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GlycoMimetics Completes Enrollment of Relapsed/Refractory AML Patient Cohort in Phase 2 Portion of Clinical Trial of GMI-1271

On May 31, 2017 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that the second of two patient cohorts in the Phase 2 portion of its ongoing Phase 1/2 clinical trial of GMI-1271 in patients with acute myeloid leukemia (AML) has completed enrollment (Press release, GlycoMimetics, MAY 31, 2017, View Source [SID1234519338]). This second cohort is comprised of 66 participants with relapsed/refractory AML. The study is designed to evaluate the potential of GMI-1271, an E-selectin antagonist drug candidate, in combination with chemotherapy, as a treatment for individuals with either newly diagnosed or relapsed/refractory AML. Enrollment in the study’s first arm in newly diagnosed elderly AML patients was completed in the first quarter of this year. GlycoMimetics expects to submit interim study data for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017.

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"Across the two cohorts of this Phase 1/2 clinical trial, we have a strong sample size of 91 patients and experienced brisk enrollment, which we feel is indicative of the strong interest that our clinical investigators have for this novel agent," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "We are further encouraged by GMI-1271’s achievement of European Orphan Designation as well as the recent granting of Breakthrough Therapy designation by the U.S. Food & Drug Administration (FDA) for the treatment of adults with relapsed/refractory AML. We believe GMI-1271, when combined with chemotherapy, has the potential to address an unmet therapeutic need for individuals living with AML, and we are encouraged by both our clinical results to date and the acknowledgement of the U.S. and European regulatory agencies."

Interim clinical data from the ongoing trial of GMI-1271 will be presented at the 2017 meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper). To date, GMI-1271 has been consistently well tolerated, with no obvious incremental toxicity when added to chemotherapy. In addition, patients with AML treated with GMI-1271 have experienced higher than expected remission rates and lower than expected 30- and 60-day mortality rates.

"The consistency of our data readouts is great news in and of itself, and the emerging biomarker data is especially encouraging," said Rachel King, CEO of GlycoMimetics. "AML has long been a difficult indication for the developers of new therapeutics, and we continue to feel more confident that our investigational drug, GMI-1271, may play a role in addressing key unmet needs in this deadly cancer."

In addition to the ongoing Phase 1/2 trial, clinical investigators are currently evaluating GMI-1271 in an ongoing Phase 1 clinical trial in multiple myeloma. Preclinical data supporting the multiple myeloma study was recently published in an online preview of the journal Leukemia on April 25, 2017. Specifically, the newly published preclinical results indicate that myeloma with higher levels of E-selectin ligands is a more aggressive disease that is more likely to be resistant to bortezomib, which is currently the front-line standard of care The publication reported that in preclinical studies, the combination treatment of GMI-1271 to bortezomib was able to break this chemoresistance and restore sensitivity to bortezomib which led to significant improvement in survival. This preclinical multiple myeloma conclusion supports the clinical findings on the potential biomarker that the Company is presenting at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) next month.

About AML

AML is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults. The National Cancer Institute estimates that there will be over 21,000 new cases of AML diagnosed in 2017 in the United States, and over 10,000 people will die from all forms of the disease in 2017. AML is more commonly present in elderly patients. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.

2X ONCOLOGY TO PRESENT AT JEFFERIES GLOBAL HEALTHCARE CONFERENCE

On May 31, 2017 2X Oncology, Inc. ("2X" or the "Company"), a company focused on developing targeted therapeutics to address significant unmet needs in women’s cancer, reported that its chief executive officer, George O. Elston, will present at the Jefferies 2017 Global Healthcare Conference on Friday, June 9 at 10:00 am EDT (Press release, 2X Oncology, MAY 31, 2017, View Source [SID1234526105]).

The 2X presentation will be webcast live and archived for 90 days on the Company’s website under the ‘News’ tab.

Mr. Elston will be joined by other members of the executive team for a breakout session immediately after the presentation, and for one-on-one meetings throughout the conference. Please contact your Jefferies representative or Amy Raskopf to schedule a meeting with 2X.

MabVax Therapeutics Signs Research Agreement with Memorial Sloan Kettering Cancer Center to Develop Novel CAR T-Cell Based Anti-Cancer Immunotherapies for Treatment of Pancreatic and Small Cell Lung Cancers

On May 31, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical stage oncology drug development company, reported it entered into a sponsored research agreement with Memorial Sloan Kettering Cancer Center (MSK) for the development of novel Chimeric Antigen Receptor (CAR) T-cell therapeutics using antibody targeting sequences derived from MabVax’s fully-human antibodies for pancreatic, small cell lung, and other solid tumor cancers (Press release, MabVax, MAY 31, 2017, View Source [SID1234519339]). CAR T-cell therapeutics are unique anti-cancer immunotherapies that genetically modify a patient’s own T-cells to recognize an antigen on targeted tumor cells.

Under the new agreement, MabVax will provide funding to evaluate the efficacy of multiple CAR T-cell products incorporating several different antibody targeting sequences. The research program will evaluate in xenograft models of pancreatic and small cell lung cancer targeting sequences from MabVax’s leading monoclonal antibody clinical development candidate HuMab-5B1. Multiple CAR T-cell constructs have been created and tested in cell based assays demonstrating utility and warranting continued testing in animal models of pancreatic cancer and other CA19-9 expressing tumors.

MabVax has provided a second set of novel antibody targeting sequences from its clinical and research programs to MSK for development into new CAR T-cell constructs for the treatment of solid tumors. MSK will evaluate the new CAR T-cell constructs and test in both in vitro and in animal models of solid tumors with a goal of completing investigational new drug (IND) enabling pre-clinical studies. The work will be conducted in the laboratory of Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Gene Transfer and Gene Expression at MSK.

MabVax has certain rights to the new CAR T-cell inventions developed during the collaboration, including an exclusive time-limited option to license MSK’s rights in such inventions.

"We are excited that we have finalized this important research opportunity with MSK," stated J. David Hansen, Chief Executive Officer of MabVax. "We believe that the human targeting sequences derived from our antibody program have demonstrated remarkable specificity for antigens that are over-expressed on difficult to treat cancers. Importantly, this collaboration will bring us another step forward as we aim to further understand the depth, breadth and utility of our pipeline. Incorporating those discoveries into promising CAR T-cell technology developed at MSK holds real promise for patients suffering from solid tumor cancers. We look forward to working with MSK to evaluate these novel CAR T-cell products."

TRILLIUM THERAPEUTICS ANNOUNCES PRESENTATION ON TTI-621 IMMUNE CHECKPOINT INHIBITOR TARGETING CD47 AT 2017 ASCO ANNUAL MEETING

On May 31, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, will present its TTI-621 (SIRPaFc) immune checkpoint inhibitor program at the Trials in Progress Session of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago from June 2-6 (Press release, Trillium Therapeutics, MAY 31, 2017, View Source [SID1234519335]).

Details of Trillium’s ASCO (Free ASCO Whitepaper) presentation are as follows:

Presentation Type: Poster
Abstract #: TPS3101
Title: A phase 1 dose-escalation trial of intratumoral TTI-621, a novel immune checkpoint inhibitor targeting CD47, in subjects with relapsed or refractory percutaneously-accessible solid tumors and mycosis fungoides
Presenter: John A. Thompson, M.D., University of Washington, Seattle Cancer Care Alliance, Seattle, WA
Category: Developmental Therapeutics – Immunotherapy; Sub-category – Immune Checkpoint Inhibitors
Time/Location: Monday June 5, 8-11:30 a.m. CT in Hall A, Poster Board #191a

MEI Pharma Announces Pre-Specified Response Rate Exceeded in Dose-Escalation Study of ME-401 in Chronic Lymphocytic Leukemia and Follicular Lymphoma

On May 31, 2017 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that an independent Safety Review Committee completed its pre-specified review of the first cohort of six evaluable patients in a Phase Ib, open-label, dose-escalation study of the Company’s investigational drug candidate ME-401, a potent and selective oral PI3K delta inhibitor, in relapsed refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma (Press release, MEI Pharma, MAY 31, 2017, View Source [SID1234519331]).

Based on its review of the safety and efficacy data, the Safety Review Committee declared a minimum biologically effective dose (mBED) for ME-401 at the starting dose of 60 mg and recommended escalation to a 120 mg dose cohort. According to the study protocol, the mBED is defined as a dose that is safe and achieves a response in at least three of six patients. Response assessments are based on criteria of the International Workshop on Chronic Lymphocytic Leukemia for patients with CLL or the Lugano Classification for patients with follicular lymphoma. Response is initially assessed after 8 weeks of therapy.

To date, all six patients have been on study for a minimum of 10 weeks (range, 10-28 weeks). There have been no reports of ALT AST elevations, colitis or pneumonitis, events commonly reported with other drugs in this class. One patient in the study experienced grade 3 neutropenia that was considered related to study drug. All other adverse events reported were grades 1 or 2. No patients have discontinued due to adverse events. Full data will be submitted for presentation at an upcoming scientific meeting.

"Given the high bar we have placed on the ME-401 program, we are very pleased with the early safety and efficacy data from this study," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "PI3K delta inhibitors have demonstrated clear activity in the treatment of CLL and follicular lymphoma, but at the expense of well-defined and substantial toxicities. We believe this provides an opportunity for a highly differentiated drug that is both effective and safe. Now we look forward to demonstrating the therapeutic index of ME-401 across multiple dose cohorts and presenting detailed results later this year."

ME-401 is a highly differentiated oral PI3K delta inhibitor that has a distinct chemical structure from other drugs in its class, including the approved drug idelalisib (marketed as Zydelig). Results from a Phase I first-in-human study of ME-401 showed levels of drug exposure that support the potential for an improved therapeutic window compared to idelalisib, with a half-life that supports once-daily dosing.

The ongoing Phase Ib study is designed to determine the minimum biologically effective dose, maximally tolerated dose, dose limiting toxicities and recommended Phase 2 dose of ME-401 while evaluating its safety, efficacy and pharmacokinetics. The study, which opened for enrollment in September 2016, is expected to enroll up to 84 patients at approximately 10 sites. Additional information regarding the study, including inclusion and exclusion criteria, is available at www.clinicaltrials.gov (identifier: NCT02914938).

About ME-401

ME-401 (formerly PWT143) is an orally bioavailable, potent and selective inhibitor of phosphatidylinositol 3 kinase (PI3K) delta, a molecular target that has been shown to play a critical role in the proliferation and survival of certain hematologic cancer cells. Results from a first-in-human, single ascending dose clinical study of ME-401 in healthy volunteers were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2016. The data demonstrated on-target activity at very low plasma concentrations and suggest that ME-401 has a superior pharmacokinetic and pharmacodynamic profile compared to idelalisib. The U.S. Food and Drug Administration approved an Investigational New Drug application for ME-401 in B-cell malignancies in March 2016.

MEI Pharma owns exclusive worldwide rights to ME-401.