On February 12, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will participate in a fireside chat at the 7th Annual Leerink Partners Global Healthcare Conference on Wednesday, February 14, 2018, at 1:00 p.m. EST at the Lotte New York Palace Hotel (Press release, Heron Therapeutics, FEB 12, 2018, View Source [SID1234523913]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On February 12, 2018 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK TKIs (Press release, Pfizer, FEB 12, 2018, View Source [SID1234523917]). The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib.

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"Treatment resistance resulting in disease progression is a major challenge faced by patients with ALK-positive metastatic NSCLC. Lorlatinib was developed by Pfizer scientists with the specific goal of overcoming resistance to first- and second-generation ALK-targeted therapies," said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. "The encouraging results observed in a variety of patients previously treated with ALK inhibitors provides the basis for these applications."

The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. In April 2017, lorlatinib received Breakthrough Therapy Designation from the FDA for patients with ALK-positive metastatic NSCLC previously treated with one or more ALK inhibitors.

The submissions are based on Phase 2 data from a Phase 1/2 clinical trial (NCT01970865) of lorlatinib, evaluating patients treated in distinct cohorts based on prior therapy. Full results from the Phase 2 portion of the trial were presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in October 2017.1

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2018.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide.2 NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.3 Approximately 75 percent of NSCLC patients are diagnosed late with metastatic or advanced disease where the five-year survival rate is only five percent.2,4,5

ALK gene rearrangement is a genetic alteration that drives the development of lung cancer in some patients.6,7 Epidemiology studies suggest that approximately three to five percent of NSCLC tumors are ALK-positive.8

About Lorlatinib

Lorlatinib is an investigational TKI that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.

The Phase 3 CROWN study (NCT03052608) of lorlatinib began enrolling patients earlier this year. CROWN is an ongoing, open label, randomized, two-arm study comparing lorlatinib to crizotinib for treatment-naïve patients with metastatic ALK-positive NSCLC.

Lorlatinib is an investigational agent and has not received regulatory approval anywhere in the world. A multi-center, open-label expanded access protocol (NCT03178071) is now open in the United States for lorlatinib, making it available for eligible adults with ALK-positive or ROS1-positive advanced NSCLC at select sites. More information can be found by visiting www.clinicaltrials.gov.

About Pfizer in Lung Cancer

Pfizer Oncology is committed to addressing the unmet needs of patients with lung cancer, the leading cause of cancer-related death worldwide and a particularly difficult-to-treat disease. Pfizer strives to address the diverse and evolving needs of patients with NSCLC by developing efficacious and tolerable therapies, including biomarker-driven therapies and immuno-oncology (IO) agents and combinations. By combining leading scientific insights with a patient-centric approach, Pfizer is continually advancing its work to match the right patient with the right medicine at the right time. Through our growing research pipeline and collaboration efforts, we are committed to delivering renewed hope to patients living with NSCLC.

On February 12, 2018 EUSA Pharma (EUSA), reported that the National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending tivozanib as a first-line treatment option for advanced renal cell carcinoma (aRCC) in line with its licensed indication (Press release, EUSA Pharma, FEB 12, 2018, View Source [SID1234523911]). Tivozanib was licensed by the European Commission (EC) in August 20171 and is an oral, once-daily, potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI). VEGFR-TKIs work by reducing the supply of blood to the tumour – denying it the food and oxygen it would need to grow in size.2

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In arriving at its positive recommendation, NICE considered data from the global, open-label, randomised, multi-centre Phase III trial (TiVO-1)3 which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI (sorafenib) in the treatment of 517 patients with aRCC. Patients treated with tivozanib experienced superior progression-free survival (PFS) (11.9 vs. 9.1 months in the overall population and 12.7 vs. 9.1 months in treatment naïve patients) versus sorafenib.3 There was also an improved side effect profile with tivozanib, with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events (AEs).3 In addition, fewer people on tivozanib experienced burdensome side effects, such as diarrhoea (23% vs 33%), and hand-foot syndrome (14% vs 54%).3

Dr Lisa Pickering, Consultant Medical Oncologist at St George’s Hospital, London, commented: This is excellent news for patients with aRCC. A key treatment goal is to enable patients to live without their cancer progressing for longer periods of time – we cannot cure their cancer but we can help to preserve normal living for as long as possible. That is why I’m delighted that NICE has recommended tivozanib as a treatment option."

Around 12 people in the UK die every day of kidney cancer, with more than 40% of cases in England diagnosed at a late (advanced) stage. Kidney cancer is expected to be one of the fastest increasing cancers over the next 10 years, as a result of the UK’s ageing population, and with smoking and a rise in obesity also playing a part.4

Nick Turkentine, Chief Executive of Kidney Cancer UK, said: "With over 12,500 new cases of kidney cancer being diagnosed every year this is a great result for people with aRCC and the overall fight with the disease. It is vitally important patients have access to effective, well-tolerated treatments, so they can spend more precious time with their families and loved ones. We applaud EUSA Pharma, NICE and NHS England for making this happen."

Patients with advanced renal cell carcinoma (aRCC) who may benefit from treatment with tivozanib will be able to access it from today as the final guidance is published, and should be able to have immediate access through the CDF.

Lee Morley, EUSA Pharma’s Chief Executive Officer commented "We are very pleased that NICE are recommending the use of Fotivda for the first line treatment of advanced Renal Cell Carcinoma and that Fotivda will be funded immediately in England and Wales, meaning physicians and patients can experience the benefits of Fotivda. Fotivda has the potential to become an important new first-line therapy and the recommendation by NICE is a great achievement for the EUSA team delivering on their mission to improve the lives of those patients suffering from cancer."

On February 12, 2018 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its second quarter ended December 31, 2017 (Press release, Palatin Technologies, FEB 12, 2018, View Source [SID1234523915]).

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Recent Highlights
● Bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):
● Entered into a license agreement with Kwangdong Pharmaceutical Co., Ltd. ("Kwangdong") in November 2017 for exclusive rights to develop and commercialize bremelanotide in the Republic of Korea.

● Received $417,500 in December 2017, consisting of an upfront payment of $500,000 less $82,500 which was withheld in accordance with tax withholding requirements in the Republic of Korea.

● Entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. ("Fosun"), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., in September 2017 for exclusive rights to develop and commercialize bremelanotide in the territories of mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R.

● Received $4,500,000 in October 2017, consisting of an upfront payment of $5,000,000 less $500,000 which was withheld in accordance with tax withholding requirements in China.

● Working closely with AMAG Pharmaceuticals, Inc. ("AMAG"), our licensee for North America, on completing the tasks and activities necessary to file a New Drug Application ("NDA") with the Food and Drug Administration ("FDA").

● NDA filing with the FDA by AMAG targeted by March 31, 2018.

● Melanocortin Receptor 1 Agonist ("MC1r") – under development for inflammatory bowel diseases:

● Initiated Subject Dosing in First-in-Human Clinical Study of PL-8177, an MC1r agonist.

● Received FDA Clearance of Investigational New Drug ("IND") Application for PL-8177 For Ulcerative Colitis.

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Second Quarter Fiscal 2018 Financial Results
Palatin reported net income of $3.0 million, or $0.02 per basic and $0.01 per diluted share, for the quarter ended December 31, 2017, compared to a net loss of $(10.0) million, or $(0.06) per basic and diluted share, for the same period in 2016.

The difference in financial results between the three months ended December 31, 2017 and 2016 was primarily attributable to the recognition of $10.6 million in license and contract revenue during the 2017 period pursuant to our license agreement with AMAG, and a reduction of $2.1 million in research and development expenses.

Revenue
For the quarter ended December 31, 2017, 100% of the revenue Palatin recognized was related to our license agreement with AMAG.

There were no revenues recorded in the quarter ended December 31, 2016.

Operating Expenses
Total operating expenses for the quarter ended December 31, 2017 were $7.7 million compared to $9.4 million for the comparable quarter of 2016. The decrease in operating expenses was mainly attributable to the relative development stages of bremelanotide for HSDD as we continue our progress of filing an NDA with the FDA.

Other Income/Expense
Total other expense, net was $0.3 million for the quarter ended December 31, 2017 compared to $0.6 million for the quarter ended December 31, 2016. Total other expense, net for both periods consisted primarily of interest expense related to Palatin’s venture debt.

Income Tax
Pursuant to the license agreements with Fosun and Kwangdong, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and will be recorded as an expense during the fiscal year ending June 30, 2018. For the quarter ended December 31, 2017, Palatin recorded $100,880 in income tax expense related to those withholding amounts utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $256,365 was included in prepaid expenses and other current assets at December 31, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance. The $100,880 of income tax expense is offset by a $500,000 tax benefit that Palatin recorded in the quarter ended December 31, 2017 related to the release of a valuation allowance against Palatin’s federal alternative minimum tax credit as a result of the Tax Cuts and Jobs Act signed in December 2017. Accordingly, $500,000 is included in other long-term assets at December 31, 2017.

Cash Position
Palatin’s cash, and cash equivalents were $35.0 million as of December 31, 2017, compared to cash, cash equivalents, accounts receivable and investments of $55.6 million at June 30, 2017. Current liabilities were $14.1 million, net of deferred revenue of $9.5 million, as of December 31, 2017, compared to $19.9 million, net of deferred revenue of $35.1 million, as of June 30, 2017.

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Palatin believes that existing capital resources will be sufficient to fund our planned operations through at least the next 12 months.

CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on February 12, 2018 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-289-0449 (domestic) or 1-323-794-2093 (international), conference ID 6111978. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), passcode 6111978. The webcast and telephone replay will be available through February 19, 2018.

On February 12, 2018 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the issuance of two U.S. patents – US 9,855,297 and US 9,890,393 – for the invention of certain uses of RNA-guided endonucleases, such as Cas9 or Cpf1, for the genetic engineering of T-cells (Press release, Cellectis, FEB 12, 2018, View Source [SID1234523922]). The patents came into force on January 2nd, 2018 and February 13th, 2018, respectively.

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Both patents claim methods by which T-cells are gene edited using transient expression of CRISPR/Cas9 components. These inventions are based on the early work initiated by inventors at Cellectis when the CRISPR technology first came to light.

These therapeutic-focused patents follow the grant by the European Patent Office of patent No. EP3004337 for similar inventions and previous intellectual property that Cellectis has obtained over the last two decades for major gene editing technologies including meganucleases, TALEN, MegaTAL and CRISPR.

"Cellectis is a pioneering gene editing company that has always been keen to be at the forefront of all gene editing technologies," said Dr. André Choulika, Cellectis Chairman & CEO. "We have been the first to explore the potential of CRISPR in its early days in various applications, including therapeutics and plants. These early findings ultimately led to the grant of this set of new patents. As such, these patents only reinforce Cellectis’ leadership position in the gene editing industry."

Convinced of their strong value for the future development of engineered CAR T-cells, Cellectis will make these patents available for licensing to companies that are willing to use CRISPR technologies in T-cells. The technical knowledge in these patents could, for example, help users engineer allogeneic CAR T-cells while suppressing genes involved in checkpoint inhibitions, such as PD-1, engineer drug resistance, or remove MHC (Major Histocompatibility Complex) related genes. The technology could also be used to insert a DNA CAR construct by gene targeting a specific locus in the genome of T-cells.

The inventors of these patents are Dr. André Choulika, Chairman & CEO of Cellectis and one of the pioneers in the development of nuclease-based genome editing technologies; Dr. Philippe Duchateau, Cellectis Chief Scientific Officer and seasoned gene editing expert; and Dr. Laurent Poirot, Cellectis Head of Early Discovery and expert of gene functions in immune cells.

Claims 1 and 2 of US 9,855,297:

1. A method of preparing genetically modified primary T-cells for immunotherapy comprising the steps of: (a) transfecting mRNA encoding an RNA-guided endonuclease into the primary T-cells, wherein the RNA-guided endonuclease is expressed from the transfected m RNA; (b) introducing a DNA vector that encodes a specific guide RNA, wherein the specific guide RNA directs the RNA-guided endonuclease to at least one targeted locus in the T-cell genome into the primary T-cells; (c) cleaving at least one targeted locus in the T-cell genome with the RNA-guided endonuclease; (d) generating a genetic modification at the site of the cleavage; and (e) expanding the resulting genetically modified T-cells.

2. The method of claim 1, wherein the RNA-guided endonuclease is Cas9.

Claim 1 of US 9,890,393:

1. A method of preparing T-cells for immunotherapy comprising the step of:

(a) genetically modifying primary T-cells by introduction and/or expression into the cells of at least:

– a RNA-guided endonuclease; and

– a specific guide RNA that directs said endonuclease to at least one targeted locus in the T-cell genome,

wherein said RNA-guided endonuclease is expressed from transfected mRNA;

wherein said RNA-guided endonuclease comprises the amino acid sequence set forth in SEQ ID NO:1 or SEQ ID NO:2; and

(b) expanding the resulting cells.