Coherus Biosciences Inc., of Redwood City, Calif., reported results from an ongoing three-part, phase III study of CHS-1420, a biosimilar candidate to the tumor necrosis factor binder Humira (adalimumab, Abbvie Inc.). As previously reported, this study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75 percent improvement in psoriasis area and severity index (PASI-75) at week 12. The 95 percent confidence intervals for the difference between treatment groups fell well within the pre-specified margin. Results from part two of the study focused on maintenance of response through week 24. At the start of part two (week 16), 80.3 percent of subjects in the CHS-1420 group and 77.5 percent of subjects in the Humira group achieved PASI-75. In part two (weeks 16-24), half of the subjects who were initially treated with Humira were switched to CHS-1420, modeling a chronic patient's transition to a biosimilar. Maintenance of PASI-75 was similar across the three subsequent treatment groups: CHS-1420 followed by CHS-1420, Humira followed by CHS-1420, and Humira followed by Humira. CHS-1420 and Humira were similarly well tolerated in all groups during part two. Anti-drug antibody results are preliminary at this time, but have not identified any clinically significant differences between the treatment groups.

Corvus Pharmaceuticals Inc., of Burlingame, Calif., said the protocol-predefined criteria for expansion has been reached for the cohort of patients with renal cell carcinoma treated with single-agent CPI-444 in the company's ongoing phase I/Ib study. The size of that cohort will be increased from 14 to 26 patients. The study is evaluating CPI-444, a selective and potent inhibitor of the adenosine A2A receptor, as a single agent and in combination with Basel, Switzerland-based Roche AG's Tecentriq (atezolizumab), a humanized monoclonal antibody targeting protein programmed cell death ligand 1. The study has been enrolling patients ahead of schedule. The first part of the trial (dose-selection) was completed in October 2016, and enrollment of patients in disease-specific cohorts in the second part of the trial is underway.

Critical Outcome Technologies Inc., of London, Ontario, commenced dosing women in the fourth cohort of its ongoing phase I trial of COTI-2 intended for the treatment of gynecological cancers. The objective of the fourth cohort is to continue to evaluate the safety and tolerability of COTI-2, which has a novel p53-targeting mechanism of action with selective and potent anticancer activity, the company said.

Debiopharm International SA, of Lausanne, Switzerland, announced positive results from a phase II study of the staphylococcal-selective antibiotic Debio 1450 for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This multi-center, randomized, double-blind study was designed to compare the efficacy, safety and tolerability of intravenous and oral Debio 1450 at two dose regimens with intravenous vancomycin / oral linezolid as an active comparator in 330 patients with clinically documented ABSSSI due to staphylococci including mostly Staphylococcus aureus sensitive or resistant to methicillin (MSSA or MRSA). The study objectives were met, demonstrating non-inferiority of Debio 1450 to comparator in all pathogenic staphylococci species infected patient populations including MRSA and ensuring that treatment with Debio 1450 at both doses was safe and well tolerated. Debio 1450 is a staphylococcal-selective antibiotic with a low propensity to emergence of resistance.

G1 Therapeutics Inc., of Research Triangle Park, N.C., expanded its pipeline of cancer therapies with the initiation of three development programs in breast cancer. G1 is enrolling a phase II study of its intravenous CDK4/6 inhibitor trilaciclib for the treatment of triple-negative breast cancer, and a phase Ib/IIa study of its oral CDK4/6 inhibitor G1T38 for the treatment of estrogen receptor-positive, HER2-negative breast cancer. G1 is advancing G1T48, its oral selective estrogen receptor degrader with the goal of commencing a phase I trial in the fourth quarter of 2017.

Hutchison China Meditech Ltd., of Hong Kong, started a phase I trial of its spleen tyrosine kinase inhibitor, HMPL-523, in patients with hematological malignancies in China. The first patient was dosed on Dec. 27, 2016. This study complements the ongoing phase I trial in patients in Australia with hematological malignancies, which is expected to complete dose-escalation in the first half of 2017.

Monosol Rx Inc., of Warren, N.J., said it's preparing to initiate a human proof-of-concept study of epinephrine sublingual soluble film for the treatment of anaphylaxis. The product is based on Monosol's PharmFilm technology, is being developed for use as an emergency treatment for severe allergic reactions, including anaphylaxis. Epinephrine is typically administered via auto-injection.

Newron Pharmaceuticals S.p.A., of Milan, Italy, said its partner, Zambon S.p.A., part of the Zambon Group, of Vicenza, Italy, has entered into a long-term partnership with Seqirus, a CSL Ltd. subsidiary, covering Zambon's Parkinson's disease product, Xadago (safinamide) in Australia and New Zealand. Zambon will be responsible for product supply and Seqirus will undertake registration and commercialization. The orally available monoamine oxidase-B inhibitor blocks one of the key enzymes involved in the breakdown of dopamine and has been shown to have an effect on symptoms both in combination with dopamine agonists in the early stages of the disease, and when taken with levodopa at the more advanced stages. In 2014, Xadago became the first new chemical entity in 10 years to get a positive opinion from the EMA in Parkinson's disease. (See BioWorld Today, Dec. 30, 2014.)

Pluristem Therapeutics Inc., of Haifa, Israel, said the company's phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the FDA. Pluristem's strategy is to use this single multinational phase III study to support the submission of a biologics license application to the FDA for marketing approval. Pluristem expects to begin enrolling patients during the first half of 2017. The study will be a double-blind, randomized, placebo controlled trial of about 250 patients with CLI Rutherford Category 5 who are unsuitable for revascularization. The primary endpoint is time to amputation or death. The EMA previously selected the PLX-PAD program in CLI for its adaptive pathways pilot project, which may allow for conditional marketing approval after a single pivotal study.

Redhill Biopharma Ltd., of Tel-Aviv, Israel, announced first dosing in a three-way crossover pharmacokinetic (PK) study with RHB-105 in 18 healthy volunteers intended to evaluate the bioavailability of RHB-105 actives versus the comparator in the planned confirmatory phase III study (dual therapy of amoxicillin and omeprazole) and a food-effect study with RHB-105. RHB-105 is a fixed-dose, oral combination therapy for the eradication of H. pylori infection. RHB-105 was granted qualifying infectious disease product designation by the FDA.

Tapimmune Inc., of Jacksonville, Fla., opened its phase II company-sponsored ovarian cancer study in platinum-sensitive ovarian cancer patients. The company's first three clinical sites have received regulatory and IRB approval to begin enrollment. The study will use TPIV 200, a T-cell therapy targeting the folate receptor alpha protein. This ovarian cancer study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company's lead product candidate TPIV 200 in combination with standard of care chemotherapy.

Thrombogenics NV, of Leuven, Belgium, enrolled the first patients in a phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of two dose levels of THR-317 for the treatment of diabetic macular edema (DME). THR-317 (anti-PIGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor. The study will evaluate the safety of three intravitreal injections of two dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity and to reduce central retinal thickness in subjects with DME.

Valeant Pharmaceuticals International Inc., of Laval, Quebec, reported positive results from a second confirmatory pivotal phase III, multicenter double-blind, randomized, vehicle-controlled clinical study to assess the safety and efficacy of IDP-118 (halobetasol propionate and tazarotene) lotion in the treatment of plaque psoriasis. IDP-118 showed statistical significance (p < 0.001) to vehicle with a treatment success rate at eight weeks of 35.76 percent to 6.98 percent. The primary endpoint of the 12-week study was achievement of a "clear" to "almost clear" score and at least a two grade improvement based on an Investigator Global Assessment at eight weeks, and clear to almost clear and at least two grade improvement in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints.