On September 28, 2021 Care Access, the world’s leading decentralized research organization (DRO), reported its expanded partnership with global biopharma leader Eli Lilly and Company (Lilly) to broaden patient access to clinical trials and increase representation of minority group members, including African American, Hispanic, and LatinX populations (Press release, Eli Lilly, SEP 28, 2021, View Source [SID1234590419]).

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Lilly has tapped Care Access in its phase III breast cancer clinical trial, eMonarcHER, designed to evaluate the safety and efficacy of Abemaciclib (LY2835219) in participants with hormone receptor positive and human epidermal receptor 2 positive, high risk, early breast cancer who are taking hormone therapy after surgery. Oncology clinical trials have historically under-enrolled minority group members due to geographical barriers, cultural differences, and a persistent distrust in health care. This study aims to engage diverse groups of physicians and patients to conduct research that is more fully representative of the U.S. population. There is a more intentional focus on the recruitment of Black women with breast cancer, whom we know when diagnosed with early breast cancer have a 40% higher mortality rate than white women. To increase enrollment, Care Access will utilize its dedicated Patient Access team to establish and foster local community partners including health care systems, physician groups, diversity-focused groups, advocacy groups, and community centers that serve underrepresented minority populations.

"Over the past decade, we have been committed to increasing enrollment of racially and ethnically diverse clinical trials, including educating physicians and patients about the importance of diversity and partnering with organizations dedicated to expanding representation," said Amy Davis, Senior Director of Oncology Clinical Development at Eli Lilly and Company. "This is critical for an illness like breast cancer in which women of color have been historically underrepresented in clinical trials. Our work with Care Access–an organization equally committed to increasing representation of minority group members in clinical trials–brings us one step closer to achieving these diversity goals."

Building on its work with Lilly through highly successful COVID-19 trials, Care Access will take a three-pronged approach: first, Care Access will create partnerships with surgical and medical oncologists in underrepresented minority groups to serve as PIs for the trial, helping set up and run a research program within their oncology practice. This lessens the administrative or regulatory burdens on physicians that come with running a research program. Second, Care Access will establish community-based partnerships through its Patient Access team to better reach trial gatekeepers and patients. Third, Care Access will educate patients through its Patient Education team so they can make informed decisions on whether to participate in the trial based on their medical needs.

"We have the unique ability to deliver quality care to patients in their own communities through our Sites on Demand program, creating more access and encouraging participation of all populations," said Ahmad Namvargolian, CEO of Care Access. "While there’s been a 40% decline in breast cancer deaths over the last 30 years, a stark mortality gap remains between Black women and Caucasian women. It’s absolutely critical for our industry to address these hollowing disparities. We are confident in our ability to expand patient access to deliver lifesaving treatments to patients faster and are excited to partner with Lilly on eMonarcHER to increase representation in clinical trials for minority group members immediately and for decades to come."

These enhanced measures to increase diversity for eMonarcHER is a step toward a more equitable future for all populations. Increasing representation of diverse groups in clinical trials helps to develop and deliver innovative treatments that make a meaningful difference in the lives of all people living with cancer.

On September 28, 2021 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have reached an agreement with the Cherokee Nation to pay approximately $75 million over 6.5 years to resolve opioid-related claims (Press release, Cardinal Health, SEP 28, 2021, View Source [SID1234590418]). This settlement was negotiated in connection with ongoing negotiations toward a broad resolution of opioid-related claims brought by Native American tribes that, as previously disclosed by the companies, are not covered by the ongoing settlement process involving state and local governmental entities. The companies view today’s settlement as an important step toward reaching a broader settlement with all federally recognized Native American tribes across the country.

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This settlement reflects an agreement of the Cherokee Nation to dismiss its ongoing lawsuit in exchange for the companies’ agreement that the Cherokee Nation will receive a settlement amount consistent with its anticipated allocation under a broader agreement with Native American tribes.

While the companies strongly dispute the allegations against them, they believe this resolution will allow the companies to focus their attention and resources on the safe and secure delivery of medications and therapies while delivering meaningful relief to affected communities, and will also support efforts to achieve a broad resolution with the remaining Native American tribes.

The companies remain deeply concerned about the impact the opioid epidemic is having on communities across the nation and remain committed to being part of the solution.

On September 28, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,130,803, with an expiry of May 2040, including 313 days of Patent Term Adjustment (PTA) (Press release, Scholar Rock, SEP 28, 2021, View Source [SID1234590417]). This US patent includes composition-of-matter claims, providing product protection for SRK-181, a selective inhibitor of TGFβ1 activation that avoids binding to latent TGFβ2, latent TGFβ3, or any of the three active TGFβ growth factors. SRK-181 is an investigational clinical candidate being developed to overcome primary resistance to and increase the number of patients who could benefit from checkpoint inhibitors, such as anti-PD-(L)1 therapies.

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"This is another important addition to our patent portfolio providing product protection for SRK-181 as we continue to progress the DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors"

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"This is another important addition to our patent portfolio providing product protection for SRK-181 as we continue to progress the DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors," said Nagesh Mahanthappa, Ph.D., Interim CEO of Scholar Rock. "As we observed in preclinical studies, our hypothesis remains that a selective approach to targeting the TGFβ1 isoform could allow for an improved safety and efficacy profile compared to non-selective approaches and we’re very excited to continue pursuing our unique approach to provide potential clinical benefit for patients who are resistant to treatment with PD-(L)1 inhibitors."

SRK-181 is being evaluated in the two-part DRAGON trial (NCT04291079) in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy. Part A dose escalation is evaluating the safety and pharmacokinetics of SRK-181 as a single-agent and in combination with anti-PD-(L)1 therapy to identify the recommended dose for Part B of the trial. Part B dose expansion will consist of multiple cohorts, including urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors and patients will be treated with SRK-181 in combination with an anti-PD-(L)1 therapy. An update on dose escalation and initial clinical data from Part A of the DRAGON trial is anticipated by year-end.

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity (1). Scholar Rock believes SRK-181, which specifically targets the latent TGFβ1 isoform, has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The efficacy and safety of SRK-181 have not been established. SRK-181 has not been approved for any use by the FDA nor any other regulatory agency.

(1) Martin et al., Sci. Transl. Med. 12: 25 March 2020

On September 28, 2021 The University of Texas MD Anderson Cancer Center and BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a strategic alliance to advance the development and clinical integration of multiplatform biomarker signatures (Press release, MD Anderson, SEP 28, 2021, View Source [SID1234590415]).

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The alliance brings together BostonGene’s innovative computational platform and CLIA-certified and CAP-accredited high complexity molecular laboratory with the clinical and translational research expertise of MD Anderson, leveraging scientific discovery, analytical advancement and powerful computing to develop clinically applicable solutions for patients with cancer. BostonGene’s computational platform evaluates myriad molecular and immune-based parameters to discover correlations between tumor genomics, a patient’s immune system and the effectiveness of new and emerging treatments. This agreement expands upon existing research collaborations between BostonGene and multiple MD Anderson researchers.

"As we gain deeper insights into the drivers behind each cancer, actionable biomarkers are increasingly important to inform clinical decisions and provide individualized treatments," said Funda Meric-Bernstam, M.D., Chair of Investigational Cancer Therapeutics at MD Anderson. "Through our collaboration with BostonGene, we will utilize multi-parameter discovery, big data analytics and computational support to advance and validate novel diagnostic and therapeutic biomarkers that we hope will guide physicians to deliver optimal care to each patient."

Under the terms of the agreement, BostonGene and MD Anderson will collaborate with the goal of translating unique research findings into multiple clinically actionable tests. BostonGene and MD Anderson expect to validate promising clinical biomarker targets through retrospective and prospective MD Anderson investigator-sponsored trials for patients with common and rare cancers. MD Anderson is eligible to receive certain payments based on the achievement of certain clinical milestones and commercial sales. As part of the research alliance, MD Anderson and BostonGene will work together on clinical utility studies designed to support incorporation of BostonGene testing into national guidelines and adoption as a national standard of care.

"Implementing cutting-edge technologies is a critical component in MD Anderson’s approach to improving care for our patients. This agreement with BostonGene further demonstrates our commitment to advancing the adoption of precision medicine through focused and strategic collaborations," said Ferran Prat, PhD., J.D., Senior Vice President for Research Administration and Industry Relationships at MD Anderson.

"We are proud to collaborate with MD Anderson in the pursuit of identifying optimal treatment options for cancer patients," said Andrew Feinberg, President and CEO of BostonGene. "This new agreement reinforces our combined commitment to transforming and improving patient care."

In addition to the research alliance, BostonGene recently entered into a laboratory services agreement with MD Anderson to offer BostonGene Tumor Portrait Tests, available to physicians to order through the electronic medical records system for patients meeting test requirements.

Disclosures
MD Anderson has an institutional conflict of interest with BostonGene through this strategic alliance and is implementing an Institutional Conflict of Interest Management and Monitoring Plan for all research related to this agreement.

On September 28, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that the trial Safety Monitoring Committee approved its first-in-human Phase 1 clinical study of Radspherin in ovarian cancer patients suffering from peritoneal carcinomatosis to progress to the fourth level dose cohort (Press release, Oncoinvent, SEP 28, 2021, View Source [SID1234590413]). Enrollment in this cohort, where patients will receive 7 MBq of Radspherin, is expected to begin imminently.

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"The progression of the RAD-18-001 study to the fourth dose level, continues to build our confidence as we continue to develop Radspherin for treatment peritoneal carcinomatosis, an area of high unmet need," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "we will now start dosing patients at the 7 MBq dose level, a dose level that has been found to be safe in colorectal cancer patients."

About RAD-18-001

The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin

Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.