24-week results demonstrate significant improvement in repigmentation of facial vitiligo lesions after treatment with ruxolitinib cream
Data presented at the World Congress of Dermatology support the planned initiation of a pivotal Phase 3 program, for which preparations are currently underway
Investor conference call and webcast scheduled for Monday, June 17 at 8 a.m. EDT
Incyte (Nasdaq:INCY) today announces 24-week results from its randomized, double-blind, dose-ranging, vehicle-controlled, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients (18 to 75 years of age) with vitiligo. The study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50 percent improvement from baseline in the facial vitiligo area severity index (F-VASI50) score compared to patients treated with a vehicle control (non-medicated cream). F-VASI50 response was most notably achieved with ruxolitinib cream 1.5 percent administered once daily (QD) and twice daily (BID) vs. vehicle control (50 percent and 45 percent vs. 3 percent, respectively; P<0.001).
These results are being presented at the 24th World Congress of Dermatology (WCD) in Milan, Italy, during a late-breaking research session today, June 15, 2019, from 9:25 a.m. CET to 9:35 a.m. CET (3:25 a.m. EDT to 3:35 a.m. EDT). (Location: Room Yellow 3).
The influential US pharmacy benefit manager CVS Health has said it will fund an insomnia app, allowing it to be paid for in the same way as drugs by insurers and employers.
CVS said earlier this week that it has partnered with San Francisco-based firm Big Health, which has developed the Sleepio app to treat insomnia.
Employers or health plans will be able to add Sleepio to the list of treatments that they reimburse – meaning they will be able to check patients’ eligibility using the same systems and processes used for medicines.
The move is part of a new service offered by CVS that covers emerging therapies, both digital and non-digital.
CVS said that it is looking for additional partners to join the new service, potentially including support for smoking cessation and substance abuse, care management solutions, medicine optimisation and adherence, and tools to help people manage their benefits.
Sleepio is a personalised digital sleep tool that is accessible via the app or the web.
It uses cognitive behavioural therapy (CBT) to help people make changes to improve their sleep, tailored to an individual’s needs.
Its research is referenced in guidelines by the American College of Physicians recommending CBT as treatment for chronic insomnia in adults, ahead of sleeping pills.
It has been studied in eight randomised controlled trials.
Digital therapies provide an alternative to sleeping pills – commonly prescribed insomnia drugs based on zolpidem are associated with side effects such as daytime drowsiness, weakness and light-headedness.
The drug should also not be taken in combination with alcohol and affects a person’s ability to drive or use machinery.
In April the FDA announced it required a new boxed warning – the most prominent mandated by the agency – on certain prescription insomnia drugs.
The warning follows several reports of rare, but serious injuries and deaths resulting from complex sleep behaviours after taking these medicines
Complex sleep behaviours included sleepwalking, sleep driving and other activities while not fully awake, such as unsafely using a stove.
The new warnings are required for drugs are based on eszopiclone, zaleplon, and zolpidem.
Healthcare providers’ financial pressure has dampened the outlook of staffing firms, according to a new report.
Staffing companies that serve hospitals—such as Envision, Team Health and Schumacher—are particularly vulnerable as emergency department volumes decline and health systems develop predictive tools to better measure demand, according to a new report from ratings agency Standard & Poor’s. The agency maintained a stable outlook on the staffing industry, although it is a precarious one as providers try to find their financial footing.
Hospitals and health systems are grappling with the ever-rising pressure to control costs, causing them to rethink their relationships with staffing agencies, S&P credit analyst Sarah Kahn said.
“While they have turned to outsourcing staffing, their intense focus on cost cutting has put significant pressure on staffing companies to lower prices, increase the value they add by either specializing or expanding their menu of services, or both,” she said in prepared remarks.
Not-for-profit and public hospitals’ revenue growth edged ahead of expense inflation last year for the first time since 2015, but operating margins were still low at 1.7%, according to a recent report from Moody’s Investors Service. This has launched strategies to lower their overheard as well as grow revenue.
One approach involves implementing more sophisticated, artificial intelligence-enabled solutions that allow providers to better predict the ebb and flow of patient volumes, which reduces their reliance on staffing firms. They are also developing new tools to measure and project turnover, supply utilization, diagnostics, and device resiliency as well as improve diagnostics, among other uses.
Sioux Falls, S.D.-based Sanford Health is constantly using predictive analytics to ensure proper staffing levels, which means it typically has had a low demand for staffing agencies, Darren Walker, vice president of human resources, said. Investment in internships, local residency programs and staff development have also helped, he said.
Still, predicting demand only goes so far; it does not boost the supply of doctors, staffing agency AMN Healthcare said.
“Unanticipated need is caused by many more influences than fluctuations in patient demand,” AMN Healthcare wrote in an email. “The most important influence is the scarcity of physicians.”
Notably, demand for temporary staffing agencies did not wane during the Great Recession, and the industry will struggle to replace doctors who are aging out of the labor force fast enough, the company added.
Proper staffing levels will become even more crucial as hospitals and health systems compete with reinforced competitors in the retail healthcare space and other sectors backed by third-party investors, S&P said in the report. Robust competition, as well as the push to value, will require staffing agencies to expand their portfolio related to productivity, workflow design, quality improvement and staffing-shortage mitigation.
“Facing increasing competition and pricing pressure for hospital customers, healthcare staffing companies can no longer simply increase prices,” the report said.
The pricing practices of Envision Healthcare’s EmCare, for instance, have sparked a public outcry. The ability to increase prices has become critical for staffing companies that are trying to offset volume declines as well as increasing exposure to both government reimbursement and uninsured patients as recent policy decisions have weakened the Affordable Care Act, the report continued.
Meanwhile, two key staffing industry business models are emerging—those that offer a more holistic range of services as well as niche companies, according to the report. The prevalence, growth and client retention rates of smaller competitors suggest that providers are open to contracting with smaller, more niche competitors that offer a core value proposition, S&P analysts said.
S&P analysts cited Sound Inpatient Physician Holdings, which contracts with hospitals to staff and manage teams of internal medicine physicians in acute-care settings and uses its proprietary workflow solutions technology and oversees the revenue cycle management for the hospital. Companies like AMN and Cross Country Healthcare have added some intermediary services to replace the middlemen that subcontract with staffing companies.
Radiology Partners, NMSC and U.S. Anesthesia Partners, S&P noted, have grown aggressively by acquiring established radiology and anesthesiologist groups. ScribeAmerica Intermediate Holdco bought PhysAssist Scribes, the scribe staffing business of Team Health Holdings, increasing its concentration in scribe staffing as Team Health decreases its noncore assets. Mednax has been trying to sell MedData, its IT and billing service division, while it also divests one of its noncore assets.
Meatless Future or Vegan Delusions? The Beyond Meat Valuation
In a big year for initial public offerings (IPOs), with Uber, Lyft, Pinterest and Zoom, to name just a few, already having gone public and more companies waiting in the wings, it is ironic that it is not a tech company, but a food company, Beyond Meat, that has managed to deliver the most dazzling post-IPO performance of any of the listings. As the stock increased seven-fold, investors who were able to get into the stock at the offering price have been enriched, but those who jumped on the bandwagon later have also reaped extraordinary returns. The speed and magnitude of the stock price rise has left many wondering whether investors have over reached and whether a correction is around the corner.
The Meatless Meat Company!
The Company: Let’s take a look at what Beyond Meat’s products are and the market opening it is exploiting, before diving into a story and valuation for the company. The company, headquartered in Southern California, and founded in 2009, makes makes plant-based (pea protein) products that mimic burgers and ground meat in taste, texture and aroma. In the prospectus that it filedleading up to its IPO, the company argues that its production process is revolutionary and new, and is responsible for its capacity to replicate animal-based meats.
The Competitors: While Beyond Meat is a leader right now in the specialized sub-category of meatless meats, it faces a formidable competitor in Impossible Foods, another young start-up producing its own plant-based versions of meat-like products. Since it is very likely, especially after Beyond Meat’s explosive market debut, that Impossible Foods will be going public soon, it is inevitable that there will be comparisons between the two companies. While I have done my own taste test, taste is in the mouth of the beholder, and this article perhaps has the most even-handed comparison of the two companies’ products. Both companies have also adopted similar strategies of enlisting fast-food companies as product adopters, with Impossible Foods showing up on Burger King (Impossible Whopper) and White Castle menus, and Beyond Meat countering with TGI Friday’s, Carl’s Jr. and Red Robin. Other companies are taking note, including companies like Amy’s Kitchen, a long standing producer of organic and vegan offerings, and companies like Tyson Foods and Perdue that derive the bulk of their revenues from meat, but see opportunity in this new market.
The Drivers: Both Beyond Meat and Impossible Foods have been helped by a shift away from meat to meatless alternatives, and that trend has been driven by three factors:
Health: While the research on the health consequences of eating meat continues, it has become part of conventional wisdom that meat-based diets (and red meat in particular) are associated with a greater risk of cardiovascular disease and cancer. This link provides a fairly balanced account of whether this belief is true, but for better or worse, it has led some meat eaters to cut back and sometimes stop consuming meat.
Environment: As climate change and environmental concerns rise to the top of concerns for some, they are feeling the pressure to shift away from meat, in general, and beef, in particular, because of its environmental footprint. I am not an environmental scold, but I don’t think that there is any debate that meat-based diets puts a greater pressure on the environment
Taste: Until recently, shifting away from a meat-based diet also meant giving up the taste and texture of meat, since most meat substitutes did not come close. As companies like Beyond Meat and Impossible Foods are showing, plant-based alternatives are getting better at mimicking real meat, and for those who are attached to the texture and taste of meat, that is making a difference in their diet decisions.
None of these three factors are likely to fade away. In fact, I think that we can safely assume that they will only get stronger over time, accelerating the shift from meat to meatless alternatives.
Market Sizing
All of the talk about the shift to vegan and vegetarian diets can sometimes obscure two basic facts about this market and its underlying trends:
The meatless meat market is still small, relative to the overall meat market: In 2018, the meatless meat market had sales of $1-$5 billion, depending on how broadly you define meatless markets and the geographies that you look at. Defined as meatless meats, i.e., the products that Beyond Meat and Impossible Foods offer, it is closer to the lower end of the range, but inclusive of other meat alternatives (tofu, tempeh etc.) is at the upper end. No matter which end of the range you go with, it is small relative to the overall meat market that is in excess of $250 billion, just in the US, and closer to a trillion, if you expand it globally, in 2018. In fact, while the meat market has seen slow growth in the US and Europe, with a shift from beef to chicken, the global meat market has been growing, as increasing affluence in Asia, in general, and China, in particular, has increased meat consumption, Depending on your perspective on Beyond Meats, that can be bad news or good news, since it can be taken by detractors as a sign that the overall market for meatless meats is not very big and by optimists that there is plenty of room to grow.
It is still a niche market: Meatless meat products have made their deepest inroads in urban and affluent populations and its allure is greatest with former meat-eaters rather than lifelong vegetarians, who don’t crave either the taste or texture of meat. The plus is that this market has significant buying power, but the minus is that urban, well-to-do millennials can eat only so much.
The big question that we face is in estimating how much the shift towards vegan and vegetarian diets will continue, driven by health reasons or environmental concern (or guilt). There is also a question of whether some governments may accelerate the shift away from meat-based diets, with policies and subsidies. Given this uncertainty, it is not surprising that the forecasts for the size of the meatless meat market vary widely across forecasters. While they all agree that the market will grow, they disagree about the end number, with forecasts for 2023 ranging from $5 billion at the low end to $8 billion at the other extreme. Beyond Meat, in its prospectus, uses the expansion of non-dairy milk(soy, flax, almond mild) in the milk market as its basis, to estimate the market for meatless meat to be $35 billion in the long term.
Beyond Meat: Story and Valuation
History: At the time of its public offering, Beyond Meat had all of the characteristics of a young company, not much separated from its start up days, with revenues of $87.9 million, operating losses of $26.5 million and a common equity of -$121.8 million. Its first earnings report, delivered to a rapturous market response, reported a tripling of revenues and a narrowing of operating losses, but even with it incorporated, the company remains a small, money losing company.
The Story: To value young companies, I first have to put my optimist hat on, and with it firmly in place, my story for Beyond Meat is that it is catching the front end of a significant shift towards vegan and vegetarian-based diets. The key parts of my story are below:
Total market for meatless meats will grow significantly: I see the total market for meatless meats growing from just over $1 billion in 2018 to $12 billion by 2028. While that is less than the $35 billion that Beyond Meat’s back-of-the-envelope estimate delivers, it is closer to the upper end of the range of forecasts that you have for this market.
With Beyond Meat capturing a significant market share: As the market grows, the number of players will increase, but I see Beyond Meats capturing a 25% market share of this market, building on its early entry into the market and brand name recognition, partly from its fast food connections.
While delivering operating profits similar to the large US food processing companies: Over the next five years, I see pre-tax operating margins improving towards the 13.22% that US food processing business delivered in 2018, built largely on economies of scale and pricing power.
And reinvesting a lot less, in delivering that growth: While Beyond Meat generates about a dollar in revenue per dollar in invested capital right now, I will assume that it will be able to use technology as its ally to invest more efficiently in the future. Specifically, I will assume that the company will generate $3 in revenue for every dollar in invested capital, about double what the typical US food processing company is able to generate.
Is there risk in this investment? Absolutely, and you may be surprised that my cost of capital is only 7.46%, but that reflects my assessment of risk in this investment, as a going concern and as part of a diversified portfolio. As a money-losing company that will require about $500 million in capital over the next four years to deliver on its potential, there remains a significant chance of failure, and I estimate the probability of failure to be 15%.
The Valuation: With the story in place, the valuation follows and the picture below captures the ingredients of value:
With my story, which I believe reflects an upbeat story for the company, the value that I obtain for its equity is $3.3 billion, yielding a value per share of about $47. At the end of June 10, when I completed my valuation, the stock price was close to $170, well above my estimated value. What the stock dropped almost $41 on June 11 to $127/share, it still remained over valued.
What if? As with any young company, the value of Beyond Meat is driven almost entirely by the story you tell about the company, and in this case, that story revolves around two key inputs. The first is the revenue that you believe the company can generate, once mature, and that reflects how big you think the market for meatless meats will get and Beyond Meat’s market share of the market. The second is its profitability at that point, which is a function of how much pricing power you believe the company will have. While I have assumed that Beyond Meat will deliver about $3 billion in revenues in 2028, with an operating margin of 13.22%, your story for the company can lead you to very different estimates for one or both numbers:
The shaded cells represent break even points, where you could justify buying Beyond Meat at the price ($127) it was trading at on June 11, 2019. Put differently, if your story for the meatless meat market and Beyond Meat’s place in it leads you to revenues of $5 billion or higher with an operating margin of 20%, you should be a value investor in the company.
Macro Bets and Micro Value
As you can see from the what-if analysis on Beyond Meat’s value, the value that you obtain for Beyond Meat is determined mostly by how large you believe that market for meatless meats will end up being. In fact, there are some investors whose primary reason for investing in Beyond Meat is as a bet on a macro trend towards vegan and vegetarian diets. That said, it is worth remembering that investors don’t get pay offs from making the right macro bets, but from the micro vehicles (individual investments) that they use as proxies for those bets. To get the pay off from a correct macro call, there are two additional assessments that investors have to make:
Industry structure: A growing market may not translate into high value businesses, if it is crowded and intensely competitive. That market will deliver high revenue growth, but with low or no profitability, and no pathway to sustainable profits and value added. In contrast, a growing market where there are significant barriers to entry and a few big winners can result in high-value companies with large market share and unscalable moats.
Winners and Losers: Assuming that there is potential for value creation in a market, investors have to pick the companies that are most likely to win in that market. That is difficult to do, when you are looking at young companies in a young market, but there is no way around making that judgment. In a post from 2015, I argued that in big (or potentially big) markets, you can expect companies to be collectively over valued early in the game.
In my Beyond Meat valuation, I have implicitly made assumptions about both these components, by first allowing operating margins to converge on those of large food processing companies and then making Beyond Meat one of the winners in the meatless meat market, by giving it a 25% market share. My defense of these assumptions is simple. I believe that the meatless meat market will evolve like the broader food business, with a few big players dominating, with similar competitive advantages including brand name, economies of scale and access to distribution systems. I also believe that Beyond Meat and Impossible Foods, as front runners in this market, will use their access to capital to scale up quickly. Their use of fast food chains feeds into this strategy, with bulk sales increasing revenues quickly, allowing for economies of scale, and name-brand offerings (Impossible Whopper at Burger Kind, Beyond Famous Star burger at Carl’s Jr.) helping improve brand name recognition. I will undoubtedly have to revisit these assumptions as the market evolves and some of you may disagree with me strongly on one or both assumptions. If so, please do download the spreadsheet and make your best judgments to derive your value for the company.
A Trading Play
Early in a company’s life, it is the pricing game that dominates and it is futile to use fundamentals to try to explain a stock price or day-to-day changes. This table, from one of my presentations on corporate life cycles, illustrates how investors and trades view companies as they move through the life cycle.
For a young company like Beyond Meat, making the transition from start-up to young growth, it is all pricing all the time, with stories about market size driving the pricing,. This trading phenomenon is exacerbated by the fact that it is one of the few pure plays on a macro trend, i.e., a shift in diets away from meat to plant-based options. That leads me to two conclusions. The first is an unexceptional one and it is that you will see wide swings in the stock price on a day to day basis, for little or no reason. That is a feature of priced stocks, not a bug, as mood and momentum shift for no perceptible reasons. The second is that selling short on a stock like this one (small, with a small float) is a dangerous game, since you are unlikely to have time as your ally, and while you may be right in the long term, you may bankrupt yourself before you are vindicated.
Scientists have discovered that the rotavirus vaccine reduces the likelihood of children being diagnosed with type 1 diabetes. Rotavirus causes a severe gastrointestinal illness characterized by diarrhea and dehydration. It is rarely fatal in developed countries but can be deathly in low-income countries.
Kateryna Kon | Shutterstock
The authors of the current study looked at almost 1.5 million insurance records of American children born after 2001, who were followed for periods ranging from 1 to 16.5 years, depending on their year of birth and registration with the insurance firm.
Among completely immunized children, the risk of type 1 diabetes went down by 41%. The incidence was 12.2/100 000 compared to 20.5/ 100 000 for unvaccinated and partially vaccinated children, during the period of study. In other words, skipped doses eliminated any benefit in terms of preventing diabetes.
Both the pentavalent and monovalent rotavirus vaccines are used in the US, but the greatest reduction in risk (37%) was seen with children who were completely immunized; having had three doses of the pentavalent vaccine.
When classified by birth year, researcher Dr. Mary Rogers found that type 1 diabetes risk was reduced by 33% for fully vaccinated children born between 2006 and 2011, but this went up to 54% for those born between 2012 and 2016. The reason for the difference is unknown, but might be because rotavirus delays diabetes onset, rather than preventing it altogether.
After adjusting the risk factors, the risk reduction was found to be 33% for vaccinated children born between 2006 and 2017. While there was no difference between boys and girls, babies born in winter had a lower incidence compared to those born in spring or autumn, and those who lived in the central US compared to New England and New Jersey, which have higher rates of skipped vaccination.
The incidence of type 1 diabetes in the vaccinated cohort was 55% lower compared to the five years before vaccine introduction (in 2006).
Was the risk reduction due to the rotavirus vaccine or other vaccines?
The 2006 cohort also served as the historical controls to find if other vaccines were responsible for the risk reduction. To examine this, the children from the historical cohort were analyzed for diabetes risk after they received their first three immunizations for diphtheria, tetanus, and pertussis at 2, 4 and 6 months. These records were compared with children in the current cohort who received, in addition, the rotavirus vaccine. Here again, there was a 56% reduction in type 1 diabetes incidence in the second group.
Altogether, the disease incidence reduced by almost 7% after 2006 in the age group from 0 to 19 years, in contrast to the 7% rise in each previous year. The reduction was seen almost completely in children 0-4 years old, because other age groups showed a rise in incidence.
The study also looked at how effective the vaccine was against rotavirus infection, and found that children who had received the vaccine were 94% less likely to need hospitalization for this cause. In addition, children who had received the vaccine had a 31% lower risk of hospital stay for any cause during the 60 days following the administration of the oral vaccine.
How does the rotavirus vaccine prevent type 1 diabetes?
Rotavirus infection is known to affect the beta cells in the pancreas which produce insulin. This may be responsible for the lower incidence of type 1 diabetes following this immunization, but because the disease is comparatively rare, large numbers of people must be examined before any causation hypothesis can be proved.
More studies are required over a longer time frame to find out whether the disease is truly prevented or just delayed. Other confounding factors which may have affected the results must also be identified.
This is an uncommon condition, so it takes large amounts of data to see any trends across a population. It will take more time and analyses to confirm these findings. But we do see a decline in Type 1 diabetes in young children after the rotavirus vaccine was introduced.”
Dr. Mary Rogers, First Author of the Study
As a result of this preliminary analysis, which is the first time that this trend has been examined in detail, the researchers say that strengthening commitments to enforce the immunization schedule already in place could go a long way in reducing the number of cases of this chronic medical condition.
Roche’s $4.8 billion takeout of gene therapy specialist Spark Therapeutics looked like a typical biopharma transaction — that is, until the Federal Trade Commission got involved. Now it appears the two parties may have to wait months to complete the deal as antitrust regulators demand extensive paperwork to ensure the Swiss big pharma company won’t have too much market power.
The FTC issued a “second request” for information on the deal, something that happens in 5% or fewer of transactions subject to review under U.S. antitrust law. This request compels Roche and Spark to produce paperwork, answer questions and appear before regulators. Once the agency is satisfied it has sufficient information to make a decision, there is a 30-day waiting period for regulators to decide whether they will challenge the deal as anti-competitive.
“The issuance of a second request is a big deal in merger review,” said James Burns, a health care antitrust attorney with the law firm Akerman. “It means you’re delayed and it’s going to cost you a lot of money to talk the government into letting you go forward.”
“For smaller deals, it’s a death knell,” Burns added. “I don’t think that’s going to happen here. If the parties intended to bail on it, we would have heard of it.”
Nonetheless, the request raises the possibility that the deal could come undone due to regulatory scrutiny. Jefferies analyst Michael Yee wrote in a June 10 note to clients that the spread between the offer price of $114.50 and current share price — $100.02 in mid-day trading June 12 — suggests investors are concerned about that outcome. Roche says 21.1% of Spark shares have been tendered as part of the transaction.
When first announcing plans to acquire Spark, the Swiss drugmaker said it expected the deal would close by the end of June.
Big pharma buying smaller biotechs to gain access to innovative products is typical of the sector and rarely merits more than routine FTC review, making the agency’s focus on Roche-Spark unusual. Roche pulled and refiled its pre-merger notification twice, trying to meet the FTC’s requests.
A Roche spokesperson would not say what the FTC wants to know, but the regulator’s interest could center on Roche’s hemophilia A maintenance treatment Hemlibra and Spark’s experimental gene therapy SPK-8011, a theoretically one-time treatment.
“The question or concern: Will Spark’s product be a competitor at least for some hemophilia patients, and if so, would the merger give Roche the incentive or ability to delay the Spark product from coming to the market?” said Alexis Gilman, an attorney with Crowell & Moring and a former assistant director of the FTC’s bureau of competition.
Expected competition in the form of BioMarin Pharmaceuticals’ experimental gene therapy valoctocogene roxaparvovec, or valrox, would likely be a counterargument, giving Roche an incentive to push SPK-8011 to market.
“We think the hemophilia gene therapy market is probably the most competitive and ‘crowded’ field in gene therapy,” Jefferies’ Yee noted.
However, that’s probably something regulators were already conscious of during the process of Roche withdrawing and refiling its pre-merger notification, said David Balto, an antitrust attorney and former FTC policy director. “When you pull and refile, you’re hoping there’s a silver bullet, and there are obviously no silver bullets here,” he said.
A second concern, Yee wrote, is that Roche’s ownership of both a chronic and one-time treatment might give it too much market power as it could use the combination against valrox.
Balto added that the scrutiny this deal is receiving might be a sign of things to come.
Regulators are becoming increasingly nervous about the potential for biopharma consolidation thwarting innovation. Balto expects transactions like Roche-Spark to face more serious scrutiny in the future, and pointed to calls to break up big technology firms as a sign there may be interest in investigating biopharma.
“I think this is going to make a lot of antitrust lawyers go back to the drawing board and look at how they can defend acquisitions of developing drugs,” he said. “This is like when the first mate turns to the captain on the Titanic and says, “What was that bump?”
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the presentation of results from the Company’s Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies. The results are being presented today, June 15, from 5:30-7:00 p.m. CET in a poster session titled “Chronic lymphocytic leukemia and related disorders – Clinical” at the 24th Congress of the European Hematology Association (EHA) in Amsterdam. The poster, titled “Preliminary Results of a Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s Tyrosine Kinase Inhibitor (BTKi) Vecabrutinib in B-Cell Malignancies,” Abstract No. PS1148, is available at www.sunesis.com.
“We are encouraged by the data presented today demonstrating vecabrutinib’s well-tolerated safety profile and evidence of clinical activity in CLL and other B-cell malignances,” said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. “Importantly, vecabrutinib’s median steady-state trough concentrations continue to increase with dose and are approaching levels expected to provide consistent BTK inhibition and greater clinical activity. We are currently dosing patients in the 200mg cohort and momentum in the trial continues as reflected by the robust pace of enrollment we’ve seen this year. We look forward to sharing data from the additional cohorts as we complete the Phase 1b and proceed to Phase 2 later this year.”
-1.jpg "Rotavirus is a highly contagious virus that causes gastrointestinal symptoms such as diarrhea.")
Kateryna Kon | Shutterstock