Reports Q2 revenue $23.5M, consensus $10.67M.
Wednesday, August 1, 2018
Turning off protein may up immunotherapy effect on cancer tumors
Researchers at the Bloomberg~Kimmel Institute for Cancer Immunotherapy in the Johns Hopkins Kimmel Cancer Center discovered inhibiting a previously known protein could reduce tumor burdens and enhance the effectiveness of immunotherapy treatments.
In order to investigate the role of the Yes-associated protein, or YAP, in T-cells in the cancer setting, scientists used mice genetically engineered to lack YAP in several T-cell populations, including regulatory T-cells, known as Tregs. This was the first time the relationship between YAP and Tregs has been explored.
The study was published in Cancer Discovery on June 15, 2018.
Tregs are important for health, because they prevent autoimmune diseases but can be a major obstacle in the mounting of immune responses to tumors and immunotherapy. YAP can be found in a subset of those regulatory T-cells.
Scientists tested the antitumor effects of YAP inhibitors alone and in combination with immunotherapies. Their encouraging results showed YAP plays a role in the suppression of antitumor immunity by Tregs and demonstrated by turning off YAP’s abilities, tumor killing with less restrained immune cells is possible.
Fan Pan, M.D., Ph.D., senior author of the study and associate professor of cancer immunology, said blocking YAP or the signaling pathways under its control boosted the effects of both a tumor vaccine and a checkpoint inhibitor (anti-PD1 antibody) to produce even stronger antitumor activity. He said the approach of therapeutically targeting YAP was effective over a broad scope of cancer types in mice.
Since Tregs are notorious for dampening the effectiveness of tumor-directed immunity in cancer patients, this study’s finding may pave the way for a new and promising strategy to unleash the patient immune response from the stifling grip of suppressor cell control.
While Pan and study authors are optimistic that further work could lead to effective YAP-targeting immunotherapies for cancer, they pointed out therapies aimed at enhancing YAP activity may have potential use for the treatment of autoimmune diseases.
Story Source:
Materials provided by Johns Hopkins Medicine. Note: Content may be edited for style and length.
Journal Reference:
- Xuhao Ni, Jinhui Tao, Joseph Barbi, Qian Chen, Benjamin V. Park, Zhiguang Li, Nailing Zhang, Andriana Lebid, Anjali Ramaswamy, Ping Wei, Ying Zheng, Xuehong Zhang, Xingmei Wu, Paolo Vignali, Cui-Ping Yang, Huabin Li, Drew Pardoll, Ling Lu, Duojia Pan, Fan Pan. YAP Is Essential for Treg-Mediated Suppression of Antitumor Immunity. Cancer Discovery, 2018; DOI: 10.1158/2159-8290.CD-17-1124
Kala Dosing First Patient in Phase 3 Dry Eye Disease Trial
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, today announced that the first patient has been dosed in STRIDE 3 (Short Term Relief In Dry Eye), its Phase 3 trial of KPI-121 0.25% for the short-term treatment of dry eye disease.
“We are pleased to initiate the STRIDE 3 trial of KPI-121 0.25%. If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease,” said Kim Brazzell, Chief Medical Officer. “The STRIDE 3 trial design reflects specific modifications to the inclusion/exclusion criteria of our previous trials to address key factors which we believe will improve the probability of success. We anticipate reporting topline results in the fourth quarter of 2019. We also continue to prepare for the potential approval and launch of INVELTYSTM (KPI-121 1%), which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018, and which, if approved, is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain.”
300+ Aetna members overdose on opioids each month; what Aetna is doing about it
A recent claims review by Aetna revealed that each month, between 300 and 400 of its members are treated for opioid overdoses in emergency rooms.
“The data was alarming,” Daniel Knecht, MD, Aetna’s vice president of clinical strategy and policy, told Becker’s Hospital Review. More than 142,557 Americans presented to the ER with opioid overdoses from 2016 through September 2017, according to the CDC. Dr. Knecht, chief of staff to Aetna’s CMO Harold L. Paz, MD, placed the Aetna-specific data on Dr. Paz’s desk. “We need to do something here,” he said.
The two clinical leaders designed the Guardian Angels program, a case-management pilot connecting opioid overdose members with a specially trained nurse. Among early successes of the program, which rolled out in March 2018, is a 22-year-old woman from Colorado who had two overdoses on fentanyl-laced heroin. After intervention, she began attending group therapy five times a week, Aetna CEO Mark Bertolini wrote in U.S. News & World Report. In concert with Aetna’s other opioid-related initiatives, Dr. Knecht believes Aetna is pushing past the “myopic” goal of only reducing the number of opioids prescribed.
Here, Dr. Knecht details how Aetna is confronting an epidemic gripping hundreds of its members.
Question: Can you dive deeper into the Guardian Angel program?
Dr. Daniel Knecht: We use claims data to identify our members who end up in the emergency room due to an opioid overdose. A nurse does a telephonic outreach. We rely on claims data, so it’s usually a two- to four-week lag. At first we were concerned it might be too late. But that’s not the case. I think what happens is these members suffer a brush with death and they need some time to reflect. Then they’re more open to support.
A nurse calls members up to seven times, which is assertive. Generally, industry standard is calling three times and giving up. Our nurse will leave messages in a HIPAA compliant way, and can connect with up to 40 percent of these folks. The nurse provides those members resources on treatment options in their community, naloxone, caregiver support and behavioral health case-management connections.
Q: What has member reception been like?
DK: Surprisingly, most members are appreciative of the outreach. This is such a sensitive subject. They’re in dire straits and need support. They can’t navigate the confusing healthcare system. But the nurse has worked in addiction centers, dual diagnosis space, Medicaid, and knows how to interact with these members.
Q: The Guardian Angels program is hot off the press. What results do you anticipate?
DK: We set an aspirational goal of reducing our overdose recurrence rate by 50 percent. It’s too early to see if we’ve made an impact. But we have a number of anecdotes where we managed to connect these members with providers in the neighborhood, or where people have actually gone out and picked up Narcan and naloxone. We have conversations with caregivers, because they too are impacted by the epidemic. We provide them education on Narcan and information on Narcotics Anonymous and opioid use disorder. The key point is to connect these people with treatment options like medication and therapy.
Another objective is to fight stigma. We hear time and time again that members think they’re trading one addiction for another, which is completely false. They think medication-assisted therapy like methadone and buprenorphine are the same as heroin and prescription painkillers. No — it’s a treatment option.
Q: Are these treatment options covered under members’ health insurance plans?
DK: Absolutely. The Guardian Angel plan is being funded out of Aetna’s office of the CMO. It’s a pilot, but we’re trying to help all of our members. We provide information on in-network providers and medication, and waive copays for naloxone for fully insured members. We want to connect the dots for them.
Q: Can you talk about your partnership with Pacira on Exparel, a nonopioid pain reliever that can be used for wisdom tooth extractions?
DK: We have an ongoing collaboration with Pacira, which is the manufacturer of Exparel. As we continue to deepen our collaboration, we’ve identified oral surgeons who prescribe too many opioids for wisdom tooth extractions.
Now we have DocFind, an online directory of Aetna-participating providers, and we put a flag next to oral surgeons and other surgeons. When you click the flag, it gives information on nonopioid pain options like NSAIDs and Tylenol, but also Exparel.
Patients don’t want opioids. If there is a product like Exparel that provides local analgesia for up to three days after the surgery that does not have an abuse potential, we’re promoting that. The purpose of updating DocFind is to empower our members to understand opioids are not the only treatment option for post-op pain.
Q: What is health insurers’ role in the opioid epidemic?
DK: Most of the other insurers just look at the reduction of opioids prescribed, which is good, but myopic in my opinion. What makes Aetna unique is we look as holistically as possible.
We set a five-year goal of increasing the percent of our members with access to medication-assisted therapy by 50 percent. That’s where the Guardian Angel program comes into play. It has been scientifically proven that people with opioid use disorder who get treated by some form of MAT are roughly 50 percent less likely to die than those who do not get treated with MAT. [Dr. Knecht referenced an Annals of Internal Medicine study.] This is a life-saving intervention like no other; it’s incredible. As an insurer, Aetna is in the process of becoming a health company. But we need to do everything possible to get our members with opioid use disorder to treatment.
Q: How is Aetna addressing opioid overdose on the provider side?
DK: We teamed up with the Yale School of Medicine in New Haven, Conn., the National Institute on Drug Abuse and the American College of Emergency Physicians to make a set of brief educational videos for ER physicians. The videos go over how to treat patients with opioid use disorder in the ER. We have over 600,000 physicians in our network. We can’t rely on other entities to provide this information.
Q: How do you see Aetna’s impending merger with CVS Health affecting its opioid overdose strategy? I’m thinking about getting MAT to opioid use disorder patients as quickly as possible.
DK: At a very high level, the aspiration of this transaction is to have more front doors to healthcare, to make healthcare more accessible to people. I imagine a world where we could be supporting anyone with a health issue as they walk through the doors at CVS. I think there’s potential. Healthcare as a system is broken. We need to think of innovative ways of fixing it and trying new things.
Q: What kind of innovative interventions are you thinking of?
DK: The silver lining of this national health tragedy is it’s pushing health entities to work together in nontraditional ways. Working with Pacira in such an innovative way, I feel, is unprecedented. We’re working with academics like the Yale team in a very unique way. It’s pushing the whole health ecosystem to work in a more innovative way. I just wish we could do that without the circumstances of such a health crisis.
FDA Grants Breakthrough Tag to Daiichi Sankyo Leukemia Med
FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
・ Quizartinib has received FDA Breakthrough Therapy designation in patients with relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis
・ Significant unmet medical need exists in relapsed/refractory AML, as available treatment options are limited and there are no approved targeted therapies for patients with relapsed/refractory FLT3-ITD AML
・ Third Breakthrough Therapy designation granted by FDA for a compound in the oncology pipeline of Daiichi Sankyo, reinforcing the company’s commitment to transforming science into value for patients with cancer
Incyte reports strong results in second quarter
Incyte Corporation reported 2018 second quarter financial results and highlighted growth in total product-related revenue.
Driving the growth was the blockbuster drug cancer drug Jakafi. Incyte is based near Wilmington.
“With four sources of revenue driving our fast-growing top-line, and multiple opportunities in our later-stage development portfolio that may accelerate this growth in the near-term, we believe we are well-positioned for long-term success,” stated Hervé Hoppenot, CEO. “At Incyte, we aim to build value through developing innovative medicines, and over the next six months we expect to provide multiple updates from our later-stage portfolio. These include sharing data from, and submitting the supplemental New Drug Application (sNDA) for, Jakafi in steroid-refractory acute graft-versus-host disease (GVHD), as well as presenting data for ruxolitinib cream in atopic dermatitis and updated data from our FGFR program in cholangiocarcinoma. Later this year, we also plan to present data for ruxolitinib in combination with our PI3Kδ inhibitor, which is part of our initiative to maintain and expand our leadership position in the treatment of patients with myeloproliferative neoplasms.”
For the quarter ended June 30, 2018, GAAP (Generally accepted accounting principles) net product revenues of Jakafi were $346 million as compared to $276 million for the same period in 2017, representing 25 percent growth.
For the six months ended June 30, 2018, GAAP net product revenues of Jakafi were $659 million as compared to $527 million for the same period in 2017, representing 25 percent growth.
GAAP net income for the quarter ended June 30, was $52 million, compared to a net loss of $12 million, or $0.06 per basic and diluted share for the same period in 2017. GAAP net income for the six months ended June 30, was $11 million, or $0.05 per basic and diluted share, as compared to a net loss of $200 million, or $1.00 per basic and diluted share for the same period in 2017.
Inctye’s share price dropped three percent on the earnings news on a day when the stock market posted a modest gain.
Shares have dropped about 50 percent over the past year, following disappointing news regarding some of the work in its drug development pipeline.
Pfizer to Raise R&D Spending and Expedite Drugs
Pfizer Inc. plans to increase research and development spending and focus on smaller deals in a bid to accelerate the delivery of potential blockbuster treatments to market.
“We now believe we are getting close to a growth period,” Pfizer Chief Executive Ian Read said in an interview.
The New York City-based drugmaker on Tuesday raised projections for R&D spending to between $7.7 billion and $8.1 billion, up from $7.4 billion to $7.9 billion previously, as it seeks to bring several cancer, pain and other drugs in the later stages of development to the market.
Pfizer announced the R&D spending adjustment while reporting that its second-quarter revenue rose 4% to $13.47 billion, with currency movements providing much of the lift. Its net income grew to $3.87 billion, or 65 cents a share, from $3.07 billion, or 51 cents a share.
Pfizer is now doubling down on its own R&D efforts, after looking to do a big deal in the past few years. The company expects 25 to 30 drugs from its pipeline to be approved through 2022, including as many as 15 with the potential to ring up $1 billion in yearly sales.
Citing that potential, Mr. Read told analysts the company wasn’t interested in a big deal any longer. A bid to buy AstraZeneca PLC in 2014 and a subsequent attempt to merge with Allergan both came to naught.
“I don’t believe we need such a deal to drive the growth of the company. We’d be better off focusing on developing our pipeline,” Mr. Read said during an earnings call. He said the company will look at smaller deals that would add to Pfizer’s product offerings, perhaps for a gene therapy.
Mr. Read also said it would likely help drug companies like Pfizer if the Trump administration goes through with plans to eliminate the rebates they pay to drug-benefit managers. “Removal of rebates will be very beneficial,” he told analysts.
After facing criticism from President Trump over prices, Pfizer said in July it would defer planned increases on more than 40 drugs while the administration implements its plans for tackling drug prices.
In the latest quarter, Pfizer’s results were boosted by the performance of key brands, such as the blood thinner Eliquis, Ibrance breast-cancer pills and rheumatoid-arthritis therapy Xeljanz. Pfizer also got a $377 million revenue lift from a stronger dollar.
Yet Pfizer expects foreign exchange to turn into a headwind, and it lowered its revenue target for the year to between $53 billion and $55 billion.
The company has been considering options including a sale of its over-the-counter medicines business, and it affirmed it expects to make a decision this year.
Pfizer shares, which have gained 16% over the last year, rose 3.5% to $39.93 on Tuesday.
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