On August 19, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported it had passed the regulatory compliance review at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai (Press release, Guided Therapeutics, AUG 19, 2021, View Source [SID1234586765]). Clinical trials there and at three other centers are expected to begin this quarter.

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GTHP also received a payment of $133,000 from its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI). The funds will be used to supply SMI with parts and advice for the Chinese clinical study. Parts are expected to ship this quarter and additional participating clinical sites announced over the next few weeks. SMI estimates that the clinical study will be completed during the second quarter of 2022 with full approval to sell in China expected by the end of 2022.

Under a new agreement with SMI signed last week, GTHP expects payments totaling approximately $3 Million by the end of 2022, assuming Chinese FDA approval is granted. Approximately $510,000 of those payments is expected to be received by GTHP during the clinical study, with the majority of those funds to be received this year. The remaining $2.5 million, based on a purchase order from SMI, is due upon filing the clinical study results with Chinese FDA ($620,000) and approval by Chinese FDA ($1,880,000). The new contract then calls for minimum orders of $72 Million over the first four years post Chinese FDA approval.

"We continue to be encouraged by the regulatory approvals from China," said Gene Cartwright, CEO of Guided Therapeutics. "Fudan University is recognized as a top tier research institution and viewed by Chinese FDA as a highly credible center at which to conduct our clinical study."

According to the World Health Organization, cervical cancer is one of the most frequent cancers in women in the world and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China. It is believed mortality due to cervical cancer has been increasing in China. In response, China has increased efforts to screen more women, especially in rural areas where the laboratory infrastructure for traditional screening tests is lagging. Because LuViva does not require a laboratory infrastructure and produces an immediate result at the point of care, it is well suited to screening women for cervical cancer in these environments.

On August 19, 2021 Labcorp (NYSE: LH), a leading global life sciences company, and Community Clinical Oncology Research Network, LLC (CCORN), a leading research organization, reported their collaboration to better understand the impact of disparities in precision medicine for people with cancer (Press release, LabCorp, AUG 19, 2021, View Source [SID1234586764]). Information gathered from a patient registry and biobank will be used to help design future cancer clinical trials in diverse populations.

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"Labcorp and CCORN are joining forces to ensure oncology clinical research reaches community oncology practices serving individuals from diverse populations who are living with cancer," said Prasanth Reddy, M.D., MPH, FACP, Labcorp’s senior vice president and head of oncology. "While progress has been made to improve outcomes in cancer medicine, especially over the past two decades, current standards of care remain woefully inadequate, due in part to a lack of access and diversity in clinical trials, as well as limited access to advanced diagnostic testing. Advanced diagnostic testing offered by Labcorp, much like genomic sequencing, is critical to ensure the right drug reaches the right patient at the right time in their cancer journey. The PREFER (PRospective rEgistry oF advanced stage cancER) patient registry will provide key insights derived from clinical and lab data on the unmet needs among people with cancer from diverse populations, helping us reduce the impact of health care disparities and fully realize the power of precision medicine for these patients."

Patient registries are observational study methods used to collect standardized information about a group of patients who share a condition or experience. PREFER will enroll up to 2,500 patients with advanced solid-tumor cancer from multiple sites across the United States beginning Sept. 1, 2021. OmniSeq INSIGHTsm, a comprehensive genomic and immune-profiling, tissue-based test that incorporates next-generation sequencing technology, will be used to help identify the prevalence of actionable biomarkers and driver mutations that are unique to different ethnicities.

As a part of their collaboration, Labcorp and CCORN will also create a biobank, enabling the broader oncology community to access real-world evidence and identify the source of disparities. Information from the biobank and patient registry could prove useful in improving the design of oncology clinical trials, assist in patient recruitment efforts, and help encourage the expansion of genomic profiling testing in diverse populations.

"Diverse populations already suffer from a lack of access to adequate cancer diagnosis and treatment, including reduced screening rates and staging at diagnosis, along with the financial challenges people often face following a diagnosis of cancer," said Dr. Kashyap Patel, founder and Chairman of CCORN, President of the Community Oncology Alliance and CEO of the Carolina Blood and Cancer Care. "Drug development processes have been relatively unsuccessful in reflecting demographic diversity in clinical trials, which further contributes to disparities in care and outcomes for those groups. It’s imperative that we determine how and why disparities occur, and this collaboration with Labcorp will be a major step in this regard."

The National Comprehensive Cancer Network guidelines recommend and position clinical trials as a treatment option for cancer, yet less than 5% of patients diagnosed with cancer are enrolled in these trials due to lack of awareness, social determinants of health, and geographic and logistical obstacles. By ensuring diversity in trials, the oncology community will have a deeper understanding of how to continue advancing personalized medicine in cancer care and thereby improve outcomes for all patients.

Additionally, a 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) report on cancer disparities estimated that 34% of cancer deaths among U.S. adults age 25 to 74 could be prevented if disparities in clinical trial participation were actively addressed.

On August 19, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Immunome, AUG 19, 2021, View Source [SID1234586763]).

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"We made strong progress during Q2 in the development of IMM-BCP-01, our antibody cocktail to combat SARS-CoV-2. We finalized the selection of antibodies for the cocktail, secured increased funding for the program from the Department of Defense, and demonstrated IMM-BCP-01’s potent neutralization activity against all SARS-CoV-2 variants of concern, including the Delta variant, in preclinical testing. We believe we are well-positioned for an IND filing for this program in the third quarter," said Purnanand Sarma, Ph.D., President and CEO of Immunome. "We have continued to strengthen the company through a number of executive and non-executive appointments, in addition to a successful fundraising. We believe these activities set us up for value-creating events in the near-term, including a planned IND filing for our IL-38 immuno-oncology program in the fourth quarter. I look forward to updating you further on our progress in the coming months."

Second Quarter and Subsequent Highlights

Demonstrated Potent Neutralization Activity of IMM-BCP-01 Against SARS-CoV-2 Delta Variant. In July 2021, Immunome announced that its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. An Investigational New Drug (IND) filing for IMM-BCP-001 is planned for 3Q 2021.
Selected Antibodies for IMM-BCP-001 Antibody Cocktail. In April 2021, the company announced antibody selection for its IMM-BCP-01 cocktail and shared data showing that IMM-BCP-01 neutralizes CDC SARS-CoV-2 "Variants of Concern" in preclinical testing. The cocktail was efficacious in Syrian hamsters infected with SARS-CoV-2 (USA-WA1/2020) in both prophylactic and treatment schedules. Further, the cocktail neutralized Alpha and Beta variants in live virus testing and Gamma and Epsilon variants in pseudovirus testing.
Completed a $27 million Private Placement. In April 2021, the company announced a private placement of its common stock for gross proceeds to Immunome of approximately $27 million, before deducting placement agent commissions and other offering expenses.
Awarded $4.3 million by the U.S. Department of Defense (DoD). In May 2021, Immunome announced that the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense had awarded the company $4.3 million. These funds were in addition to Immunome’s original $13.3 million award provided by the DoD in July 2020. (Contract number: W911QY2090019)
Appointed Corleen Roche as Chief Financial Officer. In April 2021, Immunome announced that it had appointed Corleen Roche as its Chief Financial Officer. Ms. Roche is a highly accomplished CFO with over 30 years of industry experience.
Appointed Franklyn G. Prendergast, M.D., Ph.D., to Board of Directors. In June 2021, the company announced that it had appointed Dr. Prendergast to its Board of Directors. Dr. Prendergast is a renowned medical and academic research professional who received the 2019 Mayo Distinguished Alumni award and has over 45 years of association with the Mayo Foundation. Over the past 20 years, Dr. Prendergast has served on the Board of Directors or Scientific Advisory Board of several biotechnology companies.
Appointed Andrew Badley, M.D., to COVID-19 Advisory Board. In June 2021, Immunome announced the appointment of Andrew D. Badley, M.D., to the company’s COVID-19 Advisory Board. Dr. Badley is a renowned infectious disease expert who has spent 19 years with the Mayo Clinic in various roles. He currently serves as the Chair of Mayo Clinic’s COVID-19 Research Taskforce.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2021 were $3.2 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2021 were $2.5 million.
Net loss: Net loss for the three months ended June 30, 2021 was $5.2 million.
Cash and cash equivalents: As of June 30, 2021, cash and cash equivalents totaled $59.8 million.

On August 19, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Merck & Co., Inc. to be in the specialty pharmacy network for WELIREG (belzutifan), a hypoxia-inducible factor inhibitor indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery (Press release, Onco360, AUG 19, 2021, View Source [SID1234586762]).

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"Onco360 is honored to be included in the Merck specialty pharmacy network for WELIREG," said Benito Fernandez, Chief Commercial Officer, Onco360. "Onco360 is committed to supporting von Hippel-Lindau patients afflicted with certain associated tumors requiring treatment."

On August 19, 2021 Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, reported that new data show the company’s cerebrospinal fluid assay, CNSide, detected tumor cells and identified actionable mutations in lung cancer patients with leptomeningeal carcinomatosis, allowing for targeted treatment decisions that may improve outcomes and extend life expectancy (Press release, Biocept, AUG 19, 2021, View Source [SID1234586761]). The study will be presented as a poster at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually Aug. 19-20, 2021.

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More than 198,000 patients are diagnosed with non-small cell lung cancer (NSCLC) each year. An estimated 3-9% of those patients will develop leptomeningeal carcinomatosis (LMC), a complication in which the cancer spreads to the membranes surrounding the brain and spinal cord. LMC is typically diagnosed through clinical evaluation, imaging and cytology, which have limited sensitivity. When left untreated, the average patient life expectancy is just four to six weeks.

The retrospective study, conducted at the University of Utah Huntsman Cancer Institute, used Biocept’s CNSide assay to detect and analyze tumor cells in the cerebrospinal fluid of 15 unique patients. Of the samples analyzed, CNSide detected tumor cells in 100% of samples with LMC, while cytology detected tumor cells in just 40% of the samples. CNSide also identified actionable biomarkers in tumor cells, which allowed oncologists to make targeted treatment decisions that reduced debilitating symptoms and extended patient lives by more than three years in some cases. The study results suggest that CNSide is more sensitive than cytology, and survival of patients with LMC can be prolonged if an actionable target is identified and treated.

"LMC is a devastating diagnosis for patients and, quite often, hospice is the only recommended course of action," said Wallace Akerley, M.D., University of Utah Huntsman Cancer Institute, and lead study investigator. "However, we now have targeted therapies that can improve and dramatically extend the lives of patients with LMC who have a treatable mutation. This study shows that using CNSide to interrogate the cerebrospinal fluid for actionable mutations provides the information needed to determine the appropriate treatment for patients with LMC. With the right therapy, we have the ability to restore quality of life and extend life expectancy for many patients."

"Identifying actionable mutations is critical for treating patients with LMC," said Michael C. Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide has demonstrated the ability to reliably detect and analyze tumor cells in the cerebrospinal fluid that may not be found in blood or tissue samples. The specific molecular targets identified in these tumor cells can help guide a physician’s choice of newer, more effective therapies and inform the response to therapy in a way that can really help these patients see an improvement of symptoms and live significantly longer lives."

The study, titled "Beyond Cytology – A Single Institution Experience Using CNSide for Diagnosing and Monitoring Treatment Response in Non-Small Cell Lung Cancer Patients with Leptomeningeal Carcinomatosis (LMC)," can be accessed here.