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.

On May 30, 2017 SYNIMMUNE GmbH, a biotechnology company focusing on the development of innovative and effective anti-tumor antibodies for orphan hematopoietic malignancies, reported that the Company has recently initiated a first-in-human clinical study of FLYSYN, a novel Fc-optimized antibody, for the treatment of acute myeloid leukemia (AML) (Press release, Synimmune, MAY 30, 2017, View Source [SID1234552070]).

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The phase I study of FLYSYN is being conducted at the University Hospital Tuebingen and at the University Hospital Ulm in Germany and will enroll up to 28 AML patients with minimal residual disease. Four patient cohorts will receive increasing doses of FLYSYN, each as a single intravenous infusion. The dose escalation phase will be followed by an expansion cohort phase to assess initial efficacy.

The primary endpoints of the study are safety and tolerability. Secondary endpoints include immunogenicity, pharmacokinetics and pharmacodynamics as well as preliminary efficacy in terms of overall response rate and duration of response. Patients will be followed for up to 18 months. Preliminary results from the trial are expected in 2018, the trial is projected to complete in early 2019.

"The initiation of this phase I study with FLYSYN is a major milestone for SYNIMMUNE, as this is the first antibody from our pipeline to be tested in humans," said Dr. Martin Steiner, CEO of SYNIMMUNE GmbH. "The key goals of this study are to determine the maximum tolerated dose and to assess the preliminary therapeutic effect of FLYSYN in AML patients with minimal residual disease. Today, the majority of these patients relapse within several months. Our antibody is intended to delay or even prevent such relapse. We therefore believe that, if proven safe and effective, FLYSYN could become an attractive treatment option for many AML patients."

About FLYSYN:

The chimeric and Fc-optimized IgG1 antibody FLYSYN binds specifically and with high avidity to the human fms-like tyrosine kinase 3 (FLT3). An increased expression of this cell surface receptor is measured on leukemic blast cells in 70-100% of AML patients, while only small amounts of FLT3 are expressed on monocytes and progenitor stem cells, avoiding off-target binding and stem cell toxicity. Therefore, FLT3 is a suitable and highly selective target for therapeutic antibodies to treat leukemia patients.

FLYSYN contains a genetic optimization of its Fc-part, resulting in optimized binding to cells expressing the Fc receptor, particularly Natural Killer (NK) cells, and thus in substantially improved antibody-dependent cell-mediated cytotoxicity (ADCC). FLYSYN is a monospecific antibody for the treatment of AML patients at a stage of minimal residual disease (MRD). Most AML patients achieve complete remission (CR) with MRD after regular chemotherapy, but the majority relapses to AML within several months, requiring additional courses of chemotherapy or stem cell transplantation. FLYSYN is intended to delay or prevent such relapse in AML patients with MRD.

On May 30, 2017 i2 Pharmaceuticals, Inc., a biopharmaceutical company focused on next generation discovery and development of therapeutics with a focus on personalized cancer treatment, reported the acquisition of all of the antibody and engineered protein technology of Sea Lane Biotechnologies, LLC, Redwood City, California, including several potential product candidates (Press release, i2 Pharmaceuticals, MAY 30, 2017, View Source [SID1234521986]).

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The acquisition consists of three distinct classes of protein therapeutics, including world-class human antibody libraries, human b-cell derived antibodies, and a new class of engineered protein therapeutics called Surrobodies. Surrobodies allow for the facile creation of bispecific therapeutic agents from vast arrays of monospecific agents. In addition, this new class of protein can be readily transformed by coupling small molecule drugs to Surrobodies to create Surrobody Drug Conjugates (SDC’s), the next generation in potent cancer therapeutics.

"We are thrilled with the acquisition of the product candidates and technologies so exquisitely crafted at Sea Lane. In particular, the antibodies and Surrobodies developed by Sea Lane for Immuno-Oncology (IO) complement existing programs at i2 Pharma in the development of cancer therapeutics," said Dr. Bruce Eaton, i2’s Founder, Chairman and CEO. "We are now uniquely positioned with protein, small molecule and RNA therapeutic modalities that can be mixed and matched to innovate beyond the traditional boundaries of drug discovery with a goal of developing next generation, highly efficacious, cost effective personalized therapeutics."

Richard Lerner, the Lita Annenberg Hazen Professor of Immunochemistry and former President of The Scripps Research Institute, believes strongly in the capabilities of the Surrobody technology. "The Surrobody technology was created as an alternative to conventional antibody based approaches, with the potential for a wide range of protein engineering advantages. The Sea Lane Biotechnologies team and their commercial and academic partners clearly demonstrated the power of the Surrobody technology for many applications including multi-specific and drug conjugate formats. With this acquisition, i2 Pharmaceuticals now has a compelling portfolio of Surrobody and antibody product candidates and technologies to add to its other exciting capabilities," Lerner stated.

"We are excited about the combination of the Sea Lane technologies and product candidates with i2 Pharma’s existing portfolio of transformative technologies for drug discovery," said Lawrence Horowitz, CEO of Sea Lane Biotechnologies.

"We share the vision at i2 Pharmaceuticals and their highly competent team. Our shared goal is efficacious, cost effective personalized therapeutics with a positive impact on patient lives. The combination of Sea Lane and i2 Pharma technologies can make that happen," said Michael Horowitz, Chief Operating Office of Sea Lane Biotechnologies.

On May 25, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the Prolaris test (Press release, Myriad Genetics, MAY 25, 2017, View Source [SID1234519305]).

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Today’s decision extends coverage to Medicare beneficiaries with favorable intermediate risk prostate cancer and builds on a prior decision that provided coverage for men with low- and very low-risk prostate cancer. The new LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website with an effective date of July 10, 2017. Prolaris is the first and only genetic test to receive Medicare coverage for favorable intermediate and low- or very low-risk prostate cancer in the United States.

"We are excited that the MolDX program has expanded Prolaris coverage to the thousands of Medicare beneficiaries with favorable intermediate risk prostate cancer," said Mark C. Capone, president and CEO, Myriad Genetics. "The coverage decision is another important step to make sure the Prolaris test is broadly accessible to the patients who need it."

Of the newly diagnosed patients with prostate cancer, approximately 20 percent will be favorable intermediate risk prostate cancer, which is defined by National Comprehensive Cancer Network (NCCN) as a Gleason score of 3+4 or less, a percentage of positive biopsy cores less than 50 percent and, at most, one NCCN determinant of intermediate-risk prostate cancer. When combined with the previous Medicare coverage decision, more than 70 percent of Medicare patients with prostate cancer will have access to the Prolaris test.

"It is clinically challenging to determine how best to treat men with favorable intermediate risk prostate cancer. Our goal is to provide physicians with genetic information and help them tailor treatments based on patients’ individual risk profiles." said Michael Brawer, M.D., senior vice president of Urology, Myriad Genetic Laboratories. "The Prolaris test accurately measures the aggressiveness of prostate cancer and give’s both the patient and physician the confidence to make appropriate medical management decisions."

About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics to quantify the aggressiveness of prostate cancer and help guide patient care. Prolaris is the only prognostic signature for prostate cancer which has been validated to predict 10-year prostate cancer specific mortality in an untreated patient cohort allowing men to make treatment decisions prior to surgical intervention. Additionally, Prolaris has been extensively validated on its ability to also predict patients that are at higher risk for biochemical recurrence and metastases. Studies have shown that following the Prolaris test almost two-thirds of men are good candidates for more conservative patient management, leading to lower treatment associated side effects and lower overall healthcare costs. For more information on how the Prolaris test can provide information to help decision-making in managing an individual’s localized prostate cancer visit www.Prolaris.com.

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, MAY 22, 2017, View Source [SID1234522121]).

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