On October 31, 2019 The Mary Kay FoundationSM reported that awarded over $3 million in cancer research and domestic violence shelter grants around the country (Press release, The Mary Kay Foundation, OCT 31, 2019, View Source [SID1234550145]). The Mary Kay Foundation was established in 1996 with the overarching purpose of eliminating cancers affecting women. In 2000, The Foundation expanded to include ending domestic violence as part of its mission.

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100 domestic violence shelters across the country, including Puerto Rico and the Virgin Islands, have been awarded $20,000 each, totaling $2 million. The Foundation is committed to funding the life-saving work of women’s shelters, and the annual shelter grant program has helped finance critical needs including emergency shelter, transitional housing, counseling and legal aid. All of these resources support women and children as they seek refuge and relief on their journey to an abuse-free life.

While a majority of domestic violence shelter grant recipients use the unrestricted funds for necessary operating expenses, others will complete repairs and facility renovations or add programs and resources based on the unique needs of their shelter and the clients they serve. Margie’s Haven House in Heber Springs, Arkansas, for example, plans to use their grant on a vehicle to help transport their clients to safety. In Decatur/Macon County, Illinois, and four surrounding counties, Dove, Inc. funds will be applied to the expense of increasing security to the entrance of their shelter. The exterior shelter door will be replaced with a fiberglass door, and an interior wall and an additional door will be added at the reception area.

Nearly 400,000 women and their families will receive domestic violence support services and free resources through the 100 agencies awarded.

After reviewing more than 70 applications, The Mary Kay Foundation Research Review Committee awarded $100,000 grants to 11 cancer research institutions across the country, totaling $1.1 million. This year’s grant recipients include the following leading research institutions:

Albert Einstein College of Medicine
Case Western Reserve University School of Medicine
Georgetown University
Michigan State University
University of California, San Francisco
University of Kansas Medical Center
University of Notre Dame
University of Utah
UT Southwestern Medical Center
Vanderbilt University Medical Center
Weill Cornell Medicine
"At The Mary Kay Foundation, we believe in helping women improve their circumstances and live their best lives," said Michael Lunceford, President of The Mary Kay Foundation Board of Directors. "Our Foundation seeks to do that in two critical ways: fund breakthrough research in our mission to eliminate cancers affecting women, and provide resources to domestic violence shelters across the country so they can aid survivors."

The Foundation’s 2019 cancer research grants will support many innovative studies. At Case Western Reserve University School of Medicine, Dr. Stefanie Avril is conducting groundbreaking research to harness the body’s immune system to eradicate breast cancer. At Georgetown University, Assistant Professor Dr. Cecil Han will utilize the grant to further her research on how changing metabolic pathways impacts the rapid growth and development of ovarian cancer cells in early stage. And at the University of Kansas Medical Center, Dr. Priyanka Sharma will use her 15 years of experience to research efforts on Triple Negative Breast Cancer, Novel Targeted Agents, Breast Cancer Genetics and Neoadjuvant Chemotherapy with the hopes of finding successful treatments for some of the most aggressive forms of breast cancer.

"We’ve seen previous grants lead to innovative breakthroughs in the study of breast, uterine, cervical and ovarian cancers, and are excited to see the research contributions of this year’s recipients," said Lunceford. "By continuing support for these scientists and institutions, we know we are continuing to better the lives of women everywhere."

Over the course of more than two decades, The Mary Kay FoundationSM has awarded more than $80 million to women’s shelters and domestic violence service providers, as well as cancer research programs and related causes throughout the United States.

On October 31, 2019 Shasqi, Inc., a privately held company focused on improving the localized delivery of cancer drugs to tumors, reported the completion of a $10 million Series A financing (Press release, Shasqi, OCT 31, 2019, View Source [SID1234550144]). The proceeds of the financing are being used to complete GMP manufacturing for the company’s lead drug candidate and to support a Phase 1 human trial, expected to commence in Q2 2020.

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Investors in the financing round included Y Combinator and a group of primarily high net-worth private investors.

José M. Mejía Oneto, M.D., Ph.D., Founder and Chief Executive Officer of Shasqi, said "In preclinical models, our novel, highly targeted delivery technology allowed us to increase active drug at a tumor site by more than 25 fold, resulting in a high level of sustainable, complete responses with fewer side-effects than current approaches. We are extremely optimistic based on these results, and anticipate that our approach should similarly enable us to treat human cancers with higher doses of powerful cancer therapies, while greatly reducing treatment-limiting toxicities.

"We are very grateful to our investors, whose support enables us to advance our novel treatment approach into human clinical trials," Dr. Mejia Oneto added.

The safety and effectiveness of most cancer therapies has been limited by the fact that only 1-2 percent of an administered drug typically reaches the tumor. The remainder of each dose is effectively being wasted and contributes to off-target side-effects. Shasqi’s local drug activation approach uses a patented proprietary biomaterial containing activating agents. When injected at the tumor site, it concentrates and activates prodrug versions of cancer drugs directly at the site of disease, maximizing the drug’s action where it is needed.

Uri Lopatin, M.D., visiting partner at Y Combinator said: "We are extremely happy to see Shasqi moving their novel cancer therapy delivery platform into human clinical trials. Part of Y Combinator’s mission is to support founders who are creating companies and technologies that can make the world a better place. It is a privilege to help companies like Shasqi that are developing novel approaches aimed at increasing cures for cancer – and we are enthused to see them advancing into human studies."

On October 31, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies to treat cancers, reported a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019, in National Harbor, Maryland (Press release, Eureka Therapeutics, OCT 31, 2019, View Source [SID1234550143]). The presentation will highlight the company’s proprietary ARTEMIS antibody T-cell receptor (AbTCR) platform used to develop ET140202 for the treatment of hepatocellular carcinoma (HCC), the most predominant type of liver cancer. ET140202 features ARTEMIS T-cell receptors engineered with a TCR-mimic antibody to target the alpha-fetoprotein (AFP) peptide/ major histocompatibility complex (MHC) on HCC cancer cells.

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SITC Poster Presentation Details:

Title: ET140202 T-cell Therapy for the Treatment of Liver Cancer is Built upon a Novel Antibody-T cell Receptor (AbTCR) ARTEMIS T-cell Platform

Poster Presentation Date: Saturday, November 9, 2019

Poster Presentation Time: 12:35 – 2:05 pm EST and 7:00 – 8:30 pm EST

Presenter: Jun Cui, Ph.D.

Poster Number: P166

Abstract Category: Cellular Therapies

Location: Poster Hall (Prince George AB)

On October 31, 2019 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported financial results for its third quarter ended September 30, 2019 (Press release, Lantheus Medical Imaging, OCT 31, 2019, View Source [SID1234550142]).

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The Company’s worldwide revenue for the third quarter of 2019 totaled $85.8 million, compared with $88.9 million for the third quarter of 2018, representing a decrease of 3.5% over the prior year period, which included $7.5 million received from the manufacture and sale of TechneLite to an international partner on an opportunistic basis. Revenue results reflect nearly 20% year-over-year growth of DEFINITY and higher than expected TechneLite sales.

The Company’s third quarter 2019 net income was $4.9 million, or $0.12 per fully diluted share, as compared to $9.3 million, or $0.24 per fully diluted share for the third quarter of 2018, representing a decrease of 47.6% from the prior year period. The reduction from prior year, for both net income and fully diluted earnings per share results, is due mainly to the aforementioned opportunistic $7.5 million of sales of TechneLite not repeated this year.

The Company’s third quarter 2019 adjusted fully diluted earnings per share were $0.28, as compared to $0.29 for the third quarter of 2018, representing a decrease of 4.5% from the prior year period.

Lastly, Free Cash Flow was $23.1 million, as compared to $19.3 million for the third quarter of 2018, representing an increase of approximately $3.8 million, or 19.9% from the prior year period.

"Once again, an impressive DEFINITY performance of nearly 20% year-over-year growth drove solid third quarter results. Additionally, TechneLite sales performed ahead of expectations realized by leveraging our expertise in radiopharmaceuticals," said Mary Anne Heino, President and CEO of Lantheus. "Earlier this month, we announced the signing of an agreement to acquire Progenics Pharmaceuticals. The combination will form a leading precision diagnostics and oncology therapeutics company, bringing a diversified and sustainable revenue model, accretion in year three, and enhanced free cash flows over longer term."

Outlook

The Company offers the following guidance for the fourth quarter as well as updating its guidance for full year 2019.

Previously stated guidance for full year 2019 was revenue growth of 0.8% to 1.9%, revenue of $346 million to $350 million, and adjusted fully diluted earnings per share of $1.09 to $1.12.

On a forward-looking basis, the Company does not provide GAAP income per common share or a reconciliation of adjusted diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted diluted EPS on a forward-looking basis is not available without unreasonable effort.

Internet Posting of Information

The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

Conference Call and Webcast

As previously announced, the Company will host a conference call on Thursday, October 31, 2019 at 8:00 a.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 1865819. A live audio webcast of the call also will be available in the Investors section of the Company’s website at www.lantheus.com.

A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

On October 31, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of results from a study validating a newly developed nomogram tool that combines information from the DecisionDx-Melanoma test with clinicopathologic features to improve prediction of patients’ risk of melanoma recurrence (Press release, Castle Biosciences, OCT 31, 2019, View Source [SID1234550140]).

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The study titled, "Development and validation of a clinically useful nomogram incorporating molecular clinicopathologic factors to predict risk of recurrence in patients with cutaneous melanoma," was presented during an Oral Abstract session at the American Society for Dermatologic Surgery (ASDS) Annual Meeting, October 24-27 in Chicago.

"The nomogram combines results from the DecisionDx-Melanoma prognostic test with clinical and pathological features to create an accurate tool that is designed to improve risk assessment beyond staging factors alone," said study co-author Ryan Thorpe, M.D., Ada West Dermatology, Meridan, Idaho. "Using the nomogram to estimate patient risk, we believe physicians can optimize treatment decisions such as sentinel lymph node biopsy, frequency of follow-up, the need for imaging, as well as evaluate entry into clinical trials."

Current melanoma guidelines recommend that treatment management be guided by an individual patient’s risk of metastasis or recurrence, which is impacted by clinical and pathologic features. This study combined the DecisionDx-Melanoma test result with clinicopathologic features to develop a nomogram tool that provides a more accurate determination of the risk of recurrence in patients with melanoma compared to clinical and pathologic features alone.

The study included a prospective cohort of 1,124 patients with melanoma from nine dermatology centers participating in the Cutaneous Oncology Research Consortium (CORC). Those with at least one year of follow-up or a recurrence event who also had complete clinicopathologic information and a DecisionDx-Melanoma result available were included in the nomogram development (n=685). The median follow-up time of this cohort was 3.0 years and median age was 67 years. The majority of patients had thin melanoma (84% had a tumor 1 mm deep or less), and ulceration was present in 7% of patients. The DecisionDx-Melanoma prognostic test for cutaneous melanoma predicts 5-year risk of recurrence and metastasis as low risk (Class 1, 1A lowest risk) or high risk (Class 2, 2B highest risk).

Key Study Findings:

Patients with Class 1A DecisionDx-Melanoma test results had significantly better recurrence-free survival (RFS) at 1.5 years compared to patients with Class 2B results (98.9% and 70.3%, respectively). Similar results were seen for distant metastasis-free survival (DMFS), with 99.6% survival for patients with a Class 1A result and 84.4% for those with a Class 2B result.
In a multivariate Cox regression model including DecisionDx-Melanoma and clinical features, only Breslow thickness and DecisionDx-Melanoma results were significant predictors for RFS (hazard ratio [HR] 1.25, p=0.0002 and 9.02, p<0.0001, respectively).
Researchers developed an optimized nomogram that includes American Joint Committee on Cancer (AJCC) T category (determined by tumor thickness and ulceration) and DecisionDx-Melanoma test results as the strongest variables contributing prognostic information. The nomogram was then independently validated for prediction of recurrence in a retrospective cohort of 901 patients who had a median follow-up of 5.8 years.
Using clinical and molecular variables, the validated nomogram improved recurrence risk prediction beyond clinicopathologic factors alone.
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 3,900 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 five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 2,000 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.