On May 31, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported new data from its ongoing TACTI-mel Phase I clinical trial (Press release, Immutep, MAY 31, 2018, View Source [SID1234526994]). This study is evaluating the combination of eftilagimod alpha ("efti" or IMP321), Immutep’s lead product, in combination with pembrolizumab (KEYTRUDA) in unresectable or metastatic melanoma patients that have had a suboptimal response or had disease progression with pembrolizumab monotherapy in the first three cohorts.

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"The new data is very encouraging, further supporting our hypothesis that the combination of efti and pembrolizumab may be a hopeful solution for cancer patients," said Marc Voigt, CEO of Immutep. "As advancements in PD-1 have enabled breakthroughs in immunotherapy, research is showing that LAG-3 has the potential to take immunotherapy to the next level, enabling more effective cancer treatments. We look forward to starting our new efti-pembrolizumab combination program in three different cancer indications as well as the results from the additional TACTI-mel patient cohort in the second half of this year."

The multi-center, open-label clinical trial includes four cohorts of six patients each – for a total of 24 patients – testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab. This latest data includes more mature data from the first two cohorts and the first data from the third cohort. Key findings were as follows:

Long lasting and durable responses seen in a subset of patients;

Overall Response Rate ("ORR") of 61% (11/18 patients) when tumor size is measured starting from cycle 1 day 1 of pembrolizumab monotherapy and following combination therapy (combo starts at cycle 5) according to irRC; and

Two complete responses related to the combination out of 18 patients according to RECIST.
The data is being presented in more detail via a global webcast today at 8am Australian Eastern Standard Time / 6pm US Eastern Daylight Time. Investors can access the webcast via the following link: View Source

An audio replay of the webcast will be made available on the Company’s website.

A subset of this new data was presented by Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Medical Officer, at the 3rd Annual Advances in Immuno-Oncology Congress on May 25.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label, dosing escalating (1, 6 or 30 mg of eftilagimod alpha or "efti") study evaluating the combination of efti with pembrolizumab for 6 months, starting at treatment cycle 5 in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869). The initial study consists of three cohorts of six patients.

In February 2018, Immutep expanded the TACTI-mel study by an additional cohort of 6 patients at 30 mg of efti in combination with pembrolizumab starting at cycle 1 and with a treatment duration of 12 months.

On May 31, 2018 GTx, Inc. (Nasdaq: GTXI) reported that Robert J. Wills, PhD, Executive Chairman, will present a company overview at the Jefferies 2018 Global Healthcare Conference on Thursday, June 7, 2018 at 10:00 am ET in New York (Press release, GTx, MAY 31, 2018, View Source;p=RssLanding&cat=news&id=2352457 [SID1234526993]).

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A simultaneous webcast of the presentation can be accessed by visiting the investor relations section of the GTx website at View Source A replay of the presentation will also be available and archived on the site for 30 days.

On May 31, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Francis Sarena, Chief Strategy Officer, will present at the Jefferies 2018 Global Healthcare Conference, June 7, 2018, at 11:00 am ET (Press release, Five Prime Therapeutics, MAY 31, 2018, View Source [SID1234526992]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On May 31, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a global phase 2 study evaluating the efficacy and safety of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with unresectable and/or metastatic non-squamous HER2-overexpressing or HER2-mutated non-small cell lung cancer (NSCLC) that has progressed after one or more prior therapies (Press release, Daiichi Sankyo, MAY 31, 2018, View Source [SID1234526991]).

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The introduction of targeted therapies and checkpoint inhibitors in recent years has improved the treatment landscape for metastatic NSCLC patients, who previously had limited options beyond systemic chemotherapy.[1],[2] However, for those who are not eligible for available treatments, or whose cancer continues to progress, new approaches are needed to help manage the disease.[1] HER2 overexpression has been reported in rates ranging from 4 to 35 percent of NSCLC, depending on the published series and methods, and is associated with poor disease prognosis and shortened overall survival.[1],[3]HER2 mutations have more recently been identified as distinct molecular targets for NSCLC and have been reported in up to 5 percent of NSCLC.[4],[5] Currently no therapy is specifically approved for HER2-overexpressing or HER2-mutated non-small cell lung cancer.

"There is renewed interest in exploring alterations in the HER2 pathway as treatment targets for NSCLC and clinical research suggests a potential role for a HER2-targeting ADC agent," said Gilles Gallant, BPharm, PhD, Vice President, Global Team Leader DS-8201, Oncology Research and Development, Daiichi Sankyo. "DS-8201 is specifically designed to target and deliver chemotherapy inside HER2-expressing cancer cells, and we are advancing it to phase 2 in non-small cell lung cancer as part of our broad program in multiple types of HER2-expressing tumors."

About the DS-8201 NSCLC Study

The global, multicenter, phase 2, open-label, two-cohort study is investigating the safety and efficacy of DS-8201 in patients with HER2-overexpressing and/or HER2-mutated unresectable and/or metastatic non-squamous NSCLC that has progressed after one or more systemic therapies (including chemotherapy, molecular targeted therapy or immunotherapy). Cohort 1 will enroll approximately 40 patients with HER2-overexpressing (defined as IHC 3+ or IHC 2+), unresectable and/or metastatic non-squamous NSCLC, and Cohort 2 will enroll approximately 40 patients with HER2-mutated, unresectable and/or metastatic non-squamous NSCLC.

The primary endpoint is objective response rate. Key secondary endpoints include efficacy (duration of response, disease control rate, progression free survival, overall survival and investigator-assessed objective response rate), safety, and pharmacokinetic endpoints. Exploratory efficacy endpoints include time to response as well as biomarker endpoints for mechanisms of response and resistance.

This study is expected to enroll the approximately 80 patients at 20 sites in North America, Japan, and Europe. For more information about the study, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cancer in the world and the leading cause of cancer deaths.[6],[7] There were approximately 1.8 million new cases of lung cancer reported globally in 2012 and approximately 1.69 million deaths globally from lung cancer in 2015.[6],[7]Lung cancer is the most common cancer in men, and incidence among women is increasing in many parts of the world.[7]

About DS-8201

DS-8201 is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

In addition to the phase 2 NSCLC study, DS-8201 is currently in pivotal phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01) in North America, Europe and Asia; pivotal phase 2 development for HER2-positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01) in Japan and South Korea; phase 2 development in advanced colorectal cancer in North America, Europe and Japan; and phase 1 development for other HER2-expressing advanced/unresectable or metastatic solid tumors in the U.S. and Japan.

DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). DS-8201 has received SAKIGAKE Designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW). DS-8201 is an investigational agent and is not approved by the FDA or any other regulatory agency worldwide as a treatment for any indication. Safety and efficacy have not been established.

On May 31, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy (Press release, Curis, MAY 31, 2018, View Source [SID1234526990]). Previously reported results from Phase 1 and Phase 2 clinical studies demonstrated that treatment with fimepinostat resulted in a complete or partial response in approximately one out of every four patients with R/R DLBCL with MYC alterations. The median duration of response for all responding patients in these studies was over one year.

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"We are pleased with this Fast Track designation, which will enable us to accelerate the development of fimepinostat for patients with R/R DLBCL, including patients whose tumors have MYC alterations," said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "Patients with this disease have a very poor prognosis and we are encouraged by the FDA’s recognition of the unmet need that may be addressed by fimepinostat, as well as the potential durable benefit that fimepinostat can provide for these patients. We expect to re-initiate enrollment this year as part of a pivotal study to assess fimepinostat’s efficacy in this patient population. As we work toward the start of this study, we are also continuing to lay the groundwork for potential registration of fimepinostat, which involves coordination with commercial product manufacturers as well as a potential diagnostic test."

The FDA Fast Track process is designed to facilitate the development and expedite review of drugs used to treat serious conditions and fill an unmet medical need. Fast Track designation provides Curis with more frequent meetings and written communications with the FDA regarding fimepinostat’s development plan, trial design and data collection to support the drug’s approval. Fast Track designation also provides eligibility for Accelerated Approval and Priority Review, if the relevant criteria are met, as well as Rolling Review with regards to the submission of the completed sections of the NDA for review by the FDA.