On December 4, 2019 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported the appointment of Rafael Bejar, M.D., Ph.D., to the position of Senior Vice President, Chief Medical Officer, effective January 1, 2020 (Press release, Aptose Biosciences, DEC 4, 2019, View Source [SID1234551957]). In his role as a member of the executive leadership team, Dr. Bejar will oversee global clinical development and regulatory initiatives for Aptose, as well as other research activities.

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"Rafael is a physician-scientist whose depth of experience both in the research setting and in treating patients with hematologic malignancies brings a unique and important perspective as we accelerate the clinical development of our hematologic product candidates," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We are very fortunate and excited to have him join Aptose and welcome him as a senior member of the management team."

Dr. Bejar is trained in internal medicine and board certified in oncology and hematology, with a special interest in hematologic malignancies and myelodysplastic syndrome (MDS). Prior to joining Aptose, he served as Associate Professor of Clinical Medicine in the Division of Hematology and Oncology at University of California San Diego in the Moores Cancer Center, where he established an MDS Center of Excellence, which provides state of the art care, clinical trials and medical expertise in one center. Dr. Bejar has authored numerous research articles published in leading journals such as The New England Journal of Medicine, Journal of Clinical Oncology, Blood and more; has served as an invited speaker and chair at multiple scientific/clinical conferences; has served in teaching capacities and has been honored extensively.

Dr. Bejar completed his internal medicine residency at the Brigham and Women’s Hospital in Boston, where he later served as a Chief Medical Resident. He then received his fellowship training in hematology and oncology at the Dana-Farber Cancer Institute. He earned his medical degree and Ph.D. at UC San Diego School of Medicine, and his bachelor’s degree in Physics at the Massachusetts Institute of Technology.

"As a physician and researcher who has dedicated my professional life to understanding the development and progression of hematologic malignancies such as AML and MDS, I’m excited join Aptose at such a pivotal moment and to have the opportunity to bring CG-806 and APTO-253 to patients in need of new therapies," said Dr. Bejar. "Our goal is to translate these discoveries into clinically meaningful improvements for these patient populations and I very much look forward to being an integral part of that endeavor."

On December 4, 2019 The International Myeloma Foundation (IMF) reported that four important research studies supported by the organization’s Black Swan Research Initiative (BSRI) to find a cure for multiple myeloma will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Dec. 7 – 10 (Press release, Myeloma UK‎, DEC 4, 2019, View Source [SID1234551950]). Approximately 32,000 new cases of multiple myeloma—a cancer of the bone marrow plasma cells—are diagnosed annually in the U.S. The disease is currently incurable, but thanks to tremendous advances in treatment, is highly treatable.

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Find the IMF at Booth 2006 at the American Society Hematology annual conference from Dec. 7–9, 2019, in Orlando.
Find the IMF at Booth 2006 at the American Society Hematology annual conference from Dec. 7–9, 2019, in Orlando.
The IMF activities at ASH (Free ASH Whitepaper) 2019 highlight the strength of each of the organization’s four pillars: myeloma research, patient education, patient support and patient advocacy:

RESEARCH

"The four BSRI-supported studies presented at ASH (Free ASH Whitepaper) this year underscore the critical importance of early diagnosis to treat and possibly ultimately cure the disease," said IMF Chairman Brian G.M. Durie, MD.

New results from the IMF-supported CESAR trial: The goal of CESAR, which treats high-risk smoldering myeloma with carfilzomib + lenalidomide + dexamethasone + autologous stem-cell transplant, is to identify patients who will have sustained minimal residual disease (MRD) negativity five years and beyond (and are potentially cured) versus those who might relapse. The ASH (Free ASH Whitepaper) 2019 update of the overall results shows that 98% of patients are alive at more than 30 months, with 93% in remission and 56% MRD-negative at the 10-6 level. The other CESAR trial presentation reports the results of mass spectrometry (Qip) of serum samples. Here, 18 MRD-negative patients were found to be positive using Qip to detect low levels of myeloma protein.
Two IMF-supported studies from the University of Pamplona: One study is of the types of T cells found in the bone marrow and blood of myeloma patients. It shows that T cells that react against myeloma cells have a pattern that is negative for the antigen CD27. These T cells build up in patients responding to treatment. The other Pamplona study is the first to report that mutations found in early ("progenitor") cells in the bone marrow are CD34 positive. This study suggests that damaged B cells in the bone marrow could be a source of myeloma cells. This insight that will play a role in efforts to develop curative therapies.
Black Swan Research Investigators Meeting, Dec. 5: Investigators will report updates on more than a dozen IMF-supported research projects currently in progress around the world focused on a cure.
i2TEAMM Meeting, Dec. 5: Co-led by IMF Chairman Brian G.M. Durie, MD, this group of researchers is working to validate MRD testing as a surrogate endpoint superior to traditional endpoints, such as CR (complete remission) or even sCR (stringent complete response) in myeloma clinical trials.
International Myeloma Working Group (IMWG) Breakfast Meeting, Dec. 7: The 200-plus members of the IMWG, the IMF’s research division, collaborate on a broad range of myeloma research projects. At ASH (Free ASH Whitepaper), members will preview the top ASH (Free ASH Whitepaper) 2019 abstracts and review ongoing and new IMWG research projects.
Brian D. Novis Research Award Reception, Dec. 7: Funded through donations from private individuals, the IMF’s annual research grants—named for the organization’s co-founder—enable investigators to become established in the field of myeloma. IMF-funded research has led to many publications in peer-reviewed journals and to a greater understanding of myeloma. Grant awardees will be joined by myeloma patients, many of whom help raise research funding.
EDUCATION

"Approaches to Achieve the Best Possible Outcomes in Myeloma," Dec. 6: This popular IMF-sponsored satellite symposium at ASH (Free ASH Whitepaper) attracts an overflow crowd each year. Moderated by Dr. Brian G.M. Durie, it features panelists Shaji Kumar, MD; Philippe Moreau, MD; S. Vincent Rajkumar, MD; Jesús F. San Miguel, MD, PhD; and Thomas G. Martin, MD.
"Making Sense of Treatment," the International Myeloma Working Group (IMWG) Livestream Conference Series, Dec. 9, 8:30 – 9:30 pm ET: Leading myeloma experts Dr. Brian G.M. Durie, Dr. Joseph Mikhael (IMF Chief Medical Officer) and Dr. María-Victoria Mateos will tackle questions facing myeloma doctors and patients in light of study results presented at ASH (Free ASH Whitepaper). Available online, both live and archived.
IMF-TV: Top myeloma experts and investigators at ASH (Free ASH Whitepaper) will share their opinions and summarize the most significant research findings in a series of brief videos, posted daily from Orlando.
"Best of ASH (Free ASH Whitepaper) 2019: What Patients and Caregivers Need to Know," Jan. 9, 7:00 pm ET: This IMF teleconference summarizes research findings for myeloma patients and caregivers.
PATIENT SUPPORT

IMF@ASH Social Media Team: The IMF brings more than a dozen myeloma patient and caregiver representatives to ASH (Free ASH Whitepaper), where they report to the community from a patient’s perspective. The IMF’s dynamic social media team consistently ranks in the "Top 10 Most Influential" list of ASH (Free ASH Whitepaper) attendees on Twitter. Follow @IMFmyeloma reporting with the hashtags #ASH19 and #IMFASH19. Blogs posted at www.ash2019blogs.myeloma.org.
PATIENT ADVOCACY

Global Myeloma Action Network (GMAN) Breakfast, Dec. 6: GMAN is a patient advocacy umbrella group that convenes international members and partners to share best practices, address mutual areas of concern, and elevate myeloma awareness.

On December 4, 2019 COTA, Inc., a healthcare technology company that uses real-world data (RWD) to bring clarity to cancer care, reported is presenting posters at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, ASH (Free ASH Whitepaper) 2019, in Orlando, FL from December 7-10, 2019 (Press release, COTA, DEC 4, 2019, https://www.prnewswire.com/news-releases/cota-presents-posters-at-ash-annual-meeting-reviewing-complexities-of-generating-rwd-and-how-it-complements-traditional-clinical-trial-data-300969065.html [SID1234551947]). Collectively, the posters review existing challenges for generating RWD and the promise of this data to support new research in cancer biology.

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"The genetic environment – whether of individual patients or cancer cells – is playing an increasing role in how patients are being treated. Examining sources of real-world data in depth allows us to quickly, inexpensively test hypotheses related to the treatment of patients with specific biomarkers and their outcomes," said Andrew Norden, MD, Chief Medical Officer at COTA.

The Unforeseen Medical and Business Challenges Found When Integrating Abstracted Data from Disparate EHR Systems While Building the Curecloud Direct-to-Patient Multiple Myeloma Registry

Researchers from COTA and Multiple Myeloma Research Foundation (MMRF) explore challenges associated with existing methods of patient data curation to build the MMRF Registry. Despite a significant investment in electronic health records in the United States, many institutions are unable to provide relevant, research-grade clinical data in a timely, cost-free, and coded manner. A comprehensive, research-focused data abstraction process for coded data exchange is being established to support future RWD projects.

Chromosome 1q Amplification Is Associated with a History of Prior Malignancies Among Patients Newly Diagnosed with Multiple Myeloma

Researchers from COTA and Hackensack University Medical Center studied patients with newly diagnosed multiple myeloma who also had a history of prior malignancy. Using COTA’s RWD, they were able to identify an association with a prior history of cancer, especially prostate cancer, and amp(1q) in multiple myeloma. This relationship is worth further exploration of whether there is a common pathway associated with these characteristics. These findings are significant because patients with prior malignancies are often excluded from enrollment in clinical trials and rarely studied. Overall, the results reported suggest that RWD is an efficient and comparatively inexpensive tool to support research in cancer biology.

Thanks to a growing understanding and acceptance of RWD by regulatory bodies, it has been increasingly incorporated into clinical research, helping to expedite studies compared with traditional clinical trial methods alone. Rather than replacing clinical trials, these two models can complement each other to improve clinical trial design and postmarket research, allowing for a more complete picture of the patient group being studied.

Members of COTA’s Life Sciences team will be at ASH (Free ASH Whitepaper) to discuss their work with the Multiple Myeloma Research Foundation (MMRF) and Hackensack University Medical Center (HUMC). Contact [email protected] to set up a meeting to learn more about how RWD can accelerate clinical research and ultimately reduce the cost of clinical trials.

The two posters will be exhibited in Hall B, Level 2 on Monday, December 9, 2019, 6:00 PM – 8:00 PM and Saturday, December 7, 2019, 5:30 PM-7:30 PM.

On December 4, 2019 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported the pricing of an underwritten public offering of 41,550,000 shares of common stock at a price to the public of $3.13 per share, for gross proceeds of approximately $130.1 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay (Press release, ViewRay, DEC 4, 2019, View Source [SID1234551946]). All of the shares to be sold in the offering will be offered by ViewRay. In addition, ViewRay has granted the underwriters of the offering a 30-day option to purchase up to an additional 6,232,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

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ViewRay intends to use the net proceeds from the offering for working capital and general corporate purposes, including capital expenditures, research and development expenses, investments, commercial expenses, clinical data generation costs and infrastructure expenses.

The offering is expected to close on or about December 6, 2019, subject to satisfaction of customary closing conditions.

On December 4, 2019 Nordic Nanovector ASA (OSE: NANO) reported that new data from preclinical studies investigating the effect of Betalutin (177Lu-lilotomab satetraxetan) on non-Hodgkin’s lymphoma (NHL) cell lines will be presented in a poster at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (7-10 December 2019 in Orlando, FL, USA) (Press release, Nordic Nanovector, DEC 4, 2019, View Source [SID1234551945]).

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The ongoing research programme aims to investigate resistance mechanisms that enable NHL cells to survive Betalutin treatment and to identify molecules that, when used in combination with Betalutin, could overcome that resistance. The findings of this research could direct future programmes designed to expand the use of Betalutin-based therapies in NHL patients.

The research being presented at ASH (Free ASH Whitepaper) builds on data previously presented (at the European Haematology Association annual meeting in June 2018) describing how a screen of more than 50 different NHL cell lines identified some cell lines that were resistant to Betalutin. Two resistant cell lines were aggressive diffuse large B-cell lymphoma (DLBCL) cell lines (the double-hit/double-expressor ABC-DLBCL cell lines RIVA and U2932).

The new poster reports how these two aggressive DLBCL cell lines have been used in a new screen where Betalutin has been combined with 384 different anti-cancer drugs to identify the Betalutin/drug combinations that could potentially contribute to reverting resistance.

Jostein Dahle, Chief Scientific Officer of Nordic Nanovector, said: "Our ongoing research programmes and collaborations continue to help us understand how NHL cells react to Betalutin treatment. Understanding the mechanisms of resistance to Betalutin, and how to overcome them, is crucial for being able to deliver optimal treatment to patients with difficult to treat tumours. In the case of Betalutin-based treatment, which to date has demonstrated an encouraging clinical profile, such combination strategies could further enhance its potential to become an important option for NHL patients."

Abstract 2574

Abstract title: The Dual Cell Cycle Kinase Inhibitor JNJ-7706621 Reverses Resistance to CD37 Targeted Radioimmunotherapy in Activated B Cell like Diffuse Large B Cell Lymphoma Cell Lines

Authors: G.E. Rødland et al.

Session Name: 605. Molecular Pharmacology, Drug Resistance-Lymphoid and Other Diseases: Poster II

Date: Sunday, 8 December 2019
Presentation Time: 6:00 PM – 8:00 PM Eastern time
Location: Orange County Convention Center, Hall B

The abstract is available at View Source and the poster will be published on the Nordic Nanovector website to coincide with the session.

About ASH (Free ASH Whitepaper)

The ASH (Free ASH Whitepaper) annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process. View Source