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.

On October 24, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its third quarter financial results on Thursday, November 3, 2022 (Press release, Iovance Biotherapeutics, OCT 24, 2022, View Source [SID1234622301]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

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To participate in the conference call, please register at https://register.vevent.com/register/BI4721983fb77a4615b46f4ab97c051712. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will be available for one year.

On October 24, 2022 Invivoscribe reported that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s investigational drug quizartinib (Press release, Invivoscribe Technologies, OCT 24, 2022, View Source [SID1234622299]). The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the FLT3-ITD mutation.

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The filing supports Daiichi Sankyo’s new drug application (NDA) for quizartinib for the proposed treatment of adult patients with newly diagnosed FLT3-ITD positive AML, which was granted Priority Review by the FDA. Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select relapsed and refractory AML patients eligible for quizartinib in Japan.

"Invivoscribe’s filing with the FDA for the use of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for quizartinib is an important milestone. This submission to the FDA further solidifies the LeukoStrat CDx FLT3 Mutation Assay as the international benchmark for FLT3 mutation assessments. We are delighted that our Streamlined CDx program continues to expand and expedite the global approval of critical oncology treatments." said Dr. Jeffrey Miller, Invivoscribe’s CSO and CEO.

Mutations in the FLT3 gene are among the most important driver mutations in AML, with approximately one-third of all newly diagnosed adult cases containing FLT3 mutations. The FLT3 internal tandem duplication (ITD) mutation occurs in about 25%, and the tyrosine kinase domain (TKD) mutation occurs in approximately 5% of all newly diagnosed patients with AML.1

Invivoscribe’s companion diagnostic is an in vitro PCR test which detects both ITD mutations and TKD mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML. This test, which is available worldwide, includes software that interprets data, generates standardized mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to multiple tyrosine kinase inhibitors.

LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, the United States, Europe and China. The LeukoStrat CDx FLT3 Mutation Assay is also available in Japan, Germany and the United States as a service through Invivoscribe’s wholly-owned LabPMM subsidiaries. Greater than 95% of patient samples tested using the FDA-approved LeukoStrat CDx FLT3 Mutation Assay and a selection of other CLIA-validated PCR-based capillary assays report out results within 48 hours of sample receipt at any of the LabPMM laboratories.