INO Slips On Clinical Hold, MRK Gets FDA Nod, Be All Ears For AKAO

(RTTNews) - Achaogen Inc. (AKAO) is scheduled to present data from Cohort 2 of phase III clinical trial of Plazomicin in patients with serious bacterial infections due to carbapenem-resistant enterobacteriaceae on Saturday, October 29, 2016.

Carbapenem-resistant Enterobacteriaceae, or CRE, are a family of germs that are difficult to treat because they have high levels of resistance to antibiotics. Klebsiella species and Escherichia coli (E. coli) are examples of Enterobacteriaceae, a normal part of the human gut bacteria, that can become carbapenem-resistant. (Source: CDC).

The phase III trial of Plazomicin, dubbed CARE, includes Cohort 1, which is a randomized one with 39 patients, and Cohort 2, which is a single-arm expanded eligibility cohort with 30 patients with confirmed CRE.

Another pivotal trial evaluating Plazomicin in complicated urinary tract infections (cUTIs), known as EPIC, is also underway.

Top-line results from the CARE and EPIC trials are expected to be reported in early Q1 2017.

AKAO closed Monday's trading at $5.31, down 3.28%.

Shares of Aduro Biotech Inc. (ADRO) fell as much as 11% on Monday on news that the clinical trials of its investigational product from its LADD platform - CRS-207 - have been placed on partial clinical hold to pause new patient enrollment.

Aduro's LADD platform uses novel, live-attenuated Listeria to deliver tumor antigens.

The partial hold was initiated after a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient who presented with gastrointestinal symptoms tested positive for Listeria.

Patients currently receiving a LADD-based agent (except one currently identified patient, due to the presence of a pacemaker) are continuing to receive treatment, with several of these patients having been on study drug for six months or longer, the company noted.

ADRO closed Monday's trading at $11.70, down 4.49%.

DBV Technologies S.A.'s (DBVT) two-year follow-up study of Viaskin Peanut for the treatment of peanut-allergic children, dubbed OLFUS-VIPES, has demonstrated favorable safety and high compliance, consistent with prior results.

OLFUS-VIPES, or OLFUS, is the follow-up study to VIPES, the company's phase IIb clinical trial of Viaskin Peanut. Previously, the company reported positive results from VIPES in September 2014 and provided an interim analysis from the first 12 months of OLFUS in October 2015.

DBVT closed Monday's trading at $35.31, down 0.73%. In after-hours, the stock was up 0.27% to $35.41.

Global Blood Therapeutics Inc. (GBT) is all set to initiate a pivotal trial for GBT440 in adults and adolescents with sickle cell disease in December of this year.

The phase III trial, dubbed HOPE, is designed to enroll up to 400 patients age 12 and older with sickle cell disease who have had at least one episode of vaso-occlusive crisis (VOC) in the previous year.

The top-line data from the HOPE study are anticipated in the first half of 2019.

GBT closed Monday's trading at $17.75, down 5.84%.

Shares of Inovio Pharmaceuticals Inc. (INO) slid more than 16% on Monday, following a clinical hold on the company's proposed phase III clinical program for VGX-3100.

VGX-3100 is an investigational DNA immunotherapy candidate designed to treat precancers and cancers caused by human papillomavirus (HPV). The treatment is administered to patients by injection into muscle (typically in the arm), followed by electroporation using Inovio's CELLECTRA device.

The phase III study of VGX-3100 has not been initiated, and has not enrolled or dosed subjects.

The FDA has requested additional data to support the shelf-life of the newly designed and manufactured disposable parts of the CELLECTRA 5PSP immunotherapy delivery device.

The company is optimistic of submitting the requested data to the FDA before the end of this year. Accordingly, the phase III clinical program of VGX-3100 will not start until the first half of 2017 pending resolution of the FDA's requests.

INO closed Monday's trading at $6.99, down 16.39%.

Ligand Pharmaceuticals Inc. (LGND) has earned a $1.5 million milestone payment from its partner Melinta Therapeutics, following the submission of New Drug Applications of IV and oral Baxdela for the treatment of patients with acute bacterial skin and skin structure infections.

Baxdela is eligible for priority review by the FDA, and a regulatory decision is expected to be announced by mid-year 2017.

LGND closed Monday's trading at $93.99, up 0.51%.

The FDA on Monday approved Merck's (MRK) KEYTRUDA for yet another indication - this time, for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.

The approval for the new indication comes 2 months ahead of the decision date of December 24, 2016.

Keytruda was first approved in September 2014 for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. The other indications for which the drug is approved are metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

The sales of the drug for full year 2015 were $566 million, and were $563 million in the first half of this year.

MRK closed Monday's trading at $60.75, down 0.74%.

Canadian specialty pharma company Theratechnologies Inc. (TH.TO) and its partner TaiMed Biologics Inc. eagerly await the top-line results of a phase III study of Ibalizumab in combination with optimized background regimen, in patients infected with multi-drug resistant HIV-1, which are expected to be available in the coming weeks.

The last patient enrolled in the trial has finished the treatment phase of the study, and analysis of the data is now being completed.

TH.TO closed Monday's trading at C$3.32, unchanged from the previous day's close.

Vanda Pharmaceuticals Inc. (VNDA) has agreed to settle its ongoing patent litigation with Taro Pharmaceuticals U.S.A., Inc. and Taro Pharmaceutical Industries Ltd. related to schizophrenia drug Fanapt.

Taro had filed an Abbreviated New Drug Application seeking approval of its generic version of Vanda's Fanapt. The patent on Fanapt expires on November 2, 2027.

Now that Vanda is settling the patent litigation, Taro has been granted a non-exclusive license to manufacture and commercialize its version of Fanapt in the U. S. effective November 2, 2027. However, if Vanda obtains pediatric exclusivity for Fanapt, Taro will have to wait until May 2, 2028 to market its generic version of the drug.

Fanapt garnered sales of $65.6 million in 2015 and $35.63 million in the first half of 2016.

VNDA closed Monday's trading at $15.85, up 0.13%.