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Friday, January 10, 2020

Medigene up on positive cancer vaccine data

Ultra-thinly traded Medigene AG (OTCPK:MDGEF +35%) is up, albeit on a miniscule 1,400 shares, on the heels of topline data from a Phase 1/2 clinical trial evaluating its autologous dendritic cell vaccine in 20 acute myeloid leukemia (AML) patients.
At month 24, the rate of overall survival (OS) was 80% (n=16/20) and the rate of progression-free survival (PFS) was 55% (n=11/20).
Detailed results will be submitted for presentation at future medical conferences.

Mersana Therapeutics up on 2020 outlook

Ahead of JPM20, Mersana Therapeutics (MRSN +3.5%announces key objectives and milestones for 2020. Highlights:
XMT-1536: Announce data in a once-every-four-week dose escalation cohort in a Phase 1 study in H1 as well as interim results from the expansion study. More mature data to be reported in H2.
XMT-1592: Initiate Phase 1 dose-escalation study in H1.
Initiate IND-enabling studies of new B7-H4 ADC (antibody-drug conjugate) candidate. Report data and the name of the name of the candidate in H2.
Identify a STING agonist ADC based on its Immunosynthen platform. Report preclinical data throughout the year.

Endo settles opioid case in Okla.

Endo International (ENDP +2.2%) announces that subsidiaries Endo Pharmaceuticals and Par Pharmaceutical have settled an investigation by the Oklahoma Attorney General’s office over their role in the opioid epidemic there.
Endo Pharmaceuticals has agreed to pay $8.75M resolve the issue without an admission of guilt or wrongdoing.
The company voluntarily stopped promoting opioids in 2017.
Many more lawsuits remain to be adjudicated.
Opioid related-stocks:  McKesson (MCK +1.8%), AmerisourceBergen (ABC +0.7%), Cardinal Health (CAH +0.2%), Mallinckrodt (MNK +1.9%), Teva Pharmaceutical Industries (TEVA +0.9%), Johnson & Johnson (JNJ +0.1%).

Pan-Resistant Candida Auris Found in NYC

Three patients in New York had “pan-resistant” Candida auris unresponsive to three or more classes of antifungal drugs, researchers found.
These individuals had no history of recent travel. Resistance apparently developed after exposure to antifungal medications, including echinocandins, during prolonged healthcare facility stays, reported Belinda Ostrowsky, MD, of the CDC, and colleagues, writing in the Morbidity and Mortality Weekly Report.
While the authors noted that there was no transmission of any pan-resistant isolates to other patients or the healthcare environment, they characterized this emerging pan-resistance as “concerning.”
“The occurrence of these cases underscores the public health importance of surveillance for C. auris, the need for prudent antifungal prescribing, and the importance of conducting susceptibility testing on all clinical isolates, including serial isolates from individual patients, especially those treated with echinocandin medications,” they wrote.
C. auris had been diagnosed in 801 patients in New York as of June 28, 2019, either through clinical culture or from skin and nostril swabs only. All three patients with pan-resistant C. auris were older than age 50 and had multiple comorbidities, though the first two lived in long-term care facilities, and the third had a prolonged hospital stay and long-term care admission. Ostrowsky and colleagues noted that the third patient was in different facilities in a different borough than the first two patients.
Isolates from all three patients were initially susceptible to echinocandins, but resistance emerged during treatment with these drugs, they wrote. They added that most C. auris strains are resistant to fluconazole and susceptible to echinocandins, which target the cell wall.
There was no known contact between any of the patients. While the first two patients were from the same borough in New York City, they were treated in different healthcare facilities, and the authors could find no epidemiologic link between them. All three patients died — one from underlying medical conditions, whereas C. auris could have contributed to the others’ deaths, although this was unclear.
Ostrowsky and colleagues added that while these emerging pan-resistant isolates appear to be rare, the South Asia clade of C. auris dominated in New York City, and that clade is known for increased antifungal resistance compared to other clades.
Patients on antifungal treatment for C. auris should be monitored for resistance, follow-up cultures should be obtained and an infectious disease specialist should be consulted, the authors said.
The authors disclosed no conflicts of interest.

FDA OKs Astellas Antifungal Injectable Drug for Newborns

The FDA approved the first antifungal drug to specifically treat invasive candidiasis in the youngest of infants, manufacturer Astellas announced on Wednesday.
A supplemental new drug application for injection micafungin (Mycamine) was approved to treat the bloodstream infection, candidemia, acute disseminated candidiasis (where the infection progresses to other organs), Candida peritonitis (inflammation of the membrane lining the abdominal wall), and abscesses without meningoencephalitis and/or ocular dissemination in infants younger than 4 months of age, the manufacturer said in a statement.
This is an expanded indication for the micafungin injection, which was first approved to treat adults with esophageal candidiasis back in 2005, and in 2008 for adults with candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses. A pediatric indication for the drug was approved in 2013, but for children 4 months and older.
The manufacturer noted that candidiasis in newborns is tied to a 20% mortality rate and is associated with significant morbidity as well.
“Although rare, invasive candidiasis in newborns constitutes a unique pathogenesis unlike that demonstrated in older children and adults as marked by a higher incidence of organ involvement, especially in the central nervous system,” Astellas senior director Laura Kovanda, PhD, said in a statement.
The drug’s safety in this population was assessed in 168 pediatric patients in nine clinical trials testing various doses, the manufacturer said. They noted that the safety and effectiveness of the micafungin injection has not been established for candidemia with meningoencephalitis and/or ocular dissemination among infants younger than 4 months, as these may require a higher dose.

Kadmon, BeyondSpring gain a bull as Nomura picks up coverage

BeyondSpring (NASDAQ:BYSIrises 2.7% and Kadmon Holdings (NYSE:KDMN) also gains 2.7% after Nomura Instinet initiates coverage of the two companies at Buy.
BeyondSpring is testing plinabulin in multiple Phase 2 and 3 studies; “we view the first of these in CIN (chemotherapy-induced neutropenia) to be the most near-term derisking event for BYSI,” Nomura analyst Christopher Marai writes.
Studies may also show benefits beyond CIN, including as an anticancer agent and in immune oncology, he adds.
Sets BYSI price target at $34, implying a 111% rise in the next 12 months.
As for Kadmon, “we believe that KDMN’s success in indications beyond cGVHD (chronic graft-vs-host disease) expected in 2020 will pave the way for a broader, and multi-blockbuster, opportunity for ROCK (Rho-associated coiled-coil kinase) inhibition across autoimmune and fibrotic diseases, analogous to JAK inhibitors and anti-TNF therapeutics,” Marai writes.
Kadmon price target at $10, implying a 117% increase in the next 12 months.

Profound Medical up on preliminary Q4 results, RadNet deal

Ultra-thinly traded micro cap Profound Medical (OTCPK:PROF +11.8%) is up on double volume, albeit on turnover of only 29K shares, on the heels of preliminary results for Q4 and 2019.
Revenue for the quarter and year should be ~$2.7M (+59%) and ~$5.4M (+108%), respectively, driven by the continued rollout of Sonalleve in China and additional uptake of TULSA-PRO.
In November 2019, the company submitted its U.S. application for a specific Medicare reimbursement code for TULSA-PRO.
This morning, it announced its first multi-state imaging center agreement for TULSA-PRO with RadNet (RDNT -0.4%). The first stage of the deal will be the placement of three rental systems at imaging centers in the Los Angeles area. If successful, more will follow.