On July 28, 2020 Novocure (NASDAQ:NVCR) reported the recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research program (Press release, NovoCure, JUL 28, 2020, View Source [SID1234562473]). The program represents a joint effort between Novocure and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields. The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer.

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Such collaborations help to deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies. Extensive preclinical and clinical evidence provides the foundation upon which Novocure executes its strategy to advance Tumor Treating Fields through additional clinical research studies across multiple solid tumor types.

"Congratulations to the recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research," said Asaf Danziger, Novocure’s Chief Executive Officer. "We value our ongoing partnership with the AACR (Free AACR Whitepaper) as we continue to deepen our understanding of the mechanism of action of Tumor Treating Fields. We look forward to learning the outcomes of the impressive research planned by our grant recipients."

"The AACR (Free AACR Whitepaper) is thrilled to welcome its newest class of grant recipients, including the recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "Our continued partnership with Novocure has played a pivotal role in providing crucially needed resources to scientists on the leading edge of discovery. The innovative research supported by these grants will contribute to our understanding of Tumor Treating Fields, and may lead to the identification of new and exciting applications for this emerging technology."

2020 AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research

Narasimha Kumar Karanam, Ph.D., University of Texas Southwestern Medical Center
"Harnessing E2F-Rb-CDK4/6 axis for novel combination therapy with TTFields"
Chirag B. Patel, M.D., Ph.D., Stanford University
"Increasing glioblastoma cell membrane permeability with TTFields"
2020 AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants

Carsten Hagemann, Ph.D., Universitätsklinikum Würzburg, Germany
"Overcoming the blood brain barrier drug delivery hurdle with TTFields"
Sandeep Mittal, M.D., FRCSC, FACS, Virginia Polytechnic Institute
"Epigenetic modifications induced by TTFields in patient-derived GBM cells"
Debabrata Saha, Ph.D., University of Texas Southwestern Medical Center
"Evaluating efficacy of TTFields and radiotherapy in preclinical tumor model"
David D. Tran, M.D., Ph.D., University of Florida College of Medicine
"Molecular mechanism of resistance to Tumor Treating Fields in glioblastoma"
Christopher Douglas Willey, M.D., Ph.D., University of Alabama at Birmingham
"Exploring Novo-TTF in advanced patient derived GBM models with multi-omics"

On July 28, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune disease, reported that it will release second quarter 2020 financial results after the market closes on Tuesday, August 4, 2020 (Press release, Xencor, JUL 28, 2020, View Source [SID1234562472]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 3066174. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

On July 28, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that management will present at the following upcoming virtual investor conferences (Press release, Arcus Biosciences, JUL 28, 2020, View Source [SID1234562471]):

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BTIG Virtual Biotechnology Conference 2020, Monday, August 10 at 11:00 am ET
2020 Wedbush PacGrow Healthcare Virtual Conference, Tuesday, August 11 at 1:45 pm ET
A live audio webcast of each presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcasts will be available for at least two weeks following the live event.

On July 28, 2020 bioAffinity Technologies, a privately held biotech company, reported it has closed a non-brokered, secured convertible note ("Note") financing for proceeds of $5,000,000.00 (the "Offering") (Press release, BioAffinity Technologies, JUL 28, 2020, View Source [SID1234562470]). The proceeds from the Note are funding operations to advance the Company’s non-invasive CyPath Lung cancer test and therapeutic research and development of novel drug candidates for the selective treatment of multiple cancers.

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"We are extremely pleased by the response from accredited investors to this Offering which recognizes the importance of both our early-stage lung cancer test and our therapeutic initiatives focused on advancing drug candidates to selectively kill cancer," said bioAffinity President and Chief Executive Officer Maria Zannes. "We expect to convert the Notes into our next class of equity securities which we anticipate will be a Preferred Series B raise to fund commercialization of CyPath Lung and other cancer and lung diagnostics, as well as the further development of breakthrough therapeutic platforms in the fight against cancer."

The Notes were offered and sold only to accredited investors in reliance on Regulation D under the U.S. Securities Act of 1933, as amended.

The Company’s first product, CyPath Lung, is a flow-cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home and ship them overnight to the laboratory for processing. Sample data is acquired by flow cytometry. Using automated analysis of pre-set parameters, CyPath Lung profiles the lung environment including the presence of cancer cells. Data acquisition and physician reports can be generated in minutes.

A test validation trial comparing people at high risk for lung cancer to patients with the disease resulted in CyPath Lung specificity of 88% and sensitivity of 82%, similar to far more invasive procedures and surgery currently used to diagnose lung cancer. CyPath Lung is a well-balanced, highly accurate test.

CyPath Lung has been licensed by Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, Texas. Precision Pathology Services anticipates certification and sale of CyPath Lung in 2020 as a Laboratory Developed Test (LDT). Following its certification as an LDT, physicians will order CyPath Lung for their patients who are smokers and former smokers at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.

People who have smoked the equivalent of one pack of cigarettes a day for 30 years or more, have not quit smoking in the past 15 years and are 55-80 years of age are recommended for annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be successfully treated, but screening has a low Positive Predictive Value (PPV) that can lead to unnecessary and risky procedures.

Using CyPath Lung after a positive LDCT screen can improve the PPV by 5.6-fold compared to LDCT alone. Early diagnosis of lung cancer followed by treatment has been shown to increase the 10-year survival rate of the disease to 88% from the present 5-year survival rate of 21.7%.

On July 28, 2020 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported that it had submitted its protocol to FDA for a clinical study to support marketing of the LuViva Advanced Cervical Scan in the United States (Press release, Guided Therapeutics, JUL 28, 2020, https://www.businesswire.com/news/home/20200728005157/en/Guided-Therapeutics-Submits-Clinical-Study-Protocol-U.S. [SID1234562469]).

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Under FDA’s Investigational Device Exemption guidelines, the Agency typically responds to companies in 30 days with comments or other observations regarding a study protocol. Earlier this year, the Company filed with FDA Pre-Submission documents and met with the Agency to agree on LuViva’s new indication for use and supporting clinical trial design. FDA provided written feedback based on both the Pre-submission documents and meeting minutes that provided the Company with guidance for drafting the study protocol.

According to the protocol, LuViva will be studied to assess its ability to help detect a significant number of the up to 40% to 50% cases missed at the point of biopsy because of limitations in current imaging technology. New national guidelines for cervical cancer management published in April of 2020 stress a risk based approach, a feature already included in LuViva’s AI based risk profile algorithms. Because the available technology of visually examining the cervix under magnification often cannot detect the correct area to biopsy, or at times fails to detect the disease at all, there is a strong need for a more sensitive test like LuViva to identify more women with disease so treatment can begin sooner.

"FDA has been very responsive and helpful as the new indication for use and study to support the device claims were developed," said Gene Cartwright, CEO. "We look forward to starting and completing our new study as the next major milestones in achieving FDA approval for LuViva."