On September 6, 2018 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it has entered into a strategic collaboration with Moffitt Cancer Center to develop multi‑targeted chimeric antigen receptor T-cell (CAR T) immunotherapies for patients with AML and B‑cell malignancies (Press release, Atara Biotherapeutics, SEPT 6, 2018, View Source [SID1234529322]). As part of the collaboration, Atara will gain access to novel CAR T targeting and co‑stimulation domains designed to improve T cell proliferation and enhance persistence. This agreement, along with Atara’s prior CAR T collaboration with Memorial Sloan Kettering Cancer Center (MSK), furthers the Company’s strategy to develop next generation engineered CAR T immunotherapies across multiple therapeutic areas and leverage the Company’s off-the-shelf, allogeneic T-cell immunotherapy platform.

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"Atara is a leader in the development of off-the-shelf, allogeneic T-cell immunotherapies based on their novel EBV-specific T-cell technology platform," said Marco Davila, M.D., Ph.D., medical oncologist in the Department of Blood and Marrow Transplantation and Medical Director of the GMP Cell Production Facility, Moffitt Cancer Center. "I look forward to rapidly advancing our CAR T engineering and multi-antigen targeting technologies with Atara to address the high unmet need in patients with advanced AML and B-cell malignancies."

Under the agreement, Atara will collaborate with Dr. Davila to develop multi-targeted CAR T immunotherapies designed to address cancers with diverse cell types that often become resistant to treatment such as AML and B-cell malignancies. In addition, the collaboration includes the use of novel CAR T intracellular co-stimulatory domains based on CD28 and 4-1BB that may improve CAR T proliferation when responding to an appropriate antigen and enhance CAR T persistence by reducing T cell exhaustion.

Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics said, "Our focus is to rapidly advance development of next generation off-the-shelf, allogeneic CAR T immunotherapies across multiple therapeutic areas by combining our EBV-specific T-cell platform, development, manufacturing and regulatory expertise with cutting edge T-cell engineering discoveries by our external collaborators. Our new strategic collaboration with Moffitt Cancer Center builds our novel CAR T preclinical pipeline and has the potential to benefit patients with myeloid and B cell malignancies."

James J. Mulé, Ph.D., Associate Center Director, Translational Research, and Director of Cell-Based Immunotherapies, Moffitt Cancer Center added, "Atara is a strong technology and development partner. The Company’s clinically advanced EBV-specific T-cell technology platform is complementary to Moffitt’s CAR T engineering and multi-antigen targeting technologies. I look forward to following the progress of Dr. Davila and Atara to develop the next generation of CAR T immunotherapies."

Under the terms of the agreement, Atara will contribute resources and relevant experience to the research activities at Moffitt. Further terms of the agreement were not disclosed.

On September 6, 2018 LabCorp (NYSE: LH) reported it will participate at the Morgan Stanley Global Healthcare Conference (Press release, LabCorp, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366346 [SID1234529384]). LabCorp’s presentation is planned for Thursday, September 13, 2018 at 2:05 pm (ET).

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A live audio webcast will be available via the Company website at www.labcorp.com and archived for replay

On September 6, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its CEO, Jan van de Winkel, Ph.D., will give a company update at the Morgan Stanley 16th Annual Global Healthcare Conference in New York, New York at 2:15 PM EDT / 8:15 PM CEST on September 12, 2018 (Press release, Genmab, SEPT 6, 2018, View Source [SID1234529323]). A webcast of the update, which will include brief opening remarks followed by a question-and-answer session, will be available on Genmab’s website at View Source

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On September 6, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and SpringWorks Therapeutics, a clinical-stage rare disease and oncology company focused on sourcing and developing innovative treatments for underserved patient populations, reported that the companies have entered into a global clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) and SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901, in patients with advanced solid tumors (Press release, BeiGene, SEPT 6, 2018, View Source;p=irol-newsArticle&ID=2366390 [SID1234529325]). Under the terms of the agreement, BeiGene will be responsible for administering the Phase 1b clinical trial that is expected to commence during the first quarter of 2019 in patients with advanced solid tumors that harbor RAS, RAF mutations and other MAPK pathway aberrations, with all costs of the clinical studies and governance responsibilities to be shared equally among both parties. SpringWorks Therapeutics will also oversee fixed-dose formulation work as part of the collaboration.

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"BeiGene is committed to developing innovative medicines for cancer patients with little or no treatment options. We are delighted to work with SpringWorks Therapeutics to explore the potential benefits of this combination in patients with RAS mutations, a patient population with high unmet medical needs," said John V. Oyler, co-founder, chief executive officer and chairman of BeiGene.

"Mutations in RAS genes are found in roughly one-fourth of all human cancers, making this a critically important area for developing new cancer treatments. Despite decades of research, no anti-RAS therapies have been approved to date," said Saqib Islam, chief executive officer of SpringWorks Therapeutics. "The combination of a MEK inhibitor with a RAF dimer inhibitor has strong scientific rationale, and we look forward to partnering with BeiGene to build upon the existing preclinical data, which have demonstrated potential benefits with this combination therapy approach."

About Lifirafenib

Lifirafenib was discovered in BeiGene’s research facilities in Beijing, China, and is an investigational small molecule kinase inhibitor with RAF monomer and dimer inhibition activities. Lifirafenib has shown antitumor activities in preclinical models and in cancer patients with tumors harboring BRAF V600E mutations, non-V600E BRAF mutations, non-small cell lung cancer and endometrial cancer harboring KRAS mutations. To date, lifirafenib has been dosed in more than 150 patients globally.

About PD-0325901

PD-0325901 was originally discovered by Pfizer scientists and is an inhibitor of MEK, a key signaling protein for cellular survival and proliferation. PD-0325901 has been shown in clinical biopsies to block MEK phosphorylation, thereby arresting cellular growth and causing cell death to occur. Preclinical models have demonstrated significant synergy between MEK and RAF inhibition in RAS-mutant solid tumors. By vertically inhibiting the MAPK pathway, the combination approach of PD-0325901 and lifirafenib may potentially overcome feedback loops that have impeded therapeutic development for RAS-mutant solid tumors.

SpringWorks Therapeutics also plans to initiate a Phase 2b study of PD-0325901 as monotherapy for neurofibromatosis type 1 patients with plexiform neurofibromas in 2019. The company is also continually evaluating new licensing and partnership opportunities for its MEK program and is seeking other innovative partnerships designed to complement the existing clinical programs to advance its ambition of developing novel therapies for underserved patient populations.

On September 6, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmic company, reported the financial results for the Nicox Group for the six months ending June 30, 2018 and provided an update on its activities (Press release, NicOx, SEP 6, 2018, View Source [SID1234529343]).

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Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: "Nicox is entering a new and exciting phase with the initiation of the Phase 2 study for our lead product candidate NCX 470 for IOP reduction in patients with open-angle glaucoma or ocular hypertension, and by strengthening our U.S. presence in our new site in Research Triangle Park in North Carolina. We have assembled the right team to achieve our important near term clinical and corporate milestones and continue delivering on all objectives in line with our growth strategy."

Key Upcoming Milestones
Q1 2019: Planned Investigational New Drug (IND) submission to the United States (U.S). Food and Drug Administration (FDA) for NCX 4251 to enable a Phase 2 clinical study in patients with acute exacerbations of blepharitis.
Q1 2019: Expected delivery of ZERVIATETM (cetirizine ophthalmic solution), 0.24% commercial product to Eyevance Pharmaceuticals LLC, followed by a launch for the spring 2019 allergy season in the U.S.
H2 2019: Expected top-line data from the NCX 470 Phase 2 study for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Product and Product Candidates Updates
A Phase 2 study was initiated in Q3 2018 for Nicox’s product candidate NCX 470, a novel second generation nitric oxide (NO)-donating prostaglandin analog. This multicenter, double-masked, 28-day, parallel group, dose response study aims to evaluate the efficacy and safety of NCX 470 compared to latanoprost 0.005% in adult patients with elevated IOP due to open-angle glaucoma or ocular hypertension. The study is expected to randomize 420 patients in clinical sites across the U.S. The primary endpoint of the study is the mean reduction in diurnal IOP after 4 weeks of treatment, while the overall objective is to identify the appropriate dose of NCX 470 to be advanced into Phase 3 studies. This Phase 2 study was initiated following the submission of an IND application in June 2018, ahead of the previously disclosed target date of the third quarter of 2018. Nicox expects to report top-line data from this Phase 2 study in the second half of 2019.

Preclinical and formulation development of Nicox’s product candidate NCX 4251, a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals, is continuing on track for the Q1 2019 IND submission to the U.S FDA to enable a Phase 2 study to evaluate the safety and efficacy of NCX 4251 compared to its vehicle in patients with acute exacerbations of blepharitis. An additional and positive pre-IND meeting was held with the U.S. FDA in June 2018, which addressed specific questions on development, including the potential primary endpoints. Based on FDA feedback, we are finalizing the design of the first-in-human Phase 2 study.

Two molecules from our future generation stand-alone NO-donors that target IOP reduction, NCX 667 and NCX 1660, are currently in formulation development and testing with the Re-Vana EyeLiefTM technology under the research collaboration agreement signed in October 2017. Depending on the release profile of these molecules with this technology in preclinical animal models of ocular pharmacokinetics, they may be advanced into further development and/or we may decide to test other molecules in the same technology.
Our research activities continue both in our research collaboration agreement with Ironwood, announced in June 2018, which is focused on combining Ironwood’s expertise in soluble guanylate cyclase with our proprietary NO-donating research platform, and in our internal programs combining NO with other undisclosed pharmacological mechanisms of action. We expect to be able to announce a preclinical candidate from one of these programs in the next 18 months.

VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024% is now a revenue generating asset for Nicox, following the U.S. launch in December 2017 by partner Bausch + Lomb. In March 2018, the Company announced an amendment to the global licensing agreement under which royalties paid to Nicox on worldwide net sales of VYZULTA will increase by 1% over the original royalty on net sales above $300 million per year. In addition, the potential milestone payments payable to Nicox by Bausch + Lomb have been increased by $20 million.
We expect to ship commercial product and trade samples for ZERVIATETM (cetirizine ophthalmic solution), 0.24% to our partner Eyevance by Q1 2019, which will allow Eyevance to launch ZERVIATETM in the United States in time for the 2019 spring allergy season. The shipment of product triggers a $1 million milestone payment to Nicox by Eyevance, with up to $3 million of potential future milestones payments related to certain regulatory acceptance provisions and certain near term manufacturing objectives.
H1 2018 Financial Summary
Net revenue1 for the first half of 2018 was €0.3 million, comprised exclusively of royalties on H1 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. The Nicox Group recorded no revenues for the first half of 2017.

The operating expenses for the first half of 2018 were consistent with the same period last year (€10.0 million for the first six months of 2018 compared to €10.2 million for the first six months of 2017).

The Nicox Group recorded a net loss of €7.6 million for the six months ended June 30, 2018, compared to a net loss of €12.2 million for the same period in 2017.

As of June 30, 2018, the Nicox Group had cash and cash equivalents of €32.7 million as compared with €36.3 million at March 31, 2018 and €41.4 million at December 31, 2017.

Reference
1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit from collaborations in the condensed consolidated statements of profit or loss for the six-month periods ended June 30, 2018.

The diligences related to the half-year review were performed by the auditors. The review report will be issued once procedures will be finalized over the half-year financial report.