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Wednesday, January 30, 2019

Moderna: Data publication shows therapeutic potential of mRNA-2752

Moderna announced the publication of pre-clinical data that shows the therapeutic potential of mRNA-2752, an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators designed to activate the immune system to recognize and eradicate tumors that are resistant to checkpoint inhibitors. The study, published in the scientific journal Science Translational Medicine, found that the local delivery of mRNA encoding the secreted cytokines IL23 and IL36gamma and the membrane-bound T-cell co-stimulator OX40L, induced a broad immune response promoting tumor regression in both injected lesions and distant un-injected tumors in mice. When combined with checkpoint inhibitors, mRNA-2752 boosted complete response rates in immunosuppressive and in immunologically barren tumor models that are otherwise unresponsive to checkpoint inhibitors. The study showed that in a MC38-R mouse cancer model that is considered immunosuppressive and found to be unresponsive to checkpoint inhibitor immunotherapy, a single dose of the Triplet administered intratumorally led to complete responses. After multiple injections in the immunosuppressive tumor model, complete response rates increased to a majority of the treated animals. In addition, a single dose of the Triplet led to near-complete control of both injected tumors and distal untreated tumors. The addition of anti-PD-L1, anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to a single dose of the Triplet improved complete response rates over either mRNA or antibody treatment alone.

China SXT Pharma gains

Relatively recent IPO China SXT Pharmaceuticals (SXTC +51.4%) is up on a healthy 43x surge in volume as bargain hunters move in. Shares had sold off 82% since touching $23.35 on January 10 before today’s action.
The company develops and sells ready-to-use Chinese Medicine Pieces, a type of traditional Chinese medicine.

Analysis of New Association Health Plans Reveals Promising Trends

A new report released today by AssociationHealthPlans.com shows promising benefit and cost trends among 28 association health plans (AHPs) recently launched in 13 states. The analysis, which offers important insights about how the market is responding to a new Department of Labor regulation finalized in June 2018, shows a trend toward comprehensive benefits and double-digit cost savings.
The Department of Labor regulation, which is being implemented in stages, makes it easier for small employers to band together to offer lower-cost “large company” health insurance. The breadth of benefits had been one of the biggest concerns among detractors of association-based insurance. However, according to the analysis, no evidence of narrow benefit designs was observed in the new AHP benefit descriptions. Moreover, advanced features such as health savings accounts (HSAs) also have a strong presence among the new plans.

“The final rule will not be fully implemented until April, but we’re already seeing 28 new association health plans in 13 states, and the results are promising for small businesses and consumers,” said Kev Coleman, president of AssociationHealthPlans.com. “Not only are we seeing a trend toward comprehensive benefits, but these groups are also claiming double-digit premium savings for their members, a welcome development for small businesses that have long struggled with rising health care costs.”
States with new association health plans include TexasFloridaOhioGeorgiaMichiganWisconsinMinnesotaAlabamaOklahomaNevadaNebraskaWest Virginia and Vermont.
As noted last fall by the National Conference for State Legislatures, small businesses pay on average 8 percent to 18 percent more than large companies for the same health insurance. Sole proprietors and the self-employed can pay even higher amounts than multi-employee businesses if they purchase individual health insurance without the benefit of a subsidy.
Other highlights of the report include:
  • Regional associations launched 71 percent of new AHPs. Employers in an association health plan must share a professional similarity or the same business region. The most common sponsors for regional associations were chambers of commerce. In fact, four out of five regional associations were sponsored by chambers of commerce.
  • Major industry players are heavily involved. Among new association health plans, 86 percent are insured by a third party as opposed to being self-funded. UnitedHealthcare and Blue Cross Blue Shield insurers are the most common companies in this emerging market and collectively provide 75 percent of coverage for AHPs that do not self-fund.
  • 43 percent of new AHPs are available to sole proprietors and the self-employed. One of the major changes to association health insurance under new regulation is its ability to cover self-employed individuals who are not part of a business with other employees.
  • Half of new AHPs include a medical savings account option such as an HSA.
  • Multi-state AHPs are taking longer to enter the market, which is not surprising given the additional preparation and insurance filings involved in multi-state AHPs.
Additional findings as well as the report’s methodology can be reviewed at “First Phase of New Association Health Plans Reveal Promising Trends.”

Amgen, Novartis reports show Ligand assets ‘looking good’: Wainwright

This morning, Ligand Pharmaceuticals (LGND) partner Novartis (NVS) reported Promacta Q4 revenue of $330M, above H.C. Wainwright analyst Joseph Pantginis’ estimate of $306M. Promacta has now hit its first year of blockbuster status with 2018 sales of $1.174B, which is an important feat in the face of new competition, Pantginis tells investors in a research note. The analyst believes Ligand’s increasing royalty revenue streams and growing number of deals that result in milestones “effectively refute the bear thesis we’ve seen in a few other firms’ freely accessible research.” With Amgen (AMGN) reporting Q4 Kyprolis revenue of $251M, the analyst says Ligand’s top assets are “looking good.” He reiterates a Buy rating on the shares with a $281 price target.

Biohaven receives FDA may proceed letter for BHV-3241

Biohaven Pharmaceutical Holding (NYSE:BHVN) has received a letter from FDA that it may proceed with its clinical investigation of BHV-3241, a novel myeloperoxidase inhibitor, developed for treatment of multiple system atrophy (MSA).
The FDA May Proceed Letter was received following Biohaven’s reactivation of IND application initially filed by AstraZeneca prior to licensing the compound to Biohaven.
The Company expects to start Phase 3 trial in Q3 2019.
BHV-3241 is an oral, brain-penetrant, irreversible inhibitor of MPO, an enzyme that acts as a key driver of pathological oxidative stress and inflammation in the brain.

Kamala Harris backs private health insurance ban: ‘Eliminate all of that!’

Bye Bye, Obamacare!
During a townhall Monday night on CNN, Sen. Kamala Harris advocated for wiping out the private insurance markets in favor the newest socialist fad taking the nation by storm.
The California Democrat said she feels “very strongly” about fully embracing “Medicare for All,” a single-payer health insurance system, which would dramatically overhaul the entire American health care market.
“We need to have Medicare for all,” Harris said to CNN anchor and host Jake Tapper.

Referring to the current healthcare system as “cruel” and “inhumane,” Harris took a page from Rep. Alexandria Ocasio-Cortez’s playbook and argued that healthcare should “should be understood to be a right.”
“It is inhumane to make people go through a system where they cannot literally receive the benefit of what medical science can offer because some insurance company has decided it doesn’t meet their bottom line in terms of their profit motivation. That is inhumane,” Harris said.
Tapper pushed Harris to expand on what a Medicare for All system means for the Americans who like their current insurance plan.
“Listen, the idea is that everyone gets access to medical care and you don’t have to go through the process of going through an insurance company, having them give you approval, going through the paperwork, all of the delay that may require — who of us has not had that situation where you’ve gotta wait for approval? And the doctor says ‘well, I don’t know if your insurance company’s gonna cover this?” Harris asked.
“Let’s eliminate all of that. Let’s move on,” she said, donning a big big smile on her face while talking about completely wiping out Obamacare, former President Barack Obama’s signature legislative “victory.”
Her plans to wipe out the private insurance markets came just days after she officially announced her bid for the presidency.
On Sunday, the California Democrat held an event in Oakland to announce her candidacy for president and promised “free” goodies for everyone.

Co-Diagnostics gains as it eliminates debt

Thinly traded nano cap Co-Diagnostics (NASDAQ:CODX) is up 44% premarket on increased volume on the heels of its sale of $3M of preferred stock at $1.20 per share. The transaction included the conversion of a $2M note to preferred shares, eliminating its debt.