On June 6, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests initially focused on non-invasive detection of high-mortality cancers in high-risk patient populations through a standard blood draw, reported it has received Clinical Laboratory Improvement Amendments (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (Press release, Bluestar Genomics, JUN 6, 2022, View Source [SID1234615663]).

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The certification confirms that Bluestar Genomics’ laboratory meets the federal regulations for clinical diagnostic testing, ensuring high quality and safety for patient testing. As part of the certification process, Bluestar Genomics recently completed analytical validation evaluating the accuracy and reliability of the company’s early detection test for pancreatic cancer. Top-line results showed significantly stronger performance than previously reported particularly in early stage (I/II) detection. Full data from the study will be published in a peer reviewed journal in the coming months.

"Securing CLIA certification is an important step for Bluestar Genomics. It underscores our pancreatic cancer test’s competitive performance, enables us to start clinical testing in our lab and allows us to move forward with larger clinical validation studies," said David Mullarkey, chief executive officer. "This certification, combined with our growing body of scientific evidence, positions us to become the first cancer detection company to offer clinical epigenomic testing for early pancreatic cancer detection."

Currently, pancreatic cancer ranks as the third most deadly cancer with a combined five-year survival rate of only 5% to 10%. Research has shown that early detection in pancreatic cancer can increase patient survival nearly ten-fold.

On June 6, 2022 The US Oncology Network (The Network), US Oncology Research and Ontada reported that Results from the second phase of the broad, collaborative MYLUNG ConsortiumTM research study in non-small cell lung cancer (NSCLC) were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, US Oncology, JUN 6, 2022, View Source [SID1234615662]). The findings show that the incorporation of a remote oncology pharmacist in clinical research teams significantly enhanced patient enrollment for Protocol 2 of the MYLUNG Consortium.

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"Advances in science are quickly enabling new treatment opportunities, but timely enrollment into clinical trials continues to be a challenge," said Elizabeth Koselke, PharmD, senior clinical pharmacist for The Network. "Our study showed that by incorporating an oncology-trained clinical pharmacist to remotely review chemotherapy regimens and a customized recruitment report, we were able to more efficiently screen patients and significantly enhance Protocol 2 enrollment."

Koselke presented the findings during an oral presentation at ASCO (Free ASCO Whitepaper) titled, "Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The US Oncology Network ’s MYLUNG Consortium."

In the study, oncology-trained clinical pharmacists reviewed over an eight-month period 506 newly diagnosed and untreated NSCLC patients from six practices in The Network. Working remotely, the pharmacist reviewed chemotherapy regimen orders and identified, screened and assisted with recruitment of eligible patients for enrollment in MYLUNG Consortium Protocol 2. Working remotely enabled the pharmacists to identify patients quickly across the country who were potential candidates for the study. Enrollments and intervention data were then tracked to monitor the impact of the pharmacist intervention. The study showed that average monthly enrollment was significantly greater after pharmacist intervention (6.6 patients a month per practice) when compared to monthly enrollment before pharmacist intervention (3.4 patients a month per practice).

"These data show that using an interdisciplinary approach to trial enrollment can be an effective method to increase speed and efficiency in real-world clinical research," noted Robert L. Coleman, MD, FACOG, FACS, chief scientific officer of US Oncology Research and the MYLUNG Consortium Principal Investigator. "As we move into Protocol 3 of the MYLUNG Consortium study, we look forward to continuing to validate pharmacist intervention across a wider spectrum of practices across The Network."

An additional study at ASCO (Free ASCO Whitepaper) 2022 took a further look at the MYLUNG Consortium Protocol 1 results that were first presented at ASCO (Free ASCO Whitepaper) 2021. These initial findings reported that fewer than 50 percent of metastatic non-small cell lung cancer patients had the recommended biomarker tests.

In a poster presentation titled, "Predictors of biomarker testing among patients (pts) with metastatic non-small cell lung cancer (mNSCLC)," MYLUNG Consortium researchers examined the social and economic factors associated with biomarker undertesting. The research found that lower comprehensive biomarker testing rates were associated with patients who were of the African American race, seen in a smaller practice size or in a practice in the southern part of the United States, or had squamous cell histology.

"This retrospective analysis took the previously reported research from Protocol 1 and further examined the patient factors that are associated with a lack of biomarker testing," said Dr. Nicholas Robert, chief medical officer of Ontada. "Understanding these clinical and social determinants of health will be important interventions to improve testing rates as we enter into the prospective phases of the MYLUNG Consortium study."

The MYLUNG Consortium is a collaborative and innovative research study comprised of three protocols over a five-year period, enabled through a unique collaboration of various organizations and stakeholders working together across the spectrum of NSCLC drug development, therapy and care. The number of consortium participants continues to grow, all bringing unique perspectives to this innovative study. The MYLUNG Consortium brings together providers and researchers in The Network, US Oncology Research and Ontada with life sciences companies Amgen, AstraZeneca, Eli Lilly and Company, Genentech (a member of the Roche Group), and Mirati Therapeutics, Inc. Patient advocacy groups LUNGevity and GO2 Foundation for Lung Cancer are also participating, playing a key role in the study by keeping the focus on patients. Participating practices in The Network include Illinois Cancer Specialists, Maryland Oncology Hematology, Minnesota Oncology, New York Oncology Hematology, Oncology Hematology Care, Rocky Mountain Cancer Centers, Texas Oncology, Southern Cancer Center, Virginia Cancer Specialists, Virginia Oncology Associates, Willamette Valley Cancer Institute and Research Center and Woodlands Medical Specialists.

Read more about the MYLUNG Consortium here. To schedule a media interview with one of the study investigators, contact Claire Crye at [email protected].

On June 6, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported abstracts accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which convenes in Chicago from June 3-7, 2022 (Press release, Tempus, JUN 6, 2022, View Source [SID1234615661]). Tempus is presenting fourteen abstracts, including one oral presentation, two poster discussions, and eleven poster presentations.

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"The research we’re presenting at this year’s conference showcases the breadth and effectiveness of our offerings for oncologists, whether it is our RNA sequencing capabilities or our just-in-time clinical trial matching program," said Dr. James L. Chen, Senior Vice President of Cancer Informatics at Tempus. "We’ve been fortunate enough to work with physicians across the country to advance research that can have a real impact in improving patient outcomes."

The presented research showcases Tempus’ comprehensive collection of precision medicine solutions that are uniquely equipped to support physicians in optimizing each patient’s treatment. Tempus’ oral discussion and poster presentation highlights, include:

Oral Discussion: Operational Metrics for the ELAINE II study Combining a Traditional Approach with a Just-in-TIME Model
Session Date & Time: June 6, 2022, 3:00 – 6:00 PM CDT
Overview: This study demonstrates the success that Tempus’ TIME Trial Program had with Sermonix’s Elaine II trial for patients with ESR1-mutant, estrogen receptor (ER)–positive, HER2-negative metastatic breast cancer. It found that TIME trial sites enrolled their first patient nearly four months faster than traditional sites, and the same sites contributed 44.8% of the patients that were enrolled in the study. Ultimately, the Elaine II trial enrolled all patients in eight months, while the anticipated enrollment duration was twelve to eighteen months
Poster Title: #69 – Clinical whole transcriptome profiling improves the detection of clinically actionable fusions over DNA sequencing alone
Session Date & Time: June 5, 2022, 8:00 – 11:00 AM CDT
Overview: In the largest fusion analysis of its kind, Tempus reviewed a real-world dataset of 84,938 patient records for improvement in clinically actionable fusion detection due to the inclusion of RNA sequencing. The study found that RNA sequencing identified 29% more patients with clinically actionable fusions that were matched to biomarker linked therapies and that would have been missed by DNA sequencing alone.
Poster Title: #9 – Dual tissue and plasma testing improves detection of actionable variants in patients with solid cancers
Session Date & Time: June 5, 2022, 8:00 – 11:00 AM & 4:30 – 6:00 PM CDT
Overview: This study found that 4 out of 10 patients had unique actionable variants linked to targeted therapies from doing both solid tumor and liquid biopsy testing that would have been missed by single modality testing alone. In the study, 42% of an overall cohort of 3,153 patients had clinically actionable variants detected through tissue-based comprehensive genomic profiling and/or liquid biopsy. Of these patients with clinically actionable variants, all linked to targeted therapies, 37% were uniquely identified through tissue testing only or by liquid biopsy only.

On June 6, 2022 InnoCare reported that Latest data of it’s robust oncology pipeline were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, InnoCare Pharma, JUN 6, 2022, View Source [SID1234615660]).

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Poster Presentation 1:
Phase I results of gunagratinib (ICP-192), a highly selective irreversible FGFR 1-4 inhibitor in patients with head and neck cancer (HNC) harboring FGF/FGFR gene aberrations
Abstract Number: 6039

In the dose-escalation study, patients with advanced solid tumors (including HNC) with or without FGF/FGFR gene alterations were treated with escalating doses (range: 2mg-26mg) of gunagratinib once daily in 21-day cycles.

12 HNC patients were treated with escalating doses (range: 14mg-22mg) of gunagratinib. Among the 9 HNC patients with FGF/FGFR gene aberrations including FGF amplification and FGFR mutation, who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, and the disease control rate (DCR) was 66.7%. The treatment-related adverse events (TRAEs) were manageable and gunagratinib was generally safe and well tolerated.

The most common treatment-related adverse events (TRAEs) included hyperphosphatemia, diarrhea, increased ALT or AST, etc. No serious TRAE were reported in HNC patients.

Professor Ye Guo from Shanghai East Hospital of Tongji University said, "This study showed the anti-tumor activity of gunagratinib in HNC patients carrying FGF/FGFR gene aberrations. Gunagratinib is safe and well-tolerated in patients with advanced solid tumors including HNC in this study.

Poster Presentation 2:
Safety, pharmacokinetics (PK) and clinical efficacy of ICP-723, a highly selective next-generation pan-TRK inhibitor, in patients with solid tumor
Abstract Number: 3106

As of 11 Feb 2022, a total of 17 patients in phase I dose escalation were treated with ICP-723 at doses of 1 mg QD, 2mg QD, 3mg QD, 4mg QD, 6mg QD and 8 mg QD. There is no DLT observed in the 6 dose groups. Six of 17 patients were confirmed as NTRK gene fusion positive tumors by either prior gene test reports or the central lab gene test.

According to RECIST 1.1 criteria, among the 6 patients with NTRK fusion, the overall response rate (ORR) was 66.7% (4 patients with partial response (PR)), the disease control rate (DCR) was 100%. The ORR was 100% in dose groups of 4mg and above. All patients who achieved PR responded to ICP-723 at the first tumor assessment after 4-week treatment and maintained sustained responses to the date of data cutoff. One patient with lung adenocarcinoma and brain metastasis achieved PR with the target brain lesion shrunk from 10 mm to 3 mm.

Dr. Xiaoli Wei from Sun Yat-sen University Cancer Center said, "ICP-723 is safe and well-tolerated in patients with advanced solid tumors. Encouraging clinical efficacy including intracranial activity was demonstrated in patients with NTRK gene fusion in various tumor types."

Online Publication:
Efficacy and safety of orelabrutinib in diffuse large B-cell lymphoma (DLBCL): a real-world analysis
Abstract Number: e19556

Fourteen patients with MCD DLBCL were included in the study. All patients received orelabrutinib 150 mg once daily. Among them, 8 were treated with R-CHOP or R-EPOCH as first-line therapy, and 6 with RICE, R-CHOP or R2 as second-line therapy. The complete response rate (CRR) for the first-line and second-line therapy were 75.00% and 66.67%, respectively.

Reported AEs were generally manageable and resolved soon after supportive treatment.

The leading PI concluded that orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL. A large-scale prospective clinical study is on registration, which would offer a new potential therapeutic option for patients with MCD DLBCL.

More information can be found at ASCO (Free ASCO Whitepaper) official website.

On June 6, 2022 Genuv Inc., a clinical-stage biotechnology company focused on innovative drug discovery for central nervous system disorders and advanced antibody therapies, and Nanocarry Therapeutics, a private company developing a new class of therapeutics capable of crossing the Blood-Brain Barrier (BBB), reported an agreement to collaborate on the development of an experimental drug to treat metastatic lung cancer (Press release, Genuv, JUN 6, 2022, View Source [SID1234615659]). Specifically, this collaboration will further develop GNUV201 to treat metastatic tumors in the brain, using Nanocarry’s AxS platform to cross the BBB.

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GNUV201 is an experimental, novel anti-PD-1 monoclonal antibody developed with Genuv’s proprietary antibody development platform Shine Mouse. GNUV201 exhibits strong cross-reactivity to both human and mouse PD-1, increasing the likelihood that animal models of disease are predictive of human clinical results. The experimental drug candidate also demonstrates superior binding affinity compared to Keytruda and Opdivo. The goal is to deliver this powerful cancer-fighting experimental antibody to treat metastatic tumors in the brain from non-small cell lung cancer (NSCLC).

"Genuv is excited to partner with Nanocarry to explore the potential of pairing their platform with our GNUV201 antibody to deliver cancer-fighting medicine directly to metastatic brain tumors," said Sungho Han, Ph.D., founder and CEO of Genuv. "We believe our collaboration could provide proof-of-concept for the first-ever brain-penetrating anti-PD-1 antibody. If we are successful, it may open up the possibility of expanding this therapy to other brain tumor types."

Revital Mandil Levin, Ph.D., cofounder and CEO of Nanocarry Therapeutics, said, "This project is an exciting opportunity to enable Genuv’s novel anti-PD-1 antibody treatments to reach its full potential, by accessing the brain. We look forward to partnering with Genuv for the development of this experimental treatment with our engineered nanoparticles and to bring new hope to patients in need."

The two firms have applied for a grant from the Korea-Israel Industrial R&D Foundation (KORIL-RDF) to support an initial feasibility study including in vitro and in vivo studies to explore targeting the brain with antibodies to treat tumors.