Health insurer to cover Interpace Diagnostics cancer tests

Interpace Diagnostics (IDXG +9.7%) says its ThyGeNEXT and ThyraMIR tests for thyroid cancer are now covered by Independence Blue Cross, which covers nearly 2.5M members in Philadelphia and southern Pennsylvania.

IDXG says its testing is made available to its members by its strategic partner, LabCorp, Independence’s primary lab services provider, through LabCorp’s Dianon Pathology specialty laboratory.

IDXG’s tests for thyroid cancer are designed for patients whose initial thyroid nodules biopsy is indeterminate, without a conclusive indication of whether the nodule is malignant or benign.

https://seekingalpha.com/news/3472750-health-insurer-cover-interpace-diagnostics-cancer-tests

Aclaris ad makes misleading claims about Eskata: FDA

An Aclaris (ACRS -2.2%) advertisement for its Eskata hydrogen peroxide topical solution “makes false or misleading claims” about the product’s risks and efficacy, the Food and Drug Administration says.

The video “fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders… in the case of exposure to the eye and severe skin reactions including scarring,” the FDA says.

Eskata, which has been available for purchase by dermatologists in the U.S. for slightly more than a year, is the first and only FDA-approved topical treatment for raised seborrheic keratoses.

https://seekingalpha.com/news/3472801-aclaris-ad-makes-misleading-claims-eskata-fda-says

What’s Pushing Nano-Cap Biotech DiaMedica’s Shares Higher

Shares of the thinly traded nano-cap biotech DiaMedica Therapeutics Inc DMAC 28.01% wererallying strongly Thursday.

What Happened

DiaMedica announced positive interim results from a Phase 1b study of its DM199, which is being evaluated for moderate-to-severe chronic kidney disease, or CKD.

DM199 is a synthetic form of human serine protease KLK1, which plays a key role in the regulation of diverse psychologic processes such as blood flow, inflammation, fibrosis, oxidative stress and neurogenesis through an increase in the production of nitric oxide, prostacyclin and other anti-inflammatory mediators.

The interim results of the study, which had 28 evaluable patients, showed the drug was safe and well-tolerated, with no drug-related serious adverse events and a pharmacokinetic profile in CKD subjects similar to that of healthy volunteers.

Pharmacokinetics, safety and tolerability were the primary endpoints of the trial.

The study also showed a dose range that the company believes will restore normal KLK1 levels in CKD patients.

Encouraging early signals in estimated glomerular filtration rate, urinary albumin to creatinine ratio and other markers — a few of the key secondary endpoints along with nitric oxide and prostaglandin E2 — were also observed, DiaMedica said.

What’s Next

The favorable interim safety, tolerability and pharmacokinetic data, complemented by pharmacodynamic observations, support the advancement of DM199 to a Phase 2 clinical trial in patients with CKD, according to the biotech.

DiaMedica said it is looking to provide full results of the study in a peer-reviewed publication and/or poster presentation.

https://www.benzinga.com/general/biotech/19/06/13950250/whats-pushing-nano-cap-biotech-diamedicas-shares-higher

Sorrento Updates on Immunotherapies, ‘Off-The-Shelf’ Cell Therapy Manufacture

Sorrento Therapeutics, Inc. (NASDAQ: SRNE, ‘Sorrento’) announces today that its Chairman and CEO, Dr. Henry Ji will be discussing the progress made, including innovative higher potency Dimeric Antigen Receptor (‘DAR’) technology and allogeneic knock-out/knock-in (‘KOKI’) cell therapy manufacturing advances related to its CD38 immunotherapies at upcoming industry conferences, investor conferences and investor meetings.

The reference presentation in support of those update discussions has been uploaded to the Sorrento investor relations website and was filed today with the Securities and Exchange Commission (‘SEC’) on a Current Report on Form 8-K.

Key progress update areas that will be discussed include: Clinical Proof-of-concept Study for Anti-CD38 Autologous CAR-T Cell Therapy.

https://www.marketscreener.com/SORRENTO-THERAPEUTICS-INC-14708339/news/Sorrento-Therapeutics-Provides-Updates-on-CD38-Immunotherapies-and-Implementation-of-Disruptive-GM-28786667/

Glaxo offers concessions to address EU concerns over Pfizer deal

GlaxoSmithKline has offered concessions to address EU antitrust concerns over its planned joint venture with Pfizer’s consumer health business, the European Commission said on Thursday.

The EU competition enforcer will decide by July 10 whether to accept the proposal, demand more or open a full-scale investigation, according to a filing on its site.

GSK announced the deal in December last year, a move which will put it ahead of rivals Johnson & Johnson, Bayer and Sanofi.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GlaxoSmithKline-GSK-offers-concessions-to-address-EU-concerns-over-Pfizer-deal-28786189/

Denovo Biopharma Acquires Global Rights to Experimental Alzheimer’s Drug

With the multiple failures in targeting amyloid plaque in the treatment of Alzheimer’s disease, San Diego-based Denovo Biopharma is taking a different approach by targeting the Alpha2C adrenoceptor.

On Tuesdau, the company announced it licensed ORM-12741 from Finland-based Orion Corporation. The new asset, now known as DB105, is a highly potent and selective alpha-2c adrenoceptor (AR) antagonist. The asset will be assessed as a potential treatment for neuropsychiatric indications such as Alzheimer’s disease, schizophrenia, and depression, among others. Under terms of the deal with Orion, which were not disclosed, Denovo has gained global rights to develop, manufacture and commercialize DB105.

Denovo Chief Executive Officer Wen Luo said most companies that have gone after Alzheimer’s, such as Biogen and Eli Lilly, had programs aimed at beta amyloid or tau. DB105 offers a distinct mechanism of action by targeting the alpha-2c adrenoceptor, Luo said.

“Despite the failures of most Alzheimer’s drug development programs across the pharmaceutical industry, we believe our biomarker platform and targeted personalized medicine approaches may provide a breakthrough to address this serious unmet medical need,” Luo said in a statement.

When DB205 was under development by Orion, the drug had shown some promise in treating patients with Alzheimer’s. Results of a 2013 Phase II study showed that ORM-12741 demonstrated significant positive effects on episodic memory in patients with moderate Alzheimer’s disease. After three months, the patients who took ORM-12741 tested higher on the tests of memory compared to those who received the placebo pill, Orion announced at the time of the study.

In its announcement today, Denovo said more than 540 patients across 11 clinical studies have been dosed with ORM-12741. The drug has been found to be safe and well-tolerated, the company said. The information generated from those previous studies will provide a rich data set for Denovo to conduct its biomarker discovery, the company said.

In its announcement, Denovo did not outline its planned developmental steps for DB105 but noted that more licensing is likely to come to expand the company’s pipeline. Michael Haller, Denovo’s chief business officer, said the licensing of the new asset provides Denovo with four late-stage compounds in oncology and neurology. Haller said Denovo intends to expand its portfolio in these two therapeutic areas.

Haller said the company has pushed its lead asset DB102 (enzastaurin) into a Phase III trial as first-line therapy for the treatment of Diffuse large B-cell Lymphoma. That asset, which it acquired from Eli Lilly, is also Phase III-ready in a glioma study. DB102 has received orphan drug certification in the U.S. and Europe. A data readout for the Phase III DLBCL trial is expected in mid-2021, the company said.

In addition to DB102 and the newly licensed DB105, the company has two additional late-stage programs targeting CNS diseases. DB103 is in development for schizophrenia and DB104 is in development for depression.

https://www.biospace.com/article/denovo-biopharma-acquires-global-rights-to-experimental-alzheimer-s-drug/

Merck to Showcase Oncology Pipeline Amid Concerns on Keytruda Dependence

With two new approvals for its vaunted checkpoint inhibitor Keytruda and a rapidly expanding oncology pipeline following M&A deals, Merck & Co. plans to share outlines for the future of its cancer treatment at the first investor day held in five years.

While Merck’s Keytruda has racked up nearly 20 approvals from the U.S. Food and Drug Administration, there is some investor concern that the company is too dependent on the product for its future, The Wall Street Journal reported this morning. Keytruda, which has been approved as both a monotherapy and in combination with other drugs, has significantly contributed to explosive growth in Merck’s market capitalization to a record $217 billion, the Journal noted. Last year, Keytruda generated $7 billion in sales for Merck and is projected to become the world’s top-selling drug in 2024, the Journal said.

Success is bringing concern to Merck investors who don’t want to see the company become too dependent on Keytruda for growth, much like AbbVie and its top-selling drug Humira. Credit Suisse AG analyst Vamil Divan told the Journal that there is an emerging view among investors that Merck is too tied to Keytruda, particularly as projections indicate that cancer treatments will account for 40% of the company’s returns by 2024.

Merck, like many other companies, sees oncology as a promising growth market, and has invested in its own R&D efforts, as well as snapped up several companies with promising pipelines. Over the past 30 days, Merck has acquired two oncology-focused companies, Peloton Therapeutics and Tilos Therapeutics. The pipelines of both of these companies are expected to provide new revenue sources for the company. Merck has also partnered with a number of companies in oncology and some of those are paying off, particularly its partnership with AstraZeneca on the PARP inhibitor Lynparza. Following strong Phase III results in pancreatic cancer, the first time a PARP inhibitor demonstrated activity in germline BRCA-mutated metastatic pancreatic cancer, the two companies plan to seek regulatory approval.

During the investor day, the Journal noted that Merck will also focus its attention on other portions of its pipeline, including its vaccine and HIV programs. Earlier this month Merck won a new approval for Zerbaxa for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain bacteria. Analysts predict the drug could hit blockbuster status, the Journal said.

HIV is also an area of growth for Merck. Last year, the company won approval for two new HIV treatments, Delstrigo, a once-per-day triple combination treatment, and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor. Mike Robertson, an executive director at Merck and an infectious disease specialist, told BioSpace in an exclusive interview last week that the company also has other HIV treatments in development, including MK8591. If the anti-retroviral hits its clinical endpoints, Robertson predicted the drug will become a cornerstone of Merck’s HIV franchise. He said it has a unique mechanism of action and the company believes it could be a novel class of drug. Because it has a long half-life, Robertson said it remains in the body for some time and continues to work. That means that the drug would not need to be taken as often and provide some pill relief to HIV patients who take multiple pills daily.

“When you think about it, people will take these therapies for years and decades. Anything that reduces the pill burden they have to take… we think could make it more preferable for many patients,” he told BioSpace.

Merck will highlight these drugs, as well as many others, at the investor day Thursday, the Journal said.

https://www.biospace.com/article/merck-to-showcase-oncology-pipeline-and-other-drugs-at-investor-day/