On May 20, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp) clinical data in blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF) have been selected for poster presentations at the upcoming 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper), to be held from June 13-16, 2019, in Amsterdam (Press release, Stemline Therapeutics, MAY 20, 2019, View Source [SID1234536482]).

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Details on the presentations are as follows:

Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)

• Abstract: PF672
• Presenter: Mrinal M. Patnaik, MBBS; Mayo Clinic
• Date: Friday, June 14
• Time: 5:30-7:00 PM CET
Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate, or High Risk, Relapsed/Refractory Myelofibrosis (MF)

• Abstract: PF668
• Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
• Date: Friday, June 14
• Time: 5:30-7:00 PM CET
Results of Pivotal Phase 2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

• Abstract: PS1063
• Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
• Date: Saturday, June 15
• Time: 5:30-7:00 PM CET
Please visit the BPDCN disease awareness booth (#1351) during the 24thCongress of EHA (Free EHA Whitepaper).

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

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

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On May 20, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that it will be presenting at the Sachs Associates 5th Annual Immuno-Oncology BD&L and Investment Forum in Chicago (Press release, Phio Pharmaceuticals, MAY 20, 2019, View Source [SID1234536481]).

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Dr. Gerrit Dispersyn, Dr. Med. Sc., President and CEO, will present an overview of the Company’s RNAi technology, its relevance in immuno-oncology and an update on the Company’s product development activities in this field. The presentation will be held in Track B of the Faulkner Room of the Waldorf Astoria Chicago Hotel at 11:50 AM CT on May 31, 2019.

The presentation will be available under the "Investors – Events and Presentations" section of the Company’s website, www.phiopharma.com, approximately one hour following the presentation.

The Company will also be attending the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held at McCormick Place in Chicago from May 31 – June 4, 2019 and will be available for investor and company meetings throughout the conferences.

On May 20, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has made further important progress in optimizing the complete manufacturing process, including significant improvement of the growth characteristics of the cells from PharmaCyte’s Master Cell Bank (MCB) after encapsulation (Press release, PharmaCyte Biotech, MAY 20, 2019, View Source [SID1234536480]). These encapsulated cells will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

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PharmaCyte can now provide additional information as an update to its recent press release on the production of its clinical trial product called, "CypCaps." PharmaCyte, together with its team of experts, has successfully implemented additional changes to the manufacturing process that have resulted in a remarkably improved and more reproducible encapsulated live cell product.

Use the link below to view a picture that captures the growth process post encapsulation from day 8 to day 22 of the cells from the MCB. In the linked picture, you will see the cells from the MCB growing in the capsules over the course of 22 days. On day 22 the cells in the capsules have stopped growing because of contact inhibition and have been placed into syringes and frozen. They have also been thawed and tested for viability and the level of enzymatic activity necessary to convert ifosfamide from its inactive form to its cancer-killing form. Both tests met the required specifications: View Source

As previously reported, the cells from PharmaCyte’s MCB that were produced by Eurofins Lancaster Laboratories showed slightly different growth properties when compared to the cells that were previously tested by Austrianova from PharmaCyte’s Research Cell Bank, a finding that is not unusual when a new cell bank is established. Although minor in nature, these different growth characteristics of the MCB cells initially affected many of the steps required for the overall production process of the CypCaps, necessitating counter measures to re-align and restructure the production process.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "With these changes in place, GMP production of the CypCaps for PharmaCyte can now proceed at Austrianova’s manufacturing facility in Bangkok, Thailand.

"This is great news for everyone who has worked so diligently through what has been a complicated and meticulous process to get the production of our clinical trial product exactly right before we approach the FDA with an Investigational New Drug application. It’s also great news for our many shareholders who have waited patiently as we navigated these unchartered waters with encapsulating the live cells from our MCB."

On May 20, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that the company will present at Advances in Immuno-Oncology Congress UK 2019 in London on May 21st at 11:00 AM BST (Press release, Personalis, MAY 20, 2019, View Source [SID1234536479]).

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The presentation, entitled "Advancing Precision Oncology Biomarker Discovery with a Multi-dimensional Immunogenomics Platform," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will introduce preliminary data from an ongoing study in which this platform is being used to evaluate IO-related biomarkers and potential tumor escape mechanisms in a cohort of melanoma patients treated with anti-PD-1 therapy.

ImmunoID NeXT is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Robert Power, MS, Global Product Manager for Personalis.

On May 20, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that, after discussions with the FDA, the company has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma (Press release, Oncopeptides, MAY 20, 2019, View Source [SID1234536478]). The company targets to submit the application in the first quarter of 2020.

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During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether melflufen could be eligible for accelerated approval based on the promising data generated in the ongoing phase 2 HORIZON clinical trial. The target indication would be for the treatment of patients with relapsed refractory multiple myeloma whose disease is triple-class refractory (i.e. refractory to at least one IMiD, one proteasome inhibitor and one anti-CD38 monoclonal antibody). In the discussions, the FDA has requested and received all available clinical data at hand for melflufen.

As a result of the dialogue with the FDA, Oncopeptides has initiated preparations for an NDA submission based on the available HORIZON data. The detailed plan for the filing process is still under development, but Oncopeptides currently targets to submit the application during the first quarter of 2020. This could then lead to the first melflufen market approval in the US in 2020.

"We are very excited over the opportunity to help patients with triple-class refractory multiple myeloma who currently have very limited treatment options to potentially access a new treatment alternative that may have a large impact on their lives. The outcome of the regulatory discussions during the spring is even better than we anticipated and is a major milestone for Oncopeptides as it means that we can start the application process and potentially attain market approval significantly earlier than planned," says Jakob Lindberg, CEO of Oncopeptides.

"Potential approval will of course depend on the formal FDA review once we have submitted the application, but based on the discussions and the data at hand, we believe we have a very good chance to secure an approval, provided that the results generated in the HORIZON trial continue to be in line with the data we have seen so far. It will therefore be very exciting to present updated HORIZON data at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam on June 16," concludes Jakob Lindberg.

Conference call for investors, analysts and the media
Oncopeptides will host a conference call and present an operational update on Tuesday May 21, 2019 at 10:00 (CET). It will be presented by CEO Jakob Lindberg and members of the Oncopeptides management team. The conference call will also be streamed via a link on the website: www.oncopeptides.com.

Phone numbers for participants from:
Sweden: +46 8 505 583 65
Europe: +44 3333 009 035
USA: +1 833 526 8381

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 (0)8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on May 20, 2019 at 18.00 (CET).

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class of Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.