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Monday, June 3, 2019

Addus HomeCare Completes Purchase of VIP , Eyes More Acquisitions

Addus HomeCare Corporation (NASDAQ: ADUS), a provider of comprehensive home care services, today announced that it has completed the purchase of the assets of VIP Health Care Services, a provider of home care services, headquartered in Richmond Hill, New York, effective June 1, 2019. VIP Health Care Services currently serves approximately 1,250 consumers in all five boroughs of New York City as well as surrounding counties. Addus funded the purchase price of $28.0 million (net of excess cash) through the delayed draw term loan portion of the Company’s credit facility and cash on hand.

Dirk Allison, President and Chief Executive Officer of Addus, commented, “We are very excited that the team at VIP Health Care Services will be joining the Addus organization. This acquisition is an important step to further our strategy of enhancing operations in key market areas where we already have a strong presence. VIP Health Care Services provides personal care coverage throughout the New York City area that complements our South Shore operations on Long Island. With annualized revenues of approximately $50.0 million, we will have combined revenues of over $110.0 million in New York, which is already one of our largest markets. Additionally, with over 1,500 caregivers operating from six locations in the New York metropolitan area, we look forward to the potential growth opportunities in this important region.

“Now that we have completed the purchase of VIP Health Care Services, our development team is continuing to work on identifying other potential acquisition targets, and our pipeline remains strong. We will remain focused on opportunities that will enhance our service offering and further extend our market reach. With a strong financial position and substantial cash flow from operations, we believe we are well positioned to fund and execute additional accretive acquisitions during 2019,” said Mr. Allison.

https://www.prnewswire.com/news-releases/addus-homecare-completes-purchase-of-vip-health-care-services-300860878.html

Nestle gears up to launch its own plant-based burger in US

The world’s largest food company sells a soy-based vegan burger in Europe, but Sweet Earth’s version is pea-based.
Beyond Meat also uses a pea proteins for its burger, while Impossible Foods’ vegan burger is soy-based.

Sweet Earth’s Awesome Burger

Source: Hardy Wilson

Nestle is looking to take a bite of the growing U.S. plant-based burger market.

Through its Sweet Earth brand, which it acquired in 2017, the global food giant will launch its Awesome Burger in the fall. The vegan meat substitute will be available at grocery stores, restaurants and universities.

Sweet Earth founders Brian and Kelly Swette said they began developing their own plant-based burger several years ago — before nearly every restaurant chain announced a plant-based option and Beyond Meat went public.

The Swettes are not newcomers to plant-based meat alternatives either. The company they founded makes about 13,000 pounds of plant-based protein, including meatless bacon and ham, every day. While the Awesome Burger is not Sweet Earth’s first veggie burger, it is the first by the brand that is meant to more closely mimic real burgers.

Although the husband and wife team are now focused on vegetarian food, they have prior experience elsewhere in the food and beverage industry. Brian Swette served as chairman of Burger King and as chief marketing officer of PepsiCo. Kelly Swette also worked at PepsiCo, first as a director of marketing and then as a director of national sales.

As the world’s largest food company, Nestle is able to help Sweet Earth with sourcing and production — a competitive advantage for the plant-based food brand, according to Kelly Swette. Both Impossible Foods and Beyond Meat, the two leading purveyors of plant-based burgers, have struggled at times to meet soaring demand because of limited production capacity.

“We have great admiration for our competitors and what they’re trying to do, but we’re also excited about competing,” Brian Swette said.

In April, Nestle launched a soy- and wheat-based veggie burger under its Garden Gourmet brand in Europe. German customers can purchase its Incredible Burger in McDonald’s.

Sweet Earth’s burger will be primarily made with yellow pea protein.

“We just felt for the U.S. market, pea protein is really trending and is popular for a variety of reasons, one of which is that it’s an extremely sustainable crop,” Kelly Swette said.

Beyond also uses pea proteins for its beef substitutes, while Impossible Foods uses a soy protein base.

An organic version of the Awesome Burger will also be sold. Kelly Swette said that the burger acts similarly to traditional beef when cooked but is higher in protein and fiber.

The Awesome Burger will be priced “competitively” to other plant-based burgers. But down the road, she said, as manufacturing and sourcing improve, the price could move closer to that of a beef burger.

Nestle is not the only Big Food company trying to compete with Impossible Foods and Beyond Meat as more consumers try to reduce how much meat they eat. Tyson Foods sold its stake in Beyond prior to the latter’s initial public offering so that it could make its own meatless burger. Kellogg’s Morningstar Farms brand plans to be entirely plant-based by 2021. And last year, Unileveracquired The Vegetarian Butcher, a Dutch maker of plant-based meat.

More U.S. consumers are eating meat substitutes as a way of reducing their meat consumption for health and environmental reasons.

Alexia Howard, a senior research analyst at Bernstein, estimates that sales of imitation products, which account for around $13 billion currently, could rise to $40 billion to $41 billion in the next 10 years.

https://www.cnbc.com/2019/06/03/nestle-gears-up-to-launch-its-own-plant-based-burger-in-the-us.html

FDA OKs Merck med for hospital-acquired, ventilator-linked pneumonia

The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014to treat complicated intra-abdominal infections and for complicated urinary tract infections. The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co., Inc.

“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”

HABP/VABP occur in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to data from the U.S. Centers for Disease Control and Prevention, HABP and VABP are currently the second most common type of hospital-acquired infection in the United States, and are a significant issue in patients in the intensive care unit (ICU).

The safety and efficacy of Zerbaxa for the treatment of HABP/VABP, administered via injection, was demonstrated in a multinational, double-blind study that compared Zerbaxa to another antibacterial drug in 726 adult patients hospitalized with HABP/VABP. The study showed that mortality and cure rates were similar between Zerbaxa and the comparator treatment.

The most common adverse reactions observed in the HABP/VABP trial among patients treated with Zerbaxa were elevated liver enzyme levels, renal impairment or failure, and diarrhea.
Zerbaxa should not be used in patients with known serious hypersensitivity to components of Zerbaxa, as well as hypersensitivity to piperacillin/tazobactam or other members of the beta lactam class of antibacterial drugs.

Zerbaxa received FDA’s Qualified Infectious Disease Product (QIDP) designation for the treatment of HABP/VABP. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, the Zerbaxa marketing application for the HABP/VABP indication was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame.

https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hospital-acquired-and-ventilator-associated-bacterial-pneumonia

ASCO: Viracta combo gets high response in Epstein-Barr linked lymphoma

The oncology community has long been aware of the association between Epstein-Barr Virus (EBV) and certain malignancies, including some forms of lymphoma, but targeting these cancers has proven challenging. Early data from a phase 1b/2 study presented at the American Society of Clinical Oncology (ASCO) annual meeting suggests that combining HDAC inhibition with an anti-viral therapy may be effective against EBV-associated lymphoma.

Patients in the trial are receiving a combination of Viracta Therapeutics’ HDAC inhibitor nanatinostat (formerly VRx-3996) and valganciclovir, a drug used to treat cytomegalovirus in patients with HIV/AIDS or in people who have recently received organ transplants.

Researchers at Sidney Kimmel Cancer Center-Jefferson Health, which is leading the study, reported that the combination produced an objective response rate of 58% and a complete response rate of 33%. Based on the results, the researchers are considering moving forward with a dosing schedule that would consist of daily doses of valganciclovir, along with nanatinostat given for four days, followed by three days off, according to a statement.

“The main purpose of this study was to develop a new treatment strategy for EBV-associated lymphomas that takes advantage of the vulnerabilities imposed on the cancer by the presence of the virus,” said Pierluigi Porcu, M.D., director of the division of hematologic malignancies and hematopoietic stem cell transplantation at Sidney Kimmel, in the statement.

Viracta was launched into the spotlight two years ago, when it raised $18.4 million in a series B funding round led by famed investor Patrick Soon-Shiong’s NantKwest. Viracta dubs its approach to fighting cancer as “Kick and Kill,” meaning the therapies are designed to activate genes that have been suppressed by a virus or the cancer itself, and then activate an immune response against the disease.

EBV is a particularly challenging target because an estimated 95% of the adult population is infected with the virus but many aren’t aware of it because it rarely produces symptoms. After infection, the virus can lurk in lymphatic cells and later turn cancerous. EBV has been linked to nasopharyngeal carcinoma and gastric cancer, in addition to lymphoma.

Viracta CEO Ivor Royston, M.D., says in a statement that he was encouraged by the study presented at ASCO because positive responses to the combination treatment were seen in both T cell and B cell lymphomas. The company plans to initiate the phase 2 study in the third quarter of this year.

https://www.fiercebiotech.com/research/asco-viracta-s-hdac-inhibitor-combo-shows-promise-ebv-associated-lymphoma

ASCO: Death in Turning Point NSCLC trial overshadows 82% Overall Response Rate

A sudden, possibly drug-related death has overshadowed Turning Point Therapeutics’ update on repotrectinib in non-small cell lung cancer (NSCLC). More than four-fifths of patients responded to the tyrosine kinase inhibitor (TKI), but shares in Turning Point fell 10% amid worries about the death.

Turning Point, fresh from an IPO, focused its update on the 82% objective response rate (ORR) in TKI-naive ROS1+ patients. All three patients with brain metastases experienced intracranial responses and remain in partial responses, suggesting repotrectinib may have an edge over older NSCLC drugs that are unable to penetrate the brain in sufficient volumes to treat tumors.

The response rate among patients previously treated with TKIs such as Pfizer’s Xalkori was lower but still potentially competitive given the rate of resistance in this population. Of the 11 TKI pretreated patients who received 160 mg or more of repotrectinib a day, six responded, resulting in an ORR of 55%.

However, investors looked past the efficacy data and zeroed in on a safety red flag. Turning Point has now seen four deaths in the trial, one of which may be related to its drug. The biotech shared more details of the death in a SEC filing posted on the same day as the data.

“The fourth grade 5 TEAE (treatment emergent adverse event) involved a patient with ALK+ NSCLC and a past medical history of diabetes, obesity and hypertension who was dosed at 240 mg QD (once daily) of repotrectinib and experienced a grade 5 event of sudden death on day 10 of cycle 1, which we determined to be possibly related to study treatment,” Turning Point wrote.

Over the course of the trial, Turning Point has reported two dropouts triggered by drug-related grade 3 events and seen a small number of dose-limiting toxicities related to dyspnea and dizziness. That makes the patient death the most significant safety event that may be related to the drug. Investors responded by driving Turning Point’s stock down by 10%.

Turning Point is pushing ahead, though. Work to finalize the recommended dose is ongoing, beyond which Turning Point plans to move into the registrational portion of its phase 2 trial. The plan is to start the registrational part of the trial in the second half of the year. Turning Point is also gearing up to start three other clinical trials.

https://www.fiercebiotech.com/biotech/asco-death-turning-point-nsclc-trial-overshadows-82-orr

ASCO: Gilead touts CAR-T franchise with Yescarta analyses, early pipeline data

As other parts of its business slump, Gilead Sciences has zeroed in on cell therapy, hoping to lead a wave into that new market. And at the American Society of Clinical Oncology’s (ASCO’s) annual meeting Monday, the company touted new info on its approved Yescarta and early data on pipeline up-and-comers.

Yescarta scored FDA approval in 2017 but hasn’t yet taken off in a way that can offset Gilead’s shortfalls in hepatitis C. The cell therapy, approved to treat large B-cell lymphoma after two or more lines of systemic therapy, generated $264 million last year. It’s vying against Novartis’ Kymriah, which won the first-ever cell therapy approval.

Yescarta’s approved indication covers adults with relapsed or resistant disease after at least two previous rounds of treatment. One ASCO analysis delved into how the therapy works in the older segment of those patients—and the answer is, better than in younger folks.

In an analysis of its pivotal Zuma-1 study, patients 65 and older saw a 92% overall response rate at a median 27.1 months, compared with 81% among patients under 65. Seventy-five percent of the older group achieved a complete response, compared with 53% for those under 65.

And at a two-year follow-up, 42% of those 65 and older were still responding to Yescarta, also known as axicabtagene ciloleucel, compared with 38% of those under 65. Further, 54% of the older patients were still alive after that two-year period, compared with 49% in the under-65 group.

The findings are important, co-lead investigator Sattva Neelapu points out, because “patients with refractory large B-cell lymphoma who have exhausted treatment options and are still facing progressive disease are often older.”

“Our results showed axicabtagene ciloleucel offered clinical benefit with a manageable safety profile in people aged 65 and over, which reinforces this therapy’s use in these patients who otherwise have limited treatment options,” Neelapu said in a statement.

Gilead also rolled out a new Yescarta safety analysis Monday showing that using steroids soon after Yescarta treatment could help manage cytokine release syndromes and other serious side effects associated with chimeric antigen receptor T-cell (CAR-T) drugs.

The findings come as Gilead works to build out its cell therapy group after its $12 billion Kite Pharma buy. New Gilead CEO Daniel O’Day, who joined from Roche, has said the technology is a critical component of the company’s strategy.

The drugmaker didn’t only present data on its approved CAR-T drug at ASCO, either. Gilead also rolled out data on an investigational CAR-T called KTE-X19 in adults with relapsed or refractory acute lymphoblastic leukemia. So far in the phase 1/2 trial, patients have seen a “high rate of response” to a single infusion. The phase 2 portion of the study is ongoing.

https://www.fiercepharma.com/pharma/asco-gilead-touts-latest-analyses-for-yescarta-plus-early-data-investigational-car-t

ASCO Day 4 blog

Exclusive live coverage from day four of the American Society of Clinical Oncology’s annual meeting in Chicago.

• To view all of our coverage from the preeminent cancer event, produced in association with Kantar Health, as well as additional content, visit the Spotlight on ASCO 2019 and the future of oncology

Key highlights for Monday:

Seattle Genetics will present details of EV-201, also known as enfortumab vedotin monotherapy in locally advanced metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.
Bayer will present additional data on its larotrectinib in TRK fusion cancers, a precision medicine that works on cancers of any origin in the body that are driven by the mutation driven by tropomyosin receptor kinase (TRK).
Another highlight is an oral presentation of the first phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of Cancer (EORTC), investigating the activity and safety of Ipsen/Exelixis’ cabozantinib in patients with metastatic gastrointestinal stromal tumour after failure of imatinib and sunitinib.

View the live coverage from day four at ASCO 2019 below (the live blog may take a few seconds to load) and we will also have live coverage from day five at ASCO:

More from the cabozantinib presentations

Cabozantinib data is being presented this morning, and is certainly making an impact.

More from that larotrectinib data presented yesterday.

It looks like a few things got moved around in the schedule. There is already some larotrectinib data floating around from yesterday, including this paper with some case studies in patients with brain metastases: https://ascopubs.org/doi/full/10.1200/PO.19.00009

Also this morning was a brief presentation from the FDA’s Richard Pazdur, director of the regulator’s oncology Center of Excellence.

The FDA wants to highlight Project Facilitate, which aims to enable patients to access to investigational oncology drugs.

The Reagan-Udall Foundation has a navigator website providing information sponsors’ policies and listings on ClinicalTrials.gov.

Meanwhile Project Facilitate will provide continuous support to healthcare professionals throughout the EA process.

Finding patients to take part in clinical trials is always a vexing issue for pharma.

Latest results suggests using expanded criteria would enable nearly twice as many lung cancer patients to consider trial participation.

Findings of the study led by Professor Donald Harvey of the Winship Cancer Institute of Emory University, show that broadened trial criteria resulted in trial populations more reflective of the patient population.

ASCO is urging all clinical trial sponsors to adopt wider the wider criteria piloted in the trial and only exclude patients for compelling scientific reasons.

The broadened criteria were: including patients with another primary cancer that does not interfere with safety/efficacy, including patients with treated and/or stable brain metastases and relaxing rules protecting against kidney toxicity.

Results: using traditional exclusion criteria generated a trial with 5,495 non-small cell lung cancer patients. Using expanded criteria almost doubled this, adding 4,851 patients to produce a trial involving 10,346 people.

In the broadened trial 22% were older than 75, compared with 16% using the traditional criteria.

This is important as there is a need to include more older people in cancer trials, said Prof Harvey.

Some promising results from Seattle Genetics/Astellas’ antibody-drug conjugate enfortumab vedotin.

The drug is being tested as monotherapy after previous treatment with platinum chemo and immune checkpoint inhibitors has failed.

Most patients receiving standard chemo require subsequent treatment in this disease.

Second line PD-1 or PD-L1 checkpoint inhibitors yield low response rates and there is no standard therapy for patients after this line of treatment.

Enfortumab vedotin targets Nectin-4, a therapeutic target highly expressed in multiple solid tumours.

Results discussed at ASCO were from one cohort of the EV-201 trial – patients had been treated with platinum chemo and PD-1/PD-L1 checkpoint inhibitor.

Results at this stage show a 44% response rate and a complete response of 12% and 7.6 months median duration of response.

Responses were observed across all subgroups and irrespective of response to PD-1/L1.

Daniel Petrylak, study author presenting the results, a professor of urology at Yale, said the results were strong enough to support an accelerated approval.

This would involve the FDA granting a conditional licence that would be confirmed by a larger study, which is ongoing.

Some sobering findings of a study into sexual harassment and gender disparities highlighted at ASCO.

The anonymous email survey went out to 1,566 gynaecologists, with 402 responding.

There were 255 female respondents, 147 male respondents.

Overall, 64% experienced sexual harassment, occurring in 71% of women and 51% of men.

However only 14.5% reported sexual harassment.

Men were more likely to report no obstacles to advancement of their careers.

Study author Marina Stasenko said that low reporting rates were caused by some people thinking the incidents were not important.

“Some folks did not know who to report to, which was more than 20% of respondents”

“Certainly improving the pipeline of who to report to and how to report is very important.”

“Over 90% of respondents knew that there was a policy in their institution but only about 60% knew what the policy was. Increasing awareness will be vastly important.”

There have been a few shout-outs for ASCO’s efforts this year to support parents in general

Riyue Sunny Bao, PhD@RiyueSunnyBao

Hoping more conferences follow the great example of #ASCO19 – and ultimately boost the engagement of #WomenInMedicine #WomenInSTEM #womeninscience !

Ishwaria Subbiah, MD MS@IshwariaMD

#ASCO19 rocks! Dr Annie Im MD (@annieimmcl) of @UPMCnews dropped of her “future members of @ASCO” at the on-site childcare to attend her morning sessions! She and they loved it! This is MEANINGFUL CHANGE for parents (of any gender) in medicine! #WomenInMedicine #medtwitter

9

18:01 – 2 Jun 2019

Fascinating press briefing this morning at ASCO.

Highlights were:

A study showing 60% of gynaecologic oncologists say they have experienced sexual harassment.
Results of a phase 2 trial of novel targeted-antibody treatment for advanced urothelial cancer
Using broader criteria for clinical trial enrolment would double number of eligible patients with lung cancer
A presentation from the FDA about expanding access to compassionate use programmes.

I will be providing more details shortly.

Kantar Health debates results from the KEYNOTE-062 trial

There were a number of debate-worthy outcomes from the KEYNOTE-062 trial that was presented at ASCO 2019 in Chicago yesterday.

The study looked at Merck & Co’s Keytruda as a first-line treatment for gastric cancer, and prompted questions about the meaningfulness of non-inferiority.

Kantar Health’s Debbie Warner and Michael Gaschler debate the results here.

A small biotech, MacroGenics, took the market by surprise earlier this year with some surprising data from its margetuximab – essentially a tweaked version of Roche’s Herceptin (trastuzumab) where a few amino acid mutations are enough to produce a stronger cellular response to cancer.

CEO Scott Koenig has been doing the rounds at the American Society of Clinical Oncology (ASCO) conference in Chicago following release of detailed data from the SOPHIA trial of margetuximab in breast cancer patients who have previously been treated with Herceptin and other similar medicines.

A multiple myeloma showdown at ASCO 2019

Day three of ASCO 2019 saw a showdown on Sunday between two anti-CD38 compounds in multiple myeloma, Janssen’s Darzalex and Sanofi’s isatuximab. Kantar Health reviews the data.

Lynparza wows ASCO with pancreatic cancer data

Finding targeted therapies for pancreatic cancer has long been an issue for pharma, meaning that for decades the only real option has been a course of chemotherapy, with unpleasant side-effects and limited efficacy.

In most cases the prognosis even with chemotherapy is between eight and 12 months, a “dismal” situation according to Hedy Kindler, from Professor of Medicine at the University of Chicago.

Kindler was presenting data from the POLO study that is already being described as a game-changer for a small group of patients with the disease.

Kantar Health reviews results from phase 3 POLO trial

Anna Boudoures from Kantar Health reviews the “practice-changing” results of the phase 3 POLO trial of AstraZeneca and Merck & Co’s drug, as presented at ASCO 2019 in Chicago. Watch the video here.

ASCO pilots EHR standards

Cancer doctors in the US have launched a new scheme that aims to improve care by setting out electronic health record standards.

There are 15 million people with cancer in the US but many electronic health record systems use different terms to describe the same type of data, or collect data in different formats, making them incompatible.

ASCO 2019 day four