Juno reports positive non-Hodgkin lymphoma data

Juno Therapeutics to highlight CD19- and BCMA-targeted CAR T therapy at ASH 2017

Juno Therapeutics to highlight CD19- and BCMA-targeted CAR T therapy. See Stockwinners.com for details

Juno Therapeutics (JUNO) announced that 15 abstracts detailing updated clinical and preclinical results from the company and its collaborators will be presented at the 59th American Society of Hematology Annual Meeting.

Senior executives will also review results and provide an update on Juno’s clinical development program at an analyst and investor event, which will also be available via webcast.

Updated data from the TRANSCEND study of JCAR017 in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma will be presented by Principal Investigator Jeremy Abramson, M.D., of the Massachusetts General Hospital, on December 11.

The presentation will include new information on enrollment, safety, response rates, duration of response, and overall survival.

The primary TRANSCEND abstract released today includes data from the core analysis group, which includes patients that represent the population that Juno is studying in the ongoing pivotal cohort. The core group includes patients with DLBCL who are ECOG Performance Status 0-1.

These patients represent a highly refractory population based on some key factors that are associated with a poor prognosis including an older age, having a double or triple hit, and being chemorefractory. Topline data from the abstract for both dose levels for the core group as of a data cutoff date of July 7, 2017 included: Dose level 2, the dose in the pivotal cohort for the TRANSCEND study, showed a 3 month overall response rate of 80% and a 3 month complete response rate of 73% in the core group.

Data support a dose response relationship. Dose level 1 showed 3 month ORR of 52% and a 3 month CR rate of 33%. Across both doses in the core group, the best overall response was 84% and the best overall CR rate was 61%.

There was no increase in cytokine release syndrome and neurotoxicity rates associated with the higher dose or between the full and core groups. Across doses in the full group, 1% experienced severe CRS and 14% experienced severe NT. 30% had any grade CRS and 20% had any grade NT. 64% had no CRS or NT.

The most common treatment-emergent adverse events other than CRS and NT that occurred at greater than or equal to25% in the full group included neutropenia, fatigue, thrombocytopenia, and anemia.

JUNO closed at $44.91.


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GlaxoSmithKline and Innoviva report positive data

GSK, Innoviva announce ‘positive’ data in Anoro Ellipta study 

GSK and Innoviva report positive COPD data. See Stockwinners.com for details

GlaxoSmithKline (GSK) and Innoviva (INVA) announced positive data from a study comparing a once-daily long-acting muscarinic antagonist and a long-acting beta agonist fixed-dose combination, Anoro Ellipta and Stiolto Respimat, for symptomatic patients with chronic obstructive pulmonary disease.

COPD, or chronic obstructive pulmonary disease, is a progressive disease that makes it hard to breathe. Progressive means the disease gets worse over time.

COPD can cause coughing that produces large amounts of a slimy substance called mucus, wheezing, shortness of breath, chest tightness, and other symptoms.

Cigarette smoking is the leading cause of COPD. Most people who have COPD smoke or used to smoke. However, up to 25 percent of people with COPD never smoked. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dusts—also may contribute to COPD. A rare genetic condition called alpha-1 antitrypsin (AAT) deficiency can also cause the disease.

These data have been published today in Advances in Therapy and are being presented today at the CHEST annual meeting of the American College of Chest Physicians in Toronto, Canada.

The primary endpoint for this eight-week, open-label, cross-over study of 236 patients with COPD was the demonstration of non-inferiority of UMEC/VI compared to TIO/OLO in improving lung function, as measured by trough FEV1 at week eight.

This endpoint was met, and furthermore UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight.

Both treatments demonstrated a comparable tolerability and safety profile with an overall incidence of on-treatment adverse events of 25% in the UMEC/VI group and 31% in the TIO/OLO group.

The most frequently-reported adverse events were upper respiratory tract infections, cough and diarrhoea.

INVA closed at $12.24. GSK closed at $36.43.


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Southcross Energy Partners sold for $815 million

American Midstream Partners to acquire Southcross Energy Partners

Southcross Energy Partners sold for $815M. See Stockwinners.com for details

American Midstream Partners (AMID) announced that it has signed an agreement to acquire certain assets of Southcross Holdings, and has proposed to merge Southcross Energy Partners (SXE) into a wholly owned subsidiary of AMID in two separate transactions valued at approximately $815 million, including the repayment of net debt.

As a result of the transactions, the pro forma partnership with an enterprise value of $3 billion is expected to generate annualized 2018 Adjusted EBITDA in excess of $300 million.

AMID has agreed to acquire equity interests in certain Southcross Holdings’ subsidiaries that directly or indirectly own 100% of the limited liability company interests of the general partner of SXE and approximately 55% of the SXE common units by issuing 3.4 million AMID common units, 4.5 million new Series E convertible preferred units, options to acquire 4.5 million AMID common units and the repayment of $139 million of estimated net debt.

The Preferred Units will be issued at a price of $15.00 per unit and may be paid-in-kind at the AMID common unit distribution rate at AMID’s option for two years. AMID will have the right to convert the Preferred Units to AMID common units if the AMID 20-day volume weighted average price exceeds $22.50.

The Options are American-style call options with an $18.50 strike price that expire in 2022.

Public unitholders of SXE will receive 0.160 AMID common units for each SXE common unit in a unit-for-unit merger, which is anticipated to have minimal, if any, tax recognition for such unitholders and which represents a 5% premium to the 20-day volume weighted average exchange ratio of AMID and SXE common units as of October 30, 2017.

The SXE transaction is conditioned on the Southcross Holdings transaction, and until both transactions have closed AMID, Southcross Holdings and SXE will continue to operate as separate companies.

AMID expects the proposal to be attractive to public holders of SXE common units as it will permit them to participate in the future anticipated growth of AMID’s businesses, including the benefit of AMID’s cash distributions on common units, currently paying $1.65 per common unit annually.

SXE closed at $2.10. AMID closed at $13.55.


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