On February 9, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company"), reported that the Database Safety Monitoring Board ("DSMB") confirmed that the combination of eftilagimod alpha ("efti", "LAG-3Ig", or "IMP321") with pembrolizumab (KEYTRUDA) is safe and well tolerated at doses up to 30 mg per subcutaneous injection (Filing, 6-K, Immutep, FEB 9, 2018, View Source [SID1234523880]).

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In this first-in-man TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial in Australia, efti is combined with pembrolizumab in unresectable or metastatic melanoma patients. The data to date shows no safety concerns from the combination with doses of efti at 1 mg, 6 mg, and 30 mg. No drug related serious adverse events have been reported and the DSMB concluded repeated injections of efti are safe and well tolerated.

The patients eligible to participate in the TACTI-mel Phase I clinical trial are those that have either had a suboptimal response or had disease progression with pembrolizumab monotherapy. In this clinical trial, the combination starts at cycle five of pembrolizumab and is limited to six months of treatment.

Encouraged by the TACTI-mel Phase I clinical trial interim results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2017 Annual Meeting in November 2017, Immutep now plans to expand the TACTI-mel study by six patients at 30 mg of efti in combination with pembrolizumab starting at cycle one and with a treatment duration of 12 months.

"There is limited clinical experience with combining an APC activator such as efti with an immune checkpoint inhibitor such as pembrolizumab, analogous to pushing the accelerator and also releasing the brakes on cancer-fighting T cells", said Dr. Frédéric Triebel, Immutep’s Chief Scientific and Medical Officer. "Therefore, the TACTI-mel trial design included certain key safety measures such as starting with a low dose and at cycle five, which excludes patients with early severe adverse events to pembrolizumab, and limiting treatment to six months. The positive results now provide the basis to safely extend the clinical trial to start at cycle one with the recommended Phase II dose and for a 12-month duration, meaning patients could benefit earlier and for longer from the combination."

As previously disclosed, all three cohorts of the TACTI-mel Phase I clinical trial totalling 18 patients have been fully recruited and the data from these three cohorts is expected in H1 2018.

On February 9, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, and Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology company developing innovative, targeted therapies for cancer, reported they have entered into a collaboration and license agreement with the goal of developing multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers (Press release, Seattle Genetics, FEB 9, 2018, View Source;p=RssLanding&cat=news&id=2331570 [SID1234523875]).

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The collaboration leverages the expertise and core technologies of both companies to develop novel Antibody-Anticalin fusion proteins. Pieris’ proprietary suite of agonistic costimulatory Anticalin proteins, when fused to a tumor-targeting antibody, can activate the immune system preferentially in the tumor microenvironment. Seattle Genetics, through its industry-leading work in the field of antibody-drug conjugates (ADCs), has a substantial portfolio of cancer targets and tumor-specific monoclonal antibodies from which programs will be selected for the collaboration. The bispecific drug candidates in this alliance will be designed to enable the patient’s immune cells to specifically attack tumors.

"As the industry leader in ADCs, we bring deep expertise in targeted cancer therapy development to this collaboration with Pieris," said Dennis Benjamin, Ph.D., Senior Vice President of Research at Seattle Genetics. "Pieris’ Anticalin technology and Antibody-Anticalin bispecific approach are intended to overcome the limitations of currently available immuno-oncology products. This partnership leverages our cancer targets and tumor-specific antibodies to explore multiple novel bispecific combinations, with the goal of developing targeted therapies that improve outcomes for people with cancer."

Under the terms of the agreement, Seattle Genetics will pay Pieris a $30 million upfront fee, tiered royalties on net sales up to low double-digits, and up to $1.2 billion in total success-based payments across three product candidates. The companies will pursue multiple Antibody-Anticalin fusion proteins during the research phase, and Seattle Genetics has the option to select up to three therapeutic programs for further development. Prior to the initiation of a pivotal trial, Pieris may opt into global co-development and US commercialization of the second program and share in global costs and profits on a 50/50 basis. Seattle Genetics will solely develop, fund and commercialize the other two programs.

"Pieris was the first company to bring a tumor-targeted costimulatory bispecific to patients with PRS-343, and we are looking forward to broadening our bispecific pipeline through this alliance. Seattle Genetics is a compelling partner for Pieris with a long-standing commitment to oncology," said Stephen S. Yoder, President and CEO of Pieris. "The collaboration combines the excellent protein engineering and translational capabilities of both companies, utilizing Seattle Genetics’ tumor-targeted monoclonal antibodies and Pieris’ Anticalin proteins to create novel bispecifics. This is our third significant alliance since January 2017 and is in alignment with our goal to create a respiratory- and oncology-focused commercial company."

About Anticalin Therapeutics:

Anticalin proteins are derived from lipocalins, small human proteins that naturally bind, store and transport a wide spectrum of molecules. Anticalin proteins feature the typical four-loop variable region and a rigidly conserved beta-barrel backbone of lipocalins, which, together, form a shapeable cup-like binding pocket. Proprietary to Pieris, Anticalin proteins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin is a registered trademark of Pieris.

On February 9, 2018 Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that senior management will present at upcoming investor conferences (Press release, Immune Design, FEB 9, 2018, View Source [SID1234523900]).

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Leerink Partners 7th Annual Global Healthcare Conference
Thursday, February 15, 2018 at 9:30 a.m. Eastern Time in New York.

RBC Capital Markets 2018 Global Healthcare Conference
Wednesday, February 21, 2018 at 4:05 p.m. Eastern Time in New York.

Cowen & Company 38th Annual Health Care Conference
Monday, March 12, 2018 at 12:00 p.m. Eastern Time in Boston.

A live webcast of each presentation will be available online from the investor relations page of the company’s corporate website at View Source After the live webcast, an archive of each presentation will be available on the company website for 30 days.

On February 9, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2018 first quarter ended December 31, 2017 (Press release, Arrowhead Research Corporation, FEB 9, 2018, View Source [SID1234523890]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 4788374.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 4788374.

Selected Fiscal 2018 First Quarter and Recent Events

Filed a Clinical Trial Application for ARO-AAT, a second generation subcutaneously administered clinical candidate for the treatment of alpha-1 antitrypsin deficiency liver disease

Filed a Clinical Trial Application for ARO-HBV, a third generation subcutaneously administered clinical candidate for the treatment of chronic hepatitis B virus infection

Presented new clinical data at HEP DART 2017 demonstrating up to 5.0 log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following RNAi therapy, ARC-520, in the 2001 open-label extension study

Made continued progress on a two-product cardiovascular collaboration with Amgen, in which one that was previously called ARO-LPA against the target lipoprotein(a) has been formally nominated as a potential clinical candidate and which is now referred to as AMG 890 by Amgen

Expanded Arrowhead’s cardiometabolic pipeline, which now includes ARO-APOC3, targeting apolipoprotein C-III, and ARO-ANG3, targeting angiopoietin-like protein 3 (ANGPTL3); with CTA filings planned around the end of 2018

Achieved continued progress with the Company’s extra-hepatic platform and pipeline, including:

ARO-Lung1, Arrowhead’s first candidate against an undisclosed gene target in the lung, which achieved nearly 90% target knockdown following inhaled administration in rodents

ARO-HIF2, the Company’s candidate targeting renal cell carcinoma, which achieved 85% target gene knockdown in a rodent tumor model

On February 9, 2018 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the company will present a company overview at the upcoming 2018 RBC Capital Markets Global Healthcare Conference on Thursday, February 22nd at 2:35 pm ET (Press release, PTC Therapeutics, FEB 9, 2018, View Source [SID1234523882]).

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The presentation will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at www.ptcbio.com. The presentation will be archived for two weeks following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.