EMA rejects Puma’s neratinib, Shares tumble

Puma says EMA communicates negative trend vote over MAA for neratinib

sTOCKS TO WATCH, FDA Approves Breast Cancer Drug. See Stockwinners.com Market Radar, Stocks to Buy, Stocks to Invest In, Stocks to Buy on Margin
EMA rejects Breast Cancer Drug!
Puma Biotechnology (PBYI) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has communicated a negative trend vote after meeting with the company today to discuss the Marketing Authorisation Application for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

 

A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe.

 

CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival benefits observed to-date may lack sufficient clinical relevance.

 

CHMP’s opinion was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

BACKGROUND

 On July 17, 2017, the company announced that the U.S. FDA has approved #NERLYNX (neratinib), formerly known as #PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. The drug became commercially available in September of 2017 under the trade name as NERLYNX.

EUROPEAN  DATA 

Last September, Puma Biotechnology (PBYI) presented positive results from the Phase III clinical trial of Puma’s drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain.

PRICE ACTION

Today’s EMA decision was a surprise to the market. PBYI closed at $90.90. Shares last traded at $66.00 in extended trading.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.


Seattle Genetics presents breast cancer data

Seattle Genetics presents updated Phase 1 data for SGN-LIV1A 

https://stockwinners.com/blog
Seattle Genetics presents updated Phase 1 data for SGN-LIV1A

Seattle Genetics (SGEN) announced updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer at the 2017 San Antonio Breast Cancer Symposium, taking place December 5-9, 2017.

Ladiratuzumab vedotin is an investigational antibody-drug conjugate designed to deliver a potent and clinically validated cell-killing agent, monomethyl auristatin E, to cancer cells which express the protein LIV-1.

LIV-1 is expressed on multiple solid tumors including breast, prostate, melanoma, ovarian, uterine, and cervical cancers.

A total of 81 patients with LIV-1-expressing metastatic breast cancer were treated with ladiratuzumab vedotin monotherapy given every three weeks.

Patients enrolled in the study had received a median of four prior systemic metastatic therapies. Of these patients, 63 were diagnosed with TNBC and 18 had hormone receptor-positive / human epidermal growth factor receptor 2-negative breast cancer.

At the completion of dose escalation at doses ranging from 0.5 to 2.8 milligrams per kilogram, TNBC expansion cohorts were opened at 2.0 and 2.5 mg/kg to further evaluate safety and antitumor activity of ladiratuzumab vedotin in metastatic TNBC patients.

Based on efficacy and safety, the recommended dose is 2.5 mg/kg with a maximum dose of 200 mg per cycle.

Key findings in this heavily pre-treated patient population were presented by Dr. Jennifer Specht, Seattle Cancer Care Alliance and include: Among the 60 efficacy-evaluable patients with metastatic TNBC, the objective response rate (ORR) was 25 percent, representing all partial responses.

The clinical benefit rate was 28 percent. CBR is defined as patients achieving complete response or PR of any duration, plus patients achieving stable disease lasting at least 24 weeks. Of the 17 efficacy-evaluable patients treated at the recommended dose, 29 percent achieved an objective response, and the CBR was 29 percent.

The median progression-free survival and median duration of response for patients treated across all dose levels were 11 weeks and 13.3 weeks, respectively. In 19 patients treated at the recommended dose, the median PFS was 12.1 weeks, and the median DOR was 17.4 weeks.

SGEN closed at $56.75.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Atossa Genetics breast cancer drug shows promise

All objectives met in Phase 1 study of oral Endoxifen

Atossa Genetics breast cancer drug shows promise. See Stockwinners.com for details

Atossa Genetics (ATOS) reported preliminary results from its Phase 1 study of its proprietary oral Endoxifen.

All objectives were successfully met.

Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen.

Tolerability: Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.

Pharmacokinetics: Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer. These data demonstrate the suitability of oral Endoxifen for further clinical development.

“Based on these positive preliminary results, we are advancing our oral Endoxifen into Phase 2 studies,” commented Dr. Steven C. Quay, CEO and President.

“We expect our initial Phase 2 study will be in women who are refractory to tamoxifen and we expect to begin that study in the first quarter of 2018,” continued Dr. Quay.

BACKGROUND

Researchers at the Mayo Clinic Cancer Center are developing a new drug to help women with estrogen receptor positive breast cancer who are unable to derive benefit from the drug tamoxifen. These women need an alternative to #tamoxifen because their bodies are unable to effectively metabolize the drug to its active agent, endoxifen.

Tamoxifen is a hormone therapy that has been used for more than 40 years to reduce the risk of breast cancer and to prevent recurrence. However, research has demonstrated that patients with very low levels of a critical enzyme called CYP2D6 and those with low endoxifen levels have a higher risk of recurrence or progression when treated with tamoxifen.

Endoxifen, also known as N-desmethyl-4-hydroxytamoxifen, is an orally active nonsteroidal selective estrogen receptor modulator (SERM) of the triphenylethylene group that is or was under development for the treatment of estrogen receptor-positive breast cancer. It is also being evaluated as an antipsychotic for treatment of mania and other psychotic disorders.

ATOS haled at $1.22.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Watch Puma Biotechnology!

Puma Biotechnology announces “positive” results from Phase III ExteNET trial

sTOCKS TO WATCH, FDA Approves Breast Cancer Drug. See Stockwinners.com Market Radar, Stocks to Buy, Stocks to Invest In, Stocks to Buy on Margin

Puma Biotechnology (PBYI) announced the presentation of positive results from the Phase III clinical trial of Puma’s drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain.

#Neratinib was approved by the FDA in July for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX tablets.

The most common adverse reactions were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab in patients with early stage HER2-positive breast cancer.

The predefined 5-year invasive disease free survival analysis as a follow-up to the primary 2-year iDFS analysis of the Phase III ExteNET trial was presented.

The ExteNET trial randomized 2,840 patients in 41 countries with early stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab.

After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ, or death for a period of five years after randomization in the trial.

The patient characteristics in the trial were well balanced between the neratinib and placebo arms of the trial. For the 1,420 patients in the neratinib arm of the trial, 1,085 were node positive while of the 1,420 patients in the placebo arm of the trial, 1,084 were node positive.

Additionally, in the neratinib arm of the trial, 816 patients were hormone receptor positive, and in the placebo arm of the trial, 815 patients were hormone receptor positive.

The median time from the last trastuzumab dose to entry into the trial was 4.4 months for the neratinib-treated patients and 4.6 months for the placebo-treated patients. The primary endpoint of the trial was invasive disease free survival.

The results of the trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo.

The 5-year iDFS rate for the neratinib arm was 90.2% and the 5-year iDFS rate for the placebo arm was 87.7%. The secondary endpoint of the trial was invasive disease free survival including ductal carcinoma in situ. The results of the trial demonstrated that treatment with neratinib resulted in a 29% reduction of risk of disease recurrence including DCIS or death versus placebo.

The 5-year iDFS-DCIS rate for the neratinib arm was 89.7% and the 5-year iDFS-DCIS rate for the placebo arm was 86.8%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 40% reduction of risk of invasive disease recurrence or death versus placebo.

The 5-year iDFS rate for the neratinib arm was 91.2% and the 5-year iDFS rate for the placebo arm was 86.8%.

For the pre-defined subgroup of patients with hormone receptor negative disease, the results of the trial demonstrated that treatment with neratinib resulted in a hazard ratio of 0.95.

RELATED BLOGS


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Stocks to Watch: Puma Biotechnology

Puma Biotechnology confirms FDA approval of NERLYNX for treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer

 

sTOCKS TO WATCH, FDA Approves Breast Cancer Drug. See Stockwinners.com Market Radar, Stocks to Buy, Stocks to Invest In, Stocks to Buy on Margin

Puma Biotechnology announced that the U.S. FDA has approved #NERLYNX (neratinib), formerly known as #PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.

Puma expects neratinib to become commercially available in September 2017 and to be marketed as NERLYNX.

Puma Biotechnology said up to one in four patients experience recurrence after treatment, but studies of its drug showed a 34% reduction in recurrence.

“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” Richard Pazdur, director of the FDA Oncology Center of Excellence.

“Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”

See our previous blogs on Puma and its progress toward the approval.

STOCK PRICE

On May 11, 2017 when PBYI was trading at $30.75, Stockwinners predicted that Puma stock will double by the end of May.  PBYI closed at $86.10 on Monday. It has a 52-week trading range of $28.35 – $94.70.

STOCKWINNERS

To read timely stories similar to this along with money making trade ideas, sign up for a membership to Stockwinners.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

 

 

Nektar Therapeutics Announces Positive Results

Nektar presents new ‘positive’ preclinical results for NKTR-358

 

Stockwinners offers winning stock and option picks since 1998

Nektar Therapeutics (NKTR) announced positive preclinical results for NKTR-358, a first-in-class resolution therapeutic for autoimmune disease.

The new preclinical data demonstrate that treatment with NKTR-358 induces profound regulatory T cell effects and suppresses inflammation in multiple preclinical models.

The data were highlighted in an oral presentation at the 13th Annual World Congress on Inflammation on July 9, 2017.

“These studies show that NKTR-358 increases the suppressive capacity and prolongs activation and proliferation of regulatory T cells with limited effects on conventional T cells in order to address the imbalance found in many autoimmune diseases,” said Jonathan Zalevsky, PhD, Senior Vice President, Biology and Preclinical Development at Nektar Therapeutics. “NKTR-358 also demonstrated suppression of antigen-driven inflammation in multiple preclinical models including systemic lupus erythematosus.

We are very excited about NKTR-358’s potential as a resolution therapy in autoimmune disease.”

Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person’s body.iv A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic auto-reactive T lymphocytes that conduct this attack. NKTR-358 works by optimally targeting the interleukin-2 (IL-2) receptor complex in order to stimulate proliferation and activation of regulatory T cells. By increasing the number of regulatory T cells, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and regulatory T cells can be achieved to restore the body’s self-tolerance mechanisms.

In preclinical studies, #NKTR-358 demonstrates attenuated and optimized affinity for human IL-2 receptors to promote biological activity favoring activation of regulatory T cells over conventional T cells. This preferential activity combined with prolonged exposure in vivo led to significant Treg mobilization in blood and spleen following a single subcutaneous administration in rodents.

Increases in regulatory T cells were sustained for 7 to 10 days, and were concomitant with increases in cytometric markers of activation and increased suppressive capacity.

Visit Stockwinners to read more.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Blackstone to sell Logicor to China Investment

China Investment Corporation (CIC) is in advanced negotiations to acquire Blackstone’s European logistics platform for over $13.4 billion.

Blackstone originally considered steering Logicor to an IPO, Deal could be announced this week

If completed, the transaction would mark Europe’s largest-ever real estate deal. 

 

bx

 

China Investment Corporation (CIC) is in advanced negotiations to acquire Blackstone’s European logistics platform for over $13.4 billion.

China’s sovereign wealth fund has reportedly moved ahead of rivals in the pursuit of the Logicor warehouse portfolio, after formal bids having been submitted by last Thursday.

CIC is now said to be scheduled to sign a deal for Blackstone’s (BX) giant’s 630 European distribution centers within the next two to three days. If completed, the transaction would mark Europe’s largest-ever real estate deal.

In March, Blackstone began shopping Logicor to institutional investors including CIC, #Singaporean warehouse group Global Logistics Properties (GLP), and a joint venture between Singapore’s #Mapletree Investments and #Temasek Holdings. The sale of the 146.4 million square foot warehouse platform would mark the biggest logistics property deal in history.

CIC is said to benefit from its close relationship with #Blackstone.  In January 2014, CIC purchased London’s Chiswick Park office complex from Blackstone for over $1.28  billion.

Blackstone originally considered steering Logicor to an IPO, but is reported to have shelved that option in favor of a trade sale, aggressively driving the bidding process forward over the past few weeks. A trade sale would potentially achieve a higher price while allowing Blackstone to dispose of the business in a faster and more efficient manner than an #IPO.

Logicor was founded by Blackstone’s real estate business in 2012 and has rapidly grown into one of Europe’s largest warehousing specialists, with modern logistics facilities in 17 countries across the continent. Investors continue to pile into the logistics real estate sector amidst a boom in online retail, soaring prices and relatively high yields compared to other property asset classes.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.