On August 27, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, reported a collaborative agreement with Mass General Cancer Center (MGCC) of Massachusetts General Hospital, related to an investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali), a CDK4/6 inhibitor, for the treatment of ER-positive breast cancer (LEADER), the first circulating tumor DNA (ctDNA)-based study of a CDK4/6 inhibitor in ER-positive early stage breast cancer (Press release, Natera, AUG 27, 2020, View Source [SID1234564122]).

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LEADER (part II) will randomize patients who have localized post-menopausal breast cancer with detectable ctDNA after surgery as evidence of minimal residual disease (MRD), and will determine tumor molecular response after Ribociclib in combination with endocrine therapy versus endocrine therapy alone. Natera’s Signatera test will be used to determine patient enrollment eligibility based on presence of ctDNA via longitudinal monitoring and to evaluate response based on ctDNA clearance as the primary endpoint.

"With the overwhelming evidence that patients with detectable ctDNA are at high risk for relapse, our goal is to investigate a new treatment strategy for these patients and reduce risk of disease recurrence," said Aditya Bardia, MD, MPH, the study’s principal investigator from MGCC, Harvard Medical School. "Since the LEADER trial is in the MRD setting, it is critical to use a highly sensitive assay."

Breast cancer remains the second leading cause of cancer death in women in the United States,1 and the U.S. Food and Drug Administration (FDA) has approved Ribociclib in combination with aromatase inhibitors as a first-line treatment option for advanced/metastatic (stage IV) disease.

"We are proud to partner with Massachusetts General Hospital on this exciting new approach of using Signatera personalized ctDNA analysis for enrollment and evaluation of treatment response to CDK4/6 inhibitors in the MRD setting," said Alexey Aleshin, MD, MBA, Natera’s Senior Medical Director for Oncology. "We believe this collaboration may pave the way for more trials using ctDNA to study the effectiveness of an investigational drug in early stage breast cancer."

About Signatera

Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On August 27, 2020 HJB, a biologics Contract Development and Manufacturing Organization (CDMO) committed to quality, reliability and speed for each and every CMC package delivered to its partners, reported it enters into a strategic partnership for CMC development and manufacturing with Ansun Biopharma ("Ansun"), a clinical stage biopharmaceutical company, on its therapeutic biologics pipeline (Press release, HJB pharma, AUG 27, 2020, View Source [SID1234564121]). The first program is expecting to submit an Investigational New Drug (IND) application in 2021.

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Under the agreement, Ansun will have the ability to leverage HJB’s comprehensive expertise and capacities from cell line development, process and assay development to GMP manufacturing, IND-enabling full-service package and clinical and commercial supply in the global territory for the next three years. The agreement provides a strong support for Ansun’s development goals and a potential significant acceleration of its portfolio to market.

"We are very excited about this strategic agreement with HJB, which we consider to be a key piece of foundation for advancing Ansun’s strong biologics pipeline in the coming years," said, George Wang, Sc.D, Chief Technology Officer of Ansun. "As the company continues to expand its pipeline by advancing more early stage assets into clinical development, a partnership with a reliable and capable CDMO such as HJB will accelerate the successful transition of the promising sciences into clinical benefit for global patients."

"We are proud to be selected as the CMC development and manufacturing partner of Ansun to support expedited and high-quality packages of their innovative biologics programs," said Jerry Yang, Ph.D., General Manager of HJB. "A robust and top-notch supply chain is fundamental to biotech to achieve speed and success to market. The recent global disruption on drug development and manufacturing capacities due to a pandemic has made it even more pressing for companies to secure the much needed capacities while remaining focused and agile. We will continue creating value as a dedicated CDMO by empowering all our global and domestic partners to bring better treatments to the patients."

Since its Hangzhou facility’s first GMP run in mid-2018, HJB has taken more than 20 CDMO projects, delivered 30 batches of GMP products and has been recognized by its global partners for quality, reliability and speed. Currently, HJB’s comprehensive capabilities include cell line and cell bank development, process and formulation development, technology transfer and optimization as well as GMP manufacturing, with three DS production lines (500 – 2,000L), and a DP fill-and-finish line. HJB has served more than double amount of client programs during the first half of 2020 despite a minimal disruption of operation due to COVID-19. The performance demonstrated HJB’s commitment to execution, delivery and quality system.

On August 27, 2020 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported the launch of new longitudinal study in collaboration with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) titled Understanding the lung cancer Patient ExperiEnce in the Real-world setting (Project PEER) (Press release, LUNGevity Foundation, AUG 27, 2020, View Source [SID1234564120]). The overarching goal of Project PEER is to understand the lung cancer patient experience, irrespective of diagnosis (stage/histology), outside of the clinical trial setting.

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The Project PEER collaboration seeks to systematically understand how patients with lung cancer feel and function and whether this experience is affected by their specific diagnosis and treatment. The real-world data from Project PEER will be used to explore patterns in patient experiences and compare those patterns to what is seen in clinical trial data within the same patient population.

LUNGevity and the FDA have signed a multi-year Research Collaboration Agreement to work together on Project PEER. FDA OCE investigators will have the opportunity through the collaboration to understand different aspects of patient experience (e.g., impact of a diagnosis on physical role-functioning, emotional well-being) in a real-world setting using standardized patient-reported outcome (PRO) instruments commonly used in cancer clinical trials. De-identified data collected through Project PEER will be available to FDA-CDER investigators as well as third-party investigators free of charge. The data collected is not meant for registrational purposes and is meant to be exploratory and hypothesis-generating only.

"In the last few years, science has progressed at an unprecedented rate as new categories of therapies have become available and the application of existing therapies has expanded," says Dr. Upal Basu Roy, PhD, MPH, Vice President of Research at LUNGevity and project lead of Project PEER at LUNGevity. "However, reasons for treatment discontinuation (adverse events, progression, mechanisms of resistance, etc.) are not well documented beyond a clinical trial context. Similarly, how patients experience their disease in terms of symptoms, impacts, outcomes, and quality of life throughout their disease progression is unclear. We are excited to launch this study to better understand these issues and, ultimately, help provide the best care possible to the lung cancer community."

The project will be using the EmpiraMed PRO Portal Software Platform that deploys 100% site-less virtual studies to better evaluate patient experience in the real world. The EmpiraMed PRO Portal will be used to allow study participants to participate in Project PEER more easily while compensating them for their data and time in an engaging manner.

"LUNGevity is proud to collaborate with the FDA to better understand the lung cancer patient experience," says Andrea Ferris, President and CEO of LUNGevity. "Project PEER provides the Agency real-world data about how our patient population, particularly those underrepresented in clinical trials, respond to therapies. Our collaboration with the FDA has the potential to make an impact on the future of treatment for lung cancer, resulting in better outcomes for patients."

"Characterizing how patients with lung cancer experience treatment in the real-world setting is an important opportunity to improve our understanding of cancer therapy," said Paul Kluetz, MD, Deputy Director of the FDA’s Oncology Center of Excellence. "We are pleased to collaborate with LUNGevity to explore alternative data sources and increase our understanding of the patient experience."

You can find more information on Project PEER at the study website: View Source

Project PEER is an international study and open to any adult participant with lung cancer or caregiver who is able to read and respond to questions in English. There is no limit on the number of participants or countries included in Project PEER. LUNGevity hopes to enroll around 1,200 patients and 300 caregivers.

On August 27, 2020 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will present at the following investor conference in September (Press release, Medpace, AUG 27, 2020, View Source [SID1234564119]):

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Baird’s Global Healthcare Conference
Date: Thursday, September 10, 2020
Presentation: 3:45 p.m. ET
Speakers: August Troendle, President & Chief Executive Officer, Jesse Geiger, Chief Financial Officer & Chief Operating Officer, Laboratory Operations, and Kevin Brady, Executive Director of Finance

This is a virtual conference available to registered participants only.

On August 27, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 2,142,858 shares of common stock of the Company, at a price to the public of $2.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, AUG 27, 2020, View Source [SID1234564118]). The closing of the offering is expected to occur on or about September 1, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 321,428 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $4.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source 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 a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.