On September 18, 2020 Case Western Reserve reported that researchers think they have a better idea—and the National Institutes of Health has given them $420,000 to advance it (Press release, Case Western Reserve University, SEP 18, 2020, View Source [SID1234565354]).

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Highly collaborative in nature, the project teams researchers from the university’s schools of dental medicine, medicine and engineering.

Their concept combines imaging and algorithmic technologies to assess whether or not a lesion’s cells are malignant.

Aaron Weinberg, chair and professor in the Department of Biological Sciences in the School of Dental Medicine and professor of otolaryngology and pathology in the School of Medicine,
Aaron Weinberg, chair and professor in the Department of Biological Sciences in the School of Dental Medicine and professor of otolaryngology and pathology in the School of Medicine
"The idea is to quickly, easily, non-invasively and cost-effectively determine if a suspicious lesion is cancerous, or in other cases, to screen individuals on a regular basis to see if their lesion has progressed to cancer," said dental faculty member Aaron Weinberg, the project’s principal investigator.

On average, oral cancer claims the life of someone in America every hour, according to the Oral Cancer Foundation.

Early detection is the key to survival, said Weinberg, chair and professor in the dental school’s Department of Biological Sciences. Their approach not only aims to reduce the need for biopsies, but also provide a much-needed diagnostic alternative in places where pathology services are few and difficult to access.

How it works
Researchers envision a hand-held device that can determine the ratios of two key proteins, where one goes up in cancer while the other one does not. By collecting cells swabbed from suspicious oral lesions, and using fluorescent antibodies that bind specifically to one or the other protein within the cells, the device collects images of fields of cells and an app converts the fluorescence intensity of each protein into numbers and calculates the ratio.

The numerical value above a given threshold indicates cancer.

This procedure has already proven to be accurate and effective in laboratory-based techniques, Weinberg said—and the intention is to convert the lab procedure into a device that will cut the time in obtaining results from two days to about 30 minutes.

"This will address major unmet needs in early oral cancer detection worldwide, especially in resource poor settings where pathology review is lacking and/or unreliable," he said.

Weinberg is joined in the research by Umut Gurkan, the Warren E. Rupp Associate Professor at the Case School of Engineering; Anant Madabhushi, the F. Alex Nason Professor II of Biomedical Engineering and director of the Center for Computational Imaging and Personalized Diagnostics; and Rod Rezaee, associate professor in the Department of Otolaryngology at the School of Medicine and University Hospitals.

On September 18, 2020 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, reported second quarter 2020 financial results and provided an update on recent progress (Press release, Checkmate Pharmaceuticals, SEP 18, 2020, View Source [SID1234565352]).

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"This is an exciting time for our company as we rapidly develop CMP-001 across multiple tumor types in combination with checkpoint inhibitors," said Barry Labinger, Chief Executive Officer. "Our recent public offering positions us well to execute on our clinical and strategic plans, including advancement of CMP-001 towards registration in melanoma and towards demonstration of proof of concept in additional tumor types, including head and neck cancer. We are on track to initiate key new clinical trials by late 2020/early 2021 as planned."

Recent Progress

In August 2020, Checkmate closed its initial public offering of 5,000,000 shares of common stock at $15 per share. Including the subsequent partial exercise of the underwriters’ overallotment option, total gross proceeds were approximately $76.6 million, before deducting underwriting commissions and offering expenses.
In July 2020, the U.S. Food and Drug Administration granted Fast Track designation to Checkmate’s product candidate, CMP-001, a differentiated Toll-like receptor 9 (TLR9) agonist, in combination with a programmed death receptor 1 (PD-1) blocking antibody (nivolumab or pembrolizumab) in both anti-PD-1 refractory melanoma and first-line metastatic melanoma.
Checkmate is actively engaging with potential clinical sites and remains on track to initiate three Phase 2 trials combining CMP-001 with PD-1 blockade by late 2020/early 2021 for the treatment of:
First-line head and neck cancer
Anti-PD-1 refractory melanoma
First-line metastatic or unresectable melanoma
Second Quarter 2020 Financial Results

Cash and cash equivalents: Cash and cash equivalents were $80.3 million as of June 30, 2020 (excluding proceeds from the IPO which was completed in August 2020).
Research and development expenses (R&D): R&D expenses were $6.5 million for the quarter ended June 30, 2020, compared to $5.8 million for the quarter ended June 30, 2019. The increase was primarily attributable to start-up costs for upcoming clinical trials as well as manufacturing and process development costs.
General and administration expenses (G&A): G&A expenses were $1.8 million for the quarter ended June 30, 2020, compared to $1.1 million for the quarter ended June 30, 2019. The increase was primarily attributable to expenses incurred in connection with the Checkmate’s preparation for operating as a publicly-traded company.
Net loss and comprehensive loss: Net loss and comprehensive loss was $8.3 million for the quarter ended June 30, 2020, compared to $6.9 million for the quarter ended June 30, 2019.

On September 18, 2020 IntegraGen (FR0010908723 – ALINT – Eligible PEA PME), a company specializing in the decryption of the human genome, which performs interpretable genomic analyzes for academic and private laboratories, reported its financial results for the first half of 2020 (Press release, Integragen, SEP 18, 2020, View Source [SID1234565351]). The accounts were approved by the Board of Directors at a meeting held on 17 September 2020.

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Bernard Courtieu, Chairman and CEO of IntegraGen, said: "The results IntegraGen the first half 20 20 confirms the performance we achieved for the second half of 2019, with an EBITDA positive operating performance. We are also announcing business growth of 15% on a comparable basis to 2019 in an environment particularly complicated by the COVID-19 health crisis during the second quarter of this year. This performance confirms the soundness of our model of focusing on genomics and has been enabled by the trust and loyalty of our customers in our ability to meet their needs and by the efforts and dedication of all IntegraGen employees.

Finally, we are very happy to be able to lead the industrial and commercial merger project with the Belgian company OncoDNA. In fact, our complementary assets will enable us to create a European market leader in Genomic Services and to accelerate our international efforts while sustaining and developing jobs within the two companies."

Sales revenue for the first half 20 20 was up by 15 % to 4,706 thousand euros on a comparable basis against 4,102 thousand euros during the same period in 2019, excluding income of diagnostics related activities, the assets of which were sold at the start of 2020. After considering transfer charges and reversal of depreciation and amortization, revenues were 4,745 thousand euros compared to 4,183 thousand euros during the first half of 2019, which included 62 thousand euros in diagnostic revenue.

The operating expenses amounted to 4,613 thousand euros, down 1% compared to the first half of 2020. Optimization of resources enabled a second consecutive 6-month period to achieve balance. Reagent costs remain stabled. As of June 2020 the company had 47 employees. The operating profit before tax, depreciation and amortization (EBITDA) was a positive 248 thousand euros during the first half 2020 compared to a loss of 325 thousand euros in the first half 2019.

The operating profit before tax showed a gain of 132 thousand euros, also a very clear improvement compared to the same period of 2019 (-484 thousand euros). Of note was the exceptional result of-166 thousand and Credit of Tax Innovation (CTI) related to the research conducted during the period. The net result was a profit of 17 thousand euros, compared to a loss of 538 thousand euros in the first half of 2020.

The net cash of IntegraGen as of June 30, 2020 totaled 5,730 thousand euros compared to 2,749 thousand euros at the end of December 2019. This variation is mainly explained by the obtaining of a State Guaranteed Loan (PGE) of 1,800 thousand euros through the implementation of various adaptation measures aimed at preserving cash flow during the COVID-19 pandemic and by cash flow generated by day-to-day operations.

ACTIVITY

▪ Genomic Services Sales growth resulted from an increase in all sequencing activities, in particular the SeqOIA platform (+33%), activity relating to outsourced platforms (+18%), and, finally, services dedicated to laboratories, research and the teams responsible for clinical research (+9%).

▪ Software As a reminder, the company sells interpretive software and consulting services to its customers. The sales of software are growing but showed limited development during the first half of 2020 due to the impact of the COVID-19 pandemic which affect results and planned of projects. In March the company announced that the Dana-Farber Cancer Institute, a leading cancer referral center in the United States, would begin using MERCURYTM, IntegraGen’s proprietary software, to support the efforts to analyze and report tumor sequencing data for patients with cancer.

▪ Impact of COVID-19 The company has fulfilled its commitments to its customers and employees by rigorously adjusting its resources. The team based at the laboratory of Evry and one based at the Institut Pasteur have continued their activities. The operations of SeqOIA laboratory were suspended for a few weeks but now have resumed. The company has set up a continuity plan, including teleworking devices for all IT and sales teams, but also, since March 20th, the company implemented short term working measures for several employees and the deferral of payment for some charges. The company also obtained a $1,800 thousand euros loan guaranteed by the State to Société Générale in order to save cash and reduce risk.

▪ Perspectives 2020: Confirmed growth IntegraGen has succeeded in maintaining high activities for both research services and with the company’s industrial sequencing platform for clinical use over the past several months. The company expects an acceleration of software sales in the coming months and the continuation its sales efforts to implement new and strong partnerships and sustain business with leading research institutes, as developed with the Dana-Farber Cancer Institute, whose collaboration has been in place since March 2020. F

RIENDLY PUBLIC TENDER OFFER OF ONCO DNA On July 9, 2020, OncoDNA SA and IntegraGen SA announced that they had signed an agreement on July 8, 2020 under which the Belgian company OncoDNA filed a draft friendly cash tender offer relating to IntegraGen shares, including securities trading on the Euronext Growth market of Euronext Paris, at a unit price of € 2.20, valuing 100% of IntegraGen securities for €14.5m. The Autorité des Marchés Financiers (AMF) and the Ministry of the Economy in charge of enforcing the regulations applicable to foreign investments in France have approved this offer which was launched as of September 17, 2020.

OncoDNA is a Belgian company who has an international business related to precision medicine for oncology. The company has developed products for clinicians that helps guide the choice of the best treatment for patients with advanced cancers. OncoDNA also provides liquid biopsy monitoring solutions to better track the progression of the disease. The merger between the two companies will, among other things, create a European leader in genomic services, present in France, Belgium and Spain, employing more than 100 individuals.

On September 18, 2020 Foundation Medicine, Inc. and Takeda Pharmaceuticals USA, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), reported a collaboration for the development of Foundation Medicine’s tissue- and blood-based companion diagnostics for use with marketed and investigational treatments in Takeda’s late-stage lung cancer portfolio (Press release, Foundation Medicine, SEP 18, 2020, View Source [SID1234565350]). If approved, the appropriate companion diagnostics would be used to identify patients who may be eligible for mobocertinib, an investigational drug being evaluated for the treatment of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC), and ALUNBRIG (brigatinib), Takeda’s tyrosine kinase inhibitor (TKI) recently FDA-approved to treat patients with TKI-naïve anaplastic lymphoma kinase-positive (ALK+) mNSCLC.

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NSCLC is the most common form of lung cancer, accounting for approximately 85 percent of the estimated 1.8 million new patients diagnosed each year worldwide;1 ,2 and forty percent of patients with NSCLC are diagnosed with metastatic disease.3 EGFR Exon20 insertion mutations occur in approximately 1-2 percent of patients with mNSCLC and these patients have no FDA-approved treatment options designed to target these Exon20 alterations.4, 5 ALK+ mNSCLC is a complex and aggressive form of lung cancer found in approximately 3-5 percent of patients with mNSCLC.6,7,8

"Our collaboration with Foundation Medicine will address an urgent need for broad access to genomic tests, ultimately expanding treatment options and potentially improving outcomes for people with ALK+ and EGFR Exon20 insertion+ mNSCLC," said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "Robust, accurate and timely testing is crucial to enable oncologists to make informed treatment decisions so that advanced cancer patients receive the optimal therapy for their disease."

Foundation Medicine’s proven portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOneCDx and FoundationOneLiquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies. Through this collaboration, FoundationOne CDx and FoundationOne Liquid CDx will be developed for use with Takeda’s therapies.

"We’re proud to partner with Takeda on this important journey to allow more lung cancer patients to have access to genomic testing to inform personalized treatment decisions," said Cindy Perettie, Chief Executive Officer at Foundation Medicine. "Takeda shares our patient-centric approach to research and development and mission to advance personalized cancer care. This collaboration leveraging our portfolio of FDA-approved genomic tests will accelerate our shared vision and make precision medicine a reality for more patients."

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

About Mobocertinib (TAK-788)

Mobocertinib is a potent, small-molecule TKI specifically designed to selectively target epidermal growth factor receptor (EGFR) and human EGFR2 (HER2) Exon 20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC). In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy. The mobocertinib development program began in the NSCLC population and is expected to expand to additional underserved populations in other tumor types. Mobocertinib is an investigational drug for which efficacy and safety have not been established.

About ALUNBRIG (brigatinib)

ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target anaplastic lymphoma kinase (ALK) molecular alterations.

ALUNBRIG is approved in the U.S. and European Union (EU) as a first-line treatment for patients with ALK-positive (ALK+) metastatic non-small cell lung cancer (mNSCLC) previously not treated with an ALK inhibitor. ALUNBRIG is also approved in more than 40 countries, including the U.S., Canada and the EU, for the treatment of people living with ALK+ mNSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.

On September 18, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported additional results from its pivotal Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). The on-demand mini oral session is part of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 Science Weekend being held September 19 – 21, 2020 (Press release, Spectrum Pharmaceuticals, SEP 18, 2020, View Source [SID1234565346]).

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"This is the first presentation to the medical and scientific community of the positive results from our registrational Cohort 2 from the ZENITH20 clinical trial," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "There is no approved treatment for NSCLC patients with HER2 exon 20 insertion mutations, and we look forward to sharing this data with the FDA and discussing the path forward for poziotinib registration."

The presentation titled "ZENITH20, a multinational, multi-cohort Phase 2 study of poziotinib in NSCLC patients with EGFR or HER2 Exon 20 mutations" is available to members of ESMO (Free ESMO Whitepaper) and can be accessed on the meeting website here: View Source;r=st%7E12. A copy of the slides can also be found at: View Source

ZENITH20 Trial Design and Results for Cohort 2

Cohort 2 of the ZENITH20 trial enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% CI, 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The disease control rate (DCR) was 70% while tumor reduction occurred in 67 patients (74%), with median tumor reduction of 22%. The evaluable patient analysis (n=74) demonstrated a confirmed ORR of 35.1% (95% CI, 24.4% – 47.1%) with a disease control rate of 82.4%.

The median duration of response was 5.1 months (range 1 to >12.3), with a median follow up of 8.3 months and the median progression free survival was 5.5 months (range 0 to >13.1). 13 patients (14%) had treatment-related serious adverse events and 11 patients (12%) permanently discontinued due to adverse events. Grade 3 treatment related rash was observed in 27 patients (30%) with diarrhea in 23 patients (26%). Stomatitis/mucosal inflammation Grades 3 and 4 occurred in 21 patients (23%). Dose interruptions were reported in 78 patients (87%), and dose reductions in 70 patients (78%), which was similar to the rates in Cohort 1.

Cohort 2 was designed to be a registrational study. Based on these results, Spectrum has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission.

The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 – 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 – 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. This amendment did not impact Cohorts 2 and 3 as these cohorts were fully enrolled. Top line results from Cohort 3 are expected by the end of the year.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.