On March 22, 2018-Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, reported that it will present at the 25th BioCentury Future Leaders conference at the Millennium Broadway Hotel & Conference Center in New York City (Press release, , 22 22, 2018, View Source [SID1234524954]). Chief Executive Officer and President, Paul Lammers, M.D., M.Sc. will be presenting on March 23 from 8:45-9:00am ET in Presentation Room 508.

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President & CEO of Triumvira Immunologics, Paul Lammers will be presenting at BioCentury’s Future Leaders conference in New York on March 23

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Dr. Lammers will provide an overview of Triumvira and the improvements the company is making over current therapies with its novel immuno-oncology platform T Cell-Antigen Coupler (TAC). Dr. Lammers will also be giving updates on Triumvira’s lead drug, CD19 TAC#921, which is targeted to enter clinical development in Q1 2019 – Phase 1/2 in patients with relapsing/refractory diffuse large B-cell lymphoma (DLBCL).

The Future Leaders conference offers Wall Street and pharma executives the opportunity to assess private and public companies with healthy financial profiles, poised to deliver on milestones that could lead to the next tier of valuations.

On March 22, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company") reported the initiation of patient dosing in the new cohort of the TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase 1 clinical trial (Press release, Immutep, MAR 22, 2018, View Source [SID1234524958]). This clinical study is evaluating the combination of Immutep’s lead immunotherapy product candidate eftilagimod alpha ("efti" or "IMP321") with pembrolizumab (KEYTRUDA) in unresectable or metastatic melanoma patients in Australia.

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The additional cohort consists of six patients that will receive 30 mg of efti in combination with pembrolizumab starting at cycle one of pembrolizumab. Patients will be treated for up to 12 months. Yesterday the first patient in this cohort received their first dose of the two drugs. Safety assessment is the main objective of this study.

"This additional cohort of the ongoing TACTI-mel clinical trial is very important to the clinical development of efti, especially in the light of our new collaboration study announced on 12th of March 2018, as we are now dosing efti at cycle one in combination with KEYTRUDA with the highest dose and for a 12-month duration," said Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer. "We look forward to presenting additional data from the TACTI-mel study during the middle of this calendar year as we hope it will further support our hypothesis that combining an antigen-presenting cell activator (efti) with a checkpoint inhibitor (KEYTRUDA) results in a therapeutic synergy and a potential benefit over checkpoint inhibitor monotherapy."

About TACTI-mel

The ongoing TACTI-mel Phase I clinical trial is a multi-centre, open-label, dosing escalating (1, 6 or 30 mg of efti) study evaluating the combination of efti with pembrolizumab (for 6 months, starting at cycle 5) in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pemobrolizumab monotherapy. Each cohort of the study is comprised of six patients. As previously reported in December 2017, the last patient of the third cohort (30 mg) has been dosed, bringing the total number of patients recruited and dosed in the trial to 18. Preliminary data from the 1 and 6 mg cohorts were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2017 Annual Meeting in November 2017. As reported at SITC (Free SITC Whitepaper), anti-tumour activity (tumour reduction) was observed in 7/12 patients (58%) in the first two cohorts of the study. Prior to treatment with efti, all of these patients had either a suboptimal response or had disease progression when treated with pembrolizumab monotherapy. The TACTI-mel trial was expanded with the addition of a new cohort in February 2018.

About Eftilagimod Alpha

Eftilagimod alpha ("efti" or "IMP321"), a LAG-3Ig fusion protein, is a MHC class II agonist that activates antigen-presenting cells ("APCs") such as dendritic cells and monocytes (primary target cells) and then CD8 T-cells (secondary target cells). The activation of the dendritic cell network and the subsequent T cell recruitment at the tumour site with efti may lead to stronger anti-tumor CD8 T cell responses than observed

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with checkpoint inhibitor monotherapy, as in the case of the TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial (clinicaltrials.gov identifier NCT02676869). In combination with chemotherapy, the activation of the APC network with efti the day after injection of a single agent chemotherapy may lead to stronger cytotoxic cellular responses associated with an improved long-term Th1 (IFN-g) immune status, both parameters being essential for a potent immune response against the tumour, as in the case of the AIPAC (Active Immunotherapy PAClitaxel) Phase IIb clinical trial (clinicaltrials.gov identifier NCT02614833).

On March 22, 2018 ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the year ended December 31, 2017 (Press release, Arca biopharma, MAR 22, 2018, View Source [SID1234525078]).

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"During 2017, we continued to make progress on our lead development program as we completed the GENETIC-AF clinical trial evaluating Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "We reported top-line Phase 2B results for the GENETIC-AF clinical trial in February 2018 and are requesting a meeting with the U.S. FDA for the second quarter of 2018 to review the data and future development plans."

2017 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $11.8 million as of December 31, 2017, compared to $23.5 million as of December 31, 2016. The Company raised net proceeds of approximately $3.4 million in January 2018 from sales of its common stock under its "at-the-market" offering facility. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of 2018.

Research and development (R&D) expenses for the year ended December 31, 2017 totaled $14.1 million compared to $12.3 million for 2016. The $1.7 million increase in research and development expenses in 2017 as compared to 2016 was primarily due to increased expenses for the GENETIC-AF clinical trial. The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

General and administrative (G&A) expenses for the year ended December 31, 2017 were $4.6 million compared to $4.3 million in 2016. ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

Total operating expenses for the year ended December 31, 2017 were $18.7 million compared to $16.6 million in 2016. The increase in total operating expenses for 2017 was primarily due to the increase in R&D expense due to the increased expense of the GENETIC-AF clinical trial.

Net loss was $18.5 million, or $1.77 per share, for 2017 compared to $16.4 million, or $1.81 per share, for 2016.

Caladrius Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Caladrius Biosciences, 2018, MAR 22, 2018, View Source [SID1234524943]).

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On March 22, 2018 Celyad Reported 2017 Financial and OperatingResults and Expected Key Milestones for 2018 (Press release, Celyad, MAR 22, 2018, View Source(3).pdf [SID1234532496]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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