On July 6, 2021 Biocept, Inc. (NASDAQ: BIOC), a leading provider of molecular diagnostic assays and services, reported that it has been awarded a South Korean Patent for its Primer-Switch technology, which detects rare mutations in circulating tumor DNA (ctDNA) using real-time PCR and associated analysis methods (Press release, Biocept, JUL 6, 2021, View Source [SID1234584627]). The patent (No. 2252447) is titled Methods for Detecting Nucleic Acid Sequence Variants.

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This is the fourth issued patent for the technology, which identifies rare cancer biomarkers found in tissue, blood, and cerebrospinal fluid (CSF). Primer-Switch provides a unique method for specifically enriching patient specimens for mutations of interest. It can be used to enhance the performance and specificity of the PCR method, the most widely used amplification approach for research and clinical diagnostic applications. It also enables the interrogation of fragmented DNA that is often found in biological fluids.

"Primer-Switch methodology adds to the capabilities of our Switch-Blocker technology used in our Target Selector assays, providing key information about cancer biomarkers to aid physician decision-making, with the goal of improving outcomes for patients with cancer," said Michael Nall, Biocept’s President and CEO. "Our strong and growing intellectual property portfolio enables Biocept to develop and commercialize our highly differentiated technologies and testing services."

Biocept’s core technologies and products are protected by more than 70 issued patents in the U.S., EU, Australia, China, Japan, and South Korea, as well as other countries. This includes worldwide patent protection on its highly sensitive methods for detecting cancer biomarkers that are used by physicians for treatment decisions.

On July 6, 2021 Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the company’s IND application for a systemic siRNA (small interfering RNA) drug candidate STP707 received the U.S. Food and Drug Administration (FDA) acknowledgment "Study May Proceed", in patients with advanced solid tumors (Press release, Sirnaomics, JUL 6, 2021, View Source [SID1234584612]). This "Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP707 Administered Intravenously in Subjects with Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy" is expected to begin enrolling in coming months.

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Sirnaomics’ lead product candidate, STP707, is an anti-cancer siRNA (small interfering RNA) therapeutic. It takes advantage of a dual-targeted inhibitory property and a proprietary polypeptide nanoparticle (PNP)-enhanced targeted delivery to solid tumors and metastatic tumors via systemic administration. Initial preclinical study has demonstrated that knocking down TGF-β1 and COX-2 gene expression simultaneously in tumor microenvironment increases active T cell infiltration. A further combination study demonstrated a synergistic antitumor activity between STP707 and PD-L1 antibody using a mouse orthotopic liver cancer model.

"The IND green light from the US FDA for Sirnaomics’ first IV oncology drug, STP 707, represents another major milestone for the company’s mission in discovery and development of novel siRNA therapeutics for unmet clinical needs. Sirnaomics’ drug target selection and tumor targeting delivery should support a high rate of success for novel anticancer siRNA therapeutics, which have been verified in our clinical and preclinical studies" said the Founder and CEO of the company, Dr. Patrick Y. Lu. "Sirnaomics is currently in a strong position to lead the RNAi community in the development of novel oncology therapeutics."

"This IND approval represents a sentinel moment for the company as we can now expand our therapeutic reach in IV administration. This will allow more opportunities to target critical diseases with high unmet clinical need," stated Chief Medical Officer, Michael Molyneaux M.D. "We expect that our rigorous oncology basket clinical study design will enable us to gain great insights into the impact of STP707 on multiple solid tumor types. Our IND enabling non-clinical studies with STP707 demonstrated an excellent safety profile as well as very good efficacy in multiple tumor types."

About STP707

STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics’ STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. The drug substances in STP707 are two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively. Over-expressions of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, intravenous (IV) delivery resulted in knock-down of TGF-β1 and COX-2 gene expressions in various organs including liver and lung. In addition, in preclinical models STP707 had antitumor activity in various solid tumor types.

On July 6, 2021 GE Healthcare and SOPHiA GENETICS reported that they have signed a letter of intent to collaborate on advancing cancer care, with the goal of better targeting and matching treatments to each patient’s genomic profile and cancer type, helping to ensure the most effective and personalized treatment (Press release, GE Healthcare, JUL 6, 2021, View Source [SID1234584628]).

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The companies aim to develop new artificial intelligence (AI)-powered analytics and workflow solutions to serve both the clinical and biopharma markets. They’ll be deploying GE Healthcare’s extensive medical imaging and monitoring capabilities and Edison platform-enabled data aggregation with the SOPHiA DDM cloud-based software-as-a-service analytics genomic insights platform and related solutions, which are available in more than 750 hospitals, laboratories and biopharma companies.

GE Healthcare has deep expertise in clinical workflows, deep learning AI algorithms for image reconstruction and image segmentation, analytics and standardization, while SOPHiA GENETICS is a pioneer in data-driven medicine. Their cloud-based software-as-a-service analytics platform uses AI and machine learning to generate actionable insights for clinicians and researchers from complex multimodal datasets. The companies aim to break down the data silos across instruments and sites that so often delay or even prevent patients from getting the most appropriate treatment both in cancer and in other diseases.

As cases of cancer continue to rise and are predicted to reach 29.5 million new cases per year by 2040,1 there is a growing demand for data-driven medicine, both for clinical practice and clinical trials. GE Healthcare is utilizing its Edison platform to integrate data from diverse sources, such as electronic health records (EHR) and radiology information systems (RIS), imaging and other medical device data. This integrated data can be used to develop and deploy AI enabled solutions to help simplify oncology patient workflows, better understand increasingly complicated clinical patient data, and compare data from patient to patient.

"The integration of genomics-based artificial intelligence into oncology workflow solutions would be a major breakthrough for integrated cancer medicine and for future clinical research, which increasingly depend on the ability to select those patients most likely to respond to new therapies," said Jan Makela, President & CEO, Imaging at GE Healthcare. "This collaboration represents another step in GE Healthcare’s vision of making precision health—more efficient and personalized care— a reality."

"By bringing together our global platform and insights-sharing network with GE Healthcare’s international reach and cutting-edge products, healthcare professionals will be able to leverage their expertise and work together for the benefit of patients all over the world. Cancer patients will be able to receive equal access to better diagnoses and treatments through secure data pooling and knowledge sharing, unlocking the promise of data-driven medicine at scale," said Jurgi Camblong, co-founder and CEO, SOPHiA GENETICS.

Next-generation sequencing (NGS) is rapidly becoming a new standard of care in cancer diagnostics, particularly as novel therapies require genomic information to be prescribed in a personalized way. Today, these sets of information and insights are often bespoke and difficult for clinicians to easily and quickly obtain and recall along the patient care journey.

On July 6, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2021 financial results on Thursday, July 22, 2021, before the market opens (Press release, Quest Diagnostics, JUL 6, 2021, View Source [SID1234584613]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-360-3307 for domestic callers or 203-369-0162 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 22, 2021 until midnight Eastern Time on August 5, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 6, 2021 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibodies, reported dose administration for the first patient in a Phase 1/2 clinical trial of EMB-02, a bispecific antibody targeting PD-1 and LAG-3, in patients with advanced solid tumors, as well as in a Phase 1/2 clinical trial of EMB-06, a bispecific antibody targeting B cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3), in patients with recurrent and refractory multiple myeloma (Press release, EpimAb Biotherapeutics, JUL 6, 2021, View Source [SID1234584629]). The company also announced the approval of its Investigational New Drug (IND) application for EMB-02 by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).

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"We are excited to continue the momentum of our pipeline advancement with the dosing of the first patients in Phase 1/2 trials for our two new clinical programs, EMB-02 and EMB-06, as well as the IND clearance for EMB-02 in China," said Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "This validates the power of our FIT-Ig platform to efficiently generate novel bispecific programs, as well as its broad applicability across a variety of targets, which is important as we continue to pursue promising target combinations. We look forward to advancing additional preclinical and clinical assets derived from our FIT-Ig platform as well as expanding into utilizing additional proprietary platform technologies to develop complex multi-functional molecules with unique capabilities."

"The target combination of PD-1 and LAG-3 has received industry attention recently for its potential in difficult-to-treat cancers that do not respond to standard anti-PD-1 monotherapies. Our preclinical data revealed that EMB-02 can show significant improvement in tumor models resistant to standard anti-PD-1 monotherapies," said Bin Peng, MD, Ph.D. CMO of EpimAb Biotherapeutics. "We look forward to establishing ourselves as a leader in the development of best-in-class bispecific therapeutics as we further evaluate the potential of EMB-02 in global clinical trials in the U.S., China and Australia. We are also eager to continue the advancement of EMB-06, a bispecific antibody targeting BCMA and CD3, and evaluate its potential to benefit patients with multiple myeloma."

The EMB-02 Phase 1/2 study is a multi-center, open label, multiple-dose, first in human study to assess the safety and tolerability of EMB-02 in patients with advanced solid tumors. The primary objective for the Phase 1 portion of the study is to identify the recommended Phase 2 dose (RP2D) and schedule assessed to be safe for EMB-02. Pharmacokinetics, immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of EMB-02 will be evaluated in an expanded cohort at the RP2D. The trial is being conducted at two clinical trial sites in the U.S. and one in Australia. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04618393).

The EMB-06 Phase 1/2, multi-center, open label, multiple-dose, first in human study is designed to assess the safety and tolerability of EMB-06 in patients with relapsed or refractory multiple myeloma. The primary objective for the study is to identify the recommended Phase 2 dose (RP2D) and schedule assessed to be safe for EMB-06. Pharmacokinetics, immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed. In the Phase 1 portion of the trial, patients will receive EMB-06 once weekly at different ascending dose levels. Once the RP2D is determined, an expanded cohort will receive EMB-06 at the RP2D. The trial is being conducted at 4 clinical trial sites in Australia and is being expanded to further countries. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04735575).