On October 8, 2020 ChromaDex Corp. (NASDAQ:CDXC) reported highlighted a new study from Nature Immunology that found nicotinamide riboside (NR) helped energize tumor infiltrating T-cells (TILs) in samples extracted from mice (Press release, ChromaDex, OCT 8, 2020, View Source [SID1234568239]. In a preclinical mouse model, NR was shown to improve T-cell function, which is a component of new cancer immunotherapies such as PD-1 and PDL-1 inhibitors. These findings lend further data to the potential role of NR in supporting healthy mitochondrial function.

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T-cells are immune cells tasked with recognizing and eliminating infected, damaged or cancerous cells. The researchers from the University of Lausanne and the Ludwig Institute for Cancer Research found that NR could prevent mitochondrial dysregulation and exhaustion in T-cells. By doing so, NR was also shown to improve T-cell mitochondrial function and responsiveness to anti-PD-1 cancer immunotherapy, a mainstay of cancer treatment approved for use against many solid tumor types. The tumor bearing mice fed with NR experienced less tumor growth, and an additive antitumor effect was observed when NR was combined with immunotherapy.

This research built upon a previous preclinical study, also conducted at the University of Lausanne, that found NR could promote hemopoietic stem cell (HSC) maturation in mice by stimulating mitochondrial function. Immune cells such as T-cells arise from these stem cells, as do essential red blood cells and platelets.

The prior study suggested that NR supplementation could facilitate cancer treatment by preventing myelosuppression in mice, (i.e. depletion of stem cells and all the cells they produce, caused by repeated chemotherapies).

This latest study from Nature Immunology indicates a new potential niche for NR supplementation by suggesting a synergistic effect with T-cell immunotherapies used for many solid tumors. NR has also been shown preclinically to possibly prevent neuropathy caused by paclitaxel, a common chemotherapy used for breast cancer treatment.

More research is required to validate this preclinical data and translate the findings into humans. Over 50 human trials investigating NR’s various health benefits are registered on ClinicalTrials.gov, 11 of which have been peer-reviewed and published through the ChromaDex External Research Program (CERP).

"We’re excited to see the discovery of so many potential applications for NR’s proven ability to promote mitochondrial function," said Dr. Andrew Shao, ChromaDex Senior Vice President of Global Scientific & Regulatory Affairs. "We know mitochondrial function is essential to the function of energy-expensive cells, including stem cells and immune cells. Their proper function, in turn, may play a key role in avoiding a wide array of diseases, including many cancers. We’re pleased to see that NR can support these essential cells and hope to elucidate its potential in human health and disease with further trials."

ChromaDex, the exclusive licensee of Dr. Charles Brenner’s patented NR, has invested over $35 million in investigating, manufacturing and offering NR in the form of Niagen and has secured more than 20 patents. ChromaDex has demonstrated the safety and efficacy of Niagen in 11 published human trials (and over 20 additional ongoing studies further evaluating its safety and efficacy) and has achieved government regulatory acceptance in the United States, Canada, the European Union, and Australia.

On October 8, 2020 Shattuck Labs, Inc. ("Shattuck"), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of cancer and autoimmune disease, reported the pricing of its upsized initial public offering of 11,882,352 shares of common stock at a public offering price of $17.00 per share (Press release, Shattuck Labs, OCT 8, 2020, View Source [SID1234568238]). The gross proceeds to Shattuck from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Shattuck, are expected to be approximately $202 million. All of the shares are being offered by Shattuck. The shares are expected to begin trading on The Nasdaq Global Select Market on October 9, 2020 under the ticker symbol "STTK." In addition, Shattuck has granted the underwriters a 30-day option to purchase up to an additional 1,782,352 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on October 14, 2020 subject to the satisfaction of customary closing conditions.

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Citigroup, Cowen, and Evercore ISI are acting as joint book-running managers for the offering. Needham & Company is acting as lead manager for the offering.

The registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 8, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by telephone at (800) 831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.