On October 28, 2020 Diaceutics PLC, (AIM: DXRX), reported the launch of DXRX – The Diagnostic Network which has been designed to accelerate the end-to-end development and commercialization of precision medicine diagnostics by reducing time to peak biomarker test adoption for cancer testing from years to months (Press release, Diaceutics, OCT 28, 2020, View Source [SID1234569251]). As a solution to today’s broken testing ecosystem, DXRX brings together stakeholders from across the industry to collaborate in a vibrant marketplace to solve real-world testing issues in a secure, standardized way for patients.

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DXRX integrates a pipeline of global diagnostic testing data into one secure platform providing access to transparent, real-time reporting on diagnostic utilization at a local level across multiple therapeutic areas.

Early collaborations between pharma, labs and diagnostic companies are live on the platform’s marketplace with 38 Laboratories and Diagnostic Companies onboarded from across EU, Asia and the US. These collaborations are designed to improve test standardization, reimbursement, regulatory support and External Quality Assessment (EQA). Collaborators today include Synlab, PathGroup (US), SRL Diagnostics (Asia), Fundación Jimenez Díaz, The Royal Marsden NHS Foundation Trust, Istituto Nazionale Tumori Regina Elena Roma and Diatech Pharmacogenetics (EU). Two global pharmaceutical clients are also piloting the technology.

The platform enables pharma clients to monitor and enhance test quality at local level to increase return on investment across multiple brands, and leverage a broad network of local partnership opportunities to implement best-in-class testing for their precision medicine portfolios. DXRX also enables clients to outsource the end-to-end diagnostic development and commercialization process from biomarker discovery to in-market test availability in order to reduce time to market for new therapies.

Furthermore, DXRX also provides users access to a global expert advisory panel of key opinion leaders from the areas of oncology, including lung cancer research and colorectal research; pathology, including tissue pathology and uropathology; molecular diagnostics; digital image analysis; telemedicine and informatics; external quality assessment (EQA); and FDA-expertise.

The end-to-end service offering provided by DXRX is enabled by a growing network of industry leading service providers in 51 countries. They cover precision medicine diagnostics to deliver implementation services such as test standardization, reimbursement, regulatory support and External Quality Assessment (EQA). Recent partnerships include Histocyte Laboratories, Targos Molecular Pathology, EMQN CIC, CPQA-ACP, NordiQC and UKNEQAS ICC & ISH.

An example of a recent collaboration to go live on the platform brings together multiple users to improve the reimbursement model for PD-L1 testing in the US. The desired outcome of this collaboration is to establish a more equitable level of reimbursement for PD-L1 testing through the assignment of a reimbursement coding specific to the biomarker. Data published in Diaceutics’ latest PM Readiness Report reveals that, although PD-L1 has a test adoption rate of 80% for NSCLC, hurdles such as reimbursement which are inadequately addressed at launch planning stage have resulted in a time to test adoption of up to 4 years and only 50% of patients getting the right treatment at the right time, which is an industry red flag needing to be urgently addressed for patients.

Head of Global Marketing at Diaceutics, Sarah Colgan said, "As we see exponential growth in the number of precision medicine therapies coming to market, our pipeline of global diagnostic testing data points to a growing number of hurdles in the testing ecosystem. We need to urgently address these with a better model. The opportunity for collaboration to address these testing hurdles for patients can only be addressed by a transformational solution which is global, digital, and scalable and that is why DXRX has been launched.

"The fact that it can take years for a biomarker test to reach optimal adoption – as is the case with PD-L1 today – is unacceptable for patients. DXRX has been purpose built to accelerate time to peak therapy prescription by reducing that lag time from years to just months. The testing hurdles in PD-L1 are just the tip of the iceberg in terms of the opportunities for collaboration around biomarker testing hurdles which DXRX has been designed to enable.

"We believe that DXRX sets a new industry standard for precision medicine which, until today, has been reliant upon a business model entirely unfit for purpose. It’s exciting to see a network of early collaborators across the industry already discovering the vibrant Marketplace and we look forward to the successful outcomes of these collaborations and others already in the pipeline.

"There is a better way to get every patient the treatment they deserve. We believe that DXRX is that way. As we launch the platform today, we invite all stakeholders in the industry to take their seat at the table as early collaborators in what promises to be an entirely new era for precision medicine."

Markus Eckstein, MD, University Hospital Erlangen and DXRX Network Advisor said, "It has been clear for some time that our collective approach to precision testing needed a radically new model. Some 25 years since the first true precision therapies arrived, we are still too siloed in the way we are helping patients get access to the right test at the right time. DXRX data and expert guided collaborations can practically unite us in eliminating those access barriers for patients and help us to further move precision oncology forward."

On October 28, 2020 The Multiple Myeloma Research Foundation (MMRF) and Indapta Therapeutics reported a partnership to support the advancement of the company’s universal G-NK cell therapy into clinical trials for the treatment of patients with multiple myeloma (Press release, Indapta Therapeutics, OCT 28, 2020, View Source [SID1234569250]). Indapta Therapeutics, Inc., is a biotechnology company focused on developing and commercializing a proprietary, off-the-shelf, allogeneic FcRγ-deficient natural killer (G-NK) cell therapy for the treatment of multiple cancers. The collaboration is supported with an investment in Indapta by the MMRF’s venture philanthropy arm, the Myeloma Investment Fund (MIF).

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"Our investment in Indapta’s G-NK cell therapy is consistent with our strategy to fund the development of first-in-class, potentially transformative treatments," said Paul Giusti, President and Chief Executive Officer of the MMRF. "Indapta’s off-the-shelf cell therapy uses a promising new class of NK cells, which could provide a significant benefit for patients."

About Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change, rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence, and enhanced cryopreservation than multiple mAb therapies alone or mAb therapies combined with conventional NK cells.

When a monoclonal antibody binds to the tumor target and to Indapta’s G-NK cell therapy product, it initiates the release of dramatically more cancer killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety of Indapta’s G-NK cell therapy.

"This collaboration with the MMRF and MIF will be invaluable in helping us advance the clinical development of our universal, allogeneic G-NK cell therapy," said Guy DiPierro, Founder, and Chief Executive Officer of Indapta Therapeutics. "We look forward to tapping into MMRF’s deep myeloma expertise and other critical resources, including genomic datasets. The Foundation’s insights into patient recruitment and study networks will help us reach multiple myeloma patients for our own clinical trials."

On October 28, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported that it will report its third quarter 2020 financial results on Thursday, November 5, 2020 (Press release, Deciphera Pharmaceuticals, OCT 28, 2020, View Source [SID1234569249]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 4:30 PM ET on Thursday, November 5, 2020, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 6048987. A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On October 28, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the last patient in the low-dose cohort has completed six months of NOX-A12 therapy in the Phase 1/2 brain cancer clinical trial (Press release, NOXXON, OCT 28, 2020, View Source [SID1234569248]). The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed MGMT1 promoter unmethylated glioblastoma patients, a difficult-to-treat brain cancer.

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Patients participating in the study would not have benefitted clinically from the standard of care chemotherapy due to their MGMT promoter methylation status. They also all had tumor tissue remaining after surgical resection before being recruited into the study.

Tumor volume reductions were observed in two of three patients during the six-month treatment, and in the third patient in the period after a second surgery following continued NOX-A12 treatment. Maximum tumor volume reductions were 6% and 60% for the first two patients. The third patient experienced 23% tumor volume reduction relative to the post-second surgery baseline. Tumor volume reductions were reported as the average of two independent central MRI readers and results included unscheduled scans. Two of three patients had stable or decreasing tumor volumes for 16 weeks or longer (one following a second surgery) and both are currently in the treatment-free follow-up period. One patient deceased from tumor progression during the treatment period.

NOX-A12 steady-state plasma levels were in the targeted range following administration of 200 mg per week. With a data cutoff date of October 23, 2020, the adverse event profile was similar to that expected from radiotherapy alone in glioblastoma patients. Eighteen of 90 adverse events were noted as being potentially related to NOX-A12 and disease or radiotherapy. There were five adverse events potentially related only to NOX-A12 which were all mild or moderate (grade 1 or 2), confirming the manageable safety and tolerability profile for NOX-A12 in combination with radiotherapy.

"It is encouraging to see that two of the first three patients are responding to treatment with shrinking tumor volumes, indicating early signs of clinical activity, especially considering that this is the lowest NOX-A12 dose being tested. Next, we need to follow up with the patients to understand how their condition will evolve over time, especially after the completion of therapy after six months," said Dr. Jarl Ulf Jungnelius, Senior Medical Advisor to NOXXON Pharma.

Going forward NOXXON’s planned clinical development strategy for NOX-A12 will be focused on two indications: brain cancer and pancreatic cancer. Each indication will test a different combination strategy, thereby providing multiple possibilities to successfully advance the clinical development plan: NOX-A12 plus radiotherapy in brain cancer, and NOX-A12 plus immuno-/chemotherapy in pancreatic cancer.

In brain cancer, NOXXON plans to complete the ongoing Phase 1/2 study testing three doses of NOX‑A12 combined with radiotherapy. The company is considering expanding the dose cohort, which is finally chosen for the planned pivotal trial, in order to gain experience in a larger group of patients for discussions with regulatory agencies. The next planned trial will be a pivotal, randomized Phase 2 trial comparing NOX-A12 plus radiotherapy to standard of care in MGMT unmethylated first-line glioblastoma patients. MGMT unmethylated patients represent approximately 50% of all first-line glioblastoma patients, or approximately 6,000 patients per year in the EU and 5,000 patients per year in the US.

NOXXON’s planned clinical development strategy for pancreatic cancer will initially involve a two-arm clinical trial testing the combination of NOX-A12 plus anti-PD-1 immunotherapy in second-line patients. In each arm, a different second-line standard of care chemotherapy regimen will be combined with NOX‑A12 plus anti-PD1. This will allow NOXXON to choose the best combination therapy to move forward into a randomized, controlled pivotal trial.

On October 28, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and nine months ended September 30, 2020 (Press release, Odonate Therapeutics, OCT 28, 2020, View Source [SID1234569247]).

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As of September 30, 2020, Odonate had $188.3 million in cash, compared to $180.5 million as of December 31, 2019. This increase in cash resulted primarily from the receipt of $87.4 million of net proceeds from Odonate’s September 2020 underwritten public offering, less cash used in operating activities for the nine months ended September 30, 2020 of $81.6 million. Odonate’s net loss for the three and nine months ended September 30, 2020 was $30.5 million and $94.1 million, or $0.93 and $3.00 per share, respectively, compared to $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, for the same periods in 2019.

"We are pleased to have recently announced positive top-line results from CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "These results have been selected for an oral presentation at the 2020 San Antonio Breast Cancer Symposium in December. We continue to plan to submit a New Drug Application for tesetaxel to the FDA in mid-2021."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS.