On January 30, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Duke University investigators have dosed the first patient in a proof-of-concept Phase 1b study to evaluate GlycoMimetics’ novel GMI-1359 drug candidate in patients with advanced breast cancer (Press release, GlycoMimetics, JAN 30, 2020, View Source [SID1234553716]). The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis. GMI-1359 is a dual inhibitor of both E-selectin and CXCR4. The trial is designed to evaluate safety, pharmacokinetics and pharmacodynamic measures of biologic activity, such as increases in circulating tumor cells and mobilization of CD34+ and immune T-cell subsets. GlycoMimetics expects the trial results to be available in late 2020, the conclusions of which the Company will use to inform future development of GMI-1359.

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Kelly Marcom, M.D., and Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute, are the trial’s co-principal investigators. This clinical trial builds on published findings from Dr. Sipkins on the key roles of both E-selectin and CXCR4 in the trafficking of metastatic cancer cells and of their establishment as micro-metastases in bone. Dr. Sipkins’ research suggests that both E-selectin and CXCR4 mediate key mechanisms that promote progression and migration of cancer cells to protective niches in the bone marrow micro-environment, and reveals the potential for an E-selectin and CXCR4 inhibitor like GMI-1359 to molecularly excise disseminated breast cancer cells.1

"The initiation of enrollment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer," said GlycoMimetics Senior Vice President of Clinical Development and Chief Medical Officer Helen Thackray, M.D., FAAP. "We’re pleased to have such distinguished researchers at Duke University begin to explore the use of this investigational therapy and look forward to learning more about its potential impact as clinical study advances."

More information on this clinical trial can be found at www.clinicaltrials.gov.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as acute myeloid leukemia and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity.

On January 30, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that its partner Bayer AG has decided to advance a further programme from the endometriosis multi-target alliance into clinical Phase I development (Press release, Evotec, JAN 30, 2020, View Source;announcements/press-releases/p/evotec-and-bayer-advance-further-programme-into-phase-i-clinical-development-5905 [SID1234553682]). Evotec will receive a milestone payment of € 2 m upon first dosing in the Phase I clinical trial and may be eligible for further significant clinical and sales milestones as well as royalties depending on the future progress during clinical development and potential commercialisation of a drug in the future.

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The companies entered into their endometriosis multi-target discovery alliance in October 2012 with the aim to discover three clinical candidates. So far, the alliance generated six pre-clinical candidates, of which a fourth has now progressed into Phase I. Bayer advanced the first programme into a Phase II trial in refractory chronic cough in 2018. The Phase II study yielded positive results which met all of the targeted endpoints. For more information about this Bayer/Evotec alliance also see "White Paper on Bayer/Evotec Alliance".

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are very pleased that the excellent collaboration between Bayer and Evotec has now officially surpassed the ambitious initial target by delivering a fourth clinical drug candidate. The candidates we have identified and developed together are performing extremely well and hold great potential, most likely also beyond the initially surveyed indications."

On January 30, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Duke University investigators have dosed the first patient in a proof-of-concept Phase 1b study to evaluate GlycoMimetics’ novel GMI-1359 drug candidate in patients with advanced breast cancer (Press release, GlycoMimetics, JAN 30, 2020, View Source [SID1234553700]). The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis. GMI-1359 is a dual inhibitor of both E-selectin and CXCR4. The trial is designed to evaluate safety, pharmacokinetics and pharmacodynamic measures of biologic activity, such as increases in circulating tumor cells and mobilization of CD34+ and immune T-cell subsets. GlycoMimetics expects the trial results to be available in late 2020, the conclusions of which the Company will use to inform future development of GMI-1359.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Kelly Marcom, M.D., and Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute, are the trial’s co-principal investigators.This clinical trial builds on published findings from Dr. Sipkins on the key roles of both E-selectin and CXCR4 in the trafficking of metastatic cancer cells and of their establishment as micro-metastases in bone. Dr. Sipkins’ research suggests that both E-selectin and CXCR4 mediate key mechanisms that promote progression and migration of cancer cells to protective niches in the bone marrow micro-environment, and reveals the potential for an E-selectin and CXCR4 inhibitor like GMI-1359 to molecularly excise disseminated breast cancer cells.1

"The initiation of enrollment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer," said GlycoMimetics Senior Vice President of Clinical Development and Chief Medical Officer Helen Thackray, M.D., FAAP. "We’re pleased to have such distinguished researchers at Duke University begin to explore the use of this investigational therapy and look forward to learning more about its potential impact as clinical study advances."

More information on this clinical trial can be found at www.clinicaltrials.gov.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as acute myeloid leukemia and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity.

On January 30, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, February 14, 2020 to discuss its 2019 operating results (Press release, ImmunoGen, JAN 30, 2020, View Source [SID1234553717]). Management will also provide a brief update on the business.

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Conference Call Information
To access the live call by phone, dial (877) 621-5803; the conference ID is 3989656. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location.

On January 30, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and RIKEN Innovation Co., Ltd. (HQ: Saitama, Japan; President and CEO: Yoshihiro Aburatani) reported that they have signed a partnership agreement to use the research results from National Research and Development Institute RIKEN (HQ: Saitama, Japan; President: Hiroshi Matsumoto) to jointly create new businesses and return benefits to society (Press release, Sysmex, JAN 30, 2020, View Source [SID1234553683]).

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Through this agreement, the companies aim to apply advanced and broad-ranging research results from RIKEN, a comprehensive research institution for the natural sciences. The objective is to create high-value testing and diagnostic technologies to resolve global medical issues and contribute to the realization of personalized medicine.

The healthcare issues faced by individual countries have grown more diverse in recent years, due to aging populations and the expansion of preventive medicine in developed countries, and the establishment of healthcare infrastructures in emerging markets. With IT and other technological innovations making industries increasingly borderless, it is important to respond to increasingly diverse healthcare needs, proactively collaborate with companies and research institutions that go beyond their industry boundaries, and conduct R&D activities leading to efficient and effective innovation and the creation of new business opportunities.

Sysmex has established an open innovation lab at Technopark (Nishi-ku, Kobe) to pursue collaboration with researchers in Japan and overseas. The Company is pursuing numerous joint research projects at global R&D centers and through its network of Group companies, centering on the development of new diagnostic applications. In these ways, Sysmex aims to acquire unique diagnostic technologies through open innovation with medical and research institutions in Japan and overseas.

As a wholly owned subsidiary of RIKEN, RIKEN Innovation is tasked with promoting collaboration between industry and academia that will quickly return value to society based on RIKEN’s research results. As Japan’s key comprehensive research institution for the natural sciences, RIKEN is involved in a broad range of research fields. By promoting the joint creation of businesses, RIKEN Innovation will leverage research results from diverse researchers engaged in fundamental and applied research. As a result, RIKEN Innovation aims to work together on a variety of measures that will help resolve issues faced by companies and society.

Sysmex and RIKEN Innovation have entered into a partnership agreement in the aim of leveraging RIKEN’s cross-disciplinary research results and Sysmex’s R&D knowhow related to diagnostic technologies to create new diagnostic technologies and new businesses that can be rolled out globally.

Based on this partnership agreement, the two companies will collaborate in searching for needs with a view to creating new diagnostic technologies, outlining diagnostic technology development themes, and building an R&D structure. The companies will pursue open innovation aimed at creating new businesses.

Going forward, by providing diagnostic technologies created under this agreement, Sysmex, RIKEN Innovation and RIKEN aim to create treatment opportunities for patients with diseases that have no established diagnostic methods and contribute to medical economy through more efficient healthcare.