ImmunoGen Announces Conference Call to Discuss Its 2019 Operating Results

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.

First Patient With Advanced Breast Cancer Receives First Dose in Clinical Trial of GlycoMimetics’ GMI-1359

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.

Georgia Bio Names 2020 Golden Helix Award Winners

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

Genetron Health to Participate in China National Key Research and Development Project on Cancer Early Screening

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."

F-star Therapeutics Announces FDA Acceptance of IND Application for FS120

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.