On January 9, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported its corporate and program priorities for 2020 (Press release, MacroGenics, JAN 9, 2020, View Source [SID1234552968]).

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"Following the submission in 2019 of our first BLA with the FDA, 2020 has the potential to be a transformative year for MacroGenics. As the product candidates in our deep pipeline enter later-stage clinical trials, we are prioritizing certain programs in order to efficiently utilize our financial, human and intellectual capital on programs with the highest commercial and scientific merit and the potential to achieve regulatory approval," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are excited to advance multiple product candidates in registration-directed studies and believe our program prioritization positions us to capitalize on what we hope will be a pivotal year for the Company."

Program Prioritization

The Company’s research and development priorities for its investigational molecules in 2020 are highlighted below.

Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers.

•Biologics Licensing Application (BLA) for Metastatic Breast Cancer. Pending acceptance and review of the BLA submitted in December 2019 to the Food and Drug Administration (FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenics expects a Standard Review process in which the FDA will likely require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.

•Phase 2/3 MAHOGANY Study in Advanced Gastric and Gastroesophageal Junction Cancer. MacroGenics is enrolling patients in this front-line study designed to evaluate the combination of margetuximab with anti-PD-1 based therapies. Initial safety and efficacy data are expected in the second half of 2020 from Module A of this study, which is evaluating a chemotherapy-free regimen. Module A has been designed to support a potential accelerated approval in the U.S. based on evaluation of objective response rate in a single-arm study.

Flotetuzumab is a bispecific CD123 x CD3 DART molecule being evaluated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). MacroGenics intends to define a potential registration path in the U.S. for the treatment of patients with primary induction failure and early relapsed AML in the first half of 2020, pending continued discussions with the FDA.

MGA012 (INCMGA0012) is an anti-PD-1 monoclonal antibody that has been exclusively licensed to Incyte Corporation. There are currently 18 disclosed Phase 1-3 clinical studies evaluating MGA012 in monotherapy and combination regimens across a broad range of tumor types.1

MGD013 is a first-in-class, bispecific PD-1 x LAG-3 DART molecule being evaluated in a Phase 1 dose expansion study. MacroGenics is selecting indications for further development and expects to submit data from the ongoing study for presentation at a scientific conference in the first half of 2020.

Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 monoclonal antibody. To further inform the development
of this molecule, MacroGenics plans to evaluate the activity of both enoblituzumab plus MGA012 and enoblituzumab plus MGD013 as chemotherapy‐free regimens in front‐line patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) before proceeding with the full Phase 2/3 study.

MGC018 is an antibody-drug conjugate (ADC) targeting B7-H3 and MGD019 is a bispecific PD-1 x CTLA-4 DART molecule. The Company expects to complete dose escalation for each of these molecules in early 2020 and then initiate a focused dose expansion in select tumor types.

MGD009 is a B7-H3 x CD3 DART molecule and MGD007 is a gpA33 x CD3 DART molecule. In connection with its strategic prioritization, the Company will discontinue development of these programs.

Cash Balance and Cash Runway

The Company’s estimated cash, cash equivalents and marketable securities balance as of December 31, 2019 was approximately $215 million (unaudited), compared to $232.9 million as of December 31, 2018. Through the prioritization of programs and ongoing realignment of its resources, as well as anticipated and potential collaboration payments, MacroGenics is focused on extending its cash runway through 2021. The Company will provide further guidance in connection with reporting 2019 fourth quarter and annual financial results and company progress in late February 2020.

Slide Presentation

A slide presentation describing these corporate priorities, research and development goals and other information will be available on the Investors page on the Company’s website at www.macrogenics.com after the market close on Friday, January 10, 2020.

On January 9, 2020 Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA testing, reported a nationwide multi-center registry study called BESPOKE CRC for patients diagnosed with Stage II-III colorectal cancer (CRC) (Press release, Natera, JAN 9, 2020, View Source [SID1234552961]). The study’s objective is to measure the clinical impact of serial blood-based testing with Signatera, Natera’s personalized and tumor-informed test for molecular residual disease (MRD) assessment, earlier relapse detection, and better patient risk stratification after surgery.

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The BESPOKE CRC study will prospectively enroll 1,000 or more patients at time of surgery. Signatera testing will be performed multiple times in the first 6 months after surgery to help inform the need for adjuvant chemotherapy, and then approximately every 3 months in the surveillance setting to detect relapse early and enable more curative interventions. Patients will be followed for up to two years, to measure treatment changes and patient outcomes. The study will begin enrollment in early 2020, and it is expected to complete in 2023.

"Signatera offers a tremendous opportunity to reduce unnecessary treatment and improve long-term outcomes in patients with early-stage colorectal cancer," said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director of Oncology. "We believe the BESPOKE study will help establish basic clinical protocols that will eventually become the standard of care worldwide."

In published validation studies, Signatera detected relapse in patients with Stage II-III CRC up to 16.5 months earlier (average 8.7 months earlier) than standard diagnostic tools including CT imaging and CEA.1 In May 2019, the FDA designated Signatera as a Breakthrough Device, and in August 2019, Medicare proposed to cover its use in select patients diagnosed with Stage II or Stage III colorectal cancer. There are estimated to be 145,600 new CRC diagnoses per year in the U.S., and more than one million CRC survivors.2

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019 it was granted Breakthrough Device Designation by the FDA. 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 help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.

Signatera was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.

On January 9, 2020 American Brain Tumor Association (ABTA) reported a new partnership with the Uncle Kory Foundation to accelerate brain tumor research (Press release, American Brain Tumor Association, JAN 9, 2020, View Source [SID1234552960]). Through this partnership, the Uncle Kory Foundation will invest $100,000 in the ABTA research program to fund two glioblastoma research projects. For more than 46 years, the ABTA has served the brain tumor community by funding research and delivering patient programs and services.

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"Through collaboration with the Uncle Kory Foundation, we aim to leverage the strengths of each organization to maximize impact and drive change within this underserved disease population," said Ralph DeVitto, president and chief executive officer of the ABTA.

With an established and sophisticated mechanism to evaluate and foster brain tumor research, the ABTA has earned recognition as a trusted and committed research conduit for organizations and foundations who aim to advance brain tumor research. Since 1976, the ABTA has awarded more than $32 million in research grants to scientists from around the world to discover more about the causes, effects, diagnosis and treatment of pediatric and adult brain tumors.

The Uncle Kory Foundation was founded in 2014 in honor of Kory Hunter, with the mission to advance innovative and collaborative brain cancer research to specifically improve the survival rate and treatment of those diagnosed with glioblastoma.

"This collaboration is the key to success," said Renee Vachon, director of operations of Uncle Kory Foundation. "By leveraging the ABTA research platform we can adhere to our mission of funding innovative research for glioblastoma in a concise and effective effort."

The Uncle Kory Foundation is an important new partner for the ABTA’s research initiatives. The ABTA is grateful to them and other established research collaborators within the brain tumor community, including the Joel A. Gingras, Jr. Memorial Foundation and Humor to Fight the Tumor.

On January 9, 2020 Omniome, Inc., developer of an innovative DNA sequencing platform capable of delivering unsurpassed sequencing accuracy, reported it has raised an additional $60 million with the completion of its Series C financing (Press release, Omniome, JAN 9, 2020, View Source [SID1234552959]). The funding round was led by Madrone Capital Partners. Current investors include ARCH Venture Partners, Decheng Capital, Domain Associates, Biomatics Capital Partners, Altitude Life Sciences Ventures, Nan Fung Life Sciences and others.

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The company, which raised $60 million in financing in mid-2018, will utilize the new $60 million equity financing in addition to previous debt financing in order to accelerate late-stage product development and launch planning.

"Our product development efforts are advancing rapidly and shifting towards delivering our first beta prototype instruments," said Dave Mullarkey, President and CEO at Omniome. "We welcome Madrone and appreciate ongoing support from our current investors in executing on our plans."

The company will deploy portions of the financing proceeds to expand the company’s capabilities by hiring new team members across multiple disciplines, particularly in manufacturing, engineering, development, customer support and commercial. The company will continue to optimize its proprietary technology while accelerating instrument development and delivery of commercially-impactful sequencing platforms.

"Omniome has made incredible progress over the past couple years maturing from an early product concept company to a late stage product development company," said Ken Song, M.D., Omniome’s Executive Chairman. "The goal and vision have always been to develop a disruptive sequencing technology taking into account accuracy, speed, throughput, and cost. The team’s success in advancing product development across these dimensions has attracted considerable interest from top tier investors."

On January 9, 2020 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that Michael Chang, Ph.D. Chairman and CEO, will present a company overview at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 4:30 p.m. PST/ 7:30 p.m EST, in San Francisco, CA (Press release, OBI Pharma, JAN 9, 2020, View Source [SID1234552958]).

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