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Entry Into A Material Definitive Agreement

On October 24, 2022 Yumanity Therapeutics, Inc., a Delaware corporation ("Yumanity"), reported that entered into an Asset Purchase Agreement (the "Asset Purchase Agreement") with Janssen Pharmaceutica NV ("Janssen") (Filing, 8-K, Yumanity Therapeutics, OCT 24, 2022, View Source [SID1234622307]). Concurrently with the execution of the Asset Purchase Agreement, on June 5, 2022, Yumanity entered into an Agreement and Plan of Merger with Kineta, Inc., a Washington corporation ("Kineta"), and Yacht Merger Sub, Inc., a Washington corporation and wholly-owned subsidiary of Yumanity (the "Merger Agreement" and the transactions contemplated thereby, the "Merger").

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Amendment to PIPE Securities Purchase Agreement

As previously reported in the Current Report on Form 8-K filed by Yumanity with the U.S. Securities and Exchange Commission (the "SEC") on June 6, 2022 (the "Original Report"), Yumanity previously entered into a securities purchase agreement (the "Securities Purchase Agreement"), dated June 5, 2022, with certain investors (the "PIPE Investors"), pursuant to which, and on the terms and subject to the conditions of which, the PIPE Investors agreed to purchase an aggregate of 14,354,067 shares (subject to proportional adjustment for any reverse stock split) of common stock of Yumanity, par value $0.001 per share ("Common Stock"), for $2.09 per share, for an aggregate purchase price of $30 million, in a private placement expected to close immediately following, and conditioned upon, the closing of the Merger (the "Private Placement").

On October 24, 2022, the PIPE Investors and Yumanity agreed to change the purchase price per share to $1.65 per share of Common Stock such that the PIPE Investors will purchase an aggregate of 18,181,818 shares of Common Stock in the Private Placement. October 24, 2022, Yumanity, Kineta and each of the PIPE Investors entered into an amendment to the Securities Purchase Agreement (the "Securities Purchase Agreement Amendment"), to (i) amend the per share purchase price and aggregate number of shares to be purchased, each as reflected therein, and (ii) provide for the issuance of an aggregate of 6,031,668 warrants to purchase shares of Kineta (the "Warrants"). The Warrants were issued by Kineta and will be treated in the same manner as all other outstanding warrants of Kineta at the effective time of the Merger, as described in the Registration Statement (as defined below), and will receive a portion of the consideration allocated to other Kineta securityholders under the terms of the Merger Agreement. For the avoidance of doubt, the Warrants are not issued by Yumanity. Any Warrants issued to a PIPE Investor will only be exercisable following the closing of the Private Placement and will expire in the event any PIPE Investor fails to consummate the Private Placement pursuant to the terms of the Securities Purchase Agreement, as amended by the Securities Purchase Agreement Amendment.

Amendment to Registration Rights Agreement

As previously reported in the Original Report, Yumanity previously entered into a Registration Rights Agreement (the "Registration Rights Agreement"), dated June 5, 2022, with the PIPE Investors concurrently with the execution of the Securities Purchase Agreement. Pursuant to the Registration Rights Agreement, Yumanity will prepare and file a resale registration statement with the SEC within 60 calendar days following the closing of the Private Placement covering the shares of Yumanity’s common stock issued in the Private Placement. Yumanity has also agreed, among other things, to indemnify the PIPE Investors and their respective directors, officers, stockholders, members, partners, employees and agents, and each person who controls such PIPE Investor, from certain liabilities and to pay certain expenses incurred by Yumanity in connection with the registration of the shares issued in the Private Placement.

On October 24, 2022, the PIPE Investors and Yumanity entered into an amendment to the Registration Rights Agreement (the "Registration Rights Agreement Amendment"). The Registration Rights Agreement Amendment amended the Schedule of Purchasers attached to the Registration Rights Agreement to reflect the number of shares purchased by each PIPE Investor pursuant to the Securities Purchase Agreement Amendment.

The foregoing descriptions of the Securities Purchase Agreement Amendment, the Warrants, the Registration Rights Agreement Amendment and the transactions contemplated thereby are not complete and are subject to, and qualified in their entirety by reference to, the text of the Securities Purchase Agreement Amendment, the Warrants and the Registration Rights Agreement Amendment, forms of which are included as Exhibit 10.1, Exhibit 10.2 and Exhibit 10.3, respectively, to this Current Report on Form 8-K (this "Current Report"), and incorporated herein by this reference.

Veracyte Data Presented at ATA Annual Meeting Provide New Insights into Molecular Underpinnings of Thyroid Cancer

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 .

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.

Step Pharma Announces First Patient Dosed with STP938, the World’s Most Advanced CTPS1 Inhibitor, in a Phase 1/2 Trial for T cell and B cell lymphomas

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]).

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.

Scenic Biotech Appoints Jens Wu?rthner as Chief Medical Officer

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.

"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.

Novo Nordisk A/S – Share repurchase programme

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.

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.