On November 21, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody (Press release, Zymeworks, NOV 21, 2022, View Source [SID1234624311]). Zanidatamab in combination with palbociclib and fulvestrant was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive HR+ breast cancer . A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 6-9, 2022.

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Abstract highlights from the February 24, 2022 data cut:

Thirty-four heavily pretreated patients with HER2-positive HR+ breast cancer were treated with zanidatamab in combination with palbociclib and fulvestrant.
The confirmed objective response rate was 34.5% and the disease control rate was 93.1% in 29 response-evaluable patients.
Ongoing durable responses were seen out to 14.9+ months, with 18 patients still on treatment at the time of the data cut.
Treatment-related adverse events were generally consistent with previous reports of zanidatamab and/or chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.
This regimen has the potential to be a chemotherapy-free treatment option in patients with HER2-positive HR+ metastatic breast cancer.
The abstract is available on the SABCS conference website. The spotlight poster presentation will be available on Friday, December 9 at 7:00 am Central Time (CT) to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

Title: Treatment of HER2-positive (HER2+) hormone-receptor positive (HR+) metastatic breast cancer (mBC) with the novel combination of zanidatamab, palbociclib, and fulvestrant

Lead Author: Santiago Escrivá-de-Romani, MD, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital; Barcelona, Spain

Program Number: PD18-10

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2 and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.

On November 21, 2022 Scorpion Therapeutics, Inc. ("Scorpion"), a pioneering oncology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, reported that it will present preclinical data on STX-478, its potential best-in-class mutant-selective PI3Kα inhibitor, in a poster session at San Antonio Breast Cancer Symposium ("SABCS") in San Antonio, Texas, taking place December 6 – 10, 2022 (Press release, Scorpion Therapeutics, NOV 21, 2022, View Source [SID1234624310]).

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STX-478 is a highly selective, allosteric and CNS-penetrant inhibitor of mutant PI3Kα, designed to improve outcomes in patients harboring tumors with prevalent PI3Kα kinase or helical domain mutations. Scorpion has completed IND-enabling studies for STX-478 and expects to submit an IND application to the U.S. Food and Drug Administration ("FDA") in the first quarter of 2023.

"We are excited to present preclinical data that further support STX-478’s potential as a best-in-class PI3Kα inhibitor and advances its development as a novel therapeutic for the treatment of many solid tumors that are underserved by existing options," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion Therapeutics. "Despite PI3Kα being one of the most highly-mutated targets in cancer, currently available therapies suffer from serious limitations, including a lack of wild-type selectivity, which induces metabolic dysfunction and causes dose-limiting toxicities, and an inability to penetrate the central nervous system (CNS), which leaves brain metastases – a common occurrence in solid tumor patients – unaddressed. We are confident that STX-478 can address these challenges through superior monotherapy activity, as well as in combination with relevant co-treatments, without sacrificing tolerability."

On November 21, 2022 Researchers at the University of Wisconsin–Madison, the first U.S. clinical evaluation site for GE Healthcare’s industry-first silicon-based photon counting CTi, reported that it will begin human scanning using the device, which is engineered with Deep Silicon detectors with the goal of greatly enhancing imaging capabilities to help clinicians improve patient outcomes across oncology, cardiology, neurology, and other clinical CT applications (Press release, GE Healthcare, NOV 21, 2022, View Source [SID1234624309]).

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The collaboration comes nearly one year after GE Healthcare announced its first clinical evaluation site at Karolinska Institute and MedTechLabs in Sweden. Since then, the company has made rapid progress in enhancing the developing technology, building a new system prototype to include:

A larger detector with the possible goal of enabling quicker scan times as well as expanding coverage;
ECG-gated cardiac scan capabilities designed for coronary artery imaging; and
Faster acquisition speed with the intent to reduce the likelihood of blurred images due to motionii.
"Photon counting CT has promise to embody the best of CT imaging available to date," explains Dr. Meghan G Lubner, professor of radiology at the UW School of Medicine and Public Health. "This technology has the potential to expand the scope of current indications by combining refined energy resolved data, high spatial resolution, reduced noise and improved soft tissue contrast. We are working with GE Healthcare by testing their novel photon counting solutions in human subjects to assess issues ranging from improving commonly encountered CT image quality limitations to evaluating whether previously out of reach clinical questions can now feasibly be answered."

Photon counting CT could potentially advance the capabilities of CT, including the visualization of minute details of organ structures, improved tissue characterization, more accurate material density measurement (or quantification) and lower radiation dose.

GE Healthcare is pursuing a unique approach to photon counting CT, which may enable higher spatial and spectral resolution at the same time, thanks to several advantages provided by Deep Silicon detectors, including: the detector’s material purity, innovative geometric design, and true multi-bin technologies for high performance spectral imaging. As such, the research being done at UW–Madison will assist GE Healthcare in better understanding the heights of these unique capabilities.

"Photon counting detectors push CT technology forward in two major ways: better spatial resolution and better contrast resolution," shares Tim Szczykutowicz, Ph.D., associate professor radiology at the school. Szczykutowicz is also affiliated with the Departments of Medical Physics and Biomedical Engineering. "I think for CT, photon counting is undoubtedly the next big thing. We are a part of the process of evaluating and developing this unique approach to photon counting based on Deep Silicon technology."

UW–Madison will facilitate human subject research and produce technical feedback to test and advance GE Healthcare’s photon counting CT technology with Deep Silicon. The study will assess reconstruction methods, image presentation workflows, and clinical benefits for specific pathologies and disease types to determine how to best optimize photon counting CT with Deep Silicon detectors to enable better visualization and utilization.

"Innovation requires close collaboration between medical technology innovators and academia," concludes Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE Healthcare. "We are thrilled to deliver our newest prototype to our long-time collaborators at UW–Madison and UW Health. Together with UW, Karolinska Institute and MedTechLabs, we are advancing a cutting-edge technology with the potential to provide clinicians and patients with more information sooner – all with the goal of helping to improve patient outcomes."

On November 21, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the 34th Annual Piper Sandler Healthcare Conference on Wednesday, November 30, 2022 at 1:30 p.m. Eastern Time in New York, NY (Press release, Personalis, NOV 21, 2022, View Source [SID1234624308]).

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On November 21, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that financial results for the three and nine months ended September 30, 2022 and provides a business update (Press release, Biocept, NOV 21, 2022, View Source [SID1234624307]).

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"Our third quarter financial results reflect solid increases in CNSide orders, up 8% sequentially and 176% year-over-year," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "We are executing well on our strategy to generate further evidence to secure higher reimbursement for CNSide and support its adoption into clinical care guidelines. The first site in our FORESEE clinical trial is now open for patient enrollment and we expect at least one additional site to be cleared for enrollment in the coming months. We recently announced our participation in an investigator-initiated study with leading breast cancer oncologists at the University of California San Francisco aimed at learning more about how metastatic breast cancer develops and progresses. I’m also pleased that at last week’s Society for Neuro-Oncology annual meeting three posters featuring CNSide were presented by prominent neuro-oncologists."

Third Quarter Financial Results

Net revenues for the third quarter of 2022 were $5.6 million, which included $4.7 million in RT-PCR COVID-19 test revenue. This compared with net revenues for the third quarter of 2021 of $17.5 million, which included $16.5 million in RT-PCR COVID-19 test revenue.

Biocept accessioned 49,874 commercial samples during the third quarter of 2022, compared with 152,796 commercial samples during the third quarter of 2021, with the decline due primarily to lower RT-PCR COVID-19 testing volume. The average value per commercial accession for the third quarter of 2022 was $111, compared with $114 for the third quarter of 2021, with the decrease due to payor mix.

Cost of revenues for the third quarter of 2022 was $5.8 million, compared with $11.3 million for the prior-year period, with the decrease primarily related to lower RT-PCR COVID-19 testing volume.

Research and development (R&D) expenses for the third quarter of 2022 were $1.4 million compared with $1.3 million for the third quarter of 2021. General and administrative (G&A) expenses for the third quarter of 2022 were $3.0 million, compared with $3.5 million for the third quarter of 2021, with the decrease primarily due to lower stock-based compensation and lower headcount. Sales and marketing expenses for the third quarter of 2022 were $1.0 million, compared with $1.9 million for the third quarter of 2021, with the decrease due primarily to a reduction in sales commissions expense.

Net loss attributable to common stockholders for the third quarter of 2022 was $5.5 million, or ($0.33) per share on 17.0 million weighted-average shares outstanding. This compares with net loss attributable to common stockholders for the third quarter of 2021 of $0.6 million, or ($0.04) per share on 15.4 million weighted-average shares outstanding.

Nine Month Financial Results

Net revenues for the first nine months of 2022 were $36.1 million, compared with $47.3 million for the first nine months of 2021.

Operating expenses for the first nine months of 2022 were $49.5 million, and included cost of revenues of $24.1 million, R&D expenses of $4.9 million, G&A expenses of $14.2 million, of which $3.5 million are non-recurring, and sales and marketing expenses of $6.3 million. Operating expenses for the first nine months of 2021 were $46.9 million, and included cost of revenues of $27.7 million, R&D expenses of $3.5 million, G&A expenses of $9.9 million and sales and marketing expenses of $5.8 million.

Net loss attributable to common stockholders for the first nine months of 2022 was $13.6 million, or ($0.80) per share on 16.9 million weighted-average shares outstanding. This compares with net income attributable to common stockholders for the first nine months of 2021 of $0.1 million, or $0.01 per diluted share on 14.3 million weighted-average shares outstanding.

Biocept reported cash as of September 30, 2022 of $18.0 million, compared with $28.9 million as of December 31, 2021.

Conference Call and Webcast

Biocept will hold a conference call on Monday, November 28, 2022 beginning at 4:00 p.m. Eastern time to discuss these results and answer questions. Participants can pre-register for the conference call here. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the call start time.

The conference call can be accessed at the time of the live call by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for international callers. A live webcast of the conference call will be available here.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for international callers. Please use event passcode 9945142. A replay of the webcast will be available for 90 days.