed with stage IV metastatic pancreatic adenocarcinoma. Best response for the evaluable population of 15 patients showed 4 partial response and 8 stable disease patients resulting in overall disease control in 12 out of 15 patients; study is ongoing and median progression free survival and overall survival were not yet reached; survival data remain on track for mid-2020; the combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone. Fifteen serious adverse events were reported by 10 patients and 2 patients discontinued the study due to SAEs. Complete study results are expected to be released in mid-2020.

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Conference/Events
BioLineRx Investor Breakfast Meeting » 06:55
12/04/19
12/04
06:55
12/04/19
06:55
BLRX

BioLineRx

$2.85 /

+0.13 (+4.78%)

Investor meeting to be…

Investor meeting to be held in New York on December 4 at 7:45 am. Webcast Link

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