On November 30, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), reported a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, highlighted four upcoming ELZONRIS (tagraxofusp; SL-401) presentations, including an oral presentation, at this weekend’s American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 1-4, 2018 in San Diego, CA (Press release, Stemline Therapeutics, NOV 30, 2018, View Source [SID1234531750]).

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Additionally, the Company will host an investor/analyst event on December 3, 2018, where it will provide updates on the progress of its pre-commercial activities, disease awareness campaign, and ongoing market expansion efforts. If interested in attending, please contact Investor Relations ([email protected]).

Details on the ASH (Free ASH Whitepaper) presentations are below. Presentations will be available on the Stemline website, Scientific Presentations tab, after their delivery, as well as at our Stemline corporate booth (#205) at ASH (Free ASH Whitepaper) 2018.

Saturday, December 1st – Poster Presentations

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

Monday, December 3rd – Oral Presentation

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

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

On November 30, 2018 Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported financial results for the nine months ended September 30, 2018 and provided recent clinical development and corporate updates (Press release, Can-Fite BioPharma, NOV 30, 2018, View Source [SID1234531749]).

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"Prolonged longevity of patients in our Namodenoson Phase II advanced liver study was reported this quarter. It is a significant highlight in our clinical trial progress and because of this development, we now expect to release top-line results during the first quarter of 2019," said Pnina Fishman, Ph.D., CEO of Can-Fite. "This development provides further encouragement that this therapy could bring value to patients with chronic liver disease and cirrhosis with a Child Pugh B score, whose disease has progressed on sorafenib therapy."

Dr. Fishman continued, "With the need for better treatments for autoimmune inflammatory conditions such as rheumatoid arthritis and psoriasis, as well as for liver diseases such as liver cancer and NASH, we are encouraged by the progress we are making in our ongoing clinical studies. We believe there is a significant role we can play in a market that has been searching for novel therapeutic solutions for better patient care."

Recent Highlights:

Namodenoson for the Treatment of Liver Diseases

Can-Fite announced that due to patient survival, top-line results of the Namodenoson Phase II advanced liver cancer study were expected to be released in Q1 2019. The statistical plan for this trial requires that the primary efficacy analysis occurs when no more than 3 of the original 78 patients survive.
In anticipation of the Phase II liver cancer data release, Can-Fite brought on board Professor Joseph Llovet, a Key Opinion Leader in the field of liver diseases, founder and director of the Liver Cancer Program and full professor of medicine at the Mount Sinai School of Medicine, New York University (USA). Professor Llovet will assist in the analysis of the Phase II data that are anticipated in Q1 2019.
Can-Fite presented a poster titled "Namodenoson Anti-Fibrogenic Effect is Mediated via De-Regulation of the Wnt/β-catenin Pathway," at the Hepatic Fibrosis Conference of the American Association for the Study of Liver Diseases (AASLD) in September. The data, highlighting the anti-fibrogenic effects of Namodenoson, demonstrated significant decrease in liver fibrosis upon chronic treatment with Namodenoson in the CCL4 NAFLD/NASH model.
Can-Fite’s CEO Dr. Pnina Fishman presented on Namodenoson at NASH Summit Europe 2018 in October. Dr. Fishman spotlighted preclinical data from three experimental animal models showing that the anti-inflammatory, anti-steatotic and anti-fibrogenic effects of Namodenoson are mediated via the Wnt/β-catenin pathway, highly active in the liver of NAFLD/NASH animals or individuals.
Can-Fite CEO Dr. Pnina Fishman presented on Namodenoson at The NYC Oncology Investor Conference 2018 in October. She presented the molecular mechanism mediating the anti-cancer effects of Namodenoson and described clinical data from the Company’s earlier Phase I/II liver cancer study. In addition, she presented the status of the current Phase II study in patients with advanced hepatocellular carcinoma, Child Pugh B.
Piclidenoson for the Treatment of Rheumatoid Arthritis and Psoriasis

Phase III clinical studies for the treatment of psoriasis and rheumatoid arthritis continue to enroll patients.
Financial Results

Revenues for the nine months ended September 30, 2018 were $3.5 million compared to $0.7 million for the same period in 2017. The increase in revenue was mainly due to the recognition of the $2 million advance payment received in August 2018 under the distribution agreement with CMS Medical and from a portion of the $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro.

Research and development expenses for the nine months ended September 30, 2018 were $4 million compared with $3.5 million for the same period in 2017. Research and development expenses for the nine months of 2018 were comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through the rest of 2018 and beyond.

General and administrative expenses for the nine months ended September 30, 2018 were $2.4 million, compared to $2.1 million for the same period in 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that the annual general and administrative expenses for 2018 will be higher compared to 2017.

Financial expenses, net for the nine months ended September 30, 2018 were $0.2 million compared to financial income, net of $0.2 million for the same period in 2017. The increase in financial expenses, net was mainly due to recognition of interest expenses related to implementation of revenue recognition accounting standard IFRS 15, while in the same period in 2017, financial income was mainly due to fair value revaluation of warrants which were offset by financial expenses from exchange rate differences.

Can-Fite’s net loss for the nine months ended September 30, 2018 was $3.1 million compared with a net loss of $4.7 million for the same period in 2017. The difference in net loss was primarily attributable to an increase in revenues in 2018.

As of September 30, 2018, Can-Fite had cash and cash equivalents of $5.7 million as compared to $3.5 million at December 31, 2017. The increase in cash during the nine months ended September 30, 2018 is due to U.S. $4.37 million received from the issuance of shares and warrants, net of issuance expenses, the $2.2 million advance payment received from Gebro, and $2 million advance payment received from CMS Medical which were offset by our operating expenses.

The Company’s consolidated financial results for the nine months ended September 30, 2018 are presented in accordance with International Financial Reporting Standards.

On November 30, 2018 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported the injection of the first patient in the Phase 1 alloSHRINK trial evaluating the Company’s non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable metastatic colorectal cancer (mCRC) (Press release, Celyad, NOV 30, 2018, View Source [SID1234531747]).

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"The initiation of the alloSHRINK trial marks a critical milestone for our organization," said Dr. Christian Homsy, CEO of Celyad. "CYAD-101 represents a potential first-in-class approach to allogeneic CAR-T therapy and continues to build up Celyad’s leadership position in the allogeneic field, which is anchored by the Company’s robust allogeneic patent estate in the United States and complemented by our novel shRNA-based non-gene edited platform."

Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, "CYAD-101 represents Celyad’s second oncology program to enter the clinic for the treatment of metastatic colorectal cancer and balances the Company’s autologous clinical candidate CYAD-01, which has demonstrated encouraging preliminary results in the Phase 1 SHRINK trial. We believe investigating CYAD-101 in the alloSHRINK trial will leverage our clinical experience to date in the treatment of metastatic colorectal cancer as we look to develop novel therapies for this devastating disease."

Celyad also announced that ONO Pharmaceutical Co., Ltd. has given notice to the Company that it will no longer pursue development of CYAD-101 in Japan, Korea and Taiwan. Celyad and ONO Pharmaceutical entered into an exclusive license agreement for the development and commercialization of CYAD-101 in these specified territories in July 2016. Based on the agreement, ONO Pharmaceutical was required to exercise an option following the initiation of the Phase 1 trial for CYAD-101. The agreement has now expired and Celyad controls worldwide development and commercialization rights to CYAD-101.

Press Release

30 November 2018

07:00 am CET

CYAD-101 and alloSHRINK Trial Design

CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). TCR signaling is responsible for Graft versus Host Disease (GvHD). The expression of TIM reduces signaling of the TCR complex and could therefore reduce or eliminate GvHD in patients treated with CYAD-101.

The alloSHRINK trial (NCT03692429) is an open-label, dose-escalation trial that will assess the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC. Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks 48 hours after the initiation of chemotherapy cycles one, two and three. The three dose levels to be evaluated are 100 million, 300 million and 1 billion cells per injection, respectively.

On November 30, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported presentations of clinical and scientific data related to Peripheral T-cell Lymphoma (PTCL) and EVOMELA (melphalan) at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) being held in San Diego, California, from December 1-4, 2018 (Press release, Spectrum Pharmaceuticals, NOV 30, 2018, View Source [SID1234531743]).

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For more information about the ASH (Free ASH Whitepaper) annual meeting and for a complete list of abstracts, please refer to the conference website at View Source

The following posters will be presented at the ASH (Free ASH Whitepaper) meeting:

Management of Mucositis with Use of Leucovorin as Adjunct to Pralatrexate in Treatment of Patients with Hematological Malignancies including of Peripheral and Cutaneous T-Cell Lymphomas-Results from a Prospective Multicenter Phase 2 Clinical Trial. Poster 2910; Presented on Sunday, Dec 2, 6:00 PM-8:00 PM, Hall GH
Role of Single Agent and Combination Chemotherapy Strategies in Relapsed/Refractory Peripheral T-Cell Lymphoma: Results from the Complete Registry. Poster 2926; Presented on Sunday, Dec 2, 6:00 PM-8:00 PM, Hall GH
Safety and Efficacy of Evomela in Myeloma Autotransplants; Poster 3446; Presented on Sunday, Dec 2, 6:00 PM-8:00 PM, Hall GH

On November 30, 2018 IGEM Therapeutics (IGEM or "the Company"), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer, reported it has secured an additional £3 million to close its Series A round at £5 million (Press release, IGEM Therapeutics, NOV 30, 2018, View Source [SID1234531742]). Two new investors, Alsa Holdings and UCL Technology Fund (co-managed by Albion Capital and UCLB, UCL’s commercialisation company) have joined initial investor Epidarex Capital who also committed further capital in this second close.

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The funding will enable IGEM to further develop its portfolio of IgE antibody candidates against a variety of cancers. The epsilon constant region of IgE has evolved to fight complex, multicellular parasitic organisms resident in tissue by recruiting powerful immune effector cells such as macrophages, basophils and monocytes. IGEM believes that potent immune responses arising from IgE are suited to the destruction of solid tumours which also reside in tissue. Pre-clinical proof of concept data repeatedly shows superior efficacy for IgE versus cognate IgG antibodies in a range of cancer models.

Alek Safarian, Chief Executive Officer of Alsa Holdings, commented: "We are excited by the promise that IGEM’s technology holds for major therapeutic advances in a host of oncology indications, and are looking forward to working with the management team to help bring new options to oncology patients in the future."

Dr Christoph Ruedig, Partner at Albion Capital commented: "The UCL Technology Fund strives to back innovative early stage companies that are seeking to translate ground-breaking research into commercial and societal impact. The pioneering work of Dr Sophia Karagiannis and her collaborators, which includes significant clinical development by clinical academics from UCL, highlight the profound potential of IgE antibody technology in cancer therapeutics. We are delighted to invest alongside Epidarex and Alsa and look forward to working with IGEM’s accomplished executive team."

Dr Peter Finan, Partner at Epidarex Capital, commented: "IGEM continues to make great progress on this disruptive platform. We look forward to working closely with Alsa and Albion to maximise IGEM’s potential"

Dr Tim Wilson, Chief Executive Officer of IGEM, commented: "This new financing will allow IGEM to continue to pioneer the development of IgE therapeutic antibodies for the treatment of cancer. We are very pleased to have attracted new investors of the calibre of Alsa Holdings and UCL Technology/Albion to IGEM as well as receiving further investment from initial investor Epidarex Capital."