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Wednesday, June 12, 2019

Alkermes advancing ALKS 4230 in kidney cancer and melanoma

Alkermes plc (NASDAQ:ALKS) has initiated the monotherapy expansion stage of its Phase 1/2 ARTISTRY-1 trial evaluating ALKS 4230 in patients with renal cell carcinoma or melanoma. This portion of the study will assess ALKS 4230 administered intravenously for five consecutive days in up to 105 patients who have not responded to prior therapies.
ALKS 4230 is an engineered fusion protein designed to preferentially bind to and signal through the intermediate- affinity interleukin 2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding expanding immunosuppressive cells that interfere with the anti-tumor response.
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Concert’s CTP-692 shows favorable safety profile in early-stage studies

Concert Pharmaceuticals (NASDAQ:CNCE) announces that results from single-dose and multiple-ascending-dose Phase 1 trials evaluating the safety, tolerability and pharmacokinetics of CTP-692 in healthy volunteers showed that it was well-tolerated across all dose ranges tested, including those to be assessed in Phase 2 studies. Analyses of blood and urine biomarkers did not indicate any signs of renal impairment.
A Phase 2 trial in schizophrenia should launch in Q4.
CTP-692 is a deuterium-modified form of an amino acid called D-serine. The company says it has the potential to restore NMDA receptor activity in key areas of the brain in schizophrenia sufferers, adding that it will be initially developed as an adjunctive therapy with standard antipsychotic medications.
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Study supports use of Pfizer’s Xeljanz alone in rheumatoid arthritis

Results from a Phase 3b/4 clinical trial, ORAL Shift, evaluating the efficacy of Pfizer’s (NYSE:PFE) XELJANZ (tofacitinib) XR after the withdrawal of methotrexate in adults with moderately to severely active rheumatoid arthritis (RA) showed it to be non-inferior (no worse than) to XELJANZ XR + methotrexate at week 48. The data are being presented at EULAR in Madrid.
Metroplex Clinical Research Center’s Stanley Cohen, M.D. says, “The results of ORAL Shift provide important information on the use of XELJANZ XR as monotherapy after methotrexate withdrawal, which is significant as some people living with rheumatoid arthritis are unable or unwilling to use methotrexate.”
The FDA approved XELJANZ in November 2012 for RA.
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Catalyst sues FDA over approval of Firdapse competitor

Citing violations of its own regulations, Catalyst Pharmaceuticals (NASDAQ:CPRX) is suing the FDA over its recent approval (May 6) of Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of children with an autoimmune disorder called Lambert-Eaton syndrome (LEMS).
The agency approved Catalyst’s Firdapse (amifampridine) for LEMS in November 2018 under Orphan Drug status which is supposed to provide a seven-year period of market exclusivity in the U.S. for the indication.
Shares are down 2% premarket on light volume.
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Immuron up 11% on encouraging Travelan data

Thinly traded nano cap Immuron Limited (IMRN +11.4%) is up in early trade on the heels of encouraging results from a Shigella challenge study of in non-human primates aimed at assessing the effectiveness of Trevalen for preventing dysentery.
12 juvenile rhesus monkeys were segregated into two groups, eight who received Travalen and four who received placebo prior to oral challenge with Shigella, a bacterial group that causes stomach cramps, fever and diarrhea.
All four monkeys in the placebo group developed acute dysentery within 24 – 36 hours of Shigella challenge.
Six of the eight monkeys in the Travalen group showed no signs of dysentery while two “displayed” signs of dysentery.
The results were reported by Bangkok, Thailand-based U.S. Armed Forces Research Institute of Medical Sciences, a laboratory of the Walter Reed Army Institute of Research.
The active ingredient in Travalen is hyperimmune bovine colostrum powder which binds to Enterotoxigenic E. coli, the most common cause of traveler’s diarrhea. It is also designed to reduce the risk of infection by other diarrhea-related bacteria like Shigella and Salmonella.
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Zai Lab gets nod in Macau to sell Zejula for ovarian cancer

Zai Lab Limited (ZLAB +1.1%) announces that it has received regulatory approval to commercialize Zejula (niraparib) in Macau for the treatment of adult patients with with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete or partial response to platinum-based chemotherapy.
The company in-licensed the PARP inhibitor from TESARO (GSK +0.9%) in September 2016 for the China market.
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Oklahoma judge blocks Teva’s $85M settlement

Teva Pharmaceutical Industries (TEVA -5.5%) continues to battle bad news. Bloomberg reports that a district court judge in Oklahoma will not approve the company’s $85M settlement over its role in the opioid epidemic there because AG Mike Hunter has not shown that the proceeds will go into the state’s treasury as mandated under a recent law.
Oklahoma lawmakers enacted the legislation after the $270M settlement with Purdue Pharma which will fund research and treatment programs instead of being deposited into the state’s coffers.
It appears unlikely, though, that the issue the TEVA settlement cannot be quickly resolved.
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