On October 7, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an expert panel consensus statement that includes appropriate use criteria for DecisionDx-Melanoma in patients with cutaneous melanoma (Press release, Castle Biosciences, OCT 7, 2019, View Source [SID1234540092]). The study was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine.

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A panel of nine expert dermatologists, dermatologic surgeons, and dermatopathologists performed a systematic review of published evidence and developed appropriate use criteria supporting the integration of DecisionDx-Melanoma and two other validated, widely used molecular tests in melanoma patient care. The systematic review of peer-reviewed medical literature identified studies relating to clinical validity, outcomes or utility of DecisionDx-Melanoma. Employing a modified Delphi consensus technique, the panel determined the level of evidence for publications as well as an overall strength of recommendation for selected indications using standard Strength of Recommendation Taxonomy (SORT) methodology.

Key Findings

Eleven publications were identified as achieving quality levels 1 or 2, with two publications achieving the highest level of evidence (Level 1).
Eight consensus-based appropriate use criteria recommendations achieved a rating of "A" or "B", with "A" rating indicating the highest strength of recommendation.
The expert consensus-based appropriate use criteria provide an evidence-based framework to integrate the DecisionDx-Melanoma test into the management of patients with cutaneous melanoma.
"This important publication is the first to provide expert consensus-based appropriate use criteria to help clinicians integrate technologies like the DecisionDx-Melanoma test into their melanoma practice," said study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University (NYU) School of Medicine. "The DecisionDx-Melanoma test has been well validated as a predictor of risk of metastasis or recurrence. The appropriate use criteria recommendations align with the current clinical use of DecisionDx-Melanoma to guide the post-diagnostic decisions to perform a sentinel lymph node biopsy surgical procedure in certain patients, and determine appropriate management plans regarding follow-up regimens, inclusion of imaging and referral to oncology."

The full published study can be accessed at the journal’s website.

On October 7, 2019 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing treatments for hormone driven cancers, reported a Phase 2 clinical collaboration with the Wisconsin Oncology Network (Press release, Context Therapeutics, OCT 7, 2019, View Source [SID1234540077]). This clinical collaboration will evaluate whether the addition of Apristor to the antiestrogen, fulvestrant, can enhance outcomes for patients with metastatic breast cancer whose cancer has progressed on prior therapies.

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The Phase 2 trial will assess the combination of the progesterone receptor antagonist, Apristor (onapristone ER) plus the antiestrogen, Faslodex (fulvestrant), in up to 40 patients who have ER+,PR+, and HER2- tumors and who have received prior antiestrogen (aromatase inhibitor) plus CDK4/6 inhibitor treatment. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of Apristor, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of the combination in these patients, as well as biomarker and functional imaging analyses to explore predictive factors of response to complete hormone blockade. This data will support Context’s ongoing Phase 2 studies and help design a future Phase 3 trial.

20191007 WON Announcement.jpg
"Currently, there are limited therapeutic options to treat hormone driven breast cancer in the advanced setting. Recent preclinical findings in models of antiestrogen and/or CDK4/6 inhibitor resistance give us reason to believe that Apristor when combined with an antiestrogen can provide complete hormone blockade and help women with ER+,PR+,HER2- breast cancers," said Martin Lehr, CEO of Context Therapeutics. "We are humbled by the enthusiasm and support of Wisconsin Oncology Network (WON), coordinated out of the University of Wisconsin Carbone Cancer center, a leading breast cancer clinical consortium in the Midwest. The skill and scale of WON, under the leadership of Drs. Ruth O’Regan, Ryan Mattison, and Kari Wisinski, gives our company tremendous confidence that WON will maximize patient access to this important trial."

The study will be coordinated by the Study Chair, Dr. Sailaja Kamaraju, an Associate Professor of Medical Oncology at the Medical College of Wisconsin, and study’s Primary Investigator, Dr. Kari Wisinski, Associate Professor of Medical Oncology at the University of Wisconsin Carbone Cancer Center. Final study design and other details will be announced upon enrollment of the first patient, expected in early 2020.

"The majority of breast cancer patients have hormone driven breast cancer. The hormones estrogen and progesterone drive breast cancer progression in those patients, but antiestrogens are the only antihormonal therapy available to clinicians. Therefore, treatment of those patients to date has consisted of antiestrogens alone or in combination with agents, including CDK4/6 inhibitors, that enhance the antitumor activity of antiestrogens. Given the broad use of antiestrogens, antiestrogen resistance is now a major clinical challenge," said Dr. Kamaraju. "We believe that a progesterone receptor antagonist has the potential to address antiestrogen resistance, which we believe will lead to better outcomes for patients. This study, run in parallel with other Apristor breast cancer studies, including a window of opportunity (neoadjuvant) study at SOLTI and a first line (1L) biochemical recurrence study at Memorial Sloan Kettering Cancer Center, will provide clinicians with a complete picture of how Apristor works in advanced ER+,PR+,HER2- breast cancer and inform the design of a future Phase 3 trial."

About Hormone Driven Breast Cancer
Hormone receptor positive (HR+) breast cancer is the most common form of breast cancer and accounts for more than 70% of all breast cancers. Metastatic HR+ cancer is usually treated with antiestrogen therapies first that help stop tumor growth. For many patients, antiestrogen therapy becomes ineffective over time and the cancer becomes resistant to antiestrogen therapy. In this recurrent setting, progesterone receptor has emerged as a prominent resistance mechanism. It is estimated that there are over 750,000 patients with recurrent disease worldwide.

On October 7, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that the Company will release third quarter 2019 financial results after the close of trading on Monday, November 4, 2019 (Press release, NanoString Technologies, OCT 7, 2019, View Source [SID1234540093]). Company management will host a conference call beginning at 4:30pm ET to discuss those results and provide a business update.

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Individuals interested in listening to the conference call may do so by dialing (866) 211-0364 for domestic callers, or (647) 689-6861 for international callers. Please reference Conference ID: 9358402. To listen to a live webcast, please visit the investor relations section of the company’s website at nanostring.com.

A replay of the call will be available beginning November 4, 2019 at 7:30pm ET through midnight on November 11, 2019. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 9358402. The webcast will also be available on the Company’s website for one year following the completion of the call.

On October 7, 2019 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical stage, antibody-centric biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases, reported that it has entered into definitive agreements with several healthcare-focused institutional investors for the purchase in a registered direct offering of 10,869,566 shares of its common stock and warrants to purchase up to 10,869,566 shares of its common stock, at a combined purchase price of $2.30 per share and related warrant (Press release, Sorrento Therapeutics, OCT 7, 2019, View Source [SID1234540078]). The offering is expected to close on or about October 9, 2019, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $2.40 per share of common stock, will be exercisable immediately upon issuance and will expire seven years from the issuance date.

The gross proceeds of the offering are expected to be approximately $25 million, before deducting the placement agent’s fees and other estimated offering expenses. Sorrento currently intends to use the net proceeds from the offering for the continued clinical development of its RTX and CD38 CAR-T programs and general research and development, working capital and general corporate purposes.

The securities described above are being offered by Sorrento pursuant to a "shelf" registration on Form S-3 (File No. 333-221443) previously filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, amended on December 1, 2017 and declared effective by the SEC on December 6, 2017. The offering of the securities will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

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

On October 7, 2019 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported new data validating the performance of its investigational multi-cancer early detection blood test for the first time in an independent cohort of participants. The results from this validation analysis demonstrate the ability of GRAIL’s technology to detect more than 20 cancer types across all stages with a single, very low false positive rate. When cancer was detected, the test also identified where the cancer was located in the body (the tissue of origin) with high accuracy. In a pre-specified group of 12 deadly cancer types, which are responsible for approximately two-thirds of all cancer deaths, there was an even greater detection rate.

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GRAIL’s large-scale clinical study program is designed to train and develop a multi-cancer early detection test, as well as validate its performance. This new analysis, comprising data from the second pre-planned sub-study of its foundational Circulating Cell-free Genome Atlas (CCGA) study, evaluated performance of the test in an independent group of participants. Performance in the validation analysis was consistent with previously reported results from data used to train GRAIL’s cancer detection algorithm to classify cancer and non-cancer signals.

"Today, cancer remains the second leading cause of death worldwide, and we believe an effective multi-cancer early detection technology has the potential to transform the cancer care landscape," said Hans Bishop, Chief Executive Officer at GRAIL. "We are excited to present these new validation data that support the potential clinical applicability of our targeted methylation technology, and reinforce our ongoing efforts to bring our multi-cancer early detection test into the clinic to begin returning test results to patients."

The independent set used to validate GRAIL’s test included participants from the CCGA (n=927; 654 cancer, 273 non-cancer) and STRIVE (n=337 non-cancer) studies, spanning more than 20 cancer types across all stages. These new data show strong performance at high specificity (99.3%), representing a very low false positive rate. A low false positive rate is important for tests designed for use at population-scale in order to minimize unnecessary testing and associated harms.

The overall detection rate for the group of 12 pre-specified deadly cancer types at 99.3 percent specificity was 76 percent (n=273/359; 95% confidence interval: 72-81%), and a combined analysis of this group of cancers showed robust detection across all stages with detection rates of 39 percent (27-52%), 69 percent (56-80%), 83 percent (75-90%), and 92 percent (86-96%) at stages I (n=62), II (n=62), III (n=102), and IV (n=130), respectively.

In this group of 12 high mortality cancers, a tissue of origin result was provided for 97 percent (265/272), and of these, the test correctly identified the tissue of origin in 93 percent of cases (246/265). Accurately identifying where the cancer originated in the body is critical to inform the diagnostic work-up and next steps.

The 12 pre-specified deadly cancers in the independent validation set include anal, bladder, colorectal, esophageal, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreatic, plasma cell neoplasm, and stomach.

"Performance validation with an independent group of participants is critical prior to returning results of a multi-cancer early detection test to patients," said Minetta Liu, MD, Research Chair and Professor, Department of Oncology, Mayo Clinic. "The promising results from this independent validation demonstrate the robustness of the test’s performance, its ability to detect more than 20 cancer types across all stages, and its generalizability to broader populations due to a low false positive rate."

In the group of more than 20 cancer types, the overall detection rate at 99.3 percent specificity was 55 percent (n=361/659; 95% confidence interval: 51-59%), with detection rates of 18 percent (13-25%), 43 percent (35-51%), 81 percent (73-87%), and 93 percent (87-96%) at stages I (n=185), II (n=166), III (n=134), and IV (n=148), respectively. A tissue of origin result was provided for 96 percent (344/359), and of these, the test correctly identified the tissue of origin in 93 percent of cases (321/344).

These new data will be presented at the inaugural ASCO (Free ASCO Whitepaper) 2019 Breakthrough in Bangkok, Thailand, taking place October 11-13.

ASCO Breakthrough Presentation Details

Abstract 44

Minetta Liu, et al. Simultaneous multi-cancer detection and tissue of origin (TOO) localization using targeted bisulfite sequencing plasma cell-free DNA (cfDNA)

Poster Session: October 11, 2019: 1:45 – 2:15PM ICT, Centara Grand at CentralWorld

About CCGA

The Circulating Cell-free Genome Atlas (CCGA) study is a prospective, observational, longitudinal, case-control study that has completed enrollment of approximately 15,000 participants with and without cancer across 142 sites in the United States and Canada. CCGA is designed to characterize the landscape of genomic cancer signals in the blood and to discover, train, and validate GRAIL’s multi-cancer early detection blood test through three pre-planned sub-studies.

About GRAIL’s Investigational Multi-Cancer Early Detection Test

GRAIL is developing a next-generation sequencing (NGS) blood test for the early detection of multiple deadly cancer types. GRAIL’s high efficiency methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL’s sequencing database of cancer and non-cancer methylation signatures, which GRAIL believes to be the largest of its kind, covers approximately 30 million methylation sites across the genome. More than 20 cancer types across stages are represented within the database.

DNA methylation is a natural process used by cells to regulate gene expression. It is a chemical modification to DNA and a well-studied epigenomic feature of the genome. In cancer, abnormal methylation patterns and the resulting changes in gene expression can contribute to tumor growth. For example, hypermethylation can cause tumor-suppressor genes to be inactivated.