On November 4, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported progress on its clinical development programs and its financial results for the quarter ended September 30, 2016 (Filing, Q3, GlycoMimetics, 2016, NOV 4, 2016, View Source [SID1234516276]).

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"For GlycoMimetics, the third quarter was highlighted by continued achievements in our clinical development programs, particularly with regard to GMI-1271, our clinical-stage E-selectin antagonist. We announced initiation of a Phase 1 clinical trial of GMI-1271 in multiple myeloma, expanding potential uses of the drug candidate. We continue to enroll the Phase 2 portion of the GMI-1271 AML trial in both newly diagnosed and relapsed/refractory patients. We also announced the initiation of a Phase 1 clinical trial of our next drug candidate, GMI-1359, in healthy volunteers. After the close of the quarter, we announced the acceptance of multiple abstracts for six posters and one oral presentation at ASH (Free ASH Whitepaper) in December 2016. With our new trial initiations and continued enrollment in our ongoing trials, we expect to be in a position to provide additional news on the clinical development of GMI-1271 and GMI-1359 in late 2016 and throughout 2017," said Rachel King, GlycoMimetics’ Chief Executive Officer.

Key Operational Highlights:
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GlycoMimetics dosed the first patient in a Phase 1 clinical trial of GMI-1271 for multiple myeloma (MM) in September 2016. The multi-center, open-label dose escalation trial, which has begun in Ireland, is designed to measure the efficacy, safety and pharmacokinetics of GMI-1271 in combination with bortezomib-based chemotherapy among patients who have been diagnosed with MM and have not responded well to standard chemotherapy.

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GlycoMimetics initiated dosing in a Phase 1 clinical trial of its next drug candidate, GMI-1359, in healthy volunteers. GMI-1359 is a small molecule drug candidate that simultaneously inhibits both E-selectin and CXCR4. In this first-in-humans trial, volunteer participants will receive a single injection of GMI-1359, after which they will be evaluated for safety, tolerability, pharmacokinetics

and pharmacodynamics over 16 days. The randomized, double-blind escalating dose study is being conducted at a single site in the United States.

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We continue to recruit and dose patients in the Phase 2 portion of our clinical study evaluating GMI-1271 in AML in both newly diagnosed and relapsed/refractory patients at 8 active sites in the United States, Ireland and Australia. Having recently been granted fast track status by the FDA for GMI-1271 in this indication, GlycoMimetics plans to continue to engage with the FDA to discuss clinical and manufacturing planning as the program progresses.

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GlycoMimetics also recently announced that six posters and one oral presentation on data from three of the company’s clinical programs will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s Annual Meeting in December 2016.

Third Quarter 2016 Financial Results:

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Cash position: As of September 30, 2016, the Company had cash and cash equivalents of $45.3 million as compared to $46.8 million as of December 31, 2015.

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Revenue: Revenue for the three-month periods ended September 30, 2016 and 2015 was not material. There were no milestone or royalty payments due from Pfizer during the three months ended September 30, 2016 or 2015.

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R&D Expenses: The Company’s research and development expenses increased to $5.9 million for the quarter ended September 30, 2016 as compared to $5.0 million for the third quarter of 2015. The increase was due to higher costs associated with the clinical trials for GMI-1271 in AML and MM and for GMI-1359 in healthy volunteers, partially offset by a decrease in expenses related to manufacturing and process development for GMI-1271.

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G&A Expenses: The Company’s general and administrative expenses decreased to $2.0 million for the quarter ended September 30, 2016 as compared to $2.1 million for the third quarter of 2015. The decrease was related to slightly lower legal expenses, patent fees and commercial research fees.

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Shares Outstanding: Shares outstanding as of September 30, 2016 were 23,063,430.

About GMI-1271
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow, we believe that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that affect the bone marrow such as AML and MM, as compared to targeting CXCR4 alone. In December 2015 at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), we presented preclinical data suggesting that GMI-1359 may enhance the ability of chemotherapy to target and improve survival rates in patients with a high-risk form of mutated AML.
About Rivipansel
GlycoMimetics’ most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer.

On November 4, 2016 Apogenix, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, reported the achievement of additional milestones under its licensing agreement with CANbridge Life Sciences for the development and commercialization of lead candidate APG101 (INN: asunercept) in China, Macao, Hong Kong and Taiwan, triggering further paymentsto Apogenix (Press release, Apogenix, NOV 4, 2016, View Source [SID1234524576]). The milestones are related to the successful implementation of the technology transfer necessary for the production of this CD95 ligand inhibitor at the Chinese production site.

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Over the course of the past few months, Apogenix and CANbridge have successfully transferred the necessary cell banks, assays, protocols, and know-how for the manufacturing of asunercept to China. The manufacturing process has proven to be very robust with product quality and process yields of the active substance comparable to the manufacturing process developed by Apogenix

CANbridge also reported that clinical development of asunercept is now underway in Taiwan. The recently initiated Phase I/II trial is evaluating asunercept plus temozolomide (TMZ) during and after radiation therapy in 55 patients with newly diagnosed glioblastoma. The study design consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II part will evaluate efficacy and safety.

"We are very pleased with the progress of our collaboration with CANbridge and the achievement of additional milestones," said Thomas Hoeger, Ph.D., CEO of Apogenix. "With the successful technology transfer and the initiation of the Phase I/II trial in Taiwan,the clinical development of asunercept in Asia in now well underway. We look forward to CANbridge initiating further trials in China soon."

James Xue Ph.D., Chairman and CEO of CANbridge: "The complex transfer of asunercept production technology and know-how has been very efficient due to the excellent collaboration between the CANbridge and Apogenix teams. In particular, we were impressed by the exceptional level of enthusiasm and professional handling during the entire process."

About Asunercept (APG101)
Apogenix’s lead immuno-oncology candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. Asunercept is being developed for the treatment of solid tumors and malignant hematological diseases. By blocking the CD95 ligand, which negatively regulates erythrocyte production in myelodysplastic syndromes (MDS) patients, asunercept directly addresses the cause of the disorder and could thus potentially provide a cure for MDS. The World Health Organization (WHO) has recently assigned the international nonproprietary name (INN) "asunercept" for APG101.

On November 4, 2016 Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, reported that the United States Patent and Trademark Office (USPTO) has granted two patents: Patent No. 9,468,687 B2 – Immuno Gene Therapy for Treatment of Cancer and Hyperproliferative Diseases, which expands the use of GEN-1 into additional cancer treatment modalities in combination with other chemotherapeutics and Patent No. 9,144,546 – Nucleic Acid-Lipopolymer Compositions, which expands and extends previous patent claims on the making of and composition of formulations consisting of our PPC delivery polymer and nucleic acids (Press release, Celsion, NOV 4, 2016, View Source [SID1234516252]).

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These new patents further strengthen coverage of GEN-1, the Company’s DNA-based immunotherapy in development for the localized treatment of ovarian cancer and glioblastoma multiforme (GBM), which is already covered by a composition of matter patent in the United States.

"Issuance of these patents further strengthens Celsion’s growing position as a leader in the development of gene-based immunotherapies addressing some of the most difficult-to-treat cancers, such as ovarian cancer and GBM by covering the use of GEN-1 for treating solid tumors as a monotherapy and in combination with chemotherapy," said Michael H. Tardugno, chairman, president and CEO. "GEN-1 leverages our proprietary TheraPlas technology platform, harnessing the power of IL-12 immunotherapy with a targeted delivery system engineered to overcome the limitations associated with the development of other dosage forms of IL-12 therapies."

About GEN-1
GEN-1 is being evaluated in an ongoing Phase 1b dose-escalating clinical trial (the "OVATION Study") combining GEN-1 with the standard of care for the treatment of newly diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debunking surgery. The OVATION Study is designed to enroll three to six patients per dose cohort at escalating doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an antitumor immune response.

As previously reported, all six patients in the first two cohorts of the OVATION Study experienced a clinically meaningful response, ranging from stable disease to one pathologically confirmed complete response. In addition, all patients sustained decreases of 90% or greater of the prospective indicator of the presence of ovarian cancer cells, CA-125 protein as well as highly impressive pathologically responses, which is associated with prolonged survival. The first three cohorts each enrolled three patients. Enrollment in the fourth and final cohort is underway, and Celsion expects to report full data from the OVATION Study by the first quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil for the treatment of recurrent ovarian cancer.

On November 4, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; "Sumitomo Dainippon Pharma") reported that clinical data of an investigational WT1 cancer peptide vaccine, DSP-7888 will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego from December 3 to 6, 2016 (Press release, Dainippon Sumitomo Pharma, NOV 4, 2016, View Source [SID1234516253]).

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Planned poster sessions include:
1. Abstract #4335, [637. Myelodysplastic Syndromes―Clinical Studies: Poster III]
Preliminary Results from a Phase 1/2 Study of DSP-7888, a Novel WT1 Peptide-Based Vaccine, in Patients with Myelodysplastic Syndrome (MDS)
Presenter: S. Miyakoshi (Department of Hematology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo, Japan)
Monday, December 5 from 6:00 p.m. – 8:00 p.m. (local time), Hall GH
The abstract is now available on the official website of ASH (Free ASH Whitepaper) (URL: View Source)
Highlights of the abstract】
In phase 1 portion, azacitidine (the first-line treatment option) failure higher-risk (7 patients) and transfusion-dependent lower-risk (5 patients) MDS patients (total 12 patients) were enrolled in 3.5 or 10.5 mg/body cohorts. Safety and tolerability were evaluated, and delayed type hypersensitivity (DTH), WT1-specific CTL induction and expression of WT1 mRNA in peripheral blood and bone marrow cells were also examined.

DSP-7888 was well-tolerated in MDS patients and dose-dependent toxicity was not observed except for ISR, although ISR was observed in all patients.

Disease control rate (PR+SD) was observed in 66.6 % and CTL induction, one of the secondary clinical activities, was observed in 50% of the 12 evaluable patients.

2. Abstract #4715, [802. Chemical Biology and Experimental Therapeutics: Poster III]
DSP-7888, a Novel Cocktail Design of WT1 Peptide Vaccine, and Its Combinational Immunotherapy with Immune Checkpoint-Blocking Antibody Against PD-1
Note:This data is non-clinical evaluation. 2
Presenter: M. Goto (DSP Cancer Institute, Sumitomo Dainippon Pharma Co., Ltd., Japan) Monday, December 5 from 6:00 p.m. – 8:00 p.m. (local time), Hall GH
The abstract is now available on the official website of ASH (Free ASH Whitepaper) (URL: View Source)

On November 4, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that data from three drug candidates in its development pipeline will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Expo (Press release, GlycoMimetics, NOV 4, 2016, View Source [SID1234516348]). The ASH (Free ASH Whitepaper) meeting will take place December 3 to 6, 2016, at the San Diego Convention Center.

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The oral presentation and six posters to be shared at the ASH (Free ASH Whitepaper) meeting will review the results of pre-clinical and clinical research on the pan-selectin antagonist, rivipansel, that GlycoMimetics is developing in partnership with Pfizer, Inc.; the company’s E-selectin antagonist, GMI-1271; and the company’s dual E-selectin/CXCR4 antagonist, GMI-1359. The data presented will show significant progress in a clinical trial for acute myeloid leukemia (AML), pre-clinical data further expanding on the mechanism and potential for therapeutic benefit in sickle cell anemia, and pre-clinical data on effects of GMI-1359 in models of hematologic malignancies. The company will present updates with interim data from an on-going Phase 1/2 trial of GMI-1271 in patients with AML. This will include an update on patients enrolled in the Phase 1 portion of the trial as well as data on evaluable patients enrolled to date in the two Phase 2 arms of the study. The Phase 2 portion includes one arm enrolling patients with relapsed or refractory disease and one arm enrolling patients over the age of 60 with newly diagnosed disease.

"We are delighted to have multiple abstracts accepted at ASH (Free ASH Whitepaper), highlighting the success and breadth of our growing pipeline," said Rachel King, Chief Executive Officer of GlycoMimetics. "Our new clinical and preclinical data show the scientific rationale for continuing development of all three drug candidates, as well as significant momentum in our clinical program for GMI-1271 in AML."

Details of the data to be presented at ASH (Free ASH Whitepaper), including session times and locations, include:

Oral Presentation (submitted by Pfizer, Inc.)

Abstract #270-Rivipansel: A Small Pan-Selecting Antagonist Improves Cerebral Perfusion and Inhibits Leukocyte Adhesion and in Murine Sickle Cell Disease Model. Sunday, Dec. 4, 7:30-9:00 a.m. PT, Room 7AB.

Posters (all poster sessions are in the San Diego Convention Center, Hall G)

Abstract #4049–A Phase I/II Study of GMI¬1271, a Novel E¬Selectin Antagonist, in Combination with Induction Chemotherapy in Relapsed/Refractory and Elderly Previously Untreated Acute Myeloid Leukemia; Results to Date. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session

Abstract #3826–E¬Selectin Antagonist GMI¬1271 Shows a Favorable Safety, PK and Bleeding Profile in Phase I Studies of Healthy Volunteers. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session

Abstract #2823–Vascular E-Selectin Protects Leukemia Cells from Chemotherapy By Directly Activating Pro-Survival NF-Kb Signaling – Therapeutic Blockade of E-Selectin Dampens NF-Kb Activation. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #3519—Dual E-Selectin/CXCR4 Antagonist GMI-1359 Exerts Efficient Anti-Leukemia Effects in a FLT3 ITD Mutated Acute Myeloid Leukemia Patient-Derived Xenograph Murine Model. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #2826—Administration of the Dual E-Selectin/CXCR4 Antagonist, GMI-1359, Results in a Unique Profile of Tumor Mobilization from the Bone Marrow and Facilitation of Chemotherapy in a Murine Model of FLT3 ITD AML. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #2509–Rivipansel (GMI-1070) Inhibits E-Selectin Recognition of Sialyl LewisX Activation and Arrest of Human Neutrophils Expressed on CD62L (L-selectin) and Blocks Integrin. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

The meeting abstracts are available at ASH (Free ASH Whitepaper)’s website.