Basel, October 30, 2020 Novartis today announced the receipt of marketing authorization from Japans Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan. This approval makes FBRI the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia.

Behind our efforts to reimagine medicine with CAR-T cell therapy lies a commitment to build a manufacturing network that brings treatment closer to patients, commented Steffen Lang, Global Head of Novartis Technical Operations. The expertise and infrastructure of FBRI, a world-leading manufacturing organization, allows us to bring CAR-T manufacturing to Asia. With the Japan MHLW commercial manufacturing approval, the recent capacity expansion in the US and our ongoing efforts to optimize and evolve our processes, we are well-positioned to deliver this potentially curative treatment option to more patients around the world.

Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) recently approved a further increase in manufacturing capacity.

Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia, which was first-of-its-kind in CAR-T research and development.

About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 26 countries and at more than 260 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut fr Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.

ImportantSafety information from the Kymriah SmPC

EU Name of the medicinal product:

Kymriah 1.2 x 106 6 x 108 cells dispersion for infusion

Important note: Before prescribing, consult full prescribing information.

Presentation: Cell dispersion for infusion in 1 or more bags for intravenous use (tisagenlecleucel).

Indications: Treatment of pediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse posttransplant or in second or later relapse. Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Dosage and administration:

B-cell patients: For patients 50 kg and below: 0.2 to 5.0 x 106 CAR-positive viable T-cells/kg body weight. For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T-cells (non-weight based).

DLBCL Patients: 0.6 to 6.0108 CAR-positive viable T-cells (non-weight based).

Pretreatment conditioning (lymphodepleting chemotherapy): Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is 1,000 cells/L. The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.

Precautions before handling or administering Kymriah: Kymriah contains genetically modified human blood cells. Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

Preparation for infusionThe timing of thaw of Kymriah and infusion should be coordinated. Once Kymriah has been thawed and is at room temperature (20C 25C), it should be infused within 30minutes to maintain maximum product viability, including any interruption during the infusion.

Administration Kymriah should be administered as an intravenous infusion through latexfree intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20mL per minute by gravity flow. If the volume of Kymriah to be administered is 20mL, intravenous push may be used as an alternative method of administration.

All contents of the infusion bag(s) should be infused.

Clinical assessment prior to infusion: Kymriah treatment should be delayed in some patient groups at risk (see Special warnings and precautions for use).

Monitoring after infusion: Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurological events. After the first 10 days following the infusion, the patient should be monitored at the physicians discretion. Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.

Elderly (above 65 years of age): Safety and efficacy have not been established in B-cell patients. No dose adjustment is required in patients over 65 years of age in DLBCL patients.

Paediatric patients: No formal studies have been performed in paediatric patients with B-cell ALL below 3 years of age. The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established in DLBCL. No data are available.

Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV): There is no experience with manufacturing Kymriah for patients with a positive test for HIV, active HBV, or active HCV infection. Leukapheresis material from these patients will not be accepted for Kymriah manufacturing.

Contraindications: Hypersensitivity to the active substance or to any of the excipients of Kymriah. Contraindications of the lymphodepleting chemotherapy must be considered.

Warnings and precautions: Reasons to delay treatment: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), significant clinical worsening of leukaemia burden or rapid progression of lymphoma following lymphodepleting chemotherapy. Blood, organ, tissue and cell donation: Patients treated with Kymriah should not donate blood, organs, tissues or cells.

Active central nervous system (CNS) leukaemia or lymphoma: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma. Therefore the risk/benefit of Kymriah has not been established in these populations. Risk of CRS: Occurred in almost all cases within 1 to 10 days post infusion with a median time to onset of 3 days and a median time to resolution of8 days. See full prescribing information for management algorithm of CRS. Risk of neurological events: Majority of events, in particular encephalopathy, confusional state or delirium, occurred within 8 weeks post infusion and were transient. The median time to onset of neurological events was 8 days in B-cell ALL and 6 days in DLBCL; the median time to resolution was 7 days for B-cell ALL and 13 days for DLBCL. Patients should be monitored for neurological events. Risk of infections: Delay start of therapy with Kymriah until active uncontrolled infections have resolved. As appropriate, administer prophylactic antibiotics and employ surveillance testing prior to and during treatment with Kymriah. Serious infections were observed in patients, some of which were life threatening or fatal. After Kymriah administration observe patient and ensure prompt management in case of signs of infection Risk of febrile neutropenia: Frequently observed after Kymriah infusion, may be concurrent with CRS. Appropriate management necessary. Risk of prolonged cytopenias: Appropriate management necessary. Prolonged cytopenia has been associated with increased risk of infections. Myeloid growth factors, particularly granulocyte macrophage colony stimulating factor (GM CSF), not recommended during the first 3 weeks after Kymriah infusion or until CRS has been resolved. Risk of secondary malignancies: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer and should be monitored lifelong for secondary malignancies. Risk of hypogammaglobulinemia or agammaglobulinemia: Infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be managed per age and standard guidelines. In patients with low immunoglobulin levels preemptive measures such as immunoglobulin replacement and rapid attention to signs and symptoms of infection should be implemented. Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment was not studied. Vaccination with live virus vaccines is not recommended at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah. Risk of tumor lysis syndrome (TLS): Patients with elevated uric acid or high tumor burden should receive allopurinol or alternative prophylaxis prior to Kymriah infusion. Continued monitoring for TLS following Kymriah administration should also be performed. Concomitant disease: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions of Kymriah and require special attention. Prior stem cell transplantation: Kymriah infusion is not recommended within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of potential risk of worsening GVHD. Leukapheresis for Kymriah manufacturing should be performed at least 12weeks after allogeneic SCT. Serological testing: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV. Screening for HBV, HCV and HIV, must be performed before collection of cells for manufacturing. Hepatitis B virus (HBV) reactivation, can occur in patients treated with medicinal products directed against B cells and could result in fulminant hepatitis, hepatic failure and death. Prior treatment with anti CD19 therapy: There is limited experience with Kymriah in patients exposed to prior CD19 directed therapy. Kymriah is not recommended if the patient has relapsed with CD19 negative leukaemia after prior anti-CD19 therapy. Interference with serological testing: Due to limited and short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result. Sodium and potassium content: This medicinal product contains 24.3 to 121.5mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2g sodium for an adult. This medicinal product contains potassium, less than 1mmol (39mg) per dose, i.e. essentially potassium free. Content of dextran 40 and dimethyl sulfoxide (DMSO): Contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration. Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.

Interaction with other medicinal products and other forms of interaction

Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females: Pregnancy status for females of reproductive potential should be verified prior to starting treatment with Kymriah. Consider the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.

Pregnancy: There are no data from the use of Kymriah in pregnant women. It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B cell lymphocytopenia. Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnant women should be advised on the potential risks to the foetus. Pregnancy after Kymriah therapy should be discussed with the treating physician. Pregnant women who have received Kymriah may have hypogammaglobulinaemia. Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.

Breast feeding: It is unknown whether Kymriah cells are excreted in human milk, a risk to the breast fed infant cannot be excluded. Women who are breast feeding should be advised of the potential risk to the breast fed infant. Breast-feeding should be discussed with the treating physician.

Fertility: There are no data on the effect of Kymriah on fertility.

Effects on ability to drive and use machinesDriving and engaging in hazardous activities in the 8 weeks following infusion should be refrained due to risks for altered or decreased consciousness or coordination.

Adverse drug reactions:

B-Cell ALL patients and DLBCL patients:

Very common (10%): Infections - pathogen unspecified, viral infections, bacterial infections, fungal infections, anaemia, haemorrhage, febrile neutropenia, neutropenia, thrombocytopenia, cytokine release syndrome, hypogammaglobulinaemia, decreased appetite, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, anxiety, delirium, sleep disorder, headache, encephalopathy, arrhythmia, hypotension, hypertension, cough, dyspnoea, hypoxia, diarrhoea, nausea, vomiting, constipation, abdominal pain, rash, arthralgia, acute kidney injury, pyrexia, fatigue, oedema, pain, chills, lymphocyte count decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, aspartate aminotransferase increased.

Common (1 to 10%): Haemophagocytic lymphohistiocytosis, leukopenia, pancytopenia, coagulopathy, lymphopenia, infusion-related reactions, graft versus host disease, hypoalbuminaemia, hyperglycaemia, hyponatraemia, hyperuricaemia, fluid overload, hypercalcemia, tumor lysis syndrome, hyperkalaemia, hyperphosphataemia, hypernatraemia, hypermagnesaemia, dizziness, peripheral neuropathy, tremor, motor dysfunction, seizure, speech disorder, neuralgia, ataxia, visual impairment, cardiac failure, cardiac arrest, thrombosis, capillary leak syndrome, oropharyngeal pain, pulmonary oedema, nasal congestion, pleural effusion, tachypnea, acute respiratory distress syndrome, stomatitis, abdominal distension, dry mouth, ascites, hyperbilirubinaemia, pruritus, erythema, hyperhidrosis, night sweats, back pain, myalgia, muscolosceletal pain, influenza-like illness, asthenia, multiple organ dysfunction syndrome, alanine aminotransferase increased, blood bilirubin increased, weight decreased, serum ferritin increased, blood fibrinogen decreased, international normalized ratio increased, fibrin D dimer increased, activated partial thromboplastin time prolonged, blood alkaline phosphate increased, prothrombin time prolonged.

Uncommon: B-cell aplasia, ischaemic cerebral infarction, flushing, lung infiltration.

Packs and prices: Country-specific.

Legal classification: Country-specific.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visithttps://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com

References

1.Kymriah (tisagenlecleucel) Summary of Product Characteristics (SmPC), 2018.

# # #

Novartis Media RelationsE-mail: media.relations@novartis.com

Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

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Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia - GlobeNewswire

Cardiac Stem Cells Comments Off on Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia – GlobeNewswire | October 31st, 2020

Is the United States a step closer to approving a form of stem cell transplantation as a treatment for multiple sclerosis? I believe it may be.

Thats because the National Multiple Sclerosis Society (NMSS) has slightly changed its view of autologous hematopoietic stem cell transplantation, or aHSCT.

aHSCT involves removing a patients own stem cells from the blood or bone marrow, using chemotherapy to kill off most of the immune system, and then injecting the stem cells back into the patient. Those stem cells regenerate the immune system, hopefully without any of the rogue immune cells that attack the nervous system and create MS symptoms.

In the past, the National MS Society has failed to make recommendations about how any form of stem cell treatment should be used, at least as far as my research can determine. Now, in an article in JAMA Neurology, a group of neurologists, including members of the NMSS National Medical Advisory Committee, are outlining parts of a stem cell protocol.

The NMSS is now being specific about who might be a candidate for aHSCT:

The National Multiple Sclerosis Society believes that AHSCT may be a useful treatment option for people with relapsing multiple sclerosis who demonstrate substantial breakthrough disease activity (ie, new inflammatory central nervous system lesions and/or clinical relapses) despite treatment with high-efficacy disease-modifying therapy or have contraindications to high-efficacy disease-modifying therapies.

That language seems more aggressive than what the NMSSwrote about an Italian study published earlier this year. In that commentary, the society suggested the procedure might be appropriate for people with secondary progressive MS, and it suggested further study with a larger group:

These results suggest that HSCT might be appropriate in a subgroup of people with SPMS that have significant inflammatory activity as measured by MRI. Further study in larger numbers are needed to understand who among those with secondary progressive MS might benefit from HSCT.

The new guidelines clearly outline which people with relapsing-remitting MS might benefit. They are younger than 50 and have lived with an MS diagnosis for less than 10 years.

The authors recommend that stem cell transplantation be performed in medical centers with substantial experience and expertise. A follow-up regime is proposed, along with the creation of a single database to track people who undergo the procedure. But the article cautions that more research is needed to establish best practices for handling the stem cells and other technical processes.

Some hospitals and clinics in Russia, Mexico, and other locations offer aHSCT to MS patients at a cost of about $50,000. aHSCT also is provided to some MS patients through the U.Ks National Health Service. A list of aHSCT facilities worldwide is available at http://www.hsctstopsms.com.

The authors of the JAMA Neurology article suggest a clinical trial may be the place for someone who wants their MS treated with a stem cell transplant right now. A well-known trial by Dr. Richard Burt shut down about a year ago. However, a trial called BEAT-MS has been enrolling patients at several locations in the U.S. You can find information about other studies at clinicaltrials.gov.

The authors note that joining a trial would assure the patient of quality care with an acceptable protocol and provide the personal satisfaction of knowing they are contributing to answering a very important question for people with MS.

That sounds like a pretty good suggestion to me since the U.S. likely has a long way to go before aHSCT for MS becomes common here, even with the NMSS backing. But its encouraging that finally it is gaining some traction.

Youre invited to follow my personal blog at http://www.themswire.com.

***

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Diagnosed with MS at age 32 in 1980, Ed has written the MS Wire column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. Hes won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. Hes the author of Were Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis. Ed and his wife split time between the Washington, D.C. suburbs and Floridas Gulf Coast.

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aHSCT Gets a Boost in US With NMSS Recommendations - Multiple Sclerosis News Today

Bone Marrow Stem Cells Comments Off on aHSCT Gets a Boost in US With NMSS Recommendations – Multiple Sclerosis News Today | October 31st, 2020

DetailsCategory: Small MoleculesPublished on Friday, 30 October 2020 17:39Hits: 249

- Enrollment to cease immediately; topline data anticipated in H1 2021-

TEL AVIV, Israel I October 30, 2020 I 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 http://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

SOURCE: BioLineRx

Link:
BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small...

Bone Marrow Stem Cells Comments Off on BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small… | October 31st, 2020

The latest Stem Cell Banking market research report offers a top to bottom analysis of this business sphere in terms of potential industry size, supply chain, growth dynamics, opportunity analysis, and competitive landscape. Furthermore, it extends through abstracts on various industry segments, inclusive of a rundown of the business scenario across the various regional markets. Additionally, the study provide insights into to the impact of Covid-19 pandemic and recommends strategies that could maximize ROI amid these uncertain times.

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An overview of the regional analysis:

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What are sales, revenue, and price analysis by types and applications of Stem Cell Banking Industry?

Request Customization on This Report @ https://www.aeresearch.net/request-for-customization/341604

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Stem Cell Banking Market to witness an impressive growth during the forecast pe - News by aeresearch

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market to witness an impressive growth during the forecast pe – News by aeresearch | October 31st, 2020

HOUSTON, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced interim data from its BPX-601 dose-escalation clinical trial in patients with relapsed/refractory metastatic pancreatic cancer. Findings from the first four patients treated with BPX-601 followed by repeat rimiducid dosing showed evidence of rimiducid-mediated CAR-T cell activation. Clinically meaningful efficacy as measured by RECIST criteria was not observed.

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Bellicum Announces Interim BPX-601 Data and Corporate Restructuring

Global News Feed Comments Off on Bellicum Announces Interim BPX-601 Data and Corporate Restructuring | October 31st, 2020

LYON, France, Oct. 29, 2020 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will host a Third Quarter 2020 conference call and webcast on Friday, November 6, 2020, at 2:30 PM CET/8:30 AM EST to discuss operational highlights.

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ERYTECH to Host Third Quarter 2020 Conference Call and Business Update on November 6, 2020

Global News Feed Comments Off on ERYTECH to Host Third Quarter 2020 Conference Call and Business Update on November 6, 2020 | October 31st, 2020

BERLIN, Oct. 29, 2020 (GLOBE NEWSWIRE) -- A-LabInsider has recently launched their app to help biotech companies find and work with academic life science labs. What the ALabInsider team is creating is an easy access new app, which will help both sides connect with each other better. It will help create a central database for biotech SMEs to find academic labs through their literature, keep an eye out for relevant and up-to-date labs, and gain lead generation and market intelligence of each lab.

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A-LabInsider Launches App to Help Biotech SMEs Collaborate with Academic Labs

Global News Feed Comments Off on A-LabInsider Launches App to Help Biotech SMEs Collaborate with Academic Labs | October 31st, 2020

WESTLAKE VILLAGE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced it will present new data from the previously announced Phase 2 studies of ARQ-151 (topical roflumilast cream) in chronic plaque psoriasis and atopic dermatitis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress (EADV Virtual), the Society of Dermatology Physician Assistants (SPDA) Digital 2020 conference, and the virtual 2020 Fall Clinical Dermatology Conference.

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Arcutis Biotherapeutics to Present New Data from ARQ-151 (Topical Roflumilast Cream) Clinical Program at Three Global Dermatology Conferences

Global News Feed Comments Off on Arcutis Biotherapeutics to Present New Data from ARQ-151 (Topical Roflumilast Cream) Clinical Program at Three Global Dermatology Conferences | October 31st, 2020

GUANGZHOU, China, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that analytical validation data of its fully-automated NGS library preparation platform, Magnis BR, will be presented at the Association for Molecular Pathology (AMP) 2020 annual meeting, in a platform presentation (abstract number TT04) on Thursday, November 19, 2020. Link to conference schedule here.

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Burning Rock to Present Validation Data of Magnis BR at the AMP Annual Meeting

Global News Feed Comments Off on Burning Rock to Present Validation Data of Magnis BR at the AMP Annual Meeting | October 31st, 2020

REGULATED INFORMATION

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Bone Therapeutics Provides Third Quarter 2020 Business Update

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The first presentation of new data characterizing the anti-ChemR23 antibody was at the FOCIS Virtual Annual Meeting held October 28-31, 2020 The first presentation of new data characterizing the anti-ChemR23 antibody was at the FOCIS Virtual Annual Meeting held October 28-31, 2020

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OSE Immunotherapeutics Presents OSE-230 as a Novel Agonist Monoclonal Antibody Therapy Triggering Resolution of Chronic Inflammation

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Montrouge, France, October 30, 2020

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DBV Technologies Reports September 30, 2020 Cash Position

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Oslo, Norway, 30 October 2020

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Vistin Pharma ASA: Third quarter and YTD 2020 financial results

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30 October 2020 - Financial report for the period 1 January 2020 to 30 September 2020

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Novo Nordisk's operating profit increased by 6% in Danish kroner and by 7% at constant exchange rates (CER) in the first nine months of 2020

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BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, will host a live virtual R&D Day Webinar, with presentations by key opinion leaders in hematology, today from 1:00 – 3:00 pm Eastern Time.

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Aprea Therapeutics to Highlight Changing Treatment Paradigm in MDS as well as Development Pipeline Progress at Virtual R&D Day Today

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Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe

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Euro-Australian collaboration offers scalable solutions for biotech: announced at Bio-Europe 2020

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October 30, 2020 – announcement no. 26

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Lise Mortensen assumes responsibility as new CFO

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Data supporting antibody and intrabody candidates that selectively target toxic TDP-43 while preserving normal protein highlighted Data supporting antibody and intrabody candidates that selectively target toxic TDP-43 while preserving normal protein highlighted

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ProMIS Neurosciences’ Dr. Neil Cashman CSO, to Speak at 2020 ALS ONE Research Symposium

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TORONTO and CHICAGO and MONTREAL, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) announced today that it has entered into a consulting agreement (the “Consulting Agreement”) with Westmount Capital (“Westmount”) to provide European investor relations services to the Company in compliance with the policies and guidelines of the TSX Venture Exchange and applicable legislation. Under the terms of the Consulting Agreement, Westmount will receive C$5,000 per month for an initial trial period of 3 months, commencing on November 1, 2020, following which a possible extension will be reviewed by the Company. The services contemplated under the Consulting Agreement include introducing the Company to various institutional investors, fund managers, family offices and other potential investors throughout Europe.

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Medexus Announces Engagement of Westmount Capital and Equity Incentive Grants to Insiders

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NEWARK, Calif., Oct. 30, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that it will host a conference call and live audio webcast on Thursday, November 5, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter and nine months ended September 30, 2020 and to provide a business update.

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CymaBay Therapeutics to Report Third Quarter 2020 Financial Results on Thursday, November 5, 2020

Global News Feed Comments Off on CymaBay Therapeutics to Report Third Quarter 2020 Financial Results on Thursday, November 5, 2020 | October 31st, 2020