Tandem Diabetes Care Launches New Insulin Pump in US

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps with continuous glucose monitoring (CGM) integration, today announced its launch of the t:slim X2™ Insulin Pump with Basal-IQ™ Technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia). It is integrated with the Dexcom G6® CGM System, which requires no fingersticks for calibration or diabetes treatment decisions.^1,2 The Company has begun sending emails with update instructions to all in-warranty t:slim X2 users in the United States, who have the option to add the new feature free of charge via remote software update.³ t:slim X2 Pumps pre-loaded with Basal-IQ Technology are expected to begin shipping to new customers by the end of August.

Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. In the pivotal clinical study, use of the t:slim X2 Pump with Basal-IQ Technology demonstrated a 31 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature. The system received high usability scores in the study, with 93 percent of participants indicating that the system was easy to use, and 97 percent indicating that they felt confident using the system.⁴

“This launch marks the achievement of our goal to offer people with diabetes a simple-to-use automated insulin delivery feature that can reduce time spent low without adding significant burden to the pump therapy experience,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “Our ability to provide remote software updates, allowing in-warranty t:slim X2 Pump users the ability to add Basal-IQ Technology to their current pumps using a personal computer, is unparalleled in the industry and further differentiates the t:slim X2 Insulin Pump from other devices on the market.”

https://bit.ly/2Bkno7l

Healthy Interactions, Merck in Digital Patient Diabetes Management Plan

Healthy Interactions, a global leader in health education, in collaboration with Merck  (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch of map4health™ – a digital platform and mobile application in the U.S. that was designed to help facilitate and enhance communications between diabetes patients and educators. This technology was developed as an extension of the Journey for Control collaboration between Healthy Interactions and Merck, and will make its debut today at the 2018 American Association of Diabetes Educators (AADE) Annual Conference in Baltimore.

Map4health is designed as a platform to help improve the quality of diabetes patient support in between in-person coaching sessions by enabling patients to connect with educators through text and video-chat, as well as providing weekly digital activities to sustain patient engagement. Patients may choose to securely log health information that their educators are able to review and respond to within the platform.

“Healthy Interactions has collaborated with Merck for over 10 years on Journey for Control to encourage patients living with diabetes to become more engaged stewards of their health,” said Paul Lasiuk, co-founder and chief executive officer, Healthy Interactions. “Today, we are proud to introduce map4health, and believe this tool will further enhance the positive impact that diabetes educators are making in the lives of their patients.”

In 2007, Healthy Interactions and Merck, also in collaboration with the American Diabetes Association (ADA), launched Journey for Control – a patient-centric education initiative targeting diabetes educators and utilizing the U.S. Diabetes Conversation Map^® – to collaborate on developing tools focused on lifestyle and behavioral change to help healthcare providers improve diabetes management for people living with the disease.

“The American Diabetes Association supports technology-based methods, along with individual and group settings, for the delivery of effective diabetes self-management education and support,” according to Matt Petersen, vice president at the American Diabetes Association. “The ADA has been extremely satisfied with the ability to connect providers and patients that has been enabled through our collaboration with Healthy Interactions and Merck.”

“We are thrilled our work with Healthy Interactions will provide diabetes patients and educators a digital platform for dialogue and personalized self-management tools,” added Lisa French, associate vice president, strategy and commercial model innovation, Merck.

For more information on map4health, please visit www.map4health.com.

https://bit.ly/2L1BD0r

Iovance Continues Path in Developing TIL Treatments for Solid Tumors

Maria Fardis, chief executive officer of Iovance Biotherapeutics, sees tumor infiltrating lymphocyte (TIL) therapies as the best immunotherapy option to treat solid cancers.

In an interview last year with BioSpace, Fardis explained that TIL technology is a “boosting” of the body’s natural immunity. The TIL is removed from a cancerous tumor, “amplified” through genome sequencing to attack the disease, then reinserted into the tumor to do the work. Because the amplified TILs can attack the whole tumor, including any potential mutations, Fardis described it as “the most exquisite kind of personalized medicine for a patient.”

Earlier this year, Iovance released preliminary data from two Phase II trials evaluating its lead candidate lifileucel (LN-145). One was the C-145-03 trial in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The preliminary data showed three of the eight patients in the trial showed a 30 percent decrease in tumor size. That was noted as a partial response. The other trial, C-145-04, evaluated the effect of LN-145 in patients with recurrent, metastatic or persistent cervical carcinoma. BioSpace noted at the time that only two patients were evaluable, one confirmed Partial Response and one had stable disease. In May, the company was granted orphan-drug designation from the U.S. Food and Drug Administration (FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.

LN-145 is also being developed as a potential treatment for metastatic melanoma. The FDA granted Fast Track designation for LN-144 in this indication. An update on the melanoma project is expected later this year and Iovance could be eying early talks with the FDA about a potential pathway to approval. Last year, the company presented some preliminary data that showed three of nine patients had partial responses and the company was waiting to confirm if a fourth patient showed a partial response. More data from this trial is expected to be disclosed later this year.

Despite Iovance’s work, though, the company is not getting any love in an article on Forbes. Titled “Does Tiny Iovance Deserve to Ride the T-Cell Wave?”, the article questions whether or not Iovance’s TIL technology is an effective path in treating solid tumors, or if it’s “riding a wave of hype?” The article points to a “lack of data” that Iovance has provided regarding its TIL therapies, particularly whether or not the treatments would be marketable and profitable. The article suggests that most data now is anecdotal and needs to be backed by hard data that demonstrates the efficacy of the TIL technology. The article also looked at some of the company’s past failures in cancer research before it became Iovance. Despite the question of hype, the Forbes piece outlines the scope of what Iovance is doing with TIL research.

Citing the National Cancer Institute’s Steven Rosenberg, a TIL pioneer that Iovance licensed its TIL technology from, Forbes said Iovance is not on his radar when it comes to TIL therapies. Rosenberg’s research, according to Forbes, shows that “24 percent of 101 patients with melanoma had a complete response to TIL therapy, with half of the patients still alive three years after treatment.” Rosenberg is bullish on TIL technology as a potential treatment for solid tumors.

“If you find something that works, the genius of modern industry will find out ways to make it available,” he told Forbes.

https://bit.ly/2nKS341

Novo Nordisk Acquires Ziylo in Possible $800 Million-Plus Deal

Copenhagen, Denmark-based Novo Nordisk acquired Bristol, UK-based Ziylo in a deal that could exceed $800 million.

Ziylo was spun out of the University of Bristol and is based at the Unit DX incubator in Bristol. The company has been developing a technology platform based on synthetic glucose binding molecules. As part of the deal, Novo Nordisk gains full rights to Ziylo’s glucose binding molecule platform to develop glucose-responsive insulins, which is consistent with Novo Nordisk’s focus on the diabetes market.

It is believed that a glucose-responsive insulin might help eliminate the risks of low blood sugar, which is one of the primary risks associated with insulin treatment in diabetics.

Before the acquisition, some of Ziylo’s research activities were spun out of the company into a new company, Carbometrics. Carbometrics has inked a research collaboration with Novo Nordisk to help with optimization of the glucose binding molecules. Carbometrics licensed rights to develop non-therapeutic approaches of the glucose binding molecules with plans to focus on developing continuous glucose monitoring applications. Carbometrics will stay at the Unit DX location.

“Ziylo is the first major success coming out of the Unit DX Scientific Incubator,” said Keith MacDonald, chairman and co-founder of Unit DX, in a statement. “It was set up to incubate the next generation of science companies and help develop a new breed of science entrepreneurs. In a very short period of time, the incubator has grown to house 25 high-quality science driven companies and has been instrumental in retaining Bristol’s world-class scientific talent and research. I am pleased to say we now have a waiting list of companies wanting to join the incubator which is validation of the high-quality research in Bristol.”

Under the terms of the deal, Novo Nordisk bought all Ziylo shares for an upfront payment and various contingent milestone payments. Although specific details were not released, total payments could exceed $800 million.

Marcus Schindler, senior vice president, Global Drug Discovery for Novo Nordisk, stated, “We believe the glucose binding molecules discovered by the Ziylo team together with Novo Nordisk world-class insulin capabilities have the potential to lead to the development of glucose responsive insulins which we hope can remove the risk of hypoglycemia and ensure optimal glucose control for people with diabetes.”

Ziylo was co-founded by Harry Destecroix while he was completing his doctorate in the Anthony Davis laboratory at the University of Bristol. Destecroix is also the co-founder of Unit DX along with Tom Smart, chief financial officer, and Keith MacDonald, chairman.

Although a powerhouse in the diabetes market, Novo Nordisk is facing the same pricing pressure in the U.S. as the other companies in the field. At its recent second-quarter financial report, revenue was down 4 percent, with income from operations down 9 percent. Part of that was year-over-year revenue was hit by lower current rates for the Danish kroner. Its top-selling GLP-1 diabetes drug, Victoza, grew 6 percent year-over-year, driven by international sales, which were 14 percent. The same drug sold as Saxenda for obesity, had an increase of sales by 40 percent, although those sales were only $126.8 million compared to Victoza’s sales of $855 million.

https://bit.ly/2L3velo

FDA OKs Bristol Opdivo as 1st Med in 20 Years for Some Small Cell Lung Cancers

Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.¹ Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

https://bit.ly/2OJpDD8

Regeneron: FDA approves application for EYLEA Injection for wet AMD

Regeneron Pharmaceuticals announced that the U.S. FDA has approved a supplemental Biologics License Application for EYLEA Injection in patients with wet age-related macular degeneration. The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule. These data are now included in the updated EYLEA label. EYLEA is also approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.

https://bit.ly/2nIWRHd

Amedisys price target raised to $125 from $103 at Oppenheimer

Amedisys price target raised to $125 from $103 at Oppenheimer. Oppenheimer analyst Michael maintained an Outperform rating on Amedisys and raised his price target to $125 from $103, telling investors in a research note that he remains a buyer following meetings with management. The company is hopeful that CMS will either change or be force to change the 6.2% behavioral adjustment, Wiederhorn says, adding that Amedisys is particularly bullish on the outlook for the hospice business, which now accounts for 45% of EBITDA.

https://bit.ly/2PiBj0q