On May 17, 2018 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the selection of four abstracts for oral and poster presentations at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 14-17, 2018 in Stockholm, Sweden (Press release, Verastem, MAY 17, 2018, View Source [SID1234526786]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. An oral presentation by Dr. Matthew Davids, Dana-Farber Cancer Institute, will highlight the latest data from a Phase Ib/II study of duvelisib in combination with FCR (dFCR) as a frontline treatment in younger patients with chronic lymphocytic leukemia (CLL). Three posters will highlight additional duvelisib data, including crossover extension results from the Phase 3 DUO study in patients with relapsed or refractory CLL/small lymphocytic lymphoma (CLL/SLL), and new biomarker analyses on the tumor microenvironment modulation from DUOTM and the Phase 2 DYNAMOTM study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and the dual PI3K-delta and PI3K-gamma activity of duvelisib in the CONTEMPOTM study in patients with untreated follicular lymphoma who are treated with duvelisib in combination with CD20 antibody immunotherapy.

"At EHA (Free EHA Whitepaper) 2018, Dr. Matthew Davids will deliver an oral presentation describing results from the ongoing Phase Ib/II study evaluating duvelisib in combination with FCR (chemo-immunotherapy) in younger CLL patients," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology. "To date, the combination regimen has shown to be effective as an initial therapy with an ORR of 97%, including 28% of evaluable patients achieving a complete response or complete response with incomplete blood count recovery, and 69% achieving a partial response. A high rate of 81% bone marrow MRD negativity was observed in patients with at least one evaluation. Collectively, the data being presented at EHA (Free EHA Whitepaper) this year continue to provide important insights to guide the future clinical development of duvelisib across a wide range of hematologic malignancies, both as a monotherapy and in combination with other agents."

Details for the EHA (Free EHA Whitepaper) 2018 presentation and posters are as follows:

Oral Presentation

Title: A Phase IB/II Study of duvelisib in combination with FCR (DFCR) for Frontline Therapy of Younger CLL Patients
Lead author: Dr. Matthew Davids, Dana-Farber Cancer Institute
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Combination treatment with targeted agents in CLL
Date and Time: Saturday, June 16, 12:15 – 12:30 CEST
Location: Victoria Hall
Final Abstract Code: S807
Poster Presentations

Title:The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in a Phase 3 Crossover Extension Study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF354

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma.
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF646

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study).
Lead author: Dr. David Weaver, Verastem Oncology
Topic: Non-Hodgkin lymphoma Biology & Translational Research
Session Title: Non-Hodgkin lymphoma Biology & Translational Research
Date and Time: Friday, June 15, 17:30 – 19:00 CEST
Location: Poster area
Final Abstract Code: PF649

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov

On May 17, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported the pricing of a global offering of 1,800,000 ordinary shares, comprised of 523,913 ordinary shares in the form of American Depositary Shares (ADSs) offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $26.28, and 1,276,087 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €22.29 (the "global offering") (Press release, Celyad, MAY 17, 2018, View Source [SID1234532516]). Each ADS represents the right to receive one ordinary share. The price per ADS was determined based on an exchange rate of $1.1789 per euro. The gross proceeds to Celyad from the global offering are expected to be approximately $47.3million (approximately €40.1 million), before deducting underwriting commissions and estimated offering expenses.
In addition, Celyad has granted the underwriters a 30-day option to purchase up to an additional 270,000 ordinary shares, which may be in the form of ADSs, on the same terms and conditions. The closing of the global offering is expected to occur on May 22, 2018, and is subject to customary closing conditions.

Celyad’s ADSs are currently listed on the NASDAQ Global Select Market under the symbol "CYAD" and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris.

Wells Fargo Securities, LLC and Bryan, Garnier & Co. are acting as joint bookrunning managers for the offering. Bank Degroof Petercam NV is acting as a co-manager for the private placement and LifeSci Capital LLC is acting as a co-manager for the global offering. Kempen & Co NV is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement dated May 15, 2018 relating to and describing the terms of the offering was filed with the SEC on May 16, 2018. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or email a request to [email protected] or Bryan, Garnier & Co., Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that clinical data from SL-801 and SL-701 trials have been selected for poster presentations at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 1-5, 2018, at McCormick Place in Chicago, Illinois (Press release, Stemline Therapeutics, MAY 17, 2018, View Source [SID1234526753]). Abstracts are now available on the ASCO (Free ASCO Whitepaper) conference website.

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Details on the presentations are as follows:

Phase 2 Trial of SL-701 in Relapsed/Refractory Glioblastoma (GBM): Correlation of Immune Response with Longer-Term Survival

Abstract: 2058
Session: Central Nervous System Tumors
Presenter: David Peereboom, MD; Cleveland Clinic
Date: Saturday, June 2, 2018
Time: 1:15 – 4:45 PM CT
Interim Results from A Phase 1 Trial Of SL-801, A Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors

Abstract: 2560
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Presenter: Judy Wang, MD; Florida Cancer Specialists and Research Institute
Date: Monday, June 4, 2018
Time: 8:00 – 11:30 AM CT
About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.

On May 17, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that the Company has been issued Patent No. 9,856,324 by the United States Patent and Trademark Office (USPTO) for a patent titled, "HUMAN MONOCLONAL ANTIBODIES TO GANGLIOSIDE GD2 (Press release, MabVax, MAY 17, 2018, View Source [SID1234526770])."

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This is the second patent issued in the antibody portfolio created through MabVax’s unique discovery platform, which uses blood samples from patients vaccinated with selected tumor associated carbohydrate antigens. The recovery of human antibodies directly from vaccinated cancer patients makes the antibodies discovered by MabVax highly unique and potentially useful while reducing the kinds of toxicities induced by non-human antibodies. Similar to the Company’s sialyl lewis A (sLea) and Thomsen-nouveau (Tn) antigen targeting antibodies, the ganglioside GD2 targeting antibodies have the potential to be developed as therapeutic and diagnostic products. Additional disease targets for anti-GD2 antibodies include sarcoma, melanoma, and neuroblastoma.

"The issuance of this patent represents another valuable intellectual property asset brought forward by MabVax and is an important component of our unique discovery strategy and expands our robust patent estate. Importantly, this filing is timely as we evaluate additional product candidates that have the potential to address significant unmet needs in the treatment of cancers to fuel our pipeline and expand our partnering discussions," stated David Hansen, MabVax’s President and Chief Executive Officer.

The Company has already made substantial progress required to translate the GD2 preclinical development program into clinical development. In collaboration with St. Jude Children’s Research Hospital, data from the preclinical development program were presented as a poster at the World Molecular Imaging Conference last year. The results of the study demonstrated the anti-GD2 antibodies had high specificity and antibody drug conjugates based on these antibodies were readily internalized and cytotoxic. Immuno-PET agents developed with these antibodies showed good accumulation on osteosarcoma tumors and demonstrated potential utility as a diagnostic imaging agent.

On May 17, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that an abstract highlighting X4P-001-RD, the company’s CXCR4 antagonist, has been selected for poster presentation at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 14-17 in Stockholm, Sweden (Press release, X4 Pharmaceuticals, MAY 17, 2018, View Source [SID1234526787]). The presentation will describe interim clinical results from the ongoing Phase 2/3 study of X4P-001-RD in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease.

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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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X4 Pharmaceuticals will present clinical data from a PH2 study of X4P-001-RD in WHIM syndrome at the annual European Hematology Assoc. meeting #EHA23

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Details of the presentation on X4P-001-RD in WHIM syndrome are as follows:

Title: Phase 2 Study of X4P-001: A Targeted Oral Therapy for Patients with WHIM Syndrome

Author: David Dale, M.D., University of Washington

Abstract #: PS1056

Poster Session: Bone marrow failure syndromes incl. PNH – Clinical

Date and Time: Saturday, June 16, 5:30-7:00 p.m. CEST

About WHIM Syndrome

WHIM syndrome is a primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene resulting in susceptibility to certain types of infections. WHIM is an abbreviation for the characteristic clinical symptoms of the syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. Within the overall category of primary immunodeficiencies, there are between 15,000 and 100,000 patients in the US that are classified with primary immunodeficiency disease of unknown origin – of which WHIM is one.1,2,3 WHIM syndrome is a rare disorder and the precise prevalence or incidence of patients that have the genetic mutation responsible for WHIM syndrome is unknown. Because patients are highly susceptible to infections, WHIM syndrome is associated with significant morbidity beginning in early childhood and continuing throughout life. Current therapy is limited to treatment of acute infections with antibiotics or prevention through the use of intravenous immunoglobulin or G-CSF. There is no approved therapy for the treatment of WHIM syndrome.