D-Day For CHRS, ENDO Pained, FDA Lifts Clinical Hold On INO's VGX-3100 Trial

(RTTNews) - Today's Daily Dose brings you news about FDA's decision on Endo's marketed opioid pain medication; Adamas' updated analysis of phase III trial results of ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease; BioTime's clinical trial catalyst to watch out for; Genentech's "walk-out" of a deal with NewLink and Inovio's progress related to its phase III program of VGX-3100.

Read on...

Adamas Pharmaceuticals Inc's (ADMS) updated analysis of efficacy and tolerability data from its phase III long-term safety and efficacy study of ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease has shown tolerability and durability out to 88 weeks.

The updated analysis expands on previously reported 64-week data.

ADS-5102 for the treatment of levodopa-induced dyskinesia is currently under FDA review, with a decision date set for August 24, 2017. If approved, ADS-5102 will be the first and only FDA-approved medicine indicated for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease.

ADMS closed Thursday's trading at $17.40, down 0.57%.

Applied Genetic Technologies Corp.'s (AGTC) investigational adeno-associated virus (AAV)-based gene therapy for X-linked retinoschisis has been found to be generally well tolerated and demonstrated a good safety profile across treatment groups in a phase 1/2 study.

X-linked retinoschisis, or XLRS, is characterized by abnormal splitting of the layers of the retina, resulting in poor visual function in young boys, which can ultimately result in legal blindness in adult men.

The results are related to the first 12 subjects enrolled in the low, middle and high dose groups of the Phase 1/2 dose escalation study. The Phase 1/2 dose study was initiated in May 2015, and several subjects have been followed for more than one year.

Mild to moderate ocular inflammation was observed in the treated eye for the majority of patients and resolved or was controlled either without further intervention or after treatment with topical or oral corticosteroids. No treatment related serious adverse events were reported and the treatment was generally well tolerated, added the Company.

AGTC closed Thursday's trading at $5.00, up 3.09%.

BioTime Inc. (BTX) is slated to report top line data from its European pivotal trial of Renevia for the treatment of HIV-associated lipoatrophy before the US market open on Wednesday, June 14, 2017.

Facial wasting or facial lipoatrophy is the loss of subcutaneous fat from the face and is associated with medication for treatment of HIV infection. Signs of lipoatrophy include the loss of subcutaneous fat primarily in the temporal region and cheeks and this tends to produce an emaciated appearance.

Early data from the study that was reported last November indicated that Renevia was safely administered with no serious adverse events and 3-D imaging suggested that volumetric improvements were sustained through a one-year follow up.

BTX closed Thursday's trading at $3.17, up 0.96%.

If the FDA sticks to its deadline, tomorrow (June 9, 2017) we will know whether or not Coherus BioSciences Inc.'s (CHRS) product candidate CHS-1701 gets the green light.

CHS-1701 is a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta that was approved in 2002.

Neulasta is used to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy. The drug generated sales of $4.65 billion in sales for Amgen last year.

On May 10, 2017, Amgen sued Coherus for allegedly infringing a patent covering Neulasta. In March of this year, Amgen had sued Coherus over Neulasta's trade secrets.

CHRS closed Thursday's trading at $22.70, up 9.93%.

Shares of Endo International plc (ENDP) were down over 13% in extended trading on Thursday after being asked by the FDA to voluntarily withdraw reformulated Opana ER from the market. This is the first time that the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

In March of this year, an FDA panel, which reviewed reformulated Opana ER designed to be crush-resistant, had voted 18 to eight, with one abstention, that the benefits of the drug no longer outweigh its risks.

Opana ER was approved by the FDA in 2006 for patients requiring continuous, around-the-clock opioid treatment for an extended period of time. A reformulated Opana ER intended to be resistant to physical and chemical manipulation for abuse by intranasal and intravenous routes received FDA approval in December 2011, and it replaced the original Opana ER over first few months of 2012.

In June 2015, the Centers for Disease Control and Prevention blamed the abuse and manipulation of the reformulated Opana ER for an outbreak of HIV in southern Indiana.

Net sales of Opana ER in 2016 declined to $158.94 million from $175.77 million in 2015.

ENDP closed Thursday's trading at $13.78, up 11.13%. In after-hours, the stock fell 13.50% to $11.92.

The FDA has removed the clinical hold on Inovio Pharmaceuticals Inc.'s (INO) proposed phase 3 clinical trial of its investigational immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus.

A clinical hold was imposed on the phase III clinical program for VGX-3100 last October as the FDA required additional data to support the shelf-life of the Company's immunotherapy delivery device CELLECTRA 5PSP.

Inovio satisfied the FDA's request for information relating to its CELLECTRA 5PSP delivery device, resulting in the FDA removing the clinical hold on the phase II program.

The phase III program of VGX-3100, named REVEAL, will consist of a primary study (REVEAL 1) and confirmatory study (REVEAL 2), which will be conducted in parallel. The studies will each enroll 198 patients in more than 100 study centers globally. Inovio plans to immediately begin recruiting patients for the phase III trial.

INO closed Thursday's trading at $8.19, up 10.83%. In after-hours, the stock was up 3.30% to $8.46.

NewLink Genetics Corp. (NLNK) plunged over 41% on Thursday after Roche Group's Genentech announced its decision to return the rights to IDO inhibitor Navoximod.

In October 2014, NewLink and Genentech had entered into an exclusive worldwide license agreement for the development of Navoximod (formerly NLG 919, GDC 0919). Under the terms of the deal, NewLink was eligible to receive in excess of $1 billion in milestone payments as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.

Navoximod is under phase I trials in solid tumors.

Now that, Genentech has decided to walk away from the deal, Navoximod will revert to NewLink Genetics when the termination becomes effective.

NewLink has another IDO pathway inhibitor Indoximod in its pipeline, which is under phase 1 and phase II trials in multiple cancer types including melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer.

Commenting on the development, Charles Link, CEO of NewLink said, "We are obviously disappointed in this decision. We remain committed to advancing our IDO pathway inhibitor indoximod, which continues to generate exciting data in combination with anti-PD-1 agents, cancer vaccines, and chemotherapy in multiple cancer types including melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer."

NLNK closed Thursday's trading at $6.24, down 41.24%.

The FDA has granted OncoSec Medical Inc. (ONCS) Orphan Drug Designation for Tavokinogene telsaplasmid, the active biologic agent in the Company's lead product candidate, ImmunoPulse IL-12.

OncoSec is initiating the registration-directed phase IIb trial, dubbed PISCES, to evaluate the safety and efficacy of ImmunoPulse IL-12 and the approved anti-PD-1 agent, pembrolizumab, in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.

Commenting on the Orphan Drug status, Punit Dhillon, CEO and President of OncoSec, said, "This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization. We are diligently working to address a significant unmet medical need in melanoma patients who are progressing or have progressed after treatment with anti-PD-1."

ONCS closed Thursday's trading at $1.12, up 5.66%. In after-hours, the stock was up another 4.46% to $1.17.