On December 5, 2019 Genmab A/S (Nasdaq: GMAB) reported that it has achieved a USD 100 million sales volume milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc (Press release, Genmab, DEC 5, 2019, View Source [SID1234551951]). The milestone was triggered by confirmation from Janssen that sales of DARZALEX reached USD 2.5 billion in a calendar year. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

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"We remain very pleased with the robust uptake seen with DARZALEX since its initial launch and with new approvals this year and potential approvals in 2020, we hope that it becomes even more widely available for the many multiple myeloma patients in need," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The milestone was included in the original financial guidance issued by Genmab on February 20, 2019, and in the improved financial guidance issued on November 6, 2019, as such there is no change to the company’s financial guidance for 2019.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On December 4, 2019 BioHybrid Solutions, LLC (BHS), a Pittsburgh-based protein engineering company, reported that it was awarded a contract worth up to $30 million from the United States Department of Defense to develop a next-generation prophylactic medical countermeasure (Press release, Myris Therapeutics, DEC 4, 2019, View Source [SID1234650500]). The project was sponsored by the U.S. Government through the Medical CBRN Defense Consortium (MCDC).

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The U.S. Defense Threat Reduction Agency (DTRA) selected BHS through a request for prototype proposal under the MCDC to apply its proprietary NanoArmored protein engineering technology to improve pharmacokinetics of the prophylactic while reducing the potential for immunogenic side effects. Over the five-year program, BHS will develop NanoArmored drug candidates, conduct studies to demonstrate functionality, scale manufacturing, and complete regulatory activities towards approval of the countermeasure by the U.S. Food and Drug Administration (FDA). BHS is leading the program in collaboration with FLIR Systems, Battelle, Ology Bioservices, the Allegheny Health Network, BTG PLC (now part of Boston Scientific) and the US Army.

"We have developed a unique way to protect against the toxic effects of chemical warfare agents and are honored to have been selected by DTRA to lead this very important program," said Alan Russell, Co-Founder and CEO of BioHybrid Solutions.

In order to expedite development, BHS will utilize its specialized high-throughput discovery technology to rapidly select the NanoArmor needed and then manufacture that drug candidate. "Our technology allows us to rationally tune protein performance through precision modification of proteins with a wide variety of synthetic polymers," noted Krzysztof Matyjaszewski, BHS Co-Founder and CSO. "To date, we have created thousands of different NanoArmored proteins for a variety of industrial and therapeutic indications. We are well positioned to apply our technology to this important national security and public health application."

On December 4, 2019 Omeros Corporation (Nasdaq: OMER) ("Omeros"), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported that it has commenced a registered underwritten public offering of its common stock (Press release, Omeros, DEC 4, 2019, View Source [SID1234551970]). In addition, Omeros has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering.

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Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

Omeros intends to use the net proceeds of the offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization. Omeros may also use the net proceeds for working capital, the repayment of debt obligations, acquisitions or investments in businesses, products or technologies that are complementary to its own, and other capital expenditures.

A registration statement on Form S-3 relating to the securities was filed with the Securities and Exchange Commission (the "SEC") on December 4, 2019 and became automatically effective upon filing. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering will be filed with the SEC on December 4, 2019 and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected].

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.