CYCC In STOPCOVID, EXEL Hits New High, NVS Trialing Malaria Drug For COVID-19

pharma sept27 21apr20

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

Read on…

Bristol-Myers Squibb (BMY) has announced positive results from its CheckMate -743 study.

The CheckMate -743 study is a pivotal phase III trial evaluating Opdivo in combination with Yervoy in previously untreated malignant pleural mesothelioma (MPM).
Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy (pemetrexed and cisplatin or carboplatin), the Company noted.

Opdivo and Yervoy, both from the stable of Bristol-Myers Squibb, generated global annual sales of $7.2 billion and $1.49 billion, respectively, in 2019.

BMY closed Monday's trading at $61.68, up 1.78%.

Cyclacel Pharmaceuticals Inc. (CYCC) has entered into an agreement with the University of Edinburgh to study its clinical-stage drug candidates Fadraciclib (CYC065) and Seliciclib as potential early treatments for the inflammatory response observed in COVID-19 patients. This agreement is part of the University of Edinburgh's project known as STOPCOVID, which aims to test existing and experimental drugs to find a treatment for COVID-19.

Professor Kev Dhaliwal, STOPCOVID lead and Consultant in Respiratory Medicine at The University of Edinburgh, said, "We are eager to evaluate the potential role of Cyclacel's CDK inhibitors as enablers of inflammatory neutrophil apoptosis."

Previously published research from The University of Edinburgh and other investigators have found that CDK inhibitors, including Seliciclib, help resolve undesirable inflammation by promoting apoptosis of inflammatory neutrophils. CDK inhibitors were shown to reduce levels of the anti-apoptotic protein Mcl-1 and inhibit transcription of interleukin-6 (IL-6), both of which are believed to be drivers of the overactive systemic inflammatory response severely damaging the lungs of symptomatic COVID-19 patients, the Company noted.

CYCC closed Monday's trading at $8.64, up 34.79%.

Shares of Exelixis Inc. (EXEL) touched a new 52-week high of $54.90 in intraday trading on Monday, following positive results from CheckMate -9ER study.

The CheckMate -9ER study is a pivotal phase III trial evaluating Bristol Myers' Opdivo in combination with Exelixis' CABOMETYX against Pfizer's Sunitinib in previously untreated advanced or metastatic renal cell carcinoma.

The trial met its primary endpoint of progression-free survival (PFS) at the final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).

If approved, the combination of Opdivo and CABOMETYX may become an important new first-line option for patients with metastatic renal cell carcinoma, noted Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.

CABOMETYX, as monotherapy, is approved for the treatment of patients with advanced renal cell carcinoma (RCC), and patients with hepatocellular carcinoma (HCC) who have been previously treated with Bayer's Nexavar.

The annual revenue generated by CABOMETYX was $733 million in 2019 compared to $599.9 million in 2018.

EXEL closed Monday's trading at $23.58, up 21.27%.

Esperion (ESPR) has entered into a collaboration agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of NEXLETOL and NEXLIZET tablets in Japan.

NEXLETOL and NEXLIZET, indicated to reduce LDL cholesterol, were approved in both the US and EU recently.

Under the terms of the agreement, Esperion will grant Otsuka exclusive rights to NEXLETOL and NEXLIZET tablet development and commercialization in Japan. Otsuka will be responsible for all development, regulatory, and commercialization activities in Japan. In addition, Otsuka will fund all Japan-specific development costs associated with the program. Esperion estimates this amount to total up to $100 million over the next few years.

In return, Esperion will receive an upfront cash payment of $60 million as well as up to an additional $450 million in total development and sales milestones. Esperion will also receive tiered royalties from 15 percent to 30 percent on net sales in Japan.

ESPR closed Monday's trading at $40.19, up 7.14%.

Novartis (NVS) is all set to proceed with a phase III clinical trial with approximately 440 patients to evaluate the use of malaria drug Hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease.

The trial will be conducted at more than a dozen sites in the United States, and will be comprised of three groups. The first group will receive Hydroxychloroquine, the second group will receive hydroxychloroquine in combination with Azithromycin, an antibiotic therapy, and the third group will receive placebo.

Novartis plans to begin enrollment for this study within the next few weeks and report results as soon as possible.

NVS closed Monday's trading at $89.78, up 0.55%.

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