On October 24, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported data that provide new insights into thyroid tumor behavior (Press release, Veracyte, OCT 24, 2022, View Source [SID1234622306]). The findings were derived from whole-transcriptome analyses of Veracyte’s extensive thyroid nodule database and were presented at the American Thyroid Association Annual Meeting, held October 19-23 in Montreal .

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In one study, Veracyte researchers reviewed over 300 pathology reports from the training sets used to develop the company’s market-leading Afirma Genomic Sequencing Classifier (GSC). Levels of tumor invasion and metastasis were scored and tested against over 400 literature-derived gene expression signatures to identify potential predictors of these tumor behaviors. They found that the top-performing signatures were able to stratify nodules as low-risk with a negative predictive value for no invasion or metastasis of 95% and 100%, respectively. Conversely, the highest-performing signatures had a positive predictive value of 57% for invasion and 41% for metastasis.

"We evaluated gene expression-based signatures with the potential to predict thyroid tumor invasion and metastasis. This information could potentially be used to help personalize surgery and therapy decisions for patients with thyroid cancer," said Joshua Klopper, M.D., Veracyte’s medical director, Endocrinology, who presented the poster. "Moreover, these findings underscore the potential to utilize our significant thyroid nodule database and whole-transcriptome capabilities to help unlock the next phase of innovation in thyroid cancer care."

Additional data presented at the ATA conference demonstrate the Afirma GSC’s ability to inform diagnosis and treatment decisions for patients with thyroid nodules. While thyroid stimulating hormone receptor (TSHR) mutations are mostly associated with benign thyroid nodules, researchers found that when the Afirma GSC identified a thyroid nodule with a TSHR mutation and a result that was "suspicious" for cancer, the risk of malignancy was significantly higher at 15.3%, compared to those classified by the Afirma GSC as benign where the extrapolated risk is <1.5%.

About the Afirma GSC

Veracyte estimates that each year in the United States approximately 565,000 people with thyroid nodules undergo fine-needle aspiration (FNA) biopsies to assess potentially cancerous nodules. Up to 30 percent of these patients receive indeterminate results – meaning their nodules are not clearly benign or malignant based on traditional cytopathology evaluation. Historically, most of these patients were directed to surgery to remove all or part of their thyroid, with 70% to 80% of these nodules proving to be benign. The Afirma Genomic Sequencing Classifier helps physicians identify patients with benign thyroid nodules among those with indeterminate FNA results, so that they may avoid unnecessary thyroid surgery. The test was developed with RNA whole-transcriptome sequencing and machine learning technology to provide physicians with clinically actionable results from the same FNA biopsy used for initial cytopathology. As part of the Afirma offering, the Xpression Atlas provides genomic alteration content from the same FNA samples used in Afirma GSC testing to help physicians decide, with greater confidence, on the surgical or therapeutic approach for their patients.

On October 24, 2022 Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, reported that the first patient has been successfully dosed with STP938, in a Phase 1/2 trial in adult subjects with relapsed/refractory B cell and T cell lymphomas (Press release, Step Pharma, OCT 24, 2022, View Source [SID1234622305]).

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The dose-escalation part of the open label, non-randomised Phase 1/2 trial comprises multiple cohorts dosed with STP938, administered as an oral monotherapy, ascending in a stepwise manner. The primary objective in Phase I is to assess the safety and tolerability of STP938.

Brian Schwartz, Chief Medical Officer of Step Pharma, commented:

"We are developing STP938, a highly selective, first-in-class treatment based on ground-breaking genetics. The dosing of the first patient into our Phase 1/2 trial is an important step to identify an optimal dose to take forward into further clinical development for relapsed/ refractory T cell and B cell lymphomas."

STP938 is a first-in-class oral cancer therapeutic that specifically inhibits nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, originally identified as an essential gene for lymphocyte proliferation. By targeting CTPS1, Step Pharma has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This ground-breaking approach should enable the highly selective treatment of both blood cancers and solid tumours.

On October 24, 2022 Scenic Biotech, a pioneer in the discovery of genetic modifiers developing therapeutics to treat severe diseases, reported the appointment of Jens Würthner, MD, PhD, as Chief Medical Officer (Press release, Scenic Biotech, OCT 24, 2022, View Source [SID1234622304]). Dr. Würthner brings Scenic Biotech 20 years of clinical development expertise. His track record includes the successful progression of drug candidates from Phase I initiation to regulatory submission, most recently during his tenure as Vice President, Head of Global Clinical Development at ADC Therapeutics. Dr. Würthner has also led clinical development programs at large pharmaceutical companies, namely Novartis, GlaxoSmithKline and AstraZeneca. As a member of the Scenic Biotech leadership team, he will be responsible for the clinical evaluation of the Company’s lead candidate targeting QPCTL, the druggable modifier of the CD47 innate immune checkpoint, as well as Scenic Biotech’s pipeline of genetic modifier-based small-molecule candidates to treat severe metabolic diseases.

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"Jens joins us at a pivotal time as we transition toward becoming a clinical development-stage company with a growing pipeline of proprietary and partnered programs," said Oscar Izeboud, CEO of Scenic Biotech. "His deep understanding of clinical strategy, trial execution and regulatory affairs as well as therapeutic expertise in oncology and rare diseases gained at leading international biopharmaceutical companies makes him an outstanding addition to our team."

"Scenic Biotech has established a robust technology platform to identify genetic modifiers and translate those discoveries into small molecule drug candidates to treat a range of severe diseases. I am excited to work alongside Oscar and everyone at Scenic Biotech as we advance a broad portfolio of disease-modifying therapeutics for the benefit of patients," added Dr. Jens Würthner, Chief Medical Officer of Scenic Biotech.

Dr. Würthner’s career spans the biotechnology and pharmaceutical industries as well as research institutes and academic hospitals. Prior to his role at Scenic Biotech, Dr. Würthner served as the Vice President, Head of Global Clinical Development at ADC Therapeutics, where he oversaw all aspects of clinical development including that of loncastuximab teserine (Zynlonta) among other successful development programs. Before that, he was Lead Clinical Program Leader at Novartis, where he was responsible for the advance of small molecule compounds and a monoclonal antibody through multiple clinical trials. Additionally, he held a seat on Novartis’ Integrated Safety Assessment Board, reviewing all therapeutic compounds moving into first-in-human studies. Prior to that, Dr. Würthner was Director and Indication Leader of Translational Pharmacology and Discovery Medicine at GlaxoSmithKline. He served as an Oncology Research Physician at AstraZeneca, where he was appointed Member of the Immunotoxicology Advisory Panel. Dr. Würthner has been a featured author on numerous publications and serves as visiting professor for Kings College, Faculty of Life Sciences & Medicine. He holds an MD and a PhD from the University of Hamburg and completed a postdoctoral fellowship at the Laboratory of Cell Regulation & Carcinogenesis, National Cancer Institute, National Institutes of Health in Bethesda, Maryland.

On October 24, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, OCT 24, 2022, View Source [SID1234622303]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

Since the announcement 17 October, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 22,705,511 B shares of DKK 0.20 as treasury shares, corresponding to 1.0% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 21 October 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 20,994,732 B shares at an average share price of DKK 770.14 per B share equal to a transaction value of DKK 16,168,800,539.

On October 24, 2022 GlaxoSmithKline ("GSK") reported that Lyell Immunopharma, Inc. ("Lyell" or the "Company") that, as part of a number of strategic actions it is taking, it is discontinuing its development of product candidates targeting NY-ESO-1, including the second‑generation product candidates incorporating Lyell’s genetic and epigenetic reprogramming technologies (LYL132 and LYL331), as well as other second-generation approaches GSK was exploring (Filing, 8-K, Lyell Immunopharma, OCT 24, 2022, View Source [SID1234622302]). On October 24, 2022, GSK provided notice of its decision to terminate the License and Collaboration Agreement between the Company and GlaxoSmithKline Intellectual Property (No. 5) Limited and Glaxo Group Limited, dated as of May 23, 2019, as amended (the "GSK Agreement"). The termination is effective on December 24, 2022.

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Lyell’s understanding is that the discontinuation of these programs is based on a strategic review of GSK’s pipeline and follows Lyell’s update in August 2022 that GSK had received data from the study of its first-generation lete-cel product candidate in non-small cell lung cancer ("NSCLC"), which does not incorporate any of Lyell’s reprogramming technologies.

The Investigational New Drug ("IND") application for LYL132 was cleared in January 2022 and the IND for LYL331 has not yet been submitted to the U.S. Food and Drug Administration. Given the early stage of these second-generation programs, the termination is not based on any clinical efficacy or safety data from these programs.
This termination of the GSK Agreement has minimal impact to Lyell operations as, with the exception of the manufacturing of LYL132, which incorporated Lyell’s proprietary Epi-R manufacturing protocol, the programs were being run by GSK. Due to the previously announced stop in enrollment, no patients have been treated with LYL132 and Lyell is discontinuing any further work on these programs. Glaxo Group Limited remains a significant stockholder of the Company.
This does not change the Company’s guidance that cash, cash equivalents and marketable securities balances are expected to be sufficient to meet working capital and capital expenditure needs into 2025.

Background on GSK Agreement
In 2019 Lyell and GSK entered into the GSK Agreement to research and develop potential T-cell therapies that applied Lyell’s technologies and cell therapy innovations to CAR or TCR targets. Lyell received $250 million in the form of a combined upfront payment and equity investment and would have been eligible for technology validation, development and sales milestones as well as single digit royalties on potential future products.
As disclosed in our Quarterly Report on Form 10-Q filed in August 2022, uncertainty regarding the further development of product candidates under our collaboration with GSK resulted from preliminary clinical data GSK received from a study of its first-generation lete-cel product candidate in NSCLC, which does not incorporate any of our reprogramming technologies.
The foregoing description of the GSK Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of (i) the GSK Agreement, which was filed as Exhibit 10.15 to the Company’s Amendment No. 1 to the Registration Statement on Form S-1 on June 9, 2021, and (ii) the Second Amendment to the Collaboration and License Agreement between the Company and GSK, dated December 16, 2021, which was filed as Exhibit 10.16 to the Company’s Annual Report on Form 10-K on March 29, 2022, each of which is incorporated herein by reference.