On January 30, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets, reported a strategic corporate restructuring to focus its resources on its lead clinical programs: varlitinib in biliary tract cancer (BTC), ASLAN003 in acute myeloid leukaemia (AML) and ASLAN004 in atopic dermatitis (Press release, ASLAN Pharmaceuticals, JAN 30, 2019, View Source [SID1234532971]).

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ASLAN will focus its resources on the late-stage development of varlitinib as a potential novel treatment for first- and second-line BTC. Enrolment in a global pivotal study of varlitinib in second-line BTC, the TreeTopp (TREatmEnT OPPortunity) study, was completed ahead of schedule in December 2018 and topline data is expected in the second half of 2019. ASLAN will be closing the ongoing single-arm second-line BTC study in China as it is now expected to read out after the TreeTopp study. If positive, data from the TreeTopp study will be used to submit a New Drug Application (NDA) in China, the US and other major geographies.

ASLAN recently reported positive phase 1b results from an ongoing study of varlitinib as a first-line treatment for BTC which demonstrated that varlitinib increased objective response rate compared to standard of care and this study will continue to recruit patients to strengthen this dataset.

The clinical development of ASLAN003 in AML and ASLAN004 in atopic dermatitis remains on track. ASLAN expects to complete the first part of the phase 2 study of ASLAN003 in AML and the phase 1 SAD study of ASLAN004 in the first half of 2019.

Following this strategic review, ASLAN will reduce its cost base, including a reduction in headcount by 30%. In total, the planned changes will lower operational costs by 50%. ASLAN does not expect to incur any material restructuring charges.

In addition to the reduction in headcount, Dr Bertil Lindmark, currently Chief Medical Officer, has announced he will retire and return to Europe. Dr Chih-Yi Hsieh, currently VP Medical and GM Taiwan, will assume the role of acting Chief Medical Officer. Dr Mark McHale, Chief Operating Officer, will transition to the role of Chief Development Officer and Head of R&D with immediate effect.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We remain committed to ensuring the most effective use of capital to support the development of our three key assets, varlitinib, ASLAN003 and ASLAN004, each of which have the potential to be critical value-drivers. We are approaching several significant milestones in 2019 and beyond, so it is important we complete key studies over the next two years. Restructuring the organisation has involved some tough decisions. It is difficult to lose outstanding members of the team who have contributed to ASLAN over the years and have tackled some of the most challenging obstacles to advancing new treatments for cancer."

On January 30, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the European Medicines Agency (EMA) has completed its validation of the Marketing Authorization Application (MAA) for ELZONRIS (tagraxofusp-erzs) (Press release, Stemline Therapeutics, JAN 30, 2019, View Source [SID1234532956]). Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Stemline submitted the MAA earlier this month seeking approval of ELZONRIS for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the MAA was granted accelerated assessment.

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Under European Union legislation, a medicinal product of major public health interest may be reviewed under an accelerated assessment procedure. Accelerated assessment can significantly reduce the timeframe for the EMA Committee for Medicinal Products for Human Use (CHMP) to review an MAA.

ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with BPDCN. ELZONRIS is currently commercially available in the U.S.

"The validation of our MAA by the EMA represents another major step forward in our effort to provide patients with BPDCN in Europe access to ELZONRIS as expeditiously as possible," said Ivan Bergstein, M.D., Chief Executive Officer of Stemline Therapeutics. "With ELZONRIS now commercially available in the U.S., we remain committed to increasing access for patients with BPDCN who may benefit from ELZONRIS treatment, worldwide."

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to, and validated by, the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases.

On January 30, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported its plans to host a Research and Development Day on February 26, 2019 from 8:00 a.m. – 11:30 a.m. ET in New York City (Press release, CytomX Therapeutics, JAN 30, 2019, View Source [SID1234532972]).

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Members of CytomX’s senior executive team will be joined by:

Alex Spira, M.D., Ph.D., FACP, Director, Virginia Cancer Specialists Research Institute, Assistant Professor, Johns Hopkins School of Medicine and Medical Director, US Oncology Lung Program
The event will be webcast live under the "Investors & News" section of CytomX’s website at View Source Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

Institutional investors and equity analysts seeking information on or registration for the live event in New York City please contact Chris Keenan at [email protected].

On January 29, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported updates on its clinical program for its lead investigational treatment, DPX-Survivac, as a potential monotherapy in advanced recurrent ovarian cancer (Press release, IMV, JAN 29, 2019, View Source [SID1234534098]). In December 2018, IMV met with the U.S. Food and Drug Administration (FDA) in a Type B meeting to discuss the results-to-date of its DECIDE1 clinical trial and ongoing development plan, as well as to obtain agency guidance on a potential accelerated regulatory pathway for DPX-Survivac as a T cell immunotherapy for the treatment of advanced ovarian cancer in patients with progressing disease.

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"This FDA meeting was an important milestone for the DPX-Survivac program, and we are very pleased to be aligned with the agency on key aspects of our clinical development plan," said Frederic Ors, Chief Executive Officer at IMV. "We believe that, with no currently approved immunotherapy options available, ovarian cancer remains a serious unmet medical need. We look forward to advancing our ongoing phase 2 DECIDE study in order to potentially expedite DPX-Survivac development as a possible first-in-class T cell immunotherapy treatment for patients with advanced ovarian cancer."

FDA Meeting Highlights

The purpose of IMV’s Type B meeting with the FDA was to request feedback on the design of the clinical program for DPX-Survivac. This program includes the ongoing DECIDE phase 2 clinical study and a potential future registration trial for accelerated approval in a subset of ovarian cancer patients.

The FDA reviewed the Company’s proposed clinical development plan and acknowledged the potential for accelerated approvals in advanced ovarian cancer based on objective response rate (ORR) according to RECIST 1.1 criteria with reported median duration of response (DOR). In addition, the FDA provided important guidance on clinical design considerations for different lines of therapy and platinum-sensitive and -resistant patient populations.

In addition, IMV submitted a protocol amendment for a predictive enrichment approach to the phase 2 DECIDE trial, and further discussed those details with the FDA during the Type B meeting. The phase 2 primary endpoint, based on objective response rate (ORR) per RECIST 1.1 criteria, is intended to confirm the high response rate and duration of clinical benefits observed in previously announced results in a patient population defined by a clinical biomarker based on baseline tumor burden (BTB).

Multiple clinical sites are now open for enrollment in the DECIDE phase 2 trial. Subject to phase 2 results, IMV plans to schedule a follow-up meeting with FDA to finalize the design of a potential pivotal trial based on ORR and DOR.

About the DECIDE Phase 2 Trial Cohort

The DECIDE (DPX-Survivac with low dose intermittent cyclophosphamide) phase 2 study is an open label safety and efficacy study for individuals with advanced platinum-sensitive and -resistant ovarian cancer with sum of base line target lesions per RECIST criteria less than 5 cm. Primary and secondary endpoints include:

Safety profile,

ORR and DOR using RECIST 1.1 criteria,

Induction of systemic survivin-specific T cells in the blood, and

Induction of T cell infiltration into tumors.

On January 29, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company") reported that it will host a key opinion leader (KOL) breakfast on targeted conditioning for bone marrow transplant (BMT) and CAR-T from 8:00 AM to 9:30 AM EST on Thursday, February 7th, in New York City (Press release, Actinium Pharmaceuticals, JAN 29, 2019, View Source [SID1234532940]).

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The event will feature a presentation by KOL Sergio Giralt, MD, Chief of Adult BMT, Memorial Sloan Kettering Cancer Center, who will discuss the potential of targeted conditioning with ARCs or Antibody Radiation-Conjugates in conjunction with BMT or Bone Marrow Transplant for patients ineligible or underserved by current conditioning regimens. Dr. Giralt’s presentation will highlight an initial safety and feasibility analysis of data from Actinium’s pivotal Iomab-B Phase 3 SIERRA trial, which were presented in an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018. Dr. Giralt will be available at the conclusion of the event to answer any questions from the audience.

In addition, members of the Actinium management team will discuss how the Company is applying its ARCs for targeted conditioning in patients prior to CAR-T with the goal of eliminating the need for chemotherapy conditioning regimens like Flu/Cy (Fludarabine and Cyclophosphamide). Finally, management will introduce their AWE or Antibody Warhead Enabling technology platform that has enabled combination trials with Venetoclax, a bio-better of J&J’s darzalex, and a research collaboration with Astellas Pharma, Inc.

This event is intended for institutional investors, sell-side analysts, and business development professionals only and they are requested to RSVP Click Here. For those who are unable to attend in person, a live webcast and replay will be accessible via the link Click Here.

About Dr. Sergio Giralt
Dr. Giralt, MD, Chief of Adult BMT, Memorial Sloan Kettering Cancer Center; Chair, Myeloma Service; and a board-certified hematologist/oncologist whose clinical practice and research focus on stem cell transplantation for patients with blood disorders. Previously, Dr. Giralt was Deputy Chair of the Department of Stem Cell Transplantation and Cellular Therapies at the University of Texas MD Anderson Cancer Center.

Dr. Giralt and his colleagues pioneered the use of reduced-intensity conditioning regimens for older or more debilitated patients with blood cancers, and are currently using and studying T cell depletion techniques to dramatically reduce the risk of graft-versus-host disease, a serious complication of donor stem cell transplantation. Dr. Giralt’s clinical and research activities include stem cell transplantation for patients with blood disorders and improving treatments for older patients who have acute and chronic leukemia. He has published and presented extensively on these topics. Additionally, Dr. Giralt has served as the principal investigator for a number of clinical trials that examine new treatment approaches for multiple myeloma and other blood cancers that aim to reduce symptom burden and improve treatment tolerability.

Dr. Giralt received his medical degree from Universidad Central de Venezuela. He completed his residency at Good Samaritan Hospital and his fellowship at The University of Texas MD Anderson Cancer Center. Dr. Giralt is Professor of Medicine at Weill Cornell Medical College and the Chief Attending Physician of the Adult Bone Marrow Transplant Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center in New York City. In addition, he is the Melvin Berlin Family Chair in Myeloma Research.