On February 19, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a global Phase 2 trial of zanubrutinib, an investigational inhibitor of Bruton’s tyrosine kinase (BTK), in patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL), which BeiGene refers to as the MAGNOLIA trial (Press release, BeiGene, FEB 19, 2019, View Source;p=RssLanding&cat=news&id=2388014 [SID1234533466]).

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Zanubrutinib was discovered by BeiGene scientists and is being developed globally as a monotherapy and in combination with other therapies to treat various hematologic malignancies. Zanubrutinib is being studied in several clinical trials as part of a broad development program and was granted Breakthrough Therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and Fast Track designation for the treatment of patients with Waldenström macroglobulinemia (WM) by the U.S. Food and Drug Administration (FDA). BeiGene plans to submit an initial new drug application (NDA) to the FDA for zanubrutinib in 2019 or early 2020. In addition, BeiGene has submitted NDAs in China for R/R MCL and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), which have been accepted for review by the National Medical Products Administration (NMPA) and granted priority review.

"We are excited to initiate this Phase 2 trial following the preliminary results from our Phase 1 trial of zanubrutinib in patients with relapsed or refractory marginal zone lymphoma, in which seven objective responses in nine patients were reported. More than 1,300 patients worldwide have been treated with zanubrutinib, and we look forward to evaluating its potential in the MAGNOLIA trial for these patients who may find benefit with this novel BTK inhibitor," commented Jane Huang, M.D., Chief Medical Officer for Hematology at BeiGene.

The global, Phase 2, open-label, multi-center MAGNOLIA trial is expected to enroll approximately 65 patients with R/R MZL. The primary efficacy endpoint is overall response rate (ORR) determined by independent central review. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), ORR by investigator assessment, and safety and tolerability.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Marginal Zone Lymphoma
Marginal zone lymphoma is a group of indolent (slow growing) B-cell lymphomas that account for approximately 8% of all non-Hodgkin’s lymphoma (NHL) cases, according to the Lymphoma Research Foundation.1 The average age at diagnosis is 60 years, and it is slightly more common in women than in men.1 There are three types of MZL: extranodal marginal zone B-cell lymphoma or mucosa-associated lymphoid tissue (MALT), the most common type of MZL, which occurs outside the lymph nodes in places such as the stomach, small intestine, salivary gland, thyroid, eyes, and lungs; nodal marginal zone B-cell lymphoma, which occurs within the lymph nodes; and splenic marginal zone B-cell lymphoma, which occurs most often in the spleen and blood.

About Zanubrutinib

Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted by the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of patients with WM, and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy. The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.

On February 19, 2019 National Brain Tumor Society (NBTS), a leading nonprofit dedicated to the brain tumor community in the United States, reported a new partnership with the Brain Science Foundation (BSF) (Press release, National Brain Tumor Society, FEB 19, 2019, View Source [SID1234553933]). Under terms of the partnership, the organizations have established the Meningioma Research Fund to raise and grant funds specifically for meningioma research poised to identify and advance treatments aimed at dramatically improving survival and quality of life.

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Meningioma is the most common primary brain tumor, accounting for 37 percent of all brain tumor diagnoses and approximately 30,000 new cases every year in the United States. There are fifteen types of meningiomas presenting a wide range of physical, emotional, and occupational challenges – and can ultimately be life-threatening.

"Given the legacy of the Brain Science Foundation and its association with meningioma, and our shared goals with the National Brain Tumor Society to fund research aimed to advance the development of treatments, it quickly became evident that the community of patients, advocates, and healthcare providers could benefit from a formal collaboration between our respective organizations," says Steven Haley, founder of the Brain Science Foundation. "We believe NBTS’s depth and breadth of assistance, combined with the continuity of the BSF mission on a larger platform will be compelling and welcomed in the community we serve."

The Meningioma Research Fund creates an opportunity for donors specifically interested in supporting research on this tumor type to join together to scale up the impact of their philanthropy.

"Medical research directed toward meningioma is disproportionately small compared to other brain tumor types," says David Arons, Chief Executive Officer, National Brain Tumor Society. "Yet, meningiomas can be life-altering and cause lasting deficits to patients, as the only treatment option for many is invasive brain surgery. This partnership with the Brain Science Foundation and the creation of the Meningioma Research Fund will allow us to invest in best-in-class science and accelerate research that is aimed at advancing better treatment options for these patients."

The Brain Science Foundation was established in 2002 and has gone on to fund nearly $1 million annually in support of outstanding physician-scientists in brain tumor research, with a particular focus on meningioma. To date, BSF-funded researchers have impacted lives through a variety of research programs that have included the creation of advanced diagnostic tools, surgical instruments and techniques, post-operative care protocols and therapies that are less invasive but more effective.

About Meningioma

Meningioma is the most common primary brain tumor, accounting for 37.1 percent of all brain tumor diagnoses. It is estimated that 31,990 individuals will be diagnosed with a meningioma in the United States in 2019. Meningioma is most commonly diagnosed in adults, with an average age at diagnosis of 66, and is more common in women than men. African Americans are significantly more likely than Caucasians to develop meningioma. The 10-year relative survival rate for all meningioma patients is 81.5 percent, but only 53.5 percent for those with a malignant meningioma.

On February 19, 2019 Molecular Templates, Inc. (Nasdaq: MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported the appointment of Roger J. Waltzman, M.D., as Chief Medical Officer, effective Tuesday February 19, 2019 (Press release, Molecular Templates, FEB 19, 2019, View Source [SID1234533485]). Dr. Waltzman will report to Eric E. Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates, and will be responsible for all clinical development and regulatory activities.

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"Roger has an exceptional track record in leading the clinical development of successful oncology drugs, having played major roles in developing products such as Glivec and Jakafi, and we are excited to welcome him to our team as Chief Medical Officer," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "Roger’s experience in managing both early and late stage clinical programs, overseeing successful regulatory applications and supervising expert research teams will be invaluable as we advance our pipeline of novel oncology candidates."

"I am excited to join Molecular Templates, a company which is at the forefront of oncology drug development. I believe that its ETB platform represents one of the most exciting oncology technologies industry-wide," said Dr. Waltzman. "I look forward to leading our clinical development team towards developing novel drugs for cancer and expanding treatments options for oncology patients."

Dr. Waltzman is a board-certified medical oncologist with over 20 years of experience in the pharmaceutical and biotechnology industries, and in medical practice/academia. His career highlights include 9 years in senior drug development roles at Novartis Pharmaceuticals Corporation, including 6 years in positions of increasing responsibility at Novartis Oncology (2007–2013). He played a leading role in the development of highly successful Novartis branded oncology drugs, Glivec (imatinib) and Jakafi (ruxolitinib). His last role at Novartis was as Executive Director and Full Development Head of Malaria Drug Development (2013-16). More recently, Dr. Waltzman was CMO at Rgenix, where he supervised the development of immuno-oncology and metabolic inhibitor assets through Phase 1 a/b. Previously, he served as CMO and CSO at Jaguar Health and Napo Pharmaceuticals, where he led scientific aspects of development and commercialization of Mytesi (crofelemer) for patients with HIV and diarrhea, as well as development programs in chemotherapy-induced diarrhea and various indications for companion and production animals.

Prior to joining industry, Dr. Waltzman held assistant professorships in medical oncology and palliative care at Saint Vincent’s Hospital and Mount Sinai School of Medicine in New York. At Saint Vincent’s Hospital, he was responsible for overseeing oncology care for patients with breast, gastrointestinal, gynecologic, thoracic, and AIDS-related malignancies. He completed his fellowship in hematology/oncology at Memorial Sloan Kettering Cancer Center. Dr. Waltzman earned an M.B.A. at Columbia Business School where he graduated valedictorian, an M.D. from Brown University School of Medicine and a B.A. from Brown University.

On February 19, 2019 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that management will host a conference call in conjunction with the announcement of its fourth quarter and full-year 2018 financial results and present at the 8th Annual Leerink Partners Health Care Conference (Press release, Epizyme, FEB 19, 2019, View Source [SID1234533504]). Details of both events are as follows:

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Fourth Quarter and Full-Year 2018 Financial Results: Management will host a conference call and webcast to discuss its fourth quarter and full year 2018 financial results and other business highlights at 8:30 a.m. ET on Tuesday, February 26, 2019. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 1088195.
8th Annual SVB Leerink Global Health Care Conference Presentation: Management will present a company overview at the 8th Annual SVB Leerink Global Health Care Conference on Thursday, February 28, 2019 at 2:30 p.m. ET in New York City.
Live webcasts will be available in the investor section of the company’s website at www.epizyme.com. The webcasts also will be archived for 60 days following the call and presentation.

On February 19, 2019 Fusion Pharmaceuticals, a biopharmaceutical company focused on radiotherapeutics (specifically, targeted alpha therapeutics), reported that the first patient was dosed in a Phase 1, first-in-human clinical trial of lead product candidate [225Ac]-FPI-1434 in patients with advanced solid tumors (Press release, Fusion Pharmaceuticals, FEB 19, 2019, View Source [SID1234533468]).

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"The entire Fusion team takes tremendous pride in having developed a new targeted alpha therapeutic and in moving it from the discovery phase to a clinical trial," said John Valliant, Ph.D., Founder and Chief Executive Officer of Fusion Pharmaceuticals. "We are excited to start clinical development of a new generation of radiopharmaceuticals utilizing our Fast-ClearTM Linker to address the need for better cancer treatments."

The Phase 1 clinical study (FPX-01-01) is a dose-escalation study that will characterize the safety and tolerability of a single dose [225Ac]-FPI-1434 Injection in patients with advanced solid tumors. [225Ac]-FPI-1434 is a targeted alpha radioimmunoconjugate that consists of a humanized monoclonal antibody targeting the insulin-like growth factor-1 receptor 1 (IGF-1R), Fusion’s Fast-ClearTM Linker, a bifunctional chelate, and actinium-225. Patients will be screened for target expression with the imaging agent [111In]-FPI-1547. [111In]-FPI-1547 contains the same targeting antibody, Linker, and bifunctional chelate as the [225Ac]-FPI-1434 therapeutic form, however it will contain indium-111 in place of actinium-225. Only those patients who have IGF-1R expression will be receiving the [225Ac]-FPI-1434 therapeutic radioimmunoconjugate. Investigators will evaluate the safety and tolerability of a targeted alpha-emitting radiotherapeutic. Up to 30 patients will be treated and followed for safety and for signs of efficacy. For more information about this study, visit: View Source

About Fusion’s Fast-Clear Technology Platform and FPI-1434

Fusion uses its proprietary Fast-Clear Technology Platform to convert molecules into radiopharmaceuticals. Fast-ClearTM linkers promote increased clearance of radoisotopes – the linkers are engineered to improve the safety of radiopharmaceuticals without impacting efficacy. The predecessor [225Ac]-FPI-1434 antibody (AVE1642) is a humanized antibody against IGF-1R (insulin-like growth factor receptor) that had previously been in Phase I and II clinical trials. Fusion has an exclusive license to AVE1642 from ImmunoGen, Inc. Fusion applied its Fast-Clear linker to convert AVE1642 into a potent radiopharmaceutical, [225Ac]-FPI-1434.