IMV to Participate at the upcoming H.C. Wainwright Global Life Sciences Conference

On March 1, 2021 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that IMV’s executive management team will be participating at the H.C. Wainwright Global Life Sciences Conference which will be held virtually on March 9-10 (Press release, IMV, MAR 1, 2021, View Source [SID1234575835]).

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H.C. Wainwright Global Life Sciences Conference
Presentation availability time: Tuesday, March 9, 2021 at 7:00 AM Eastern Time

A link to this presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website at the above-mentioned time and for approximately 30 days thereafter.

OrbiMed Raises $3.5 Billion Across Private Investment Funds

On March 1, 2021 OrbiMed, a leading life sciences investment firm, reported $3.5 billion in commitments for its latest private investment funds, including $1.5 billion for OrbiMed Private Investments VIII, $800 million for OrbiMed Asia Partners IV, and $1.2 billion for OrbiMed Royalty & Credit Opportunities III (Press release, OrbiMed Advisors, MAR 1, 2021, View Source [SID1234575834]). Investors in these new funds include a broad range of medical institutions, university endowments, foundations, pension funds and sovereign wealth funds.

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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

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OrbiMed Private Investments VIII invests primarily in venture capital stage opportunities in North America and Europe, with a focus on biotechnology, medical device, and diagnostics companies. This fund targets investments from $10 million to $100 million across approximately 40 portfolio companies.
OrbiMed Asia Partners IV invests primarily in China and India, from venture capital through growth stage across biotechnology, pharmaceuticals, medical devices, diagnostics, and healthcare services. This fund targets investments from $10 million to $100 million in approximately 20 portfolio companies.
OrbiMed Royalty & Credit Opportunities III invests globally through providing structured credit and royalty monetization financing solutions for healthcare companies and institutions. This fund generally invests from $10 million to $150 million per opportunity.
Where appropriate, OrbiMed invests across multiple funds, bringing potential investment amounts to upwards of $250 million per portfolio company. These new funds bring OrbiMed’s assets under management to approximately $18 billion across public equity, private equity and credit/royalty strategies. These extensive financial resources allow OrbiMed to partner with healthcare companies across their life cycle, solving financing needs from start-up seed capital through to growth equity and non-dilutive debt capital.

OrbiMed is led by its nineteen partners, with a growing team of more than 100 professionals contributing diverse, complementary skills across finance, strategy, and new company formation. OrbiMed combines its substantial financial resources with extensive global team capabilities to partner with exceptional management teams in building the next generation of world-class healthcare companies.

Merck KGaA, Darmstadt, Germany, Builds on Leadership in Head and Neck Cancer Through Worldwide Licensing Agreement with Debiopharm for Pivotal-Stage Xevinapant

On March 1, 2021 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported a worldwide in-licensing agreement with Debiopharm, Lausanne, Switzerland, for the development and commercialization of xevinapant (Debio 1143) (Press release, Merck KGaA, MAR 1, 2021, View Source [SID1234575833]). Xevinapant, a potent oral Inhibitor of Apoptosis Proteins (IAP) antagonist, is the only medicine in its class in late-stage clinical development and has the potential to be first in class. Xevinapant is currently being investigated in the Phase III TrilynX study for previously untreated high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy.

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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

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"As a leading science and technology company, we are constantly evolving our three business sectors to ensure we are best-positioned to create sustainable value. This includes the addition of highly promising technologies, such as the in-licensing of xevinapant. This late-stage asset complements our Healthcare pipeline, which will be one of our key growth drivers in the coming years," said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany.

"By bringing our expertise and heritage in head and neck cancer to the development of xevinapant, we have the opportunity to explore an important new treatment option in an area of high unmet need where other approaches, including immunotherapy, have seen limited success. The promising long-term efficacy of xevinapant in the Phase II trial suggests that antagonism of IAP has the potential to be a transformative approach in this cancer," said Peter Guenter, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. "Looking forward, we will continue to pursue opportunities to augment the in-house innovations in our oncology portfolio with new solutions for patients with cancer."

Under the terms of the licensing agreement, Merck KGaA, Darmstadt, Germany, gains exclusive rights to develop and commercialize xevinapant worldwide, including in the U.S. Merck KGaA, Darmstadt, Germany, will co-fund with Debiopharm the ongoing Phase III registrational TrilynX study, a global double-blind, placebo-controlled, 700-patient randomized clinical trial to evaluate the efficacy and safety of xevinapant vs. placebo when added to definitive chemoradiotherapy (CRT) in cisplatin-eligible patients with high-risk LA SCCHN. Merck KGaA, Darmstadt, Germany, also will initiate a second global Phase III study to evaluate xevinapant in patients with LA SCCHN who are unable to tolerate high-dose cisplatin in combination with radiotherapy. The agreement also includes development rights for preclinical follow-on compounds to xevinapant. Debiopharm will receive €188 million in upfront payments and up to €710 million in regulatory and commercial milestones, as well as royalty payments. The parties anticipate the closing of the transaction in early Q2 2021.

"The data for xevinapant to date show its potential to enhance the standard of care in this curative setting for head and neck cancer, addressing a significant unmet medical need for patients with this disease," said Bertrand Ducrey, Chief Executive Officer of Debiopharm. "Our partner is exceptionally qualified to advance xevinapant, given their extensive knowledge in head and neck cancer and their commercial oncology capabilities around the world."

"Locally advanced head and neck cancer is uniquely debilitating, often impairing the ability to swallow, speak and breathe. With the current standard treatments, at least half of patients will relapse, typically within the first two years. Based on the efficacy seen in the Phase II study, in which adding xevinapant to CRT cut the risk of death by half, this investigational medicine has the potential to offer a much-needed new standard of care," said Prof. Jean Bourhis, Department Head of Radio-Oncology at the University Hospital of Lausanne and lead investigator of the Phase III TrilynX study.

Previously reported results from the randomized, double-blind Phase II study showed the addition of xevinapant to standard-of-care CRT provided a statistically significant 21% point improvement in locoregional control rate at 18 months, the primary endpoint, vs. placebo and CRT in patients with high-risk LA SCCHN (54% [95% CI: 39 to 69] vs. 33% [95% CI: 20 to 48]; odds ratio 2.69 [95% CI: 1.13 to 6.42]; p=0.026). A significant progression-free survival (PFS) benefit was also observed vs. the control arm after a two-year follow-up period (HR=0.37, 95% CI: 0.18 to 0.76; p=0.0069).1 At three years of follow-up, xevinapant plus CRT showed a statistically significant 51% reduction in the risk of death versus placebo plus CRT (HR=0.49, 95% CI: 0.26 to 0.92; p=0.0261). About two-thirds of patients in the xevinapant arm were alive at three years, compared with 51% in the control arm. Statistically significant improvements in PFS and duration of response were also sustained at three years.2 Xevinapant showed a predictable and manageable safety profile without substantial additional toxicity to standard CRT.1,2 Primary results of the study were published in The Lancet Oncology, and the three-year follow-up data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020.

In February 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to xevinapant for treatment of patients with previously untreated LA SCCHN, in combination with current standard of care, platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy, based on the Phase II results.

About Head and Neck Cancer
Worldwide, head and neck cancer accounts for more than 650,000 cases and 330,000 deaths annually, making it the 6th most common cancer type.3 LA SCCHN is a highly debilitating disease that can lead to impaired breathing, swallowing, and speech as it progresses.4 Despite standard-of-care CRT, at least 40% to 60% of patients with LA SCCHN develop locoregional or distant relapses, which are usually detected within the first two years of treatment, underscoring the need to identify new therapeutic approaches.5

About Xevinapant
Xevinapant (Debio 1143) is a potentially first-in-class potent oral antagonist of IAPs (Inhibitor of Apoptosis Proteins). In preclinical studies, xevinapant restores sensitivity to apoptosis in cancer cells, thereby depriving them of one of their major resistance mechanisms. As the most clinically advanced IAP antagonist, xevinapant has established proof of efficacy in combination with chemoradiotherapy (CRT) in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), with a clinically significant and sustained clinical benefit compared with CRT alone.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe to register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

Genprex to Participate in Upcoming March Investor Conferences

On March 1, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it will participate in the following investor conferences in the month of March, with presentations led by the Company’s President and Chief Exeutive Officer, Rodney Varner (Press release, Genprex, MAR 1, 2021, View Source [SID1234575832]).

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Sachs 14th Annual European Life Sciences CEO Forum (Virtual)

Date: March 10-12, 2021

Time: On demand, starting at 10 a.m. Central European Time (CET) on Wednesday, March 10

Registration Link: http://bit.ly/3pRX0FG

33rd Annual Roth Conference (Virtual)

Date: March 15-17, 2021

Time: On demand, starting at 9 a.m. Eastern Standard Time (EST) on Monday, March 15

Registration Link: http://bit.ly/3srur3N

The Company invites investors to join the webcast presentations, and Mr. Varner will be available for one-on-one meetings with investors throughout the conferences. The presentations will be available for replay on the Company’s website (www.genprex.com) for a period of time following the conferences.

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."