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 Sarah Cannon reported that it will present its latest cancer research insights through more than 85 presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sarah Cannon Research Institute, MAY 31, 2018, View Source [SID1234527012]). Hosted in Chicago, from June 1-5, 2018, the ASCO (Free ASCO Whitepaper) Annual Meeting is bringing together global oncology leaders to discuss "Delivering Discoveries: Expanding The Reach of Precision Medicine." Sarah Cannon experts will participate in a number of presentations and educational sessions focused on personalized medicine and targeted investigational therapies that are transforming the current and future state of cancer treatments.

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"Sarah Cannon’s 25-year history has been highlighted by leading in a number of innovative areas of clinical research," said Howard A. "Skip" Burris, III, MD, President of Clinical Operations and Chief Medical Officer at Sarah Cannon. Dr. Burris will also serve as the ASCO (Free ASCO Whitepaper) President for the 2019-2020 term. "From novel antibodies to targeted biologics, and now advancements in the field of cellular therapies, we are bringing cutting-edge treatments to patients closer to home."

As part of ASCO (Free ASCO Whitepaper)’s Meeting focus, Sarah Cannon’s leaders will participate in the following highlighted sessions:

A presentation with Dr. Burris, who will discuss "Most Patients Should Be Tested" in the education session "Point/Counterpoint: Next Generation Sequencing – Is It Right for Every Patient?" which will take place on June 1 from 1:20-1:40pm in S102.
A "Best of ASCO (Free ASCO Whitepaper)" clinical science symposium titled "A Phase 1 Study of LOXO-292, A Potent And Highly Selective RET Inhibitor, In Patients With RET-Altered Cancers" featuring Sarah Cannon co-authors Todd Bauer, MD, and Melissa Johnson, MD, as part of the session "Tumor Genomics: Finding The Target, Hitting The Target" on June 2 from 8-9:30am in Hall D1.
A poster presentation by Stephanie Graff, MD, titled "Implementation of Breast Cancer Pathway For Genetic Counseling And Testing In Multi-State Health System" as part of the session "Health Services Research, Clinical Informatics, and Quality of Care," on June 2 from 1:15-4:45pm in 6521 Hall A.
A poster presentation by Holli Dilks, PhD, and Andrew McKenzie, PhD, titled "Identifying And Interpreting Actionable Molecular Alterations From Next-Generation Sequencing Results In The Community: A Sarah Cannon Molecular Cancer Conference" on June 2 from 1:15-4:45pm in 6601 Hall A.
A poster session by David Moore, MD, titled "Routine Use of A Modest Next Generation Sequencing Panel Provides Additional Clinically Useful Data Beyond Single Gene Testing In Non-Small Cell Lung Cancer And Is Fit For Purpose As A Clinical Assay: Collated Data From A Single Molecular Diagnostic Laboratory" on June 3 from 8-11:30am in 8540 Hall A.
Additionally, Sarah Cannon investigators are presenting noteworthy studies and insights at ASCO (Free ASCO Whitepaper) with the following presentations:

Dr. Burris’ poster session on "Maintenance Of Health-Related Quality Of Life In Elderly Patients Treated With Ribociclib + Letrozole In MONALEESA-2" taking place on June 2 from 8-11:30am in 1041 Hall A.
A poster session by Erika Hamilton, MD, titled "Results from a Phase I Study of Andecaliximab In Combination With Paclitaxel In Patients With Previously Untreated Metastatic Breast Cancer," on June 2 from 8-11:30am in 1032 Hall A. Dr. Hamilton will also highlight research on "Phase 1 Dose Escalation Of XMT-1522, A Novel HER2-Targeting Antibody-Drug Conjugate, In Patients With HER2-Expressing Breast, Lung And Gastric Tumors" in a poster session on June 4 from 8-11:30am in 2546 Hall A.
A poster session with Kent Shih, MD, on "Dianhydrogalactitol In Bevacizumab-Refractory GBM: Further Analysis Of A Phase 1-2 Trial," on June 2 from 1:15-4:45pm in 2061 Hall A.
A poster discussion by Dr. Bauer titled "A Phase 1 Study of MDM2 Inhibitor DS-3032b In Patients With Well/De-Differentiated Liposarcoma, Solid Tumors And Lymphomas" on June 2 from 3-4:15pm in S404.
A poster session by Dr. Johnson on "First In Human Phase 1/2a Study of PEN-221 Somatostatin Analog (SSA)-DM1 Conjugate For Patients With Advanced Neuroendocrine Tumor Or Small Cell Lung Cancer: Phase 1 Results" on June 3 from 8-11:30am in 4097 Hall A. Dr. Johnson will also present a poster on "A Phase I, Open-Label, Multicenter Dose Escalation Study To Assess The Safety, Tolerability, And Pharmacokinetics Of AZD2811 Nanoparticle In Patients With Advanced Solid Tumors" on June 4 from 8-11:30am in 2592 Hall A.
An education session with David Spigel, MD, on "Reimbursement And Payment Of Multiplex Testing In The United States" taking place on June 3 from10:15-10:30am in S100a.
An education session with Dr. Graff on "How Close Is Too Close: Navigating Difficult Situations" as part of the session titled, "When Cancer Hits Close to Home: Treating Colleagues and Loved Ones" on June 4 from 8:30-8:45am in S504.
A poster session by Judy Wang, MD, titled "Interim Results From A Phase 1 Trial Of SL-801, A Novel XPO-1 Inhibitor, In Patients With Advanced Solid Tumors" on June 4 from 8-11:30am in 2560 Hall A.
A poster session by Manish Patel, MD, titled "A Phase 1b Dose-Escalation Study Of Prexasertib, A Checkpoint Kinase 1 (CHK1) Inhibitor, In Combination With Cisplatin In Patients With Advanced Cancer" on June 4 from 8-11:30am in 2579 Hall A.
A poster session by Kathleen Moore, MD, on "Phase 1/2 Open-Label, Multiple Ascending Dose Trial of AGEN2034, An Anti-PD-1 Monoclonal Antibody, In Advanced Solid Malignancies: Results Of Dose Escalation" on June 4 from 8-11:30am in 3086 Hall A.
For a full listing of all presentations authored by Sarah Cannon investigators, visit sarahcannon.com/asco.

Additional Sarah Cannon leaders are co-authors on research presented at the conference, including:

Bertrand Marquess Anz, Raid Aljumaily, MD, Hendrik-Tobias Arkenau, MD, PhD, FRCP, Edward Arrowsmith, MD, Johanna Bendell, MD, Jesus Berdeja, MD, Brook Blackmore, Simon Chowdhury, MA, MRCP, PhD, Mick Correll, Brooke Daniel, MD, Davey Daniel, MD, William Bruce Donnellan, MD, Crystal Dugger, James Essell, MD, Gerald Falchook, MD, MS, Gustavo Fonseca, MD, FACP, Ian Flinn, MD, PhD, Troy Gifford, Lowell Hart, MD, Derek Weldon Holland, MD, Suzanne Jones, PharmD, Darrell Johnson, MD, Sylvia Lynne Krueger, MD, Dax Kurbegov, MD, Andrew Mackenzie, PhD, Michael Maris, MD, Jeffrey Matous, MD, Carmen Murias, MD, Benjamin Rolland Nadeau, MD, Michael Stipanov, MD, DK Strickland, MD, An Tran, MD, Kimberly Tucker, and Denise Yardley, MD.

The researchers represent Sarah Cannon’s global network of strategic sites:

Colorado Blood Cancer Institute, Sarah Cannon Research Institute at Florida Cancer Specialists, Sarah Cannon Research Institute at HCA Midwest Health (Kansas City), Sarah Cannon Research Institute at HealthONE (Denver), Sarah Cannon Research Institute at Tennessee Oncology, , Sarah Cannon Research Institute – United Kingdom, and The Stephenson Cancer Center at the University of Oklahoma

On May 31, 2018 TapImmune Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company, reported that its President and CEO, Peter L. Hoang, will present at the Jefferies 2018 Global Healthcare Conference taking place June 5-8, 2018, in New York City (Press release, TapImmune, MAY 31, 2018, View Source [SID1234527013]).

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TapImmune Company Presentation
Date: Thursday, June 7, 2018
Time: 3:30 PM ET

An audio webcast will be accessible via the News and Events section of the TapImmune website: View Source An archive of the audio will remain available for 90 days following the presentation.

On May 31, 2018 Intensity Therapeutics, Inc., a privately held US biotechnology company developing proprietary immune cell-activating cancer treatments, reported that an abstract highlighting progress in the INT230-6 clinical development program will be presented as a poster at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Intensity Therapeutics, MAY 31, 2018, View Source [SID1234526977]).

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"The abstract being presented at ASCO (Free ASCO Whitepaper) 2018 highlights the progress of our clinical program and the potential of INT230-6 as a medicine for multiple cancer types," said Lewis H. Bender, President and CEO of Intensity Therapeutics, Inc. "We are pleased to describe our current clinical study evaluating INT230-6 at this prestigious meeting, which to date has had no dose limiting toxicities following treatments to fourteen patients having nine different solid tumor types."

Details of the trials-in-progress abstract accepted for presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting are below.

Abstract TPS2609: Phase 1/2 trial evaluating intratumoral administration of INT230-6 alone and in combination with an anti-PD1 antibody for advanced malignancies.

Presenter: Yada Kanjanapan, MBBS
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Clinical Trial Registry Number: NCT03058289
Date/Time: June 4, 2018, 8:00 AM-11:30 AM
Location: Hall A; Poster Board Number: 428b

About INT230-6
INT230-6 is a novel, anti-cancer drug for direct intratumoral injection. The product contains potent anti-cancer agents that disperse throughout tumors and diffuse into cancer cells. INT230-6 was identified from Intensity’s DfuseRxSM platform and is being evaluated in a clinical trial; IT 01. In preclinical studies INT230-6 administration eradicated tumors by a combination of direct tumor kill coupled with recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models the drug has shown strong synergy with checkpoint blockage including anti-PD-1 and anti-CTLA4 antibodies.

About Study IT-01
IT-01 is entitled A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers. The trial aims to enroll approximately 60 patients with different types advanced solid tumor malignancies in a multicycle dosing regimen. The study is currently recruiting in the U.S. and Canada with plans to open additional sites in multiple countries. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6 with or without an anti-PD-1 or other checkpoint blockade antibodies. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The trial includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in subjects receiving INT230-6. Further information can be found at www.clinicaltrials.gov (NCT#03058289).

On May 31, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will participate in the following upcoming investor conferences (Press release, Karyopharm, MAY 31, 2018, View Source [SID1234526996]):

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The Jefferies 2018 Global Healthcare Conference on Thursday, June 7, 2018 at 8:30 a.m. ET.

The JMP Securities 2018 Life Sciences Conference on Wednesday, June 20, 2018 at 8:00 a.m. ET.
A live webcast of each of these events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of each webcast will be archived on the Company’s website for 90 days following the presentation.