On June 20, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that findings from a study interrogating the role of the IL-27 pathway in the development of hepatocellular carcinoma (HCC) have been published in the online edition of Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Surface Oncology, JUN 20, 2022, View Source [SID1234616101]). The study was conducted by Cedars-Sinai Medical Center and Fox Chase Cancer Center in collaboration with Surface.

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Researchers found that IL-27 receptor signaling promoted HCC development in mice, and that IL-27 served as an immunological checkpoint that regulates natural killer (NK) cell and innate immune cell activation. The study also demonstrated that pharmacological neutralization of IL-27 using an antibody developed by Surface led to increased NK and innate immune cell activation and reduced HCC development. The study incorporated observations on the effect of IL-27 on several models of HCC development, including a model of non-alcoholic steatohepatitis (NASH), a known risk factor for the development of liver cancer, which is increasing in prevalence.

"The findings published in Cancer Discovery, combined with previously reported translational and early clinical data, support our hypothesis that IL-27 blockade is a promising immunotherapy for patients with cancer," said Vito Palombella, Ph.D., chief scientific officer at Surface. "HCC is the most common form of liver cancer and characterized by a poor survival rate and limited treatment options. These data bolster our belief that SRF388, a first-in-class IL-27 neutralizing antibody, holds the potential to become an important treatment option for patients confronting this devastating disease."

Surface’s lead IL-27 antibody, SRF388, is currently being evaluated in multiple clinical studies, including a randomized Phase 2 trial designed to evaluate its efficacy and safety in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC. SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of HCC from the FDA.

On June 20, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that findings from a new meta-analysis provide real-world evidence that the Afirma Genomic Sequencing Classifier (GSC) can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules and that, when the test deems a nodule as suspicious, the patient’s risk of malignancy is consistent, and higher than that reported in the test’s original clinical validation (CV) study (Press release, Veracyte, JUN 20, 2022, View Source [SID1234616102]). The findings were presented for the first time at the ENDO 2022 Annual Conference (Poster LBSAT255).

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"The Afirma GSC’s clinical validation study provided high-quality evidence of our test’s ability to rule out malignancy in indeterminate thyroid nodules to help these patients avoid unnecessary surgery. Our new findings show that the real-world experience supports this data, further demonstrating that the likelihood of malignancy in Afirma GSC-suspicious nodules is even greater than what was reported in the validation study," said Joshua Klopper, M.D., Veracyte’s medical director for endocrinology and an author on the study.

In the new meta-analysis, researchers evaluated 13 independent studies and found that the Afirma GSC’s real-world ability to identify benign nodules with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97 percent vs. 91 percent and 99 percent vs. 96 percent, respectively). Additionally, the meta-analysis data show that the Afirma test’s real-world performance surpasses that shown in the CV study when predicting the risk of malignancy in nodules labeled suspicious (65 percent positive predictive value vs. 47 percent).

Veracyte estimates that each year approximately 565,000 people undergo fine-needle aspiration (FNA) biopsy evaluation for potentially cancerous thyroid nodules and that more than 110,000 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 diagnostic surgery, even though 70 percent to 80 percent of the time, the nodules proved to be benign. Current American Thyroid Association guidelines include molecular testing as a recommended option to achieve definitive diagnosis for nodules classified as indeterminate following FNA biopsy.

On June 20, 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, JUN 20, 2022, View Source [SID1234616121]). 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 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 13 June 2022, 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 14,731,381 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% 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 17 June 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 12,991,818 B shares at an average share price of DKK 757.73 per B share equal to a transaction value of DKK 9,844,234,990

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, and YouTube.

On June 19, 2022 Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") officially reported that an organoarsenic drug "DARVIAS Injection 135mg" (SP-02, hereinafter DARVIAS) has been approved for relapsed or refractory Peripheral T-Cell Lymphoma (hereinafter "PTCL") by the Ministry of Health, Labor and Welfare (MHLW). Solasia filed an NDA with the MHLW in Japan in June 2021 (Press release, Solasia, JUN 19, 2022, View Source [SID1234616087]). In October 2021, Nippon Kayaku Co., Ltd. (TSE: 4272, Headquarters: Tokyo, Japan, President: Atsuhiro Wakumoto) secured a license agreement with DARVIAS for marketing rights in Japan.

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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. DARVIAS is believed to exert an anticancer effect by inducing cell cycle arrest and apoptosis. This approval is based on the result of an Asian Multinational phase II study of SP-02 in patients with relapsed or refractory PTCL, Japan being the first country in the world where it was approved.

Mr. Yoshihiro Arai, President and CEO of Solasia, commented for this approval as follows:
Since its founding, we have been focusing on developing new treatment options that solve the quality of life of patients in the treatment of cancer that affects one in two Japanese people. The two products, episil Oral Solution and Sancuso, which have been successfully developed so far, are not for the treatment of cancer itself, but used as supportive care such as suppression of nausea / vomiting caused by chemotherapy and alleviation of pain associated with oral mucositis caused by chemotherapy and radiotherapy. DARVIAS is our first NDA approved anticancer drug. Nippon Kayaku is our commercial partner with strengths in the field of oncology. We are very pleased to have this opportunity to deliver DARVIAS to nationwide medical institutions providing new cancer treatment by utilizing Nippon Kayaku’s extensive experience in oncology and contribute to the treatment of patients suffering from PTCL.

About DARVIAS
DARVIAS, an organoarsenic drug, is a novel anticancer agent targeting mitochondria.
DARVIAS provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. In addition to the PTCL, it has been suggested that potential target indications be other hematologic cancers (lymphoma, leukemia), and solid tumors. Regarding future expansion of indications, Solasia will explore clinical development strategies in consultation with Nippon Kayaku. DARVIAS has been granted orphan drug designation in the US and EU.

On June 17, 2022 International digital therapeutics (DTx) innovator, Sidekick Health (www.sidekickhealth.com), reported an integrated digital therapeutics solution in conjunction with pharmaceutical company Eli Lilly and Company (www.lilly.com) for patients battling breast cancer (Press release, Eli Lilly, JUN 17, 2022, View Source [SID1234616078]).

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"We are extremely excited to be announcing our collaboration with Lilly," comments Dr. Tryggvi Thorgeirsson, CEO and Co-Founder of Sidekick. "Cancer is one of the leading causes of death worldwide and is sadly a disease that will likely affect everyone’s lives at some point, whether directly or indirectly. Breast cancer is one of its most prevalent forms. At Sidekick, it is our goal to empower patients to take real steps toward better managing their disease and alleviating the negative side effects of treatment. Cancer treatment often leaves patients physically and emotionally drained and, as a result, we are making it as easy and convenient as possible to access life-saving guidance by bringing healthcare into people’s homes."

The collaboration will mark the first phase of Sidekick and Lilly’s relationship. The integrated digital therapeutics offering will be initially rolled out in Germany where, according to the World Health Organization, there were 69,697 new cases of breast cancer in 2020, representing 24.5% of all cancers affecting females that year, and 11.1% of cancers affecting all sexes[1]. This further expansion of Sidekick’s portfolio to treat breast cancer will be tailored to support the needs of patients

within Lilly’s oncology treatment programs.

"Breast cancer takes a toll on an individual’s physical and mental health, making support of both extremely important during the treatment journey," said Rich Carter, Lilly’s Chief Digital Officer. "This collaboration combines Lilly’s expertise in digital health and medicine development with Sidekick’s deep knowledge in behavioral research and digital therapeutics to work towards better outcomes for people with breast cancer. This platform will allow us to extend the reach of our digital solutions and bring on-demand and in-the-home solutions to patients when and where they need them most."

Through Sidekick’s unique platform, patients will be given access to a tailored digital treatment plan that engages in health-improving tasks, which promote behavior modification and overcome barriers to change. Sidekick’s solution focuses on five main areas: physical activity, tailored diet, sleep, stress management, and medication adherence, the latter representing a significant obstacle to recovery in patients undergoing cancer treatment. Patients will also be given access to educational content that has been created in close collaboration with clinical experts and patient advocacy groups, helping to provide them with unique insights into living with cancer.

The launch of this digital solution for breast cancer patients in Germany, as well as patients on a branded Lilly medication, is being scheduled for July of this year. Next steps for collaboration are being considered, including other international markets.