On August 26, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the first patient has been dosed in the Company’s investigator-sponsored phase 2 study of pelareorep-anti-PD-1 combination therapy in unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (Press release, Oncolytics Biotech, AUG 26, 2020, View Source [SID1234564043]). The study, known as IRENE, is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte. Participants in the multi-center study receive pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012).

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The recently announced IRENE study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future registrational trials by facilitating study design and patient selection. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, commented, "The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I’m looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer."

For more information about the IRENE study, refer to ClinicalTrials.gov (NCT04445844).

About IRENE
The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.
Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On August 26, 2020 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported an oversubscribed $270 million Series C financing, bringing the company’s total financing to over $500 million since the company’s launch (Press release, Freenome, AUG 26, 2020, View Source [SID1234564042]). The proceeds will be used to accelerate the PREEMPT CRC clinical trial for Freenome’s blood test for colorectal cancer screening and precancerous lesion detection, advance a pipeline of blood tests for both the early detection and early intervention of additional cancers, and continue building the company’s proprietary multiomics platform. PREEMPT CRC is an FDA registrational study launched in May 2020 to support approval by the U.S. Food and Drug Administration (FDA) for the first front-line blood test to help the 45 million people who are currently not up-to-date on colorectal cancer screening guidelines in the U.S.

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The Series C financing was led by new investor Bain Capital Life Sciences and existing investor Perceptive Advisors. They were joined by a group of other new investors, including Fidelity Management & Research Company, LLC, Janus Henderson Investors, Farallon Capital Management, Rock Springs Capital, Cormorant Asset Management, EcoR1 Capital, LLC, Catalio Capital Management, and the Colorectal Cancer Alliance. Freenome’s existing investors also participated in the financing, including RA Capital Management, funds and accounts advised by T. Rowe Price Associates, Inc., American Cancer Society’s BrightEdge Ventures, Sands Capital, Andreessen Horowitz, DCVC, GV (formerly Google Ventures), Kaiser Permanente Ventures, Novartis, Polaris Partners, Roche Venture Fund, Soleus Capital, and Section 32.

Freenome CEO Gabriel Otte stated, "We are delighted to have Bain Capital Life Sciences and Perceptive Advisors as lead investors, and thank all of our new and existing investors for their ongoing confidence in Freenome and our mission to improve accessibility and adherence to cancer screening. We are moving closer every day to a world where cancer can be detected early or even in a precancerous state and ultimately save many lives."

Jeffrey Schwartz, a Managing Director at Bain Capital Life Sciences said, "Freenome’s innovative approach to detecting cancer early, when it is most treatable, is on the leading edge of the liquid biopsy field with features that are advanced and differentiated for cancer screening. The platform’s ability to detect a range of cancer types is compelling and we look forward to working with the company as it continues its growth."

The financing accelerates Freenome’s efforts to expand its platform to create a portfolio of industry-leading blood tests for multiple cancers. The company’s platform, with capabilities to characterize tumor and immune signatures, enables a differentiated and comprehensive blood testing technology for early cancer detection. With a comprehensive multiomics approach – analyzing large, complex biological datasets – Freenome’s platform integrates technologies applying genomics, transcriptomics, methylomics, and proteomics with advanced computational biology and machine learning techniques to understand multiple signatures for early cancer detection.

Ellen Hukkelhoven, Ph.D., a Managing Director at Perceptive Capital noted, "Freenome is at an exciting inflection point as it moves its first product through pivotal testing, and we see future opportunities on the horizon to expand its platform to create blood-based screening tests for a range of additional cancers. There is so much untapped potential to bring advanced technology to improve cancer screening and to make testing more accessible and cancer more preventable." Concurrent with the Series C financing, Dr. Hukkelhoven will join the Freenome Board of Directors.

Freenome CFO William Quirk commented, "This funding will allow us to execute on our business plans by accelerating the registrational study for our blood test for colorectal cancer screening toward approval, reimbursement, and commercialization while, at the same time, advancing our pipeline of blood tests for screening other cancers. We are well positioned for Freenome’s next stage of growth, leveraging the full potential of our novel multiomics platform as a disruptive technology for cancer screening."

On August 26, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming virtual investor conferences (Press release, Boston Scientific, AUG 26, 2020, View Source [SID1234564037]).

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On September 9, 2020, Mike Mahoney, chairman and chief executive officer, and Susie Lisa, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst at the Wells Fargo 2020 Virtual Healthcare Conference. The session will begin at approximately 9:20 a.m. EDT.

On September 16, 2020, Mike Mahoney, Dan Brennan, executive vice president and chief financial officer, and Susie Lisa will participate in a 30-minute question-and-answer session with the host analyst at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference. The session will begin at approximately 8:00 a.m. EDT.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.

On August 26, 2020 Kinnate Biopharma Inc., a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically-defined cancers, reported that it has raised $98 million in a Series C financing (Press release, Kinnate Biopharma, AUG 26, 2020, View Source [SID1234564036]). The financing was led by RA Capital Management with participation from additional new investors: Viking Global Investors; Venrock Healthcare Capital Partners; Fidelity Management & Research Company, LLC; Janus Henderson Investors; Surveyor Capital (a Citadel company); Boxer Capital of Tavistock Group; Logos Capital; and an investment fund associated with SVB Leerink. Existing investors Foresite Capital, OrbiMed, Nextech Invest, and Vida Ventures also participated in the round. In December 2019, Kinnate closed a $74.5 million Series B financing.

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"In just over two years, Kinnate has built a proprietary pipeline of kinase inhibitors from the ground up, and this significant financing positions us to advance at least one of our lead product candidates into clinical development in the first half of next year," said Nima Farzan, CEO of Kinnate. "We are pleased to expand our syndicate of world-class healthcare investors during this exciting time of growth for the company. Their expertise will be invaluable as we execute on our vision of increasing the availability of targeted therapies for the many cancer patients who currently lack access to effective precision medicines."

Through its deep expertise in structure-based drug discovery, translational research, and patient-driven precision medicine, Kinnate has developed a wholly owned kinase inhibitor portfolio of new targeted therapy candidates that aim to help patients who are non-responders or express resistance to currently available precision medicines. The company’s lead preclinical programs include small molecule inhibitors targeting specific classes of BRAF kinase mutations (Class II and Class III mutations) and FGFR2 or FGFR3 alterations that aim to overcome resistance commonly limiting the efficacy of existing therapies. The company is also advancing a number of other research programs. To help advance these programs, Kinnate is working with leaders at experienced precision medicine cancer centers including Massachusetts General Hospital Cancer Center and the UC San Diego Moores Cancer Center.

"The rapid advancement of genomic technologies has enabled the identification of many more people who may benefit from genomically-targeted therapies. However, because of non-response or resistance mutations, many fail to benefit from these potentially life-saving medicines," said Peter Kolchinsky, PhD, managing partner at RA Capital Management. "We are proud to support the Kinnate team and see tremendous potential for their lead programs to significantly increase the number of people who could benefit from targeted precision oncology therapeutics."

On August 26, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it will be presenting at the LD 500 Virtual Investor Conference on Tuesday, September 1, 2020 at 1:20 p.m. ET. Rodney Varner, Chairman and Chief Executive Officer of Genprex, will present virtually to an online audience (Press release, Genprex, AUG 26, 2020, View Source [SID1234564035]).

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Mr. Varner will deliver a Company overview and provide updates on its product pipeline, including its lead drug candidate, GPX-001, which received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for use in combination with AstraZeneca’s Tagrisso in late stage lung cancer patients with EGFR mutations whose tumors progress on Tagrisso. Mr. Varner will also provide an overview of the Company’s preclinical diabetes gene therapy candidate that may have the potential to cure Type 1 and Type 2 diabetes.

The presentation will be webcast live and available for replay on the LD 500 conference website here and via the investor relations section of the company’s website at Genprex.com.

Event: The LD 500 Virtual Conference

Presentation Date: Tuesday, September 1, 2020

Presentation Time: 1:20 p.m. ET – Track 2

Registration Link: https://ld-micro-conference.events.issuerdirect.com/

Webcast Link: https://bit.ly/31b1i20

The LD 500 will take place September 1-4, 2020 and will feature some of the most prominent companies in the micro-cap world, alongside interviews and keynotes with small-cap leaders.

View Genprex’s LD 500 profile here: https://bit.ly/2CHzOrt