On July 20, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, reported that it has obtained Institutional Review Board (IRB) approval to initiate its clinical trial aimed at obtaining FDA approval for the Company’s flagship product, the LuViva Advanced Cervical Scan (Press release, Guided Therapeutics, JUL 20, 2022, View Source [SID1234616820]).

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The study protocol has been approved by WCG IRB, a leader in quality ethical review with over 50 years of experience and their approval is accepted by multiple clinical sites including the two key centers that have agreed to participate in the LuViva study. Both of these centers have enough patient volume to provide the number of patients required by FDA, projected to be up to approximately 400 women. The study is expected to start enrolling patients in about 30 to 60 days.

LuViva is already approved for sale in the European Union under the CE Mark and currently is undergoing clinical trials in China for National Medical Products Administration approval, China’s equivalent of the U.S FDA.

"Multiple COVID-19 surges have had a significant impact on the start of our study, as it has for most non-COVID related products," said Gene Cartwright, CEO of Guided Therapeutics. "We are extremely gratified to have received a blanket IRB approval from WCG IRB that allows us to begin our study at prestigious medical institutions that are excited to be working with LuViva."

On July 20, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that it will release its second quarter 2022 financial results on Wednesday, August 3, 2022 (Press release, Personalis, JUL 20, 2022, View Source [SID1234616819]). In conjunction with the release, Personalis will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call.

The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On July 20, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its second quarter 2022 financial results and provide an update on its clinical development programs and regulatory and business outlook on Monday, August 8, 2022, before the open of the US financial markets (Press release, Clovis Oncology, JUL 20, 2022, View Source [SID1234616818]). Clovis’ senior management will host a conference call and live audio webcast at 8:30am ET to discuss Clovis’ results and business outlook in greater detail.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

Dial-in numbers for the conference call are as follows: US participants 888.440.4615 International participants 646.960.0682, conference ID: 2259685.

On July 20, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") reported that it entered a strategic collaboration with LiberoThera Co., Ltd ("LiberoThera") to co-develop fully human GPCR antibodies using Biocytogen’s advanced antibody discovery platform based on fully human antibody RenMabTM mice combined with LiberoThera’s outstanding membrane antigen preparation technology (Press release, Biocytogen, JUL 20, 2022, View Source [SID1234616817]). In around a year since the collaboration was established, the two parties have screened out a number of fully human therapeutic antibody clones with excellent anti-tumor activity in vitro and in vivo against the first mutually selected GPCR target, CCR8, which has the potential to become a best-in-class product. These antibody clones exhibit high affinity binding to human CCR8 with species cross-reactivity and good manufacturability. Mechanistically, these clones can deplete Tregs from the tumor micro-environment through enhanced ADCC activity, and can also inhibit the activities of Tregs in the tumor micro-environment by inhibiting CCR8 signaling mediated by its ligand CCL1, thereby enhancing the anti-tumor immune response. In the future, the collaborations between two parties will also be extended to other GPCR targets.

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GPCRs are seven-transmembrane proteins with short extracellular domains and high homology among them which make it difficult to find antibodies against them with high specificity and desired functions. However, both the success rate and the speed of GPCR antibody discovery have greatly increased by combining Biocytogen’s target knocked-out fully human antibody mice RenMab KO, various immunization and antibody discovery technologies, high-throughput in vitro and in vivo screening platform and LiberoThera’s deep understanding of GPCR target structures plus membrane antigen preparation technologies.

"We are very pleased that with the joint efforts of us and LiberoThera, the drug development of CCR8, a potential target for tumor immunotherapy, is progressing smoothly." said Dr. Yuelei Shen, Founder, Chairman and CEO of Biocytogen. "This undoubtedly validates that LiberoThera’s advanced antigen preparation technology synergizes with our RenMice KO platform to generate diverse fully human antibodies. Furthermore, our high-throughput in vivo and in vitro screening capabilities ensured that antibodies against GPCRs can be efficiently obtained. We look forward to advancing our CCR8 antibodies into the clinic soon and we also look forward to continue working with LiberoThera to tackle more GPCR targets."

"Many GPCRs are important drug targets for a variety of indications. However, due to the special structure of such targets, the development of antibody drugs against them has always been challenging," said Dr. Toru Kanke, CEO of LiberoThera. "The structural GPCR antigens prepared with LiberoThera’s proprietary cell-free membrane synthesis technologies together with non-natural amino acid incorporation methods can provide a solution for generating quality antibodies against the challenging targets. Biocytogen’s streamlined fully human antibody development platform greatly accelerates the translation of GPCR research. We are very happy to see the rapid progress and discovery of the best-in-class therapeutic antibodies against CCR8 under the collaboration of both parties. We also look forward to the collaborations in the future with Biocytogen to work on more GPCR targets so that to benefit more patients around the world."

On July 20, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported an upcoming presentation on DecisionDx-Melanoma, the Company’s risk stratification gene expression profile (GEP) test, at the 2022 American Academy of Dermatology (AAD) Innovation Academy, being held in Vancouver, Canada, July 21-24 (Press release, Castle Biosciences, JUL 20, 2022, View Source [SID1234616815]).

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DecisionDx-Melanoma is designed to inform two clinical questions in the management of cutaneous melanoma:

a patient’s individual risk of sentinel lymph node positivity; and
a patient’s personal risk of recurrence and/or metastasis.
Integrating a patient’s tumor biology and their clinicopathologic features, DecisionDx-Melanoma provides comprehensive and actionable results to guide risk-aligned patient care.

Aaron Farberg, M.D., FAAD, dermatologist and Mohs surgeon at Derm Texas and Baylor Scott & White Health System in Dallas, Texas, will be sharing an overview of the test and data highlights that demonstrate how incorporating DecisionDx-Melanoma test results into decision-making between a patient and his/her clinician can help guide cutaneous melanoma management decisions and improve patient outcomes. The presentation details are as follows:

Presentation Title: The 31-Gene Expression Profile Test for Cutaneous Melanoma
Session: Future of Dermatology Session 2: Advanced Diagnostics
Date: Thursday, July 21, 2022
Location: Ballroom B
Time: 2:40-2:55 p.m. Pacific time

"DecisionDx-Melanoma provides clinically actionable and personalized risk stratification information, based on each patient’s tumor biology, that I cannot obtain through any other test," said Farberg. "It gives me confidence that I am making more informed, risk-based treatment plan decisions aligned with each patient’s risk of metastasis or recurrence."

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 (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 9,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration resulted in a study to evaluate melanoma-specific survival and overall survival where the patients tested with DecisionDx-Melanoma had better survival rates than untested patients. This data suggests that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. DecisionDx-Melanoma has been validated in four archival risk of recurrence studies of more than 900 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.