MedNess: bite-size biopharma and medtech news

FDA Approves FYARRO™ for Patients with Locally Advanced Unresectable or Metastatic Malignant Perivascular Epithelioid Cell Tumor (PEComa)
Brendan Delaney, Chief Operating Officer of Aadi, added, “We have built a strong commercial team and devised a thoughtful strategy in preparation for FYARRO’s launch. With FYARRO’s demonstrated clinical profile we believe it will become a standard of care for advanced malignant PEComa. We look forward to engaging with physicians to educate the market about this new treatment.”

FDA placed KOMET-001 Ph 1b study of KO-539 in patients with R/R AML on a partial clinical hold
“We share the FDA’s commitment to patient safety, and we appreciate our ongoing dialogue as we work diligently to address their questions,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Differentiation syndrome is known to be an on-target effect associated with therapeutic agents that induce differentiation, and we want to ensure physicians are fully informed and prepared to address these events if they occur. Based on the totality of preclinical and clinical data, we continue to believe that KO-539 has the potential to address the significant unmet medical need of AML patients, including those with NPM1 mutations and KMT2A rearrangements.”

Health disparities in oncology clinical trials identified by data analytics
Underrepresentation of certain demographics in clinical trials, as suggested by data analytic tools, can be causal factor in health disparity (defined as differences in outcomes or disease burden between disparate groups). Increasing diversity within trial population serves the critical requirement of identifying treatment safety and efficacy throughout different genetic makeups within the subjects, leading the NIH to promote several initiatives. Recently, Juan F. Javier-DesLoges, MD, MS, of UC San Diego Health, and his colleagues analyzed the NCI Clinical Data Update System, containing records on participants in NCI-sponsored clinical trials, to examine the representation of minorities, women, and older patients in 766 breast, colorectal, lung, and prostate cancer trials from 2000–2019. The cumulative data represented 242,720 participants of which 197,320 were Non-Hispanic White (81.3 percent), 21,190 Black (8.7 percent), 11,587 Hispanic (4.8 percent), and 6,880 Asian/Pacific Islander (2.8 percent) patients. The demographics tend to change according to cancer types as well. For example, Hispanic and Black patients were more likely to be included in breast, lung, and prostate cancer trials in recent years than the past. Women tend to participate more in lung cancer trials vs. colorectal cancer. The researchers hope that the analysis will help in gaining balance in clinical trials, which in turn, will aid health equity and population health.

U Pittsburgh partners with Orange Grove Bio to Commercialize Therapies Developed at the University
Orange Grove Bio LLC, an Ohio based drug investment and development firm is partnering with the University of Pittsburgh to commercialize therapies targeting cancer and autoimmune and inflammatory diseases.Orange Grove, a preclinical drug investment and development firm started in 2019, works with about 50 universities. The company will provide funding and guidance to Pitt researchers, which is necessary to form startup companies and commercialize new therapies. The partnership, which will also include internships for Pitt’s doctoral students,is a part of the university’s continuing efforts to pivot toward generating revenue from basic research.
The announcement of the Orange Grove partnership comes a day after the Richard King Mellon Foundation announced a $100 million grant to Pitt to build BioForge,  a huge biomanufacturing facility at the Hazelwood Green.
In a typical arrangement, Pitt would hold the patent for a technology developed by its researchers, but Orange Grove would have exclusive licensing rights.

Qurient Announces Collaboration Agreement with MSD to Evaluate Selective Triple Inhibitor Q702 in Combination With KEYTRUDA® (pembrolizumab)
Kiyean Nam, Ph.D., CEO of Qurient, said, “We are pleased to collaborate with MSD to evaluate Q702 in combination with KEYTRUDA for the treatment of esophageal, gastric, hepatocellular, and cervical cancers, where limited immuno-oncology treatment options are currently available. We have previously shown the potential additive benefit of Q702 in combination with anti-PD-1 therapy in preclinical models, so this combination study is designed to evaluate clinical benefit of Q702 and KEYTRUDA for patients.”