On February 28, 2023 Nested Therapeutics, a biotechnology company pioneering a next-generation precision medicine platform to address hard-to-treat cancers, reported the nomination of the company’s first drug development candidate from its NEST-1 program, NST-628, a mechanistically novel non-degrading molecular glue that targets multiple nodes in the RAS/MAPK pathway (Press release, Nested Therapeutics, FEB 28, 2023, View Source [SID1234627936]).

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"This milestone was achieved in less than two years since inception of the company and represents an important step for Nested as it further validates our novel approach and the potential to unlock other cancer targets that are notoriously hard to drug," said Darrin Miles, Chief Executive Officer of Nested Therapeutics. "By targeting the RAS pathway via the differentiated mechanism of a pan-RAF/MEK and KSR/MEK molecular glue compound, along with a balanced metabolic profile that includes complete brain penetration, we can potentially address the unmet needs of a large patient group, including those who do not have precision medicine options today."

NST-628 is being developed with proprietary structural insights of how signaling complexes form and function in cancer and addresses common pitfalls of other MAPK-targeted compounds, which remain unable to circumvent the risk of intrinsic resistance via signaling pathway reactivation. In addition, NST-628 effectively crosses the blood-brain barrier, suggesting potential advantage for treatment of brain metastases and primary CNS malignancies with MAPK pathway alterations. Preclinical data evaluating several oncology biomarkers relevant to RAS/MAPK-driven models collectively demonstrate superior anti-tumor activity, including in central nervous system-implanted tumor models, and tolerability of NST-628 compared to other MAPK-targeted compounds administered as either single agents or combinations.

"By expanding to a 3-D view of mutations, we have the ability to look beyond active sites as targets, which allows us to locate unexplored driver mutations and druggable pockets across a protein’s surface," said Klaus Hoeflich, Ph.D., Co-Founder and Chief Scientific Officer at Nested Therapeutics. "Leveraging such structural insights allow us to gain a deeper understanding of the underlying molecular interactions that cause cancer progression and identify the right druggable pockets and novel targeting strategies."

Nested Therapeutics plans to submit an IND for NST-628 following completion of ongoing preclinical and IND-enabling studies, to support first-in-human studies to start in 2024. The company’s pipeline also includes NEST-2, an allosteric molecule targeting a transcriptional regulator frequently mutated in cancer. Selective target binding to novel cryptic pockets has been demonstrated and lead chemical series are advancing to in vivo proof-of-concept. For its NEST-2 program, Nested Therapeutics anticipates nominating its second development candidate in 2024.

About DeCRYPTion Platform

Nested Therapeutics’ DeCRYPTion Platform is a purpose-built, insightful drug discovery platform that enables Nested to identify new, overlooked areas of opportunity in the form of high value targets and design therapeutics for a perfect fit. The platform includes three critical components: (1) mapping mutational clusters onto the structural proteome, (2) identifying druggable pockets and cancer-driving mechanisms, and (3) designing novel drugs optimized for the druggable pocket.

On February 28, 2023 JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported the initiation of clinical study of JWATM214 in patients with advanced hepatocellular carcinoma (HCC) and the first patient infusion (Press release, JW Therapeutics, FEB 28, 2023, View Source [SID1234627935]).

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Primary hepatic cancer is a common malignant tumor of the digestive system worldwide, with high malignancy and hepatic prognosis. As the most common pathological type, HCC accounts for 85% to 90% of primary liver cancer. China has the highest incidence rate and mortality rate of primary hepatic cancer in the world, with 466,000 new cases and 422,000 deaths each year. The median progression-free survival of patients after first- and second-line current treatment is approximately 6 months, providing limited benefits for patients. Therefore, there is an urgent need to develop an effective treatment for patients with recurrent and metastatic advanced HCC.

This first-in-human study of JWATM214 aims to evaluate the safety and tolerability, determine the recommended phase 2 dose (RP2D), and evaluate the pharmacokinetic profile and preliminary efficacy of JWATM214 in adult patients with GPC-3-expressing advanced HCC.

As overexpressed in many malignant tumors including HCC, glypican-3 (GPC-3) has become a target for the diagnosis and treatment of HCC. The feasibility of T-cell immunotherapy targeting GPC-3 for the treatment of HCC patients has been preliminarily demonstrated and reported. JWATM214 is an autologous T-cell immunotherapy candidate drug targeting GPC-3, independently developed by JW Therapeutics based on the ARTEMIS platform of Eureka and Lyell’s T cell anti-exhaustion technology. It combines the high affinity and specificity of GPC-3 monoclonal antibody, and added cJun protein regulation based on JWATM204 to delay T cell exhaustion, to achieve more durable and superior anti-tumor activity, potentially providing novel treatment for GPC-3-expressing advanced HCC patients.

JW Therapeutics reached agreements with Eureka and Lyell in 2020, and in-licensed the rights of Eureka’s ARTEMIS technology and Lyell’s T cell anti-exhaustion technology to develop, manufacture and commercialize products in China (including mainland China, Hong Kong, Macao and Taiwan) and the member countries of the Association of Southeast Asian Nations.

References

Di-Yang Xie, Zheng-Gang Ren, Jian Zhou, Jia Fan, and Qiang Gao. 2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights. Hepatobiliary Surg Nutr. 2020 Aug; 9(4): 452–463.

Shi, D., Shi, Y., Kaseb, A.O., Qi, X., Zhang, Y., Chi, J., Lu, Q., Gao, H., Jiang, H., Wang, H., et al. (2020). Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase I Trials. Clin Cancer Res 26, 3979-3989. 10.1158/1078-0432.CCR-19-3259.

About JWATM214

JWATM214 is an autologous T-cell immunotherapy candidate drug targeting GPC-3, independently developed by JW Therapeutics based on the ARTEMIS platform of Eureka and Lyell’s T cell anti-exhaustion technology. It combines the high affinity and specificity of GPC-3 monoclonal antibody, and added cJun protein regulation based on JWATM204 to delay T cell exhaustion, to achieve more durable and superior anti-tumor activity, potentially providing novel treatment for GPC-3-expressing advanced HCC patients.

on February 28, 2023 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company in the healthcare space, reported that Synergy Oncology, part of Synergy Laboratories, a full-service diagnostic laboratory based in Mobile, Alabama, will use SOPHiA DDM to develop a new cancer profiling solution (Press release, Sophia Genetics, FEB 28, 2023, View Source [SID1234627934]). The combination of technology from Synergy Oncology and SOPHiA GENETICS will expand Synergy’s oncology portfolio while helping to further the U.S. oncology market.

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Synergy Oncology, which specializes in the use of innovative platforms to improve patient care, will pair SOPHiA DDM for Hereditary Cancers Solution with their state-of-the-art laboratory technologies to launch Totality, a comprehensive end-to-end solution for tumor profiling that will benefit cancer research, clinical studies, and patient care.

"Our mission at SOPHiA GENETICS is to democratize data-driven medicine by increasing accessibility to synthesized, digestible data in this space," said Ken Freedman, Chief Revenue Officer, SOPHiA GENETICS. "Synergy is known to be a best-in-class facility and their use of the SOPHiA DDM is an important step in creating cancer profiling solutions that will progress research and treatments of hereditary cancers for the medical community."

"Our decision to collaborate with SOPHiA GENETICS was simple," said Joseph Cohil, Head of Synergy Oncology. "Our collaboration with SOPHiA GENETICS will accelerate Synergy’s leading hereditary cancer technology to the forefront of patient outcomes."

The use of next generation sequencing (NGS) is prevalent in the detection of biomarkers for hereditary cancers but comes with a vast and complex dataset for analysis. The SOPHiA DDM for Hereditary Cancers Solution uses Artificial Intelligence and machine learning with patented technologies to analyze raw NGS data, streamlining it for simplified interpretation, and expedited reporting. The SOPHiA DDM platform can serve as a one-stop solution for Synergy Laboratories as it looks to scale into other oncology offerings.

Synergy’s new Totality product analyzes genes from solid tumor tissue, and through the use of SOPHiA DDM for Hereditary Cancers, it provides physicians with a compact report that matches detected molecular alterations with FDA approved therapies and clinical trials. The pairing of SOPHiA DDM for Hereditary Cancers with Synergy Oncology’s technology is designed to give experts the ability to analyze and interpret findings from NGS data with confidence, turning high-quality data into valuable insights for researchers and care providers. Synergy Oncology offers the most comprehensive NGS kit of its kind, including liquid biopsy testing, hereditary testing, and myeloid malignancies.

On February 28, 2023 Median Technologies (ALMDT:PA) reported new and breakthrough results for its iBiopsy Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx1 Software as Medical Device (SaMD) to characterize malignant lung nodules in low dose CT scans (LDCT) (Press release, MEDIAN Technologies, FEB 28, 2023, View Source [SID1234627933]).

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New results released today demonstrate considerable increase of Median’s proprietary algorithms performance with a sensitivity2 of 96.5% for a specificity3 of 97.2% on end-to-end lung nodule detection and malignancy characterization. These results complement the results released previously (March 22, 2022), which were based on a cohort of 1,760 patients and showed a 94.7% sensitivity at a 93.3% specificity. New results are calculated on a much larger cohort of 9,863 patients corresponding to 195,943 nodules (vs. 16,789 lung nodules in March 2022). Consistent with previously released results, the performance corresponds to end-to-end detection and characterization at nodule level.

"On February 27, 2023 we announced the completion of the Q-Submission phase with the FDA regarding clinical protocols pre-submission, a major milestone in the roadmap of our iBiopsy LCS CADe/CADx SaMD. Our pivotal study protocols are now finalized and ready for study execution. Today, with the release of our improved performance results, we are more than ever confident for the next steps which will drive our iBiopsy LCS CADe/CADx SaMD to the FDA clearance. Our next milestone is now the execution of the pivotal studies, based on imaging and clinical data we started to collect at the end of 2022 from very prestigious clinical sites and cancer centers in the US and Europe", highlights Fredrik Brag, CEO and founder of Median. "Subsequent to this breakthrough performance, we recently filed two patents", Brag added.

Results will be presented at the European Congress of Radiology (ECR) AIX Theater, on Wednesday, 1 March, at 4:00 pm CET and on Thursday, 2 March at 1:30 pm CET. Median’s team will be available at booth #AI-35 for the duration of the technical exhibition (March 1-4).

The European Congress of Radiology (ECR) organized by the European Society of Radiology (ESR) is the premier European event in radiology and the second largest in the world. The congress conveys more than 20,000 with a split of more than 10,000 professional delegates (radiologists, technologists etc.), and ~8,000 industry participants (imaging modalities, PACS etc.). Radiology professionals from Europe and beyond attend to gather knowledge through educational courses, to see the latest innovations presented by technical exhibitors, and to discover groundbreaking research from scientific paper presentations. More about the ECR: View Source

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of AI/ML tech-based Software as Medical Devices (SaMD), to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Disease (NAFLD/NASH)

Forward-looking statements: This press release contains express or implied information and statements that may be considered forward-looking information and statements about Median Technologies. They are not historical facts. Such information and statements include financial projections that are based on certain assumptions and assessments made by Median Technologies’ management in light of its experience and perception of historical trends, current economic and industry conditions, expected future developments and other factors it deems relevant. These forward-looking statements include statements that generally use conditional verbs and contain words such as "expects", "anticipates", "believes", "intends", "plans" or "estimates" and variations and conjugations thereof and words of similar import. Although Median Technologies’ management believes that the forward-looking statements and information are reasonable, Median Technologies’ shareholders and other investors are cautioned that the realization of these expectations is inherently subject to various known and unknown risks and uncertainties that are difficult to predict and generally beyond the control of Median Technologies. These risks could cause actual results and developments to differ materially from those expressed, implied or projected in the forward-looking statements. This press release contains only summary information and should be read in conjunction with the public information filed by Median Technologies with the AMF and that are available on Median Technologies’ website. Other than as required by applicable law, Median Technologies is issuing this press release as of the date hereof and does not undertake to update or revise any forward-looking information or statements.

On February 28, 2023 Xencor, Inc. (the "Company") reported that it has entered into a Sales Agreement (the "Sales Agreement") with SVB Securities LLC (the "Sales Agent"), pursuant to which the Company may issue and sell through the Sales Agent up to $200 million of shares of common stock, $0.01 par value per share, of the Company (the "Common Stock"), subject to the limitations set forth in Section 5(c) (the "Placement Shares") of the Sales Agreement (Filing, 8-K, Xencor, FEB 28, 2023, View Source [SID1234627931]).

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The Common Stock sold in the offering will be issued pursuant to a sales agreement prospectus filed with the Securities and Exchange Commission (the "SEC") on February 27, 2023 and the accompanying base prospectus dated February 27, 2023 forming part of the Company’s shelf registration statement on Form S-3ASR (Registration No. 333-270030) filed with the SEC on February 27, 2023.

Subject to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal laws, rules, and regulations and the rules of the Nasdaq Global Market ("Nasdaq"), to such sell Placement Shares up to the number or amount specified in and otherwise in accordance with the terms of the Sales Agreement.

The Company is not obligated to make any sales of Placement Shares under the Sales Agreement. The Company or the Sales Agent may, upon notice to the other party in writing, suspend any sale of Placement Shares, subject to the limitations set forth in the Sales Agreement. The offering of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of the Common Stock under the Sales Agreement having an aggregate gross sales price equal to $200 million and (ii) the termination of the Sales Agreement by the Company and the Sales Agent as permitted therein.

The Company made certain customary representations, warranties and covenants concerning the Company and the registration statement in the Sales Agreement and also agreed to indemnify the Sales Agent against certain liabilities, including liabilities under the Securities Act.

The Company intends to use the net proceeds from any sales of the Common Stock to or through the Sales Agent for general corporate purposes, which may include research and development, capital expenditures, working capital, and general administrative expenses. The Company may also use a portion of the net proceeds to acquire or invest in businesses, products and technologies that are complementary to its own, although it has no current plans, commitments or agreements to do so.

The compensation to the Sales Agent will be an amount not to exceed 3.0% of the gross proceeds of any shares sold under the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Sales Agreement, copy of which is attached hereto as Exhibit 10.1 and the terms of which are incorporated herein by reference.