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Friday, April 5, 2019

NIH Begins Trial of Potential Universal Flu Vaccine

The flu season is almost over and from physicians’ accounts, it has been a bad one across the United States – even for those people who received a flu shot in the fall.
Globally, there are about 650,000 deaths from the flu worldwide and millions of people are hospitalized due to the illness. According to the U.S. Centers for Disease Control and Prevention, those people who are considered at high risk of serious flu complications include people over the age of 65, as well as people who have pre-existing conditions such as asthma, diabetes, heart disease or chronic lung disease.
While there are flu shots available for patients, they are not guarantees that a patient will not get the flu, as there are multiple strains of the bug that the shot does not necessarily provide protection. Things could be changing for the better though. This week, scientists at the National Institutes of Health (NIH) launched a trial to examine a potential universal flu vaccine candidate, known as H1ssF_3928. According to the NIH, the experimental vaccine is designed to “teach the body to make protective immune responses against diverse influenza subtypes by focusing the immune system on a portion of the virus that varies relatively little from strain to strain.” The hope is that H1ssF_3928 will provide long-lasting protection from many strains of the flu for all age groups.
The vaccine candidate was developed by a team of NIH scientists attached to the agency’s Vaccine Research Center (VRC) Clinical Trials Program. H1ssF_3928 displays part of hemagglutinin (HA), an influenza protein, on the surface of a microscopic nanoparticle made of nonhuman ferritin, NIH said in a statement. Ferritin is a natural protein found in cells and is useful as a vaccine platform “because it forms particles that can display multiple influenza HA spikes on its surface, mimicking the natural organization of HA on the influenza virus,” according to the NIH. HA enables the influenza virus to enter a human cell and the body can then mount an immune response.

The VRC team anticipates enrollment in the Phase I trial to be completed by the end of 2019 and expects to begin reporting results in early 2020. Trial participants will record their temperature and any symptoms on a diary card for one week after each injection. They also will be asked to visit the clinic to provide blood samples at various time points. Investigators will test the samples in the laboratory to characterize and measure levels of anti-influenza antibodies. The patients will not be exposed to any influenza virus as part of the clinical trial.
“Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci said in a statement. “This Phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine.”
Other headway is being made in the battle against the flu. Last year, a group of scientists launched a study of a llama antibody as a potential flu vaccine. A team from the Scripps Institute in Southern California has been able to take antibodies made by llamas and used them as the basis for a flu vaccine. The llama antibodies are effective enough to work on a wide number of flu viruses, according to the report.
Also last year, the U.S. Food and Drug Administration approved Genentech’s Xofluza, a single-dose treatment for the flu, the first new flu treatment greenlit by the FDA in nearly 20 years.

Thursday, April 4, 2019

Piper Jaffray stays Overweight on Alder Biopharma, Amgen after Novartis filing

Piper Jaffray analyst Christopher Raymond maintains his Overweight rating on Alder Biopharma (ALDR) and Amgen (AMGN) after the filing by Novartis (NVS) alleging legal dispute with the latter about their migraine collaboration. The analyst says that Novartis tried to beat Amgen to the punch after entering agreement with Alder to manufacture eptinezumab, which prompted Amgen to terminate their commercialization agreement. Raymond adds that a resolution of this dispute could take a year or more but believes that investors may conclude that the spat reflects the value of anti-CGRP assets

Acceleron ACE-2494 program was ‘high-risk’, says Piper Jaffray

Piper Jaffray analyst Danielle Brill keeps her Overweight rating and $74 price target on Acceleron after its discontinued Phase 1 safety trial of ACE-2494. The analyst says the program was already seen as ” high-risk due to several failures with similar approaches” and it was not included in her valuation. The analyst keeps a positive view on the stock, expecting the company’s Phase 2 myelofibrosis data to drive shares higher in the second half of 2019.

Is Walgreens CEO Pessina Opening Up To A Big Merger?

After what he called “the most difficult quarter” since Walgreens Boots Alliance was formed, Stefano Pessina may be leaning toward more than just executing partnerships as a way to grow the global drugstore chain and boost its battered stock price.
The Italian billionaire, who is Walgreens CEO and biggest individual shareholder, has long said he prefers partnerships rather than a large transformative acquisition. There’s been speculation dating back two years that Walgreens will buy the rest of giant distributor AmerisourceBergen Corp. that it doesn’t own or might acquire a health insurer like Humana, which already has a joint venture with the drugstore giant to develop senior health clinics.
But Walgreens hasn’t made a sizable acquisition since its $4.4 billion purchase of more than 1,900 Rite Aids and Wall Street appears to be getting restless. By comparison, CVS Health spent $70 billion to buy Aetna, the nation’s third-largest health insurer.
After being pressed on Walgreens quarterly earnings call by the noted J.P. Morgan analyst Lisa Gill, Pessina revealed the drugstore chain was reviewing some targets.
“We are constantly reviewing a certain number of companies,” Pessina said on a longer-than-usual 90-minute call Tuesday to discuss earnings. “Don’t ask me the names, I cannot give you the names. But of course, until now, we have not found the right numbers to do a combination with these companies.”
Wall Street is looking for results from Walgreens partnership strategy after the drugstore chain in the last three years has signed deals with Microsoft,the grocer Kroger, Humana and UnitedHealth Group’s urgent care business. For much of the last two years, such deals have been testing concepts and piloting healthcare services and technology to develop what executives have called the “drugstore of the future.”
But the partnerships won’t churn out profits for awhile.
“On the partnership front, for the first time (Walgreens) highlighted the multiple partnerships formed over the past few years probably will not be accretive to earnings until 2022, which is likely later than street expectations,” Mizuho Securities USA analyst Ann Hynes wrote this week.
Meanwhile, Pessina has said repeatedly for the last two years that he’s not going to execute a big merger or acquisition for the sake of doing one even though he said this week “some acquisition could be done mainly financing them through cash.”
“I can just give the same answer that I have given in the past,” Pessina said, responding to JP Morgan’s Gill. “We are open to any kind of partnership which makes sense, which is compatible with what we are doing, provided that the price is correct and provided that the organization of the company that we buy or that we merge is compatible with us because the prices are important. But also if you don’t have a compatible teams at the end, the merger will not work and you will not be able to deliver synergies.”

Health Canada plans to suspend Allergan’s breast implant license

Health Canada plans to suspend the license for Allergan Plc’s Biocell breast implant due to the risk of a rare cancer linked to such implants, the regulator said in a notice to the Botox-maker on Thursday.

Breast augmentation using implants is a popular form of cosmetic surgery but regulators are studying textured implants, which have a rough surface, and their possible link to anaplastic large cell lymphoma (ALCL).
Allergan has 15 days to respond to Health Canada, after which the regulator would suspend the license to sell the implants, if the company’s response is not satisfactory, the agency said.
Allergan is reviewing Health Canada’s notice and intends to respond within the deadline, a company spokeswoman said.
About 28 cases of breast implant-associated ALCL have been brought to the notice of Health Canada, out of which 24 involved the Biocell breast implant, the agency said.
The health regulator said its move followed the completion of its assessment of textured breast implants as part of a larger ongoing safety review.
Allergan’s Biocell implant is the only macro-textured device available in Canada.
Advisers to the U.S. Food and Drug Administration last week concluded a two-day hearing about the pros and cons of breast implants. The agency has not yet proposed any change to how implants are used on the basis of the recommendations of the advisers.
Allergan stopped the sale of its textured breast implants in Europe in December, a day after they were recalled by France’s National Agency for the Safety of Medicines & Health Products due to non-renewal of their safety certification by another agency.

Merrimack to discontinue development of MM-310

Merrimack announced the company is discontinuing development of MM-310, its antibody-directed nanotherapeutic for the treatment of solid tumors. This decision was the result of a comprehensive review of available safety data from its Phase 1 study. Based on emerging data since the recent amendment of the clinical protocol, the company has concluded that the study would not be able to reach an optimal therapeutic index for MM-310. Merrimack has terminated the study and expects to initiate a workforce reduction as it closes out clinical activities, reflective of its narrowed preclinical pipeline and in line with prior cost-cutting measures. “We are disappointed that amending the trial protocol does not appear to have solved the cumulative toxicity observed in patients treated with MM-310,” said Sergio Santillana, M.D., M.Sc., Chief Medical Officer of Merrimack. “However, we are grateful to our investigators and patients for their commitment to cancer research, and to our team for all their efforts in supporting the development and clinical evaluation of MM-310.” “Due to our ongoing exploration of strategic alternatives and given these unfortunate challenges in identifying a clinically meaningful safety profile for MM-310, we have decided to halt further development of the program,” said Richard Peters, M.D., Ph.D., President & Chief Executive Officer of Merrimack. “Additionally, as we have narrowed the scope of our pipeline to our two most promising preclinical programs, MM-401 and MM-201, we are initiating steps to close out remaining clinical activities in order to further preserve our resources. We continue to prudently advance these programs as we work expeditiously to bring our ongoing strategic process to conclusion.” In November, Merrimack announced the observation of emerging cumulative grade 3 peripheral neuropathy in three solid tumor patients following multiple cycles of treatment with MM-310 and amended the clinical protocol to extend the dosing schedule from an every three week to an every four week regimen, tightened inclusion and exclusion criteria and implemented proactive dose-reduction rules at the first signs of peripheral neuropathy. Despite the amended protocol, emerging data show MM-310 administered every four weeks continues to result in significant cumulative peripheral neuropathy, which precludes the study from reaching an optimal therapeutic index for MM-310. Merrimack plans to work swiftly to close out clinical activities and carry out associated cost-cutting measures and expects to provide an update on these efforts with its first quarter 2019 financial results. Additionally, in light of its ongoing strategic process, the Company continues to prudently advance its preclinical immuno-oncology pipeline: MM-401, an agonistic antibody targeting a novel immuno-oncology target, TNFR2; and MM-201, a highly stabilized agonist-Fc fusion protein targeting death receptors 4 and 5. Encouraging data from both programs were presented at the American Association for Cancer Research Annual Meeting held March 29 – April 3 in Atlanta, GA.
https://thefly.com/landingPageNews.php?id=2888897

Piper maintains Overweight rating, $3 target on Aveo after stock sale

Piper Jaffray analyst Edward Tenthoff maintains his Overweight rating and $3 price target on Aveo Pharmaceuticals after the company “opportunistically” raised $25M by issuing 21.7M shares at $1.15 per share and 21.7M in warrants with a $1.25 strike price. The analyst, who estimates that Aveo now holds pro forma cash of about $57M, said the primary driver for the stock remains the OS analysis for TIVO-3 that is scheduled to be reported in Q4. If the hazard ratio does not drop to less than 1.0 for tivozanib, Tenthoff does not believe the FDA will accept a new NDA filing, he noted