On January 5, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the appointment of Mr. Kenneth Galbraith as Chair and Chief Executive Officer (CEO) of Zymeworks, effective on or before February 1, 2022 (Press release, Zymeworks, JAN 5, 2022, View Source [SID1234598283]). Mr. Galbraith will succeed Zymeworks co-founder Ali Tehrani, Ph.D., who has served as President and CEO since 2003. Dr. Tehrani will remain as an advisor to the Company to assist with the transition.

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"Ken Galbraith is an outstanding global leader who brings more than 30 years of life science industry, venture capital and commercialization experience to Zymeworks, along with a proven track record of strong leadership and operational skills," said Lota Zoth, Zymeworks’ current Board Chair. "The Board unanimously believes that Ken is the ideal leader to implement our next phase of development as we continue late-stage clinical trials for zanidatamab and expand our R&D pipeline. We thank and recognize Ali for his outstanding service in creating a solid foundation and advancing Zymeworks to a late-stage clinical company with valuable R&D programs, numerous productive pharmaceutical partnerships, and a high-quality management team."

A former Zymeworks Board member from 2009 to 2013, Ken Galbraith has been working since 1987 as a life sciences executive, director, investor and advisor in the growth of both private and public companies from early-stage through regulatory approval and commercialization. Most recently, he served as executive-in-residence with Syncona (LSE:SYNC), a large British closed-ended healthcare investment trust dedicated to life science investments. He began his biotechnology career in Vancouver as CFO at QLT, where he was instrumental in growing the company to over 500 employees while gaining market approvals for several new medicines prior to his departure in 2000. During his lengthy career, Ken has played a pivotal role in the development of several successful biotechnology companies throughout North America, including AnorMED, Macrogenics, Alder Pharmaceuticals, Celator Pharmaceuticals, Novadaq and Angiotech, among others. He holds a Bachelor of Commerce degree with honors from the University of British Columbia.

"I have long believed in the potential of innovative technology platforms to generate novel multispecific antibodies and antibody-drug conjugates and transform the treatment of cancer. Zymeworks’ innovative approach, technology platforms and emerging product pipeline represent a tremendous opportunity, and I look forward to leading the Company during this exciting period of innovation in cancer therapies," said Ken Galbraith. "This year, we expect to progress our two ongoing pivotal clinical studies for zanidatamab, present important new data for zanidatamab and ZW49 to inform additional clinical development opportunities, further advance our preclinical product pipeline and gain insights from our pharmaceutical partners’ programs as they advance into and through clinical development."

The Company also announced that CFO Neil Klompas was promoted to the dual position of COO and CFO, effective immediately.

Ken Galbraith added, "Neil has been instrumental to the growth and financing of Zymeworks for 15 years, and I look forward to working closely with him, our employees, our partners and our Board of Directors to develop the next generation of biotherapeutics with the potential to improve outcomes for patients around the world with difficult-to-treat cancers."

On January 5, 2022 Median Technologies (ALMDT:PA) reported outstanding performance for its iBiopsy Lung Cancer Screening (LCS) CADe algorithm in detecting potentially cancerous lung nodules (Press release, MEDIAN Technologies, JAN 5, 2022, View Source [SID1234598282]).

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When screening for lung cancer, the entire lung must be scanned, which can generate hundreds of images for each patient to detect very small lung nodules. Time constraints and the very large numbers of images to review render it difficult for radiologists to exhaustively detect lung nodules without an automation tool. Without such automation tools, diagnostic errors may result when radiologists are dealing with fatigue. Automated detection tools can help radiologists read images and must offer high sensitivity to minimize false negatives and avoid missing nodules. These tools should also minimize the number of false positives to ensure that radiologists do not focus their attention and time on regions that are not clinically relevant, and will help to avoid lung biopsies as well as unnecessary follow up procedures for the patients.

iBiopsy LCS offers an integrated detection/diagnosis approach (CADe/CADx). The first step is detecting, as thoroughly as possible, all lung nodules in the CT scan images with minimal false negatives and false positives per scan. After automated detection, the diagnostic component (CADx) of iBiopsy LCS aims to reach high levels of sensitivity and specificity, accurately characterizing the presence of cancer while minimizing the false positive rate. False positives are one of the major barriers to adopting screening programs globally. It bears recalling that the outstanding characterization results of iBiopsy CADx were published on September 6, 2021 (performance characterizing cancerous nodules at all stages) and on November 23, 2021 (focus on stage 1 cancers).

The results released today by Median Technologies specifically focus on the lung nodule detection function, which applies Median’s proprietary deep learning algorithms to low-dose computed tomography (LDCT). They are based on a cohort of 888 patients from the LIDC/IDRI2 public database. The 10-fold cross-validation method was used for training (800 train/88 test patients). The overall result, obtained by aggregating the ten test fold results, showed a sensitivity of 94.9% for a false positive rate of 1 per CT scan.

According to publicly available data on the performance of lung CADe devices currently on the market, iBiopsy detection algorithms show the best combination of sensitivity/false positives per CT scan.

"After announcing iBiopsy’s first outstanding results for malignant vs. benign lung nodule characterization in 2021, we are proud to announce our detection algorithm’s performance," highlights Fredrik Brag, CEO and founder of Median. "These results give us reason to be optimistic as we enter the final phase of iBiopsy Lung Cancer Screening’s technological risk mitigation. We are now working on combining detection and diagnosis modules to determine integrated performance. We believe it is only by integrating these two functions in the same software as a medical device (SaMD) that we can remove the current barriers to implementing lung cancer screening programs. Large international trials have already shown the major impact of LDCT lung screening programs on mortality. In parallel, as demonstrated by studies such as the IASLC staging project and an I-ELCAP cohort study respectively, detecting and diagnosing the disease at its earlier stage, when lung nodules are still very small and manageable is key to drastically increasing the patient 5-year and 15-year overall survival rates, saving the lives of patients suffering from lung cancer," Brag added.

On January 5, 2022 Phase Genomics, Inc., a biotech company leading advancements in next-generation sequencing (NGS) solutions for genome assembly and analysis, reported the launch of its new platform for precision oncology (Press release, Phase Genomics, JAN 5, 2022, View Source [SID1234598281]).

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The OncoTerra platform implements a rapid, cost-effective alternative to current cytogenomic analysis tools while unlocking information in even the most challenging of sample types. The platform offers genome-wide detection of a wide range of chromosomal abnormalities without the need for actively dividing cells, high molecular weight DNA extraction, or a high starting cell volume—all in a single assay. Furthermore, it is most uniquely effective on formalin-fixed paraffin-embedded (FFPE) samples, enabling a host of new oncology applications.

"Capturing structural genomic information in previously inaccessible sample types and transforming it into actionable insights relevant to human health is an immensely powerful capability of our technology," said Ivan Liachko, Founder and CEO of Phase Genomics. "Accessing the vast amounts of clinical information that has been locked away in FFPE samples will be of great use to translational researchers in the oncology space."

FFPE samples currently make up >90% of samples from biopsies, or over 2 billion samples. The OncoTerra platform offers the unique capacity to unlock cytogenomic information stored in these samples, allowing researchers to collect more data than ever before, potentially leading to advancements in clinical care and diagnostics.

The platform is powered by Phase Genomics’ ultra-long-range sequencing technology that captures physical proximity data from DNA sequences in the genome. These data are then analyzed via proprietary machine learning tools to detect diverse chromosomal aberrations and rearrangements, including tumorigenic rearrangements, that cause and characterize diseases.

The Phase Genomics platform is for research use only and is not for use in diagnostic procedures. More information on the platform is available here.

View a webinar, hosted by Phase Genomics to learn more about this technology and follow Phase Genomics on Twitter for the latest news and information.

On January 5, 2022 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported that Stephen Squinto, Ph.D., chief executive officer and chair of the board, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 at 7:30 a.m. ET (Press release, Gennao Bio, JAN 5, 2022, View Source [SID1234598280]).

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On January 5, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that recent advances in its EpiCheck Next Generation Sequencing (NGS) platform and lung cancer detection program for early stage disease (Press release, Nucleix, JAN 5, 2022, View Source [SID1234598279]). The company also recently secured an additional $22 million in funding, as an extension to the previously announced $55 million financing, bringing the total capital raised in 2021 to $77 million, to rapidly advance the next generation of its highly sensitive lung cancer product and drive a multi-center prospective trial for clinical validation. Additionally, the company strengthened its leadership team with the appointment of Catherine Schnabel, Ph.D., as its chief scientific officer.

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"Nucleix has incredible momentum as we enter 2022. We have the core methylation technology, the capital and a robust clinical program to advance Lung EpiCheck for early lung cancer detection," said Chris Hibberd, chief executive officer of Nucleix. "EpiCheck is an ultra-sensitive technology for the detection of methylation changes and is compatible with both next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms. We are utilizing the NGS application of EpiCheck for deep discovery, to reveal new biomarkers for the early detection and monitoring of cancer. To demonstrate this capability, we conducted a side-by-side analysis which compared the EpiCheck NGS platform against conventional bisulfite approaches, using stage I lung cancer patients. While EpiCheck revealed many promising markers that are indicative of early-stage disease, the bisulfite approach only identified 1% of what EpiCheck detected. This result strengthens our belief that the EpiCheck technology sees biology that other approaches miss. We look forward to advancing research and product development in this area, both on our own and through collaborative efforts."

Nucleix’s Lung EpiCheck is a simple blood test that analyzes changes in multiple methylation markers to screen for lung cancer, with a focus on testing high-risk individuals based on smoking history. Currently there are very few options for early lung cancer detection and only 10% of the nearly 15 million high-risk smokers recommended to receive low-dose CT imaging adhere to current guidelines.1 Lung EpiCheck has been optimized to focus on sensitivity, so that patients have a better chance for early detection and successful treatment.

"Lung cancer remains a leading cause of death globally, due to its high incidence and late-stage diagnosis. Most patients are currently diagnosed with late-stage lung cancer, though research has shown that five-year survival rates are up to 10 times greater when lung cancer is detected early2," said Hibberd. "We are advancing Lung EpiCheck to detect minute cancer epigenetic signals with greater sensitivity. Detecting lung cancer earlier increases the chances of patients having long-term benefit."

Multi-Center Clinical Trial Initiated

In a peer-reviewed, published study, Nucleix’s Lung EpiCheck detected 85% of early-stage lung cancers among individuals at high risk for developing the disease based on their age and smoking history. Nucleix is now leveraging its deep discovery NGS platform to advance an improved version of the assay and recently launched a prospective, multi-center clinical study aiming to enroll approximately 5,000 patients.

Key Executive Appointed

Catherine Schnabel, Ph.D., joins Nucleix with more than 25 years of scientific experience and achievement in molecular and cellular biology. Previously the chief scientific officer of Biotheranostics Inc., Schnabel brings significant expertise developing and translating genomic technologies into commercial products that are new standards of care. At Nucleix, Schnabel will oversee R&D, product development and strategic research programs.

"With the company poised for tremendous success in the liquid biopsy field, I am thrilled to be joining the Nucleix team at such an incredibly exciting time, given its core strength in methylation and the potential to transform early lung cancer screening," said Schnabel.

New Financing Secured

Following the success of its $55 million financing announced in April 2021, Nucleix extended this financing in December 2021 by securing an additional $22 million in an investment led by Sands Capital. This brings the total capital raised in 2021 to $77 million.

"The Nucleix team has successfully executed on a number of fronts this year and demonstrated their ability to discover and translate new biology using the ultra-sensitive EpiCheck platform," said Parker Cassidy, Partner at Sands Capital. "We’re excited to partner with the team as they help transform cancer care."