Personalis to Announce Third Quarter 2022 Financial Results

On October 19, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that it will release its third quarter 2022 financial results on Wednesday, November 2, 2022 (Press release, Personalis, OCT 19, 2022, View Source [SID1234622199]). 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.

Orionis Biosciences Secures $55 Million Financing to Support Advancement into Clinic

On October 19, 2022 Orionis Biosciences, a life sciences company pioneering innovation of highly selective and tunable therapeutics for cancer and beyond, reported it has completed a $55 million financing round and expanded its team, naming Robert Petit, Ph.D., as Senior Vice President, Early Clinical Development and Bihua Chen to the Orionis Board of Directors (Press release, Orionis Biosciences, OCT 19, 2022, View Source [SID1234622198]).

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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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Founded in 2015, Orionis has since developed its proprietary technology platforms, grown a deep pipeline and cemented a drug discovery deal with Novartis. This latest financing round provides the company with additional capital for R&D expansion, pipeline growth and advancement of its lead cancer immunotherapy programs into clinical trials. Existing and new investors participated in the round, including Cormorant Asset Management, Novartis and a series of high-caliber investment funds.

"We are grateful for the strong support of a world-class investor syndicate that shares our passion for advancing new modalities in cancer and other diseases," said Nikolai Kley, Ph.D., Co-founder, President and Chief Executive Officer at Orionis. "As we near the clinic, we are thrilled to bring on Robert Petit, Ph.D., a pioneer in the development of cancer immunotherapies, as our Head of Early Clinical Development. In addition, we are pleased to welcome industry veteran Bihua Chen to our Board as we enter this next stage of growth. With two distinct precision medicine platforms, which focus on expanding druggability through genome-scale molecular glue discovery and on selectively targeting immune cells with conditionally active cytokines to reactivate the cancer immunity cycle, we are well-positioned to advance a diverse pipeline and translate our innovative approaches into new therapies."

"I have spent my career working to develop new and better cancer therapies, so I’m incredibly excited to have joined to lead the team’s translational and clinical development efforts," said Dr. Petit. "We are moving quickly to advance and expand our pipeline of first-in-class immunotherapies. The extraordinary technology platforms at Orionis have the potential to create a new class of more effective and better-tolerated cancer treatments that could significantly extend the potential of immunotherapy. I look forward to supporting Orionis in its path toward a clinical-stage company."

Dr. Petit brings decades of experience in drug development, including at Bristol Meyers Squibb, where he led U.S. Medical development of the first FDA-approved immune checkpoint therapy. He has deep experience across medical and scientific aspects of pharmaceutical development and has directed programs in discovery, translational development and intellectual property development. Dr. Petit received his Ph.D. from The Ohio State University College of Medicine and a B.S. from Indiana State University.

"With its proprietary platform technologies, Orionis has the opportunity to solve some of the biggest challenges in oncology and beyond," said Ms. Chen. "I am honored to join the Board of Directors at Orionis and to work with such an accomplished team."

Ms. Chen is founder and CEO of Cormorant Asset Management, where she manages investments in public and private biopharmaceutical companies. She previously served as a sub-adviser to a large, multi-strategy hedge fund based in New York. Ms. Chen earned an MBA from The Wharton School of the University of Pennsylvania, an M.S. in molecular biology from the Graduate School of Medical Sciences at Cornell Medical College and a B.S. in genetics and genetic engineering from Fudan University.

Orionis is rapidly advancing a deep pipeline of biologics for the treatment of cancer based on its A-Kine platform, which engineers target-selective, conditionally active cytokines designed to trigger anti-tumor immune responses even in "cold" tumors that lack prevalent immune involvement and are refractory to checkpoint inhibitor therapies. A-Kines aim to avoid the systemic toxicities observed with traditional cytokine therapies.

In addition, Orionis is developing a diverse spectrum of small molecule molecular glues using its Allo-Glue platform, harnessing a first-in-class, genome-scale approach to discovery and rational design of molecular glues in order to reach previously intractable targets. Orionis will present preclinical data from its molecular glue platform in October at the following conference:

Nucleix Receives CAP Accreditation and CLIA Certification for its San Diego Clinical Laboratory

On October 19, 2022 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that their San Diego-based clinical laboratory received accreditation by the College of American Pathologists (CAP) (Press release, Nucleix, OCT 19, 2022, View Source [SID1234622197]). This achievement follows the recent certification under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services. These designations highlight the commitment, work ethic and quality demonstrated by the laboratory team.

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"As we ramp up research and laboratory operations to evaluate, develop and commercialize methylation-based assays for early cancer detection, receiving these designations provides validation of our ability to accept and report on clinical samples," said Chris Hibberd, Chief Executive Officer at Nucleix. "We are proud of these achievements as we continually seek opportunities to optimize our efforts and ultimately, build technology solutions that help physicians and their patients diagnose cancer earlier, when treatment is most effective."

The CAP Laboratory Accreditation Program is the gold standard for laboratory excellence. Their program fosters an environment for continuous improvement and patient safety.

CLIA certification confirms that Nucleix’s clinical laboratory meets the federal regulations for clinical diagnostic testing, ensuring high quality and safety for patient testing. As part of the certification process, Nucleix completed analytical and clinical validation evaluating the accuracy and reliability of its EpiCheck early detection test platform.

College of American Pathologists (CAP) Accreditation

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, CAP serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The Accreditation Committee of the College of American Pathologists has awarded this prestigious recognition based on results of a rigorous on-site inspection of the laboratory’s records and quality control of procedures, laboratory staff qualifications, equipment, facilities, safety program, record and overall management. CAP Accreditation is an internationally recognized program that awards accreditation to laboratories that meet stringent requirements of quality, accuracy, and consistency.

Clinical Laboratory Improvement Amendments (CLIA) Certification

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Under provisions of the U.S. Department of Health and Human Services’ CMS, the California Department of Public Health granted the company initial registration for high complexity testing through the CLIA Certification Program and follows California State laboratory licensure.

Biocept to Present at the LD Micro Main Event XV

On October 19, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that management will present at the LD Micro Main Event XV on Wednesday, October 26 at 2:30 p.m. Pacific time (5:30 p.m. Eastern time) (Press release, Biocept, OCT 19, 2022, View Source [SID1234622196]). The conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles.

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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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A webcast of the presentation will be live and archived on the Events and Presentation section of the company website.

Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) and Investigational 18F-rhPSMA-7.3 in Biochemically Recurrent Prostate Cancer at Upcoming ASTRO Annual Meeting

On October 19, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) and investigational 18F-rhPSMA-7.3 at the upcoming American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting, to be held in San Antonio, Texas, from October 23 to 26, 2022 (Press release, Blue Earth Diagnostics, OCT 19, 2022, View Source [SID1234622195]). Details of selected oral and moderated poster presentations are listed below.

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An oral presentation on the investigational radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compound, 18F-rhPSMA-7.3, is being made at the conference. It includes additional results from the Company’s Phase 3 SPOTLIGHT study (NCT04186845) evaluating the impact of clinical factors on the detection rate of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Presentations on studies of Axumin (fluciclovine F 18) include interim analyses from a randomized trial of 18F-fluciclovine and 68Ga-PSMA PET/CT in post-prostatectomy radiotherapy, experience on the prognostic utility of 18F-fluciclovine PET after salvage radiotherapy, and timing and patterns of potentially salvageable recurrences after SBRT for localized prostate cancer. Additionally, the Company will host an Industry-Expert Theater event, "Emerging Data on the Impact of Axumin (fluciclovine F 18) PET Imaging on Radiotherapy Decisions." Details of selected oral and poster presentations by Blue Earth Diagnostics and its collaborators are listed below.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment. Currently, 18F-rhPSMA-7.3 is investigational and has not received regulatory approval.

Blue Earth Diagnostics invites participants at the 2022 ASTRO Annual Meeting to attend the presentations above and visit the company at Exhibit Booth 4142. Blue Earth Diagnostics is hosting an Industry-Expert Theater event, "Emerging Data on the Impact of Axumin (fluciclovine F 18) PET Imaging on Radiotherapy Decisions," with invited speaker Dr. Edward Obedian, MD, Radiation Oncologist, St. Francis Hospital, Long Island, NY. The event will be held on Sunday, October 23, 2022, from 11:00 AM to 12:00 PM CT, in Room 216, Meeting Level, Henry B. Gonzalez Convention Center. For full session details and scientific presentation listings, please see the ASTRO online program here.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.