Case Comprehensive Cancer Center researchers to lead Northeast Ohio initiative to increase prostate cancer screening in African American men

On March 1, 2021 Case Western Reserve University reported African American men in Cuyahoga County have a 60% increased risk of being diagnosed with prostate cancer and an 80% increased risk of dying from prostate cancer compared to white men, according to data from the Case Comprehensive Cancer Center (Press release, Case Western Reserve University, MAR 1, 2021, View Source [SID1234575830]).

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With a new $2.75 million, three-year grant from the Bristol Myers Squibb Foundation, researchers at the Case Comprehensive Cancer Center at Case Western Reserve University will collaborate with a team of community partners in a different approach to fight this health disparity.

The Cleveland African American Prostate Cancer Project, directed by Erika Trapl, an associate professor in the Department of Population and Quantitative Health Sciences at Case Western Reserve School of Medicine, will develop and implement a comprehensive, sustainable, community-based program to increase the number of African Americans screened for prostate cancer.

Trapl, the research project’s principal investigator, director of the Office of Community Outreach and Engagement at the Case Comprehensive Cancer Center and director of the Prevention Research Center for Healthy Neighborhoods, said prostate cancer does not have any known modifiable risk factors, so early screening is the only way to reduce prostate cancer mortality.

"The best bet," she said, "is to identify prostate cancer early and reduce late-stage diagnosis."

To do so, Trapl has established a team of researchers that includes expertise in cancer disparities, social work, bioethics, culturally specific intervention development, urology, genetic epidemiology, community outreach, and dissemination and implementation science.

The collaboration includes the Case Comprehensive Cancer Center Community Advisory Board, the Urban Barber Association, Cleveland Department of Public Health, Office of Minority Health, The Gathering Place, University Hospitals Seidman Cancer Center, Cleveland Clinic Taussig Cancer, MetroHealth Cancer Center and the Cleveland Institute for Computational Biology. The team hopes to engage other partners as the work grows.

The project is designed to develop and evaluate a community-based prostate cancer screening program, increase the number of African American men who receive baseline prostate-specific antigen (PSA), establish awareness of prostate cancer risk and reduce cancer disparities.

Elevated or continuously rising levels of PSA—proteins produced by the prostate gland—could be a sign of prostate cancer. Studies to define the normal range of PSA levels are based on mostly white populations. By establishing a baseline for African American men at an earlier age, researchers can establish baseline PSA ranges to help detect cancer at an earlier stage.

The initiative has four objectives:

Create a culturally and linguistically appropriate approach to prostate cancer screening education and testing in partnership with barbers, community navigators and health care providers.
Develop and implement a Community Navigation program that provides supportive services and returns screening results, ensuring that the needs of participants and their families are met.
Implement prostate cancer education and screening in barbershops with African American men (ages 40 and older).
Convene regional grassroots and institutional partners to raise awareness of prostate cancer disparities and screening.
"From our experience addressing health disparities and helping to eliminate barriers to equitable access to quality health care around the world, we recognize that this program has the elements needed for success," said Catharine Grimes, program director for the Bristol Myers Squibb Foundation. "Through the innovative approach that recognizes the value of barbershops as community hubs, strong, deep collaborations facilitated by patient navigators and a comprehensive and strategic plan for implementation and evaluation, we are confident this program will deliver positive impact in the fight against prostate cancer for African American men."

Focusing on communities most at risk of suffering the impacts of serious diseases in the regions of the world that are hardest hit, the Bristol Myers Squibb Foundation empowers partners to build innovative solutions to advance health equity and improve access to quality health care for patients. Its programs are addressing cancer, cardiovascular disease, and immunologic disease, as well as clinical trial diversity in the United States, and prevalent cancers in Africa, Brazil and China.

The idea for the project was born in a Case Comprehensive Cancer Center Community Advisory Board meeting last year. Budding research questions are presented to the group to ensure community needs are considered from the beginning of a project through execution. Complicated science was distilled to simplified images and metaphors, making it easier to understand.

Waverly Willis, a member of the Community Advisory Board, acknowledges a history of distrust between minority people and others coming into their neighborhoods and communities. "You have to be tactful and meet people where they are," said Willis. Barbershops make up part of the fabric of the neighborhood and are a trusted environment, said Willis, owner of Urban Kutz barbershop, executive director of the Urban Barber Association and chairman of the Ohio Barber and Beauty Alliance.

"Our board pushed us to bring the work to locations central to men’s lives, such as barbershops," Trapl said. "From there, the idea has taken off, thanks to the partnership of people living in this community facing these genuine issues. We hope it will become a national model."

Selecta Biosciences to Participate in the H.C. Wainwright Global Life Sciences Conference

On March 1, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., and Chief Financial Officer, Brad Dahms, will participate in the virtual H.C. Wainwright Global Life Sciences Conference to be held March 9-10, 2021 (Press release, Selecta Biosciences, MAR 1, 2021, View Source [SID1234575829]).

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The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7 a.m. EST on Tuesday, March 9, 2021.

A webcast will also be available in the Investors & Media section of the company’s website at www.selectabio.com.

Allakos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

On March 1, 2021 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update (Press release, Allakos, MAR 1, 2021, View Source [SID1234575828]).

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2020 Accomplishments

Announced positive results from our prospective prevalence study showing that 45% (181/405) of symptomatic patients biopsied with chronic unexplained gastrointestinal (GI) symptoms or functional gastrointestinal disorders (FGIDs) such as irritable bowel syndrome (IBS) and functional dyspepsia (FD) met the histologic criteria for eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). The results suggest that EG and/or EoD are significantly underdiagnosed among these patients. Millions of patients in the U.S. are under the care of a gastroenterologist and suffer from chronic unexplained gastrointestinal symptoms or FGIDs. These results provide evidence that prevalence of EG and EoD is significantly higher than reported in the literature.
Announced positive safety, pharmacokinetic and pharmacodynamic results from a randomized, double-blind, placebo-controlled Phase 1 study of subcutaneous (SC) lirentelimab in healthy volunteers. Bioavailability of SC lirentelimab was 63% and SC lirentelimab resulted in extended eosinophil suppression at all dose levels tested. At dose levels of 3.0 and 5.0 mg/kg and with the fixed dose of 300 mg, SC lirentelimab resulted in eosinophil suppression in all subjects through Day 85. The pharmacokinetic and pharmacodynamic results suggest that SC lirentelimab may be given monthly or potentially less frequently. SC lirentelimab was well tolerated, and there were no serious adverse events, no injection site reactions and no infusion-related reactions with SC lirentelimab.
Published results from a Phase 2 study of lirentelimab in patients with EG and/or EoD (ENIGMA) in the New England Journal of Medicine.
Announced positive interim results from an open-label long term extension study of ENIGMA. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting.
Closed an underwritten public offering, issuing 3,506,098 shares of common stock at an offering price of $82.00 per share. Aggregate net proceeds received from the offering were approximately $271.7 million, after deducting underwriting discounts and commissions.
Upcoming 2021 Milestones

Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG and/or EoD expected in the fourth quarter of 2021.
Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with eosinophilic esophagitis (EoE) expected in the fourth quarter of 2021.
Initiation of a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EoD expected in the second quarter of 2021.
Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of SC lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
Fourth Quarter and Full Year 2020 Financial Results

Research and development expenses were $28.5 million in the fourth quarter of 2020 as compared to $16.6 million in the same period in 2019, an increase of $11.9 million. Research and development expenses were $105.5 million for the full year 2020 as compared to $61.9 million in the same period in 2019, an increase of $43.6 million.

General and administrative expenses were $15.8 million in the fourth quarter of 2020 as compared to $10.3 million in the same period in 2019, an increase of $5.5 million. General and administrative expenses were $51.5 million for the full year 2020 as compared to $29.6 million in the same period in 2019, an increase of $21.9 million.

Allakos reported a net loss of $44.3 million in the fourth quarter of 2020 as compared to $24.6 million in the same period in 2019, an increase of $19.7 million. Net loss per basic and diluted share was $0.86 for the fourth quarter of 2020 compared to $0.51 in the same period in 2019. Net loss was $153.5 million for the full year 2020 as compared to $85.4 million in the same period in 2019, an increase of $68.1 million. Net loss per basic and diluted share was $3.10 for the full year 2020 compared to $1.89 in the same period in 2019.

Allakos ended the fiscal year 2020 with $659.0 million in cash, cash equivalents and marketable securities.

Phio Pharmaceuticals and AgonOx, Inc. Announce Collaboration on Clinical Development of Novel T Cell-based Cancer Immunotherapies

On March 1, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported it has entered into a clinical development collaboration with AgonOx, Inc. to develop novel T cell-based cancer immunotherapies using Phio’s lead INTASYL based product candidate PH-762 and AgonOx’s "double positive" (DP) tumor-infiltrating lymphocyte (TIL) technology (Press release, Phio Pharmaceuticals, MAR 1, 2021, View Source [SID1234575827]). The companies have shown that the combination of their respective technologies can result in enhanced TIL therapeutics, and based on these data, the collaboration will focus on conducting a clinical study for PH-762 treated DP TILs. The study is expected to start enrolling patients later this year.

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AgonOx in collaboration with the Earle A. Chiles Research Institute, a division of the Providence Cancer Institute, developed a method for the identification, isolation and expansion of tumor-specific CD8 T cells from cancer patients. AgonOx has also shown that "double positive" (DP) CD8 T cells isolated from human solid tumors have increased tumor killing activity when compared to CD8 TIL that were not enriched prior to expansion. Preclinical data presented at SITC (Free SITC Whitepaper) 2020 by AgonOx in collaboration with Phio show that treating the DP CD8 TIL with Phio’s PH-762, increases the tumor killing activity of the CD8 DP TIL even further (two-fold increase). As a result, the use of PH-762 treated DP CD8 TIL is expected to enhance therapeutic responses in cancer patients.

Under the terms of the collaboration agreement, AgonOx will receive financial support for the clinical trial from Phio and Phio is entitled to certain future development milestones and sales related royalty payments from AgonOx’s DP TIL technology.

"Autologous T cell therapies hold a lot of promise, however, there is still a lot of research needed to be done to unlock its full therapeutic potential, including ways to improve upon the first generation of TIL products, and ways to use TIL therapy in more types of cancer," said Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals. "By joining forces with AgonOx, we believe our collaboration can fulfil these unmet needs, without the need for complex and costly technologies, such as genetic engineering."

"Our collaboration with Phio is based on data showing that PH-762 increases the activity of our CD8 DP TIL technology, therefore we believe this combination should increase the therapeutic efficacy of this first-in-man study," stated by Dr. Andrew Weinberg, President/CSO of AgonOx, Inc. and Full Member at the Earle A. Chiles Research Institute.

Dr. James Cardia, VP of Business Operations of Phio Pharmaceuticals, commented: "Both the clinical community and the investment community are embracing the broad potential of cell-based immunotherapy, and TIL therapy in specific, based on recent clinical and corporate development activities in this field. Our data show the important role that INTASYL based products can play in improving adoptive cell therapy, and we look forward to working with AgonOx to bring better cell therapies to patients."

About TIL Therapy and "DP" TILs

In TIL therapy, T cells are extracted from a patient’s own tumor. These cells are then expanded ex-vivo, and infused back into the patient. The infused TIL naturally recognize the tumor and then attack the cancer cells. Currently, clinical applications focus on indications such as metastatic melanoma and cervical cancer. Increasing the frequency of tumor-reactive cells within TIL products should allow for improved response rates in these indications and expand the use of this form of treatment to patients with locally advanced, recurrent or metastatic cancers including head and neck, non-small cell lung cancer and other solid tumor types. AgonOx developed methods to enrich for tumor-killing T cells, which could greatly improve the immune response in cancer patients – potentially leading to successful treatment of tumors. Their research in collaboration with the Earle A. Chiles Research Institute, entitled "Co-expression of CD39 and CD103 identifies tumor-reactive CD8 positive T cells in human solid tumors" was published in Nature Communications and forms the basis of this clinical study (Duhen, T., Duhen, R., Montler, R. et al, 2018: Co-expression of CD39 and CD103 identifies tumor-reactive CD8 T cells in human solid tumors. Nat Commun 9, 2724).

About PH-762

PH-762 is a self-delivering RNAi compound that targets the checkpoint protein PD-1. Checkpoint proteins, such as PD-1, normally act as a type of "off switch" that prevents T cells from attacking certain cells, such as cancer cells, in the body. PH-762 silences PD-1 checkpoint expression, thereby removing the "off switch" and resulting in enhanced T cell activation and tumor cytotoxicity. Experimental data shows that PH-762 can silence the expression of PD-1 in target human T cells in a potent and durable manner, and can increase function of patient derived TILs or engineered cells, such as CAR T-cells for use in adoptive cell therapy. PH-762 use does not involve genetic engineering, and its cell delivery does not require special formulations or other complex delivery tools.

VBI Vaccines to Present at the Raymond James 42nd Annual Institutional Investors Conference

On March 1, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, President and Chief Executive Officer, and David E. Anderson, Ph.D., Chief Scientific Officer, will participate in an analyst-led fireside chat at the Raymond James 42nd Annual Institutional Investors Conference on Tuesday, March 2, 2021, at 4:40 PM ET (Press release, VBI Vaccines, MAR 1, 2021, View Source [SID1234575815]).

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Presentation Details

Event: Raymond James 42nd Annual Institutional Investors Conference
Presenters: Jeff Baxter, President and CEO, and David E. Anderson, Ph.D., Chief Scientific Officer
Date: Tuesday, March 2, 2021
Time: 4:40 – 5:20 PM ET
Webcast: View Source

A recording of the webcast will be available on the "Events and Presentations" page of the Company’s website: View Source