On February 1, 2018 Boston-based cancer company Partner Therapeutics, Inc. (PTx) reported that it has acquired the global rights to develop, manufacture, and commercialize Leukine (sargramostim) from Sanofi (Press release, Partner Therapeutics, FEB 1, 2018, View Source [SID1234610372]). Leukine is an immuno-stimulant that promotes the growth and activation of a broad range of white blood cells important in activating the body’s immune response to fight infections. Leukine is used to treat or prevent severe and life-threatening infections and is the only immune modulator approved by the FDA for the treatment of acute myelogenous leukemia (AML) in older patients and for use in both allogeneic and autologous bone marrow transplantation.

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In connection with the acquisition of Leukine, PTx will also acquire a dedicated manufacturing facility in Lynnwood, Washington. The facility is a state of the art biologics manufacturing plant that was certified for commercial production in 2012. The Lynnwood facility will serve as the core manufacturing and supply chain center for PTx’s operations.

Leukine is the only FDA-approved recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF). It has been demonstrated to promote growth and activation of monocytes, macrophages, neutrophils and dendritic cells. It is currently indicated for the treatment of AML in older adults to reduce the incidence of severe and life-threatening infections resulting in death; use in the treatment of allogeneic bone marrow transplants to reduce the incidence of bacteremia and other culture positive infections and shorten the median duration of hospitalization; and to prolong the survival of patients who are experiencing bone marrow transplant failure or delay.

PTx will support the development of Leukine for new indications. The product is being tested in a diverse set of clinical trials for its potential to improve survival and reduce adverse events in combination with leading immuno-oncology therapies. A 250 patient, randomized Phase II study in refractory melanoma in combination with ipilimumab demonstrated an improvement in survival (hazard ratio of 0.64) over ipilimumab alone1. Leukine is currently being tested in a Phase III trial in front-line melanoma in combination with ipilimumab and nivolumab, being conducted by the ECOG-ACRIN Cancer Research Group (Principal Investigator: F Stephen Hodi, MD, Director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute) and sponsored by the National Cancer Institute (ClinicalTrials.gov Identifier: NCT02339571).

Leukine is also in development for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS). Data presented at the 2016 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), demonstrated Leukine’s ability to increase survival in non-human primates exposed to myelosuppressive doses of radiation without supportive whole blood transfusions or individualized antibiotics2. A supplemental biologics licensing application (sBLA) was filed in September of 2017 with the FDA requesting approval of Leukine for the treatment of H-ARS. In December, the application was granted Priority Review with a PDUFA date of March 29, 2018.

"We are delighted to have the opportunity to build a new future for Leukine and welcome the talented and dedicated team in Lynnwood to the PTx family", said Robert Mulroy, CEO of PTx. "The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections."

"In contrast to other approved growth factors that stimulate one cell type, Leukine’s ability to stimulate a broader variety of cells, endows it with unique clinical potential to address serious medical needs across hematologic diseases and cancer as well as infectious, neurological and pulmonary disorders," said Dr. Debasish Roychowdhury, Chief Medical Officer. "We are excited to have the opportunity to work with investigators and healthcare professionals to explore new indications that can take advantage of Leukine’s unique biological and immuno-stimulatory attributes and clinical properties."

PTx plans to provide commercial and medical support of Leukine in the United States and explore commercialization opportunities outside the U.S.

On February 1, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that they have entered into an exclusive agreement under which CANbridge will develop and commercialize NERLYNX (neratinib) in mainland China, Taiwan, Hong Kong, and Macau (greater China) (Press release, Puma Biotechnology, FEB 1, 2018, http://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-canbridge-life-sciences-enter-exclusive-licensing-agreement-com [SID1234523716]).

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NERLYNX is not approved currently for commercialization outside of the United States. CANbridge will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing NERLYNX in greater China. Puma will receive an upfront payment of $30 million and potential milestone payments totaling up to $40 million upon achievement of certain regulatory milestones. In addition, Puma will receive significant double-digit royalties on NERLYNX sales in greater China and potential milestone payments upon the achievement of certain sales-based milestones.

"Puma is committed to providing access to NERLYNX to patients around the world, and greater China represents a very large market opportunity," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "While we continue to focus our commercial resources on the U.S. market, we believe this new partnership with CANbridge will help patients in greater China to access NERLYNX at the earliest opportunity."

"We are excited about the opportunity to provide this therapy to patients with HER2-positive cancer in our region," said James Xue, Ph.D., Chief Executive Officer and President of CANbridge Life Sciences. "We plan to engage our local regulatory authorities in greater China to expedite commercial access to NERLYNX, which we expect to provide in parts of greater China by mid-2019. We are honored to have been selected by Puma to develop and commercialize this important therapy, which we believe has significant commercial potential in greater China in HER2-positive cancers, including gastric cancer, where CANbridge will be leading the clinical development in greater China."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 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 (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) 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.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:

Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

On February 1, 2018 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported additional findings from its Phase 1 study of Atossa’s proprietary oral Endoxifen (Press release, Atossa Genetics, FEB 1, 2018, View Source [SID1234523677]). Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high-risk patients.

The additional findings from the oral arm of the Endoxifen Phase 1 study are summarized as follows:

The median time for patients in the study to reach the steady-state serum levels of Endoxifen while taking daily doses of Atossa’s oral Endoxifen was 7 days. Published literature indicates that it takes approximately 50-200 days for patients to reach steady-state Endoxifen levels when taking daily doses of oral tamoxifen.

The median time for patients in the study to reach the maximum serum level of Endoxifen after taking Atossa’s oral Endoxifen was ranged from 4 to 8 hours (depending on dose). The 4 mg dose of Endoxifen produced a maximum serum level of Endoxifen in 4 to 8 hours at levels above the generally accepted threshold for a therapeutic effect on estrogen-dependent breast cancer.
"These additional findings are important for several reasons," commented Steve Quay, Ph.D., MD, CEO and President of Atossa. "Breast cancer patients do not typically want to wait weeks or even months for the current standard of care, oral tamoxifen, to take effect. Our study data indicates that our proprietary oral Endoxifen reaches a steady-state in about 7 days, while the literature indicates that it can take 50-200 days for tamoxifen to reach a steady-state – keeping in mind that a breast cancer tumor can double in size in as little as 29 days. Not only does it take up to several months for oral tamoxifen to take effect, oral tamoxifen also does not benefit up to 50% of patients, partly because many patients cannot metabolize tamoxifen. For these reasons, we believe our oral Endoxifen may reduce the incidence of this deadly disease and fundamentally change the paradigm for breast cancer treatment," added Dr. Quay.

The additional findings will also be discussed during the conference call today at 4:30 pm EST. Due to expected high call attendance, participants are asked to preregister for the call through the following link: View Source Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or who are unable to pre-register may dial in by calling: 1-844-824-3830 (domestic), 1-412-317-5140 (international) and Canada Toll Free: 1-855-669-9657. Callers should ask to be joined into the Atossa Genetics call.

The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company’s IR events page at View Source

Management will answer pre-submitted questions gathered prior to the conference call in the Question and Answer period of the call. Interested parties may submit questions for management’s consideration prior to the call by submitting them in writing to Atossa Genetics’ Investor Relations at [email protected].

A replay of the call will be available approximately one hour after the end of the call through March 1, 2018. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay access code is 10116753.

The objectives of Atossa’s double-blinded, placebo-controlled, Phase 1 study of 48 healthy female subjects were to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms as single (oral) and repeat (oral and topical) doses, as well as to assess safety and tolerability. Preliminary results from the study, which were announced on September 14, 2017 and October 25, 2017, showed that all objectives of the study were successfully met: there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, low but measurable Endoxifen levels were detected in the blood in a dose-dependent fashion. In the oral arm of the study, participants exhibited dose-dependent Endoxifen levels that met or exceeded the published therapeutic level.

Atossa is developing proprietary Endoxifen with two routes of delivery anticipated to address two distinct patient populations: oral Endoxifen for breast cancer survivors and topical Endoxifen for women with a condition called mammographic breast density (or, MBD). When a patient is treated for breast cancer, doctors typically prescribe oral tamoxifen for 5-10 years to reduce the risk of recurrent and new tumors. Tamoxifen can have uncomfortable as well as serious side effects. Perhaps more importantly, not all patients benefit from tamoxifen therapy due to their inability to effectively metabolize tamoxifen into Endoxifen. Recent research continues to confirm the key role Endoxifen plays in reducing the risk of recurrent and new breast cancer in these patients. It is estimated that more than one million breast cancer survivors in the U.S. are recommended to take tamoxifen. Atossa is developing oral Endoxifen for these patients who are "refractory" to tamoxifen meaning that they are not benefiting from tamoxifen.

There is no FDA-approved treatment for MBD, which affects more than ten million women in the U.S. It is well accepted that MBD increases the risk of breast cancer, which is why 30 states currently require that a finding of MBD be reported to the patient, physician or both. It is believed that not only does MBD make mammography less effective because MBD can hide cancerous tumors, but also the tissue itself may be more prone to develop cancer. For these reasons, Atossa is developing topical Endoxifen as a potential treatment for MBD.

Results from Atossa’s Phase 1 study have paved the way for upcoming Phase 2 studies: a study using Atossa’s proprietary topical Endoxifen to treat MBD which will be performed at South General Hospital in Stockholm and a study using Atossa’s proprietary oral Endoxifen to treat women who are refractory to tamoxifen. We plan to open both of these studies in the first quarter of 2018.

Atossa has also started a program to deliver Chimeric Antigen Receptor Therapy, or CAR-T, cells into the ducts of the breast for the potential targeted treatment of breast cancer. This is a novel approach using Atossa’s proprietary intraductal microcatheter technology for the potential transpapillary, or "TRAP," delivery of T-cells that have been genetically modified to attack breast cancer cells. We believe this method has several potential advantages including the reduction of toxicity by limiting systemic exposure of the T-cells; improved efficacy by placing the T-cells in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; and, lymphatic migration of the CAR-T cells potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. We are also using our intraductal microcatheters in a Phase 2 study at Montefiore Medical Center in New York where we are targeting the delivery of Fulvestrant to the site of early stage breast cancer and ductal carcinoma in situ.

Atossa is developing its products to reduce the risk of developing breast cancer and to provide new approaches to effectively treat breast cancer patients in a cost-effective and safer manner. A study conducted by Defined Health, a leading market research firm, estimates that the potential market for Endoxifen exceeds $1 billion in annual sales and the potential market for Atossa’s intraductal microcatheters to delivery therapeutics exceeds $800 million as a treatment and replacement for surgery.

CAR-T has been the subject of much attention recently. In October 2017, pioneer CAR-T company Kite Pharma was acquired for $11.9 billion by Gilead; in August 2017 Novartis received the first FDA approval in the CAR-T field for Kymriah for the treatment of B-cell Acute Lymphoblastic Leukemia; and in January 2018 Celgene Corporation announced the acquisition of Juno Therapeutics for $9 billion.

Atossa’s 2018 potential milestones include:

First quarter of 2018 – opening the Phase 2 Study of topical Endoxifen to treat MBD at Stockholm South General Hospital in Sweden (which we plan to complete in 2018).
First quarter of 2018 – opening the Phase 2 Study of oral Endoxifen to treat patients who are not responding to Tamoxifen (which we plan to complete in 2018).
Second half of 2018 – commencing one or more studies administering TRAP CAR-T with our microcatheters.
Throughout 2018 – continuing our Phase 2 study administering Fulvestrant with our microcatheters.
The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.

On February 1, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that Mr. Dror Ben-Asher, RedHill’s Chief Executive Officer, will present a corporate overview at the BIO CEO & Investor Conference, on Monday, February 12, 2018, at 10:45 am EST, at the New York Marriott Marquis Hotel, NY (Press release, RedHill Biopharma, FEB 1, 2018, View Source [SID1234523717]).

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A live audio of the presentation will be available on the Company’s website at: View Source A copy of the presentation will be available on the Company’s website and a replay of the webcast will be available on the Company’s website for a period of 30 days.

On February 1, 2018 Celgene Corporation (NASDAQ: CELG) reported that it plans to present at two upcoming investor conferences where Celgene management will provide an overview of the Company (Press release, Celgene, FEB 1, 2018, View Source [SID1234523678]). The conferences will be webcast live and will be available in the Investor Relations section of the Company’s website at www.celgene.com.

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Thursday, February 15, 2018, Celgene will present at the Leerink Partners Global Healthcare Conference in New York City at 1:30 pm ET

Wednesday, February 21, 2018, Celgene will present at the RBC Capital Markets 2018 Global Healthcare Conference in New York City at 11:30 am ET