Ultra-thinly traded Vaccinex (VCNX+26%) is up on over 50% higher volume, albeit on turnover of only ~13K shares, on the heels of thee presentations at AACR related to its anti-SEMA4D technology.
The company states that the details of each of the three are on its website, but only the titles appear.
The FDA issued a statement from outgoing Commissioner Scott Gottlieb on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, in which he stated in part: “In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis and its components, including cannabidiol, or CBD…We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.” The FDA is announcing a number of new steps and actions to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities, Gottlieb said. These new steps include: A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety; The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health; Updates to its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products; and the issuance of multiple warning letters to companies marketing CBD products with “egregious and unfounded claims that are aimed at vulnerable populations.” Publicly traded companies in the cannabis space include Aphria (APHA), Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC), MediPharm Labs (MLCPF) and Tilray (TLRY).
Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $75 price target on Crispr Therapeutics, and added that Crispr remains a top pick for 2019, after the company announced the expansion of its wholly-owned allogeneic CAR-T pipeline at the American Association for Cancer Reseach, or AACR. Tenthoff said he expects more preclinical CAR-T data at the American Society of Gene and Cell Therapy, or ASGCT, in April. The analyst believes the biggest driver for the company remains “first-in-man Phase I/II CTX001 data in Beta-thal and potentially Sickle Cell Disease” this year. https://thefly.com/landingPageNews.php?id=2887545
Probiotics are wildly popular. After all, the microbial cocktails are available over the counter and have been shown to be helpful in the treatment of gastrointestinal illnesses for some people.
But some scientists worry probiotics aren’t as innocuous as they seem — and might be affecting the way other medicines work in the body.
The latest cautionary note comes in the form of a preliminary study released Tuesday, in which researchers found that melanoma patients were 70 percent less likely to respond to cancer immunotherapy if they were also taking probiotic supplements. The study group was small — just 46 patients — but the findings support broader suggestions that probiotics might actually upset the balance of so-called “good” bacteria in the gut and interfere with the immune response.
The research was conducted by MD Anderson Cancer Center in Houston and the Parker Institute for Cancer Immunotherapy in San Francisco.
“We wanted to bring this to the forefront of people’s minds: That probiotics sold over the counter aren’t necessary,” said Dr. Jennifer Wargo, lead author of the study and an associate professor of surgical oncology at MD Anderson. “They may not help you, and might even harm you.”
But because probiotics — like vitamins and other such supplements — are only loosely regulated by the Food and Drug Administration, consumers are free to sprinkle these prepackaged bacterial spores in with their standard therapeutic regimens. And that could have serious implications for their medical outcomes.
“I strongly, strongly question why the general public takes probiotics when medical evidence to this routine is not really available,” said Eran Elinav, an immunology researcher at the Weizmann Institute of Science in Israel.
Probiotic mixes vary dramatically from pill to pill. Companies aren’t even required to maintain the same combination of bacterial strains from one batch to the next, meaning what people put in their bodies could vary widely. Some of these strains may hinder the efficacy of one medicine, while others may enhance it.
There are too many unknowns to render any given probiotic totally safe, said Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School and an internist at Cambridge Health Alliance, who wrote about the issue last year in JAMA Internal Medicine.
Probiotics do work for some people, and some conditions: They’re helpful in treating colitis, for instance, and other gastrointestinal illnesses, said Dr. Rishi Sharma, a gastroenterologist in Walnut Creek, Calif.
Cancer patients often take probiotics to help mitigate some of the side effects of treatment — particularly diarrhea that stems from chemotherapy. While oncologists tend to be loathe to suggest their patients take over-the-counter probiotics, many with cancer still do: The MD Anderson study found that 42 percent of the patients studied were also taking probiotic supplements.
“When you see a study like this, suggesting immunotherapy might not work that well — I’d just avoid taking the probiotic,” Sharma said. “Your whole goal is to treat the cancer. And when it comes to probiotics, there’s just a lot of really bad data out there.”
Immunotherapies generally work in about a quarter of patients with certain cancers, but it’s still unclear exactly why. The MD Anderson/Parker Institute study was designed to probe whether there was a correlation between diet, the gut microbiome, and patient response to immunotherapy.
Forty-six metastatic melanoma patients beginning treatment at MD Anderson were asked to take a survey on what they ate and drank, and what supplements they took. Before the start of the therapy, researchers also took fecal samples from each patient — profiling the bacterial makeup of their respective microbiomes. The study also found that higher fiber intake was correlated with more lush microbiomes — and stronger responses to immunotherapy.
The research was presented as an abstract at the American Association of Cancer Research meeting this week in Atlanta. It hasn’t yet been published in a peer-reviewed journal.
“This study shows you that a patient’s response to immunotherapy is highly modulated by the microbiome,” said Elinav.
Elinav said the findings “are in perfect agreement” with conclusions from his own research: He published a pair of studies in Cell in 2018, finding that probiotic supplements actually decreased the diversity of participants’ microbiomes after they’d taken a course of antibiotics. In fact, the guts of those who took probiotics took much longer than those who did not to fully recover.
The MD Anderson/Parker Institute findings are far from conclusive. Wargo said that she and her team have been expanding the patient cohort being studied; they are also working with Seres Therapeutics, a Cambridge, Mass.-based biotechnology company, on whether bespoke combinations of probiotics might actually improve immunotherapy responses. Still, not all researchers are convinced by the early conclusions.
The Parker Institute is now conducting such a trial in collaboration with MD Anderson and Seres Therapeutics. This randomized, placebo-controlled clinical study is evaluating whether a specially designed oral microbiome pill with specific types of bacteria could positively impact a patient’s response to checkpoint inhibitors.
“I think it’s a provocative finding,” said Dr. Adil Daud, a professor of medicine and director of melanoma clinical research at University of California, San Francisco. “But I still think it’s too early to really conclusively say that probiotics interfere with immunotherapy.”
The trial was too small, and too many variables could have influenced its outcome, he said. Microbiota vary too significantly from person to person, and immunotherapy responses might even vary depending on age, ethnicity, and gender, Daud said. The study was too small to possibly take all of these factors into consideration, he said.
Daud noted that he did have one melanoma patient that he treated with pembrolizumab — an anti-PD-L1 immunotherapy — who actually seemed to benefit from probiotic use. Upon stopping a drug that had proved effective, the patient’s tumor began to grow back. When Daud restarted the pembrolizumab, the patient chose to also take a probiotic from Whole Foods; with the addition of the supplement, the same drug had a lasting effect on keeping the cancer at bay.
“But this is an isolated, n=1 case — so I don’t know how much weight this carries,” Daud said.
Daud tells his patients that, rather than focusing on probiotics, they’d be better served to work on their diet — increasing fiber intake, for instance.
Cohen, the internist at Cambridge Health Alliance, said he “can’t make heads or tails” of the latest study — it’s too small and vague, in his view.
“My two cents would be, this study reminds us that there’s no question that probiotics have a powerful impact on the immune system,” Cohen said. “That, and we have almost no data to demonstrate that these live microorganisms actually improve health.”
Piper Jaffray analyst Christopher Raymond reported that the American Academy of Neurology posted emerging science abstract titles this morning, adding that full abstracts are not anticipated until May 3. It appears Phase 3 data on Alexion’s (ALXN) Soliris for Neuromyelitis Optica Spectrum Disorder, or NMOSD, will be presented as an emerging science abstract and that data from a Phase 1/2 study of Biogen’s (BIIB) BIIB067 in SOD1 mutant ALS patients will also be presented, making the meeting potentially “meaningful” for both. Raymond keeps Overweight ratings on Alexion and Biogen.
Wells Fargo analyst Jim Birchenough raised his price target for Sangamo Therapeutics to $34 from $24 following this morning’s clinical update on the company’s gene therapy, gene editing and cell therapy pipeline. The stock in morning trading is up 35%, or $3.35, to $12.88. The update was better than expected, particularly for hemophilia gene therapy and beta thalassemia ex vivo gene editing, Birchenough tells investors in a research note. The analyst is “encouraged” by Sangamo’s progress against the higher technical hurdle of in vivo genome editing. He believes direct evidence of genome editing, “strong” fetal hemoglobin response and early signs of transfusion independence bode well for ultimate success and should translate into improved likelihood of success in the larger opportunity of sickle cell disease. The analyst reiterates an Outperform rating on Sangamo Therapeutics.
Five Star Senior Living and Senior Housing Properties Trust (SNH) will enter into new management agreements for 261 senior living communities that Five Star leases and operates as part of a restructuring deal to improve Five Star’s financial position, the organizations announced Tuesday morning.
SNH and its shareholders also will take an increased ownership stake in the company.
The modified business arrangement will be effective Jan. 1 and will have a 15-year term. Five Star will have the option of two five-year extensions, subject to the company maintaining portfolio financial performance.
The agreement, Five Star President and CEO Katie Potter said, “removes the cloud of uncertainty that has hung over Five Star recently and allows Five Star to continue delivering on its mission of providing an excellent resident and client experience across the enterprise.”
The company “expects its current financial position and near-term liquidity challenges will be immediately improved because of the transaction,” according to a news release.
“The transaction announced today provides an immediate and long-term solution to stabilize our largest operator and protect the value of our senior living communities,” SNH President and CEO Jennifer Francis said. “In fact, we believe Five Star will be a healthy company at the end of this transaction.”
Under the agreement, which was unanimously approved by both the special board committees and the full boards of Five Star and SNH, the existing five master leases for 184 of SNH’s senior living communities (19,979 units) that are leased to Five Star, as well as the existing management agreements and pooling agreements with Five Star for 77 of SNH’s senior living communities (10,135 units), will be terminated and replaced with new management agreements.
Five Star also will issue common shares to SNH and its shareholders, resulting in their ownership of Five Star equal to approximately 34% and 51%, respectively, post-issuance. SNH’s current ownership stake is 8.3%.
“While Five Star is issuing a substantial ownership stake to SNH and SNH shareholders as part of this restructured business arrangement with SNH, we think it is in the best interest of Five Star, because this transaction provides both an immediate solution to Five Star’s liquidity challenges and provides a materially improved long-term financial outlook for Five Star,” Barbara Gilmore and Donna Fraiche, co-chairs of the special committee of Five Star’s Board of Directors, said in a statement.
The boards’ special committees and advisers had met for the past four months, according to John Harrington, chair of the special committee of SNH’s Board of Trustees.
“Some of the options we considered included evaluating whether we should engage new operators rather than Five Star to run some or all the communities as well as whether we should try to sell the entire portfolio,” he said. “We ultimately concluded for a variety of reasons that the transaction announced today was the best option for SNH and our shareholders in light of the difficult circumstances we faced.”
Also as part of the agreement:
Five Star’s aggregate monthly rent payable to SNH under the five master leases with Five Star was reduced from approximately $17.4 million to $11 million effective Feb. 1. Five Star has paid its February rent payment, which previously was deferred to March 31, at the reduced amount.
SNH has purchased from Five Star approximately $50 million of fixed assets and improvements related to the leased senior living communities.
SNH has provided a $25 million short-term revolving credit facility to Five Star that is secured by six of Five Star’s wholly owned senior living communities. Five Star will reduce its indebtedness under the SNH credit facility, and SNH will assume certain of Five Star’s liabilities and / or make a cash payment to Five Star equal to $75 million in aggregate.
Because of the lower cash flow from Five Star, the REIT expects to lower its common share distribution rate beginning with its next regularly scheduled quarterly distribution. SNH said it expects to pay an annual distribution of $0.55 to $0.65 per common share going forward.
To reduce leverage, SNH expects to sell up to $900 million in properties by the end of the year, focusing on underperforming senior living communities and non-healthcare related assets, including stand-alone skilled nursing facilities and wellness centers.
The REIT’s long-term strategy remains the same — expanding its medical office and life science buildings portfolio, Francis said.
“While our portfolio of senior living communities is expected to decrease as a percentage of our total property portfolio in the future, today’s announcement underscores our commitment to ensuring all of our properties are positioned for long-term success,” she added.
