Tuesday, January 8, 2019
GlaxoSmithKline to look for early-stage assets – CEO
GlaxoSmithKline Plc will actively look to buy early-stage assets and partner with companies, the drugmaker’s chief executive officer said on Tuesday.
Britain’s biggest drugmaker is also likely to evaluate licensing deals and would continue to invest in early-stage HIV treatments, CEO Emma Walmsley said at the JP Morgan healthcare conference in San Francisco.
Walmsley said the company had extensive plans for its experimental drug to treat multiple myeloma, which targets a protein called BCMA, adding that it could be launched by 2020.
On the company’s portfolio of cancer medicines, she said GlaxoSmithKline had almost doubled the size of its immuno-oncology pipeline over the past few months.
The company’s plan to acquire U.S.-based Tesaro for $5.1 billion (£4 billion) in December is among several large healthcare deals in recent months to pump money into cancer drug development.
That was followed by Bristol-Myers Squibb Co’s $74 billion deal to buy Celgene Corp and Eli Lilly & Co’s $8 billion acquisition of Loxo Oncology earlier this month.
In what was widely considered a bold move on Walmsley’s part, last month GlaxoSmithKline also said it would split into two businesses after forming a new joint venture with Pfizer consumer health division.
Global Blood says pre-NDA meeting scheduled with FDA
Bloomberg cites Global Blood Therapeutics CEO Ted Love making the comments at the JPMorgan Healthcare conference.
https://thefly.com/landingPageNews.php?id=2845731
Piper Jaffray believes Argenx’s lead drug efgartigimod is ‘best-in-class’
Piper Jaffray analyst Edward Tenthoff continues to believe Argenx’s lead drug efgartigimod is a “best-in-class anti-FcRn antibody with a biological mechanism amenable to treating several autoimmune diseases characterized by upregulation of IgG.” Further, the analyst is looking forward to the May 16 R&D Day to “highlight Argenx’s exceptional drug discovery capabilities with introduction of ARGX-117 and ARGX-118.” Tenthoff reiterated an Overweight rating and $161 price target on Argenx shares.
https://thefly.com/landingPageNews.php?id=2845739
Medicaid plans cover doctor visits, hospital care—and now GEDs
Emilia Ford became pregnant at 15 and, after her daughter was born, dropped out of high school.
As she held down different jobs during the past decade—including housekeeping and working in a relative’s retail store—she always thought about going for her GED to show she met high school academic skills.
But the Brookhaven, Pennsylvania, woman needed assistance finding tutors and paying for the set of four tests, which cost $20 each.
She found help from an unexpected source: her Medicaid health plan.
AmeriHealth Caritas, a Philadelphia-based insurer with 2 million Medicaid members in Pennsylvania and five other states, helps connect members with nonprofit groups providing GED test preparation classes, offers telephone coaching to keep members on track and pays the testing fees.
Ford is one of 62 plan members who have earned a GED certificate since the benefit began in 2013. “I could not believe this was something a health insurance company would do,” said Ford, 25. “I thought health insurers only paid for medical costs.”
Not anymore.
Medicaid health plans are starting to pay for non-traditional services such as meals, transportation, housing and other forms of assistance to improve members’ health and reduce medical costs.
That change follows efforts by state Medicaid programs to give health plans financial incentives to control spending, said Jill Rosenthal, senior program director for the National Academy for State Health Policy.
Rather than continue to pay a set fee each month to cover members’ health costs, many states are implementing policies that let health plans share in any savings they can demonstrate. That provides motivation for insurers to address factors such as literacy and poor housing, which can drive up health costs.
“Health plans now have incentives for them to find the root causes of problems that will reduce costs that will benefit the plan, its beneficiaries and the states,” Rosenthal said.
But Tufano acknowledged that only a small fraction of people who need the assistance reach out for it. About 1,000 members have started GED training through the insurer in Pennsylvania, Louisiana, South Carolina and Delaware.
“Many of our members are just surviving to keep their heads over water, holding on to jobs and dealing with issues like safe housing, access to food and transportation to get to work or doctor,” he said.
AmeriHealth Caritas is one of just a handful of Medicaid health plans that offer a GED benefit.
WellCare, which covers 2.2 million Medicaid recipients in Missouri, Nebraska, Georgia, Kentucky, Hawaii and Illinois, had 226 members sit for their GED exams since the plan began paying for it in 2012, said spokeswoman Alissa Lawver. The Tampa-based plan does not know how many passed.
A Wellcare survey of its Medicaid adult members in Georgia in 2012 found that about 20 percent did not have a high school diploma or a GED.
“There is a significant relationship between education and health,” Wendy Morriarty, president of WellCare’s ‘Ohana Health Plan in Hawaii, said when launching the benefit in 2016. “A GED is a tool that can lead to increased opportunities for our members to attend college, seek higher-paying jobs and find stable housing. This benefit has the ability to improve the health and well-being of local families and communities.”
Advocates for Medicaid praise the health plans’ efforts.
“I think this sets the standard for the unique role of Medicaid managed care in bridging health care and social services,” said Sara Rosenbaum, health law and policy professor at George Washington University.
Ford said having a coach at AmeriHealth walk her through the sign-up process for GED classes, help her register for tests and call her twice a week to keep her motivated was vital to her success. The program also offered child care and transportation to the prep classes and exam sites. She started in May 2017, taking two classes a week, and passed her exams last summer.
When she finished, AmeriHealth hired Ford as an intern in its member services department. In December 2017, the insurer hired Ford to a full-time position—with health benefits—to work as a GED coach for other Medicaid members.
The job meant Ford became the first of nine siblings to get off Medicaid and find employer-based coverage.
“I feel like I was saved from the struggle I was going through,” Ford said. “This is something big that my family was proud of.” While she was growing up, she said, her father drove a school bus and her mom took care of the kids.
In the past year, Ford has helped 12 plan members earn their GEDs and she’s coaching 30 more.
“I can tell them I have been where you are on the other side of the phone and can share my experience and it helps give them more trust in me,” Ford said.
“The hardest thing is not giving up even after failing a test and being able to get back up and push yourself and get over the discouragement,” she said. “There is always something good that you can take from a bad situation.”
Unity takes up option on Ascentage aging drug
A collaboration between California’s Unity Biotech and China’s Ascentage Pharma has yielded a development candidate to treat age-related diseases of the eye.
Unity and Ascentage have been working together since the middle of 2016 on “senolytic drugs,” compounds that can remove aging or senescent cells from the body that are thought to contribute to a range of age-related illnesses. Clearing the cells seems to delay the onset of these disorders, according to animal studies. The collaboration has focused on the Bcl-2 pathway, thought to play a key role in programmed cell death or apoptosis.
The first drug to emerge from that effort is UBX1967, which could have potential in a range of eye disorders including age-related macular degeneration (AMD) as well as diabetic macular edema and diabetic retinopathy, says Unity.
The company’s lead drug candidate is UBX0101, an inhibitor of p53-MDM2 interaction which is in early-stage testing for osteoarthritis, and UBX1967 will be its second clinical program.
The multibillion-dollar market for drugs to treat AMD and similar retinal conditions is dominated by biologic anti-VEGF drugs like Lucentis and Eylea, which can slow the progression of the disease but have to be delivered by injection directly into the eye. There could be strong demand for a small-molecule alternative that could be dosed orally or via eye drops.
Other companies company trying to develop alternatives to injectables for retinal diseases include startup Macregen, which has an eye drop-delivered peptide in clinical trials, and PanOptica with oral VEGF inhibitor PAN-90806 in phase 1/2.
Unity’s intention is to start dosing its drugs locally in the first instance to get proof-of-concept, and if successful start to explore systemic dosing that could open up new disease indications.
“We plan to submit our IND application and commence a phase 1 clinical study [of UBX1967] in an ophthalmological indication in the second half of 2019,” says Unity on its website.
Ascentage’s CEO Dajun Yang, M.D., Ph.D., said the company is “pleased that Unity has chosen one of our compounds for IND-enabling studies focused on age-related diseases of the eye.”
“Their decision further validates our industry-leading expertise in the discovery and development of small molecules for complex and difficult-to-target protein-protein interactions including Bcl-2 and other apoptotic pathways,” he added.
The latest compound licensing agreement puts Ascentage in line for an undisclosed upfront payment in Unity stock, as well as cash milestone payments and royalties. Unity completed an $85 million IPO last year to help fund its clinical programs.
Cellectis CEO Choulika on deals, validation and the future of CAR-T
The future of CAR-T is off the shelf, according to Cellectis CEO André Choulika. Allogeneic CAR-T therapy, which uses donor T cells, has the potential to clear the hurdles that come with autologous CAR-T, which uses a patient’s own T cells. Those challenges include the cost, complexity and time-consuming nature of autologous treatments, as well as distribution and market access. Some patients can’t benefit from autologous CAR-T because they don’t have enough T cells or T cells of good enough quality to make those treatments.
“With off-the-shelf CAR, you don’t ask patients to provide part of the raw materials for their treatment,” Choulika said at the J.P. Morgan Healthcare Conference. And the allogeneic approach could expand the reach of CAR-T treatments beyond certain indications, namely those in which patients don’t need that particular tissue to survive.
Take the blood cancers for which CAR-T therapies have already been approved—two different forms of B-cell lymphoma. If the CAR-T cells remain in the body for a long time, “that’s OK,” Choulika said. “The patient can survive without B cells.”
“If the target is expressed on myeloid progenitor cells … the patient cannot rebuild blood, even red blood cells,” Choulika said. “You don’t want the CAR to stay there forever, so it doesn’t really make sense to make an autologous CAR.”
Founded nearly 20 years ago as a gene-editing company, Cellectis found validation—and “a bit of cash”—in a deal with Servier in 2014.
“[It] was a really difficult decision for us … If we’d had the same amount of cash [in 2014] that we have today, I wouldn’t have licensed any of our targets to anyone,” Choulika said.
But at the time, the autologous treatments Kymriah and Yescarta hadn’t been approved and no one really believed in allogeneic CAR-Ts, Choulika said. So the company licensed out its lead asset, UCART19, to gain some credibility and to be able to move it forward. Later in 2014, Cellectis licensed another 14 assets to Pfizer.
Between them, Cellectis, Servier and Pfizer had programs with 31 targets, though some of the disease areas overlap. Working in the same indications doesn’t necessarily spell out competition, though. Combining these treatments could make them more effective, reducing relapse in patients.
Four years later, in 2018, Pfizer spun out its CAR-T portfolio, the assets finding their way to Arie Belldegrun and David Chang’s Allogene.
It was a good decision, Choulika said.
“We are excited to be working with very experienced people such as Belldegrun and Chang … It’s great for UCART19 that has been licensed from Servier to Allogene and it’s good for us because we benefit from this experience that the Allogene team had in past in our current development.”
Choulika sees autologous CAR-T therapies as something to be used in a hospital setting, like a bone marrow transplant, with off-the-shelf versions being the way forward. He also sees the technology being applied to not just T cells, but other immune cells, such as natural killer cells, to tackle other diseases, expanding its utility from liquid cancers into solid tumors and then into other areas, such as autoimmune diseases.
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