Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
$BLRX is in 'good' company, eg $GMDA, $EVGN,
$PLX, $CGEN to name a few. It seems that the
bio sector in general is not doing too well to say
the least.
I have no educated explanation or reasoning.
"midastouch017"
So what are your thoughts with this dropping like a lead balloon? I bought a few more thousand this morning in the $1.30s . There is no bad news so it seem the shorts are on the loose at this point. I am still very profitable and if they take it to a buck I will probably go for another 5000 and then sit on it till it goes through at least 3 quarterly reports. I wish every short had a family member suffering from this deadly problem and then just maybe they would leave this little company alone. YES I AM A NASTY PERSON WHEN SOMEONE OR GROUP MESSES WITH A COMPANY THAT IS TRYING TO SAVE MILLIONS OF PEOPLES LIVES and of course my money.
#AACRPan23 talk by Dr. Gulam Manji @columbiacancer on CheMoMETPANC 👉🏽 gemcitabine plus nab-paclitaxel + motixafortide (CXCR4 antagonist) + cemiplimib in advanced #PancreaticCancer. Responses observed in both primary & metastatic sites, with 64% partial responses & 27% stable… pic.twitter.com/IWQfGPQxEg
— Anirban Maitra (@Aiims1742) September 28, 2023
From Dr. Manji's presentation: pancreas and liver tumors shrinking
Proud to report the results of the pilot phase of our investigator-initiated clinical trial @AACR Pancreas.
— Gulam Abbas Manji (@DrGManji) September 29, 2023
I started the preclinical study in KPC mice in @KenOliveLab and then work continued in my lab. Randomized phase 2 to activate soon at 5 sites! pic.twitter.com/qpOfUKdXPF
From the PDAC abstract: Notice how the Biomarkers for Cancer begin to decline after the immune system starts to ramp up
Proud to be a part of this exciting Phase 1 trial of chemo/immuno therapy in #pdac @columbiacancer led by my former fellow/current colleague @DrGManji. Started with a preclinical trial in our lab, now moving to randomized phase 2. Presented @aacr pdac2023. #justkeepswimming pic.twitter.com/fXVv87ptYD
— KenOliveLab (@KenOliveLab) September 28, 2023
Exhibit 1
FOR IMMEDIATE RELEASE
BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination
Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)
- 6 of 11 Patients in the Pilot Phase Experienced a Partial Response, with 4 Confirmed;
One Patient Experienced Resolution of the Hepatic Metastatic Lesion -
- Data Presented at AACR Special Conference on Pancreatic Cancer -
- Multi-Center, Randomized Phase 2 Study Currently Enrolling -
TEL AVIV, Israel, September 28, 2023 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced encouraging data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial evaluating the company’s CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
The data were published in an online abstract as part of the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts from September 27-30, 2023. An oral presentation of the data will take place later today, September 28, 2023.
The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer. As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 82%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care, the chemotherapy combination gemcitabine and nab-paclitaxel.
“These initial data from the pilot phase of this ongoing Phase 2 study give us hope that motixafortide could potentially serve as the backbone of a new treatment regimen for PDAC, which is among the most difficult cancers to treat,” said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. “We are deeply committed to this important collaboration with Columbia University investigators and eagerly look forward to the data from the randomized phase of the trial.”
Based on these pilot data, earlier this year, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. The trial, sponsored by Columbia University, is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).
Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and is expected to be the second leading cause of cancer-related death in the U.S. by 2023. Because it is typically diagnosed at later stages, greater than 80 percent of pancreatic cancer is inoperable. Most pancreatic cancer is incurable and unfortunately newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways.
An earlier single-arm, Phase 2a clinical trial (COMBAT/KEYNOTE-202) and pre-clinical studies evaluating motixafortide in combination with PD-1 immunotherapies and chemotherapies in PDAC have been promising, suggesting the ability of motixafortide to support an immune response.
__________________________________
Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer
Westin Copley Place, Boston Massachusetts
Plenary Session Details
Title:
CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma
Presenter:
Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.
Session:
Plenary Session 3: Clinical Updates
Date:
Thursday, September 28, 2023
Time:
2:30-4:40 pm EDT
About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel, alone in 102 patients. The trial’s primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.1 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company’s first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for?autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at?www.biolinerx.com, or on?Twitter?and?LinkedIn.?
Forward Looking Statement
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 "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors 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; whether the clinical trial results for APHEXDA will be predictive of real-world results; 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, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; 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 and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. 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 22, 2023. 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.
Contacts:
United States
John Lacey
BioLineRx
Something is wrong here. Hope we don't have another GMDA. The PR this morning was at best very mundane. The announcement should have had lights and bells and whistles around it. The people getting the word out are terrible as they are not good at flaring the word The company needs to understand we kept them alive when things were not so positive. Get off your asses and get the word out. There is no one more positive on this company. but don't screw it up
BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)
https://finance.yahoo.com/news/biolinerx-announces-encouraging-data-pilot-110000312.html
- 6 of 11 Patients in the Pilot Phase Experienced a Partial Response, with 4 Confirmed; One Patient Experienced Resolution of the Hepatic Metastatic Lesion -
- Data Presented at AACR Special Conference on Pancreatic Cancer -
- Multi-Center, Randomized Phase 2 Study Currently Enrolling -
TEL AVIV, Israel, Sept. 28, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced encouraging data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
The data were published in an online abstract as part of the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts from September 27-30, 2023. An oral presentation of the data will take place later today, September 28, 2023.
The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer. As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 82%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care, the chemotherapy combination gemcitabine and nab-paclitaxel.
"These initial data from the pilot phase of this ongoing Phase 2 study give us hope that motixafortide could potentially serve as the backbone of a new treatment regimen for PDAC, which is among the most difficult cancers to treat," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "We are deeply committed to this important collaboration with Columbia University investigators and eagerly look forward to the data from the randomized phase of the trial."
Based on these pilot data, earlier this year, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. The trial, sponsored by Columbia University, is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).
Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and is expected to be the second leading cause of cancer-related death in the U.S. by 2023. Because it is typically diagnosed at later stages, greater than 80 percent of pancreatic cancer is inoperable. Most pancreatic cancer is incurable and unfortunately newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways.
An earlier single-arm, Phase 2a clinical trial (COMBAT/KEYNOTE-202) and pre-clinical studies evaluating motixafortide in combination with PD-1 immunotherapies and chemotherapies in PDAC have been promising, suggesting the ability of motixafortide to support an immune response.
Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer
Westin Copley Place, Boston Massachusetts
Plenary Session Details
Title: CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma
Presenter: Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.
Session: Plenary Session 3: Clinical Updates
Date: Thursday, September 28, 2023
Time: 2:30-4:40 pm EDT
About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel, alone in 102 patients. The trial's primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%. In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
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 "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding
management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors 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; whether the clinical trial results for APHEXDA will be predictive of real-world results; 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, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; 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 and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. 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 22, 2023. 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.
Contacts:
United States
John Lacey
BioLineRx
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
ASCO Cancer.Net. Cancer.Net Editorial Board Approval March 2023.
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-encouraging-data-from-pilot-phase-of-phase-2-combination-clinical-trial-with-motixafortide-in-first-line-pancreatic-cancer-pdac-301941126.html
SOURCE BioLineRx Ltd
Business Wire
First Patient Receives Gam
Conclusions:
Preliminary results from this pilot study of MCGN in mPDAC were promising, with a durable PR rate of 55% and disease control rate (DCR) of 82%, compared to historic PRs and DCRs of 23% and 48% reported with gemcitabine and nab-paclitaxel (GN), respectively. Based on these results, the study was amended to transition to a randomized phase 2 trial testing MCGN compared to GN (N=112). The primary endpoint is progression free survival (PFS).
What is wrong with GMDA ???? Glad I cashed in a while back (still at a profit) and bought more BLRX.
Teaser is my middle name!
adamp is a short don't waste your time with him just block him out. He rolls out when things look good for us longs and his shorts FLAME UP.
Great finish to a great day. Hopefully this will carry through to the end of the month where new momentum will care us even further. It looks like shorts are in trouble. I called my two brokerage houses that hold shares of BLRX for me and told them under no circumstances are they to use my shares in any way until I tell them to and told them I will not sell under $150/share or I tell them otherwise.
BioLineRx Announces Acceptance of Oral Presentation on Pilot Phase Data from Phase 2 Combination Clinical Trial with Motixafortide in First-Line PDAC at AACR Special Conference on Pancreatic Cancer
https://finance.yahoo.com/news/biolinerx-announces-acceptance-oral-presentation-110000805.html
Abstracts to be Published on American Association of Cancer Research (AACR)
Virtual Meeting Platform at 5:30 pm EDT on Wednesday, September 27, 2023
Oral Presentation on Thursday, September 28, 2023, in Boston, Massachusetts
TEL AVIV, Israel, Sept. 19, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that pilot phase data from an investigator-initiated, open-label, multicenter Phase 2 clinical trial with motixafortide in first-line pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts, September 27-30, 2023. The Phase 2 clinical trial is designed to evaluate the company's CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
Sponsored by Columbia University, the single-arm pilot phase of the Phase 2 trial focused on the safety of the drug combination. Additionally, based on the original protocol, if =3 of the planned 10 patients within the pilot phase experienced a partial response (PR) by RECIST criteria within 16 weeks, the combination would be considered promising and an expansion cohort of an additional 30 patients would be initiated for enrollment. Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).
Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer
Westin Copley Place, Boston Massachusetts
Plenary Session Details
Title: CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma
Presenter: Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.
Session: Plenary Session 3: Clinical Updates
Date: Thursday, September 28, 2023
Time: 2:30-4:40 pm EDT
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of people who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
About BioLineRx
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with commercial operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
BLRX might help 3/4 of pancreatic cancer patients
This article is from December of 2019. "Seventy-seven percent of patients were able to achieve disease control rate," said Philip Serlin, chief executive officer of BioLineRx.
https://www.jpost.com/HEALTH-SCIENCE/New-Israeli-pancreatic-cancer-treatment-could-extend-most-patients-lives-611085
Bottom-Line Summary
BLRX has a drug approved, full stop. This is a big landmark for any company, and their drug definitely has a role to play in multiple myeloma. Exactly how big a role remains a question, since there's generic plerixafor competition now (even if plerixafor is marginally worse than motixafortide), and fewer patients need immediate autologous transplants. This stock is worth a close watch, since if they can bounce off this approval into decent sales relatively quickly, then the current market cap of $120 million is basically a joke.
Assessing BioLineRx As A Buy After Drug Approval
Sep. 18, 2023 1:28 AM ETBioLineRx Ltd. (BLRX)
Summary
BioLineRx has received approval for their stem cell mobilizing compound, motixafortide, for certain forms of blood cancer.
The compound has shown impressive results in mobilizing stem cells in patients, with a high success rate in optimal stem cell collection.
However, there are concerns about competition from generic versions of a similar drug and the decreasing need for immediate autologous transplants in patients with multiple myeloma.
Topline Summary
BioLineRx (NASDAQ:BLRX) is a biotech company focused mainly on developing a stem cell mobilizing compound to help patients with certain forms of blood cancer. Their exciting news is that they've received a first approval for their compound, but there is reason for caution moving forward, given that their setting of choice continues to be questioned in the literature. There's also generic competition, although BLRX has attempted to get in front of this with a post-hoc analysis suggesting better benefits with their drug. Long story short: this stock is sitting at a bargain price if they're able to capitalize decently on their recent approval.
Pipeline Overview
Motixafortide
The main compound being developed by BLRX is motixafortide, an inhibitor of CXCR4. This target has numerous potential benefits for patients with cancer and blood diseases, but the most advanced in BLRX's pipeline is as a stimulator of blood stem cell production and mobilization.
Why? Transplant of blood stem cells, either from the patients themselves (autologous) or from a donor (allogeneic), has been a core piece of managing blood cancers like leukemia and lymphoma for decades. In patients with multiple myeloma, autologous stem cell transplantation was for a long time one of the best options for patients.
That is, it's one of the best options if you're able to get the body to move stem cells into the blood so you can collect them. And a large number of patients are unable to present enough of these stem cells in the blood with standard procedures. Addition of the CXCR4 inhibitor plerixafor and the growth factor G-CSF (filgrastim) has improved this rate of mobilization, but many patients continue to struggle with getting the optimal number of stem cells, which can negatively impact how well they do post-transplant.
Motixafortide is a more potent CXCR4 inhibitor that was assessed in the phase 3 GENESIS trial, part 2 of which compared motixafortide plus filgrastim versus placebo plus filgrastim. This study showed impressive mobilization of stem cells with motixafortide, with 96.3% of patients achieving optimal stem cell collection by day 3, compared with 36.5% in the placebo group. Moreover, optimal collection was achieved after just one round of apheresis in 88.8% of patients with motixafortide.
Outcomes post-transplant, like engraftment of cells and graft durability, were similar between the two arms, suggesting that motixafortide did not negatively alter the stem cells that were collected. Almost 2 years since that presentation, motixafortide was approved on September 11, 2023, in combination with filgrastim to help mobilize hematopoietic stem cells in patients with multiple myeloma.
At ASH 2022, the company presented an indirect comparison of motixafortide versus plerixafor that suggested motixafortide could achieve optimal stem cell mobilization in fewer rounds of treatment, with concomitant potential benefit in terms of cost overall.
BLRX is continuing to develop motixafortide in different applications, mainly in sickle cell disease, but few developments have been announced in this direction.
More recently, the company announced that an investigator-initiated, randomized, phase 2 trial to investigate motixafortide plus cemiplimab plus gemcitabine/nab-paclitaxel in patients with advanced pancreatic cancer, hoping to build on results they observed in the COMBAT study in the second-line setting.
Financial Overview
As of their Q2 2023 filing, BLRX held $10.1 million in cash and equivalents, with another $22.7 million in short-term bank deposits. This was set against a $9.9 million operating loss, most of which went to expansion of their sales capabilities in anticipation of their approval. There was an unusual $7.7 million in non-operating income loss, as well, related to the revaluation of outstanding warrants, so the net loss reached $18.5 million for the quarter, compared with $7.4 million in the same fiscal quarter 2022.
Assuming this net loss was anomalous, BLRX has approximately 3 quarters of cash and current assets on hand to fund operations from the end of Q2. That gives them approximately 7 months to get a launch off the ground.
Strengths and Risks
A drug approval is the holy grail for developmental biotechs, and now BLRX gets to begin the transition into a commercial entity. That is indisputable, and now the company is going to be able to gain traction.
The only question, then, is how much traction? There are 2 red flags that come to mind for motixafortide. First, the GENESIS trial did not include plerixafor as a comparator, and their attempts to compare the cost/benefit of the 2 agents in a post-hoc analysis underscores how important a question it is to answer whether the new drug is as good or better than the old.
You cannot do this convincingly by these kinds of analyses. So it will remain a question whether a clinician should use plerixafor or motixafortide. A future head-to-head study could definitively answer the question, which would be a boon because the cost-effectiveness of plerixafor has also been called into question.
Now that plerixafor has multiple generic versions launched, BLRX may have an uphill battle.
The other potential red flag is that novel therapies have continuously undermined the role of upfront stem cell transplant for patients with multiple myeloma. Most recently, the DETERMINATION trial demonstrated that stem cell transplant offered no overall survival benefit after RVD therapy compared with RVD alone.
Long story short: newer, better therapies are delaying and preventing the need for a costly stem cell transplant in more patients than ever, which could tighten the pool of patients that could potentially benefit from motixafortide. Of course, it is approved to mobilize stem cells for storage in case of a future transplant, and a lot of patients may opt for that strategy.
But it's uncertainty, meaning that motixafortide is very much not a slam dunk as a commercial product. We'll have to watch carefully how BLRX handles the rollout.
That said, all of these risks cannot trump that motixafortide has impressive phase 3 data and drug approval. Some analysts on Seeking Alpha have proposed that BLRX is a strong buyout candidate, but that is very much speculative. Cash is another issue BLRX will need to solve in the near term. Hopefully, they can launch motixafortide sales before they need to do an equity raise.
Bottom-Line Summary
BLRX has a drug approved, full stop. This is a big landmark for any company, and their drug definitely has a role to play in multiple myeloma. Exactly how big a role remains a question, since there's generic plerixafor competition now (even if plerixafor is marginally worse than motixafortide), and fewer patients need immediate autologous transplants. This stock is worth a close watch, since if they can bounce off this approval into decent sales relatively quickly, then the current market cap of $120 million is basically a joke.
HC Wainwright& Co. analyst Joseph Pantginis maintains BioLine Rx (NASDAQ:BLRX) with a Buy and raises the price target from $19 to $21.
HC Wainwright & Co. Maintains Buy on BioLine Rx, Raises Price Target to $21
6:11 am ET September 15, 2023 (Benzinga
Bon chance! It will not be a smooth ride,
but long term you stand to gain imo.
Just bought another 3,300 shares.
A positive write up......hoping it plays out well. Still up even after the recent price slaughter. :)
Summary
BioLineRx reported its second piece of material good news in as many weeks with FDA approval of Aphexda for stem cell mobilization in multiple myeloma patients. The approval of the drug delivers additional credibility to BioLineRx’ other motixafortide programs and provides a tailwind to commercialization efforts in Asia. We expect to see IIA approval for the Asia deal in the next few months and could see first ex-US revenues shortly after. Other highlights for the company include the start of the Columbia University-sponsored Phase II PDAC trial, Washington University’s work on sickle cell disease and efforts advancing AGI-134 in solid tumors. The US commercialization team has been hard at work preparing for Aphexda’s approval and could have first sales in the next few weeks. Based on the approval of Aphexda, we increase our valuation to $7.00 per share reflecting an increase in the probability of regulatory success to 100%.
BLRX: …Go!
https://finance.yahoo.com/news/blrx-093600390.html
By John Vandermosten, CFA
FDA Approval of Aphexda
On September 11th, BioLineRx Ltd. (NASDAQ:BLRX) announced FDA approval of Aphexda, its stem cell mobilization product for autologous transplantation in multiple myeloma. The product was the 36th novel drug approved for 2023. Based on the strong data generated in the Phase III GENESIS trial, we had high expectations for approval and were not disappointed. Management made a considerable effort to prepare for commercialization of Aphexda and has assets in place to build relationships with payors and providers including a medical affairs scientific exchange, preparation for journal publication and medical service liaison (MSL) engagement.
Management provided additional detail on pricing for the product, with a targeted list of $5,900 per vial. The amount of product required is based on weight and, on average, two vials are expected to be required for each patient’s collection with an administration of Aphexda sufficient to produce stem cells for a second apheresis session if needed. Now that the label has been finalized, product packaging is taking place. Quality assurance checks will be performed and shipping to a third-party logistics center will occur as Aphexda makes its way to transplant centers.
The commercialization team is in discussions with payors for coverage and reimbursement and BioLineRx is engaging leading physicians in the specialty to educate the community. The team has identified the top centers around the United States which represent more than 85% of autologous transplants. Customer targeting has been even more refined based on local need which could be based on apheresis unit capacity and low yields to identify those most receptive to the product and the benefits it brings. Centers that were involved in the GENESIS trial will also be among the first to see the product given their familiarity with it.
Valuation
Upon FDA approval of Aphexda, we increase our probability of success of Aphexda commercialization in the United States to 100% from 85%. Pricing is adjusted to reflect management’s guidance of $5,900 per vial and the use of an average of ~2 vials per treatment. We maintain our probabilities in the EU until approval in that region and will add contributions from Asia after approval for the deal is granted by the Israeli Innovation Authority (IIA). We maintain our values for the motixafortide PDAC and AGI-134 programs. The result of our adjustment supports an increase in the valuation to $7.00 per share.
We are keeping our eye on the next valuation-driving catalyst, which is the approval of the license agreement with Guangzhou Gloria Biosciences Co., Ltd., which we discuss in further detail below. As approval for Aphexda was granted before year-end 2023, BioLineRx remains eligible for the higher royalty rates. There are also several jurisdictions in the licensed regions where commercialization may begin when FDA approval is granted, requiring only a minor bridging study and administrating filings. This suggests that first foreign revenues could begin flowing over the next few quarters.
Asia License Agreement
Along with its second quarter earnings release, BioLineRx announced that it had signed an exclusive license agreement to develop and commercialize motixafortide in Asia along with an equity investment from two partners. Features of the arrangement include:
? $15 million upfront payment
? Potential development, regulatory and sales milestones
? Tiered double-digit royalties
? Initiation of a registrational study in stem-cell mobilization in China
? Initiation of a randomized Phase II/III study in first line pancreatic cancer
? Equity investment of $14.6 million
The equity investment was made at $2.136 per American Depository Share (ADS) and did not include warrants. This represents 6,829,137 shares. Other closing conditions of the transaction include the requirement that it be approved by the Israeli Innovation Authority within four months. While only select financial details were made public, this appears to be a standard agreement for a strong candidate and if successful will open up one of the largest markets in the world to motixafortide in multiple indications. We expect to update our valuation model to reflect this following FDA approval and launch of motixafortide in the United States.
The license agreement has been made between BioLineRx and two separate entities. The first is Guangzhou Gloria Biosciences Co., Ltd., a company organized under the laws of the People’s Republic of China. The second company is Hong Seng Technology Limited, a company organized under the laws of the Special Administrative Region of Hong Kong.
Additional detail in the Form 6-K filing show more specific detail including that BioLineRx is further entitled to $49 million based on reaching development and regulatory milestones in China and Japan and up to $197 million in sales milestones based upon defined sales targets. Royalties will range from 10-20% of revenues. Further discussion of the arrangement is available in the filing.
Upcoming Milestones
? Motixafortide, Phase II (Columbia) PDAC study data release – 2023
? Presentation of GENESIS data at medical meetings & conferences – 2023
? Data published for Phase II PDAC trial – 2H:23
? Motixafortide, Phase I in Sickle Cell Disease – 2H:23
? Motixafortide in SCM target action (PDUFA) date – September 2023
? US launch of motixafortide in SCM – 3Q:23
? Approval of Asia Licensing Agreement (Gloria) by Israeli Innovation Authority – 4Q:23
? Potential initiation of randomized Phase 2 study of AGI-134 – 2023
Summary
BioLineRx reported its second piece of material good news in as many weeks with FDA approval of Aphexda for stem cell mobilization in multiple myeloma patients. The approval of the drug delivers additional credibility to BioLineRx’ other motixafortide programs and provides a tailwind to commercialization efforts in Asia. We expect to see IIA approval for the Asia deal in the next few months and could see first ex-US revenues shortly after. Other highlights for the company include the start of the Columbia University-sponsored Phase II PDAC trial, Washington University’s work on sickle cell disease and efforts advancing AGI-134 in solid tumors. The US commercialization team has been hard at work preparing for Aphexda’s approval and could have first sales in the next few weeks. Based on the approval of Aphexda, we increase our valuation to $7.00 per share reflecting an increase in the probability of regulatory success to 100%.
I wish you best of luck with
$BCLI in 2 weeks time!
A PDUFA delay would have driven
the stock to 50 cents.
What is causing the downfall is this:
BioLineRx Announces $15 Million Registered Direct Offering
September 19, 2022
TEL AVIV, Israel, Sept. 19, 2022 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 13,636,365 of the Company's American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 13,636,365 ADSs, at a combined purchase price of $1.10 per ADS and associated warrant. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about September 21, 2022, subject to satisfaction of customary closing conditions.
The warrants will have an exercise price of $1.15 per ADS and will be exercisable at any time upon issuance and will expire five years from the date of issuance.
You’d think we had gotten a PDUFA delay or something based on this price action!
Sheesh!
Tanking again on 250k shares
But keep listening to gamblers talk about how many teslas they’re leasing because of this stock.
Steady tank since approval. Only hope is buyout and that’s basically a lottery ticket.
If these drug stocks don’t pop hard at approval, they’re done.
Stocktwits is also informative.
Wish I heard about this board in February.
I found out about this stock when it was at $1.66.
$GMDA "we have onboarded 12 transplant centers and have 8 additional transplant
centers currently in the onboarding process against the goal of 10 to 15 for the year. "
$BLRX:"Company to accelerate availability to patients and maximize value through
independent commercialization to well-defined U.S. transplant center community. "
Why not share? why not cooperate?
adamp
I recommended on this very board to buy at
late Feb 2023, the price then was ~$0.55
https://tradingeconomics.com/blrx:us
Many of those who bought at this price level probably
sold out along the way.
With FDA approval achieved, agreements, collaborations
etc, the long term strongly suggests a positive outlook.
Hang on, come visit in 6 months time, find out who had
it right.
lol... don't get used to it
For anyone who bought this recently this thing is a stinker. I could care less how things went with this stock years ago. For anyone holding this now, this one is a liability. There is NO reason to buy this now. We are, what, months from any revenues from this drug? Meanwhile other projects will drain 10s to 100s of millions of dollars putting more pressure on the pps. From 13M+ shares traded and no movement, to 2.59M the next day. It's over. We have months to get revenue reports from this drug, in the meantime, nothing but sellers and shorters to drive this below a dollar. If you're so wise, tell everyone how this one recovers without buyers, because they are effectively gone. I saw this with MCRB, I saw this with PRVB who got lucky with a buyout for their bogus drug. If you're such a 'wise' trader, then you're shorting the hell out of this thing at this point.
adamp
Correction to my previous post to you. I have taken from my gain on BLRX $62,000 to put aside to buy instead to lease my a 2024 Tesla model 3. I have given my 5 grand children $5000 each to pay for books when they are ready for college and still have just under 100,000 shares left that will make my wife and me very comfortable along with her pention from teaching for 35 years and my reserves from running my own business plus both our social security. Just so you understand I have series 6 and 66 licenses from when I studied the market and studied for the series 7 license to become a broker but never took the test. I decided I could not be a broker and have to take money from people I knew could not afford to lose those dollars. You see son I am some 35 years older then you and seem to have a lot more wisdom. ENOUGH SAID. Oh and last point I have been been in the market for 53 years and have spent only the markets money the last 40 years.
Son learn to treat people the same as you want to be treated IT WORKS!!!!
Lol… one day? You’re an idiot I’ve see.n this play out many times before. Lose all your money. Seres Mcrb died after fda approval and keeps dying. I can name many others. This one is doomed. I hope you’re still around when it reverse splits. Only a buffoon keeps faith in a company that tanks like this after approval
One day bad showing and you throw in the towel on them. What has changed. just wait for the string of good financial news and you will be crying in your glass of water,What a weakie you have to learn how to play this market. It always is the case buy up to the news then sell on the news. Let's see what the end of the week looks like. Oh you sold out sucks to be you. Study the stock so you can understand the company. Better yet understand the market or don't play where you don't belong.
Buyers are done. Nothing but sellers, starting tomorrow.
There’s nothing here. A meaningful fda approval should have shot us up 300%
Buyers are done. Nothing but sellers, starting tomorrow.
There’s nothing here. A meaningful fda approval should have shot us up 300%
adamp
Let's take a look at what BLRX has done for me so far. So far I have put away $62,000 thanks to this company for re-leasing another Tesla model 3 in 2024. much more shares still under the wing . So how did your short position do
FDA approval and this thing just tanks. Praying that we can get back down to $1.40 so I can dump my straddle. What a total POS. I feel bad for everyone who got super bullish on this. Try again next time, I guess.
warrants people. warrants. they are just about done exercising
Bought another 5000 this morning
I just bought some 2.15s
No one is going to touch a stock that performs so poorly after fda approval. All the buyers are done, they’ve all set stop losses, and all those stops will be triggered within 2 trading days. I’ve seen this all play out before. The stock either pops or it dies. This one looks like it’s going to die. Between day traders selling on news, big firms shorting relentlessly, and companies dumping diluted shares into any run, there’s just too much to overcome with a disinterested buyer base
Followers
|
127
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
2853
|
Created
|
09/13/11
|
Type
|
Free
|
Moderators midastouch017 |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |