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BerGenBio Presents Updated Clinical Data From Two Phase II Studies Of Bemcentinib in AML and MDS Patients At Ash 2020

BERGEN, Norway, Dec. 6, 2020 /PRNewswire/ — BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AX……

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BERGEN, Norway, Dec. 6, 2020 /PRNewswire/ — BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, will present updated clinical data from two Phase II studies of bemcentinib in acute myeloid leukemia and high-risk myelodysplastic syndrome, in two poster sessions at the American Society of Hematology (ASH) Annual Meeting being held virtually from 5-8 December 2020.

Dr Sonja Loges will provide an update from the Company’s Phase II study of bemcentinib (BGBC003) in combination with low dose cytarabine (LDAC) in elderly previously treated, relapsed and refractory AML patients.

The data indicates that treatment with the bemcentinib-LDAC combination shows promising efficacy in relapsed patients who are unfit for intensive chemotherapy. Of 11 evaluable relapsed patients a response rate of 45% to date has observed. CR/CRi rate was 36% with durable responses observed, and clinical benefit observed in eight patients (73%) to date. Although the study is ongoing, patients remain on drug, with median treatment of 6.2 months in CR patients.

The Company is currently undertaking an in-depth translational research program aiming to identify predictive molecular and biological factors associated with response.

Dr Sonja Loges, Principal Investigator on the trial commented “The current prognosis for relapsed AML patients is very bleak, so we are pleased to see such a positive clinical benefit rate in relapsed second line patients with many patients remaining on drug for extended durations. We are currently undertaking an analysis to identify the suspected immune based factors that potentiate the effects of the drug in certain patients. We hope that this will enable us to identify specific biomarkers that will help us decide which patients may benefit most from treatment with bemcentinib.”

Details of this Poster presentation as follows:

Title: The Combination of AXL Inhibitor Bemcentinib and Low Dose Cytarabine Is Well Tolerated and Efficacious in Elderly Relapsed AML Patients: Update from the Ongoing BGBC003 Phase II Trial (NCT02488408)

Date: Sunday, December 6, 2020

Session name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II

Time: 7.00am – 3.30pm (Pacific Time) / 4.00pm – 12.30am (CET)

Abstract: https://ash.confex.com/ash/2020/webprogram/Paper136566.html

An update will also be presented from the fully recruited investigator sponsored BERGAMO Phase II Trial investigating bemcentinib monotherapy in patients having relapsed treatment with hypomethelating agents (HMAs) with High Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML).

The primary endpoint of overall response rate (ORR) was met, with the MDS cohort achieving a 36% response rate, while 8.3% of patients with AML achieved stable disease. Three patients remain on drug, with median treatment exceeding 8 months. A comprehensive translational research program is ongoing to identify and verify soluble plasma biomarkers, including sAXL, that continue to be predictive of response.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: “We are pleased to continue sharing updates from our phase II clinical studies assessing bemcentinib with the scientific and medical community. Data from both of the studies being presented at ASH continue to show encouraging results in patients with a very poor prognosis with current treatment options. We believe these data provide further validation for our clinical development strategy in these indications as we prepare to progress bemcentinib into late stage randomised trials.”

Details of this Poster presentations as follows:

Title: Efficacy and Safety of Bemcentinib in Patients with Myelodysplastic Syndromes or Acute Myeloid Leukemia Failing Hypomethylating Agents

Date: Saturday, December 5, 2020

Session name: 637 Myelodysplastic Syndromes – Clinical Studies: Poster I Hematology Disease Topics & Pathways: Diseases, Therapies, MDS, Myeloid Malignancies, Clinically relevant

Time: 7.00am – 3.30pm (Pacific Time) / 4.00pm – 12.30am (CET)

Abstract: https://ash.confex.com/ash/2020/webprogram/Paper140240.html

Presentations will be made available at our website www.bergenbio.com under Investors/Presentations at the date of the conference.

-End-

About AML and the BGBC003 trial

Acute myeloid leukaemia (AML) is a rapidly progressing blood cancer. AML is the most common form of acute leukaemia in adults, where malignant AML blasts interfere with the normal functioning of the bone marrow leading to a multitude of complications like anaemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive chemotherapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in relapsed/refractory patients, particularly those that are ineligible for intensive therapy or bone marrow transplant.

The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib in combination with cytarabine (part B2) and low dose decitabine (part B3 & B5) in patients with AML who are unsuitable for intensive chemotherapy as a result of advanced age or existing-co-morbidities.

For more information please access trial NCT02488408 at www.clinicaltrials.gov.

About MDS

Myelodysplastic syndromes (MDS) are stem cell disorders characterised by a decreased ability of the bone marrow to produce normal blood cells and platelets. MDS is associated with increased risk of developing AML and immune dysfunctions are seen in patients both with lower and higher-risk MDS. Hypomethylating agents (HMAs) are the standard of care for patients with higher-risk myelodysplastic syndrome not eligible for intensive chemotherapy or allogeneic stem cell transplantation. However, the majority of patients do not respond to these agents or relapse, and face a dismal outcome with very limited treatment options available. Hence, there is an urgent need for novel therapies to treat MDS

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, drug resistant cancers. The company’s proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad Phase II oncology clinical development programme focused on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing Phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy. BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications
[email protected]
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

[email protected]
+47 995 13 891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

This information was brought to you by Cision https://news.cision.com

https://news.cision.com/bergenbio-asa/r/bergenbio-presents-updated-clinical-data-from-two-phase-ii-studies-of-bemcentinib-in-aml-and-mds-pat,c3249801

The following files are available for download:

https://mb.cision.com/Main/15728/3249801/1344731.pdf

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Cision View original content:https://www.prnewswire.com/news-releases/bergenbio-presents-updated-clinical-data-from-two-phase-ii-studies-of-bemcentinib-in-aml-and-mds-patients-at-ash-2020-301186909.html

SOURCE BerGenBio ASA

Markets Insider and Business Insider Editorial Teams were not involved in the creation of this post.

The Company is currently undertaking an in-depth translational research program aiming to identify predictive molecular and biological factors associated with response.

Source: https://markets.businessinsider.com/news/stocks/bergenbio-presents-updated-clinical-data-from-two-phase-ii-studies-of-bemcentinib-in-aml-and-mds-patients-at-ash-2020-1029867562

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Entrepreneur

The Unbearably High Price of ‘Free’

Using the word ‘free’ in your marketing is a quick way to get attention, but it’s also a double-edged sword that has tripped up a lot of businesses.

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Using the word ‘free’ in your marketing is a quick way to get attention, but it’s also a double-edged sword that has tripped up a lot of businesses.

Free Book Preview: Brand Renegades

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June 13, 2021 5 min read

Opinions expressed by Entrepreneur contributors are their own.

One of the most powerful words in the English language is the term “free.” Do any of these phrases sound familiar?

  • “Buy one get one free.”
  • “Get a free gift with purchase, valued at $499.”
  • “Get a free eye examination.”
  • “Try our membership for FREE.”
  • “Get FREE delivery”

It seems like just about every company uses some kind of “free offer” in their marketing. So why is the term “free” used so liberally?

Because, frankly, it works — by appealing to our basic human emotion of greed.

The word “free” has appeared in more advertisements than there are grains of sand on a beach. And it goes way back to the genesis of advertising when giving free samples was the best (and only) new way to get customers. So what makes “free” work so well?”

Free gets attention. It makes people feel like they are getting a great deal. On a subconscious level, it works in reverse, too — you feel like you’re missing out if you don’t take advantage of something for free.

But using the word “free” in your marketing can be a double-edged sword, especially if you don’t use it correctly.

Related content: The 5 Triggers of Psychological Pricing

Is there a wrong way to use the term “free” in your marketing?

Absolutely. There are thousands of ways that using the term “free” in your marketing can trip you up, reduce your product or service value, and do irreparable damage to your brand.

Let me give you a real example. One of our clients was in the business of producing extremely high-end Italian-made leather shoes and bags for men. Their most famous pair of boots retailed for $3,500. Their most popular bag, a messenger-style laptop bag, retailed for $950. The company’s previous marketing agency advised them that the best way to double their boot sales would be to offer the messenger bag for free.

As far as irresistible offers go, that’s a pretty good one, and it did in fact, increase sales of the boots — in the short term. But it was a strategic disaster in the long term because now they had conditioned their clients to expect the messenger bag for free.

In other words, by offering it for free, they had completely devalued that product (remember it was the company’s top-selling bag.) Even worse, by offering something of high perceived value for free, they had also damaged their own luxury brand. Why would people ever pay full price again?

The good news is that people have a short attention span, and with the right strategic pivot and messaging, you can erase the damage of using “free.” But it takes time.

The same dangers apply when you start using discounts in your business. If you discount your products, why would people ever pay full price? They just wait for them to go on sale. When our Italian client came to us, they had a branding and sales disaster on their hands through no fault of their own. Fortunately, we were able to get them out of their pickle by repositioning their products and reinventing their brand — a move that resulted in them being purchased eighteen months later by a competitor.

Moral of the story: Using a free offer can be a slippery slope and must be used sparingly and carefully.

Related: The Price Is Right: How to Price Your Product for Long-Term Success

Before using “free” in your business, ask yourself:

  • Does this have a real value that we depend on for revenue?
  • By offering this item or service for free, will this adversely impact another related service or product (for example, if you offer the first consult for free, and expect to be paid for all future consults)?
  • Why are we considering offering something for free? What else could we offer that would help us achieve the same result?
  • What if it’s not your business using “free”, but your competitors?

    Now, if you’re on the other side of the fence and your competitor is offering something for free that you are charging for, it’s time to put your marketing into high gear.

    Just because there is no money exchanged doesn’t mean that it’s not paid for in other ways — for example, in lost time, huge frustration or poor quality.

    Think of the experience and quality of “free” healthcare versus a private plan. Draw these analogies in your marketing to establish your value in the minds of your clients.

    “Free” is still a mighty word used to grab attention in marketing. But handle with extreme caution, and don’t be lured into using it to stimulate short-term sales at the expense of long-term growth.

    Related: 3 Lessons About Setting Your Price Learned From a Vegas Prostitute

    It seems like just about every company uses some kind of “free offer” in their marketing. So why is the term “free” used so liberally?

    Source: http://feedproxy.google.com/~r/entrepreneur/latest/~3/-ft2fOOD5wI/372155

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    CNBC

    RH beats earnings, hikes outlook as retail rebound boosts high-end home goods; shares jump

    Shares of the high-end furniture retailer surged Wednesday after the company beat analysts’ profit and sales estimates for the fiscal first quarter.

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    Jason Kempin | Getty Images Entertainment | Getty Images

    Shares of the high-end furniture retailer RH surged in extended trading Wednesday after the company beat analysts’ profit and sales estimates for the fiscal first quarter.

    RH also hiked its full-year outlook, building on the momentum it’s seeing in the luxury home category, and gave a stronger-than-expected sales forecast for the second quarter.

    In a letter to shareholders, Chief Executive Officer Gary Friedman said the remainder of this year “will surely be a tale of two halves” for the retail industry. But he said that “the un-masking of the general public could lead to a Roaring Twenties type of consumer exuberance.”

    The company’s stock was last up more than 7%.

    Here’s how RH did in the quarter ended May 1 compared with what analysts were anticipating, using Refinitiv estimates:

    • Earnings per share: $4.89 adjusted vs. $4.10 expected
    • Revenue: $861 million vs. $758 million expected

    RH’s net income for the fiscal first quarter grew to $130.7 million, or $4.19 per share, compared with a loss of $3.2 million, or 17 cents per share, a year earlier. Excluding one-time adjustments, it earned $4.89 per share, topping expectations for $4.10.

    Revenue surged 78% to $861 million from $483 million a year earlier. That also beat expectations for $758 million.

    Friedman said that a strong housing and renovation market, a record stock market, low interest rates, and the reopening of the U.S. economy all bode well for the company in the quarters ahead.

    RH hiked its fiscal 2021 outlook for revenue growth to a range of 25% to 30%, compared with a prior range of 15% to 20%. Analysts had been looking for a 19.7% increase year over year.

    For its fiscal second quarter, RH expects revenue to grow 35% to 37%. Analysts had been looking for a 27.2% jump.

    The company is preparing to kick off its global expansion in the spring of 2022, starting with England. To drive future growth, it is also considering expanding into new services, potentially into areas such as landscape architecture. It currently offers interior design consulting.

    RH shares are up roughly 37% year to date. The company has a market cap of about $13 billion.

    Find the full earnings press release from RH here.

    Source: https://www.cnbc.com/2021/06/09/rh-earnings-q1-2021.html

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    Techcrunch

    Jeff Bezos’ Blue Origin auctions off seat on first human spaceflight for $28M – TechCrunch

    Blue Origin has its winning bidder for its first ever human spaceflight, and the winner will pay $28 million for the privilege of flying aboard the company’s debut private astronaut mission. The winning bid came in today during a live auction, which saw 7,600 registered bidders, from 159 countries compete for the spot. This was […]

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    Blue Origin has its winning bidder for its first ever human spaceflight, and the winner will pay $28 million for the privilege of flying aboard the company’s debut private astronaut mission. The winning bid came in today during a live auction, which saw 7,600 registered bidders, from 159 countries compete for the spot.

    This was the culmination of Blue Origin’s three part bidding process for the ticket, which included a blind auction first, followed by an open, asynchronous auction with the highest bid posted to the company’s website whenever it changed. This last live auction greatly ramped up the value of the winning bid, which was at just under $5 million prior to the event.

    This first seat up for sale went for a lot more than what an actual, commercial spot is likely to cost on Blue Origin’s New Shepard capsule, which flies to suborbital space and only spends a few minutes there before returning to Earth. Estimates put the cost of a typical launch at someone under $1 million, likely closer to $500,000 or so. But this is the first, which is obviously a special distinction, and it’s also a trip that will allow the winning bidder to pretty much literally rub elbows with Blue Origin founder Jeff Bezos, who is going to be on the flight as well, along with his brother Mark, and a fourth passenger that Blue Origin says it will be announcing sometime in the coming “weeks,” ahead of the July 20 target flight date.

    As for who won the auction, we’ll also have to wait to find that out, since the winner’s identity is also going to be “released in the weeks following” the end of today’s live bidding. And in case you thought that $28 million might represent a big revenue windfall for Blue Origin, which has spent years developing its human spaceflight capability, think again: The company is donating it to its Club for the Future non-profit foundation, which is focused on encouraging kids to pursue careers in STEM in a long-term bid to help Bezos’ larger goals of making humanity a spacefaring civilization.

    You can re-watch the entire live bidding portion of the auction via the stream below.

    As for who won the auction, we’ll also have to wait to find that out, since the winner’s identity is also going to be “released in the weeks following” the end of today’s live bidding. And in case you thought that $28 million might represent a big revenue windfall for Blue Origin, which has spent years developing its human spaceflight capability, think again: The company is donating it to its Club for the Future non-profit foundation, which is focused on encouraging kids to pursue careers in STEM in a long-term bid to help Bezos’ larger goals of making humanity a spacefaring civilization.

    Source: https://techcrunch.com/2021/06/12/jeff-bezos-blue-origin-auctions-off-seat-on-first-human-spaceflight-for-28m/

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