On March 15, 2021 Istari Oncology reported that An immunotherapy derived from the polio virus has shown improved survival rates in early-phase trials in patients with an aggressive type of brain tumor known as glioblastoma (Press release, Istari Oncology, MAR 15, 2021, View Source [SID1234576693]). UConn Health will be one of a select few sites in the U.S. for the second phase, which will pair it with the cancer immunotherapy pembrolizumab (Keytruda).
As a promising new therapy for certain brain tumors reaches the second phase of clinical trials, UConn Health will be one of the select few locations in the United States to make this treatment available to patients during the further evaluation of its safety and efficacy.

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The therapy combines what researchers are calling PVSRIPO, a viral immunotherapy based on the polio vaccine, with pembrolizumab, an immunotherapy drug shown to be effective in treating many other types of cancers, marketed under the brand name Keytruda. The rationale for studying these agents in combination is evidence that indicates these drugs work synergistically to activate the immune system to fight cancer. PVSRIPO has been granted "breakthrough therapy designation" from the U.S. Food and Drug Administration for recurrent glioblastoma. It is also being studied across a range of cancers including melanoma, for which the FDA has granted "orphan drug status."

Istari Oncology, Inc., the North Carolina-based biotechnology company sponsoring the research, has selected UConn Health as a site for this phase of the trial.

"This is a tremendous example of the innovative trials we envision as we build our neuro-oncology program at UConn," says Dr. Kevin Becker, director of neuro-oncology and UConn Health’s primary investigator for this trial. "We are extremely honored to be one of only a few selected sites for the LUMINOS-101 trial. This is truly a landmark trial for patients with recurrent glioblastomas."

Headshot of Dr Kevin Becker
Dr. Kevin Becker
This is a tremendous example of the innovative trials we envision as we build our neuro-oncology program at UConn.

LUMINOS-101 is how Istari Oncology is branding this clinical trial.

The investigators believe the one-two punch of therapies may be able to generate "a potent and specific anti-tumor response" in patients with recurrent malignant glioblastoma, a type of aggressive and often fatal brain tumor.

"To be selected as one of a handful of sites in the world for this trial is truly a tribute to Dr. Becker’s leadership, and it is also a tribute to the great multidisciplinary team that has been created through the Carole and Ray Neag Comprehensive Cancer Center and our Brain and Spine Institute," says Dr. Ketan Bulsara, chief of UConn Health’s Division of Neurosurgery. "UConn Health’s involvement in this very promising trial affirms our standing as a world-class institution for clinical care and research in neuro-oncology."

UConn Health will share additional details about the research, including information on eligibility requirements and how patients can participate, later this year.

On March 15, 2021 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its President and Chief Executive Officer, Peter L. Hoang, will present at the upcoming Virtual Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021 at 3:10 p.m. ET (Press release, Marker Therapeutics, MAR 15, 2021, View Source [SID1234576676]).

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A live webcast of the presentation will be accessible from the Investors section of the company’s website at markertherapeutics.com and will be available for replay following the event.

On March 15, 2021 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP), reported in collaboration with Pfizer Inc., ten projects have been chosen to receive funding to support innovative approaches to improve the processes related to appropriate biosimilar adoption in oncology (Press release, NCCN, MAR 15, 2021, View Source [SID1234576675]).

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The selected organizations and research projects are:

American Society of Clinical Oncology, Inc., ASCO (Free ASCO Whitepaper)’s PracticeNET Learning Network
Analysis of Biosimilar Utilization and Perspectives within ASCO (Free ASCO Whitepaper)’s PracticeNET Learning Network
Baptist Memorial Hospital Tipton
Adoption of Biosimilars in Oncology
Cancer Support Community
Frankly Speaking About Cancer: Biosimilars – Researching Oncology Patient and Caregiver Perceptions
Cedars-Sinai Medical Center
Optimize Systemic Platform to Assure Quality, Value and Evidence-Based Decision Making on Biosimilar Products Use in Oncology Patients
City of Hope Medical Foundation
Challenges to Biosimilar Adoption in Community Oncology Due to Diverse Payer Preferences for Different Biosimilar
Houston Methodist
Impact of Discordant Preferred Drug Status between Hospitals and Payers for Chemotherapeutic Biosimilars
Roswell Park Comprehensive Cancer Center
Identifying Best Practices in Biosimilar Implementation
University of Illinois at Chicago
Developing a Human-Centered Information Packet to Increase Trastuzumab Biosimilars Uptake
The University of Texas at Austin
Biosimilar Optimization in Community Oncology Practice
UT Southwestern Medical Center
Developing a Clinical Decision Support Tool for Biosimilar Use in Oncology
"This research highlights NCCN’s commitment to exploring new avenues for increasing the availability of affordable, effective treatment options in oncology," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "These projects will help us to determine best practices for using biosimilars—when safe and appropriate—and how to educate providers and patients about them."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology. For more information, visit NCCN.org/ORP.

On March 15, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that PEPAXTO (melphalan flufenamide) is now commercially available across the United States and that the first patients are being treated with the drug (Press release, Oncopeptides, MAR 15, 2021, View Source [SID1234576674]). PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

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"I am very pleased that PEPAXTO is now available as an innovative treatment option for patients with multiple myeloma at hospitals and community practices across the United States," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. "We are committed to working closely with payers and healthcare providers to ensure that all appropriate patients who receive a PEPAXTO prescription have access to the drug".

About melphalan flufenamide

Melphalan flufenamide, also known as melflufen, is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma. Melphalan flufenamide uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound. Due to its high lipophilicity, melphalan flufenamide is distributed into cells. Melphalan flufenamide is designed to leverage aminopeptidases, which are overexpressed in multiple myeloma cells and cause the release of cytotoxic agents. Melphalan flufenamide is administered once monthly, by a thirty-minute infusion.

In the US, PEPAXTO (melphalan flufenamide) is indicated in combination with dexamethasone for the treatment of adult patients with triple class refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-monoclonal directed antibody. PEPAXTO is a registered trademark in the U.S.

On March 15, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that John Climaco, CEO of CNS Pharmaceuticals will present at the inaugural Emerging Growth Virtual Conference presented by M Vest LLC and Maxim Group LLC (Press release, CNS Pharmaceuticals, MAR 15, 2021, View Source [SID1234576673]). The conference will take place virtually on March 17th and 18th and will feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

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In addition to the presentation, Mr. Climaco will participate in a live glioblastoma panel discussion on Wednesday, March 17th from 9:30-10:30 am ET.

Interested parties are invited to attend the virtual conference and access exclusive content by becoming an M-Vest member and registering HERE. To learn more about the event, please visit the conference website: Emerging Growth Virtual Conference.