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 Georgia Bio, the state’s life science trade association, reported that it will celebrate its Golden Helix Awards & Annual Gala on Friday, March 13th at Factory Atlanta in Chamblee. Georgia Bio is pleased to announce the winners of the 2020 Golden Helix Awards (Press release, Georgia Bio (GaBio), JAN 30, 2020, View Source [SID1234553715]).

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Patty Fritz, Georgia Bio Chair and VP, U.S. Corporate Affairs for UCB, Inc. and Philip G. Gibson, Ph.D., Georgia BioEd Institute Chair and Director, Georgia BioScience Training Center at Quickstart are the recipients of the 2020 Industry Growth Awards. The Industry Growth Awards are the highest honors bestowed each year by Georgia Bio.

The Golden Helix Awards celebrate the contributions and achievements of Georgia legislative, academic, corporate and other organizational leaders working to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. The event is expected to draw 300 of the state’s life sciences industry leaders.

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"Our life sciences community continues to collaborate and foster innovation to create a healthier world," said Dr. Christopher McKinney, Chair of the Georgia Bio Awards Committee and Associate VP for Innovation Commercialization at Augusta University. "There has been 121% growth in Life Science patents between 2007 and 2017 and an average of 760 clinical trials starting each year in Georgia. Additionally, more than $780 million venture capital was raised in 2018, mostly going towards drug discovery and therapeutic devices. It is important to recognize the individuals and organizations supporting healthcare innovation and leadership here in Georgia. We look forward to bringing the sector together on March 13th for an evening of networking and celebration."

Georgia Bio presents awards to individuals and companies in eight categories: Industry Growth; Deals of the Year; Community; Innovation; Emerging Leader; Biotech Teacher of the Year; Legislator of the Year; and the Metro Atlanta Chamber sponsored Phoenix Award. Winners are some of Georgia’s hardest working innovators and entrepreneurs producing advanced medicines, diagnostics and technologies to improve medical care.

Companies being honored with the distinguished Deal of the Year award include: Alcon for its acquisition of PowerVision; Aruna Bio for raising $13 million to continue development of therapies for the treatment of neurodegenerative diseases such as ALS, Huntington’s Disease, and stroke; Danimer Scientific for a $6.5 million investment from Advantage Capital to boost capacity and significantly increase its workforce in Bainbridge, GA; Emory Vaccine Center and the University of Georgia Center for Vaccines and Immunology for their NIH grants that could exceed $200 million to advance work toward a universal flu vaccine; Georgia Cancer Center for their $6.5 million grant to improve access to clinical trials for minorities and underserved communities; Guide Therapeutics for an initial equity investment from GreatPoint Ventures to continue development of lipid nanoparticles (LNPs) that deliver therapeutics for gene therapy; Tempus for its acquisition of AKESOGen; and Takeda Pharmaceutical for its acquisition of Shire.

"Golden Helix Award winners showcase the best in innovation and leadership in our community," said Maria Thacker Goethe, President and CEO, Georgia Bio. "They are working to improve patients’ lives, support life science workforce development and grow Georgia’s economy. The awards program is a night for our members and community partners to pause and recognize the individuals and companies who are making lasting contributions to the life sciences sector in Georgia."

AWARD WINNERS

Georgia Bio Industry Growth Awards: Presented to two people who have made an extraordinary contribution to the growth of the life sciences industry in Georgia.

Patty Fritz, Georgia Bio Chair and VP U.S. Corporate Affairs for UCB, Inc.
Philip G. Gibson, Ph.D., Georgia BioEd Institute Chair and Director, Georgia BioScience Training Center at Quickstart
Phoenix Award: Presented to two Georgia honorees who have forged academic and industry relationships that will drive translation and lead to new treatments and cures. This award is sponsored by the Metro Atlanta Chamber.

Children’s Healthcare of Atlanta / Georgia Institute of Technology
Deals of the Year Awards: Presented to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2018-December 31, 2019, based on the importance of the transaction to Georgia’s life sciences industry.

Acquisitions
Alcon
Takeda Pharmaceutical
Tempus and AKESOgen

Private Financing
Aruna Bio
Danimer Scientific
Guide Therapeutics

Public Financing
Emory Vaccine Center
Georgia Cancer Center
University of Georgia Center for Vaccines and Immunology

Community Awards: Presented to a small number of individuals, companies or institutions whose contributions to Georgia’s life sciences community are worthy of special recognition.

Michael Fisher, Global Center for Medical Innovation
Gerresheimer
Jayne Morgan, M.D., Piedmont Healthcare
Cynthia Sundell, Ph.D., Georgia Institute of Technology
University of Georgia Poultry Diagnostic & Research Center
Innovation Awards: Presented to the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology.

AnemoCheck Platform, Sanguina, Inc.
DisasterMed, R6 Industries
Micro C, OXOS Medical, Inc.
Non-Invasive Technology to Measure Oxygen Delivery & Use in Muscle, Infrared Rx, Inc.
Emerging Leader of the Year Awards: Presented to young individuals who have made a significant impact on the life sciences industry through their studies or employment.

Alexa Morse, Global Center for Medical Innovation
Teacher of the Year Award: Presented to a Georgia biotechnology high school teacher who exhibits excellence in STEM teaching and support for the biotechnology pathway.

Stan Harrison, Morgan County High School
Legislators of the Year Award: Presented to state legislators for their support of the life sciences industry in Georgia.

The Honorable Ellis Black, Georgia State Senate
The Honorable Robert Dickey, Georgia State Senate
The Honorable Terry England, Georgia House of Representatives
The Honorable Jack Hill, Georgia State Senate
The Honorable Randy Nix, Georgia House of Representatives
The Honorable John Wilkinson, Georgia State Senate

On January 30, 2020 Genetron Health, a China-based precision oncology company that provides full cycle cancer management solutions, reported it was selected to participate in 2019 China National Key Research and Development Project led by the China National Center for Biotechnology Development, to support research on development and evaluation of liquid biopsy technology for early screening of cancer (Press release, Genetron Health Technologies, JAN 30, 2020, View Source [SID1234553714]).

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Led by the Cancer Hospital Chinese Academy of Medical Sciences, this research, which is part of the 2019 China National Key Research and Development Project, aims for a technology breakthrough in liquid biopsy technology of early screening and treatment of malignancy by December 2021, which would establish a high-sensitivity, high-specificity, high-efficiency, and cost-effective diagnosis technology system.

As a pioneer in the innovation of cancer early screening technology, Genetron Health will leverage its independently developed Mutation Capsule technology to detect tumor-specific mutations and methylation in cell free DNA (cfDNA) , and establish models for cancer early diagnosis.

In addition, Genetron Health plans to commercialize the early screening product by conducting prospective cohort studies on a large sample size regarding lung cancer and digestive system cancers in selected areas. Study results will be compared and examined against widely applied screening technologies and will apply for IVD registration as testing assays.

In 2019, Proceedings of the National Academy of Sciences of the USA (PNAS) published promising results of a pilot study on a liver cancer early screening study using cfDNA and protein markers, a collaborative effort between Genetron Health and the National Cancer Center/ Cancer Hospital Chinese Academy of Medical Sciences.

"Genetron Health is working diligently to develop technologies and products for early screening of malignancy," said Mr. Sizhen Wang, co-founder and CEO of Genetron Health, "The company is expanding the early screening technology platform to cover multiple cancers, accelerating the design of new assays and starting the commercialization to benefit the public."

On January 30, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for FS120, F-star’s proprietary tetravalent bispecific antibody targeting CD137 and OX40 (Press release, f-star, JAN 30, 2020, View Source [SID1234553713]).

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FS120 is a first-in-class dual agonist bispecific antibody that has the potential to overcome cancer resistance by simultaneously targeting CD137 (4-1BB) and OX40 (CD134, TNFRSF4), two receptors present on the surface of tumor-infiltrating lymphocytes. Unlike checkpoint inhibitors, the mechanism of action of FS120 triggers a positive signal that enhances several cellular functions essential for killing tumor cells. FS120 has a natural antibody format with silenced Fc effector functions, providing increased specificity and superior performance while reducing toxicity through conditional, crosslink-dependent activation upon binding to both CD137 and OX40, when compared to traditional monoclonal antibodies.

F-star expects to enroll 70 patients in a Phase 1 dose escalation clinical trial to assess the safety, tolerability and efficacy of FS120 in patients with advanced malignancies.

Dr Louis Kayitalire, CMO of F-star, said: "The FDA acceptance of our IND application is a crucial milestone for this first-in-class dual agonist, as well as significant validation for the program. Advancing our pipeline and moving our second asset into the clinic brings us another step closer to providing more effective therapies for patients with otherwise difficult-to-treat cancers. Preclinically FS120 has demonstrated an effective tumor-killing response and, importantly, a good tolerability profile."

Preclinical data recently presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting demonstrated that FS120’s conditional, unique crosslink-dependent activation approach has the potential to provide therapeutic benefit, for example in combination with checkpoint inhibitors, and reverse T cell exhaustion in immunosuppressive tumor environments.

On January 30, 2020 Bayer reported that results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated NUBEQA (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a significant improvement in overall survival (OS) in patients receiving NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT (Press release, Bayer, JAN 30, 2020, View Source [SID1234553712]). Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT; however OS data were not yet mature at the time of the MFS analysis. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.

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NUBEQA, an oral androgen receptor inhibitor (ARi), has been approved in the U.S., Brazil, and Japan, and filings in the European Union and other regions are underway or planned. The compound is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About NUBEQA (darolutamide)

On July 30th, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or placebo plus ADT. The primary efficacy endpoint was MFS, defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death due to any cause within 33 weeks after the last evaluable scan, whichever occurred first. NUBEQA plus ADT demonstrated a statistically significant improvement in MFS, with a median MFS of 40.4 months versus 18.4 months with placebo plus ADT [HR=0.41, 95% CI (0.34, 0.50), p<0.0001].

Adverse reactions occurring more frequently in the NUBEQA arm (≥2 % over placebo) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.1 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

INDICATION

NUBEQA is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥ 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Clinically significant adverse reactions occurring in ≥ 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.