Hologic Announces Multi-Year, Multi-Pronged Commitment to Tackling Breast Cancer Screening Disparities for Black Women in Partnership with the Black Women’s Health Imperative and RAD-AID

On October 1, 2020 Hologic, Inc. (Nasdaq: HOLX), an innovative medical technology company primarily focused on improving women’s health, reported a multi-year commitment to decreasing breast cancer screening disparities for Black women (Press release, Hologic, OCT 1, 2020, View Source [SID1234567923]).

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

                  Schedule Your 30 min Free Demo!

The program is in partnership with the Black Women’s Health Imperative (BWHI), the only nonprofit organization created by Black women to help protect and advance the health and wellness of Black women and girls through awareness and education, and RAD-AID, a nonprofit dedicated to ensuring equal access to radiology health services for medically underserved communities.

Research has shown that Black women are almost 40 percent more likely to die from breast cancer than non-Hispanic white women.1 Hologic’s initiative, which launched today in conjunction with the start of Breast Cancer Awareness Month, is designed to encourage all Black women to get annual mammograms beginning at age 40, and to provide women in underserved communities with access to superior breast cancer screening technology. The situation has become even more urgent due to the COVID-19 pandemic, as the National Cancer Institute recently predicted that 10,000 more people in the United States will die in the next decade from breast or colorectal cancer because of delayed screening and treatment.2

The multi-pronged initiative includes BWHI’s P.O.W.E.R. of Sure campaign, which will examine common barriers to early screening and encourage Black women to schedule and attend their annual mammograms. The campaign features Grammy award winning, Oscar and Golden Globe nominated artist Mary J. Blige and a multimedia digital hub with resources including common facts and myths about mammography, frequently asked questions regarding breast cancer and screening guidelines, a list of locations offering breast cancer screening, and information about what to expect when getting a mammogram during the COVID-19 pandemic.

"As a nonprofit laser-focused on the health and wellness of Black women and girls, we have a deep understanding of the barriers Black women face when it comes to annual breast cancer screening," said Linda Goler Blount, MPH, President and CEO, Black Women’s Health Imperative. "The P.O.W.E.R. of Sure campaign will address those barriers head-on, with the help of our spokeswoman, Mary J. Blige, whose voice resonates like no other when it comes to speaking directly to Black women in an authentic and inspiring way."

Additionally, in partnership with RAD-AID, Hologic will fund screening and diagnostic services, and ensure there is a pathway for medically disenfranchised women to receive treatment. "Our approach is evidence-based to target regions of the United States having urgent need for breast cancer screening and diagnostics, particularly where breast cancer disproportionately impacts women of color due to healthcare inequalities," said Dr. Daniel J. Mollura, MD, Founder and CEO of RAD-AID. "Our interdisciplinary solution will help patients by mobilizing RAD-AID’s 12,000+ volunteer radiologists, technologists, nurses, radiation oncologists/therapists, IT professionals, health navigators, and public health specialists for new service models that overcome racial barriers."

Hologic’s grant to RAD-AID for this initiative will support innovative care, radiology, public education, and nurse navigation at multiregional sites selected by RAD-AID as clinical partners to provide critical screening, diagnostic breast imaging, and treatment for women who may otherwise go without. Sites and facilities under development for this program are located in regions including the Bronx/Washington Heights areas of New York, the South Side of Chicago, Washington D.C., North Carolina, Georgia, Mississippi, Alabama, Arizona, Seattle/Pacific Northwest, and Colorado.

Facilities supported through this collaborative program will be equipped with Hologic’s 3D Mammography system, which features the Genius 3D Mammography exam. The Genius exam is the only mammogram FDA approved as superior to 2D mammography for all women, including those with dense breasts, which is common among Black women.3,4,5,6

"As a company committed to improving women’s health and well-being, we have always played an active role in increasing awareness and access among all women, including those who are traditionally underserved, because it’s core to our mission and our culture," said Jennifer Meade, Hologic’s Division President, Breast and Skeletal Health Solutions. "We believe this initiative will make a significant impact, as it unites our passion for women’s health with that of our nonprofit partners, BWHI and RAD-AID, who share our commitment to increasing awareness of the importance of breast cancer screening and improving access to 3D mammography, the standard of care for annual screenings."

The Genius 3D Mammography exam (also known as the Genius exam) is only available on a Hologic 3D Mammography system. It consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set. There are more than 7,000 Hologic 3D Mammography systems in use in the United States alone, so women have convenient access to the Genius exam. To learn more, visit View Source

Personalis, Inc. to Present at IO Combinations 360˚

On October 1, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the company’s participation at IO Combinations 360˚ which will be held online, October 1-2, 2020 (Press release, Personalis, OCT 1, 2020, View Source [SID1234567919]).

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

                  Schedule Your 30 min Free Demo!

The presentation, titled "Comprehensive immunogenomics to enable composite biomarkers for immunotherapy response using a sample sparing approach," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Travis Yates, PhD, will present for Personalis.

Dr. Yates will discuss the benefits of this unique, innovative design for immuno-oncology translational research, including mastering challenging samples, utilizing optimized algorithms, and obtaining accurate genomic data for identifying novel predictors of response. He will review a case study from a cohort of metastatic melanoma patients treated with an immune checkpoint blockade and will highlight the analytical capabilities provided by this immunogenomic profiling solution for understanding mechanisms of tumor evasion and creating composite biomarkers. Additionally, he will introduce NeXT Liquid Biopsy, an exome-wide liquid biopsy approach combined with ImmunoID NeXT, to further explore critical areas of tumor biology.

Codiak Initiates Patient Dosing in Phase 1/2 Clinical Trial of exoSTING™ for the Treatment of Solid Tumors

On October 1, 2020 Codiak BioSciences, Inc., a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported the initiation of patient dosing in its Phase 1/2 clinical trial of exoSTING (Press release, Codiak Biosciences, OCT 1, 2020, View Source [SID1234567918]). exoSTING is a novel exosome therapeutic candidate engineered with the company’s engEx Platform and designed to deliver Codiak’s proprietary STING (stimulator of interferon genes) agonist specifically to tumor-resident antigen presenting cells (APCs) to locally activate the innate immune response. The trial, which will study exoSTING in solid tumors, is Codiak’s second human clinical trial and the second clinical development program the Company has initiated in the past month.

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

                  Schedule Your 30 min Free Demo!

"We are enormously proud to now have both of our lead candidates in the clinic, the result of years of engineering and manufacturing innovation and a significant step forward towards fulfilling our goal of pioneering the development of engineered exosomes as a new class of medicines for diseases with high unmet medical needs," said Douglas E. Williams, Ph.D., CEO, Codiak. "With exoSTING, the data from our in vitro and in vivo preclinical studies support our desired product profile, demonstrating that we can achieve targeted engagement of the STING pathway to potentially overcome the lack of cell specificity, tolerability, and limited single-agent antitumor activity associated with previous STING agonists."

exoSTING is an exosome therapeutic candidate engineered with Codiak’s engEx Platform to incorporate its proprietary STING agonist inside the lumen of the exosome while expressing high levels of the exosomal protein, PTGFRN, on the surface. The high-level display of PTGFRN is designed to promote targeted delivery of Codiak’s proprietary STING agonist into APCs in the tumor microenvironment.

Engagement of the STING pathway has been validated to elicit an anti-tumoral response, yet therapeutic development has been generally limited by non-selective cell delivery, off-target toxicity to important immune cells in the tumor and dose-related toxicity due to leakage of the STING agonist into the circulation. In preclinical models of exoSTING, the targeted delivery of a STING agonist to tumor resident APCs promoted localized innate immune activation, T cell attraction and expansion in the tumor, and the development of systemic immunity not observed with a STING agonist delivered without exosomes (e.g., "free").

The Phase 1/2 dose escalation clinical trial of exoSTING is designed to investigate safety, tolerability, pharmacological activity, and objective tumor response in patients with advanced/metastatic, recurrent, injectable solid tumors, with a focus on tumors likely to be enriched in APCs. Examples of such tumors include metastatic head and neck squamous cell cancer (HNSCC), triple-negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC), and cutaneous squamous cell carcinoma (cSCC). Safety, biomarker and preliminary efficacy data from the dose-escalation phase of the trial is expected in mid-2021. As part of the Phase 2 portion of the trial, Codiak intends to enroll further expansion cohorts of patients at the optimal exoSTING dose to be identified in the Phase 1 portion of the clinical program.

About exoSTING

exoSTING is Codiak’s exosome therapeutic candidate engineered to incorporate a proprietary STING (stimulator of interferon genes) agonist inside the lumen of the exosome while expressing the exosomal protein, PTGFRN, on the exosome surface to facilitate specific uptake in tumor-resident antigen presenting cells (APCs). Codiak believes that exoSTING has the potential to overcome certain limitations of free STING agonists, and enhance the therapeutic index and selectivity of delivery to desired cells in the tumor microenvironment.

Codiak is developing exoSTING for the treatment of multiple solid tumors enriched in the target APCs. exoSTING has demonstrated encouraging activity in preclinical models and is now being evaluated in a Phase 1/2 clinical trial in patients with advanced/metastatic, recurrent, and injectable solid tumors. Future development of exoSTING may be expanded to neuro-oncology indications such as glioblastoma and leptomeningeal cancer disease.

About the engEx Platform

Codiak’s proprietary engEx Platform is designed to enable the development of engineered exosome therapeutics for a wide spectrum of diseases and to manufacture them reproducibly and at scale to pharmaceutical standards. By leveraging the inherent biology, function and tolerability profile of exosomes, Codiak is developing engEx exosomes designed to carry and protect potent drug molecules, provide selective delivery and elicit the desired pharmacology at the desired tissue and cellular sites. Through its engEx Platform, Codiak seeks to direct tropism and distribution by engineering exosomes to carry on their surface specific targeting drug moieties, such as proteins, antibodies/fragments, and peptides, individually or in combination. Codiak scientists have identified two exosomal proteins that serve as surface and luminal scaffolds. By engineering the exosome surface or lumen and optimizing the route of administration, Codiak aims to deliver engEx exosomes to the desired cell and tissue to more selectively engage the drug target, potentially enhancing the therapeutic index by improving potency and reducing toxicity.

Exicure Secures Debt Facility for Up to $25.0 Million

On October 1, 2020 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported it has entered into a $25.0 million senior secured term loan with MidCap Financial Trust (MidCap), as agent, and Silicon Valley Bank (SVB) (Press release, Exicure, OCT 1, 2020, View Source [SID1234567915]).

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

                  Schedule Your 30 min Free Demo!

The lenders under the debt facility have made available to Exicure an aggregate principal amount up to $25.0 million. Exicure has now received $17.5 million of proceeds and an additional $7.5 million can be drawn at Exicure’s discretion anytime between April 1, 2021 and September 30, 2021. The loan requires interest payments only for 24 months followed by 36 months of straight-line amortization after the interest only period.

"We believe this non-dilutive debt facility has enhanced Exicure’s financial flexibility," said David Giljohann, CEO of Exicure. "We are grateful to MidCap and SVB for the confidence they have shown in our preclinical and clinical programs in neurology and oncology, and plan to use these funds for the ongoing execution and expansion of our pipeline," concluded Dr. Giljohann.

Mustang Bio to Participate in Chardan’s Virtual 4th Annual Genetic Medicines Conference 2020

On October 1, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in a fireside chat at Chardan’s Virtual 4th Annual Genetic Medicines Conference 2020 on Monday, October 5, 2020, at 1:00 p.m. EDT (Press release, Mustang Bio, OCT 1, 2020, View Source [SID1234567913]).

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

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be available on the Events page of the Investor Relations section of Mustang’s website: www.mustangbio.com. An archived replay of the webcast will be available for approximately 30 days following the fireside chat.