On November 2, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp; SL-401), a novel targeted therapeutic directed to CD123, will be featured in four presentations, including an oral presentation, at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 1-4, 2018 in San Diego, CA (Press release, Stemline Therapeutics, NOV 2, 2018, View Source [SID1234530630]).

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Additionally, the Company is hosting an investor/analyst event on December 3, 2018 and plans to provide updates on the progress of its pre-commercial activities, disease awareness campaign, and market expansion efforts.

Details on the ASH (Free ASH Whitepaper) presentations are as follows:

BPDCN – Oral Presentation
Title: Results of Pivotal Phase 2 Trial of Tagraxofusp (SL-401) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 765
Session: 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: New Treatment Strategies
Date/Time: Monday, December 3, 2018 3:15 PM PT
Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F

Chronic Myelomonocytic Leukemia (CMML)
Title: Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)
Presenter: Mrinal Patnaik, MBBS; Mayo Clinic
Abstract: 1821
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM–8:15 PM PT
Location: San Diego Convention Center, Hall GH

Myelofibrosis (MF)
Title: Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 1773
Session: 634. Myeloproliferative Syndromes: Clinical: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM–8:15 PM PT
Location: San Diego Convention Center, Hall GH

Tagraxofusp + Hypomethylating Agents: Chronic Myelomonocytic Leukemia (CMML)
Title: Evaluation of Combination Tagraxofusp (SL-401) and Hypomethylating Agent (HMA) Therapy for the Treatment of Chronic Myelomonocytic Leukemia (CMML)
Presenter: Aishwarya Krishnan, Memorial Sloan Kettering Cancer Center
Abstract: 1809
Session: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM PT
Location: San Diego Convention Center, Hall GH

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We are honored that ASH (Free ASH Whitepaper) has selected the BPDCN pivotal results for oral presentation. This selection underscores the heightening awareness of the disease – BPDCN, the target – CD123, and the clinical impact of the drug candidate – ELZONRIS. In addition, our regulatory team continues to work diligently in an effort to make ELZONRIS available to patients as quickly as possible, and our commercial team continues to execute on our broad-based pre-launch initiatives. This includes the build-out of our sales, marketing and reimbursement teams as well as continuing to advance our disease awareness campaign. In parallel, we are excited to present updated clinical data from our ongoing clinical trials in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF). Based on these data, we are enthusiastic about our plans to implement pivotal trials, or cohorts, in these devastating malignancies."

About BPDCN
Please visit the BPDCN disease awareness booth at ASH (Free ASH Whitepaper) 2018 (#205) and the website: www.bpdcninfo.com.

On November 2, 2018 Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that it will release third quarter 2018 financial and operating results on Monday, November 12, 2018 after the close of the U.S. financial markets (Press release, BioTime, NOV 2, 2018, View Source;p=RssLanding&cat=news&id=2375072 [SID1234530688]). The Company will host a conference call and webcast on November 12, 2018 at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and corporate developments.

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 888-394-8218. For international participants outside the U.S./Canada, the dial-in number is 323-794-2591. For all callers, refer to Conference ID 6651165. To access the live webcast, go to View Source

A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 6651165. Additionally, the archived webcast will be available at View Source

On November 2, 2018 FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, reported that it will report third quarter 2018 financial results on Thursday, November 8, 2018, after market close, and will host a conference call to discuss financial results and provide a business update at 5:00 p.m. ET (2:00 p.m. PT) (Press release, FibroGen, NOV 2, 2018, View Source;p=irol-newsArticle&ID=2375179 [SID1234530689]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 4778 0296#.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 47780296

On November 2, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the first patient has been dosed in a clinical study evaluating CV301, the Company’s targeted immunotherapy candidate, and durvalumab, AstraZeneca’s PD-L1 inhibitor, in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancers (Press release, Bavarian Nordic, NOV 2, 2018, View Source [SID1234530665]).

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Bavarian Nordic’s CV301 targets tumor-associated antigens, CEA and MUC1, which are overexpressed on multiple solid tumors, including colorectal and pancreatic cancers. Preclinical data has shown that vaccination resulted in the induction of tumor specific T-cells that infiltrated the tumor resulting in the upregulation of PD-L1 on tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

CV301 is administered in an innovative manner designed to generate a potent and durable T-cell response. Patients receive an enhanced priming regimen of the highly attenuated, non-replicating vaccinia virus MVA-BN-CV301 in 4 different injection sites on days 1 and 29, followed by boosters of the recombinant fowlpox virus FPV-CV301 at tapering intervals during the course of the treatment with durvalumab and maintenance chemotherapy.

The investigator-sponsored trial is being led by Dr. Michael Pishvaian, Associate Professor in the Department of Hematology/Oncology at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center in Washington, D.C., with material support from Bavarian Nordic and AstraZeneca. The clinical trial is being conducted at several other top cancer centers including the Mayo Clinic, Indiana University and Emory University. The trial will begin with a small lead-in study to determine the safety and tolerability of the combination, as well as the recommended Phase 2 dose of durvalumab in combination with CV301 and maintenance chemotherapy. The Phase 2 portion of the study will consist of two parallel trials, enrolling up to 26 patients with metastatic disease for each disease setting. The primary endpoint for both arms of the study will be progression-free survival (PFS) with multiple secondary endpoints, including objective response rate (ORR), overall survival (OS), and disease control rate (DCR).

"We are excited to continue demonstrating CV301’s potential in multiple cancers and combinations, particularly in a treatment setting in which checkpoint inhibition alone has yet to show significant benefit. The combination of a targeted cancer vaccine with a checkpoint inhibitor could result in a novel approach to fighting colorectal and pancreatic cancers, which are among the most difficult-to-treat malignancies to date," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

Additional information on the study is available at: View Source

About CV301
CV301 is an active immunotherapy candidate that targets two tumor-associated antigens, CEA and MUC1, long known to be overexpressed in most solid tumors. The poxvirus-based prime/boost vaccine incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules. Preclinical data shows that antigen specific vaccination results in T cell infiltration into areas of antigen expression and upregulation of PD-L1 on antigen expressing tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

On November 2, 2018 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that new data from three abstracts on the Company’s pipeline of investigational agents will be presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), December 1-4 in San Diego, California (Press release, Tolero Pharmaceuticals, NOV 2, 2018, View Source [SID1234530690]). Among the presentations, updated data from Zella 201, an ongoing Phase 2 study evaluating the efficacy and safety of alvocidib, a potent CDK9 inhibitor, in combination with cytarabine and mitoxantrone in patients with relapsed or refractory MCL-1-dependent acute myeloid leukemia (AML) will be featured in an oral presentation. Additional data from Tolero’s pipeline will also be presented, including preclinical findings on the activity of alvocidib and decitabine, as well as preclinical data evaluating the activity of TP-1287, an oral CDK9 inhibitor, in combination with bortezomib or venetoclax for the potential treatment of multiple myeloma. Three additional abstracts on Tolero sponsored research will be presented by independent research institutions.

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"We look forward to sharing the latest data from our pipeline at the ASH (Free ASH Whitepaper) Annual Meeting, including updated findings from the Zella 201 study, which further informs our understanding of the potential role of alvocidib in relapsed or refractory MCL-1-dependent acute myeloid leukemia," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "These data at ASH (Free ASH Whitepaper) reinforce our commitment and progress in advancing our clinical programs focused on hematologic and oncologic diseases."

Below are the details for the Tolero presentations:

Abstract Title

Details

Presenter

Zella 201: A Biomarker-Guided Phase II
Study of Alvocidib Followed by Cytarabine
and Mitoxantrone in MCL-1 Dependent
Relapsed/ Refractory Acute Myeloid
Leukemia (AML)

Abstract #30

December 1, 8:45 a.m. PT

Oral Presentation

Joshua F. Zeidner,
Lineberger Comprehensive
Cancer Center, University of
North Carolina, Chapel Hill, NC

The Oral CDK9 Inhibitor, TP-1287, Is
Active in Non-Clinical Models of Multiple
Myeloma

Abstract #3269

December 2, 6 – 8 p.m. PT

Poster Presentation

Clifford Whatcott,

Tolero Pharmaceuticals, Inc.

The CDK9 Inhibitor, Alvocidib, Potentiates
the Non-Clinical Activity of Azacytidine or
Decitabine in an MCL-1-Dependent
Fashion, Supporting Clinical Exploration of
a Decitabine and Alvocidib Combination

Abstract #4355

December 3, 6- 8 p.m. PT

Poster Presentation

Wontak Kim, Tolero
Pharmaceuticals, Inc.

Below are selected details for the presentations from Tolero sponsored research:

Abstract Title

Details

The PIM Kinase Inhibitor TP-3654 in Combination with
Ruxolitinib Exhibits Marked Improvement of Myelofibrosis in
Murine Models

Abstract #54

December 1, 8:45 am PT

Oral Presentation

Enhanced Expression of Beta-Catenin and Axl Receptor
Tyrosine Kinase (RTK) in Chronic Lymphocytic Leukemia
(CLL) B-Cells with Co-Culture on Marrow Stromal Cells:
Implications for Leukemic Cell Drug Resistance

Abstract #3125

December 2, 6 – 8 p.m. PT

Poster Presentation

Axl-RTK Inhibition Modulates T Cell Functions and Synergizes
with Chimeric Antigen Receptor T Cell Therapy in B Cell
Malignancies

Abstract #728

December 3, 3 p.m. PT

Oral Presentation

A bout Alvocidib
Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in a Phase II study, Zella 201, in patients with relapsed or refractory MCL-1 dependent acute myeloid leukemia, AML, in combination with cytarabine and mitoxantrone ( NCT02520011 ). Alvocidib is also being evaluated in Zella 101, a Phase I clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with (7+3) in newly diagnosed patients with AML ( NCT03298984 ), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes, MDS, in combination with decitabine ( NCT03593915 ). In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax ( NCT03441555 ).

About TP-1287
TP-1287 is an investigational oral cyclin-dependent kinase 9 ( CDK9) inhibitor entering into a Phase 1 study in patients with advanced solid tumors ( NCT03604783) . TP-1287 has shown favorable oral bioavailability in preclinical models. TP-1287 is enzymatically cleaved, yielding the parent drug, alvocidib, a potent inhibitor of CDK9.

About CDK9 Inhibition and MCL-1
MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.2 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.3 In MCL-1–dependent AML, MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.2,4 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).5,6 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.5 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.2