BLRX BioLineRx Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
|
Phase 2
Phase 2
|
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|
|
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
|
Phase 3
Phase 3
|
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|
Motixafortide
Acute respiratory distress syndrome (ARDS) secondary to COVID-19
|
Phase 1b
Phase 1b
|
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|
|
AGI-134
Solid tumors
|
Phase 1/2
Phase 1/2
|
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|
Motixafortide and Libtayo
First-line pancreatic ductal adenocarcinoma
|
Phase 2
Phase 2
|
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Motixafortide (BL-8040) - BLAST
Consolidation treatment for AML cancer patients
|
Phase 2b
Phase 2b
|
Phase 2b trial did not meet primary endpoint - November 23, 2020.
|
|
BL-8040 in combination with KEYTRUDA
Pancreatic cancer
|
Phase 2a
Phase 2a
|
Phase 2a data presented at ESMO December 13, 2019.
|
Latest News
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TEL AVIV, Israel, Nov. 23, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended September 30, 2020 and provides a corporate update.
Significant events and achievements during the third quarter 2020 and subsequent period:
- Reported positive results from a pre-planned interim analysis of GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. The Data Monitoring Committee (DMC) found statistically significant evidence favoring treatment with motixafortide in the primary endpoint, and subsequently issued a recommendation to cease patient enrollment immediately. In accordance with the DMC's recommendation, study enrollment was completed at 122 patients (instead of 177 as originally planned). SCM is the Company's most efficient path to registration;
- Announced initiation of Phase 2 investigator-initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC. The study is being run by Columbia University;
- Announced initiation of investigator-initiated Phase 1b study, led by Wolfson Medical Center in Holon, Israel, to evaluate motixafortide in patients hospitalized with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections;
- Renewed study enrollment in Part of Phase 1/2a trial for AGI-134, which had been temporarily suspended in the second quarter of 2020 due to clinical operating risks associated with the COVID-19 pandemic;
- Conducted interim analysis for Phase 2b BLAST study in consolidation AML; analysis did not demonstrate statistically significant effect in primary endpoint; DMC recommended not to continue the study.
"The past several months have been very exciting for BioLineRx, highlighted by the very positive result of the interim analysis of our Phase 3 GENESIS study in stem cell mobilization" stated Philip Serlin, Chief Executive Officer of BioLineRx. "A statistically significant benefit in the primary endpoint was observed by combining motixafortide with the standard of care, G-CSF, leading the DMC to recommend that we cease study enrollment at 122 patients, instead of the 177 originally planned. We look forward to publishing final results of the study in the first half of next year, as we continue to advance motixafortide toward registration.
"With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we've had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the University of Halle, as study sponsor, and Dr. Carsten Müller-Tidow, as principal study investigator, as well as the other investigators and the patients who made this important trial possible.
"Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year's ESMO IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA®, together with chemotherapy, will prove beneficial to survival as well.
"The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers," Mr. Serlin concluded.
Upcoming Expected Milestones
- Overall final results, including PFS and OS data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC by the end of 2020;
- Final results from the Phase 3 GENESIS trial in SCM in the first half of 2021;
- Preliminary results of the Phase 1b study in ARDS in the first half of 2021;
- Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
- Data from the Columbia University-initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC in mid-2022;
Financial Results for the Quarter Ended September 30, 2020
Research and development expenses for the three months ended September 30, 2020 were $3.5 million, a decrease of $2.1 million compared to $5.6 million for the comparable period in 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019 and from lower expenses associated with the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic carried out in the second and third quarters of 2020. Research and development expenses for the nine months ended September 30, 2020 were $13.5 million, a decrease of $1.7 million, compared to $15.2 million for the nine months ended September 30, 2019. The decrease resulted primarily from lower expenses associated with the motixafortide COMBAT clinical trial and the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic mentioned above.
Sales and marketing expenses for three months ended September 30, 2020 were $0.3 million, an increase of $0.1 million compared to $0.2 million for the comparable period in 2019. The increase resulted primarily from consultancy services and market research for motixafortide offset by a decrease in payroll and related expenses related to a reduction in headcount. Sales and marketing expenses for the nine months ended September 30, 2020 were $0.7 million, similar to the comparable period in 2019.
General and administrative expenses for the three months ended September 30, 2020 were $0.9, similar to the comparable period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $2.8 million, similar to the comparable period in 2019.
The Company's operating loss for the three months ended September 30, 2020 amounted to $4.6 million, compared to an operating loss of $6.6 million for the comparable period in 2019. The Company's operating loss for the nine months ended September 30, 2020 was $17.1 million, compared to $18.7 million for the comparable period in 2019.
Non-operating income (expenses) for the three- and nine-month periods ended September 30, 2020 and 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses and issuance expenses of the Company's ATM program.
Net financial expenses for the three months ended September 30, 2020 amounted to $0.3 million compared to net financial expenses of $0.4 million for the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the nine months ended September 30, 2020 amounted to $0.9 million, similar to the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.
The Company's net loss for the three months ended September 30, 2020 amounted to $4.6 million, compared with a net loss of $3.9 million for the comparable period in 2019. The Company's net loss for the nine months ended September 30, 2020 amounted to $18.0 million, compared with a net loss of $15.6 million for the comparable period in 2019.
The Company held $20.8 million in cash, cash equivalents and short-term bank deposits as of September 30, 2020.
Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2020, compared with net cash used in operating activities of $17.2 million for the nine months ended September 30, 2019. The $0.6 million increase in net cash used in operating activities during the nine-month period in 2020 was primarily the result of the decrease in accounts payable and accruals in the 2020 period.
Net cash provided by investing activities was $8.1 million for the nine months ended September 30, 2020, compared to net cash provided by investing activities of $2.1 million for the nine months ended September 30, 2019. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.
Net cash provided by financing activities was $10.9 million for the nine months ended September 30, 2020, compared to net cash provided by financing activities of $16.6 million for the nine months ended September 30, 2019. The cash flows in 2020 primarily reflect the May and June financings and the net proceeds from the Company's ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of our ADSs in February 2019, as well as net proceeds from the ATM facility.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, November 23, 2020 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0664 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.
A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until November 25, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5929 internationally.
(Tables follow)
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
December 31,
September 30,
2019
2020
in USD thousands
Assets
CURRENT ASSETS
Cash and cash equivalents
5,297
6,552
Short-term bank deposits
22,192
14,275
Prepaid expenses
108
269
Other receivables
613
327
Total current assets
28,210
21,423
NON-CURRENT ASSETS
Property and equipment, net
1,816
1,462
Right-of-use assets, net
1,650
1,423
Intangible assets, net
21,891
21,731
Total non-current assets
25,357
24,616
Total assets
53,567
46,039
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loans
2,692
2,969
Accounts payable and accruals:
Trade
7,794
5,933
Other
1,280
1,374
Lease liabilities
202
200
Total current liabilities
11,968
10,476
NON-CURRENT LIABILITIES
Warrants
658
5,600
Long-term loans, net of current maturities
5,799
3,554
Lease liabilities
1,762
1,601
Total non-current liabilities
8,219
10,755
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities
20,187
21,231
EQUITY
Ordinary shares
4,692
8,281
Share premium
265,938
271,107
Capital reserve
12,132
12,835
Other comprehensive loss
(1,416)
(1,416)
Accumulated deficit
(247,966)
(265,999)
Total equity
33,380
24,808
Total liabilities and equity
53,567
46,039
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three months ended September 30,
Nine months ended
September 30,2019
2020
2019
2020
in USD thousands
in USD thousands
RESEARCH AND DEVELOPMENT EXPENSES
(5,558)
(3,484)
(15,252)
(13,546)
SALES AND MARKETING EXPENSES
(201)
(309)
(683)
(666)
GENERAL AND ADMINISTRATIVE EXPENSES
(884)
(856)
(2,763)
(2,843)
OPERATING LOSS
(6,643)
(4,649)
(18,698)
(17,055)
NON-OPERATING INCOME (EXPENSES), NET
3,055
294
3,976
(80)
FINANCIAL INCOME
247
39
628
214
FINANCIAL EXPENSES
(597)
(302)
(1,484)
(1,112)
NET LOSS AND COMPREHENSIVE LOSS
(3,938)
(4,618)
(15,578)
(18,033)
in USD
in USD
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
(0.03)
(0.02)
(0.11)
(0.08)
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE148,920,707
296,508,550
142,527,942
231,380,969
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
Ordinary Shares
Share premium
Capital reserve
Other
comprehensive
lossAccumulated deficit
Total
in USD thousands
BALANCE AT JANUARY 1, 2019
3,110
250,192
11,955
(1,416)
(222,520)
41,321
CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30,
2019:Issuance of share capital, net
1,018
11,266
-
-
-
12,284
Employee stock options exercised
1
53
(53)
-
-
1
Employee stock options forfeited and expired
-
919
(919)
-
-
-
Share-based compensation
-
-
1,170
-
-
1,170
Comprehensive loss for the period
-
-
-
-
(15,578)
(15,578)
BALANCE AT SEPTEMBER 30, 2019
4,129
262,430
12,153
(1,416)
(238,098)
39,198
Ordinary Shares
Share premium
Capital reserve
Other
Comprehensive LossAccumulated deficit
Total
in USD thousands
BALANCE AT JANUARY 1, 2020
4,692
265,938
12,132
(1,416)
(247,966)
33,380
CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2020:
Issuance of share capital, net
3,581
4,754
-
-
-
8,335
Employee stock options exercised
8
224
(224)
-
-
8
Employee stock options forfeited and expired
-
191
(191)
-
-
-
Share-based compensation
-
-
1,118
-
-
1,118
Comprehensive loss for the period
-
-
-
-
(18,033)
(18,033)
BALANCE AT SEPTEMBER 30, 2020
8,281
271,107
12,835
(1,416)
(265,999)
24,808
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)Ordinary
Share
Capital
Other
ComprehensiveAccumulated
Shares
premium
reserve
Loss
deficit
Total
in USD thousands
BALANCE AT JULY 1, 2019
4,001
261,522
11,835
(1,416)
(234,160)
41,782
CHANGES FOR THREE MONTHS ENDED SEPTEMBER 30, 2019:
Issuance of share capital, net
128
829
-
-
-
957
Employee stock options exercised
-
26
(26)
-
-
-
Employee stock options forfeited and expired
-
53
(53)
-
-
-
Share-based compensation
-
-
397
-
-
397
Comprehensive loss for the period
-
-
-
-
(3,938)
(3,938)
BALANCE AT SEPTEMBER 30, 2019
4,129
262,430
12,153
(1,416)
(238,098)
39,198
Ordinary
Share
Capital
Other
ComprehensiveAccumulated
Shares
premium
Reserve
Loss
deficit
Total
in USD thousands
BALANCE AT JULY 1, 2020
8,281
271,107
12,639
(1,416)
(261,381)
29,230
CHANGES FOR THREE MONTHS ENDED SEPTEMBER 30, 2020:
Issuance of share capital, net
-
-
-
-
-
-
Employee stock options exercised
-
-
-
-
-
-
Employee stock options forfeited and expired
-
-
-
-
-
-
Share-based compensation
-
-
196
-
-
196
Comprehensive loss for the period
-
-
-
-
(4,618)
(4,618)
BALANCE AT SEPTEMBER 30, 2020
8,281
271,107
12,835
(1,416)
(265,999)
24,808
BioLineRx Ltd
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Nine months ended September 30,
2019
2020
in USD thousands
CASH FLOWS - OPERATING ACTIVITIES
Comprehensive loss for the period
(15,578)
(18,033)
Adjustments required to reflect net cash used in operating activities
(see appendix below)
(1,658)
259
Net cash used in operating activities
(17,236)
(17,774)
CASH FLOWS - INVESTING ACTIVITIES
Investments in short-term deposits
(34,517)
(28,500)
Maturities of short-term deposits
36,637
36,626
Purchase of property and equipment
(54)
(1)
Net cash provided by investing activities
2,066
8,125
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital and warrants, net of issuance costs
16,836
13,411
Employee stock options exercised
1
8
Repayments of loans
(70)
(2,338)
Repayments of lease liabilities
(165)
(162)
Net cash provided by financing activities
16,602
10,919
INCREASE IN CASH AND CASH EQUIVALENTS
1,432
1,270
CASH AND CASH EQUIVALENTS - BEGINNING
OF PERIOD
3,404
5,297
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
49
(15)
CASH AND CASH EQUIVALENTS - END OF PERIOD
4,885
6,552
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Nine months ended
September 30,2019
2020
in USD thousands
Adjustments required to reflect net cash used in operating activities:
Income and expenses not involving cash flows:
Depreciation and amortization
667
737
Long-term prepaid expenses
(3)
-
Exchange differences on cash and cash equivalents
(49)
15
Fair value adjustments of warrants
(4,429)
(727)
Share-based compensation
1,170
1,118
Warrant issuance costs
417
593
Interest and exchange differences on short-term deposits
(628)
(209)
Interest on loans
512
370
Exchange differences on lease liability
-
4
(2,343)
1,901
Changes in operating asset and liability items:
Decrease in prepaid expenses and other receivables
265
125
Increase (decrease) in accounts payable and accruals
420
(1,767)
685
(1,642)
(1,658)
259
Supplemental information on interest received in cash
628
342
Supplemental information on interest paid in cash
782
671
View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-third-quarter-2020-financial-results-and-provides-corporate-update-301178794.htmlSOURCE BioLineRx Ltd.
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Management to hold a conference call at 10:00 a.m. EST
TEL AVIV, Israel, Nov. 18, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended September 30, 2020 on Monday, November 23, 2020, before the US markets open.
The Company will host a conference call on Monday, November 23, 2020 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.
To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until November 25, 2020; please dial +1-877-456-0009 from the U.S. or +972-3-925-5929 internationally.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD, as well as a Phase 2b study in consolidation AML.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-to-report-third-quarter-2020-results-on-november-23-2020-301175789.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, Nov. 18, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company's lead drug candidate, the CXCR4-inhibitor Motixafortide, will be evaluated in an investigator-initiated clinical trial in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.
The open-label, single-arm, Phase 1b study will be conducted at the Wolfson Medical Center in Holon, Israel, with Dr. Yasmin Maor, Head of the Infectious Disease Unit, as lead investigator.
"Severe COVID-19 cases, where patients are hospitalized with ARDS and require ventilation, have generated renewed interest in the underlying pathology of acute respiratory stress disorder," noted Dr. Maor. "Substantial data is emerging regarding the involvement of neutrophils, neutrophil extracellular traps (NETs), monocytes and macrophages in the development of ARDS secondary to COVID-19 and other viral infections; as well as the key involvement of CXCR4 as a mediator of those cells in the inflamed pulmonary tissue. Based on the scientific data indicating the importance of blocking the CXCR4/CXCL12 axis during ARDS, Motixafortide could be of potential benefit for such patients. COVID-19 case counts are again surging in many parts of the world and addressing ARDS has become a top global health priority."
The primary endpoint of the study is to assess the safety of Motixafortide in patients with ARDS secondary to COVID-19 and other respiratory viral infections. Respiratory parameters and inflammatory biomarkers will be assessed as exploratory endpoints. Up to 25 patients will be enrolled, with a preliminary analysis planned after ten patients have completed the initial treatment period. Based on the preliminary evaluation, a decision to continue or not will be conducted by Dr. Maor, together with the Company.
"We believe there is strong scientific rationale for exploring Motixafortide in ARDS, and we are grateful to Dr. Maor for initiating this study," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We have compiled a significant body of data demonstrating Motixafortide's utility as a best-in-class CXCR4 inhibitor and we are eager to evaluate its effectiveness in blunting the cytokine storm that is associated with poor COVID-19 infection outcomes. We look forward to results from the preliminary analysis in the first half of next year.
"In parallel, we remain on track to announce full data from our Phase 2a COMBAT/KEYNOTE-202 study in pancreatic cancer, as well as interim results from our Phase 2b BLAST study in AML, by the end of this year," Mr. Serlin concluded.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD, as well as a Phase 2b study in consolidation AML.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]SOURCE BioLineRx Ltd.
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TEL AVIV, Israel, Oct. 30, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.
At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.
In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.
"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."
The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, motixafortide (BL-8040), is a cancer therapy platform 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 MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-positive-results-from-interim-analysis-of-genesis-phase-3-trial-of-motixafortide-bl-8040-in-stem-cell-mobilization-301163726.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, Oct. 29, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company's lead drug candidate, the CXCR4-inhibitor Motixafortide, will be tested in combination with the anti-PD-1 cemiplimab (LIBTAYO®) and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
This investigator-initiated Phase 2 study, led by Columbia University, will initially enroll 10-12 PDAC patients, and will be expanded to a total of 40 patients following an evaluation of the initial 10-12 patients based on pre-defined criteria. The primary endpoint of the study is the overall response rate (ORR). Secondary endpoints include safety and tolerability, progression free survival (PFS), duration of clinical benefit (DCR) and overall survival (OS). Data from the study is anticipated in mid-2022.
"Chemotherapy is the current standard of care for patients with metastatic PDAC, however the rates of response and survival remain very low. In addition, although immunotherapy has resulted in a paradigm shift in the treatment of a number of solid tumors, trials with immune checkpoint blockade in PDAC have been disappointing," stated Dr. Gulam Manji, Assistant Professor of Medicine and Director of Pancreas Medical Oncology and Translational Research at Columbia University Vagelos College of Physicians and Surgeons, and lead investigator. "Over several years of pre-clinical research, we have found that combining a CXCR4 inhibitor with immunotherapy and chemotherapy shows promising results in a mouse model of pancreatic cancer. In this regard, Motixafortide, with its high affinity and long receptor occupancy, together with the encouraging preliminary results published from the COMBAT trial, makes it an attractive candidate for a combination therapy with anti-PD-1 and chemotherapy. We look forward to initiating the first clinical trial to treat patients in first-line metastatic PDAC with this promising treatment regimen."
"We are excited to collaborate with Dr. Manji on this trial, which will further assess the utility of Motixafortide as the backbone of a potentially promising combination therapy in this challenging cancer indication," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The results reported to date in our ongoing COMBAT-KEYNOTE-202 study, which is evaluating Motixafortide in combination with KEYTRUDA® and chemotherapy in second-line metastatic PDAC, demonstrate an encouraging anti-tumor effect when compared to historical data. We are hopeful that we can replicate these improved responses in this first-line study and look forward to data in mid-2022. This is yet another potentially value-creating milestone that further validates Motixafortide's potential ability to treat a range of cancers across all stages of disease."
About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.
Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.
In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2% of new cancer cases. In 2018, approximately 450,000 individuals globally were diagnosed with this condition, 55,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed until it reaches an advanced stage. Surgical resection does not offer adequate treatment since only 20% of patients have resectable tumors at the time of diagnosis. Even among patients who undergo resection for pancreatic cancer and have tumor-free margins, the five-year survival rate is only 10%-25%. The overall five-year survival rate among pancreatic cancer patients is 10%, which constitutes the highest mortality rate among solid tumor malignancies. The overall median survival is less than one year from diagnosis, highlighting the need for the development of new therapeutic options.
Despite advances in chemotherapeutics and immunotherapy, increases in median and overall survival rates in pancreatic cancer have been modest. Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane®) in combination with gemcitabine for first-line treatment in 2013 and Onivyde® in combination with fluorouracil and leucovorin for second-line treatment in 2015. The limited clinical benefits demonstrated by these existing standard treatment options reinforce the need for additional approaches.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform 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 MSD. Motixafortide is also being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation and a Phase 2b study in consolidation AML.
BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-initiation-of-phase-2-clinical-trial-in-first-line-metastatic-pancreatic-cancer-301162941.htmlSOURCE BioLineRx Ltd.
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