On October 22, 2019 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed (Press release, BerGenBio, OCT 22, 2019, View Source [SID1234542424]). There are currently no marketed drugs specifically approved for all relapsed AML patients, representing a significant unmet medical need. BerGenBio has ongoing phase 2 trials in this indication and plans to seek regulatory advice from the FDA and European Medicines Agency (EMA) to determine the optimal regulatory path for bemcentinib in relapsed AML.

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Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. A drug that receives Fast Track designation is eligible for the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are thrilled that bemcentinib has been granted Fast Track Designation. Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of bemcentinib in this significant unmet medical need we are trying to address. Currently, bemcentinib is in expanded Phase II trials in the U.S. and Europe for the treatment of AML and the Company has recently announced positive interim top line data."

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, as monotherapy and in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy). Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

About AML

Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia. In 2018, it is estimated there will be nearly 20,000 new cases of AML diagnosed in the United States. Many AML patients older than age 60 are unable to tolerate intensive induction chemotherapy treatment.

On October 22, 2019 BERG, the clinical stage biopharmaceutical company that uses artificial intelligence (AI) to discover the biology of underlying disease, reported results from a preclinical study of its investigational drug BPM 31510 (novel ubidecarenone formulation) in glioblastoma models (Press release, Berg Pharma, OCT 22, 2019, View Source [SID1234542423]). The study, presented as a poster at the Society for Neuroscience (SfN) Annual Meeting in Chicago, demonstrated a novel oxidative stress dependent mechanism of action of BPM 31510 associated with anti-cancer responses in Glioblastoma Multiforme (GBM).

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"We are excited to observe independent validation by a team of researchers at Stanford University School of Medicine of novel mechanisms of redox regulation by BPM 31510 that seem largely cancer cell selective," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "The data are consistent with predictions by our proprietary Interrogative Biology platform that BPM 31510 affects mitochondrial-centric metabolism and can be applied to highly metabolic tumor types such as GBM. It is notable that this hallmark of cancer was awarded the 2019 Nobel Prize in Medicine1."

GBM is an aggressive type of brain cancer associated with very high morbidity and mortality rates. Currently, there are limited treatment options, thus there is an urgent need for novel therapeutic approaches to improve outcomes for this disease. BPM 31510 is a unique therapeutic modality specifically targeting cell metabolism, shifting the cancer’s glycolytic dependency toward mitochondrial oxidative phosphorylation inducing oxidative stress and cell death specifically of cancer cells. GBM’s glycolytic dependency makes it a particularly relevant target indication for BPM 31510.

"These exciting findings support an entirely novel mechanism of cancer chemotherapy," said Eric J. Nestler, MD, PhD, Past President of SfN and the Nash Family Professor of Neuroscience at the Icahn School of Medicine at Mount Sinai in NYC. "BPM 31510 not only shows therapeutic promise for GBM in animal models, but has proven to be well tolerated in humans in a recent Phase 1 study. It will be important to establish its efficacy in human GBM patients." Dr. Nestler is a member of the Board of Directors of BERG.

The study was led by Lawrence Recht, MD, Professor of Neurology & Neurosurgery at Stanford University School of Medicine, with other Stanford researchers and in collaboration with BERG.

Details of the BERG presentation:
Date: Tuesday, October 22, 2019
Harnessing redox homeostasis as a therapeutic modality in glioblastoma
Session number 557 (Neuro-Oncology)
Location – Hall A, McCormick Place, Chicago, IL, USA
Time – 1:00 – 5:00 PM

In its commitment to serve patients afflicted with cancer, BERG has collaborated on other projects with leading institutions like MD Anderson Cancer Institute (clinical trials) and Harvard/BIDMC (Project Survival), among others.

On October 22, 2019 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.45 per share dividend for the fourth quarter of 2019 (Press release, Amgen, OCT 22, 2019, View Source [SID1234542422]). The dividend will be paid on Dec. 6, 2019, to all stockholders of record as of the close of business on Nov. 15, 2019.

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On October 22, 2019 Walgreens reported a new collaboration with Susan G. Komen and The Leukemia & Lymphoma Society to enable research in tough-to-treat cancers and increase access to care with a pledge to contribute more than $25 million to the organizations, collectively, over the next five years (Press release, The Leukemia & Lymphoma Society, OCT 22, 2019, View Source [SID1234542421]). Through a combination of corporate donations and in-store fundraising, the commitment will enable new research in metastatic breast and pediatric blood cancers, as well as increase access, treatment and support services for those living with these diseases.

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"At Walgreens, we see the devastating impact of a cancer diagnosis and the challenges people living with cancer and their caregivers face in one of the toughest journeys of their lives," said Richard Ashworth, Walgreens president of operations. "By collaborating with Susan G. Komen and The Leukemia & Lymphoma Society, we aim to advance critical needs in research, expand prevention programs and help families with the everyday challenges of living with cancer."

Walgreens customers can get involved by donating to the organizations during checkout at the more than 9,500 U.S. Walgreens retail pharmacy locations November 3 through 17. The Leukemia & Lymphoma Society and Susan G. Komen are committed to supporting patient services and increasing access to screening and treatments locally and nationally. All donations Walgreens receives in November will be split equally between the two organizations.

"Susan G. Komen is thankful for the support of Walgreens and their customers and excited about the potential of this collaboration to accelerate the pace of research discovery, particularly as it relates to understanding and combating why breast cancers recur and become metastatic," said Paula Schneider, CEO, Susan G. Komen. "Thanks to this partnership, we will be able to help support people touched by breast cancer today, while we spur the development of more effective treatments."

According to Louis DeGennaro, Ph.D., LLS President and CEO, "Our partnership with Walgreens is setting a new standard for what nonprofits and industry can do through collaboration to help more patients. Our investment of nearly $1.3 billion in cancer research is moving the needle, but new therapies can’t help patients who don’t have access to them. Through this partnership, we aim to reach more patients with critical support and services, in their communities."

Breast cancer and blood cancers are complex to treat and remain prevalent in the United States. Currently, more than 3.8 million people living in the U.S. today have been treated for or are living with breast cancer – the most commonly diagnosed cancer in women – and nearly 1.4 million are living with or in remission from blood cancer in the United States.

In support of meeting the critical needs of their communities, Susan G. Komen and The Leukemia & Lymphoma Society will focus on:

Susan G. Komen: Accelerating the pace of research discovery, particularly as it relates to understanding and combating breast cancer recurrence and metastasis, and will support people facing breast cancer today with trustworthy information and by helping them overcome barriers to timely, high-quality health care.
The Leukemia & Lymphoma Society: Accelerating the delivery of cancer treatment advances to pediatric patients and help patients, caregivers and survivors with the financial, emotional and psychological effects of cancer and its treatment.
Walgreens is supporting cancer patients through strategic collaborations with leading cancer organizations, specialized training to enable pharmacists to best serve those battling the disease and a suite of support offerings available through Walgreens more than 300 community-based specialty pharmacies.

Earlier this year, Walgreens launched Feel More Like You. The program offers an integrated approach to cancer care with specially trained Walgreens beauty consultants and pharmacists working in select stores to provide personalized expertise and support to people living with cancer. Most recently as part of Feel More Like You, Walgreens created a ten-part podcast that explores how living with cancer not only impacts health, but identity. With a panel of experts, the first-of-its kind podcast offers advice on what to expect during cancer treatment, and personal stories to help individuals feel more like themselves.

Walgreens and its parent company Walgreens Boots Alliance (WBA) are committed to improving societal health and wellbeing around the world. In May, WBA announced the transatlantic "Collaboration for Cancer Prevention, Research and Support" aimed to develop and facilitate innovative cancer research in the U.S. and Europe, and to share best practices to improve patient care and support. The transatlantic effort and research collaboration includes the European Organization for Research and Treatment of Cancer (EORTC), U.K.’s Macmillan Cancer Support, Susan G. Komen, and The Leukemia & Lymphoma Society. Walgreens Boots Alliance focuses on three priorities in efforts to support cancer programs: working with organizations that advance research, expanding prevention programs and assisting people living with cancer and their loved ones.

On October 22, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for third quarter 2019 after the close of trading on Wednesday, November 6, 2019 (Press release, Quanterix, OCT 22, 2019, View Source [SID1234542420]). Company management will host a conference call at 4:30 p.m., ET to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix.

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Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 5798993. A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.