On October 8, 2020 Agilent Technologies Inc. (NYSE: A) reported the expansion of Visiopharm’s validated image analysis algorithm to incorporate HercepTest mAb pharmDx for Dako Omnis, both CE-IVD marked and recently released for sale in Europe (Press release, Agilent, OCT 8, 2020, View Source [SID1234568237]). This development enables pathologists to use the Visiopharm HER2 APP for objective decision support in the assessment of HercepTest mAb pharmDx stained slides, saving valuable time for both pathologists and patients.

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The HercepTest mAb pharmDx assay is intended for breast cancer patients where Herceptin treatment is being considered. HercepTest mAb pharmDx (Dako Omnis) includes a rabbit monoclonal antibody that provides robust and reproducible staining of the cancer biomarker, Human Epidermal Growth Factor Receptor 2 (HER2) in breast cancer tissue. If HER2 is over-expressed, the patient may be a candidate for Herceptin treatment, which targets HER2 in the cancer cell.

Visiopharm’s HER2 APP uses automated image analysis to reproducibly assess and score HER2 staining in brightfield digital images of breast cancer tissue sections. The APP provides objective decision support to pathologists, who would traditionally only visually review slides under a microscope. This decision support reduces the number of inconclusive readings and therefore saves the pathologist time, and helps to provide a faster, more accurate diagnosis for the patient.

Dirk Vossen, Chief Diagnostics Officer of Visiopharm commented, "The HER2 APP delivers objective, reproducible diagnostic decision support that enables pathologists to quickly and accurately review staining results. We are delighted that the algorithm is now validated for HercepTest mAb pharmDx for Dako Omnis."

Furthermore, the addition of HercepTest mAb pharmDx assay to the Dako Omnis menu means that pathology labs can further benefit from patient case management with Dako Omnis, which helps them improve case delivery times and provide consistent, precise results for patients.

"Together, the HercepTest mAb pharmDx for Dako Omnis and Visiopharm’s HER2 APP represents an exciting step forward in our shared commitment towards improving end-to-end standardization in tissue diagnostics, enabling our customers to quickly and efficiently generate accurate diagnoses," remarked Simon Østergaard, Agilent vice president and general manager of the company’s pathology group.

For in vitro diagnostic use in Europe.

HercepTest mAb pharmDx (Dako Omnis) (Code GE001):
The licensed antibody is created by Epitomics Inc. (an Abcam company), using Abcam’s proprietary rabbit monoclonal antibody technology covered under Patent No’s 5,675,063 and 7,402,409.

HercepTest and Herceptin are trademarks owned by Genentech, Inc.

On October 8, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that Medicare Administrative Contractor, Palmetto GBA MolDx, has issued a final expanded local coverage determination (LCD) for the company’s DecisionDx-Melanoma test. The LCD effective date is Nov. 22, 2020 (Press release, Castle Biosciences, OCT 8, 2020, View Source [SID1234568236]). Details on the LCD and the billing and coding article are posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.

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DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors. The test has been studied in more than 5,700 patient samples.

"We are pleased to have received positive expanded coverage for our DecisionDx-Melanoma test for patients diagnosed with cutaneous melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe that adding the personalized genomic information provided by our DecisionDx-Melanoma test to traditional clinical and pathology factors can help clinicians and their patients make improved treatment decisions. This coverage decision provides greater access to our test for people with melanoma, as it allows additional Medicare beneficiaries to incorporate DecisionDx-Melanoma into their management plans."

Castle Biosciences plans to continue generating and publishing scientific data to demonstrate enhanced clinical utility of the DecisionDx-Melanoma test, which is currently supported by 26 peer-reviewed publications.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.

On October 8, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that two abstracts have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), including two corresponding posters. SABCS 2020 will be held in a virtual format from December 8-11, 2020 (Press release, Greenwich LifeSciences, OCT 8, 2020, View Source [SID1234568235]). SABCS anticipates publishing the abstracts in late November 2020 and the posters on December 9, 2020.

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Snehal Patel, CEO of Greenwich LifeSciences, commented, "While we previously reported that in the GP2 Phase IIb clinical trial that no recurrences were observed in the HER2/neu 3+ adjuvant setting after 5 years of follow-up if the patient received their primary GP2 treatments, we are pleased to be able to present the final 5 year analysis, including Kaplan-Meier disease free survival curves and patient demographics."

Dr. F. Joseph Daugherty, CMO of Greenwich LifeSciences, commented, "We look forward to sharing this data with breast cancer key opinion leaders as we recruit clinicians and clinical sites for participation in our planned Phase III clinical trial. This data will further advance the development of GP2 and support our common goal to provide patients and clinicians with a safe and effective treatment option to prevent recurrences following surgery, and thereby prevent metastatic breast cancer."

The first abstract and poster will present the final 5 year follow-up efficacy and demographic data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical study evaluating the reduction of recurrences. The presentation will include disease free survival curves for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including the demographics for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy or trastuzumab.

The second abstract and poster will present the design of the planned Phase III clinical trial. The trial is designed as a single registration trial which will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application (BLA).

The 2 abstracts and posters are entitled:

Program Number: PS10-23 – Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer

Program Number: OT-13-03 – A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer

About SABCS

The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On October 8, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported an agreement for a commitment of up to $56 million from the Defense Advanced Research Projects Agency (DARPA) to fund development of a mobile manufacturing protype leveraging Moderna’s existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics (Press release, Moderna Therapeutics, OCT 8, 2020, View Source [SID1234568234]). The agreement builds on a previous assistance grant with DARPA established in 2013.

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The award is part of DARPA’s Nucleic Acids On Demand World-Wide (NOW) initiative to develop a mobile, end-to-end automated manufacturing platform to provide in-field, just-in-time manufacturing of Good Manufacturing Practice (GMP) quality nucleic acid (including mRNA) vaccines and therapeutics intended to deliver near-instantaneous protections and treatments to both military personnel and local populations. The design envisions a manufacturing unit capable of producing hundreds of doses of medicines in a matter of days in a 6 foot x 6 foot x 6 foot (1.8m x 1.8m x 1.8m) container in remote locations around the world.

"We are pleased to continue our collaboration with DARPA with a new award and we look forward to building on our experience rapidly designing and manufacturing vaccines as demonstrated with mRNA-1273, our COVID-19 vaccine currently in a Phase 3 study, and mRNA-4157, our personalized cancer vaccine currently in a Phase 2 study," said Stéphane Bancel, Chief Executive Officer of Moderna. "This new award will allow us to explore the reach of our technology to potentially enable fast, in-field, automated manufacturing of vaccines and therapeutics for both military personnel and civilians around the world in a container that can be deployed rapidly to make customized vaccines or therapeutics. The ability to make medicines in a mobile unit could have an important impact on the ability to respond to future viral challenges. Moderna is committed to being part of the solution in preventing future pandemics."

DARPA’s financial support of the NOW program is part the Agency’s commitment to creating innovative biotechnological approaches to rapidly detect, characterize and mitigate threats from newly emerging or engineered pathogens.

Conference Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, October 8, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5596196. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.

On October 8, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its President and Chief Executive Officer, Christopher J. Schaber, Ph.D., will deliver a corporate presentation at the BIO Investor Forum, held virtually October 13-15, 2020 (Press release, Soligenix, OCT 8, 2020, View Source [SID1234568233]). The presentation will be available on-demand for conference attendees.

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