On November 2, 2018 Sandoz, a Novartis division and the pioneer and global leader in biosimilars, reported that it will not pursue its submission for biosimilar rituximab in the US at this time (Press release, Novartis, NOV 2, 2018, View Source [SID1234530687]). The decision follows a request by the US Food and Drug Administration (FDA) for additional information to complement the submission. Sandoz will focus on progressing its biosimilar pipeline in areas of greatest unmet access needs.

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"We appreciate the important conversations with the FDA, which have provided specific requirements for our potential US biosimilar rituximab, but believe the patient and marketplace needs in the US will be satisfied before we can generate the data required," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz.

"We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia. Given the breadth of our biosimilar pipeline, we believe we should now focus on opportunities in the US and around the world where we can best meet rapidly evolving patient and healthcare system needs."

Sandoz remains committed to enabling early and expanded patient access and creating savings for healthcare systems through a robust biosimilar portfolio. Sandoz has seven approved biosimilars worldwide, three of which are approved in the US, and is currently awaiting marketing authorization in the EU for pegfilgrastim, following a CHMP positive opinion in September 2018.

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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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.