FDA Approves Beigene’s Brukinsa for Mantle Cell Lymphoma

The United States Food and Drug Administration (FDA) has granted approval to Brukinsa (Zanubrutinib). A blood cancer drug from Chinese company, BeiGene, giving access to Americans to a Chinese cancer therapy for the first time.

This is an important FDA approval since Mantle cell lymphoma (MCL) is a rare and very aggressive type of non-Hodgkin lymphoma mostly suffered by men over the age of sixty years. And it’s said that about three thousand to four thousand are diagnosed every year t in the United States. This explains why the Food and Drug Administration (FDA) has been working effortlessly to improve outcomes for patients battling with it worldwide and not just United States alone.

This new Bruton tyrosine kinase inhibitor known as Zanubrutinib is a small molecule that works by forming a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of Bruton tyrosine kinase activity. It is an important treatment option for people with refractory mantle cell lymphoma (MCL) who had received other therapies earlier.

The FDA relied largely on clinical trial data generated outside the US for the approval. According to the company, the treatment was tested on 118 patients, 10-15 per cent of whom were from the US. The approval was based on data from a single-arm, open-label, multicenter phase 2 trial that evaluated the safety and efficacy Brukinsa in 86 patients with MCL who had received at least one earlier treatment or therapy. From the analysis, it was noted that Brukinsa triggered an overall response rate of 84% with a median duration of response of 19.5 months. While on the other hand, a complete response was observed in 59% of affected persons and 24% of others achieved a partial response.

Although, Brukinsa is the first BeiGene-discovered drug to be approved by US FDA for her citizens, it is expected to be the first of many approvals for Brukinsa as researchers continue to evaluate its potentials in other hematologic cancers. Today, BeiGene becomes the first FDA green light and first BeiGene-discovered cancer drug in China. And with plans to launch Brukinsa soon, BeiGene will surely be competing with similar blood therapies like Johnson & Johnson and AbbVie’s Imbruvica, AstraZeneca’s Calquence, and Celgene’s Revlimid. It will be interesting to see who emerges top from the healthy rivalry. Beigene, has maintained that it expects to see another one of its cancer drugs very soon, and is equally running a confirmatory phase 3 trial for patients who are not fit for stem cell transplantation.

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AnaptysBio’s Eczema Drug Fails to Meet Phase II Endpoints

AnaptysBio, Inc. is a clinical-stage biotechnology company that is developing its first in class antibody products that are focused on the unmet medical needs in inflammation. It announced the top-line data from its ATLAS trial

This trial was a Phase 2b randomized, placebo-controlled, double-blinded, multi-dose study in approximately 300 adult patients treated with etokimab from moderate-to-severe atopic dermatitis. 

As a result of this trial, each one of the etokimab dosings failed to fulfil the primary endpoints of the trial that included the demonstration of a statistically great improvement in the Eczema Area and the Severity Index (EASI) relative placebo at week 16. 

The company will now be receiving more details and a plan so that they can provide an update later next year in the first quarter. 

As of now, they have decided to postpone the initiation phase of the Phase 2b etokimab’s clinical trial in eosinophilic asthma, until they get the opportunity to be able to analyze the complete data set from the ATLAS trial fully. 

The Company will, however, continue conducting its ECLIPSE trial which is a randomized, placebo-controlled Phase 2 trial on approximately 100 patients(adults) suffering from chronic rhinosinusitis with the top-line data from an interim analysis that is expected to be done in the first quarter of 2020.

President Hamza Suria’s comments about the trial:

Here’s what the President and the chief executive officer of AnaptysBio, Hamza Suria has to say about this trial;

“We are surprised and very disappointed by the top-line results of the ATLAS trial.” He also added; “We would like to thank all involved in the participation and support of the ATLAS study, including the patients, the investigators, their staff and our employees. We look forward to continuing our strategy of advancing our wholly-owned clinical and preclinical pipeline programs.” 

About AnaptysBio’s eczema drug:

The drug anti-IL-33 antibody used for the treatment of eczema initially cleared the mid-stage study in asthma last year but later failed to pass the phase 2b trial testing in eczema or atopic dermatitis.

It did a worse job at easing symptoms like skin itching or inflammation than even placebo even after 16 weeks of continuous treatment, and due to this, it’s stock tanked more than 70% in the pre-market trading.

According to ClinicalTrials.gov, the ATLAS study performed on the drugs took four doses of etokimab against placebo in 300 adult patients of eczema in their moderate to severe eczema, and all four of these doses missed the primary phase II endpoint.

The drug put up some proof data in peanut allergy but later as questions about the size of the study and about its authenticity were raised, the indication was removed from the company’s page.

This is all there is at this stage. However, more information is expected to come out next year, in the fall of 2020, as the company is expected to conduct further analysis on the complete data.

Google Mines Healthcare Data For Project ‘Nightingale’

Nobody can deny the fact that the healthcare industry is booming nowadays and has become a multi-billion industry. Due to this, it has been becoming the focus of many giants out there hoping to get an entry. 

Same stands for Google as well, as recently, the healthcare industry has been on their radar. What’s more interesting is that Google has launched a project recently called ‘Nightingale’ according to which they are getting provided with personal details of patients from over 2600 hospitals in around 21 states. Let’s dive in deep to explore the details. 

1. Why is Google Interested? 

As we mentioned earlier, it’s not just now that Google is getting pretty excited about entering the industry. Rather, its been quite a time since they have been making strategies about how to capture the healthcare industry and start getting their share out of it. 

So, Google is claiming to be helping Ascension centralize its database of patients and devise a brand new artificial intelligence system that will predict and help the diagnosis and other medical situations of patients. 

2. Why Does The World Care? 

Apparently, there has been a lot going around related to how Google is mining data of so many patients and how they intend to use and protect it. So, why do people care, and what is the problem with Google acquiring all this data? 

A representative of world privacy forum that the digital records are necessary however it is also as much important to know the intentions of the company with that private data and also if they are taking any measures for protecting it. 

Hence, the major concern here is how the tech giant is exactly planning to use such personal data related to that huge amount of people. 

Global network. Blockchain. 3D illustration. Neural networks and artificial intelligence. Abstract technological background with binary code elements

3. Is The Data Secure With Google? 

As we cannot know for sure if the claims of Google about their intentions with the data are true or not, we certainly have an idea about how they are housing the data and if its safe in their hands or not. 

Pam Dixon, quoted earlier as well, being a member of World Privacy Forum, said “The Department of Health and Human Services actually tracks all of the medical data breaches and actually some of the largest data breaches in history have been medical data breaches. So it is a significant concern.” So, breaches and leaks of data are too of a concern to ignore. 

However, according to a press release of Google and Ascension, they were quoted to be pretty “robust data security and protection effort”. Moreover, they claimed to be fully compliant with the HIPAA, the Health Insurance Portability and Accountability Act of 1996 that protects patient privacy. 

However, Dixon still felt that there is more that needs to be done by saying “But I do think that there is room for having an independent, third party taking a look at what’s happening at that health information that’s at Google,” 

4. Wrap Up 

Among the tech giants out there, there are other contenders as well looking to make their entry into the healthcare industry such as Apple & Amazon. However, Google has taken the lead with this project is the biggest advancement so far.

What are your thoughts on Google entering the healthcare industry?

Celgene’s Car-T Data Beats its Competitors

Have you heard of CAR T? If you’re new to biotechnology, you may be wondering what I’m talking about. Don’t worry, after reading. You’ll be an expert about this technology, disrupting the way we look at healthcare and treat patients. CAR T is short for Chimeric Antigen Receptor T cells, cells removed from a patient, engineered, and administered back to target their cancer or disease.

This technology is starting to get traction, where many biotech companies are engineering these T cells to target specific cancers and solid tumors. Car T are usually engineered to be armed receptors targeting CD22 or CD19 before they become cancer-killing machines.

Where do we see the industry heading?

Well, if you look at drug approvals to date, we see Gilead’s Yescarta and Novartis’s Kymriah treating patients who have non-Hodgkin lymphoma.

Soon Celgene’s lisocabtagene maraleucel (liso-cel), an anti CD19 drug, may take over the lymphoma market with the data submitted to ASH Annual Meeting. The data provided shows that in 255 patients, they had a complete response rate of 53% and an overall response rate in 73% in patients. They are beating the response rate of Gilead by 20 percentage points on Kymriah and two percentage points on Yescarta, outcompeting its competitors in the field.

Toxicity also showed better data than its competitors. There were only four patients that faced adverse effects (died) from this clinical trial.

Analyst predicts the drug to be approved by the FDA in 2020; a no brainer when your drug is beating other CAR- Ts that are marketed to patients. A positive outlook for Celgene that sees approval for their drug, but they still face some challenges. The biggest problem is manufacturing CAR T cells fast. It takes an average of 24 days to engineer and manufacture a T cell for patients. Those 24 days may be the difference between life or death.

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New Ebook on Amazon, Learn How to Break Into the Biotech Industry

Ever wonder how to break into the biotech industry? We are happy to give out a free booklet that details how to break into an industry that is making an impact in the lives of many Americans. As our industry moves from treating symptoms to now curing patients suffering from diseases like Muscular Atrophy. We see our industry serving patients in finding better treatments and hopefully cures.

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